Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
CEFACLOR
Chanelle Medical
J01DC04
CEFACLOR
500 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
cefaclor
Not Marketed
2007-04-13
ID: PL 116/117 M IE VERSION: 05 REVIEW DATE: 18/01/2017 PREPARED BY: APPROVED BY: PAGE 1 OF 3 PACKAGE LEAFLET: INFORMATION FOR THE USER CEFACLOR 250 MG CAPSULES CEFACLOR 500 MG CAPSULES Cefaclor 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 Cefaclor Capsules are and what they are used for 2. What you need to know before you take Cefaclor Capsules 3. How to take Cefaclor Capsules 4. Possible side effects 5. How to store Cefaclor Capsules 6. Contents of the pack and other information Cefaclor capsules contain the active ingredient cefaclor, which is an antibiotic. Cefaclor capsules are 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) DO NOT TAKE CEFACLOR CAPSULES IF: you are allergic (hypersensitive) to cefaclor, any cephalosporin (other similar antibiotics) or any of the other ingredients of Cefaclor capsules (these are listed in Section 6 of this leaflet). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE TAKING CEFACLOR CAPSULES IF YOU have had an allergic reaction to penicillins or other drugs in the past have a history of gas সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefaclor 500 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 mg of cefaclor (as monohydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Cefaclor 500 mg capsules are grey and green. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefaclor is indicated for the treatment of the following infections due to susceptible microorganisms: Rispiratory 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. Cefaclor 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 250 mg every eight hours. A dosage of 250 mg, 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 4 g 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 20 mg/kg/day, in divided doses, every eight hours, as indicated. For bronchitis and pneumonia, the dosage is 20 mg/kg/day in divided doses, administered 3 times daily. For otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours. Safety and efficacy have not been established for use in infants aged less than one month. In more serious infections, otitis media and infections caused by less suscepti সম্পূর্ণ নথি পড়ুন