Trimethoprim Tablets 200mg
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Patient Information Leaflet
TRIMETHOPRIM 200MG TABLETS
Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet, See section 4.
In this leaflet:
1. What Trimethoprim is and what it is used for
2. What you need to know before you take
Trimethoprim
3. How to take Trimethoprim
4. Possible side effects
5. How to store Trimethoprim
6. Contents of the pack and other information
1. What Trimethoprim is and what it is used for
Trimethoprim is an antibacterial medicine used to treat a wide range of infections including urinary and respiratory tract infections. It is also used for long term prevention of recurrent urinary tract infections.
2. What you need to know before you take Trimethoprim
Do not take Trimethoprim if you:
• are sensitive (allergic) to trimethoprim or any of the other ingredients of the tablet (see section 6)
• are pregnant
• have severe liver disease
• have severe kidney problems and your blood levels cannot be monitored regularly
• have megaloblastic anaemia (a blood disorder characterized by tiredness and breathless) or any other blood disorders
Trimethoprim should not be given to premature infants or during the first four months of life.
Warnings and precautions
Talk to your doctor or pharmacist before taking these tablets if you:
• have other kidney problems
• have a deficiency of folic acid (may cause anaemia)
Other medicines and Trimethoprim
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Trimethoprim can affect the way some other medicines work, also some other medicines may change the way Trimethoprim works.
In particular, tell your doctor if you are taking:
• cytotoxic drugs (tumour suppressing)
• pyrimethamine (malaria prevention)
• phenytoin (anticonvulsant-to treat epilepsy)
• ciclosporin (prevention of graft rejection)
• warfarin (anticoagulants - to prevent blood clots)
• rifampicin (treatment of tuberculosis)
• digoxin or procainamide(to treat heart conditions)
• mercaptopurine or methotrexate (used as bone marrow depressants)
If you are not sure, talk to your doctor or pharmacist before taking Trimethoprim.
Trimethoprim with food and drink
There are no special instructions for taking Trimethoprim 200mg Tablets with food and drink.
Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice before taking any medicine. Trimethoprim 200mg tablets should not be taken if you are pregnant. If you are breastfeeding you may use these tablets for short term course of treatment, although trimethoprim is known to pass into breast milk.
Driving and using machines
There are no known effects on driving ability or using machines.
Trimethoprim tablet contains lactose
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine as this medicine contains lactose.
Tests
Special precautions should be taken if you are prone to folate deficiency (i.e. the elderly) or if you have kidney or liver impairment, regular blood tests should be performed in order to monitor your condition, during long-term therapy.
3. How to take Trimethoprim
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. It is important to finish a full course of treatment.
Trimethoprim tablets should be taken by mouth and only in the doses prescribed by your doctor.
Dosage
The usual dose for adults and children is given below
Severe or sudden infections: Treatment will usually be between 3 - 14 days, depending on the type and severity of infection.
Your doctor may double your first dose.
For urinary and respiratory tract infections:
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.
If you feel that this medicine is not working as well after you have taken it for a short time (12 weeks) do not increase the dose or stop taking the tablets, instead check with your doctor.
Long-term treatment and prevention of urinary tract infections:
Adults and children over 12 years: 100mg at night
Children 6 - 12 years: 50mg at night. The usual dose is around 2 mg per kg body weight of the child per day.
Elderly patients: You may be prescribed a lower dose depending on how well your liver and kidneys are working.
If you take more tablets than you should
If you or a child accidentally takes too many tablets, contact your nearest hospital casualty department or contact your doctor immediately. 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.
Symptoms of Overdose include diarrohea, vomiting, abdominal pain, dizziness and confusion.
If you forget to take a dose
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 the tablets
Do not stop your course of treatment without talking to your doctor even if you feel better. You may feel well but the tablets are helping to treat or prevent another attack of your disease. If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking these tablets and see a doctor or go to a hospital straight away if you notice the following serious side effects
• Allergic reactions: swelling of the face, lips, tongue or throat, difficulty breathing, shock or collapse
• Severe skin reactions such as 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)
• 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 or pharmacist if you notice any of the following side effects
• Blood: altered number and type of certain blood cells. There is a possibility of the patient developing anaemia, mostly megaloblastic anaemia on prolonged treatment. This is more probable in patients who are prone to low levels of folate (a substance in the body which comes from several foods). Blood test should be done at regular intervals during long term therapy.
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). If you take Trimethoprim over a long period of time and feel tiredness and breathlessness after exercise consult your doctor
• 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),
• 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/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Trimethoprim
Keep all medicines out of the sight and reach of children
• Do not use the tablets after the expiry date stated on the label after ‘EXP’. The expiry date refers to the last day of that month
• Store below 25° C in a dry place protected from light
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Trimethoprim tablets contain Trimethoprim 200mg tablets:
• The active substance is 200mg of Trimethoprim
• The other ingredients are lactose, polyvinylpyrrolidone, maize starch, sodium starch glycollate, magnesium stearate, sodium lauryl sulphate, stearic acid and polyethylene glycol 4000
See end of section 2 for further information on lactose.
What Trimethoprim looks like and contents of the pack
• Trimethoprim 200mg tablets are white, flat bevelled edged tablets embossed T/200 on one face and ‘PV’ on the other face
• Trimethoprim 200mg tablets are available in packs containing “14, 28, 30, 100, 250, 500 and 1000 tablets”
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Pharmvit Ltd, 177 Bilton Road, Perivale, Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444 Fax: 0208 997 5433
To request a copy of this leaflet in large print or audio format or additional copies, please contact the licence holder at the address (or telephone, fax) above.
PL 04556 / 0031
Reference: 00310816/03
The leaflet was last revised in August 2016
