Riik: Holland
keel: hollandi
Allikas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AMOXICILLINE 3-WATER 574 mg/stuk SAMENSTELLING overeenkomend met ; AMOXICILLINE 0-WATER 500 mg/stuk ; KALIUMCLAVULANAAT 148,9 mg/stuk SAMENSTELLING overeenkomend met ; CLAVULAANZUUR 125 mg/stuk
Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)
J01CR02
AMOXICILLINE 3-WATER 574 mg/stuk SAMENSTELLING overeenkomend met ; AMOXICILLINE 0-WATER 500 mg/stuk ; KALIUMCLAVULANAAT 148,9 mg/stuk SAMENSTELLING overeenkomend met ; CLAVULAANZUUR 125 mg/stuk
Filmomhulde tablet
BASISCH GEBUTYLEERD METHACRYLAAT COPOLYMEER (E 1205) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), BASISCH GEBUTYLEERD METHACRYLAAT COPOLYMEER ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
Amoxicillin and beta-lactamase inhibitor
2019-04-11
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMOXICILLINE/CLAVULAANZUUR POLPHARMA 500 MG/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 (or for your child). 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. WHAT IS IN THIS LEAFLET 1. What Amoxicilline/Clavulaanzuur Polpharma is and what it is used for 2. What you need to know before you take Amoxicilline/Clavulaanzuur Polpharma 3. How to take Amoxicilline/Clavulaanzuur Polpharma 4. Possible side effects 5. How to store Amoxicilline/Clavulaanzuur Polpharma 6. Contents of the pack and other information 1. WHAT AMOXICILLINE/CLAVULAANZUUR POLPHARMA IS AND WHAT IT IS USED FOR Amoxicilline/Clavulaanzuur Polpharma 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. Amoxicilline/Clavulaanzuur Polpharma 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 AMOXICILLINE/CLAVULAANZUUR POLPHARMA DO NOT TAKE AMOXICILLINE/CLAVULAANZUUR POLPHARMA: • if you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine ( Lugege kogu dokumenti
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amoxicilline/Clavulaanzuur Polpharma 500 mg/125 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin ( _Amoxicillinum_ ) and potassium clavulanate equivalent to 125 mg clavulanic acid ( _Acidum clavulanicum_ ). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off white 22 mm by 8 mm oblong film-coated tablet with score line. 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 Amoxicillin/clavulanic acid 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 and 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 Amoxicilline/Clavulaanzuur Polpharma 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) 2 • 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. those that provide higher doses of amoxicilli Lugege kogu dokumenti