Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
NM Pharma Limited 3/4, Cantrija Complex Triq it-Targa, il-Maghtab Naxxar NXR 6613 , Malta
J01FA09
CLARITHROMYCIN 500 mg
FILM-COATED TABLET
CLARITHROMYCIN 500 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: Romania - 9033/2016/01
Authorised
2024-01-22
Page 1 of 8 PACKAGE LEAFLET Page 2 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FROMILID 500 MG FILM-COATED TABLETS clartihromycin 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 Fromilid is and what it is used for 2. What you need to know before you take Fromilid 3. How to take Fromilid 4. Possible side effects 5. How to store Fromilid 6. Contents of the pack and other information 1. WHAT FROMILID 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. Fromilid 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 TAKE FROMILID DO NOT TAKE FROMILID 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 doctor for advice on alternative medicines. - you are taking medicines called simvastatin or lovastatin (commonly known as statins, used to lower increased blood fats such as cholesterol and triglycerides). - if you are taking a medicine containing lomitapide. - you are Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS Page 1 of 19 1. NAME OF THE MEDICINAL PRODUCT FROMILID 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg of clarithromycin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Oval, biconvex, yellowish-brown film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fromilidfilm-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 Fromilidfilm-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 Page 2 of 19 been conducted using clarithromycin paediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin paediatric Olvassa el a teljes dokumentumot