Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trimethoprim
Bristol Laboratories Ltd
J01EA01
Trimethoprim
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010800; GTIN: 5060013941160
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 (hypersensitive) t o 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 prema- ture 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) i Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trimethoprim 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of Trimethoprim Excipient with known effect: Also contains Lactose monohydrate 11.25 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets White to off-white circular, flat bevelled edged uncoated tablets with breakline dividing “TMP” and “100” 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 Long-term prophylaxis of recurrent urinary tract infections. Consideration should be given to official guidance regarding the appropriate use of antibacterial agents 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: _Acute infections: _ Treatment should continue for a period of between 3days (eg, uncomplicated bacterial cystitis in women) to 2weeks depending on the nature and severity of the infection. The first dos 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. _Dosage advised schedule where there is reduced kidney function: _ eGFR (ml/min) Dosage advised Over 30 Normal 15 - 30 Normal for three 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 te Preberite celoten dokument