देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
AMOXICILLIN CLAVULANIC ACID
Pinewood Laboratories Ltd,
AMOXICILLIN CLAVULANIC ACID
500/125 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER PINACLAV 500MG/125MG TABLETS AMOXICILLIN AND CLAVULANIC ACID READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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 your child). Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Pinaclav is and what it is used for 2. Before you take Pinaclav 3. How to take Pinaclav 4. Possible side effects 5. How to store Pinaclav 6. Further information 1. WHAT PINACLAV IS AND WHAT IT IS USED FOR Pinaclav 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. Pinaclav is used in adults and children to treat the following infections: 500 mg/125 mg tablets • middle ear and sinus infections • respiratory tract infections • urinary tract infections • skin and soft tissue infections including dental infections • bone and joint infections. 2. BEFORE YOU TAKE PINACLAV DO NOT TAKE PINACLAV: • if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Pinaclav (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 prob पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pinaclav 500mg/125mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of amoxicillin as amoxicillin trihydrate and 125 mg of clavulanic acid as potassium clavulanate. Excipients: also includes sucrose, 0.072mg per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets Yellowish-white or light yellow oblong-formed, biconvex tablet with ‘625’ on one side and an engraved line on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Pinaclav 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 Pinaclav 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 Pinaclav (e.g. those that provide higher doses of amoxicillin and/or पूरा दस्तावेज़ पढ़ें