Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLAVULANIC ACID; AMOXYCILLIN
KOMEDIC SDN BHD
CLAVULANIC ACID; AMOXYCILLIN
20 Tablet Tablets; 16 Tablet Tablets
MEDOCHEMIE LTD (Factory B)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ MOXICLAV TABLET Amoxicillin/ Clavulanic acid (500mg/ 125mg or 875mg/ 125mg) 1 WHAT IS IN THIS LEAFLET 1. What MOXICLAV is used for 2. How MOXICLAV works 3. Before you use MOXICLAV 4. How to use MOXICLAV 5. While you are using it 6. Side effects 7. Storage and disposal of MOXICLAV 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT MOXICLAV IS USED FOR MOXICLAV 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 HOW MOXICLAV WORKS MOXICLAV 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 MOXICLAV _When you must not use it _ Do not take MOXICLAV: - If you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of MOXICLAV (listed at the end of this leaflet) - If you have ever had a severe allergic (hypersensitive) reaction to any other antibiotic. This can include a skin rash or swelling of the face or neck - If you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic _Before you start to use it _ _Tell your doctor or pharmacist if you: _ • have glandular fever • are being treated for liver or kidney problems • are not passing water regularly If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking MOXICLAV. In some cases, your doctor may investigate the type of bacteria that is causing your infection. Depending on the results, you may be given a different strength of MOXICLAV or a dif Læs hele dokumentet
1 MOXICLAV 1. NAME OF THE MEDICINAL PRODUCT MOXICLAV 625 mg film-coated tablets MOXICLAV 1g film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of MOXICLAV 625 mg contains amoxicillin trihydrate equivalent to 500mg amoxicillin base and potassium clavulanate equivalent to 125mg clavulanic acid. Each tablet of MOXICLAV 1 g contains amoxicillin trihydrate equivalent to 875 mg amoxicillin base and potassium clavulanate equivalent to 125mg clavulanic acid. Excipient with known effect: propylene glycol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, convex, capsule-shaped, film-coated tablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS The administration of MOXICLAV is indicated in the treatment of infections caused by susceptible microorganisms, such as: LOWER RESPIRATORY TRACT INFECTIONS caused by β-lactamase producing strains of _Haemophilus influenza _ and _Branhamella _ _catarrhalis _ OTITIS MEDIA caused by β-lactamase producing strains of _Haemophilus influenza _ and _Branhamella catarrhalis _ SINUSITIS caused by β-lactamase producing strains of _Haemophilus influenza _ and _Branhamella catarrhalis _ UROGENITARY TRACT INFECTIONS caused by, β-lactamase producing strains of _Escherichia coli_ , _Klebsiella _ spp. And _Enterobacter _ _spp_ . SKIN AND SKIN STRUCTURE INFECTIONS caused by β-lactamase producing strains of _Staphylococcus aureus_ , _Escherichia coli _ and _Klebsiella spp_ . Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual administered dose is: Adults and children over 14 years old: In severe infections, one MOXICLAV tablet (875 + 125) mg every 12 hours or one MOXICLAV tablet (500 + 125) mg every 8 hours. In mild to moderate infections, one MOXICLAV tablet (250 + 125) mg every 8 hours or one MOXICLAV tablet (500 + 125) mg every 12 hours. For dental infections one MOXICLAV tablet (250 + 125) mg every 8 hou Læs hele dokumentet