Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cefaclor monohydrate
Kent Pharma (UK) Ltd
J01DC04
Cefaclor monohydrate
500mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010201
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFACLOR 500MG CAPSULES (CEFACLOR MONOHYDRATE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may want to read it again. • If you have any further questions, please 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 is and what it is used for 2. What you need to know before you take Cefaclor 3. How to take Cefaclor 4. Possible side effects 5. How to store Cefaclor 6. Contents of the pack and other information 1. WHAT CEFACLOR IS AND WHAT IT IS USED FOR Cefaclor belongs to a group of antibiotic medicines called cephalosporins and works by killing bacteria that cause infections. Cefaclor is used to treat the following: • A range of infections including ear, nose, and throat infections, infections of skin and soft tissue • Respiratory tract infections, including inflammation of the lungs (bronchitis, pneumonia), inflammation of the tonsils (tonsillitis), sore throat (pharyngitis) and swelling of the lining of the sinuses (sinusitis) . • Urinary tract infections, including inflammation of the bladder (cystitis) and kidney infections (pyelonephritis) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFACLOR DO NOT TAKE CEFACLOR IF: • You are allergic to Cefaclor, cephalosporins, penicillin or other antibiotics or any of the other ingredients of this medicine (listed in section 6) WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE TAKING CEFACLOR IF: • You have ever suffered from colitis (inflammation which causes abdominal pain or diarrhoea) • You suffer from kidney problems • You are due to have a Coombs test or a urine sugar test as Cefaclor Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefaclor 500mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 524.48 mg of cefaclor monohydrate, equivalent to 500 mg of cefaclor. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard gelatine capsule Size 0. Body: opaque, light grey. Cap: opaque, violet, containing white to slightly yellow powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefaclor 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. • 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, but 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:_ The usual adult dosage is 250mg every eight hours. For more severe infections or those caused by less susceptible organisms, doses may be doubled. Total daily dosage should not exceed 4g. Cefaclor 500mg Capsules may be administered in the presence of impaired renal function. Under such conditions, dosage is usually unchanged. (see section 4.4). _PATIENTS UNDERGOING HAEMODIALYSIS:_ Haemodialysis shortens serum half-life by 25-30%. In patients undergoing regular haemodialysis, a loading dose of 250mg -1g administered prior to dialysis and a therapeutic dose of 250-500mg every six to eight hours maintained during interdialytic periods is recommended. _ELDERLY:_ As for adults. _PAEDIATRIC POPULATION: _The usual recommended daily dosage for children is 20mg/kg/day in divided doses, every Lue koko asiakirja