Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Amoxicillin trihydrate; potassium clavulanate
GlaxoSmithKline (Ireland) Limited
J01CR; J01CR02
Amoxicillin trihydrate; potassium clavulanate
250/125 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor
Marketed
1982-09-06
PACKAGE LEAFLET: INFORMATION FOR THE USER AUGMENTIN 250 MG/125 MG 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 (or for your child) 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 Augmentin is and what it is used for 2. What you need to know before you take Augmentin 3. How to take Augmentin 4. Possible side effects 5. How to store Augmentin 6. Contents of the pack and other information 1. WHAT AUGMENTIN IS AND WHAT IT IS USED FOR Augmentin 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. Augmentin is used in adults and children to treat the following infections: • sinus infections • urinary tract infections • skin infections • dental infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AUGMENTIN DO NOT TAKE AUGMENTIN: • if you are allergic to amoxicillin, clavulanic acid, penicillin 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 jaundice (yellowing of the skin) when taking an antibiotic. DO NOT TAKE AUGMENTIN IF ANY OF THE ABOVE APPLY TO YOU. If you are not sure, talk to your doctor Lees het volledige document
Health Products Regulatory Authority 08 November 2023 CRN00DFX0 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Augmentin 250 mg/125 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains amoxicillin trihydrate equivalent to 250 mg amoxicillin with potassium clavulanate equivalent to 125 mg of clavulanic acid. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white, oval shaped tablets debossed with ‘Augmentin’ on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Augmentin 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 Augmentin 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 Augmentin (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 Augmentin 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 is recommended that anothe Lees het volledige document