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    Reason for update: Type IBG to update absorption statements and QRD 4 Agency Approval Date: Text Date: 31/03/2017 Text Issue and Draft No.: issue6draft1 [GSK Logo] Package leaflet: Information for the user Augmentin 1 g Tablets co-amoxiclav (amoxicillin and clavulanic acid) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • This medicine has been prescribed for you (or for your child) only. It may harm them, even if their signs of illness are the same as yours. • If you have any further questions, ask your doctor or pharmacist. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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. This combination results in an antibiotic with an increased spectrum of action and restored efficacy against amoxicillin-resistant bacteria that produce β-lactamase. Possible side effects include diarrhea, vomiting, nausea, thrush, and skin rash. As with all antimicrobial agents, antibiotic-associated diarrhea due to Clostridium difficile infection—sometimes leading to pseudomembranous colitis—may occur during or after treatment with amoxicillin/clavulanic acid. Rarely, cholestatic jaundice (also referred to as cholestatic hepatitis, a form of liver toxicity) has been associated with amoxicillin/clavulanic acid. The reaction may occur up to several weeks after treatment has stopped, and usually takes weeks to resolve. It is more frequent in men, older people, and those who have taken long courses of treatment; the estimated overall incidence is one in 100,000 exposures. Amoxicillin/clavulanic acid is the International Nonproprietary Name (INN) and co-amoxiclav is the British Approved Name (BAN). Many branded products indicate their strengths as the quantity of amoxicillin.

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