国: マルタ
言語: 英語
ソース: Medicines Authority
AMOXICILLIN, CLAVULANIC ACID
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
J01CR02
CLAVULANIC ACID 125 mg AMOXICILLIN 250 mg
FILM-COATED TABLET
CLAVULANIC ACID 125 mg AMOXICILLIN 250 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2006-12-27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MOXICLAV 375 MG FILM-COATED TABLETS Amoxicillin/Clavulanic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET : 1. What Moxiclav is and what it is used for 2. What you need to know before you take Moxiclav 3. How to take Moxiclav 4. Possible side effects 5. How to store Moxiclav 6. Contents of the pack and other information 1. WHAT MOXICLAV IS AND WHAT IT IS USED FOR 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. Moxiclav is used in adults and children to treat the following infections: • sinus infections, • urinary tract infections, • skin infections, • dental infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOXICLAV DO NOT TAKE MOXICLAV: • If you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in section 6). • 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 throat. • If you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. DO NOT TAKE MOXICLAV IF ANY OF THE ABOVE APPLY TO YOU. If you are not sure, talk to your doctor or pharmacist before taking Moxiclav. WARNINGS AND PRECAUTIONS Talk to your do 完全なドキュメントを読む
Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Moxiclav 375mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Moxiclav 375mg contains amoxicillin trihydrate equivalent to 250mg 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, scored, cap shaped film-coated tablets embossed “MC”. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Moxiclav 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) • Cystitis • Pyelonephritis • Cellulitis • Animal bites • Severe dental abscess with spreading cellulitis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Page 2 of 19 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 Moxiclav 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 Moxiclav (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 Moxiclav provides a total daily dose of 750 mg amoxicillin/375 mg clavulanic acid, when administered as recommended below. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of Moxiclav is selected 完全なドキュメントを読む