Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Amoxicillin trihydrate; Potassium clavulanate & avicel (1:1) ph. eur. equivalent to clavulanic acid
Accord Healthcare Ireland Ltd.
J01CR; J01CR02
Amoxicillin trihydrate; Potassium clavulanate & avicel (1:1) ph. eur. equivalent to clavulanic acid
875/125 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor
Not marketed
2013-09-27
1 _ _ PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CO-AMOXICLAV 875 MG/125 MG, FILM-COATED TABLETS (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 Co-amoxiclav is and what it is used for 2. What you need to know before you take Co-amoxiclav 3. How to take Co-amoxiclav 4. Possible side effects 5. How to store Co-amoxiclav 6. Contents of the pack and other information 1. WHAT CO-AMOXICLAV IS AND WHAT IT IS USED FOR Co-amoxiclav _ _ 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. Co-amoxiclav _ _ 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 CO-AMOXICLAV DO NOT TAKE CO-AMOXICLAV: - 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 sk Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 23 February 2023 CRN00DFLM Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Co-amoxiclav 875 mg/125 mg, film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains amoxicillin trihydrate corresponding to 875 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. Co-amoxiclav 875 mg/125 mg tablets are white, capsule shaped, 22.2 mm x 10.2 mm film-coated tablets inscribed with ‘A’ on one side and with ‘6’ and ‘5’ on the other side with a score line in between. 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 Co-amoxiclav 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 Co-amoxiclav 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. formu Կարդացեք ամբողջական փաստաթուղթը