Sudogest PE

Generic Name: phenylephrine (FEN il EFF rin)

Brand Names: Ah-Chew D, Dimetapp Cold Drops, Lusonal, Nasop, Nasop12, PediaCare Children's Decongestant, Phenyl-T, Sudafed PE, Sudafed PE Children's Nasal Decongestant, Sudafed PE Quick Dissolve, Sudogest PE, Triaminic Thin Strips Cold

What is Sudogest PE (phenylephrine)?

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Phenylephrine is used to treat nasal congestion and sinus pressure caused by allergies, the common cold, or the flu. Phenylephrine may be used to treat congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

Phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Sudogest PE (phenylephrine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

You should not use this medication if you are allergic to phenylephrine.

Do not use phenylephrine if you have used linezolid (Zyvox) or procarbazine (Matulane), or if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you take phenylephrine before these other drugs have cleared from your body.

Before you take phenylephrine, tell your doctor if you are allergic to any decongestants, or if you have heart disease, heart rhythm disorder, high blood pressure, circulation problems, diabetes, glaucoma, a thyroid disorder, kidney disease, an enlarged prostate or urination problems, anxiety, sleep problems, bipolar disorder or other mental illness.

Phenylephrine may interact with heart or blood pressure medications, antidepressants, diabetes medications, migraine headache medications, and other decongestants.

Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using phenylephrine, or if they get worse and your also have a fever.

What should I discuss with my healthcare provider before taking Sudogest PE (phenylephrine)?

You should not use this medication if you are allergic to phenylephrine.

Do not use phenylephrine if you have used linezolid (Zyvox) or procarbazine (Matulane), or if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you take phenylephrine before these other drugs have cleared from your body.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take phenylephrine, tell your doctor if you are allergic to any decongestants, or if you have:

• 
  

  heart disease, heart rhythm disorder;

  
  


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  high blood pressure;

  
  


• 
  

  circulation problems (such as Raynaud's syndrome);

  
  


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  diabetes;

  
  


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  glaucoma;

  
  


• 
  

  a thyroid disorder;

  
  


• kidney disease;


• 
  

  an enlarged prostate or urination problems;

  
  


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  sleep problems, anxiety; or

  
  


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  mental illness such as bipolar disorder.

  
  

FDA pregnancy category C. Is not known whether this medication will harm an unborn baby. Before you take phenylephrine, tell doctor if you are pregnant. Phenylephrine may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

Disintegrating and liquid forms of cold medicine may contain sugar or artificial sweeteners (phenylalanine). This would be important to know if you have diabetes or phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about sugar or phenylalanine.

How should I use Sudogest PE (phenylephrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. You may take phenylephrine with food if it upsets your stomach. Take the phenylephrine tablet with a full glass of water.

Measure the liquid form of phenylephrine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The chewable phenylephrine tablet must be chewed thoroughly before you swallow it.

To use the phenylephrine disintegrating strip, place one strip on your tongue and allow it to dissolve without chewing.

To use the disintegrating tablet, make sure your hands are dry and peel back the foil from the blister package. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Phenylephrine is usually taken every 4 hours. Follow the directions on the medicine label. Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using phenylephrine, or if they get worse and your also have a fever.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store phenylephrine at room temperature away from moisture and heat. Keep the disintegrating tablets or strips in their package until you are ready to take one.

Throw away any unused phenylephrine after the expiration date on the label has passed. Do not flush this medication down a toilet. Ask your pharmacist about the safest way to dispose of unused medicines.

What happens if I miss a dose?

Cold medicine is usually taken only as needed, so you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, severe dizziness, sweating, vomiting, hallucinations, fast or uneven heart rate, fainting, seizure (convulsions), and weak or shallow breathing.

What should I avoid while using Sudogest PE (phenylephrine)?

Do not use any other over-the-counter cold, allergy, or cough medication without first asking your doctor or pharmacist. Phenylephrine is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much phenylephrine. Read the label of any other medicine you are using to see if it contains phenylephrine or another decongestant.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Avoid smoking. It can add to the effects of phenylephrine in decreasing blood flow, which can lead to uncomfortable symptoms. Avoid drinking alcohol while you are taking phenylephrine.

Sudogest PE (phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using phenylephrine and call your doctor at once if you have a serious side effect such as:

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  severe dizziness, restless feeling, nervousness, or insomnia;

  
  


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  unusual thoughts or behavior;

  
  


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  feeling like you might pass out;

  
  


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  fast, pounding, or uneven heartbeat;

  
  


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  tremors or shaking;

  
  


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  numbness, tingling, or cold feeling in your hands or feet; or

  
  


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  urinating less than usual or not at all.

  
  

Less serious side effects may include:

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  headache, dizziness;

  
  


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  feeling excited or restless (especially in children);

  
  


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  upset stomach; or

  
  


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  mild sleep problems.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sudogest PE (phenylephrine)?

Tell your doctor about all other medications you use, especially:

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  other decongestants, including nasal sprays;

  
  


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  digoxin (digitalis, Lanoxin);

  
  


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  medicine to treat diabetes;

  
  


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  medicines to treat high blood pressure such as reserpine, methyldopa (Aldomet), and others;

  
  


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  migraine headache medicine such as ergotamine (Ergomar), naratriptan (Amerge), sumatriptan (Imitrex) or zolmitriptan (Zomig);

  
  


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  an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal), sotalol (Betapace), and others; or

  
  


• 
  

  a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others.

  
  

This list is not complete and there may be other drugs that can interact with phenylephrine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Sudogest PE resources

• Sudogest PE Side Effects (in more detail)
• Sudogest PE Use in Pregnancy & Breastfeeding
• Sudogest PE Drug Interactions
• Sudogest PE Support Group
• 0 Reviews for Sudogest PE - Add your own review/rating

• AH-Chew D Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Lusonal Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Nasop Dissolving Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neo-Synephrine Nasal Advanced Consumer (Micromedex) - Includes Dosage Information


• Neo-Synephrine MedFacts Consumer Leaflet (Wolters Kluwer)


• Phenylephrine Hydrochloride Monograph (AHFS DI)


• Sudafed PE MedFacts Consumer Leaflet (Wolters Kluwer)


• Sudafed PE Consumer Overview

Compare Sudogest PE with other medications

• Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about phenylephrine.

See also: Sudogest PE side effects (in more detail)

Nitro-Time Controlled-Release Capsules

Pronunciation: NYE-troe-GLIS-er-in
Generic Name: Nitroglycerin
Brand Name: Nitro-Time

Nitro-Time Controlled-Release Capsules are used for:

Preventing chronic chest pain caused by heart disease. It also may be used for other conditions as determined by your doctor.

Nitro-Time Controlled-Release Capsules are a nitrate. It works by relaxing (widening) blood vessels. Chest pain occurs when the heart needs more oxygen than it can get. Relaxing blood vessels allows blood to flow more easily. This reduces the heart's workload and the amount of oxygen needed by the heart.

Do NOT use Nitro-Time Controlled-Release Capsules if:

• you are allergic to any ingredient in Nitro-Time Controlled-Release Capsules


• you have increased pressure in or severe injury to the head


• you have severe anemia


• you are taking a phosphodiesterase type 5 inhibitor (eg, sildenafil, tadalafil, vardenafil)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nitro-Time Controlled-Release Capsules:

Some medical conditions may interact with Nitro-Time Controlled-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you drink alcoholic beverages


• if you have a history of other heart problems (eg, heart failure, enlarged heart, heart attack), overactive thyroid, stroke or other bleeding in the brain, or recent head injury


• if you have anemia, low blood pressure, dehydration, or low blood volume

Some MEDICINES MAY INTERACT with Nitro-Time Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), calcium channel blockers (eg, diltiazem), diuretics (eg, furosemide, hydrochlorothiazide), medicines for high blood pressure, phenothiazines (eg, thioridazine), or phosphodiesterase type 5 inhibitors (eg, sildenafil) because the risk of low blood pressure and dizziness on standing may be increased


• Salicylates (eg, aspirin) because they may increase the risk of Nitro-Time Controlled-Release Capsules's side effects


• Alteplase because the effectiveness of Nitro-Time Controlled-Release Capsules may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nitro-Time Controlled-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nitro-Time Controlled-Release Capsules:

Use Nitro-Time Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Nitro-Time Controlled-Release Capsules by mouth with or without food.


• Swallow Nitro-Time Controlled-Release Capsules whole. Do not break, crush, or chew before swallowing.


• Nitro-Time Controlled-Release Capsules lasts for about 12 hours. Do not take more of Nitro-Time Controlled-Release Capsules than prescribed. It is important to have a "nitrate-free" period of time for 10 to 12 hours each day for Nitro-Time Controlled-Release Capsules to continue to work well and to decrease the risk of physical dependence.


• If you miss a dose of Nitro-Time Controlled-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Nitro-Time Controlled-Release Capsules.

Important safety information:

• Nitro-Time Controlled-Release Capsules may cause dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Nitro-Time Controlled-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you drink alcohol while you are taking Nitro-Time Controlled-Release Capsules. Drinking alcohol may increase the risk of low blood pressure with Nitro-Time Controlled-Release Capsules.


• Nitro-Time Controlled-Release Capsules may cause dizziness, lightheadedness, or fainting. Sit down while taking Nitro-Time Controlled-Release Capsules to avoid falling caused by lightheadedness or dizziness.


• Contact your doctor right away if you develop slow heartbeat or new or worsening chest pain after you take Nitro-Time Controlled-Release Capsules.


• Tell your doctor or dentist that you take Nitro-Time Controlled-Release Capsules before you receive any medical or dental care, emergency care, or surgery.


• Nitro-Time Controlled-Release Capsules may give you daily headaches. This should become less noticeable with time.


• Other dosage forms of Nitro-Time Controlled-Release Capsules (eg, sublingual, or under the tongue, tablets) may not work as well while you are taking Nitro-Time Controlled-Release Capsules.


• Nitro-Time Controlled-Release Capsules takes about 1 to 2 hours to start working and should not be used for a sudden chest pain attack.


• Lab tests, including heart function, blood pressure, and blood electrolyte levels, may be performed while you use Nitro-Time Controlled-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Nitro-Time Controlled-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.


• Nitro-Time Controlled-Release Capsules are not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nitro-Time Controlled-Release Capsules while you are pregnant. It is not known if Nitro-Time Controlled-Release Capsules are found in breast milk. If you are or will be breast-feeding while you are using Nitro-Time Controlled-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time without a break, Nitro-Time Controlled-Release Capsules may not work as well. This is known as TOLERANCE. Increasing the dose is not effective in managing tolerance to Nitro-Time Controlled-Release Capsules. Tolerance to other nitrates or nitrites may also occur. Be sure to have a "nitrate-free" period of time each day to help prevent this tolerance. Talk with your doctor if Nitro-Time Controlled-Release Capsules stops working well. Do not take more than prescribed.

Some people who use Nitro-Time Controlled-Release Capsules for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. If you use Nitro-Time Controlled-Release Capsules without a break and then suddenly stop using it, you may get WITHDRAWAL symptoms. These may include chest pain, heart attack, or possibly sudden death. Be sure to have a "nitrate-free" period of time each day; this may help prevent dependence and withdrawal problems.

Possible side effects of Nitro-Time Controlled-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness, lightheadedness, or fainting when sitting up or standing; flushing of face and neck; headache; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dry mouth; fainting; flushing; heavy sweating; irregular heartbeat; new or worsening chest pain; pale skin; pounding in the chest; rapid heartbeat; severe dizziness or headache; severe or persistent nausea or vomiting; shortness of breath; slow heartbeat; swelling of the hands, ankles, or feet; unusual weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Nitro-Time side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold or blue skin; confusion; diarrhea; excessive sweating; fainting; fast, slow, or irregular heartbeat; persistent throbbing headache; seizures; trouble breathing; vision problems.

Proper storage of Nitro-Time Controlled-Release Capsules:

Store Nitro-Time Controlled-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nitro-Time Controlled-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Nitro-Time Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Nitro-Time Controlled-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Nitro-Time Controlled-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Nitro-Time resources

• Nitro-Time Side Effects (in more detail)
• Nitro-Time Use in Pregnancy & Breastfeeding
• Nitro-Time Drug Interactions
• Nitro-Time Support Group
• 0 Reviews for Nitro-Time - Add your own review/rating

Compare Nitro-Time with other medications

• Angina
• Angina Pectoris Prophylaxis
• Heart Attack
• Heart Failure
• High Blood Pressure

Carbetapentane/Carbinoxamine/Phenylephrine Drops

Pronunciation: car-beta-PEN-tane/kar-bi-NOX-a-meen/fen-ill-EF-rin
Generic Name: Carbetapentane/Carbinoxamine/Phenylephrine
Brand Name: Aridex

Carbetapentane/Carbinoxamine/Phenylephrine Drops are used for:

Relieving symptoms (eg, sinus congestion, runny nose, sneezing, cough) due to colds, allergies, hay fever, sinus congestion, flu, bronchitis, and other respiratory illnesses. It may also be used for other conditions as determined by your doctor.

Carbetapentane/Carbinoxamine/Phenylephrine Drops are a cough suppressant, antihistamine, and decongestant combination. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant works by narrowing blood vessels and reducing swelling in the nasal passages.

Do NOT use Carbetapentane/Carbinoxamine/Phenylephrine Drops if:

• you are allergic to any ingredient in Carbetapentane/Carbinoxamine/Phenylephrine Drops


• you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems


• you are taking sodium oxybate (GHB) or droxidopa, or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Carbetapentane/Carbinoxamine/Phenylephrine Drops:

Some medical conditions may interact with Carbetapentane/Carbinoxamine/Phenylephrine Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems (eg, slow or irregular heartbeat); blood vessel problems; high blood pressure; diabetes; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; an overactive thyroid; trouble sleeping; or increased pressure in the eye


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Carbetapentane/Carbinoxamine/Phenylephrine Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Carbetapentane/Carbinoxamine/Phenylephrine Drops's side effects


• Benzodiazepines (eg, diazepam), bromocriptine, hydantoins (eg, phenytoin), or sodium oxybate (GHB) because the risk of their side effects may be increased by Carbetapentane/Carbinoxamine/Phenylephrine Drops


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Carbetapentane/Carbinoxamine/Phenylephrine Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Carbetapentane/Carbinoxamine/Phenylephrine Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Carbetapentane/Carbinoxamine/Phenylephrine Drops:

Use Carbetapentane/Carbinoxamine/Phenylephrine Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Carbetapentane/Carbinoxamine/Phenylephrine Drops may be taken with or without food.


• Use the dropper that comes with Carbetapentane/Carbinoxamine/Phenylephrine Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Carbetapentane/Carbinoxamine/Phenylephrine Drops, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Carbetapentane/Carbinoxamine/Phenylephrine Drops.

Important safety information:

• Carbetapentane/Carbinoxamine/Phenylephrine Drops may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Carbetapentane/Carbinoxamine/Phenylephrine Drops. Using Carbetapentane/Carbinoxamine/Phenylephrine Drops alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Carbetapentane/Carbinoxamine/Phenylephrine Drops. Carbetapentane/Carbinoxamine/Phenylephrine Drops will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• Do not use Carbetapentane/Carbinoxamine/Phenylephrine Drops for persistent or chronic cough, such as a cough that occurs with smoking, asthma, or emphysema, or if the cough is accompanied by excessive mucus, unless directed by your doctor.


• Do not take diet or appetite control medicines while you are taking Carbetapentane/Carbinoxamine/Phenylephrine Drops without checking with your doctor.


• Carbetapentane/Carbinoxamine/Phenylephrine Drops contains phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Carbetapentane/Carbinoxamine/Phenylephrine Drops for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• Carbetapentane/Carbinoxamine/Phenylephrine Drops may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Carbetapentane/Carbinoxamine/Phenylephrine Drops. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• If you are scheduled for allergy skin testing, do not take Carbetapentane/Carbinoxamine/Phenylephrine Drops for several days before the test because it may decrease your response to the skin tests.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Carbetapentane/Carbinoxamine/Phenylephrine Drops.


• Use Carbetapentane/Carbinoxamine/Phenylephrine Drops with caution in the ELDERLY because they may be more sensitive to its effects, especially confusion, seizures, hallucinations, or stroke.


• Caution is advised when using Carbetapentane/Carbinoxamine/Phenylephrine Drops in CHILDREN because they may be more sensitive to its effects.


• Use Carbetapentane/Carbinoxamine/Phenylephrine Drops with extreme caution in CHILDREN younger than 3 months of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not take Carbetapentane/Carbinoxamine/Phenylephrine Drops if you are pregnant. If you think you may be pregnant, contact your doctor immediately. It is unknown if Carbetapentane/Carbinoxamine/Phenylephrine Drops are excreted in breast milk. Do not breast-feed while taking Carbetapentane/Carbinoxamine/Phenylephrine Drops.

Possible side effects of Carbetapentane/Carbinoxamine/Phenylephrine Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth; excitability; headache; loss of appetite; nausea; nervousness or anxiety; restlessness; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes; overexcitement; pale skin; seizures; severe dizziness, lightheadedness, headache, or restlessness; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Carbetapentane/Carbinoxamine/Phenylephrine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include confusion; difficulty urinating; fast, slow, or irregular heartbeat; flushing; increased reflexes; one-sided weakness; severe or persistent diarrhea, dizziness, headache, irritability, restlessness, or trouble sleeping; stomach cramps; tremor; vision or speech changes.

Proper storage of Carbetapentane/Carbinoxamine/Phenylephrine Drops:

Store Carbetapentane/Carbinoxamine/Phenylephrine Drops at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Carbetapentane/Carbinoxamine/Phenylephrine Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Carbetapentane/Carbinoxamine/Phenylephrine Drops, please talk with your doctor, pharmacist, or other health care provider.


• Carbetapentane/Carbinoxamine/Phenylephrine Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Carbetapentane/Carbinoxamine/Phenylephrine Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Carbetapentane/Carbinoxamine/Phenylephrine resources

• Carbetapentane/Carbinoxamine/Phenylephrine Side Effects (in more detail)
• Carbetapentane/Carbinoxamine/Phenylephrine Use in Pregnancy & Breastfeeding
• Carbetapentane/Carbinoxamine/Phenylephrine Drug Interactions
• Carbetapentane/Carbinoxamine/Phenylephrine Support Group
• 0 Reviews for Carbetapentane/Carbinoxamine/Phenylephrine - Add your own review/rating

Compare Carbetapentane/Carbinoxamine/Phenylephrine with other medications

• Nasal Congestion

Rifadin 300mg Capsules

1. Name Of The Medicinal Product

Rifadin 300mg Capsules

2. Qualitative And Quantitative Composition

Rifampicin Ph Eur 300 mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Capsule, hard.

The gelatine capsule is composed of two red halves.

4. Clinical Particulars

4.1 Therapeutic Indications

Indications for use

Tuberculosis: In combination with other active anti-tuberculosis drugs in the treatment of all forms of tuberculosis, including fresh, advanced, chronic and drug-resistant cases. Rifadin is also effective against most atypical strains of Mycobacteria.

Leprosy: In combination with at least one other active anti-leprosy drug in the management of multibacillary and paucibacillary leprosy to effect conversion of the infectious state to a non-infectious state.

Other Infections: In the treatment of Brucellosis, Legionnaires Disease, and serious staphylococcal infections. To prevent emergence of resistant strains of the infecting organisms, Rifadin should be used in combination with another antibiotic appropriate for the infection.

Prophylaxis of meningococcal meningitis: For the treatment of asymptomatic carriers of N. meningitidis to eliminate meningococci from the nasopharynx.

Haemophilus influenzae: For the treatment of asymptomatic carriers of H.influenzae and as chemoprophylaxis of exposed children, 4 years of age or younger.

4.2 Posology And Method Of Administration

Recommended Dosage

For oral administration

The daily dose of Rifadin, calculated from the patient's body weight, should preferably be taken at least 30 minutes before a meal or 2 hours after a meal to ensure rapid and complete absorption.

Tuberculosis:

Rifadin should be given with other effective anti-tuberculosis drugs to prevent the possible emergence of rifampicin-resistant strains of Mycobacteria.

Adults: The recommended single daily dose in tuberculosis is 8-12 mg/kg.

Usual Daily dose: Patients weighing less than 50 kg - 450 mg. Patients weighing 50 kg or more – 600 mg.

Children: In children, oral doses of 10-20 mg/kg body weight daily are recommended, although a total daily dose should not usually exceed 600 mg.

Leprosy:

600 mg doses of rifampicin should be given once per month. Alternatively, a daily regimen may be used. The recommended single daily dose is 10 mg/kg.

Usual daily dose: Patients weighing less than 50 kg - 450 mg. Patients weighing 50 kg or more – 600 mg.

In the treatment of leprosy, rifampicin should always be used in conjunction with at least one other antileprosy drug,

Brucellosis, Legionnaires Disease or serious staphylococcal infections

Adults: The recommended daily dose is 600-1200 mg given in 2 to 4 divided doses, together with another appropriate antibiotic to prevent the emergence of resistant strains of the infecting organisms.

Prophylaxis of meningococcal meningitis

Adults: 600 mg twice daily for 2 days.

Children (1 - 12 years): 10 mg/kg twice daily for 2 days.

Children (3 months - 1 year): 5 mg/kg twice daily for 2 days.

Prophylaxis of Haemophilus influenzae

Adults and children: For members of households exposed to H. influenzae B disease when the household contains a child 4 years of age or younger, it is recommended that all members (including the child) receive rifampicin 20 mg/kg once daily (maximum daily dose 600 mg) for 4 days.

Index cases should be treated prior to discharge from hospital.

Neonates (1 month): 10 mg/kg daily for 4 days.

Impaired liver function:

A daily dose of 8 mg/kg should not be exceeded in patients with impaired liver function.

Use in the elderly:

In elderly patients, the renal excretion of rifampicin is decreased proportionally with physiological decrease of renal function; due to compensatory increase of liver excretion, the terminal half-life in serum is similar to that of younger patients. However, as increased blood levels have been noted in one study of rifampicin in elderly patients, caution should be exercised in using rifampicin in such patients, especially if there is evidence of impaired liver function.

4.3 Contraindications

Rifadin is contra-indicated in patients who:

• are hypersensitive to any of the rifamycins or any of the excipients (see section 6.1);

• have jaundice;

• are concurrently receiving saquinavir/ritonavir therapy (see section 4.5 Interactions).

4.4 Special Warnings And Precautions For Use

Rifampicin should be given under the supervision of a respiratory or other suitably qualified physician.

Cautions should be taken in case of renal impairment if dose > 600 mg/day.

All tuberculosis patients should have pre-treatment measurements of liver function.

Patients with impaired liver function should only be given rifampicin in cases of necessity, and then with caution and under close medical supervision. In these patients, lower doses of rifampicin are recommended and careful monitoring of liver function, especially serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) should initially be carried out prior to therapy, weekly for two weeks, then every two weeks for the next six weeks. If signs of hepatocellular damage occur, rifampicin should be withdrawn.

Rifampicin should also be withdrawn if clinically significant changes in hepatic function occur. The need for other forms of antituberculosis therapy and a different regimen should be considered. Urgent advice should be obtained from a specialist in the management of tuberculosis. If rifampicin is re-introduced after liver function has returned to normal, liver function should be monitored daily.

In patients with impaired liver function, elderly patients, malnourished patients, and possibly, children under two years of age, caution is particularly recommended when instituting therapeutic regimens in which isoniazid is to be used concurrently with Rifadin. If the patient has no evidence of pre-existing liver disease and normal pre-treatment liver function, liver function tests need only be repeated if fever, vomiting, jaundice or other deterioration in the patient's condition occur.

Patients should be seen at least monthly during therapy and should be specifically questioned concerning symptoms associated with adverse reactions.

In some patients hyperbilirubinaemia can occur in the early days of treatment. This results from competition between rifampicin and bilirubin for hepatic excretion.

An isolated report showing a moderate rise in bilirubin and/or transaminase level is not in itself an indication for interrupting treatment; rather the decision should be made after repeating the tests, noting trends in the levels and considering them in conjunction with the patient's clinical condition.

Adults treated for tuberculosis with rifampicin should have baseline measurements of hepatic enzymes, bilirubin, serum creatinine, a complete blood count, and a platelet count (or estimate).

Baseline tests are unnecessary in children unless a complicating condition is known or clinically suspected.

Because of the possibility of immunological reaction including anaphylaxis (see section 4.8 Undesirable effects) occurring with intermittent therapy (less than 2 to 3 times per week) patients should be closely monitored. Patients should be cautioned against interrupting treatment.

Rifampicin has enzyme induction properties that can enhance the metabolism of endogenous substrates including adrenal hormones, thyroid hormones and vitamin D. Isolated reports have associated porphyria exacerbation with rifampicin administration.

Rifadin capsules may produce a reddish coloration of the urine, sweat, sputum and tears, and the patient should be forewarned of this. Soft contact lenses have been permanently stained.

All patients with abnormalities should have follow up examinations, including laboratory testing, if necessary.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Cytochrome P-450 enzyme interaction

Rifampicin is a potent inducer of certain cytochrome P-450 enzymes. Coadministration of rifampicin with other drugs that are also metabolised through these cytochrome P-450 enzymes may accelerate the metabolism and reduce the activity of these other drugs. Therefore, caution should be used when prescribing rifampicin with drugs metabolised by cytochrome P-450. To maintain optimum therapeutic blood levels, dosages of drugs metabolised by these enzymes may require adjustment when starting or stopping concomitantly administered rifampicin.

Examples of drugs metabolised by cytochrome P-450 enzymes are:

• Antiarrhythmics (e.g. disopyramide, mexiletine, quinidine, propafenone, tocainide),

• Antiepileptics (e.g. phenytoin),

• Hormone antagonist (antiestrogens e.g. tamoxifen, toremifene, gestinone),

• Antipsychotics (e.g. haloperidol, aripiprazole),

• Anticoagulants (e.g. coumarins),

• Antifungals (e.g. fluconazole, itraconazole, ketoconazole, voriconazole),

• Antivirals (e.g. saquinavir, indinavir, efavirenz, amprenavir, nelfinavir, atazanavir, lopinavir, nevirapine),

• Barbiturates

• Beta-blockers (e.g. bisoprolol, propanolol),

• Anxiolytics and hypnotics (e.g. diazepam, benzodiazepines, zolpicolone, zolpidem),

• Calcium channel blockers (e.g. diltiazem, nifedipine, verapamil, nimodipine, isradipine, nicardipine, nisoldipine),

• Antibacterials (e.g. chloramphenicol, clarithromycin, dapsone, doxycycline, fluoroquinolones, telithromycin),

• Corticosteroids

• Cardiac glycosides (digitoxin, digoxin),

• Clofibrate,

• Systemic hormonal contraceptives

• Oestrogen,

• Antidiabetic (e.g. chlorpropamide, tolbutamide, sulfonylureas, rosiglitazone),

• Immunosuppressive agents (e.g. ciclosporin, sirolimus, tacrolimus)

• Irinotecan,

• Thyroid hormone (e.g. levothyroxine),

• Losartan,

• Analgestics (e.g. methadone, narcotic analgesics),

• Praziquantel,

• Progestogens,

• Quinine,

• Riluzole,

• Selective 5-HT3 receptor antagonists (e.g. ondansetron)

• Statins metabolised by CYP 3A4 (e.g. simvastatin),

• Theophylline,

• Tricyclic antidepressants (e.g. amitriptyline, nortriptyline),

• Cytotoxics (e.g. imatinib),

• Diuretics (e.g. eplerenone)

Patients on oral contraceptives should be advised to use alternative, non-hormonal methods of birth control during Rifadin therapy. Also diabetes may become more difficult to control.

Other Interactions

When rifampicin is given concomitantly with the combination saquinavir/ritonavir, the potential for hepatotoxicity is increased. Therefore, concomitant use of Rifadin with saquinvir/ritonavir is contraindicated (see section 4.3 Contraindications).

When the two drugs were taken concomitantly, decreased concentrations of atovaquone and increased concentrations of rifampicin were observed.

Concurrent use of ketoconazole and rifampicin has resulted in decreased serum concentrations of both drugs.

Concurrent use of rifampicin and enalapril has resulted in decreased concentrations of enalaprilat, the active metabolite of enalapril. Dosage adjustments should be made if indicated by the patient's clinical condition.

Concomitant antacid administration may reduce the absorption of rifampicin. Daily doses of rifampicin should be given at least 1 hour before the ingestion of antacids.

When rifampicin is given concomitantly with either halothane or isoniazid, the potential for hepatotoxicity is increased. The concomitant use of rifampicin andhalothane should be avoided. Patients receiving both rifampicin and isoniazid should be monitored closely for hepatotoxicity.

If p-aminosalicylic acid and rifampicin are both included in the treatment regimen, they should be given not less than eight hours apart to ensure satisfactory blood levels.

Interference with laboratory and diagnostic tests

Therapeutic levels of rifampicin have been shown to inhibit standard microbiological assays for serum folate and Vitamin B12. Thus alternative assay methods should be considered. Transient elevation of BSP and serum bilirubin has been reported. Rifampicin may impair biliary excretion of contrast media used for visualization of the gallbladder, due to competition for biliary excretion. Therefore, these tests should be performed before the morning dose of rifampicin.

4.6 Pregnancy And Lactation

Pregnancy

At very high doses in animals rifampicin has been shown to have teratogenic effects. There are no well controlled studies with rifampicin in pregnant women. Although rifampicin has been reported to cross the placental barrier and appear in cord blood, the effect of rifampicin, alone or in combination with other antituberculosis drugs, on the human foetus is not known. Therefore, Rifadin should be used in pregnant women or in women of child bearing potential only if the potential benefit justifies the potential risk to the foetus. When Rifadin is administered during the last few weeks of pregnancy it may cause post-natal haemorrhages in the mother and infant for which treatment with Vitamin K1 may be indicated.

Lactation

Rifampicin is excreted in breast milk, patients receiving rifampicin should not breast feed unless in the physician's judgement the potential benefit to the patient outweighs the potential risk to the infant.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable Effects

Reactions occurring with either daily or intermittent dosage regimens include:

Cutaneous reactions which are mild and self-limiting and do not appear to be hypersensitivity reactions. Typically they consist of flushing and itching with or without a rash. Urticaria and more serious hypersensitivity cutaneous reactions have occurred but are uncommon. Exfoliate dermatitis, pemphigoid reaction, erythema multiforme including Stevens-Johnson syndrome, Lyells syndrome and vasculitis have been reported rarely.

Gastrointestinal reactions consist of anorexia, nausea, vomiting, abdominal discomfort, and diarrhoea. Pseudomembranous colitis has been reported with rifampicin therapy.

Hepatitis can be caused by rifampicin and liver function tests should be monitored (see section 4.4. Special warnings and precautions for use).

Central Nervous System: Psychoses have been rarely reported.

Thrombocytopenia with or without purpura may occur, usually associated with intermittent therapy, but is reversible if drug is discontinued as soon as purpura occurs. Cerebral haemorrhage and fatalities have been reported when rifampicin administration has been continued or resumed after the appearance of purpura.

Disseminated intravascular coagulation has also been rarely reported.

Eosinophilia, leucopenia, oedema, muscle weakness and myopathy have been reported to occur in a small percentage of patients treated with rifampicin.

Agranulocytosis has been reported very rarely reported.

Rare reports of adrenal insufficiency in patients with compromised adrenal function have been observed.

Reactions usually occurring with intermittent dosage regimens and probably of immunological origin include:

- 'Flu Syndrome' consisting of episodes of fever, chills, headache, dizziness, and bone pain appearing most commonly during the 3rd to the 6th monthly of therapy. The frequency of the syndrome varies but may occur in up to 50 % of patients given once-weekly regimens with a dose of rifampicin of 25 mg/kg or more.

- Shortness of breath and wheezing.

- Decrease in blood pressure and shock.

- Anaphylaxis.

- Acute haemolytic anaemia.

- Acute renal failure usually due to acute tubular necrosis or acute interstitial nephritis.

If serious complications arise, e.g. renal failure, thrombocytopenia or haemolytic anaemia, rifampicin should be stopped and never restarted.

Occasional disturbances of the menstrual cycle have been reported in women receiving long-term anti-tuberculosis therapy with regimens containing rifampicin.

Rifampicin may produce a reddish colouration of the urine, sweat, sputum and tears. The patient should be forewarned of this. Soft contact lenses may be permanently stained.

4.9 Overdose

Human Experience

• Signs and Symptoms:

Nausea, vomiting, abdominal pain, pruritus, headache and increasing lethargy will probably occur within a short time after acute ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur. Brownish-red or orange colouration of the skin, urine, sweat, saliva, tears and faeces will occur, and its intensity is proportional to the amount ingested. Facial or periorbital oedema has also been reported in paediatric patients. Hypotension, sinus tachycardia, ventricular arrhythmias, seizures and cardiac arrest were reported in some fatal cases.

The minimum acute lethal or toxic dose is not well established. However, nonfatal acute overdoses in adults have been reported with doses ranging from 9 to 12 g rifampicin. Fatal acute overdoses in adults have been reported with doses ranging from 14-60 g. Alcohol or a history of alcohol abuse was involved in some of the fatal and nonfatal reports.

Nonfatal overdoses in paediatric patients ages 1 to 4 years old of 100 mg/kg for one to two doses have been reported.

• Management:

Intensive supportive measures should be instituted and individual symptoms treated as they arise. Since nausea and vomiting are likely to be present, gastric lavage is probably preferable to induction of emesis. Following evacuation of the gastric contents, the instillation of activated charcoal slurry into the stomach may help absorb any remaining drug from the gastrointestinal tract. Antiemetic medication may be required to control severe nausea and vomiting. Active diuresis (with measured intake and output) will help promote excretion of the drug. Haemodialysis may be of value in some patients.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: J04AB02 Antimycobacterials, antibiotics.

Rifampicin is an active bactericidial antituberculosis drug which is particularly active against the rapidly growing extracellular organisms and also has bactericidial activity intracellularly. Rifampicin has activity against slow and intermittently-growing

M. Tuberculosis.

Rifampicin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme. Cross-resistance to rifampicin has only been shown with other rifamycins.

5.2 Pharmacokinetic Properties

Rifampicin is readily absorbed from the gastrointestinal tract. Peak serum concentrations of the order of 10 µg/ml occur about 2 to 4 hours after a dose of 10 mg/kg body weight on an empty stomach.

Absorption of rifampicin is reduced when the drug is ingested with food.

The pharmacokinetics (oral and intravenous) in children are similar to adults.

In normal subjects the biological half-life of rifampicin in serum averages about 3 hours after a 600 mg dose and increases to 5.1 hours after a 900 mg dose. With repeated administration, the half-life decreases and reaches average values of approximately 2-3 hours. At a dose of up to 600 mg/day, it does not differ in patients with renal failure and consequently, no dosage adjustment is required.

Rifampicin is rapidly eliminated in the bile and an enterophepatic circulation ensues. During this process, rifampicin undergoes progressive deacetylation, so that nearly all the drug in the bile is in this form in about 6 hours. This metabolite retains essentially complete antibacterial activity. Intestinal reabsorption is reduced by deacetylation and elimination is facilitated. Up to 30 % of a dose is excreted in the urine, with about half of this being unchanged drug.

Rifampicin is widely distributed throughout the body. It is present in effective concentrations in many organs and body fluids, including cerebrospinal fluid. Rifampicin is about 80 % protein bound. Most of the unbound fraction is not ionized and therefore is diffused freely in tissues.

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Corn starch	Ph Eur
Magnesium stearate	Ph Eur

6.2 Incompatibilities

None stated

6.3 Shelf Life

4 years from date of manufacture

6.4 Special Precautions For Storage

Store below 25°C.

Protect from light and moisture.

6.5 Nature And Contents Of Container

Blister packs of 100 capsules in cardboard cartons. Blister material is aluminium foil / PVDC (Aluminium 0.025 mm; PVDC 20 gsm) and transparent PVC / PVDC foil (PVC 0.25 mm; PVDC 60 gsm).

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8. Marketing Authorisation Number(S)

PL 04425/5916R

9. Date Of First Authorisation/Renewal Of The Authorisation

09/04/2005

10. Date Of Revision Of The Text

27 October 2011

LEGAL CATEGORY

POM

Gynodiol

Pronunciation: ES-tra-DYE-ol
Generic Name: Estradiol
Brand Name: Examples include Estrace and Gynodiol

Gynodiol should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Gynodiol. Talk with your doctor if you have questions about the benefits and risks of using Gynodiol.

Gynodiol should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Gynodiol.

Gynodiol is used for:

Treating conditions due to menopause (eg, hot flashes; vaginal itching, burning, or dryness), treating vulval or vaginal atrophy, and preventing osteoporosis (brittle bones). It is also used for estrogen replacement therapy after failure of the ovaries and to relieve the symptoms of breast cancer.

Treating advanced prostate cancer. It is also used to relieve symptoms of breast cancer.

Gynodiol is a female estrogen hormone. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.It works for advanced prostate cancer by antagonizing male hormones.

Do NOT use Gynodiol if:

• you are allergic to any ingredient in Gynodiol


• you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding, or have vaginal bleeding of abnormal or unknown cause


• you have known or suspected breast cancer (unless directed by your doctor) or you have cancers that are estrogen-dependent


• you have blood clots, vein inflammation, or liver disease


• you have had a recent stroke or heart attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Gynodiol:

Some medical conditions may interact with Gynodiol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a family history of breast cancer, or you have breast lumps or disease, or an abnormal mammogram


• if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)


• if you have a vaginal infection or womb problems (eg, uterine fibroids/endometriosis, abnormal vaginal bleeding, other uterine problems)


• if you have abnormal calcium levels in the blood, asthma, cancer, certain blood disorder (porphyria), cholesterol or lipid problems, depression, diabetes, epilepsy, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver disease, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures, or yellowing of the skin or eyes


• if you smoke or will be having surgery

Some MEDICINES MAY INTERACT with Gynodiol. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Blood thinners (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because their actions and the risk of their side effects may be increased by Gynodiol


• Blood thinners (eg, warfarin) because their effectiveness may be decreased by Gynodiol


• Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), or rifampin because they may decrease Gynodiol's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Gynodiol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Gynodiol:

Use Gynodiol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Gynodiol. Talk to your pharmacist if you have questions about this information.


• Take Gynodiol by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Grapefruit and grapefruit juice may increase the risk of Gynodiol's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Gynodiol.


• If you miss a dose of Gynodiol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Gynodiol.

Important safety information:

• Gynodiol may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Gynodiol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Limit alcoholic beverages while you are taking Gynodiol.


• Gynodiol may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.


• Gynodiol may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years of age).


• Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.


• Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while taking Gynodiol.


• Follow your doctor's instructions for examining your breasts and report any lumps immediately.


• Additional monitoring of your dose or condition may be necessary if you are presently taking an azole antifungal (eg, itraconazole), carbamazepine, a macrolide antibiotic (eg, erythromycin), ritonavir, cimetidine, or St. John's wort.


• If you wear contact lenses and you develop problems with them, contact your doctor.


• If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Gynodiol.


• Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.


• Some of these products may contain the dye tartrazine (FD&C Yellow No. 5), which can cause allergic reactions in certain patients. Consult your doctor or pharmacist. If you previously had allergic reactions to the dye tartrazine, contact your doctor or pharmacist to determine if the product you are taking contains the dye tartrazine.


• Gynodiol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Gynodiol.


• Diabetes patients - Gynodiol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including physical exams and blood pressure, may be performed while you use Gynodiol. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.


• Gynodiol should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Gynodiol if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Gynodiol may be found in breast milk. If you are or will be breast-feeding while you use Gynodiol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Gynodiol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast pain or tenderness; headache; hair loss; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain;breast discharge or lump in the breast; calf or leg pain or swelling; chest pain; coughing up blood; dark urine; depression; dizziness; fainting; fever; memory problems; mental or mood changes; muscle pain; one-sided weakness; painful or difficult urination; persistent or severe breast pain or tenderness; persistent or severe headache, nausea, or vomiting; severe stomach pain or swelling; slurred speech; sudden shortness of breath; sunburn-like rash; swelling of hands, legs, or feet; unusual vaginal bleeding, discharge, itching, or odor; vision changes; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Gynodiol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.

Proper storage of Gynodiol:

Store Gynodiol at room temperature, 59 to 86 degrees F (15 to 30 degrees C), in a tight, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Gynodiol out of the reach of children and away from pets.

General information:

• If you have any questions about Gynodiol, please talk with your doctor, pharmacist, or other health care provider.


• Gynodiol is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Gynodiol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Amitriptyline 25mg / 5ml Oral Solution (Rosemont Pharmaceuticals Ltd)

Amitriptyline Hydrochloride 25mg/5ml Oral Solution

• Read all of this leaflet carefully before you start taking this medicine.


• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or your pharmacist.


• This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

• 1. What is Amitriptyline 25mg/5ml Oral Solution and what is it used for


• 2. Before you take Amitriptyline 25mg/5ml Oral Solution


• 3. How to take Amitriptyline 25mg/5ml Oral Solution


• 4. Possible side effects


• 5. How to store Amitriptyline 25mg/5ml Oral Solution


• 6. Further information

What is Amitriptyline 25mg/5ml Oral Solution and what is it used for

The name of your medicine is Amitriptyline Hydrochloride 25mg/5ml Oral Solution. This belongs to a group of
medicines called tricyclic antidepressants.

Amitriptyline alters the levels of chemicals in your brain to relieve the symptoms of depression.

Amitriptyline can be used:

• to treat the symptoms of depression


• to treat bed-wetting at night by your child.

Before you take Amitriptyline 25mg/5ml Oral Solution

Do not take amitriptyline and tell your doctor if:

• you are allergic (hypersensitive) to amitriptyline or any other ingredients in this liquid (see section 6).
  An allergic reaction can include a rash, itching or shortness of breath


• you are pregnant, likely to become pregnant or breast-feeding


• you have heart problems including unusual heart beats, heart block or if you have recently had a heart
  attack


• you are taking other medicines to treat depression known as Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine or you have taken MAOIs within the last 14 days


• you suffer from periods of increased and exaggerated unusual behaviour (mania)


• you have liver disease


• you have a problem with your blood called porphyria.

If this medicine has been prescribed for a child under 6 years of age, tell your doctor as it may not be suitable for
them.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking
amitritpyline.

Take special care with amitriptyline

Before you take this medicine, tell your doctor if:

• you have epilepsy


• you are not able to pass water (urine) or you have an enlarged prostate gland


• you have increased pressure in your eye (known as narrow-angle glaucoma)


• you have thyroid problems or you are taking medicine to treat a thyroid problem


• you have a mental illness such as schizophrenia or manic depression


• you are having electroconvulsive therapy (ECT).

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking amitriptyline.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants. This is because these medicines all take about two weeks but sometimes longer to work properly.

You may be more likely to think like this if:

• you have previously had thoughts about killing or harming yourself.


• you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Having operations and tests

Tell your doctor or dentist that you are taking amitriptyline if you are going to have an anaesthetic for an
operation or dental treatment.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes
medicines bought without a prescription, including herbal medicines.

In particular tell your doctor if you are taking any of the following medicines:

• medicines to treat depression known as Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine or you have taken MAOIs within the last 14 days


• other medicines used to treat depression, including the herbal remedy St John’s Wort


• medicines used to lower high blood pressure such as guanethidine, debrisoquine, betanidine and clonidine


• medicines found in cough and cold remedies such as phenylephrine or phenylpropanolamine. Tell your pharmacist that you are taking amitriptyline before buying these medicines


• medicines to help you sleep such as ethchlorvynol


• barbiturates - used to treat epilepsy such as phenobarbital


• methylphenidate - used to treat attention deficit/hyperactivity disorder in children (ADHD)


• disulfiram - used to treat patients with alcohol problems


• medicines used to treat Parkinson’s disease


• ritonavir - used to treat HIV


• cimetidine - used to treat stomach acid problems


• thioridazine - used to treat mental illness


• medicines to treat thyroid problems.

Taking Amitriptyline with food and drink

Do not drink alcohol whilst taking amitriptyline.

Pregnancy and Breast-feeding

Talk to your doctor before taking this medicine if you are pregnant or planning to become pregnant or breast-feeding.
Do not take Amitriptyline Oral Solution during pregnancy.

Driving and using machines

Amitriptyline may make you feel drowsy. If you experience this, do not drive or use machinery.

Important information about what is in Amitriptyline 25mg/5ml Oral Solution:

This medicine contains:

• methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine


• liquid maltitol (a type of sugar). If your doctor has told you that you cannot tolerate some sugars, talk to
  your doctor before taking this medicine


• a colouring agent E122. This may cause allergic reactions.

How to take Amitriptyline 25mg/5ml Oral Solution

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.

Taking this medicine

• this medicine contains 25mg of amitriptyline hydrochloride in each 5ml


• take this medicine by mouth.

The usual doses are given below. These may be changed by your doctor:

Adults

To treat depression:

• the usual dose is 75mg each day either as a single dose at night or split into smaller doses over the day


• your doctor may increase this to a maximum of 150mg a day


• for long term treatment the usual dose is 50 to 100mg each day as a single dose at night.

Older people and people with kidney problems

Your doctor will start you on a lower dose and gradually increase it as you may be more sensitive to the
medicine.

Children

To treat bed-wetting:

• It is not recommended for children under the age of 6 years to take this medicine.


• aged 6 to 10 years: 10 to 20mg each day


• aged 11 to 16 years: 25 to 50mg each day


• The medicine should not be taken for more than 3 months.

Children under 16 years of age should not take this medicine for depression.

If you take more Amitriptyline 25mg/5ml Oral Solution than you should

If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away.

Take the medicine pack with you.

If you forget to take Amitriptyline Oral Solution

• If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose,
  skip the missed dose


• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Amitriptyline Oral Solution

You may not notice any improvement for up to 4 weeks. Do not stop taking the medicine unless your doctor tells
you to. If you stop taking the medicine abruptly, you may get side effects such as headache that makes you feel
sick and feeling weak.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Amitriptyline Oral Solution can cause side effects although not everybody gets them.

Stop taking Amitriptyline Oral Solution and see a doctor straight away if you have:

• an allergic reaction. Signs may include swelling of your face, lips, tongue or throat or difficulty breathing
  or swallowing severe itching of your skin with raised lumps.


• a serious effect on your blood, such as low sodium levels. Signs may include fever or chills, sore throat,
  ulcers in your mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruises. If you notice any of these, tell your doctor straight away.

Serious side effects: tell a doctor straight away

• If you feel more depressed, including thinking about suicide

If you get any of the following side effects, see your doctor as soon as possible:

• Effects on your heart: feeling faint and dizzy when standing up, change in blood pressure, fast or unusual heart beats, heart attack, stroke



• Effects on your brain and nervous system: feeling confused, difficulty concentrating, feeling disorientated (not knowing where you are), delusions and hearing or seeing things that are not there (hallucinations), feeling excited, restless or stressed, difficulty sleeping, nightmares, feeling slightly hyperactive, numbness or tingling or pins and needles (particularly in the hands and feet), difficulty in co-ordinating movements, shaking, fits, unconsciousness, slow or slurred speech



• Effects on your liver: hepatitis including changes in liver function that would be identified by a blood
  test, yellowing of the skin and the whites of your eyes (jaundice)



• Effects on your hormones: change in sexual function and sex drive, breast swelling in men and women,
  swelling of your testicles, production of breast milk, increased or decreased blood sugar levels, inappropriate
  secretion of the hormone ADH (antidiuretic hormone) that may make you pass water (urinate) more frequently.

Tell your doctor if you get any of these side effects:

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Effects on your ears: buzzing or ringing in the ears


• Effects on your stomach and intestines: feeling or being sick, change in appetite, diarrhoea, irritation and a nasty taste in your mouth, swollen saliva glands, black tongue, pain in and around your stomach area (the abdomen), dry mouth, fever, constipation, blockage of your small intestine


• Effects on the skin: skin rashes, skin rash due to sunlight


• Effects on your eyesight: blurred or double vision, changes in eyesight


• General effects: headache, dizziness, weakness, tiredness, change in weight, drowsiness, increased sweating, hair loss, widely dilated pupils, difficulty passing water (urine).

When used for children, the side effects are less frequent but may still happen. The most common reported effects amongst children are drowsiness, dry mouth, blurred eyesight, increased pressure in the eye, changes in eyesight, constipation, fever and difficulty in passing water (urine). There have also been rare reports of mild sweating and itching.

How to store Amitriptyline Oral Solution

• Keep out of the reach and sight of children


• Do not store above 25°C


• Do not use 6 months after you first open it


• Do not use after the expiry date (month, year) stated on the label and carton


• If it is out of date or you no longer want it, take it back to the pharmacy


• Do not use Amitriptyline Oral Solution if you notice anything wrong with the medicine. Talk to your pharmacist


• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.

Further information

What Amitriptyline 25mg Oral Solution contains

• The active ingredient is amitriptyline hydrochloride


• The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), ascorbic acid (E300), quinoline yellow (E104), fruit cup flavour (containing colour E122), orange flavour, liquid maltitol (E965) and purified water.

What Amitriptyline 25mg/5ml Oral Solution looks like and contents of the pack

A pale yellow to yellow/orange solution with a fruity odour.

It comes in a brown glass bottle holding 150ml of solution.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

UK

This leaflet was last approved in June 2008.

P0407