Trimethoprim Tablets 200mg
Package leaflet: Information for the user Trimethoprim 100 and 200 mg Tablets
Read all of this leaflet carefully before you start using 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, pharmacist.
• This medicine has been prescribed for you. 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. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Trimethoprim Tablets are and what they are used for
2. What you need to know before you take Trimethoprim Tablets
3. How to take Trimethoprim Tablets
4. Possible side effects
5. How to store Trimethoprim Tablets
6. Contents of the pack and other information
1. What Trimethoprim Tablets are and what they are used for:
The name of the tablets is Trimethoprim Tablets. Trimethoprim tablets contain Trimethoprim Ph. Eur. 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. What you need to know before you take Trimethoprim Tablets DO NOT take Trimethoprim Tablets if you:
• have ever had any unusual or allergic reactions to Trimethoprim or any of the other ingredients listed in section 6. Also tell your doctor or pharmacist if you are allergic to any other substances such as food preservatives or dyes.
• Liver problems
• Renal (kidney) problems.
• Any form of anaemia.
• It is important that you tell your doctor if you are pregnant, or likely to become pregnant.
Trimethoprim should not be administered to infants under 4 months of age
The tablet form is NOT recommended for use in children under 6 years other formulations such as oral liquids should be used.
Warnings and precautions:
• Talk to your doctor or pharmacist before taking Trimethoprim Tablets if you: suffer from kidney problems
• have a deficiency (are low) in folic acid
• are at greater risk of high levels of potassium in your blood (hyperkalaemia), e.g. the elderly or those on higher doses
• are also taking repaglinide (medicine for treating diabetes)
• suffer from porphyria (a disorder that causes skin sensitivity to light, pain attacks and muscle weakness)
You should let your doctor know and ask his/her advice if you suffer from or have ever had any of the above.
Your doctor may wish to do regular blood tests if you need long-term treatment or are prone to anaemia.
Other medicines and Trimethoprim
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
• repaglinide, used to treat diabetes
• procainamide, to treat abnormal heart rhythm
• antibiotics such as rifampicin used to treat a disease called TB
• anticoagulants to prevent your blood clotting such as warfarin
• immunosuppressant drugs - used in cancer treatment (e.g. methotrexate) or to treat organ rejection after transplant (e.g. azathioprine or ciclosporin)
• medicine used to treat heart conditions-Digoxin
• medicine used to treat epilepsy-phenytoin
• medicine used to treat malaria-pyrimethamine and dapsone
• bone marrow depressants
• diuretics (e.g. water tablets such as frusemide or eplerenone^
Pregnancy and breast-feeding
Do not use Trimethoprim during pregnancy unless your doctor considers it absolutely essential. Trimethoprim can be used by breast-feeding mothers, although Trimethoprim is passed into breast milk.
Driving and using machines
There is no evidence to suggest that Trimethoprim Tablets affect the ability to drive or operate machinery
Important information about some of the ingredients of Trimethoprim Tablets
These tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
2. How to take Trimethoprim Tablets
Always take this medicine orally as described in this leaflet or as your doctor, pharmacist have told you. Check with your doctor, pharmacist you are not sure.
The recommended dose in adults and children over 12 years of age is:
Treatment of urinary tract infections and all other infections: 200mg twice daily. Long term preventative treatment of recurrent urinary tract infections: 100mg at night before bedtime.
Older people
Dosage is dependent on kidney function.
Elderly patients with kidney problems will usually be prescribed a reduced dose.
Use in children
Trimethoprim tablets must not be given to children under 6years of age.
6 years to 12 years of age.
Treatment of urinary tract infections and all other susceptible infections: 6mg/kg bodyweight daily, subdivided into 2 equal doses. Long-term prevention of recurring urinary tract infections: 2.5mg/kg bodyweight daily given as a single dose before bedtime.
If you feel that this medicine is not working as well after you have taken it for a short time (1-2 weeks) do not increase the dose, instead check with your doctor.
If you take more Trimethoprim Tablets than you should
If you (or your child) take too many tablets, tell a doctor or pharmacist or go to the nearest hospital casualty department straight away. Remember to take this leaflet and the tablet packaging with you.
If you forget to take Trimethoprim Tablets
If you do forget to take a dose of your medicine at the correct time, take it as soon as you remember, then carry on as before. DO NOT take a double dose.
If you stop taking Trimethoprim Tablets
Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking this medicine, your condition may re-occur or get worse. If you experience symptoms on stopping treatment, contact your doctor.
4. Possible side effects
Like all medicines, Trimethoprim tablets can cause side effects, although not everybody gets them.
Rare serious allergic reactions have occurred known as anaphylactic or anaphylactoid reactions.
STOP taking Trimethoprim Tablets and contact your doctor or go to your nearest hospital casualty_
department IMMEDIATELY if you notice any of the following
Symptoms:
• difficulty breathing
• swelling of the tongue and throat
• chest pain
• fainting
• blistering/peeling of the skin
• pancreatitis (signs may include a sudden, severe upper abdominal pain)
• skin eruptions/lesions
• deep swelling of the skin (angioedema)
Tell your doctor or pharmacist if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people)
• high levels of potassium in the blood (may result in abnormal heart rhythm)
Common (may affect up to 1 in 10 people)
• feeling and being sick, diarrhoea
• headache
• skin rashes
• anaemia (may cause you to feel tired and look pale)
• sore throat and mouth ulcers (due to a decrease in white blood cells)
• thrush
Very rare (may affect up to 1 in 10,000 people)
• constipation, severe watery/bloody diarrhoea
• cough
• agitation
• abnormal behaviour
• jaundice (yellowing of the skin or whites of the eyes)
• kidney problems (signs may include painful urination or blood in the urine)
• dizziness, tiredness
• convulsions
• involuntary movements
• pins and needles, shakiness
• ringing in the ears, vertigo
• eye redness and pain
• increased sensitivity of the skin to the sun
• low blood sugar
• low levels of sodium in the blood (may cause nausea, tiredness, muscle cramping)
• anorexia
• depression, anxiety, sleeping difficulties
• confusion, hallucinations
• elevation of serum transaminases (an indication of liver damage)
• elevation of bilirubin levels
• joint and muscle ache
• wheezing, nosebleeds
• meningitis (signs may include stiff neck, fever and vomiting)
• lupus erythematosus (an auto-immune disorder)
Not known (frequency cannot be estimated from the available data)
• sore tongue and mouth
• itching
If any side effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard.
5. How to store Trimethoprim Tablets
Keep this medicine out of the sight and reach of children. Your medicine could harm them. Keep your medicine in a dry place and store below 25°C. Keep the tablets in the closed container in which they were given to you. If your doctor tells you to stop the treatment, return any remaining tablets to the pharmacist. Only keep the medicine if the doctor tells you to. Do not use Trimethoprim Tablets after the ‘Expiry Date’ printed on the pack , but return it to your pharmacist.
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.
6. Contents of the pack and other information What Trimethoprim Tablets contains
Trimethoprim Tablets are available in two strengths, 100mg and 200mg.The active ingredient is trimethoprim, which is an antibiotic.
The tablets also include the ingredients Lactose, Povidone, Crospovidone, Sodium Starch Glycollate, Magnesium Stearate, Industrial Methylated Spirits and Purified Water.
What Trimethoprim Tablets look like and contents of the pack:
Trimethoprim Tablets of both strengths are available in pack sizes of 50, 100, 500, 1000 and 5000. Both strengths of Trimethoprim tablets are also available in blister packs of 28 tablets.
Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK Trimethoprim Tablets 100 mg-PL No. 12762/0429 Trimethoprim Tablets 200 mg-PL No. 12762/0430
This leaflet was revised in January 2015