Stresam capsules

Country: Հայաստան

language: անգլերեն

source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

active_ingredient:

etifoxine (etifoxine hydrochloride)

MAH:

Biocodex

ATC_code:

N05BX03

INN:

etifoxine (etifoxine hydrochloride)

dosage:

50mg

pharmaceutical_form:

capsules

units_in_package:

(60/3x20/) in blister

prescription_type:

Prescription

authorization_status:

Registered

authorization_date:

2018-05-30

SPC

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