Trimethoprim 100mg Tablets
Package Leaflet: Information for the user
Trimethoprim 100mg Tablets 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. 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
Trimethoprim is a type of antibacterial medicine which works by killing bacteria.
Trimethoprim tablets may be used:
• to treat a wide range of infections including urinary infections and respiratory tract infections.
• for long-term prevention of recurrent urinary tract infections.
2. What you need to know before you take Trimethoprim Tablets Do not take Trimethoprim Tablets if you
• are allergic to trimethoprim or any of the other ingredients of this medicine (listed in section 6)
• are pregnant
• suffer from any blood disorders such as anaemia.
• suffer from severe kidney or liver problems Trimethoprim should not be given to infants under 4 months of age.
Warnings and Precautions
Talk to your doctor or pharmacist before
taking Trimethoprim tablets if you:
• have deficiency of folic acid (may cause anaemia).
• have kidney problems
• have acute porphyria (symptoms include severe abdominal pain, nausea, vomiting and constipation)
• are also taking repaglinide (medicine for treating diabetes)
• are at greater risk of high levels of potassium in your blood (hyperkalaemia), e.g. the elderly or those on higher doses
• Concomitant administration of Trimethoprim with certain medicines, potassium supplements and food rich in potassium may lead to severe hyperkalaemia (increased potassium blood level). The symptoms of severe hyperkalaemia might include muscle cramps, irregular heart rhythm, diarrhoea, nausea, dizziness or headache.
Other medicines and Trimethoprim Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:
• repaglinide, used to treat diabetes
• procainamide, to treat abnormal heart rhythm
• digoxin, to treat certain heart conditions
• diuretics (e.g. spironolactone)
• rifampicin, used to treat TB
• anticoagulants ( e.g. warfarin)
• phenytoin, to treat epilepsy
• pyrimethamine and dapsone, used to treat malaria
• immunosuppressant drugs - used in cancer treatment (e.g. methotrexate) or to treat organ rejection after transplant (e.g. azathioprine or ciclosporin)
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Trimethoprim Tablets contain lactose
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
Driving and using machines Trimethoprim does not have any effect on the ability to drive or use machines.
Blood tests
If you are having treatment over a long time, your doctor may carry out regular blood tests.
3. How to take Trimethoprim Tablets
• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Trimethoprim tablets are for oral administration only and should be swallowed with a drink of water. Do not crush or chew this tablets.
Dosage
Severe or sudden infections:
• Adults and children over 12 years:
200 mg twice daily.
• Children 6 years to 12 years:
100 mg twice daily.
Long-term treatment and prevention therapy:
• Adults and children over 12 years:
100 mg at night.
• Children 6-12 years: 50mg at night. where a single daily dose is required, dosage at bedtime may maximise urinary concentrations.
Children: Trimethoprim tablets are not recommended for children under 6 years of
age. A more suitable dosage form should be used in this age group.
Elderly: doses may be reduced in elderly patients. Your doctor will prescribe a suitable dose depending on how well your kidneys are working. XXXXXX
I SAME SIZE ARTWORK I 220 x 120 mm
Front
If you take more Trimethoprim tablets than you should
If you take more tablets than you should, tell your doctor immediately or go to the nearest hospital A&E (casualty department).
If you forget to take Trimethoprim tablets If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Trimethoprim tablets Do not stop taking Trimethoprim tablets because you feel better. Take the tablets for as long as your doctor has told you or your problem may come back.
| 4. Possible Side Effects |
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking these tablets and contact your doctor or go to a hospital straightaway if you experience any of the following: Allergic reactions 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, vomiting 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 or Toxic epidermal necrolysis (severe illness with blistering of the skin, mouth, eyes and genitals), skin eruptions/lesions
Pancreatitis (signs may include a sudden,
severe upper abdominal pain)
Common (may affect up to 1 in 10 people)
• feeling and being sick, diarrhoea, headache
• skin rashes, thrush
• high levels of potassium in blood (may result in abnormal heart rhythm)
• anaemia (may cause you to feel tired and look pale)
• sore throats or mouth ulcers (due to a decrease in white blood cells)
Very rare (may affect up to 1 in 10,000
people )
• constipation, severe watery/bloody diarrhoea
• sore tongue and mouth, 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, anorexia
• low levels of sodium in blood (may cause nausea, tiredness, muscle cramping)
• 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
• lupus erythematosus (an auto-immune disorder)
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 _Tablets_
• Keep this medicine out of the sight and reach of children.
• Do not use the tablets after the expiry date shown on the carton or label. The expiry date refers to the last day of that month.
• Blisters: Do not store above 250C.
Store in the original package.
• Containers: Do not store above 250C . Store in the original container.
Keep the container tightly closed.
• Do not throw away any medicines via waste water 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
• The active substance in Trimethoprim tablets is Trimethoprim
• The other ingredients in Trimethoprim tablets are Lactose monohydrate, povidone K-25, crospovidone, sodium starch glycolate, magnesium stearate.
What Trimethoprim tablets look like and contents of the pack.
• Trimethoprim tablets are white to off-white, circular, flat bevelled edged uncoated tablets with break line dividing 'TMP' and '100' or '200' on one side and plain on the other side.
• The containers are available in pack sizes of 50, 100, 250 and 500 tablets.
• The blister packs are available in sizes of 14, 28, 56, and 84 tablets.Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Limited,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Herts, HP4 1EG, UK Telephone: 0044 (0) 1442 200922 Fax: 0044 (0) 1442 873717
E-mail: info@bristol-labs.co.uk
This leaflet was last revised in October 2016
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
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