STRESAM Capsule (2010)

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Περιεχόμενα

1. Name of the medicinal product

STRESAM, capsule.

2. Qualitative and quantitative composition

Active ingredient: Etifoxine hydrochloride 50 mg. For excipients: see 6.1.

3. Pharmaceutical form

Capsule (blue and white).

4.1. Therapeutic indications

Psychosomatic manifestations of anxiety such as autonomic dystonia, notably of a cardiovascular nature.

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 Swallow the capsules with a little amount of water. ...

4.3. Contraindications

States of shock Severely impaired liver and/or renal function Myasthenia

4.4. Special warnings and precautions for use

Warning Because of the presence of lactose, this medicine is contraindicated in patients with congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficit. Precautions Because ...

4.5. Interaction with other medicinal products and other forms of interaction

Inadvisable combinations Alcohol Alcohol increases the sedative effect of these substances. Impaired alertness may make vehicle driving and machinery operation dangerous. Avoid alcoholic drinks and medicines ...

4.6. Pregnancy and lactation

Taking into account the data available, it is preferable as a safety measure to avoid using etifoxine during the pregnancy whatever is the term. Indeed the animal data are reassuring but the clinical data ...

4.7. Effects on ability to drive and use machines

Attention is drawn, of vehicle drivers and machinery operators in particular, to the risks of drowsiness associated with this medicine.

4.8. Undesirable effects

Slight drowsiness, occurring at the start of treatment and disappearing spontaneously with its continuation. Rare skin rashes, very rare allergic reactions in the form of urticaria and angio-edema.

4.9. Overdose

If a massive amount is taken, gastric washout should be the first step, followed by symptomatic treatment if necessary. There is no specific antidote.

5.1. Pharmacodynamic properties

ANTIANXIETY AGENT (N : central nervous system) Etifoxine hydrochloride belongs to the benzoxazines chemical group. As antianxiety agent, it has an autonomic regulatory action. Animal and ...

5.2. Pharmacokinetic properties

Etifoxine hydrochloride is well absorbed by oral route, it does not bind to blood cells, its plasma levels fall slowly in three phases and it is mainly eliminated in urine. Etifoxine hydrochloride crosses ...

5.3. Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, toxicity to reproduction.

6.1. List of excipients

Lactose Talc Microcrystalline cellulose Colloidal silica Magnesium stearate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

STRESAM should be stored under normal conditions of temperature and humidity.

6.5. Nature and contents of container

Capsules contained within heat-formed blister packs consisting of aluminium foil and polyvinyl chloride Cardboard box containing 60 capsules. Box of 60 capsules. A.M.M. 322 857.7 (France) General classification ...

6.6. Special precautions for disposal and other handling

See 4.2.

7. Marketing authorization holder

BIOCODEX, 7 avenue Gallieni, 94250 GENTILLY, FRANCE

8. Marketing authorization number(s)

MA239/00401

9. Date of first authorization / renewal of the authorization

February 28th, 2006

10. Date of revision of the text

July 2010

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