STRESAM Capsule Ref.[27562] Active ingredients: Etifoxine

Revision Year: 2010  Publisher: BIOCODEX, 7 avenue Gallieni, 94250 GENTILLY, FRANCE

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 of risks of reciprocal potentialisation:

  • combination with central depressants must be prescribed cautiously,
  • simultaneous intake of alcoholic drinks is inadvisable.

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 containing alcohol.

Combinations needing to be taken into account

Other central nervous system (CNS) depressants

Morphine derivatives (analgesics, antitussives and narcotic substitutes); benzodiazepines; hypnotics; neuroleptics; sedative H1 antihistamines; sedative antidepressants; central antihypertensives; baclofene, thalidomide.

Increased central depression. Impaired alertness may make vehicle driving or machinery operation dangerous.

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 are insufficient.

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.

6.2. Incompatibilities

Not applicable.

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