Stresigen 50 mg Capsules

STRESIGEN is an anti-anxiety medicine. STRESIGEN is used to decrease the various emotional and bodily reactions, which accompany anxiety.

Do not take STRESIGEN:

• if you are hypersensitive (allergic) to etifoxine hydrochloride, or to any of the ingredients of STRESIGEN (see section 6)
• if you are in a state of shock
• if you have severely impaired liver and/or kidney function
• if you suffer from myasthenia gravis (a disease which causes weak muscles)
• if you have had severe liver problems, such as inflammation of the liver (hepatitis) or injury of the liver diagnosed by a biopsy, during previous treatment with etifoxine (the active ingredient in STRESIGEN)
• if you have had severe skin reactions during previous treatment with etifoxine (the active ingredient in STRESIGEN) like a syndrome called DRESS (Drug Rash with Eosinophilia and Systemic Symptoms – severe rash with multiple organ involvement, swollen lymph nodes and blood disorders), Stevens Johnson Syndrome (a rare, serious disorder of the skin and membranes that line the body's canals and organs) and dermatitis exfoliative (severe inflammation of the entire skin surface)

Do not share medicines prescribed for you with any other person. Always use STRESIGEN exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

The usual dose is: 150 mg - 200 mg daily in two to three divided doses. The duration of treatment is usually from a few days to not more than 8 weeks, depending on your doctor’s recommendations. The capsules should be swallowed with a little water. Your doctor will tell you how long your treatment with STRESIGEN will last. If you have the impression that the effect of STRESIGEN is too strong or too weak, tell your doctor or pharmacist.

If you take more STRESIGEN than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include drowsiness or strong desire to fall asleep.

If you forget to take STRESIGEN

If you forget to take STRESIGEN, take as soon as you remember, but if it is close to your next due dose, skip the forgotten dose and take the next normal dose. Do not take a double dose to make up for forgotten individual doses.

If you stop taking STRESIGEN

Talk to your healthcare provider before you stop taking STRESIGEN.

STRESIGEN can have side effects. Not all side effects reported for STRESIGEN are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using STRESIGEN, please consult your healthcare provider for advice.

If any of the following happens, stop using STRESIGEN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to STRESIGEN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• anaphylactic shock (severe flushing, itching, nausea, vomiting, swelling of the mouth and tongue and throat)
• Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals, skin rash), Drug reaction with eosinophilia and systemic symptoms (DRESS) (symptoms include fever, rash, facial swelling, enlarged lymph nodes and kidney or liver injury)
• jaundice (yellowing of the skin and eyes), vomiting, tiredness, abdominal (belly) pain - these could be signs of severe liver problems, hepatitis
• watery diarrhoea.

Store all medicines out of reach of children. Store at or below 25 °C. Keep blisters in carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).