Aspirin Suppositories

Pronunciation: AS-pir-in
Generic Name: Aspirin
Brand Name: Generic only. No brands available.

Aspirin Suppositories are used for:

Treating pain including, headache, muscle aches, and arthritis, and the temporary reduction of fever. It is also used to reduce the risk of heart attacks and strokes in certain men and women who have already had a heart attack or ischemic stroke. It may also be used for other conditions as determined by your doctor.

Aspirin Suppositories are a nonsteroidal anti-inflammatory drug (NSAID). It works by inhibiting several different chemical processes within the body that cause pain, inflammation, and fever.

Do NOT use Aspirin Suppositories if:

• you are allergic to any ingredient in Aspirin Suppositories


• you are a child or teenager with influenza (flu) or chicken pox


• you have bleeding problems such as hemophilia, von Willebrand disease, or low blood platelets


• you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness), to aspirin, tartrazine, or an NSAID (eg, ibuprofen, naproxen, celecoxib)


• you are taking anticoagulants (eg, heparin, warfarin) or methotrexate

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

Before using Aspirin Suppositories:

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

• if you are pregnant, plan 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 or other substances


• if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day


• if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, stomach or peptic ulcers (bleeding ulcers), heartburn, upset stomach, stomach pain, influenza (flu) or chicken pox, or vitamin K deficiency


• if you are a child with a stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, or Kawasaki syndrome (a rare inflammation causing heart problems in children)

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

• Carbonic anhydrase inhibitors (eg, acetazolamide) because they may decrease Aspirin Suppositories's effectiveness


• Anticoagulants (eg, heparin, warfarin) or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, celecoxib) because the risk of their side effects, including risk of bleeding, may be increased by Aspirin Suppositories


• Insulin and oral antidiabetics (eg, glyburide, nateglinide) because the risk of their side effects, including low blood sugar (eg, hunger, shakiness or weakness, dizziness, headache, sweating), may be increased by Aspirin Suppositories


• Methotrexate or valproic acid because the risk of their actions and side effects may be increased by Aspirin Suppositories


• Angiotensin-converting enzyme inhibitors (eg, enalapril), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Aspirin Suppositories

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aspirin Suppositories 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 Aspirin Suppositories:

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

• Wash your hands before and after using Aspirin Suppositories. If the suppository is too soft to use, put it in the refrigerator for about 15 minutes. You may also run cold water over it. Remove the wrapper. Moisten the suppository with cool water. Lie down on your side. Insert the pointed end of the suppository into the rectum. Use your finger to push it in completely.


• Use Aspirin Suppositories exactly as directed on the package, unless instructed differently by your doctor. If you are taking Aspirin Suppositories without a prescription, follow any warnings and precautions on the label.


• If you miss a dose of Aspirin Suppositories and you are taking it regularly, 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 Aspirin Suppositories.

Important safety information:

• Aspirin Suppositories has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Talk to your doctor before you take Aspirin Suppositories or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day. Serious stomach ulcers or bleeding can occur with the use of Aspirin Suppositories. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Aspirin Suppositories with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


• Aspirin Suppositories may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Aspirin has been linked to a serious illness called Reye syndrome. Do not give Aspirin Suppositories to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.


• If Aspirin Suppositories has a strong vinegar-like smell upon opening, do not use. It means the medicine is breaking down. Throw the bottle away safely and out of the reach of children; contact your pharmacist and replace.


• Tell your doctor or dentist that you take Aspirin Suppositories before you receive any medical or dental care, emergency care, or surgery.


• Do not take Aspirin Suppositories for at least another 7 days after any surgery unless directed by your health care provider.


• Different brands of Aspirin Suppositories may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aspirin Suppositories while you are pregnant. Aspirin Suppositories are not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Aspirin Suppositories are found in breast milk. If you are or will be breast-feeding while you use Aspirin Suppositories, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Aspirin Suppositories:

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:

Rectal irritation.

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); rectal bleeding; Reye syndrome (nausea; vomiting; fever); ringing in your ears; stomach pain.

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: Aspirin 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 agitation; fever; hearing loss; lethargy; lightheadedness, especially upon standing; nausea; rapid breathing; rapid or irregular heartbeat; ringing in the ears; seizures; shortness of breath; stomach pain; vomiting.

Proper storage of Aspirin Suppositories:

Store in a cool place, between 46 and 59 degrees F (8 and 15 degrees C). May be refrigerated but do not freeze. Store in sealed foil wrapper away from heat, moisture, and light. Do not store in the bathroom. Keep Aspirin Suppositories out of the reach of children and away from pets.

General information:

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


• Aspirin Suppositories 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 Aspirin Suppositories. 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 Aspirin resources

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

Compare Aspirin with other medications

• Angina
• Angina Pectoris Prophylaxis
• Ankylosing Spondylitis
• Antiphospholipid Syndrome
• Aseptic Necrosis
• Back Pain
• Fever
• Heart Attack
• Ischemic Stroke
• Ischemic Stroke, Prophylaxis
• Juvenile Rheumatoid Arthritis
• Kawasaki Disease
• Myocardial Infarction, Prophylaxis
• Niacin Flush
• Osteoarthritis
• Pain
• Prevention of Thromboembolism in Atrial Fibrillation
• Prosthetic Heart Valves
• Prosthetic Heart Valves, Mechanical Valves
• Revascularization Procedures, Prophylaxis
• Rheumatic Fever
• Rheumatoid Arthritis
• Sciatica
• Systemic Lupus Erythematosus
• Thromboembolic Stroke Prophylaxis
• Transient Ischemic Attack

Doublebase Gel

Information for the user

Doublebase
Gel

isopropyl myristate 15% w/w, liquid paraffin 15% w/w

Please read all of this leaflet carefully before you start using this medicine.

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

Ask your doctor, nurse or pharmacist if you need more information or advice.

In this leaflet:

• 1. What Doublebase Gel is and what it is used for


• 2. Before you use Doublebase Gel


• 3. How to use Doublebase Gel


• 4. Possible side effects


• 5. How to store Doublebase Gel


• 6. Further information


• 7. General advice on looking after dry skin conditions

What Doublebase Gel Is And What It Is Used For

• Doublebase Gel is a treatment for application to your skin.


• It helps treat dry or chapped skin conditions that may also be itchy, red and sore. Common examples include:
  
  
  • psoriasis (scaly, pink patches of skin), elderly pruritus (itchy skin due to ageing), ichthyosis (abnormal scaly skin), various forms of eczema, dermatitis and other dry skin disorders.


• 
  All age groups can use Doublebase Gel, including babies.


• The active ingredients in this product are isopropyl myristate and liquid paraffin. These are known as emollients. The product helps to:
  
  
  • soften, moisturise and protect your skin by trapping moisture in the skin and restoring the normal protective function of the skin.
  • prevent the skin-drying and irritant effects that can be caused by washing and bathing and by the soaps, foaming additives and fragrances used in ordinary cleansing products.


• This product can be used in addition to any other emollients or treatments your doctor, pharmacist or nurse may have given or prescribed for you to treat your dry skin condition.

Before You Use Doublebase Gel

Do not use Doublebase Gel if you are allergic (hypersensitive) to isopropyl myristate, liquid paraffin or any of the other ingredients of Doublebase Gel listed in Section 6.

Using other medicines

This product is not known to affect, or to be affected by, other medicines.

Pregnancy and breast feeding

This product can be used during pregnancy and while breast feeding. The ingredients have been in widespread use in this and similar preparations for many years, without reports of problems. However, safety trials have not been conducted.

How To Use Doublebase Gel

This product is only for application to the skin.

For maximum benefit you should apply the gel on a regular basis and as often as required.

• Before using the 500 g bottle, turn the top of the pump dispenser anti-clockwise to unlock it.


• Apply Doublebase Gel to the affected areas of the skin on a regular basis and as often as required.


• Use a few gentle strokes to smooth the gel across the skin in the same direction as hair growth (like stroking a cat or dog). If necessary, allow time for any excess to soak in. Do not rub the skin vigorously.


• This product can also be used before and after washing, showering or having a bath to help condition your skin and stop it from drying further.


• If you are applying another treatment to the same areas of skin as Doublebase Gel, try to avoid mixing the two products. This can be achieved by applying the treatments alternately, leaving sufficient time to allow the previous application to soak in.

If you forget to use Doublebase Gel

Do not worry if you occasionally forget to use it, just carry on using the gel as described the next time you require it.

Possible Side Effects

Like all medicines, Doublebase Gel can cause side effects, although not everybody gets them. This product has been specially designed for use on dry or problem skin. However, in rare cases it can cause skin irritation (mild rashes) or allergic skin reactions on extremely sensitive skin. These rare effects tend to occur during or soon after the first few uses.

Stop using this gel and tell your doctor, nurse or pharmacist:

• if your skin condition seems to look or feel worse.


• if any of the side effects get serious, or you notice any other side effects not mentioned in this leaflet.

If this product is accidentally swallowed, its oily ingredients may cause diarrhoea.

If this happens:

• treat the symptoms as you would deal with any case of diarrhoea.


• drink plenty of water.


• 
  do not attempt to cause vomiting.

How To Store This Product

• Keep out of the reach and sight of children.


• Do not use Doublebase Gel after the expiry date shown on the container. The expiry date refers to the last day of that month.


• Do not store above 25°C.


• Do not freeze the product.


• After using the 500 g bottle, it is advisable to turn the top of the pump clockwise to lock it. In the case of the tube, replace the cap after use.


• Occasionally, in the 500 g bottle a small pocket of air may form around the bottom end of the pump's dip tube, making it harder to pump the gel out. This may be resolved by tapping the base of the bottle firmly on a hard surface two or three times, so the gel can settle at the bottom around the end of the dip tube. The pump should then be pumped SLOWLY.

Further Information

What Doublebase Gel contains:

The active ingredients are isopropyl myristate (15% w/w) and liquid paraffin (15% w/w). The other ingredients are glycerol, carbomer, sorbitan laurate, triethanolamine, phenoxyethanol and purified water.

What Doublebase Gel looks like and contents of the pack

• The gel is available in a plastic tube containing 100 g or a plastic pump bottle containing 500 g. (25 g packs are also available to the medical and allied professions.)


• The product has the appearance of a white gel. It contains no dye or fragrance.

The Marketing Authorisation holder is

Dermal Laboratories

Hitchin

Herts

SG4 7QR

UK

The Manufacturer is

Aeropak

Viking Road

Great Yarmouth

NR31 0NU

UK

This leaflet was last approved in March 2009.

General Advice On Looking After Dry Skin Conditions

• Emollients help soften, moisturise and protect the skin. They play a central role in the treatment and management of dry skin conditions. For maximum effect, they should be applied regularly and as often as needed.


• When bathing, try to use warm, not hot, water and avoid staying in the bath for long periods. This could make dry skin conditions
  worse.


• Try to avoid using normal soaps or bath additives (even those labelled “moisturising”). This is because they tend to dry and irritate the skin. Avoid using products containing fragrances, as these can also cause skin problems. You should try to use a fragrance-free emollient “soap substitute” instead. This type of product will not foam or lather but will be better for your dry skin condition.

Breaking the itch-scratch cycle

Some dry skin conditions like eczema and dermatitis are itchy, and can be quite sore. Although scratching relieves the itching for a short while, it further damages the skin. Badly scratched skin easily gets infected. This makes it itchier and the urge to scratch becomes even greater. It is better if scratching can be avoided by reducing the itching. The regular use of emollients or moisturisers can help with this.

• You may find it helpful to contact NHS Direct (tel: 0845 4647) or a patient support group such as the National Eczema Society (tel: 0800 0891122, 8am - 8pm, Mon - Fri) for information about your skin condition.

To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information: Doublebase Gel, 00173/0183.

This is a service provided by the Royal National Institute of Blind People.

IP18/09/1

Sildec-PE Drops

Generic Name: chlorpheniramine and phenylephrine (KLOR fen IR a meen and FEN il EFF rin)

Brand Names: Actifed Cold & Allergy, Allan Tannate Pediatric, Allerest PE, AlleRx, BP Allergy JR, C Phen, Cardec, Ceron, Chlor-Mes Jr, ChlorTan D, Cold & Allergy Relief, CP Dec, Dallergy Drops, Dallergy-JR, Dec-Chlorphen, Ed A-Hist, Ed ChlorPed D, Histadec, Nasohist Pediatric, NoHist, Ny-Tannic, PD-Hist D, PD-Hist D Drops, PediaTan D, Phenchlor Tannate Pediatric, R-Tanna, Relera, Rinate Pediatric, Rondec, Rondex, Rynatan, Rynatan Pediatric, Sildec-PE, Sinus & Allergy Maximum Strength, Sinus & Allergy PE, Sonahist, Sudafed PE Sinus & Allergy, Tanahist-D, Triaminic Cold & Allergy

What is Sildec-PE Drops (chlorpheniramine and phenylephrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

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

The combination of chlorpheniramine and phenylephrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Sildec-PE Drops (chlorpheniramine and phenylephrine)?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Do not use chlorpheniramine and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or phenylephrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and phenylephrine. Older adults may be more likely to have side effects from this medicine. 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.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

What should I discuss with my healthcare provider before taking Sildec-PE Drops (chlorpheniramine and phenylephrine)?

Do not use chlorpheniramine and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or phenylephrine, or if you have:

• 
  

  severe or uncontrolled high blood pressure;

  
  


• 
  

  severe coronary artery disease;

  
  


• 
  

  narrow angle glaucoma;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  if you are unable to urinate; or

  
  


• 
  

  if you are having an asthma attack.

  
  

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• kidney disease;


• liver disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  circulation problems;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  overactive thyroid;

  
  


• 
  

  a seizure disorder such as epilepsy;

  
  


• 
  

  asthma, emphysema or chronic bronchitis; or

  
  


• 
  

  urination problems or an enlarged prostate.

  
  

It is not known whether chlorpheniramine and phenylephrine is harmful to an unborn baby. Do not take this medication with a doctor's advice if you are pregnant. It is not known whether chlorpheniramine and phenylephrine passes into breast milk or if it 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 medicine.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Sildec-PE Drops (chlorpheniramine and phenylephrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or 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. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.

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

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

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

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while taking Sildec-PE Drops (chlorpheniramine and phenylephrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and phenylephrine. Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Chlorpheniramine and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Sildec-PE Drops (chlorpheniramine and 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 this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  fast or pounding heartbeats;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, nervousness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness; or

  
  


• 
  

  seizure (black-out or convulsions).

  
  

Less serious side effects may include:

• 
  

  blurred vision;

  
  


• 
  

  dry nose or mouth;

  
  


• 
  

  nausea, stomach pain, constipation, loss of appetite;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  feeling restless or excited (especially in children).

  
  

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 Sildec-PE Drops (chlorpheniramine and phenylephrine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine.

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

• 
  

  mecamylamine (Inversine);

  
  


• 
  

  methyldopa (Aldomet);

  
  


• 
  

  reserpine;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with chlorpheniramine and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Sildec-PE Drops resources

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

• AlleRx Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardec Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Dallergy-JR Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Ny-Tannic MedFacts Consumer Leaflet (Wolters Kluwer)


• Relera Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Rondec MedFacts Consumer Leaflet (Wolters Kluwer)


• Rynatan Prescribing Information (FDA)


• Sonahist Prescribing Information (FDA)

Compare Sildec-PE Drops with other medications

• Cold Symptoms
• Hay Fever

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine and phenylephrine.

See also: Sildec-PE side effects (in more detail)

Mydriacyl

Pronunciation: TROP-ik-ah-mide
Generic Name: Tropicamide
Brand Name: Examples include Mydral and Mydriacyl

Mydriacyl is used for:

Dilating the pupil and paralyzing certain muscles in the eye for diagnostic tests. It may also be used for other conditions as determined by your doctor.

Mydriacyl is an anticholinergic. It works by relaxing the muscles of the eye to cause the pupil to dilate or widen (mydriasis).

Do NOT use Mydriacyl if:

• you are allergic to any ingredient in Mydriacyl


• you have angle-closure glaucoma

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

Before using Mydriacyl:

Some medical conditions may interact with Mydriacyl. 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 glaucoma or you are at risk for glaucoma

Some MEDICINES MAY INTERACT with Mydriacyl. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• Carbachol, ophthalmic cholinesterase inhibitors (eg, echothiophate), or pilocarpine because their effectiveness may be decreased by Mydriacyl

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mydriacyl 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 Mydriacyl:

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

• Remove contact lenses before using Mydriacyl.


• First, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 2 or 3 minutes after using the medicine. Do not blink. Keep your eyes closed for 2 or 3 minutes. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed.


• Use Mydriacyl only in the eye. Do not get Mydriacyl in your mouth or nose.


• Wash your hands after using Mydriacyl. If the patient is a child, wash the child's hands as well.


• If you miss a dose of Mydriacyl, contact your doctor for instructions.

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

Important safety information:

• Mydriacyl may cause blurred vision or sensitivity to sunlight. Wear sunglasses if you are outside in the bright sunlight. Do not drive, operate machinery, or do anything else that could be dangerous unless you can see clearly.


• If you have an appointment for an eye examination and your doctor has told you that you will receive Mydriacyl, be sure to make arrangements to have someone drive you home in case your vision is blurry.


• Mydriacyl may be harmful if swallowed. If you may have taken Mydriacyl by mouth, contact your local poison control center or emergency room immediately.


• Pupil dilation usually reverses within 4 to 8 hours after use, but may last as long as 24 hours.


• Caution is advised when using Mydriacyl in CHILDREN because they may be more sensitive to its effects, especially mental or mood changes.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Mydriacyl during pregnancy. It is unknown if Mydriacyl is excreted in breast milk. If you are or will be breast-feeding while you are using Mydriacyl, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Mydriacyl:

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:

Blurred vision; burning; dry mouth; headache; nausea; sensitivity to sunlight; temporary stinging.

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); behavioral changes, especially in children; eye pain; irregular or rapid heartbeat; mental or mood changes, especially in children; paleness or flushing of the skin; rigid muscles; shortness of breath; vomiting.

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: Mydriacyl 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.

Proper storage of Mydriacyl:

Store Mydriacyl at room temperature, between 46 and 80 degrees F (8 and 27 degrees C). Store away from heat, moisture, and light. Do not refrigerate. Do not store in the bathroom. Keep Mydriacyl out of the reach of children and away from pets.

General information:

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


• Mydriacyl 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 Mydriacyl. 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 Mydriacyl resources

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

• Mydriacyl Prescribing Information (FDA)


• Mydriacyl Ophthalmic Advanced Consumer (Micromedex) - Includes Dosage Information


• Mydriacyl Concise Consumer Information (Cerner Multum)


• Ocu-Tropic Advanced Consumer (Micromedex) - Includes Dosage Information


• Tropicacyl Prescribing Information (FDA)

Compare Mydriacyl with other medications

• Pupillary Dilation
• Refraction, Assessment

Chlorpheniramine/Methscopolamine Suspension

Pronunciation: KLOR-fen-IR-a-meen/METH-skoe-POL-a-meen
Generic Name: Chlorpheniramine/Methscopolamine
Brand Name: Dexodryl

Chlorpheniramine/Methscopolamine Suspension is used for:

Relieving sneezing, runny nose, and watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Chlorpheniramine/Methscopolamine Suspension is an antihistamine and anticholinergic combination. It works by blocking a substance in the body that causes sneezing, runny nose, and watery eyes. It also dries the nose and chest.

Do NOT use Chlorpheniramine/Methscopolamine Suspension if:

• you are allergic to any ingredient in Chlorpheniramine/Methscopolamine Suspension


• you are taking sodium oxybate (GHB) or a monamine oxidase inhibitor (MAOI) (eg, phenelzine)


• you have severe heart blood vessel disease, severe high blood pressure, narrow-angle glaucoma, severe bleeding, severe irritation or other serious problems with the esophagus (eg, esophageal achalasia), peptic ulcer, a blockage of the stomach or bowel, bowel motility problems, severe bowel inflammation (eg, ulcerative colitis), or muscle problems (eg, myasthenia gravis)


• you have a blockage of the bladder, are unable to urinate, or are having an asthma attack

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

Before using Chlorpheniramine/Methscopolamine Suspension:

Some medical conditions may interact with Chlorpheniramine/Methscopolamine Suspension. 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 hernia, or a history of high blood pressure, diabetes, blood vessel problems, stroke, seizures, overactive thyroid, nerve problems, prostate gland problems, heart problems (eg, irregular heartbeat, congestive heart failure), sleep apnea, asthma, lung problems (eg, emphysema, chronic obstructive pulmonary disease [COPD]), or glaucoma, or you are at risk of developing glaucoma


• if you have trouble urinating or severe constipation

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

• Potassium products because they do not move properly through the intestines while you are taking Chlorpheniramine/Methscopolamine Suspension


• Anticholinergic medicines (eg, benztropine), barbiturates (eg, phenobarbital), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Chlorpheniramine/Methscopolamine Suspension's side effects


• MAOIs (eg, phenelzine) or sodium oxybate (GHB) because the risk of serious side effects, such as high blood pressure or severe drowsiness, may be increased


• Beta-blockers (eg, propranolol), digoxin, or hydantoins because the risk of their side effects may be increased by Chlorpheniramine/Methscopolamine Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Chlorpheniramine/Methscopolamine Suspension 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 Chlorpheniramine/Methscopolamine Suspension:

Use Chlorpheniramine/Methscopolamine Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Chlorpheniramine/Methscopolamine Suspension by mouth with or without food.


• Shake well before each use.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Do not take an antacid or medicine for diarrhea within 1 hour before or 2 hours after you take Chlorpheniramine/Methscopolamine Suspension.


• If you miss a dose of Chlorpheniramine/Methscopolamine Suspension and you are using it regularly, 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 Chlorpheniramine/Methscopolamine Suspension.

Important safety information:

• Chlorpheniramine/Methscopolamine Suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Chlorpheniramine/Methscopolamine Suspension 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 or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Chlorpheniramine/Methscopolamine Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 7 days, if they get worse, or if they occur with a fever, check with your doctor.


• Chlorpheniramine/Methscopolamine Suspension may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.


• Chlorpheniramine/Methscopolamine Suspension may reduce sweating. Do not become overheated in hot weather or during exercise or during other activities; heatstroke may occur.


• Chlorpheniramine/Methscopolamine Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Chlorpheniramine/Methscopolamine Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Chlorpheniramine/Methscopolamine Suspension may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Chlorpheniramine/Methscopolamine Suspension.


• Use Chlorpheniramine/Methscopolamine Suspension with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised with using Chlorpheniramine/Methscopolamine Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Chlorpheniramine/Methscopolamine Suspension should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Chlorpheniramine/Methscopolamine Suspension can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Chlorpheniramine/Methscopolamine Suspension while you are pregnant. It is not known if Chlorpheniramine/Methscopolamine Suspension is found in breast milk. Do not breast-feed while taking Chlorpheniramine/Methscopolamine Suspension.

Possible side effects of Chlorpheniramine/Methscopolamine Suspension:

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:

Blurred vision; change in appetite; constipation; dizziness; drowsiness; dry mouth; nausea; nervousness; stomach upset or pain; trouble sleeping.

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); confusion; difficulty urinating; fainting or feeling faint; fast heartbeat; fever, chills, or persistent sore throat; flushing; hallucinations; seizures; severe clumsiness; severe or persistent nervousness, dizziness, or trouble sleeping; severe drowsiness; shortness of breath; unusual bruising or bleeding; unusual tiredness or 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: Chlorpheniramine/Methscopolamine 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 difficulty breathing; fixed/large pupils; flushing; hot, dry skin; irregular heartbeat; loss of consciousness; mental or mood changes; ringing in the ears; seizures; severe drowsiness, dizziness, or headache; severe or persistent nausea or vomiting.

Proper storage of Chlorpheniramine/Methscopolamine Suspension:

Store at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chlorpheniramine/Methscopolamine Suspension out of the reach of children and away from pets.

General information:

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


• Chlorpheniramine/Methscopolamine Suspension 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 Chlorpheniramine/Methscopolamine Suspension. 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 Chlorpheniramine/Methscopolamine resources

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

Compare Chlorpheniramine/Methscopolamine with other medications

• Rhinitis

Remedeine and Remedeine forte tablets

Remedeine and Remedeine Forte tablets

Paracetamol and Dihydrocodeine tartrate

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 pharmacist.


• This medicine has been prescribed 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 the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Remedeine and Remedeine Forte tablets are and what they are used for

2. Before you take Remedeine or Remedeine Forte tablets

3. How to take Remedeine and Remedeine Forte tablets

4. Possible side effects

5. How to store Remedeine and Remedeine Forte tablets

6. Further information

What Remedeine and Remedeine Forte tablets are and what they are used for

These tablets have been prescribed for you to relieve severe pain over a period of 4 to 6 hours. They contain the active ingredients dihydrocodeine and paracetamol which belong to a group of medicines called strong analgesics or ‘painkillers’. The other ingredients are listed in section 6 of this leaflet.

Before you take Remedeine or Remedeine Forte tablets

Do not take Remedeine or Remedeine Forte tablets if you:

• are allergic (hypersensitive) to dihydrocodeine, paracetamol or any of the other ingredients of the tablets (see section 6 ‘Further Information’);


• have breathing problems, such as breathing more slowly or weakly than expected, or obstructive airways disease;


• are having an asthma attack.

Children under 12 years of age should not take these tablets.

Take special care with Remedeine and Remedeine Forte tablets

Before treatment with these tablets tell your doctor or pharmacist if you:

• have asthma or any allergies;


• have an under-active thyroid gland (hypothyroidism);


• have kidney or long-term liver problems;


• have a severe headache or feel sick due to a head injury or increased pressure in your skull (for instance due to brain disease). This is because the tablets may make these symptoms worse or hide the extent of a head injury;


• have prostate problems;


• are addicted to alcohol;


• are or have ever been addicted to drugs.

Taking other medicines

Tell your doctor or pharmacist if you are taking:

• any other medicines containing paracetamol (you should not take these tablets if you are already taking another medicine containing paracetamol);


• medicines to help you sleep (for example tranquillisers, hypnotics or sedatives);


• medicines to treat psychiatric or mental disorders;


• a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobamide and linezolid), or you have taken this type of medicine in the last two weeks;


• medicines to treat depression or anxiety;


• metoclopramide or domperidone to stop you feeling or being sick;


• cholestyramine to treat high blood pressure or diarrhoea;


• medicines such as warfarin to prevent your blood clotting or to help thin your blood.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take these tablets with some other medicines, the effect of these tablets or the other medicine may be changed.

Taking Remedeine or Remedeine Forte with alcohol

Drinking alcohol during your treatment with these tablets may make you sleepy. If you are affected you should avoid drinking alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding do not take these tablets until you have spoken to your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel sleepy when taking these tablets. If you are affected you should not drive or use machinery.

How to take Remedeine and Remedeine Forte tablets

Two different strengths of tablets are available. Your doctor will decide which strength of tablet will suit you best.

Always take these tablets exactly as your doctor has told you. The label on your medicine will tell you how many tablets to take and how often. Do not take for longer than directed by your doctor. You should check with your doctor or pharmacist if you are not sure.

Swallow your tablets whole with a glass of water.

The usual starting dose for adults and children over 12 years of age is one or two tablets every 4 to 6 hours. If you are elderly your doctor may suggest a lower starting dose. Your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these tablets discuss this with your doctor.

Do not take more than eight tablets in 24 hours.

Do not take these tablets if you are already taking another medicine containing paracetamol.

If you take more Remedeine or Remedeine Forte tablets than you should or if someone accidentally swallows your tablets

Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy and sick, and have abdominal pain. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. You should contact your doctor immediately even if you feel well as there is a risk of serious liver damage. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you to show the doctor.

If you forget to take Remedeine or Remedeine Forte tablets

If you miss a dose you should take it as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Remedeine or Remedeine Forte tablets

You should not stop taking these tablets unless your doctor tells you to. If you want to stop taking your tablets, discuss this with your doctor first.

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

Possible side effects

Like all medicines, these tablets can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.

As with all strong painkillers, there is a risk you may become addicted or reliant on these tablets.

Taking a painkiller for headaches too often or for too long can make your headaches worse.

Common side effects (Probably affecting more than 1 in 100 people taking these tablets)

Most people will have constipation when they take these tablets. Your doctor can prescribe a laxative to overcome this problem.

You may feel sick or vomit (be sick) when you take your tablets, this should normally wear off after a few days however your doctor can prescribe an anti-vomiting medicine if it continues to be a problem.

You may find that you feel more sleepy than normal when you start taking your tablets or when your dose is increased. This should wear off after a few days.

The following side effects have also been commonly reported in patients treated with these tablets:

• Headache.


• Rash or itchy skin.

Uncommon side effects (Probably affecting fewer than 1 in 100 people taking these tablets)

• An unpleasant or uncomfortable mood.


• Hallucinations.


• A feeling of dizziness or ‘spinning’.


• Difficulty in passing urine.


• A need to take increasingly higher doses to obtain the same level of pain relief (tolerance).


• Withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping taking the tablets.

Rare side effects (Probably affecting fewer than 1 in 1,000 people taking these tablets)

• Inflammation of the pancreas (which causes severe pain in the abdomen and back).


• Abnormal cells in the blood (blood dyscrasias).

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

How to store Remedeine and Remedeine Forte tablets

Keep out of the reach and sight of children.

Do not use any tablets after the expiry date which is stated on the carton. EXP 08 2010 means that you should not take the tablets after the last day of that month i.e. August 2010.

Do not store your tablets above 30°C. Keep the bottle tightly closed to protect the tablets from moisture.

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

Further information

What Remedeine and Remedeine Forte tablets contain

The active ingredients are paracetamol and dihydrocodeine tartrate. Each Remedeine tablet contains 500 mg of paracetamol and 20 mg of dihydrocodeine tartrate. Each Remedeine Forte tablet contains 500 mg of paracetamol and 30 mg of dihydrocodeine tartrate.

The other ingredients are:

• Magnesium stearate


• Maize starch

What Remedeine and Remedeine Forte tablets look like and the contents of the pack

Remedeine tablets are white and marked PD/20. Remedeine Forte tablets are white and marked PD/30.

In each bottle there are 56 or 112 tablets.

Marketing Authorisation Holder and Manufacturer

The tablets are made by

Bard Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge

CB4 0GW

UK

for the marketing authorisation holder

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge

CB4 0GW

UK

This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:

0800 198 5000

You will need to give details of the product name and reference number.

These are as follows:

Product name: Remedeine tablets

Reference number: 16950/0059

This leaflet was last approved in July 2008

Remedeine, Remedeine Forte and the NAPP device (logo) are Registered Trade Marks.

© 2008 Napp Pharmaceuticals Limited

P0082-A R1V4 UK AW 06-03-08

Remedeine P0082-A R1V4 UK AW 06-03-08 (clean copy)

Tyzeka

Generic Name: telbivudine (Oral route)

tel-BIV-ue-deen

Oral route(Solution;Tablet)

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued telbivudine; monitor hepatic function closely for several months following discontinuation of therapy .

Commonly used brand name(s)

In the U.S.

• Tyzeka

Available Dosage Forms:

• Tablet


• Solution

Therapeutic Class: Antiviral

Chemical Class: Thymidine Nucleoside Analog

Uses For Tyzeka

Telbivudine is used to treat chronic hepatitis B infection. Telbivudine is not a cure for hepatitis B infection, but it may lower the amount of virus in your body and may decrease the ability of the virus to multiply.

This medicine is available only with your doctor's prescription.

Before Using Tyzeka

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of telbivudine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of telbivudine have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of telbivudine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving telbivudine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Peginterferon Alfa-2a

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Myopathy (muscle aches, pain, weakness) or


• Peripheral neuropathy (nerve disorder with numbness, tingling)—Use with caution. May make these conditions worse.

Proper Use of Tyzeka

Take this medicine exactly as directed by your doctor. Do not take more of this medicine and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses.

This medicine should come with a Medication Guide and patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Measure the oral liquid correctly using the marked dosing cup that comes with the package. Rinse the dosing cup with water after each use.

The oral liquid contains sodium. Ask your doctor for advice if you are on a low sodium diet.

When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (solution or tablets):
  
  • For hepatitis B infection:
    
    • Adults and teenagers 16 years of age and older—600 milligrams (mg) or 30 milliliters (mL) once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused oral liquid 60 days after opening the bottle. Unused or outdated medicine should not be put directly in the trash can. Place it in a closed container first, such as a sealed bag, then into the household trash. You may also take it to a community take-back program when available.

Precautions While Using Tyzeka

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood or urine tests may be needed to check for unwanted effects.

Do not use this medicine if you are also using pegylated interferon alfa-2a (Pegasys®). Using these medicines together may increase your risk of having peripheral neuropathy.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have more than one of these symptoms: abdominal or stomach discomfort or cramping; dark urine; decreased appetite; diarrhea; a general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble with breathing; vomiting; or yellow eyes or skin.

If you have muscle aches, pain, tenderness, or weakness after using this medicine, call your doctor right away. These could be symptoms of a condition called myopathy.

Stop using this medicine and check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Hepatitis B infection may become worse if treatment with telbivudine is stopped. Do not stop taking this medicine without checking first with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

This medicine will not keep you from giving the hepatitis B virus to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has hepatitis B. The male partner should use a latex condom during sex. Do not share needles and personal items, such as toothbrushes or razor blades, that can have blood or body fluids on them with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Tyzeka Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Chills


• cough


• diarrhea


• fever


• general feeling of discomfort or illness


• headache


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• runny nose


• shivering


• sore throat


• stomach pain


• sweating


• trouble with sleeping


• unusual tiredness or weakness


• vomiting

Less common

• Back pain


• chest pain


• difficulty with moving


• muscle cramping


• muscle stiffness


• muscle tenderness, wasting, or weakness


• pain


• pain in the extremity


• swollen joints

Rare

• Burning feeling in the chest or stomach


• indigestion


• loose stools


• stomach upset


• tenderness in the stomach area

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• dark-colored urine


• decreased appetite


• fast, shallow breathing


• muscle pain or spasms


• shortness of breath


• sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Body aches or pain


• difficulty with breathing


• ear congestion


• loss of voice


• nasal congestion


• sneezing


• stuffy nose

Less common

• Acid or sour stomach


• belching


• dizziness


• heartburn


• rash


• sleeplessness


• stomach discomfort


• unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Tyzeka side effects (in more detail)

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More Tyzeka resources

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

• Tyzeka Prescribing Information (FDA)


• Tyzeka Consumer Overview


• Tyzeka Monograph (AHFS DI)


• Tyzeka MedFacts Consumer Leaflet (Wolters Kluwer)


• Telbivudine Professional Patient Advice (Wolters Kluwer)

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