Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trimethoprim
Phoenix Healthcare Distribution Ltd
J01EA01
Trimethoprim
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010800
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 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 or are having dialysis treatment • have ACUTE PORPHYRIA (symptoms include severe abdominal pain, nausea, vomiting and constipation) • are also taking repaglinide (medicine for treating diabetes) Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trimethoprim 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Trimethoprim 100mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet: white coloured flat bevelled edged tablets engraved with ‘MT100’. Slight characteristic odour. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS • Treatment of susceptible infections caused by trimethoprim sensitive organisms including urinary infections and respiratory tract infections. • Long-term prophylaxis of recurrent urinary tract infections. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Acute infections: _ Treatment should continue for a period of between three days (e.g. uncomplicated bacterial cystitis in women) and two weeks according to the nature and severity of infection. The first dose can be doubled. • Adults and children over 12 years: 200mg twice daily. • Children 6-12 years: 100mg twice daily. • Children under 6 years of age: Not recommended; a more suitable dosage form should be used in this age group. • Elderly: Dosage is dependent upon kidney function; see special dosage schedule _Long-term treatment and prophylactic therapy: _ • Adults and children over 12 years: 100mg at night. • Children 6-12 years: 50mg at night. Where a single daily dose is required, dosage at bedtime may maximise urinary concentrations. The approximate dosage in children is 2mg trimethoprim per kg body weight per day. • Elderly: Dosage is dependent upon kidney function; see special dosage schedule 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 in Přečtěte si celý dokument