מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clarithromycin
Sandoz Ltd
J01FA09
Clarithromycin
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010500; GTIN: 05015915944023 5015915944061
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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. Clarithromycin is an antibiotic which belongs to the group of macrolide antibiotics. It stops the growth of certain bacteria. Clarithromycin is used to treat: • Infections of the respiratory tract (nose, throat and lungs) such as pneumonia, bronchitis, sinusitis and pharyngitis. • Mild to moderate skin and soft tissue infections. • It can also be used, in combination with other antibacterials and appropriate ulcer healing agents, to eradicate H. pylori infections. Do not take Clarithromycin • if you are allergic to clarithromycin, other macrolide antibiotics or to any of the other ingredients of this medicine (listed in section 6). • if you or someone in your family has a history of heart rhythm disorders (ventricular arrhythmia, including torsades de pointes) or abnormality of electro-cardiogram (ECG, electrical recording of the heart) called “long QT syndrome”. • if you suffer from severe liver failure and kidney problems at the same time • if you have abnormally low levels of potassium in your blood (hypokalaemia) • if you are taking - ticagrelor (to prevent blood clotting) - ranolazine (used to treat angina pectoris) - ergotamine, dihydroergotamine (medicines to treat migraine) - cisapride (gastric medicine) - pimozide (antipsychotic) - terfenadine or astemizole (hay fever, antiallergics) - lovastatin, simvastatin (medicines to lower cholesterol) - colchicine (to treat gout). - other medicines which are קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarithromycin 500mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 500mg Clarithromycin For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. light yellow, film-coated, oval shaped tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin film-coated tablets is indicated in adults and adolescents 12 years and older for the treatment of the following bacterial infections, when caused by clarithromycin-susceptible bacteria (see section 4.4 and 5.1). • Acute bacterial exacerbation of chronic bronchitis • Mild to moderate community acquired pneumonia. • Acute bacterial sinusitis • Bacterial pharyngitis. • Skin infections and soft tissue infections of mild to moderate severity, such as folliculitis, cellulitis and erysipelas Clarithromycin film-coated tablets can also be used 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 The dosage of Clarithromycin film-coated Tablets depends on the clinical condition of the patient and has to be defined in any case by the physician. _Children older than 12 years and adults: _ • Standard dosage: The usual dose is 250 mg twice daily. • High dosage treatment (severe infections): The usual dose may be increased to 500 mg twice daily in severe infections. • Clinical trials have been conducted using clarithromycin pediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin pediatric suspension (granules for oral suspension). _Elimination of Helicobacter pylori in adults: _ In patients with gastro-duodenal ulcers due to H. קרא את המסמך השלם