Some observational studies have identified a rare short-term risk of arrhythmia, myocardial infarction and cardiovascular mortality associated with macrolides including clarithromycin. When saquinavir is co-administered with ritonavir, consideration should be given to the potential effects of ritonavir on clarithromycinThe safety of clarithromycin for use during pregnancy has not been established. In rats, the limited data available do not indicate any effects on fertility.There are no data on the effect of clarithromycin on the ability to drive or use machines. Concomitant administration with ticagrelor or renolazine is contraindicated.Concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated, as this may result in ergot toxicity. There are insufficient data to recommend a dosage regimen for use of the clarithromycin IV formulation in patients less than 18 years of age.Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.In AIDS and other immunocompromised patients treated with the higher doses of clarithromycin over long periods of time for mycobacterial infections, it was often difficult to distinguish adverse events possibly associated with clarithromycin administration from underlying signs of Human Immunodeficiency Virus (HIV) disease or intercurrent illness.In adult patients, the most frequently reported adverse reactions by patients treated with total daily doses of 1,000 mg and 2,000 mg of clarithromycin were: nausea, vomiting, taste perversion, abdominal pain, diarrhea, rash, flatulence, headache, constipation, hearing disturbance, Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvate Transaminase (SGPT) elevations. Applies to the following strengths: 250 mg; 500 mg; 125 mg/5 mL; 250 mg/5 mLImmediate-release: 250 mg orally every 12 hours for 10 daysImmediate-release: 500 mg orally every 12 hours for 14 daysImmediate-release: 250 mg orally every 12 hours for 7 to 14 daysImmediate-release: 250 mg orally every 12 hours for 7 to 14 daysCrCl less than 30 mL/min: Dose should be reduced by 50%.Safety and efficacy have not been established in patients younger than 6 months. Because of the large therapeutic window for clarithromycin, no dosage reduction should be necessary in patients with normal renal function. Caution should be exercised when prescribing clarithromycin with statins. For patients with moderate renal function (creatinine clearance 30 to 60 mL/min), the dose of clarithromycin should be decreased by 50%. It allows continued monitoring of the benefit/risk balance of the medicinal product. Electrocardiograms should be monitored for QT prolongation during co-administration of clarithromycin with these drugs. • Patients concomitantly taking other medicinal products associated with QT prolongation (see section 4.5). Doses of clarithromycin greater than 1000 mg per day should not be co-administered with protease inhibitors.Caution is advised regarding the concomitant administration of clarithromycin and calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem) due to the risk of hypotension. • 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.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. Steady state concentrations of the active metabolite 14-OH-clarithromycin were not significantly affected by concomitant administration of fluconazole.

The therapy may be repeated if the patient is still H. pylori-positiveThe duration of therapy with Clarithromycin film-coated tablets depends on the type and severity of the infection and has to be defined in any case by the physician. Due to its chemical structure (6-O-Methylerythromycin) clarithromycin is quite resistant to degradation by stomach acid.