tablets Agnesti® apply to treatment of big depressive episodes at adults.

Structure

Active ingredient: agomelatin.

1 tablet supports a sokristall of an agomelatin and citric acid – 44.739 mg (in terms of agomelatin – 25 mg).

Excipients: cellulose microcrystalline silikatizirovanny, a mannitol (E 421), povidone 30, silicon dioxide colloidal anhydrous, krospovidon (type A), the sodium stearylfumarating, magnesium stearate, stearic acid 50, a gipromeloz (hydroksipropilmetiltsellyuloz) 2910/5, polyethyleneglycol (macrogoal) 6000, the titan dioxide (E 171), talc, ferrous oxide yellow (E 172).

Contraindication

Hypersensitivity to active ingredient or any excipient of drug.

Abnormal liver function (cirrhosis or an active phase of a disease of a liver) or increase in level of transaminases more than by 3 times from the upper bound of indicators of norm.

Use in a combination with CYP1A2 inhibitors (fluvoksamin, ciprofloxacin).

Route of administration

For oral administration.

Agnesti's

, a tablet, film coated, it is possible to apply irrespective of meal.

Recommended dose makes 25 mg of 1 times a day, before going to bed.

If in 2 weeks after the beginning of therapy of improvement of a clinical state is not enough

, the dose can be raised to 50 mg of 1 times a day, that is 2 tablets on 25 mg which need to be accepted at the same time before going to bed.

should appoint

Agnesti® by

Feature of use

with care and to watch carefully all patients during the treatment period, especially with risk factors of an abnormal liver function or in case of simultaneous use of medicines which can cause developing of abnormal liver functions.

Pregnant

It is desirable for p to avoid use of Agnesti® medicine during pregnancy.

Children

does not recommend to appoint

medicament Agnesti® for treatment of a depression at children as safety and efficiency of an agomelatin are not established in this group of patients.

Drivers

to Patients should be careful at control of motor transport or work with mechanisms.

Overdose

Amount of data on cases of overdose of an agomelatin is limited to

. At overdose of an agomelatin the dizziness, cyanosis or an indisposition was reported about developing of pain in epigastric area, drowsiness, fatigue, agitation, a disturbing state, tension. It was recorded 1 case of reception of 2450 mg of an agomelatin - recovery occurred spontaneously without cardiovascular and biological deviations.

Side reactions

Most frequent side reactions were a headache, nausea and dizziness. These side reactions usually were temporary and, as a rule, did not lead to the therapy termination.

Interaction

was not obtained by

In clinical trials of the I phase in target group of patients data about pharmacokinetic and pharmakodinamichesky interaction with medicines which it is possible to appoint at the same time with agomelatiny: benzodiazepines, lithium, paroksetin, flukonazol and theophylline.

Storage conditions

to Store

in original packing for protection against moisture. Does not demand temperature restrictions. To store out of children's reach.

Expiration date - 2 years.