País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Clarithromycin
Viatris Healthcare Limited
J01FA; J01FA09
Clarithromycin
Modified-release tablet
Macrolides; clarithromycin
Marketed
1997-03-21
Package leaflet: Information for the patient KLACID LA 500 MG MODIFIED RELEASE TABLETS (CLARITHROMYCIN) 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 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 Klacid LA is and what it is used for 2. What you need to know before you take Klacid LA 3. How to take Klacid LA 4. Possible side effects 5. How to store Klacid LA 6. Contents of the pack and other information 1. WHAT KLACID LA IS AND WHAT IT IS USED FOR Klacid LA is an antibiotic belonging to a group called the macrolides. Antibiotics stop the growth of certain germs that cause infections. Its use is described below. Klacid LA tablets are modified release tablets, which means that the active ingredient is released slowly from the tablet so that you only have to take the medicine once a day. WHAT ARE KLACID LA TABLETS USED FOR? The Klacid LA tablets are used to treat infections such as: 1. Chest infections such as bronchitis and pneumonia 2. Throat and sinus infections 3. Skin and soft tissue infections, which may also be called cellulitis, folliculitis or erysipelas. Klacid LA Tablets are used in adults and children 12 years and older. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLACID LA DO NOT TAKE KLACID LA TABLETS − If you know that you are allergic to clarithromycin or other antibiotics from the same drug class (macrolide antibiotics) such as erythromycin or azithromycin, or if you are allergic to any of the other ingredients of this medicine (listed in section 6). − If you are taking ergot alkaloids (e.g. ergotamine or dihydroergotam Llegiu el document complet
Health Products Regulatory Authority 20 March 2024 CRN00F5XF Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Klacid LA 500mg Modified release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Clarithromycin 500 mg Excipients with known effect: lactose and sodium Each tablet contains 115 mg lactose monohydrate and 15.3 mg sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified release tablet. Yellow, ovaloid modified-release tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Klacid LA is indicated in adults and children aged 12 years and older for the treatment of the following infections caused by susceptible organisms (see section 5.1). Lower respiratory tract infections for example bronchitis and pneumonia (see section 4.4). Upper respiratory tract infections for example sinusitis and pharyngitis. Skin and soft tissue infections for example folliculitis, cellulitis and erysipelas (see section 4.4). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: The usual recommended dosage of Klacid LA in adults is one 500 mg modified‑release tablet daily to be taken with food. In more severe infections, the dosage can be increased to two 500 mg modified-release tablets taken as one dose daily. Dose must be taken at the same time every day. Tablets must be swallowed whole. The usual duration of treatment is 6 to 14 days. CHILDREN OLDER THAN 12 YEARS: As for adults. CHILDREN YOUNGER THAN 12 YEARS: The use of Klacid LA has not been studied in children less than 12 years of age. Clinical trials have been conducted using clarithromycin paediatric suspension in children 6 months to 12 years of age. Use of Klacid LA is not recommended for children younger than 12 years. Therefore, children under 12 years of age should use clarithromycin paediatric suspension (granules for oral suspension). PATIENTS WITH RENAL IMPAIRMENT: In pat Llegiu el document complet