Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Amoxicillin (as amoxicillin trihydrate); Clavulanic acid (as potassium clavulanate, diluted with microcrystalline cellulose (1:1))
Brown & Burk UK LTD
J01CA; J01CA04
Amoxicillin (as amoxicillin trihydrate); Clavulanic acid (as potassium clavulanate, diluted with microcrystalline cellulose (1:1))
875 mg/125 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Penicillins with extended spectrum; amoxicillin
Marketed
2012-03-09
PACKAGE LEAFLET: INFORMATION FOR THE USER CO-AMOXICLAV 875MG/125MG FILM-COATED TABLETS (Amoxicillin/clavulanic acid) 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 Co-amoxiclav Tablet is and what it is used for 2. What you need to know before you take Co-amoxiclav Tablets 3. How to take Co-amoxiclav Tablets 4. Possible side effects 5. How to store Co-amoxiclav tablets 6. Contents of the pack and other information 1. WHAT CO-AMOXICLAV TABLETS IS AND WHAT IT IS USED FOR Co-amoxiclav is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening. Co-amoxiclav is used in adults and children to treat the following infections: middle ear and sinus infections respiratory tract infections urinary tract infections skin and soft tissue infections including dental infections bone and joint infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-AMOXICLAV TABLETS DO NOT TAKE CO-AMOXICLAV: if you are allergic to amoxicillin, clavulanic acid, penicillins or any of the other ingredients of this medicine (listed in section 6) if you have ever had a severe allergic reaction to any other antibiotic. This can include a skin rash or swelling of the face or throat. if you have ever had liver problems or j Leggi il documento completo
Health Products Regulatory Authority 10 September 2019 CRN008JPX Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Co-amoxiclav 875mg/125mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 875mg amoxicillin as amoxicillin trihydrate and 125mg of clavulanic acid as potassium clavulanate diluted. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White coloured capsule shaped film coated tablet debossed with ‘I 07’ on one side and plain on other side. Tablet length = 21.70 ± 0.10mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Co-amoxiclav is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1). Acute bacterial sinusitis (adequately diagnosed) Acute otitis media Acute exacerbations of chronic bronchitis (adequately diagnosed) Community acquired pneumonia Cystitis Pyelonephritis Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis. Bone and joint infections, in particular osteomyelitis Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component. The dose of Co-amoxiclav that is selected to treat an individual infection should take into account: The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) The severity and the site of the infection The age, weight and renal function of the patient as shown below. The use of alternative presentations of amoxicillin/clavulanic acid (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4 and 5.1). For adults and Leggi il documento completo