Convulex® Syrup

Convulex® belongs to a group of medicines called anticonvulsants, which are used to treat epilepsy (fits) or used to treat bipolar disorder. Convulex® is also used to prevent migraine headaches in adults.

Do not take Convulex®:

• If you are hypersensitive (allergic) to valproic acid or sodium valproate or any of the ingredients of Convulex® (listed in section 6).
• If you have liver problems.
• If you have a family history of liver problems.
• If you suffer from porphyria (a rare metabolic condition).
• If you have pancreatic problems.
• If you have a genetic problem causing a mitochondrial disorder (e.g. Alpers - Huttenlocher syndrome)

Epilepsy

• For epilepsy, you must not use Convulex® if you are pregnant, unless nothing else works for you.
• For epilepsy, if you are a woman able to have a baby, you must not take Convulex® unless you use effective method of birth control (contraception) during your entire treatment with Convulex®. Do not stop taking Convulex® or your contraception, until you have discussed this with your doctor. Your doctor will advise you further (see below under “Pregnancy, breastfeeding and fertility – Important advice for women”).

Migraine

• You must not use CONVULEX for preventing migraine when you are pregnant. Pregnancy should be excluded before you start treatment for migraine, and you should use effective contraception.

Do not share medicines prescribed for you with any other person. Always take CONVULEX® exactly as described in this leaflet. You should check with your doctor, pharmacist or other healthcare professional if you are not sure. The total daily dose should be taken in divided dosages. Convulex® capsules should be taken whole, with some liquid, during or after meals.

Epilepsy

Adults

The initial dose is 600 mg per day in divided doses, increasing by 150 mg per day to a maintenance dosage of 1 000 - 1 600 mg per day (approx. 3 - 5 capsules of 300 mg each or 2 - 3 capsules of 500 mg each).

Children

Children weighing less than 20 kg may be given 15 - 20 mg per kg per day. Children weighing more than 20 kg may be given 450 mg daily in divided doses (e.g. 3 x 1 capsule Convulex® 150 mg).

– syrup

Acute mania in Bipolar I affective disorders

The recommended initial dose is 600 – 900 mg daily, divided into several doses, up to a maximum of 1500 mg per day in highly agitated patients.

Migraine (Adults only)

Starting at 300 mg per day in divided doses, the daily dose is slowly increased until the desired therapeutic effect is achieved, or side effects occur. Most patients can be effectively treated with 600 – 900 mg per day.

If you have the impression that the effect of Convulex® is too strong or too weak, talk to your doctor, pharmacist or other healthcare professional.

If you take more Convulex® than you should

An overdose of Convulex® may be dangerous. Symptoms of acute overdose may include nausea, vomiting, dizziness, sometimes also serious, or even fatal, side-effects on the part of the central nervous system and breathing difficulty. In serious cases immediate medical assistance is required. 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 Convulex®

If you forgot to take a dose at the right time, take it as soon as you remember. However, if you are already nearing the time for your next scheduled dose, you should skip the forgotten dose and then continue treatment as prescribed. Do not take a double dose to make up for a forgotten dose.

If you stop taking Convulex®

Do not interrupt or stop the treatment with Convulex® without consulting your doctor. This could endanger the positive effects of treatment and might induce more seizures. Please discuss any signs of intolerance or changes in the course of your illness with your treating physician doctor. If you have any further questions on the use of Convulex®, ask your doctor or pharmacist.

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

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

• Swelling of the hands, feet, ankles, face, lips, mouth, tongue or throat (angioedema) which may cause difficulty in swallowing or breathing. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Convulex®. 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:

• bizarre behaviour associated with or not with more frequent or more severe fits, loss of drive particularly if phenobarbital is taken at the same time or if Convulex® dose has been suddenly increased,
• repeated vomiting, extreme tiredness, abdominal pain, drowsiness, weakness, loss of appetite, nausea, jaundice (yellowing of the skin or whites of the eyes), swelling of the legs or worsening of your epilepsy or a general feeling of being unwell,
• blood clotting problems,
• spontaneous bruising or bleeding,
• blisters and skin detachment. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent:

• nausea, diarrhoea and minor gastric irritation,
• temporary elevation of liver test values (which can be seen in blood tests) may occur at the beginning of treatment,
• nail and nail bed disorders.

Less frequent:

• increased appetite leading to weight gain,
• disturbed coordination of movements and dizziness,
• confusion (occasionally followed by disturbed consciousness or associated with hallucinations or convulsions),
• oedema (swelling of the fingers, legs and toes),
• vasculitis (inflammation of the blood vessels),
• lethargy, temporary disturbance of brain functions, twitching of the eyes,
• impairment of hearing,
• reversible Fanconi´s syndrome (a rare kidney disorder),
• skin changes, e.g. rash,
• changes in women’s periods,
• obesity,
• double vision,
• temporary loss of consciousness, Parkinson-like symptoms such as reduced capacity of movement, trembling (shakiness), increased muscular tension,
• involuntary movements, reversible dementia (impaired memory),
• excessive growth of facial or body hair,
• increased breast growth in men.

temporary hair loss,

an increase in alertness, hyperactivity, aggression and inappropriate behaviour,

bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures.

If any of these side effects continue, are severe or bother you, tell your doctor, pharmacist or other healthcare professional. 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. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 You can also report side effects at the company email address: [email protected]. By reporting side effects, you can help provide more information on the safety of Convulex®.

Store all medicines out of reach of children.

• Store at or below 25 ºC, protected from light and moisture.
• Tightly close the container after each use.
• Do not use Convulex® after the expiry date which is stated on the container. The expiry date refers to the last day of that month.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).