Trimethoprim 50mg/5ml Suspension
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PATIENT INFORMATION LEAFLET
TRIMETHOPRIM 50mg / 5ml Suspension 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.
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 antibiotic which is used to treat or prevent bacterial infections, including urinary tract infections, in adults and children.
2. What you need to know before you take Trimethoprim Do not take Trimethoprim if you:
• are allergic to trimethoprim or any of the ingredients of Trimethoprim (see Section 6 and end of Section 2).
• have severe liver or kidney failure.
• have megaloblastic anaemia (deficient in vitamin B12 or folate) or other blood disorders.
• are pregnant
• have hereditary fructose intolerance or an intolerance to some sugars.
Warnings and Precautions
Talk to your doctor before taking Trimethoprim:
• if you have other kidney problems.
• if you have folate deficiency; you may need to take a folate supplement and have regular blood tests.
• if you are elderly or if you suffer from porphyria (a rare blood disorder which can affect your skin or nervous system).
Patients on long term treatment with Trimethoprim may need regular blood tests. Carers and patients should look out for the following signs of blood disorders:- symptoms include fever, sore throat, rash, mouth ulcers, purpura (purple spots or patches on the skin), bruising or bleeding. If any of these occur seek immediate medical attention.
Other medicines and Trimethoprim
Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. Trimethoprim may interfere with other medicines you may be taking. Especially, tell your doctor if you are taking any of the following:
• Ramipril (used to treat high blood pressure)
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• Phenytoin (for epilepsy)
• Digoxin or Procainamide (heart medications)
• Rifampicin (an antibiotic)
• Ciclosporin or azathioprine (used to prevent rejection in transplantation)
• Bone marrow suppressants (used to treat some forms of cancer)
• Amiodarone (used to help your heart beat more regularly)
• Warfarin (used to thin the blood)
• Repaglinide (used to treat diabetes)
• Pyrimethamine (used to treat malaria)
• Lamivudine (used to treat HIV)
• Oestrogen (contraceptive pill)
• Methotrexate (used to treat cancer or for your immune system)
• Amantadine (used to treat Parkinsons disease, multiple sclerosis, flu or shingles)
• Eplerenone (used to treat high blood pressure)
• Dapsone (used to treat bacterial infections)
• Diuretics (water tablets) which help increase the amount of urine you produce
Trimethoprim with food and drink:
Trimethoprim can be taken with or without food.
Pregnancy and breast-feeding
Do not take Trimethoprim if you are pregnant.
As with all medicines, ask your doctor for advice before taking Trimethoprim if you are breast-feeding.
Important information about some of the ingredients of Trimethoprim
Trimethoprim contains
• Sorbitol (E420): see your doctor before taking this medicine if you have an intolerance to some sugars
• methylhydroxybenzoate (E218) and propyl hydroxy benzoate (E216): may cause allergic reactions (possibly delayed).
3. How to take Trimethoprim
Always take Trimethoprim exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Shake well before use. The usual dose is:
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Adults (including the elderly) and children over 12 years of age: | ||
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Urinary tract infections and other susceptible infections |
Four 5ml spoonfuls twice daily | |
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Long-term prevention of recurring urinary tract infections |
Two 5ml spoonfuls at night | |
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Children 6 weeks to 12 years of age: | ||
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Urinary tract infections and other susceptible infections |
6 weeks - 5 months |
2.5ml (half a 5 ml spoonful) twice daily |
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6 months - 5 years |
One 5ml spoonful twice daily | |
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6 years -12 years |
Two 5ml spoonfuls twice daily | |
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Long-term prevention of recurring urinary tract infections |
6 months - 5 years |
2.5 ml spoonful (half a 5ml spoonful) at night |
|
6 years - 12 years |
One 5ml spoonful at night | |
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Elderly
The adult dose may need to be reduced depending on how well your kidneys function. Your doctor will advise.
Renal Impairment
It may be necessary to reduce the dosage if you are suffering from kidney problems. Your doctor will advise you.
Dialysis patients
Trimethoprim is removed by dialysis. Blood tests will be carried out before and after dialysis.
If you forget to take Trimethoprim
Take the aose as soon as you remember, unless its nearly time for your next dose. Do not take a double dose to make up for the missed dose.
If you take more Trimethoprim than you should
If you take too much Trimethoprim, go immediately to your nearest hospital casualty department, taking your medicine bottle with you to show wnat you have taken.
If you stop taking Trimethoprim
Remember to keep taking this medicine until your doctor tells you to stop. Do not stop just because you feel better. If you stop too early, your infection may return, or get worse.
If you have any further questions on the use of Trimethoprim, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Trimethoprim can cause side effects, although not everybody gets them.
STOP taking Trimethoprim and contact your doctor immediately if you experience a rare allergic reaction, as you may need emergency treatment. Symptoms include:
■ swelling of the face and/or throat
■ difficulty breathing
■ a rash
■ itching or skin reactions with blistering or peeling skin
Very rare (fewer than 1 in 10,000 people are affected) allergic reactions are:
• fainting
• chest pain
• red patches on skin
• megaloblastic anaemia (an imbalance in certain types of blood cell), particularly during prolonged treatment at high doses, symptoms are change in skin colour, pale skin colour, loss of appetite, tingling and numbness of hands and feet. Patients are advised to have their blood checked regularly
• aseptic meningitis (swelling of the layers lining the brain, without bacterial infection). Symptoms are headache, stiff neck, nausea and vomiting, abnormal sensitivity to light, muscle pain, confusion
• uveitis - inflammation of lining of the eye
• fever (high temperature) or frequent infections
• sudden wheeziness or difficulty breathing
• mouth ulcers, cold sores and ulcers or soreness of your tongue
• skin lumps or hives (raised, red or white itchy patches of the skin)
• blisters on your skin or inside of your mouth, nose, vagina or bottom
• the appearance of a rash or sunburn when you have been outside (even on a cloudy day)
• low levels of salt in your blood. Symptoms include irregular heart beat, dry mouth or not having any energy
• feeling weak, tired or listless, pale skin (anaemia)
• heart problems
• jaundice (the skin and whites of the eyes turn yellow)
• muscle pain (myalgia).
Rare (more than 1 in 10,000 to less than 1 in 1,000 people) side effects can include:
• erythema multiforme (raised red areas on the skin and mucous membranes [moist linings of the internal parts of our body])
• skin sloughing (saggy skin).
Very common (more than 1 in 10 people)
• high levels of potassium in your blood which can cause abnormal heart beats (palpitations).
Common allergic reactions (less than 1 in 10 people)
• an infection called thrush or candidiasis which can affect your mouth or vagina. It is caused by a fungus
• headache
• feeling sick (nausea)
• diarrhoea
• skin rashes.
Uncommon (less than 1 in 100 people)
• being sick (vomiting).
Reporting of side effects
If you get any side effects, talk to your doctor. 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/yelfowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Trimethoprim
Keep this medicine out the sight and reach of children. Store in the original container.
Do not use your medicine after the expiry date which is stated on the label or carton.
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 contains:
• the active substance: trimethoprim - each 5ml of the oral suspension contains trimethoprim 50mg.
• the other ingredients: agar, polysorbate 80, saccharin sodium, sorbitol (E420), methylhydroxybenzoate (E218), propylhydroxybenzoate (E216) and purified water (see end of Section 2: ‘Important information’).
What Trimethoprim looks like and contents of the pack
Trimethoprim is a white, opalescent, viscous oral suspension. This medicine contains no flavour. It is available in 100 ml amber glass bottles with pilfer-proof screw cap and expanded polyethylene liner.
Marketing Authorisation Holder and Manufacturer
PinewoocTLaboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland
PL04917/0065 This leaflet was last updated in 06/2015 23LF01235PW
