Stresam 50 mg Capsules

STRESAM is a tranquillizer used to oppose various emotional and bodily reactions, which accompany anxiety.

Do not take STRESAM

• If you are hypersensitive (allergic) to etifoxine hydrochloride or any of the other ingredients of STRESAM (listed in 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 cytolytic hepatitis, during previous treatment with STRESAM
• if you have had severe skin reactions during previous treatment with STRESAM
• if you suffer from galactosaemia (a disorder of milk sugar digestion), glucose-galactose malabsorption (a rare condition which prevents the proper digestion of the sugars glucose and galactose) or lactase deficit (unable to digest lactose).

Warnings and precautions

Talk to your doctor or pharmacist before taking STRESAM:

• If you are at risk of developing liver problems, your doctor will do some tests to check your liver function before starting STRESAM and around one month after you start treatment.
• You should stop taking the medicine and seek urgent medical attention if you experience the following events during treatment with STRESAM:
• severe skin or allergic reactions (see section 4);
• jaundice (yellowing of the skin and eyes), vomiting, tiredness, abdominal (belly) pain or swelling, swelling in the legs and ankles, dark urine colour, pale stool colour, or bloody or tar-coloured stool – these could be signs of severe liver problems (see section 4);
• watery diarrhoea (see section 4).
• Talk to your doctor or pharmacist if you experience bleeding from the uterus between menstrual periods (metrorrhagia) when on oral contraceptives during treatment with STRESAM.
• Caution is advised if you are using central nervous system depressants (medicines that slow down brain activity) such as sedatives and tranquilizers (see Other medicines and STRESAM) or alcohol-containing medicines together with STRESAM (see STRESAM with food and drink and alcohol).

If you are taking STRESAM and have any questions or concerns, speak to your doctor or pharmacist.

Other medicines and STRESAM

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

STRESAM should not be used together with other central nervous system depressants as the depressant effect may be increased. Examples of other central nervous system depressants are:

• medicines related to morphine (painkillers, cough mixtures)
• antidepressants
• hypnotic medicines (medicines used to help you sleep)
• antihistamines (medicines used to relieve allergic symptoms)
• medicines used in the treatment of high blood pressure
• baclofen (a muscle relaxant)

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

The usual dose is: 3 to 4 capsules (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 STRESAM will last. If you have the impression that the effect of STRESAM is too strong or too weak, tell your doctor or pharmacist.

If you take more STRESAM than you should

Taking too many STRESAM capsules may increase the risk of somnolence (drowsiness). In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take STRESAM

Do not take a double dose to make up for forgotten individual doses.

If you stop taking STRESAM

Stopping the treatment does not lead to withdrawal (withdrawal is a state of deprivation or lack felt after stopping certain medicines with a reappearance or worsening of the disorders).

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

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

• anaphylactic shock (severe flushing, itching, nausea, vomiting, swelling of the mouth and tongue and throat)
• severe allergic reactions of the skin and face (flushing, rashes, itching, swelling)
• allergic manifestations such as urticaria (nettle rash, hives) and angioedema (weals, swelling of lips, eyes and tongue)
• allergic reactions with fever, rash, conjunctivitis (red, swollen eyes)
• jaundice (yellowing of the skin and eyes), vomiting, tiredness, abdominal (belly) pain - these could be signs of severe liver problems
• watery diarrhoea

These are all very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Less frequent side effects:

• bleeding between the expected menstrual periods, in women taking oral contraceptive pill,
• slight drowsiness at the start of treatment and disappearing spontaneously with its continuation,
• skin rash or itchy skin,
• swelling of the face,
• intestinal disorder with watery diarrhoea,
• hepatitis (yellowing of the skin and eyes, belly pain, fever)
• feeling of rapidly progressing obstruction in the throat (Quincke’s oedema)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of STRESAM.

Store at or below 25 °C. Keep the blisters in the carton until required for use. Store in the original package and do not store in bathrooms. 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). STORE ALL MEDICINES OUT OF REACH OF CHILDREN