STRESAM® Etifoxine Capsules 50 mg

Read this leaflet thoroughly, please, before first use of the drug!
Keep this leaflet. You may read it once more.

If you have any questions, consult your doctor, please.

This drug has been prescribed only for you. Don't give it other persons. It may be harmful for them, even they have the same symptoms.

Composition of the drug:
Active ingredient: etifoxine hydrochloride;
Each capsule contains etifoxine hydrochloride 50 mg;

excipients: lactose monohydrate, talc, microcrystalline cellulose, colloidal silica, magnesium stearate.

Pharmacotherapeutic group. Anxiolytic.
Pharmacological properties. Etifoxine hydrochloride in therapeutical doses possesses anxiolytic, Etifoxine hydrochloride does not influence the velocity of the psychomotor reactions, and might be used as a diurnal tranquillizer.

- Stressory neurasthenic disorders accompanied with anxiety, fear and unrest.
- Anxio-phobic disturbances.
- Vegetative disorders with moderate fear, apathy, decreased activity.

Contraindications. Hypersensitivity to any ingredient of the drug, shock condition, myasthenia, severe disorders in the liver and/or kidneys; the drug includes lactose, so it is not recommended to prescribe the patients with congenital galactosemia, syndromes of glucose and galactose malabsorption or lactose deficit; pregnancy and lactation period.

Precautions when using. Is not prescribed for children under 15 years as there is no sufficient clinical studies conducted. Cessation of treatment with Strezam® does not cause the withdrawal syndrome. Strezam® does not influence the velocity of the psychomotor reactions, but considering significant individual reactions, one could not exclude a possibility of temporal worsening in ability to drive and use potentially hazard mechanisms during therapy with this drug. It is not recommended to use alcohol or other substances of central action (haloperidol, diazepam, imipramin) during therapy with Strezam®.

If you have ever had any allergic reactions, inform your doctor.

Interactions with other drugs. If you are taking other drugs, inform your doctor.

A reciprocal increase in effects is possible in concomitant use of Strezam® with the drugs depressing action of the central nervous system (neuroleptics, tranquillizers, antidepressants, analgetics, sedative).

Dosage and administration. Duration and treatment course should be prescribed by a physician depending on the disease severity. For adults and children above 15 years it is prescribed 1 capsule 2-3 times a day. The maximal treatment course is 12 weeks.

Overdose. It manifests with hypertension. Gastric cleavage is recommended. If necessary - symptomatic therapy. No specific antidote is exists.

Side effects. Dizziness appears sometimes which may appear at the beginning of the treatment and disappear spontaneously during the long-term therapy. Rarely - skin rash, very rarely - allergic reactions - urticaria, angiodermitis.

With appearing these undesirable events, stop using the drug and inform your doctor immediately!

Shelf-life. A shelf-life of the drug is 3 years. Don't use the drug after expiring the shelf-life.

Storage conditions. Keep out of reach of children at temperature up to 25°ะก. Don't store the drug in bath-rooms and kitchen.

Package. 20 capsules in a blister; 3 blisters in a package.

Delivery conditions. On prescription.

Name and address of manufacturer. BIOCODEX. 7 avenue Gallieni, 94250 Gentilly-France

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