Stresam 50 mg Capsule

Psychosomatic manifestations of anxiety.

150 mg to 200 mg daily taken as 2 to 3 divided doses. Treatment duration: a few days to a few weeks. Treatment duration may not exceed 8 weeks. The capsules are to be taken with a little water.

• hypersensitivity to etifoxine hydrochloride or to any of the excipients listed in section 6.1.
• States of shock.
• Severely impaired liver and/or renal function.
• Myasthenia gravis.
• Patients who have had severe cases of hepatitis or cytolytic hepatitis, during previous treatment with STRESAM.
• Patients who have had severe dermatological reactions, including DRESS syndrome, Stevens Johnson Syndrome (SJS) and dermatitis exfoliative generalized, during previous treatment with STRESAM.
• Because of the presence of lactose, this medicine is contraindicated in patients with galactosaemia, glucose and galactose malabsorption syndrome or lactase deficit.

Warnings:

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 STRESAM 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 STRESAM withdrawal. No fatal outcome due to severe cutaneous adverse reactions has been reported with STRESAM. Patients should be aware of this risk of skin toxicity and cutaneous signs and symptoms should be closely monitored. After the occurrence of skin toxicity with STRESAM, the medicine should be immediately discontinued and never reintroduced.

Severe hepatic reactions

Severe cases of cytolytic hepatitis have been reported with the use of STRESAM during post-marketing experience with a very rare frequency. As per post-marketing data, time to onset of hepatic reactions after STRESAM introduction mainly occurred between 2 weeks and 1 month of treatment. Caution should be taken in patients with risk factors for hepatic disorders such as elderly patients, patients with medical history of previous viral hepatitis or any other conditions identified on an individual basis by the practitioner. Hepatic disorders can be asymptomatic and detected only through specific laboratory tests. In patients with risk factors for hepatic disorders, liver function tests should be performed before starting STRESAM and around one month after treatment initiation. After the occurrence of liver toxicity with STRESAM, the medicine should be immediately discontinued and never reintroduced.

Lymphocytis colitis

Few cases of lymphocytis colitis have been reported with the use of STRESAM during post-marketing experience. Appropriate examinations should be considered in case of watery diarrhoea in patients treated with STRESAM. In case of watery diarrhoea with STRESAM, the medicine should be immediately discontinued.

Metrorrhagia

Cases of metrorrhagia in women on oral contraceptives have been reported with the use of STRESAM in post-marketing setting.

Precautions:

Caution is advised when STRESAM is used in conjunction with central nervous system depressants. Simultaneous intake of alcoholic drinks is not advised.

Inadvisable combinations:

Alcohol: alcohol increases the sedative effect of these substances. Impaired alertness may make vehicle driving and machinery operations dangerous. Avoid alcoholic drinks and medicines containing alcohol.

Combinations needing to be taken into account:

Other central nervous system depressants: morphine derivatives (analgesics, antitussives and narcotic substitutes); benzodiazepines; hypnotics; neuroleptics, sedative H1 antihistamines, sedative antidepressants; central antihypertensives; baclofen; thalidomide. The concurrent use of STRESAM and these agents may lead to increased central nervous system depression. Impaired alertness may make vehicle driving or machinery operation dangerous.

In the absence of sufficient clinical data, the administration of STRESAM during pregnancy and whilst breastfeeding is not recommended. STRESAM crosses the placental barrier.

Fertility: No data on male and female fertility are available.

Slight drowsiness, occurring at the start of treatment with STRESAM and disappearing spontaneously with its continuation, has been reported. Patients, particularly vehicle drivers and machinery operators, should be advised of the risks of drowsiness associated with the intake of STRESAM.

The side effects which have been reported are classified by system-organ class and by frequency defined as: very common (u22651/10), common (u2265 1/100, < 1/10), uncommon (u2265 1/1,000, < 1/100), rare (u2265 1/10,000, < 1/1,000) and very rare (< 1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ Class

• Rare
• Nervous System disorders: Slight drowsiness, occurring at the start of treatment and disappearing spontaneously with its continuation.
• Gastrointestinal disorders: Lymphocytic colitis.
• Hepatobiliary disorders: Hepatitis, cytolytic hepatitis.
• Skin and subcutaneous tissue disorders: Skin reactions: rash maculo-papular, polymorphe erythema, pruritus, face oedema. Allergic reactions: urticaria, Quinckeu2019s oedema. Serious skin reactions: DRESS syndrome, Stevens-Johnson syndrome, generalized exfoliative dermatitis. Anaphylactic shock, leukocytoclastic vasculitis.
• Reproductive system and breast disorders: Metrorrhagia in women treated with oral contraceptives.

If an overdose is taken, gastric lavage should be performed, followed by symptomatic treatment if necessary. There is no specific antidote.