ประเทศ: สหราชอาณาจักร
ภาษา: อังกฤษ
แหล่งที่มา: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trimethoprim
Actavis UK Ltd
J01EA01
Trimethoprim
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010800; GTIN: 5012617005434 5012617014962
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. x Keep this leaflet. You may need to read it again. x If you have any further questions, ask your doctor or pharmacist. x 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. x 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: x are sensitive (allergic) to trimethoprim or any of the other ingredients of the tablet (see section 6) x have severe liver disease x are pregnant x have any blood disorder Trimethoprim should not be given to premature infants or during the first few weeks of life. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking these tablets if you: x have kidney disease or are having dialysis treatment x 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 any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are taking: x cytotoxic drugs (tumour suppressing) x pyrimethamine (malaria prevention) x phenytoin (anticonvulsant-to treat epilepsy) x ciclosporin (preven อ่านเอกสารฉบับเต็ม
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trimethoprim 200 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of Trimethoprim Excipient with known effect: Also contains Lactose monohydrate 22.50 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets White circular, flat bevelled edged uncoated tablets with breakline dividing “TMP” and “200” on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of susceptible infections caused by trimethoprim-sensitive organisms including urinary and respiratory tract infections and for long-term prophylaxis of recurrent urinary tract infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ACUTE INFECTIONS: _ Treatment should continue for a period of between 3 days (eg, uncomplicated bacterial cystitis in women) to 2 weeks depending on the nature and severity of the infection. The first dose may be doubled._ _ _Adults: _200 mg twice daily Paediatric population: _Children over 12 years: Same as adult dose _ _Children 6 years to 12 years: _100 mg twice daily _Children under 6 years:_ This dosage form is not suitable for use in children younger than 6 years. _Elderly_: Dosage is dependent on renal function, see special dosage schedule below. _Advised dosage schedule where _ _there is reduced kidney function: _ eGFR (ml/min) Dosage advised Over 30 Normal 15 – 30 Normal for 3 days then half dose Under 15 Half the normal dose _ _ Monitoring of renal function and serum electrolytes should be considered particularly with longer term use, in patients with impaired renal function. Trimethoprim should only be initiated and used in dialysis patients under close supervision from specialists in both infectious disease and renal medicine. Trimethoprim is removed by dialysis. Monitoring trimethoprim plasma concentration may be considered with long term therapy but the value of this in individual cases should first be discussed with specialists in infections d อ่านเอกสารฉบับเต็ม