Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Amoxicillin; Clavulanic acid
Bluefish Pharmaceuticals AB
J01CR; J01CR02
Amoxicillin; 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
Marketed
2009-11-06
1.3.1 SPC, LABELLING AND PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER CO-AMOXICLAV BLUEFISH 875 MG/125 MG FILM-COATED TABLETS (Amoxicillin and 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 Bluefish is and what it is used for 2. What you need to know before you take Co-amoxiclav Bluefish 3. How to take Co-amoxiclav Bluefish 4. Possible side effects 5. How to store Co-amoxiclav Bluefish 6. Contents of the pack and other information 1. WHAT CO-AMOXICLAV BLUEFISH IS AND WHAT IT IS USED FOR Co-amoxiclav Bluefish 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 Bluefish 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 BLUEFISH DO NOT TAKE CO-AMOXICLAV BLUEFISH : • if you are allergic (hypersensitive) to amoxicillin, clavulanic acid or any of the other ingredients of this medicine (listed in section 6). 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET • severe allergic (hypersensitive) rea Прочитать полный документ
Health Products Regulatory Authority 05 April 2023 CRN00DFS0 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Co-amoxiclav Bluefish 875 mg/125 mg film- coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 1006.25 mg amoxicillin trihydrate equivalent to 875 mg amoxicillin and potassium clavulanate equivalent to 125 mg - clavulanic acid. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. A white, elongated capsule shaped film coated tablets with breakline on both sides.. The scoreline is only to facilitate breaking for ease of swallowing and not to divide in to 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 Dosages 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. those that provide higher doses of amoxicillin and/or different ra Прочитать полный документ