البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trimethoprim
Arrow Generics Ltd
J01EA01
Trimethoprim
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010800
Artwork No. Customer Description Market Language Size Min. Font Size Page No. Version No. Date Software 131119/1 Ennogen Trimogal Leaflet UK English 160 x 400 mm 9 pt 1 of 1 4 18-03-20 Coreldraw 12 Packaging Development Quality Assurance (QA) Quality Control (QC) Production e-mail : prasad.pdp@gmaol.com Ph : +91-09845156610 Colours Used Black Keyline ® TRIMOGAL TABLETS 100MG AND 200MG (trimethoprim) ! suffer from kidney problems/kidney disease or are having dialysis treatment ! are at greater risk of high levels of potassium in your blood (hyperkalaemia), e.g. the elderly or those on higher doses READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. 3. How to take Trimogal Tablets Trimogal Tablets contain the active substance trimethoprim. Trimethoprim is a type of antibacterial medicine which works by killing bacteria. 5. How to store Trimogal Tablets ! are allergic to trimethoprim or any of the other ingredients of this medicine (listed in section 6) ! suffer from any blood disorders such as anaemia. The tablet form is not recommended for use in children under 6 years. Alternative dosage forms are available. ! Keep this leaflet. You may need to read it again. 1. What Trimogal Tablets are and what they are used for 1. WHAT TRIMOGAL TABLETS ARE AND WHAT THEY ARE USED FOR DO NOT TAKE TRIMOGAL TABLETS IF YOU: ! suffer from severe liver problems 4. Possible 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. See section 4. ! 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. WHAT IS IN THIS LEAFLET 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIMOGAL TABLETS 2. What you need to know before you take Trimogal Tablets ! are pregnant 6. Contents of the pack and other information Trimogal is most commonly used for prevention and treatment of infections of th اقرأ الوثيقة كاملة
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 اقرأ الوثيقة كاملة