Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Clarithromycin
KRKA, d.d., Novo mesto
J01FA; J01FA09
Clarithromycin
250 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Macrolides; clarithromycin
Not marketed
2017-01-13
smer v lak en 70 mm ± 0,5 mm smer branja kode _NA.CLARITHROMYCIN KRKA _ _FCT IE _ prva s tr an smer branja kode 70 mm ± 0,5 mm PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CLARITHROMYCIN KRKA 250 MG FILM-COATED T ABLE TS CLARITHROMYCIN KRKA 500 MG FILM-COATED T ABLE TS clar tihr om y cin 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 Clarithromycin Krka is and what it is used for 2. What you need to know before you take Clarithromycin Krka 3. How to take Clarithromycin Krka 4. Possible side effects 5. How to store Clarithromycin Krka 6. Contents of the pack and other information 1. WHAT CLARITHROMYCIN KRKA IS AND WHAT IT IS USED FOR Clarithromycin belongs to a group of medicine called macrolide antibiotics. Antibiotics stop the growth of bacteria which cause infections. Clarithromycin Krka is used in adults and children 12 years and older to treat following infections: • Chest infections such as bronchitis and pneumonia, • Throat and sinus infections, • Skin and soft tissue infections, _• _ _Helicobacter pylori _infections associated with duodenal ulcers. 2. WHAT YOU NEED TO KNOW BEFORE YOU T AK E CLARITHROMYCIN KRK A DO NOT TAKE CLARITHROMYCIN KRKA 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. • you are taking medicines called ergot alkaloids, for example ergotamine or dihydroergotamine tablets or use ergotamine inhalers for migraine. Consult your do Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 24 June 2021 CRN00C91Q Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarithromycin Krka 250 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg clarithromycin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Oval, biconvex, slightly brownish yellow film-coated tablets of 15 to 15.2 mm in length and 8 mm in width. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin Krka film-coated tablets are indicated for the treatment of the following bacterial infections in adults and children 12 years and older, when caused by clarithromycin-susceptible bacteria (see section 4.4 and 5.1). • Bacterial pharyngitis • Mild to moderate community acquired pneumonia • Acute bacterial sinusitis (adequately diagnosed) • Acute exacerbation of chronic bronchitis • Skin infections and soft tissue infections of mild to moderate severity • In appropriate combination with antibacterial therapeutic regimens and an appropriate ulcer healing agent for the eradication of Helicobacter pylori in patients with Helicobacter pylori associated ulcers (see section 4.2) Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage of Clarithromycin Krka film-coated tablets depends on the type and severity of the infection and has to be defined in any case by the physician. Patients with respiratory tract/skin and soft tissue infections: _Adults and adolescents (12 years and older)_ The usual recommended dosage of clarithromycin in adults is one 250mg tablet twice daily. In more severe infections, the dosage can be increased to 500mg twice daily. The usual duration of therapy is 6 to 14 days. _Children younger than 12 years:_ The use of clarithromycin tablets has not been studied in children under 12 years. Clinical trials have been conducted using clarithromycin Διαβάστε το πλήρες έγγραφο