Nchi: Afrika Kusini
Lugha: Kiingereza
Chanzo: South African Health Products Regulatory Authority (SAHPRA)
Abbott Laboratories S.A. (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS CLARITHROMYCIN 500,0 mg
Registered
2000-01-05
1 PROPOSED PATIENT INFORMATION LEAFLET Read all of this leaflet carefully before you take these tablets. It gives a summary of the information available on this medicine. Keep this leaflet. You may need to read it again. If you have further questions or are not sure about anything, please ask your doctor or pharmacist. This medicine has been prescribed for you personally and you should not share the medicine with other people. It may harm them, even if their symptoms are the same as yours. SCHEDULING STATUS: S4 PROPRIETARY NAME AND DOSAGE FORM: KLACID XL Tablets Clarithromycin WHAT KLACID XL CONTAINS: KLACID XL tablets are modified release tablets, which means that the active ingredient is released slowly from the tablet, so that you have to take them only once a day. Each KLACID XL tablet contains 500 mg clarithromycin (6-o-methyl erythromycin A) as the active ingredient. 2 Other ingredients include: Citric acid, sodium alginate, sodium calcium alginate, lactose, povidone, talc, stearic acid, magnesium stearate, methyl hydroxypropyl cellulose, polyethylene glycol, titanium dioxide (E171), sorbic acid and quinoline yellow dye (E104). WHAT KLACID XL IS USED FOR: KLACID XL is an antibiotic belonging to a group called macrolides. Antibiotics stop the growth of bacteria (bugs) which cause infections. Its use is described below. KLACID XL is used to treat infections such as: 1. Chest infections, such as bronchitis and pneumonia 2. Throat and sinus infections 3. Skin and tissue infections such as cellulitis, folliculitis or erysipelas BEFORE TAKING KLACID XL TABLETS: DO NOT TAKE KLACID XL TABLETS: if you know that you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients in the tablets. Do not take ergotamine or dihydroergotamine tablets or use ergotamine inhalers for migraine while taking KLACID XL. Consult your doctor, pharmacist or other health care professional for advice for advice on alternative medicines. 3 Do not Soma hati kamili
Page 1 of 9 c APPROVED PACKAGE INSERT (APPROVED 01.12.2006) SCHEDULING STATUS 84 PROPRIETARY NAME (AND DOSAGE FORM) KLACID XL MODIFIED RELEASE TABLETS COMPOSITION KLACID XL MODIFIED RELEASE TABLETS: Each tablet contains 500 mg clarithromycin (6-0-methyl erythromycin A) in a homogenous matrix, which provides sustained release during its transit through the gastrointestinal tract. Other inactive ingredients in the tablet include: citric acid anhydrous, sodium alginate, sodium calcium alginate, lactose, povidone K30, talc, stearic acid, magnesium stearate, methylhydroxy propyl cellulose, polyethylene glycol, titanium dioxide and yellow dye E104 Aluminium Lake. Preservative: Sorbic acid 0.01% m/m. PHARMACOLOGICAL CLASSIFICATION A 20 .1.1 - Medium and broad spectrum antibiotics PHARMACOLOGICAL ACTION Clarithromycin is a macrolide antibiotic which exerts its antibacterial action by binding to the c SOS ribosomal sub-units of susceptible bacteria and suppresses protein synthesis . The _in-vitro _antibacterial spectrum of pathogens usually sensitive to clarithromycin is as follows _ (in-vitro _sensitivity does not necessarily imply _in vivo _efficacy) : _Streptococcus agalactiae _ _Streptococcus pyogenes _ _Streptococcus pneumoniae_ _ _ _Legionella pneumophila _ _Mycoplasma pneumoniae _ _Chlamydia trachomatis _ _Branhamella catarrhalis_ Certain strains of _Staphylococcus aureus _ _Haemophilus influenzae_ _Helicobacter (Campylobacter) pylori_ Page 2 of 9 _c_ _Mycobacterium avium _ _Mycobacterium kansasii _ _Mycobacterium chelonae_ _ _ _Mycobacterium intracel/ulare_ Clarithromycin is bactericidal to _ Helicobacter pylori, _ this activity being greater at neutral pH than at acid pH. The principal metabolite of clarithromycin in man and other primates is the 14-hydroxy- clarithromycin metabolite, which also has antibacterial activity. This metabolite is as active or 1-to-2 fold less active than the parent compound for most organisms, except for _H._ _ _ _influenzae _ against which it is twice as active. The parent compound a Soma hati kamili