Sumamed dispersible tablets 500 mg blister 3 pcs.

1 tablet contains 500 mg of azithromycin (active ingredient) in the form of azithromycin dihydrate.

Excipients: saccharin sodium dihydrate, microcrystalline cellulose, crospovidone (type A), povidone, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, aspartame (E 951), orange flavor.

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

Administer orally 1 hour before or 2 hours after meals. If a dose is missed, the missed dose should be taken as soon as possible, and subsequent doses should be taken at 24-hour intervals.

Disperse the tablet in at least 50 ml of water. Stir the resulting suspension thoroughly before use.

Adults and children over 12 years of age with a body weight ≥ 45 kg.

For infections of the ENT organs, respiratory tract, skin and soft tissues (except chronic migratory erythema), the total dose of azithromycin is 1500 mg (500 mg 1 time per day). The duration of treatment is 3 days.

For erythema migrans, the total dose of azithromycin is 3 g, which should be taken according to the following scheme: 1000 mg on the first day, then 500 mg once a day from the 2nd to the 5th day.

For sexually transmitted infections, the recommended dose of azithromycin is 1000 mg once.

Children 3-12 years old with a body weight <45 kg.

For infections of the ENT organs, respiratory tract, skin and soft tissues (except chronic migratory erythema), azithromycin is used at the rate of 10 mg/kg of body weight once a day for 3 days (the total dose of azithromycin is 30 mg/kg).

Dose calculation for children weighing <45 kg.

Children under 3 years of age are recommended to use “Sumamed”^, powder for oral suspension (100 mg / 5 ml), or “Sumamed forte”, powder for oral suspension (200 mg / 5 ml). For pharyngitis / tonsillitis caused by Streptococcus pyogenes, the drug “Sumamed” is used at a dose of 20 mg / kg / day for 3 days (course dose 60 mg/kg). The maximum daily dose is 500 mg / day.

For erythema migrans, azithromycin is used at a dose of 20 mg/kg once a day on the first day, followed by 10 mg/kg once a day from the 2nd to the 5th day.

For the convenience of using a course dose of 60 mg/kg, children are recommended to use Sumamed® ^, powder for oral suspension (100 mg/5 ml), or Sumamed forte, powder for oral suspension (200 mg/5 ml).

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 established. Therefore, azithromycin should be used during pregnancy only if the benefit outweighs the risk.

Azithromycin has been reported to pass into breast milk, but adequate and well-controlled clinical studies have not been conducted to characterize the pharmacokinetics of azithromycin excretion into breast milk.

Fertility studies have been performed in rats; pregnancy rates were reduced following administration of azithromycin. The relevance of these findings to humans is unknown.

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 dizziness, drowsiness, and visual disturbances should be taken into account.

Clinical experience with azithromycin suggests that adverse reactions occurring at higher than recommended doses are similar to those seen at usual therapeutic doses. These may include diarrhoea, nausea, vomiting, and reversible hearing loss. In the event of overdose, administration of activated charcoal and general symptomatic and supportive measures are recommended.

The following table lists adverse reactions identified from clinical trials and post-marketing surveillance with all formulations of azithromycin. Adverse reactions are listed by system organ class and frequency. Adverse reactions reported during post-marketing surveillance are in italics. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000); not known (frequency cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Adverse reactions possibly related to azithromycin based on data obtained during clinical trials and during post-marketing surveillance.

Information on adverse reactions possibly associated with the prevention and treatment of Mycobacterium Avium Complex is based on clinical trial data and post-marketing surveillance. These adverse reactions differ in type or frequency from those reported with the immediate-release and long-release formulations.

Adverse reactions possibly associated with the prevention and treatment of Mycobacterium Avium Complex.

The drug does not require special storage conditions. Keep out of the reach of children.

Shelf life – 2 years.