Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
etifoxine (etifoxine hydrochloride)
Biocodex
N05BX03
etifoxine (etifoxine hydrochloride)
50mg
capsules
(60/3x20/) in blister
Prescription
Registered
2018-05-30
1/5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT STRESAM ® 50 MG CAPSULE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Etifoxine hydrochloride ................................................................................................................ 50.00 mg For one capsule. Excipient with known effect: lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Stresam is indicated for the treatment of psychosomatic manifestations of anxiety. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Usually 3 to 4 capsules a day, taken as 2 or 3 divided doses. Treatment duration: a few days to a few weeks. METHOD OF ADMINISTRATION Oral route. Swallow the capsules with a little amount of water. 4.3. CONTRAINDICATIONS - hypersensitivity to the active ingredient or to any of the components listed in section 6.1. - states of shock, - severely impaired liver and/or renal function, - myasthenia. - patients who have had severe cases of hepatitis or cytolytic hepatitis, during previous treatment with etifoxine; - patients who have had severe dermatological reactions, including DRESS syndrome, Stevens Johnson Syndrome (SJS) and dermatitis exfoliative generalized, during previous treatment with etifoxine. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE SPECIAL WARNINGS Because of the presence of lactose, this medicine is contraindicated in patients with lactase deficit. _ _ _Severe dermatological reactions _ Severe dermatological reactions, including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome, Stevens Johnson Syndrome (SJS) and dermatitis exfoliative generalized, have been reported with etifoxine with a very rare frequency. The onset of skin toxicity with STRESAM usually ranged from a few days to 1 month, depending on the reactions. As per post-marketing data, outcome of skin reactions is mostly favorable after etifoxine withdrawal. No fatal outcome due to severe cutaneous adverse reactions Прочитать полный документ