Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Cefaclor
Flynn Pharma Limited
J01DC; J01DC04
Cefaclor
250 mg/5ml
Granules for oral suspension
Product subject to prescription which may not be renewed (A)
Second-generation cephalosporins; cefaclor
Marketed
1998-11-16
Package leaflet: Information for the user DISTACLOR 125MG/5ML & 250MG/5ML GRANULES FOR ORAL SUSPENSION Cefaclor The name of your medicine is Distaclor 125mg/5ml & 250mg/5ml Granules for Oral Suspension, which will be referred to as Distaclor suspension throughout this document. 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 DISTACLOR SUSPENSION IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DISTACLOR SUSPENSION 3. HOW TO TAKE DISTACLOR SUSPENSION 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DISTACLOR SUSPENSION 6. CONTENTS OF THE PACK AND OTHER INFORMATION. 1 WHAT DISTACLOR SUSPENSION IS AND WHAT IT IS USED FOR Distaclor suspension is made from granules of the active ingredient cefaclor, which is an antibiotic. Your pharmacist will add fresh clean drinking water to the bottle containing the granules, to make up the suspension, before you are given it. Distaclor suspension is used to treat the following infections caused by bacteria that can be killed by cefaclor: Bronchitis Infection of lung tissue (pneumonia) Bladder (cystitis) and kidney infections Throat infections including tonsillitis and pharyngitis Middle ear infections (otitis media) Skin and soft tissue (e.g. muscle) infections Infection of the sinuses (sinusitis). 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DISTACLOR SUSPENSION. DO NOT TAKE DISTACLOR SUSPENSION IF you are allergic (hypersensitive) to cefaclor, any cephalosporin (other similar antibiotics) or any of the other ingred Прочетете целия документ
Health Products Regulatory Authority 23 June 2022 CRN00CYCS Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Distaclor 250mg/5ml Granules for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cefaclor (as monohydrate), 250 mg/5 ml. Excipient(s) with known effect Sucrose 2.87 g/5 ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension. A dry pink, free-flowing, granular powder, which on reconstitution with water gives a pink coloured, strawberry flavoured suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Distaclor is indicated for the treatment of the following infections due to susceptible micro‑organisms: Respiratory tract infections, including pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis and tonsillitis, and as part of the management of sinusitis. Otitis media. Skin and soft tissue infections. Urinary tract infections, including pyelonephritis and cystitis. Distaclor has been found to be effective in both acute and chronic urinary tract infections. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx, however, data establishing efficacy in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly):_ The usual adult dosage is 250mg every eight hours. A dosage of 250mg, administered 3 times daily for 10 days, is recommended for sinusitis. For more severe infections or those caused by less susceptible organisms, doses may be doubled. Doses of 4g per day have been administered safely to normal subjects for 28 days, but the total daily dosage should not exceed this amount. > _Children:_ The usual recommended daily dose for children is 20mg/kg/day, in divided doses, every eight hours, as indicated. For bronchitis and pneumonia, the dosage is 20mg/kg/day in divided doses, administered 3 times daily. For otitis media and pharyngitis, the t Прочетете целия документ