Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
TRIMETHOPRIM, SULFAMETHOXAZOLE
Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta
J01EE01
TRIMETHOPRIM 80 mg SULFAMETHOXAZOLE 400 mg
TABLET
TRIMETHOPRIM 80 mg SULFAMETHOXAZOLE 400 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2019-10-23
Page 1 of 6 PATIENT INFORMATION LEAFLET CO-TRIMOXAZOLE CRESCENT TABLETS 80 MG/400 MG Trimethoprim 80mg & Sulfamethoxazole 400mg 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET 1. What Co-Trimoxazole Crescent Tablets 80 mg/400 mg are and what they are used for 2. What you need to know before you take Co-Trimoxazole Crescent Tablets 80 mg/400 mg 3. How to take Co-Trimoxazole Crescent Tablets 80 mg/400 mg 4. Possible side effects 5. How to store Co-Trimoxazole Crescent Tablets 80 mg/400 mg 6. Contents of the pack and other information 1. WHAT CO-TRIMOXAZOLE CRESCENT TABLETS 80 MG/400 MG ARE AND WHAT THEY ARE USED FOR Co-trimoxazole belongs to a group of medicines called antibacterials. These medicines work by killing bacteria. Co-trimoxazole is used in adults and children aged 6 years and over for the: • treatment and prevention of lung infections (pneumonia or _Pneumocystis _ pneumonia (PCP)) caused by the bacteria _Pneumocystis _ _jirovecii_ • treatment and prevention of toxoplasmosis (an infectious disease) • treatment of nocardiosis (an infectious disease affecting either the lungs or whole body) • treatment of urinary tract infections (bladder or kidney infections) • treatment of sudden worsening of chronic bronchitis (long term lung disease) • treatment of acute otitis media (an ear infection). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-TRIMOXAZOLE CRESCENT TABLETS 80 MG/400 MG DO NOT TAKE CO-TRIMOXAZOLE CRESCENT TABLETS 80 MG/400 MG IF YOU: • are allergic to trimethoprim, sulfam Διαβάστε το πλήρες έγγραφο
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Co-trimoxazole Crescent Tablets 80 mg/400 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg of trimethoprim and 400 mg of sulfamethoxazole. For excipients, see 6.1 3. PHARMACEUTICAL FORM Tablet. White, normal convex tablets engraved with Crescent moon logo on one side, a breakline and A286 on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Co-trimoxazole tablets are indicated in adults and children aged 6 years and over for the treatment of the following infections when owing to sensitive organisms (see section 5.1): Treatment and prophylaxis -of _Pneumocystis jirovecii (pneumocystis carinii) _ pneumonitis Treatment and prophylaxis of toxoplasmosis Treatment of nocardiosis. The following infections may be treated with co-trimoxazole where there is bacterial evidence of sensitivity to co-trimoxazole and good reason to prefer the combination of antibiotics in co- trimoxazole to a single antibiotic: -Acute uncomplicated urinary tract infections Page 2 of 16 -Acute exacerbations of chronic bronchitis -Acute otitis media Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: oral It may be preferable to take co-trimoxazole with some food or drink to minimise the possibility of gastrointestinal disturbances. Standard dosage recommendations for acute infections _Adults: _ 2 tablets every 12 hours. _Paediatric population: _ The dosage for children is equivalent to approximately 6 mg trimethoprim and 30 mg sulfamethoxazole per kilogram body weight per day. The schedules for children are according to the child’s age and provided in the table below. Children over 12 years 2 tablets every 12 hours Children 6 to 12 years 1 tablet twice a day Children under 6 years Not recommended Treatment should be continued until the patient has been symptom-free for two days; the majority will require tre Διαβάστε το πλήρες έγγραφο