Country: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amoxicillin trihydrate; Potassium clavulanate
Waymade Healthcare Plc
J01CR02
Amoxicillin trihydrate; Potassium clavulanate
500mg ; 125mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010103
Keep out of the sight and reach of children. Do not store above 25°C. Store in the original package. Do not take the tablets out of the blister strip until it is time to take your dose. Do not take the tablets after the expiry date which is stated on the carton and blister labels after ‘Exp’. The expiry date refers to the last day of that month. If the tablet becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist. Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to. WHAT AUGMENTIN CONTAINS Each tablet contains 500mg amoxicillin (as the trihydrate) and 125mg of clavulanic acid (as the potassium salt) as the active ingredient. The other ingredients are crospovidone, hydrated colloidal silica, low-substituted hypromellose, magnesium stearate (E572), colloidal anhydrous silica, titanium dioxide (E171), hypromellose, macrogol 4000, macrogol 6000 and dimeticone 500. WHAT AUGMENTIN LOOKS LIKE AND CONTENTS OF THE PACK Augmentin is white, oval, film-coated tablet, marked 'A/C' on one side and plain on the other side. Each blister pack contains 12 tablets. MANUFACTURED BY: Glaxo Wellcome Production, Z.I. de la Peyenniere, 53101 Mayenne Cedex France. PROCURED FROM WITHIN THE EU AND REPACKAGED BY THE PRODUCT LICENCE HOLDER: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. AUGMENTIN ® 625MG TABLETS; PL 18799/0082 Leaflet date: 14.08.2018 Augmentin is a registered trademark of the Glaxo Group Ltd. ADVICE/MEDICAL EDUCATION Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses. Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the commonest reasons for this to occur is because the bacteria causing the infection are resistant to the antibiotic that is being taken. This means that they can survive and e Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Augmentin 625 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM F ilm-coated tablet White to off-white, oval film-coated tablets debossed with ‘AC’ and a score line one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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) • 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 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 Augm Aqra d-dokument sħiħ