Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMOXYCILLIN TRIHYDRATE; POTASSIUM CLAVULANATE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
AMOXYCILLIN TRIHYDRATE; POTASSIUM CLAVULANATE
14Tablet Tablets; 10 Tablet Tablets
SMITHKLINE BEECHAM PHARMACEUTICALS
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 AUGMENTIN TABLET Amoxicillin trihydrate/ Potassium clavulanate (500 mg/125 mg, 875 mg/125 mg) WHAT IS IN THIS LEAFLET 1. What Augmentin is used for 2. How Augmentin works 3. Before you use Augmentin 4. How to use Augmentin 5. While you are using it 6. Side Effects 7. Storage and Disposal of Augmentin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT AUGMENTIN IS USED FOR Augmentin is an antibiotic 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. HOW AUGMENTIN WORKS 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. BEFORE YOU USE AUGMENTIN - _When you must not use it _ _ _ Do not take Augmentin: • if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, other penicillin based antibiotics, or similar antiobiotics called cephalosporins. if you have ever had liver problems or jaundice (yellowing of the skin and/or whites of the eyes) when taking an antibiotic. Do not take Augmentin if any of the above applies to you . If you are not sure, talk to your doctor or pharmacist before taking Augmentin. - _Before you start to use it _ _ _ Talk to your doctor or pharmacist before taking this medicine if you: • have ever had an allergic reaction to any other antibiotics or medicines. This might include a skin rash or swelling of the face or neck • have glandular fever (mononucleosis - viral infection that normally transmitted through saliva and causes sore throat, swollen glands and fever) • are taking Read the complete document
CONFIDENTIAL ________________________________________________________________________\ ______ [GSK logo] AUGMENTIN TABLETS Amoxicillin trihydrate - Potassium clavulanate QUALITATIVE AND QUAN TITATIVE COMPOSITION AUGMENTIN 625 mg tablets: Each tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate). AUGMENTIN 1 g tablets: Each tablet contains 875 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate). PHARMACEUTICAL FORM AUGMENTIN 625 mg tablets: A 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. AUGMENTI N 1 g tablets: A white to off -white capsule -shaped , film-coated tablet, debossed with ‘AC’ on both sides and a score line on one side. CLINICAL PARTICULARS Indications AUGMENTIN is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The beta-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other beta- lactam antibiotics. AUGMENTIN should be used in accordance with local official antibiotic -prescribing guidelines and local susceptibility data. AUGMENTIN oral presentations for twice daily dosing, are indicated for short -term treatment of bacterial infections at the following sites: Upper respiratory tract infections (including ENT) e.g. tonsillitis, sinusitis, otitis media. Lower respiratory tract infections e.g. acute exacerbation of chronic bronchitis, lobar and bronchopneumonia. Genito -urinary tract infections e.g. cystitis, urethritis, pyelonephritis. Skin and soft tissue infections, e.g. boils, abscesses, cellulitis, wound infections. Bone and joint infections e.g. osteomyelitis. Dental infections e.g. dentoalveolar abscess Read the complete document