Sumamed forte powder for oral suspension with banana flavor 200 mg/5 ml bottle 15 ml (600 mg) 1 pc.

Active ingredient: azithromycin;

1 dose (5 ml) of suspension contains 200 mg of azithromycin as azithromycin dihydrate;

Excipients: sucrose, sodium phosphate, hydroxypropylcellulose, xanthan gum, colloidal silicon dioxide,

Flavor(s) and/or colorant: banana flavor, cherry flavor, vanilla flavor or titanium dioxide (E 171), banana flavor, vanilla flavor, or titanium dioxide (E 171), strawberry flavor, or titanium dioxide (E 171), raspberry flavor.

Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any other component of the drug.

Sumamed forte, powder for oral suspension, is used once a day at least 1 hour before or 2 hours after a meal.

If you miss a dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken at 24-hour intervals.

Pregnant women

There are no adequate data on the use of azithromycin in pregnant women. In animal reproductive toxicity studies, azithromycin did not show teratogenic effects on the fetus, but the drug crossed the placenta. The safety of azithromycin during pregnancy has not been confirmed. Therefore, azithromycin should be used during pregnancy only if the benefit outweighs the risk.

Children

Children weighing less than 15 kg are recommended to be prescribed Sumamed (100 mg/5 ml). Sumamed forte is prescribed to children weighing more than 15 kg.

Drivers

There is no evidence that azithromycin can impair the ability to drive or use other mechanisms, but the possibility of developing adverse reactions such as delirium, hallucinations, dizziness, drowsiness, fainting, and seizures, which may affect the ability to drive or use other mechanisms, should be taken into account.

Clinical experience with azithromycin suggests that the side effects that develop when taking higher than recommended doses of the drug are similar to those observed with the use of conventional therapeutic doses. They may include diarrhea, nausea, vomiting, reversible hearing loss. In case of overdose, if necessary, it is recommended to take activated charcoal and carry out general symptomatic and supportive measures.

From the nervous system: often (≥ 1/100 to <1/10) – headache.

Gastrointestinal tract: very often (≥ 1/10) – diarrhea; often (≥ 1/100 to <1/10) – vomiting, abdominal pain, nausea.

Antacids: In a study of the effect of concomitant administration of antacids on the pharmacokinetics of azithromycin, there was generally no change in bioavailability, although the maximum plasma concentration of azithromycin was reduced by approximately 25%. Azithromycin and antacids should not be taken simultaneously.

Cetirizine: In healthy volunteers, coadministration of azithromycin for 5 days with cetirizine 20 mg at steady state did not result in any pharmacokinetic interaction or significant changes in the QT interval.

Didanosine: Coadministration of daily doses of 1200 mg azithromycin with 400 mg didanosine per day in six HIV-positive volunteers had no effect on the steady-state pharmacokinetics of didanosine compared to placebo.

Digoxin and Colchicine: Concomitant administration of macrolide antibiotics, including azithromycin, and P-glycoprotein substrates such as digoxin and colchicine has been reported to increase serum levels of the P-glycoprotein substrate. Therefore, the potential for increased serum substrate concentrations should be considered when azithromycin is coadministered with a P-glycoprotein substrate such as digoxin.

Store at a temperature not exceeding 25 °C out of the reach of children.

Store the prepared suspension at a temperature not exceeding 25 °C.

Shelf life – 2 years.

The shelf life of the finished suspension is 5 days (15 ml), 10 days (30 ml, 37.5 ml).