Stresam

Composition: One capsule contains: Active ingredient: etifoxine hydrochloride 50 mg. Excipients: lactose monohydrate, purified talc, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. Capsule shell: indigocarmine (E132), titanium dioxide (E171), gelatin, purified water. Cap: titanium dioxide (E171), purified water, gelatin.

Form: 50 mg capsules.

Indications: • Neurasthenic conditions associated with stress disorders accompanied by anxiety, fear and restlessness. • Anxiety and phobic disorders. • Autonomic disorders with moderately pronounced fear, apathy and reduced activity.

Contraindications: • Hypersensitivity to the components of the medicine. • Shock. • Myasthenia. • Severe impairment of liver and kidney function. • Pregnancy and breastfeeding. • Children under 18 years of age. • Concomitant ethanol use.

Dosage: The physician determines the dose and duration of treatment individually, depending on the severity of the disease. Adults are prescribed 1 capsule before meals 2–3 times daily. The maximum course of treatment is 6 weeks.

Side effects: Sometimes: mild drowsiness. Rarely: skin rash, Quincke’s oedema. Very rarely: urticaria, angiodermatitis.

Interactions: Concomitant use of Stresam® with central nervous system depressants (antipsychotics, tranquillisers, antidepressants, antihistamines, barbiturates, analgesics and sedatives) enhances their effects. It enhances the effects of ethanol.

Warnings: The medicine contains lactose and is therefore not recommended for patients with congenital galactosaemia, glucose and galactose malabsorption syndrome, or lactose deficiency. Alcohol and other centrally acting substances (haloperidol, diazepam, imipramine, etc.) are not recommended during treatment with Stresam®. Discontinuing Stresam® does not cause a withdrawal syndrome. Effects on the ability to drive or operate potentially dangerous machinery: refrain from driving and operating potentially dangerous machinery during treatment.

Age restrictions: From 18 years

Pregnancy: Contraindicated during pregnancy and breastfeeding.

Country of origin: France

Manufacturer: Biocodex, 7 Avenue Gallieni, 94250 Gentilly, France FRA 250

Storage conditions: Store protected from light at a temperature not exceeding 25°C. Keep out of reach of children!

Shelf life: 3 years. Do not use after the expiry date printed on the packaging.

Dispensing conditions: Prescription only.