Patient leaflet - TRIMETHOPRIM 200 MG TABLETS
Trimethoprim
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.
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– If you have any further questions, ask your doctor or pharmacist
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– 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
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1. What Trimethoprim Tablets are and what they are used for
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2. What you need to know before you take Trimethoprim Tablets
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3. How to take Trimethoprim Tablets
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4. Possible side effects
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5. How to store Trimethoprim Tablets
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6. Contents of the pack and other information
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1. What Trimethoprim tablets are and what they are used for Trimethoprim belongs to a group of medicines known as antibacterial. They are used to kill a wide range of bacteria that cause infections in your body, primarily urinary and respiratory tract infections.
This medicine can also be used for 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 to any other ingredients of this medicine (listed in the Section 6);
- Are pregnant;
- Suffer from severe liver problems;
- Suffer from any blood disorders such as anaemia.
Trimethoprim should not be administered to premature babies or infants under 4 months of age.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Trimethoprim Tablets if you:
- are pregnant
- suffer from kidney problems/kidney disease or are having dialysis treatment.
- have a deficiency (are low) in folic acid (may cause anaemia)
- 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)
- Trimethoprim should not be given to premature babies or babies during the first few weeks of life
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.
Trimethoprim can increase potassium blood levels. Patients at risk of increased potassium blood levels include those with kidney problems, poorly controlled diabetes, or those on certain medicines or potassium supplements.
The symptoms of severe hyperkalaemia might include muscle cramps, irregular heart rhythm, diarrhoea, nausea, dizziness or headache.
Your doctor may perform blood tests to monitor your potassium blood levels.
Your doctor may wish to do regular blood tests if you need long-term treatment or are prone to anaemia.
Children
This dosage form is not suitable for use in children younger than 6 years.
Other medicines and Trimethoprim:
Your medicine may interfere with other medicines that you are taking. Please inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those not prescribed.
Take care with the following medicines:
- Repaglinide, used to treat diabetes;
- Procainamide, to treat abnormal heart rhythm;
- Digoxin, to treat certain heart conditions;
- potassium supplements
- medicines known as ACE inhibitors and angiotensin II antagonists (used to treat high blood pressure and certain heart conditions).
- heparin (used to treat and prevent blood clots)
- Diuretics (e.g. Water tablets such as furosemide eplerenone, spironolactone, amiloride or triamterene);
- Rifampicin, (antibiotic) used to treat TB;
- Anticoagulants (to prevent clots from forming in the blood 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);
- Spironolactone
- Bone marrow depressants
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 should not be used in pregnancy.
DO NOT take Trimethoprim if you are pregnant or breast-feeding.
Trimethoprim tablets contain lactose. 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
There is no evidence to suggest that Trimethoprim affect the ability to drive or operate machinery.
| 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 but not chewed, and do not crush this tablets.
The recommended dose is:
Adults and children over 12 years Severe or sudden infections: usually your doctor will prescribe 200 mg taken twice daily Long term treatment and prevention therapy: 100mg at night
Elderly
Dosage is dependent on kidney function.
Elderly patients with kidney problems will usually be prescribed a reduced dose.
Children aged 6 – 12 years
Severe or sudden infections: 100 mg twice daily
Long term treatment and prevention therapy: 50 mg at night. The usual dose is around 2mg/kg body weight of the child per day.
Children under 6
This tablet form of Trimethoprim is not recommended for use in children under 6 years.
Your doctor has carefully chosen the correct dosage for you, taking into account the severity of your condition, your age and any other particular reasons special to you. Instructions on how many tablets to take and when to take them will be printed on the dispensing label on the pack.
XXXXXXX
Front
Never change the dose of your medicine without talking to your doctor first.
If you take more of your medicine than you should
If you (your child or someone else) 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 your medicine
If you do forget to take a dose of your medicine at the correct time, take it as soon as you remember then take the next dose at the right time. DO NOT take a double dose.
If you stop taking your medicine
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
| 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 face, lips, tongue and throat;
- Chest pain;
- Shock, fainting or collapse;
- Blistering/peeling of the skin;
- Pancreatitis (signs may include a sudden, severe upper abdominal pain);
- Skin eruptions/lesions;
- Deep swelling of the skin (angioedema);
- Jaundice (yellowing of the skin or whites of the eyes).
Tell your doctor or pharmacist if you notice any of the following side effects: Very Common (may affect more than 1 in 10 people)
- Hyperkalaemia (particularly in the elderly and in HIV patients) which is high levels of potassium in the blood (may result in abnormal heart rhythm).
Common (may affect up to 1 in 10 people)
- Headache
- Skin rashes
- Hives
- Thrush
- Nausea, diarrhoea, vomiting
Very rare (occurs in less than 1 in 10,000 people)
- Constipation, severe watery/bloody diarrhoea;
- Anaemia;
- Sore tongue and mouth;
- Cough;
- Agitation;
- Abnormal behaviour;
- Kidney problems (signs may include painful urination or blood in the urine);
- Dizziness, tiredness;
- Convulsions;
- Involuntary movements;
- Pins and needles, shakiness tremors;
- 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 and nightmares;
- Confusion, hallucinations;
- Elevation of serum transaminases (an indication of liver damage);
- Elevation of bilirubin levels;
- Joint and muscle ache;
- Wheezing, nosebleeds, shortness of breath;
- 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;
- lupus erythematosus (an auto-immune disorder)
- purple discolorations of the skin
- hypersensitivity, anaphylaxis, anaphylactoid reaction drug fever, allergic vasculitis
- reduction in numbers of blood cells
- sore throat
Frequency not known (cannot be estimated from the available data)
- pruritus (itching)
- Elevation of serum creatinine and blood urea nitrogen levels
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
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
15. 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 25°C. Store in the original package.
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– Containers: Do not store above 25°C. Store in the original container. Keep the container lightly closed.
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 contains
- The active substance in Trimethoprim Tablets is Trimethoprim, which is an antibiotic
- The other ingredients in Trimethoprim Tablets are Lactose monohydrate, povidone K-25, crospovidone, sodium starch glycolate and magnesium stearate.
What Trimethoprim tablets look like and contents of the pack.
- Trimethoprim 200 mg tablets are white, circular, flat bevelled edged uncoated tablets with break line dividing ‘TMP’ and ‘200’ on one side and plain on the other side.
- The containers are available in pack size of 50, 100, 250 and 500 tablets.
- The blister packs are available in sizes of 14, 28, 56, and 84 tablets.
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| SAME SIZE ARTWORK
220 × 170 mm