البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trimethoprim
Kent Pharma (UK) Ltd
J01EA01
Trimethoprim
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010800; GTIN: 5015201008194
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRIMETHOPRIM 100MG AND 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. THIS INCLUDES ANY 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 WHAT TRIMETHOPRIM TABLETS ARE AND WHAT THEY ARE USED FOR Trimethoprim Tablets belong to a group of medicines known as antibacterials. They are used to kill a wide range of bacteria that cause infections in your body, primarily urinary and respiratory tract infections. This medicine can also be used for prevention of recurrent urinary tract infections. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIMETHOPRIM TABLETS DO NOT TAKE TRIMETHOPRIM TABLETS IF YOU: • are allergic (hypersensitive) to trimethoprim or to any of the other ingredients (see section 6, Contents of the pack and other information) • are pregnant • suffer from severe liver problems • suffer from any blood disorders such as anaemia Trimethoprim should not be administered to premature babies or infants under 4 months of age. The tablet form is NOT recommended for use in children under 6 years – the oral liquid form should be used. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING TRIMETHOPRIM TABLETS IF YOU: • are pregnant • suffer from kidney problems/kidney disease or are having dialysis treatment. • have a deficiency (are low) in fol اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trimogal ® 100mg Tablets Trimethoprim 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains trimethoprim 100mg. Excipients with known effect Lactose Sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round, flat faced bevelled edge tablet with an approximate diameter of 7.5mm, embossed with 'T2' on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acute urinary tract injections and long term prophylaxis of recurrent urinary tract infections. Respiratory tract infections, in particular acute and chronic bronchopneumonia and pneumonia caused by organisms sensitive to trimethoprim. Trimogal is particularly useful for patients known to be sensitive to sulphonamides. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Acute infections: Treatment should continue for a period of between 3 days (e.g. uncomplicated bacterial cystitis in women) to 2 weeks depending on the nature and severity of the infection. The first dose may be doubled. Adults: 200mg twice daily. Paediatric population: Children over 12 years: Same as adult dose. Children 6 – 12 years: 100mg 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 اقرأ الوثيقة كاملة