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Trimethoprim 100 and 200 mg Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

IN THIS LEAFLET:

1.    What Trimethoprim is and what it is used for

2.    Before you take Trimethoprim

3.    How to take Trimethoprim

4.    Possible side effects

5.    How to store Trimethoprim

6.    Further information

What Trimethoprim is and what it is used for

•    Trimethoprim belongs to a group of medicines called antibacterials.

•    Trimethoprim is used for the prevention and treatment of infections, particularly in the urinary and respiratory tracts.

^ Before you take Trimethoprim

Do not take Trimethoprim:

•    If you are allergic (hypersensitive) to trimethoprim or any of the other ingredients of this medicine

•    If you are pregnant or breast-feeding

•    If you have any blood disorders

•    If you suffer from severe liver problems

•    If you suffer from severe kidney problems, unless your doctor is checking the levels of trimethoprim in your blood.

Take special care with Trimethoprim

Tell your doctor before you start to take this medicine if you:

•    Have kidney problems

•    Have folate-deficiency anaemia (a decrease in red blood cells due to a poor diet, which can cause tiredness, headache, a sore mouth and tongue and pale skin).

Taking other medicines

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

The effect of Trimethoprim may be increased or decreased by other medicines and vice versa. These medicines include:

•    Azathioprine (used following organ transplant and for arthritis)

•    Ciclosporin (used to prevent organ rejection after transplant surgery)

•    Digoxin or procainamide (used to treat heart problems)

•    Mercaptopurine or methotrexate (used as bone marrow depressants)

•    Phenytoin (used to treat epilepsy)

•    Pyrimethamine (used to treat malaria)

•    Rifampicin (used to treat infections)

•    Warfarin (used to prevent blood clots).

Pregnancy and breast-feeding

Do not take trimethoprim if you are pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients of Trimethoprim

Patients who are intolerant to lactose should note that Trimethoprim tablets contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

a How to take Trimethoprim

Always take Trimethoprim exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed with a drink of water. The usual dose is:

Severe or sudden infections:

Adults and children over 12 years of age: 200 mg twice a day. Children aged 6 to 12: 100 mg twice a day.

Children under 6 years of age: Not recommended; a more suitable dosage form should be used in this age group. Trimethoprim suspension is available for use in children. Elderly: The adult dose may need to be reduced depending on how well your kidneys function. Your doctor will advise you. The treatment should continue for at least one week but no longer than two weeks.

For long term treatment and for the prevention of infections: Adults and children over 12 years of age: 100 mg at night. Children under 12 years of age: Not recommended; a more suitable dosage form should be used in this age group. Trimethoprim suspension is available for use in children. Elderly: The adult dose may need to be reduced depending on how well your kidneys function. Your doctor will advise you. Renal impairment:

It may be necessary to reduce the dosage if you are suffering from kidney problems. Your doctor will advise you.

Dialysis patients:

Dialysis removes trimethoprim. Blood tests will be carried out before and after dialysis.

You should continue to take these tablets for as long as your doctor tells you to. Take the full course. Even if you start to feel better the original infection may still be present and may recur if treatment is stopped.

You may need to have blood tests if you take Trimethoprim for a long time or if your doctor thinks you are at special risk.

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If you take more Trimethoprim than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Trimethoprim

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten tablet. Take the remaining doses at the correct time.

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

Possible side effects

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

If the following happens, stop taking Trimethoprim and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    Difficulty in breathing and swelling of the lips, face and neck

•    Aseptic meningitis can occur in some patients. This may show as a combination of symptoms such as headache, fever, stiff neck, tiredness, feeling ill and your eyes become very sensitive to bright light.

•    Severe skin reactions such as exfoliative dermatitis (itchy, scaly, flaking, swollen skin), erythema multiforme (circular, irregular red patches), Stevens-Johnson syndrome (severe skin rash with flushing, fever, blisters or ulcers) or toxic epidermal necrolysis (severe rash involving reddening, peeling and swelling of the skin that resembles severe burns).

These are very serious but rare side effects. You may need

urgent medical attention or hospitalisation.

Other side effects may include:

•    Stomach upset, abdominal pain

•    Headache, fever, muscle pain

•    Feeling sick or being sick, sore mouth, swollen tongue

•    Skin redness, skin rashes and itching

•    Sensitivity to light

•    Anaemia (characterised by unusual tiredness or weakness)

•    Jaundice (yellowing of the skin or whites of the eyes), changes in liver enzymes (seen in tests)

•    Altered number and type of blood cells. If you get increased bruising, nose bleeds, sore throats or infections you should consult your doctor. Too much potassium in the blood (you may experience muscle cramps or pain, irregular heartbeats, unusual tiredness or weakness)

•    Kidney problems: increase in blood creatinine and urea levels (seen in tests).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Trimethoprim

Keep this medicine out of the sight and reach of children. Do not take Trimethoprim after the expiry date that is stated on the outer packaging.

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.

^0^ Further information

What Trimethoprim contains:

•    The active ingredient is Trimethoprim 100 or 200 mg. Each tablet contains 100 or 200 mg of the active substance, trimethoprim.

•    The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (Type A), povidone, colloidal anhydrous silica, magnesium stearate and stearic acid.

What Trimethoprim looks like and contents of the pack:

•    The name of your medicine is Trimethoprim 100 or 200 mg Tablets

•    Trimethoprim 100 mg Tablets are white, normal biconvex tablets, engraved "Berk 2H7" or "2H7" with a breakline on reverse. The breakline is only there to help you break the tablet if you have difficulty swallowing it whole.

•    Trimethoprim 200 mg Tablets are white, normal biconvex tablets, engraved "Berk 3H7" or "3H7" with a breakline on the reverse. The breakline is only there to help you break the tablet if you have difficulty swallowing it whole.

•    The 100 mg product is available in pack sizes of 7, 10, 14, 20, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, 168, 500 and 5000 tablets

•    The 200 mg product is available in pack sizes of 7, 10, 14, 21, 24, 28, 30, 50, 56, 60, 70, 84, 90, 100, 110, 112, 120, 150, 160, 168 and 500 tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for

manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: March 2016

PL 00289/0196-7

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