Sumamed of the tab. of p/o of 500 mg No. 3

Drug "Sumamed ^® " is applied at the infections caused by the microorganisms sensitive to azithromycin:

• ENT organs (bacterial pharyngitis / tonsillitis, sinusitis, average otitis);
• respiratory infection (bacterial bronchitis, community-acquired pneumonia);
• an infection of leather and soft tissues: the migrating erythema (initial stage of a disease of Lyme), an ugly face, impetigo, secondary pyodermatoses, an acne vulgaris (eels ordinary) moderate severity;
• an infection, sexually transmitted: the uncomplicated genital infections caused by Chlamydia trachomatis .

Structure

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

Excipients: calcium phosphate disubstituted waterless, a hydroksipropilmetiltsellyuloza, starch corn, the starch modified, cellulose microcrystalline, sodium lauryl sulfate, magnesium stearate, indigotin (E 132), the titan dioxide (E 171), polysorbate 80, talc.

Contraindication

Hypersensitivity to azithromycin, erythromycin, to any makrolidny or ketolidny antibiotic and also to any other component of medicine.

Route of administration

"Sumamed ^® ", tablets on 500 mg, it is necessary to apply in the form of a single daily dose irrespective of meal. To swallow of tablets without chewing. In case of the admission of reception of 1 dose of medicine it is necessary to accept the passed dose as soon as possible, and the subsequent - with an interval of 24 hours.

Adults and children with body weight ≥ 45 kg.

In infections of ENT organs, airways, skin and soft tissues (except the chronic migrating erythema) the general dose of azithromycin makes 1500 mg (500 mg of 1 times a day). Duration of treatment is 3 days.

In an acne vulgaris the recommended general dose of azithromycin makes 6 g which should be accepted according to the following scheme: 1 tablet on 500 mg of 1 times a day within 3 days, then - 1 tablet on 500 mg once a week within 9 weeks. A dose of the second week it is necessary to take in seven days after the first reception a pill, and 8 subsequent doses should be accepted with intervals in 7 days.

At the migrating erythema the general dose of azithromycin makes 3 g which should be accepted according to the following scheme: 1 g (2 tablets on 500 mg once) in the first day, then - on 500 mg of 1 times a day from the 2nd to the 5th day.

In infections, sexually transmitted, the recommended dose of azithromycin makes 1000 mg (2 tablets on 500 mg once).

Feature of application

Pregnant women

Are not present adequate data on use of azithromycin to pregnant women. In researches of reproductive toxicity at animals of a teratogenic adverse effect of azithromycin on a fruit it is noted, however medicine got through a placenta. Safety of use of azithromycin during pregnancy is not confirmed. Therefore azithromycin is appointed during pregnancy, only if the advantage exceeds risk.

Feeding by a breast. It was reported, that azithromycin gets into breast milk, but corresponding and properly controlled clinical trials which would give the chance to characterize pharmacokinetics of excretion of azithromycin in breast milk, was not carried out.

Fertility. The research of fertility was conducted on rats; the indicator of pregnancy decreased after administration of azithromycin. The relevance of these data on the person is unknown.

Children

"Sumamed ^® ", tablets on 500 mg, children should apply with body weight ≥ 45 kg. For this group of children it is recommended to appoint an adult dose.

Drivers

Proof that azithromycin can worsen ability to steer motor transport or other mechanisms are absent, but it is necessary to consider a possibility of development of side reactions, such as delirium, hallucinations, dizziness, drowsiness, a faint, spasms which can affect ability to steer motor transport or other mechanisms.

Overdose

Experience of clinical use of azithromycin demonstrates to what side effects which develop at reception of higher than is recommended, medicine doses, are similar to those that are observed at application of usual therapeutic doses. They can include diarrhea, nausea, vomiting, a reverse hearing loss. In case of overdose if necessary intake of activated carbon and performing the general symptomatic and supporting treatment is recommended.

Side reactions

In the following table according to a class of systems and bodies and frequencies it is specified by p the side reactions defined in clinical trials and in the period of post-marketing observation observed at application of all dosage forms of azithromycin. The side reactions registered in the period of post-marketing observation are italicized. Groups on the frequency of manifestations were determined by the following scale: very often (≥ 1/10); often (≥ 1/100 to <1/10); infrequently (≥ 1/1000 to <1/100); seldom (≥ 1/10000 to <1/1000), it is very rare (<1/10000); it is unknown (it is impossible to determine by the available data). Within each group on the frequency of manifestations the undesirable phenomena are specified as reduction of their weight.

Side reactions perhaps or possibly connected with azithromycin, on the basis of the data obtained during clinical trials and during post-marketing observation.

Information on side effects which, perhaps, are connected with prevention and treatment Mycobacterium Avium Complex , is based on data of clinical trials and observations during the post-marketing period. These undesirable reactions differ on type or on frequency from about what it was reported at application of high-speed dosage forms and dosage forms of long action.

Undesirable reactions which are perhaps connected with prevention and treatment of Mycobacterium Avium Complex.

Storage conditions

Drug does not demand special storage conditions. To store out of children's reach.

Expiration date - 3 years.