Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trimethoprim
Mawdsley-Brooks & Company 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 Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Trimethoprim Tablets 100 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of trimethoprim. Excipients with known effect Each tablet contains 67.5 mg lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, normal biconvex tablets, engraved Berk 2H7 or 2H7 with a breakline on reverse. The breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Trimethoprim is indicated for the treatment of susceptible infections caused by trimethoprim - sensitive organisms including urinary tract and respiratory tract infections. Trimethoprim is also indicated for the prevention of recurrent urinary tract infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Acute infections: Adults and children over 12 years of age: 200 mg twice daily Children 6 years to 12 years: 100 mg twice daily Children under 6 years of age: This dosage form is not suitable for use in children younger than 6 years, a more suitable dosage form (such as a suspension) should be used in this age group. Elderly: Depending on kidney function, see special dosage schedule. Treatment should continue for at least one week but not last longer than two weeks. The first dose can be doubled. Long-term treatment and prophylactic therapy: Adults and children over 12 years: 100 mg at night Children under 12 years of age: This dosage form is not suitable for use in children younger than 12 years, a more suitable dosage form (such as a suspension) should be used in this age group. Elderly: Depending on kidney function, see special dosage schedule. DOSAGE ADVISED 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 Read the complete document