Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Amoxicillin; Clavulanic acid
Brown & Burk IR Limited
J01CR; J01CR02
Amoxicillin; Clavulanic acid
250 mg/125 milligram(s)
Film-coated tablet
Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor
Marketed
2012-03-09
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER CO-AMOXICLAV 250MG/125MG FILM-COATED TABLETS CO-AMOXICLAV 500MG/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. 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 leaflets. See section 4. WHAT IS IN THIS LEAFLET : 1. What Co-amoxiclav Tablets are and what they areused for 2. What you need to know before you take Co-amoxiclav Tablets 3. How to use Co-amoxiclav Tablets. 4. Possible side effects 5. How to store co-amoxiclav tablets 6. Content of the pack and other information 1. WHAT CO-AMOXICLAV TABLETS ARE AND WHAT THEY ARE 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: _250 mg/125 mg film-_ _coated tablets: _ • sinus infections • urinary tract infections • skin infections • dental infections. _500 mg/125 mg film-coated tablets: _ • 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, penicillin or any of the other i read_full_document
Health Products Regulatory Authority 22 February 2024 CRN00F17V Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Co-amoxiclav 250mg/125mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg amoxicillin as amoxicillin trihydrate and 125 mg 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 05’ on one side and plain on other side. Tablet length = 16.70 ± 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) • Cystitis • Pyelonephritis • Cellulitis • Animal bites • Severe dental abscess with spreading cellulitis. 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 Co-amoxiclav (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 children ≥ 40 kg, this formulation of Co-amoxiclav provides a total daily dose of 750 mg amoxicillin/375 mg clavulanic acid, when administered as recommended below. If it is considered that a higher daily dose of amoxicillin is required, it read_full_document