País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cefaclor monohydrate
Sun Pharma UK Ltd
J01DC04
Cefaclor monohydrate
250mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010201; GTIN: 5015525039614
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFACLOR CAPSULES 250MG AND 500MG (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 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 symptoms 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. 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 1. WHAT CEFACLOR CAPSULES ARE AND WHAT THEY ARE USED FOR This medicine is called Cefaclor Capsules. Cefaclor Capsules contain the active substance cefaclor, which belongs to a group of medicines called cephalosporin antibiotics. Cefaclor is used to kill bacteria that cause infections in your body. These include throat, chest and ear infections, sinus infections, infections of the skin and soft tissue and urinary tract infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFACLOR CAPSULES DO NOT TAKE CEFACLOR CAPSULES: if you are allergic to cefaclor or to any of the other ingredients of this medicine (listed in section 6) if you are allergic to any other cephalosporin antibiotic, such as cefalexin, cefuroxime or cefradine. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Cefaclor Capsules: − if you have had an allergic reaction to penicillins, such as penicillin, ampicillin, amoxicillin or flucloxicillin − if you have a history of gastrointestinal disease, especially inflammation of the colon (colitis) − if you have severe kidney problems Tell your doctor if y Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefaclor Capsules 250mg Keftid Capsules 250mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per Capsule Cefaclor Monohydrate Ph Eur Equivalent to Cefaclor 250.00mg. 3 PHARMACEUTICAL FORM Capsules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefaclor is indicated for the treatment of infections caused by sensitive microorganisms. These are infections of the respiratory tract which include pneumonia, bronchitis (including deteriorations in chronic bronchitis), tonsillitis, pharyngitis and the management of sinusitis. Cefaclor is also effective in otitis media. It is active in acute and chronic urinary tract infections including cystitis and pyelonephritis and also in infections of the skin and soft tissues. Cefaclor may also be used in the eradication of nasopharyngeal streptococci but resulting prevention of rheumatic fever and/or bacterial endocarditis has not been proven. The following microorganisms are susceptible _in vitro _to cefaclor: - Alpha and beta-haemolytic streptococci - Staphylococci (including coagulase-negative, coagulase-positive and penicillinase- producing strains) - _Strep. pneumoniae _ - _Strep. pyogenes _(group A beta-haemolytic streptococci) - _Branhamella catarrhalis _ - _E. ccli _ - _Proteus mirabilis _ - _Klebsiella spp. _ - _Haemophilus influenzae _(including ampicillin-resistant strains) Cefaclor is inactive against _Pseudomonas _and _Acinetobacter _spp., most strains of _Enterobacter _and _Serratia _spp., _Morganella morganii, Proteus vulgaris _and _Providencia rettgeri. _ Methicillin-resistant staphylococci and most strains of enterococci including _Strep. faecalis _are resistant to cefaclor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and the elderly: _ The usual dosage is 250mg every eight hours, may be doubled to 500mg every eight hours for more severe infections or those caused by less susceptible organisms. Doses of 4g per day have been administered safely to normal subjects for 28 days, but the Leer el documento completo