Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clarithromycin
Milpharm Ltd
J01FA09
Clarithromycin
250mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010500; GTIN: 8901175023172
CLARITHROMYCIN 250 MG FILM-COATED TABLETS CLARITHROMYCIN 500 MG FILM-COATED TABLETS Clarithromycin PACKAGE LEAFLET: INFORMATION FOR THE USER 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 is and what it is used for 2. What you need to know before you take Clarithromycin 3. How to take Clarithromycin 4. Possible side effects 5. How to store Clarithromycin 6. Contents of the pack and other information. Clarithromycin belongs to a group of medicine called macrolide antibiotics. Antibiotics stop the growth of bacteria which cause infections. Clarithromycin is used 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. DO NOT TAKE CLARITHROMYCIN IF: • you are ALLERGIC to clarithromycin, other macrolide antibiotics or any of the other ingredients of this medicine (listed in section 6). • you have a history of certain abnormal HEART RHYTHMS (ventricular arrhythmia, including torsades de pointes) or changes in the heart activity as measured in the electro- cardiogram called “QT prolongation”, • you suffer from severe liver failure and kidney problems at the same time, • You are taking medicines called terfenadine or astemizole (for hay fever or allergies) or cisapride or pimozide tablets as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on altern Läs hela dokumentet
OBJECT 1 CLARITHROMYCIN 250 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 06-Apr-2017 | Aurobindo Pharma - Milpharm Ltd. 1. Name of the medicinal product Clarithromycin 250 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 250 mg of clarithromycin For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet Light yellow coloured, oval shaped, biconvex film-coated tablets, with 'D' debossed on one side and '62' on the other side. The size is 15.1 mm x 7.1 mm 4. Clinical particulars 4.1 Therapeutic indications Clarithromycin film-coated tablets are indicated for the treatment of the following bacterial infections, 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 film-coated tablets depends on the type and severity of the infection and has to be defined in any case by the physician. Adults and adolescents (12 years and older) • Standard dosage: The usual dose is 250 mg twice daily (in the morning and in the evening) • High dosage treatment (severe infections): The usual dose may be increased to 500 mg twice daily in severe infections. Children younger than 12 years: Use of Clarithromycin film-coated tablets is not recommended for children younger than 12 years with a body weight less than 30 kg. Clinical trials have been conducted using cla Läs hela dokumentet