Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
potassium clavulanate; Amoxicillin trihydrate
Rowex Ltd
J01CR; J01CR02
potassium clavulanate; Amoxicillin trihydrate
125 mg/31.25 mg/5ml
Powder for oral suspension
Product subject to prescription which may not be renewed (A)
Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor
Not marketed
2003-03-21
PACKAGE LEAFLET: INFORMATION FOR THE USER AMOCLAV 250MG/125MG 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 or nurse. - 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET 1. What Amoclav is and what it is used for 2. What you need to know before you take Amoclav 3. How to take Amoclav 4. Possible side effects 5. How to store Amoclav 6. Contents of the pack and other information 1. WHAT AMOCLAV IS AND WHAT IT IS USED FOR Amoclav 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. Amoclav 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 AMOCLAV DO NOT TAKE AMOCLAV: • if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Amoclav (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 neck. • if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. ➔ DO NOT TAKE AMOCLAV IF ANY OF THE ABOVE APPLY TO YOU. If you are not sure, talk to your doctor or phar Soma hati kamili
Health Products Regulatory Authority 22 March 2023 CRN00DFVY Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoclav 125mg/31.25mg per 5ml Powder for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 5ml reconstituted suspension contains: Amoxicillin trihydrate equivalent to 125 mg amoxicillin. Potassium clavulanate equivalent to 31.25 mg clavulanic acid. Excipients: Each 5ml reconstituted suspension contains 8.5 mg aspartame, 0.13 mg sorbitol (E420), 0.1001 microgram sulphur dioxide (E220), and 0.7 mg glucose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension. Off-white granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoclav 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 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 Amoclav 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 Amoclav (e.g. those that provide higher doses of amoxicillin and/ or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see se Soma hati kamili