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Trimethoprim 200mg Tablets

Document: leaflet MAH GENERIC_PL 20075-0291 change

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PACKAGE LEAFLET: INFORMATION FOR THE USER

TRIMETHOPRIM 200mg TABLETS

Trimethoprim

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 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 Trimethoprim 200mg Tablets are and what they are used for

2.    Before you take Trimethoprim 200mg Tablets

3.    How to take Trimethoprim 200mg Tablets

4.    Possible side effects

5.    How to store Trimethoprim 200mg Tablets

6.    Further information

1. WHAT TRIMETHOPRIM 200mg TABLETS ARE AND WHAT THEY USED FOR

Trimethoprim belongs to a group of medicines called anti-infectives: it is a broad spectrum agent which kills a wide range of bacteria causing your symptoms.

Trimethoprim is used for the treatment of infections caused by organisms that are susceptible to Trimethoprim and particularly for the prevention of recurring urinary tract infection.

2. BEFORE YOU TAKE

TRIMETHOPRIM 200mg TABLETS

Do not take Trimethoprim 200mg Tablets

•    if you are allergic (hypersensitive) to trimethoprim or any of the other ingredients of Trimethoprim 200mg Tablets.

•    If you have any blood disorder

•    If you are pregnant

•    if you have severe kidney disease

•    Trimethoprim should not be given to premature babies or babies during the first few weeks of life.

Check with your doctor or pharmacist before taking Trimethoprim tablets if you have:

   kidney disease or are having dialysis treatment

•    a deficiency of folic acid (may cause anaemia).

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.

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. Tell your doctor if you are taking any of the following:

•    Antibiotics such as rifampicin

•    Anticoagulants to prevent your blood clotting such as warfarin

•    Ciclosporin (to prevent rejection after transplantation)

•    Digoxin (to treat heart conditions)

•    Phenytoin (to treat epilepsy)

•    Pyrimethamine (to treat malaria)

•    Bone marrow depressants.

Check with your doctor before taking any such medicine while you are taking trimethoprim.

Taking TRIMETHOPRIM 200mg TABLETS with food and drink

There are no special instructions for taking Trimethoprim 200mg Tablets with food and drink.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Do not use Trimethoprim 200mg Tablets during pregnancy unless your doctor considers is absolutely essential. Trimethoprim 200mg Tablets can be used by breast-feeding mothers although trimethoprim is passed into breast milk.

Sugar Intolerance

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine; as it contains a type of sugar called lactose.

Driving and using machines

There are no known effects on driving ability or using machines.

Blood tests

If you are having treatment over a long time, your doctor may carry out regular blood tests.

Important information about some of the ingredients of TRIMETHOPRIM 200mg TABLETS

Patients who are intolerant to lactose should note that each Trimethoprim 200mg Tablet contains a small amount of lactose.

3. HOW TO TAKE TRIMETHOPRIM 200mg TABLETS

Always take Trimethoprim 200mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Take this medicine by mouth and only in the doses prescribed by your doctor.

Doses:

• Severe or sudden infections: (e.g. uncomplicated bacterial cystitis in women) treatment will usually be between 3-14 days, according to the type and severity of infection.

Your doctor may double your first dose.

-    Adults and children over 12 years: 200mg twice a day.

-    Children 6-12 years: 100mg twice a day.

-    Children under 6 years: Not recommended; a more suitable dosage form should be used in this age group.


• Long-term treatment and prevention therapy:

-    Adults and children over 12 years: 100mg at night.

-    Children 6-12 years: 50mg at night. The usual dose is around 2mg per kg body weight of the child per day.

-    Elderly: doses may be reduced in elderly patients, according to kidney function.

If you take more TRIMETHOPRIM 200mg TABLETS than you should

If you should accidently swallow a greater quantity of Trimethoprim 200mg Tablets that have been prescribed for you, contact your doctor or the Accident & Emergency Department of your nearest hospital at once. Always keep any remaining tablets in the labelled container in which they were given to you so that the medicine can be identified by the doctor or the pharmacist at the hospital.

If you forget to take TRIMETHOPRIM 200mg TABLETS

If you forget to take your medicine, just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten dose If you are not sure, ask your doctor or pharmacist for advice.

If you stop taking TRIMETHOPRIM 200mg TABLETS.

Do not stop the treatment without talking to your doctor first. You may feel well but the tablets are helping to prevent another attack of your disease. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Liver: changes in liver enzymes (seen in tests), jaundice (yellowing of skin or whites of the eyes)

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

Muscles: muscle pain.

Other: red, swollen tongue, headache.

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/vellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE TRIMETHOPRIM 200mg TABLETS

Do not store above 25°C. Store in the original container. Keep out of the reach and sight of children.

Do not use Trimethoprim 200mg Tablets after the expiry date which is stated on the carton after EXPIRY DATE. The expiry date refers to the last day of that month.

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.

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

Like all medicines, Trimethoprim 200mg Tablets can cause side effects, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.

Contact your doctor at once if you get an allergic reaction such as swelling of the face, lips, tongue or throat, difficulty breathing, shock or collapse.

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.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Blood: altered number and type of certain 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).

Stomach: feeling or being sick, sore mouth, discomfort, this is usually mild and disappears after stopping the tablets.

Skin: sensitivity to light, skin rashes which may be itchy, 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).

What Trimethoprim 200mg Tablets contains

The active substance is Trimethoprim.

The other ingredients are Lactose monohydrate, Povidone K-25, Crospovidone, Sodium starch glycolate (Type A) and Magnesium stearate.

What Trimethoprim 200mg Tablets looks like and contents of the pack

Trimethoprim 200mg Tablets are white, flat beveled edged tablets, engraved with 'MT200'.

The tablets are available in container pack sizes of 50, 100,500, 1000 and 5000. The tablets are also available in blister packs of 6, 14 and 28 tablets.

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited,

Sage House, 319, Pinner Road,

North Harrow, Middlesex, HA1 4HF, United Kingdom.

PL20075/0291

This leaflet was last revised in {12/2015}.