Država: Malta
Jezik: engleski
Izvor: Medicines Authority
CLARITHROMYCIN
Mylan Products Limited
J01FA09
CLARITHROMYCIN
MODIFIED-RELEASE TABLET
CLARITHROMYCIN 500 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
LEAFLET: PATIENT INFORMATION KLACID ® XL 500 MODIFIED-RELEASE TABLETS Clarithromycin READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS INFORMATION THAT IS IMPORTANT FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any questions, ask your doctor or pharmacist. - This medicine has been prescribed for you alone. Do not pass it on to other people, even if their symptoms are the same as yours, because it could be dangerous. - If you develop any side effects including any that are not listed in this leaflet, please contact your doctor or pharmacist. See section 4. IN THIS LEAFLET: 1. What KLACID XL is and what it is used for 2. What you need to know before you take KLACID XL 3. How to take KLACID XL 4. Potential side effects 5. How to store KLACID XL 6. Contents of the pack and other information 1. WHAT KLACID XL IS AND WHAT IT IS USED FOR KLACID XL contains clarithromycin, an active ingredient belonging to a group of drugs called antibiotic macrolides. Antibiotics are drugs that stop the growth of bacteria that cause infections. KLACID XL is used to treat: respiratory infections, such as bronchitis and pneumonia; throat infections (tonsillitis, pharyngitis) and sinus infections; skin and tissue infections, for instance impetigo, folliculitis, erysipelas, furunculosis and infected wounds; KLACID XL is a medicine in modified-release tablets, this means that the active ingredient is released from the tablet slowly. This means KLACID XL can be taken just once a day. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLACID XL DO NOT TAKE KLACID XL IF: you are allergic to clarithromycin or other kinds of macrolide antibiotics, such as erythromycin or azithromycin, or any of the other components of this medicine (listed in section 6); you are taking ergotamine or dihydroergotamine, drugs that are used for migraine. The combination of these drugs with KLACID XL could cause serious side effects. Speak with your doctor who will recommend alternative medic Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT KLACID XL 500 mg Modified-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains: active ingredient: clarithromycin 500 mg; excipients with known effects: lactose (115 mg per tablet). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release tablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Consideration should be given to official guidance on the appropriate use of antibacterial agents. KLACID is indicated in adults and children aged 12 years and older. Treatment of infections caused by pathogens susceptible to clarithromycin. Infections of the rhino-pharyngeal tract (tonsillitis, pharyngitis), paranasal sinuses. Infections of the lower respiratory tract: bronchitis, bacterial pneumonia and atypical pneumonia. Skin and soft tissue infections: impetigo, erysipelas, folliculitis, furunculosis and infected wounds; 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose for ADULTS AND CHILDREN OVER 12 YEARS OF AGE is 1 tablet per day to be taken with food. For more severe infections, the dosage may be increased up to 2 modified-release 500 mg tablets per day to be taken in a single administration. The usual duration of therapy is 5 - 14 days, excluding any treatment for community-acquired pneumonia and sinusitis which requires 6 - 14 days of therapy. _Paediatric population _ IN CHILDREN UNDER 12 YEARS OF AGE, the use of KLACID modified-release tablets is not recommended. In these patients USE KLACID 125 MG/5 ML GRANULES FOR ORAL SUSPENSION OR KLACID 250 MG/5 ML GRANULES FOR ORAL SUSPENSION. _Patients with renal impairment_ In patients suffering from renal impairment with creatinine clearance of less than 30 mL/min, the dosage of clarithromycin should be reduced by half, for instance 250 mg once daily, or 250 mg twice daily for severe infections. In these patients, treatment should not be extended beyond 14 days. Since the tablet is not abl Pročitajte cijeli dokument