Land: Holland
Sprog: hollandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AMOXICILLINE 3-WATER SAMENSTELLING overeenkomend met; AMOXICILLINE 0-WATER; KALIUMCLAVULANAAT SAMENSTELLING overeenkomend met; CLAVULAANZUUR;
Actavis Group PTC ehf
J01CR02
AMOXICILLINE 3-WATER COMPOSITION corresponding to; AMOXICILLIN 0-WATER; KALIUMCLAVULANAAT COMPOSITION corresponding to; clavulan
Filmomhulde tablet
Oraal gebruik
Amoxicillin and beta-lactamase inhibitor
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
1 BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER AMOXICILLINE/CLAVULAANZUUR ACTAVIS 500/125 MG, FILMOMHULDE TABLETTEN (Amoxicillin/Clavulanic acid) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 signs of illness 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. WHAT IS IN THIS LEAFLET 1. What /…/ is and what it is used for 2. What you need to know before you take /…/ 3. How to take /…/ 4. Possible side effects 5. How to store /…/ 6. Contents of the pack and other information 1. WHAT /…/ IS AND WHAT IT IS USED FOR /…/ 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. /…/ 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE /…/ DO NOT TAKE /…/: - 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 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. DO NOT TAKE /…/ IF ANY OF THE ABOVE APPLY T Læs hele dokumentet
1 1. NAAM VAN HET GENEESMIDDEL Amoxicilline/Clavulaanzuur Actavis 500/125 mg, filmomhulde tabletten. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains amoxicillin trihydrate corresponding to 500 mg amoxicillin and potassium clavulanate corresponding to 125 mg clavulanic acid. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. /…/ 500 mg/125 mg tablets are white, oval, 20.2 mm x 9.8 mm film-coated tablets inscribed with ‘A’ on one side and ‘64’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS /…/ 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 Amoxicillin/Clavulanic acid 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 Amoxicillin / Clavulanic acid (e.g. formulations 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). 2 For adults and children ≥ 40 kg, this formulation of Amoxicillin / Clavula Læs hele dokumentet