Country: Ísrael
Tungumál: enska
Heimild: Ministry of Health
AMOXICILLIN AS TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM SALT
GLAXO SMITH KLINE (ISRAEL) LTD
J01CR02
FILM COATED TABLETS
AMOXICILLIN AS TRIHYDRATE 500 MG; CLAVULANIC ACID AS POTASSIUM SALT 125 MG
PER OS
Required
GLAXO SMITHKLINE TRADING SERVICES LIMITED, IRELAND
AMOXICILLIN AND ENZYME INHIBITOR
AMOXICILLIN AND ENZYME INHIBITOR
Augmentin is indicated for the treatment of the following infections in adults and children :• 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.
2022-08-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed according to a physicians prescription only AUGMENTIN 500 MG TABLETS FILM-COATED TABLETS. EACH TABLET CONTAINS: 500 MG AMOXICILLIN (AS TRIHYDRATE) 125 MG CLAVULANIC ACID (AS POTASSIUM SALT) For a list of the inactive and allergenic ingredients in the preparation – see section 2 Important information about some of the ingredients of the medicine and section 6 Additional information. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or the pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Augmentin 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. Augmentin is an antibiotic that 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 whose action can sometimes be stopped (become inactive). The other active component (clavulanic acid) prevents this from happening. THERAPEUTIC GROUP Amoxicillin: Penicillin antibiotic group. Clavulanic acid: Beta-lactamase enzyme inhibitors. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • you are sensitive (allergic) to amoxicillin, clavulanic acid, penicillin or any of the additional ingredients contained in the medicine (listed in section 6) • 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 • you have ever had liver problems or jaundice (yellowing of the sk Lestu allt skjalið
Page 1 of 15 Augmentin 500 mg Tablets SUMMARY OF PRODUCT CHARACTERISTICS Augmentin 500 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 Film-coated tablet. White to off-white, oval film-coated tablets debossed with ‘AC’ and a score line on 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) Page 2 of 15 • 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, Lestu allt skjalið