Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cefalexin
Phoenix Healthcare Distribution Ltd
J01DB01
Cefalexin
500mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010201
1 _Version 4, 02/2016 _ PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFALEXIN 250 MG AND 500 MG CAPSULES Cefalexin 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 Cefalexin is and what it is used for 2. What you need to know before you take Cefalexin 3. How to take Cefalexin 4. Possible side effects 5. How to store Cefalexin 6. Contents of the pack and other information 1. WHAT CEFALEXIN IS AND WHAT IT IS USED FOR Cefalexin capsules contain the active ingredient cefalexin, which is an antibiotic. Antibiotics work by killing the bacteria (germs) that can cause an infection. Cefalexin Capsules are used to treat the following infections: the lungs and breathing airways (bronchitis and mild to moderate pneumonia) the skin and soft tissue (such as wound infection) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFALEXIN DO NOT TAKE THESE CAPSULES IF: you are allergic (hypersensitive) to cefalexin other cephalosporins (similar antibiotics) or any of the other ingredients of these capsules (see list of ingredients in section 6) An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. TELL YOUR DOCTOR BEFORE TAKING CEFALEXIN: If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking cefalexin or other antibacterials. TAKE SPECIAL CARE WITH THESE CAPSULES IF YOU: have had an allergic reaction to cefalexin, cephalosporins, penicillins or other drugs 3 develop di Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefalexin 500 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Cefalexin monohydrate equivalent to 500 mg Cefalexin. Excipients: Sunset yellow (E110), Quinoline yellow (E104) and Patent Blue V (E131). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule. Cefalexin 500 mg Capsules are size ‘0’ capsules with dark green cap and light green body imprinted with ‘500’ in black ink on cap, containing white to yellowish-white granular powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefalexin is a semi-synthetic cephalosporin antibiotic for oral administration. Cefalexin is indicated in the treatment of the following infections due to susceptible micro-organisms (see also section 4.4 and 5.1): • _Exacerbation of chronic bronchitis _ • _Mild to moderate community-acquired pneumonia _ • _Uncomplicated upper and lower urinary tract infections _ • _Skin and soft tissue infections_ Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cefalexin is administered orally. _Adults:_ The adult dosage ranges from 1-4g daily in divided doses; most infections will respond to a dosage of 500mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis, and mild, uncomplicated urinary tract infections, the usual dosage is 250mg every 6 hours or 500 mg every 12 hours. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cefalexin greater than 4g are required, parenteral cephalosporins, in appropriate doses, should be considered. _ _ _Patients with impaired renal function:_ Reduce dosage if renal function is markedly impaired (see section 4.4). _ _ _Elderly patients: _ The recommended dose for adults should be used in elderly patients except those with impaired renal function. _Children:_ The recommended daily dosage for chil Prečítajte si celý dokument