Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM
Rowex Ltd
AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM
500/125 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2014-05-28
PACKAGE LEAFLET: INFORMATION FOR THE USER AMOXICILLIN/CLAVULANIC ACID 500MG/125MG FILM-COATED TABLETS Amoxicillin/clavulanic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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 (or for your child). Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Amoxicillin/clavulanic acid is and what it is used for 2. Before you take Amoxicillin/clavulanic acid 3. How to take Amoxicillin/clavulanic acid 4. Possible side effects 5. How to store Amoxicillin/clavulanic acid 6. Further information 1.WHAT AMOXICILLIN/CLAVULANIC ACID IS AND WHAT IT IS USED FOR Amoxicillin/clavulanic acid 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. Amoxicillin/clavulanic acid 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. BEFORE YOU TAKE AMOXICILLIN/CLAVULANIC ACID Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoxicillin/Clavulanic acid 500mg/125mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Amoxicillin Trihydrate equivalent to 500mg Amoxicillin and Potassium Clavulanate equivalent to 125mg clavulanic acid. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. White to off white oval shaped, film-coated tablet debossed with "AC" and a score line on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoxicillin/Clavulanic acid 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 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 Amoxicillin/Clavulanic acid 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 differen Läs hela dokumentet