This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 21597/0004.
Convulex 150 mg/300 mg/500 mg capsules
Convulex® 150 mg capsules
Convulex® 300 mg capsules
Convulex® 500 mg capsules
Active substance: Valproic acid
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Convulex (sodium valproate) can seriously harm an unborn child when taken during pregnancy. If you are a female able to have a baby you must use effective method of birth control (contraception) without interruptions during your entire treatment with Convulex. Your doctor will discuss this with you but you must also follow the advice in section 2 of this leaflet.
Schedule an urgent appointment with your doctor if you want to become pregnant or if you think you are pregnant.
Do not stop taking Convulex unless your doctor tells you to as your condition may become worse.
1. What Convulex is and what it is used for
2. What you need to know before you take Convulex
3. How to take Convulex
4. Possible side effects
5. How to store Convulex
6. Contents of the pack and other information
Convulex is an antiepileptic, i.e. a medicine which is used to treat epilepsy (fits). Its active ingredient is valproic acid.
Talk to your doctor or pharmacist before taking Convulex.
Take special care with Convulex
Tell your doctor before starting Convulex
Talk to your doctor even if you no longer have these conditions, but have had them in the past.
Your doctor may advise blood tests before you start taking Convulex and during the first six months of treatment.
A small number of people being treated with anti-epileptics such as valproic acid have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
If taken with some other medicines, the effects of Convulex or the effects of the other medicines may be changed.
Please tell your doctor if you are taking any of the following:
In particular, tell your doctor or nurse if you are taking any of the following medicines:
Carbapenem agents (antibiotic used to treat bacterial infections). The combination of valproic acid and carbapenems should be avoided because it may decrease the effect of sodium valproate.
If you have to undergo any type of surgery, including dental procedures where anaesthesia is required, tell the doctor that you are taking Convulex.
Convulex does not appear to influence the effect of oral contraceptives.
Convulex may be taken with food and drink.
The capsules are usually taken after meals.
Important advice for women
The risks of valproate when taken during pregnancy (irrespective of the disease for which valproate is used)
Please choose and read the situations which apply to you from the situations described below:
I AM STARTING TREATMENT WITH CONVULEX
If this is the first time you have been prescribed Convulex your doctor will have explained the risks to an unborn child if you become pregnant. Once you are able to have a baby, you will need to make sure you use an effective method of contraception without interruption throughout your treatment with Convulex. Talk to your doctor or family planning clinic if you need advice on contraception.
I AM TAKING CONVULEX AND NOT PLANNING TO HAVE A BABY
If you are continuing treatment with Convulex but you are not planning to have a baby make sure you are using an effective method of contraception without interruption during your entire treatment with Convulex. Talk to your doctor or family planning clinic if you need advice on contraception.
I AM TAKING CONVULEX AND PLANNING TO HAVE A BABY
If you are planning to have a baby, first schedule an appointment with your doctor.
Do not stop taking Convulex or your contraception, until you have discussed this with your doctor. Your doctor will advise you further.
Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development which can be seriously debilitating. Your doctor will refer you to a specialist experienced in the management of epilepsy, so that alternative treatment options can be evaluated early on. Your specialist can put several actions in place so that your pregnancy goes as smoothly as possible and any risks to you and your unborn child are reduced as much as possible. Your specialist may decide to change the dose of Convulex or switch you to another medicine, or stop treatment with Convulex, a long time before you become pregnant – this is to make sure your illness is stable.
Ask your doctor about taking folic acid when planning to have a baby. Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
I AM PREGNANT AND I AM USING CONVULEX
Do not stop taking Convulex, unless your doctor tells you to as your condition may become worse. Schedule an urgent appointment with your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you further.
Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development which can be seriously debilitating.
You will be referred to a specialist experienced in the management of epilepsy, so that alternative treatment options can be evaluated.
In the exceptional circumstances when Convulex is the only available treatment option during pregnancy, you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing. You and your partner could receive counselling and support regarding the valproate exposed pregnancy.
Ask your doctor about taking folic acid. Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
Make sure you read the patient guide that you will receive from your doctor. Your doctor will discuss the Annual Risk Acknowledgement Form and will ask you to sign it and keep it. You will also receive a Patient Card from your pharmacist to remind you of valproate risks in pregnancy.
When you first start taking Convulex, or if you are taking it with other medicines, you may notice some drowsiness.
Do not drive or use any tools or machines until you know if you are affected by the intake of Convulex.
Always take Convulex exactly as your doctor has told you. Check with your doctor if you are not sure.
Convulex treatment must be started and supervised by a doctor specialised in the treatment of epilepsy.
Swallow the capsules whole, after meals, with a drink of water, unless your doctor advises differently. Do not crush or chew the capsules.
The usual dose of Convulex is between 1000 and 2000 mg per day but may be increased to 2500 mg per day. Usually, this quantity is evenly divided and taken in 2 separate doses, e.g. half in the morning and half in the evening.
Children over 20 kg
The usual dose of Convulex is based on the child’s weight. The usual dose is between 20 and 30 mg for each kg of body weight but may be increased to 35 mg for each kg of body weight per day. Usually, this quantity is evenly divided and taken in 2 separate doses, e.g. half in the morning and half in the evening.
Children under 20 kg
The usual dose of Convulex is based on the child’s weight. The usual dose is 20 mg for each kg of body weight. Usually, this quantity is evenly divided and taken in 2 separate doses, e.g. half in the morning and half in the evening.
When Convulex is first commenced, you may be prescribed a lower dose. This is because some patients need less Convulex than others to control their fits. Your doctor will increase the dosage until your condition is controlled. As a result of this it is very important that you follow the instructions your doctor has given you about how much to take. Blood tests may be needed.
If you have a kidney disease, your doctor may prescribe a lower dose.
If you are taking other medicines to control your epilepsy at the same time as Convulex, your doctor may gradually reduce the dose of these antiepileptics while increasing the dose of Convulex in small units per day, based on your body weight.
Make sure you keep your regular check up appointments with your doctor. They are very important as your dosage may need to be changed.
An overdose of this medicine may be dangerous. If you think you have taken more Convulex than you should, talk to a doctor or pharmacist, or go to the nearest hospital casualty department immediately.
If you forget to take a dose at the right time, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before. Do not take a double dose to make up for a forgotten dose.
If you wish to stop taking Convulex, talk to your doctor first.
Do not stop taking Convulex just because you feel better, as this may lead to an immediate relapse and your condition may get worse.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Please note that the following list includes all reported side effects – even those that occur very rarely.
It is very important that you immediately contact your doctor if you develop any of the following symptoms, because urgent medical measures may be necessary:
Very common side effects (affecting more than 1 person in 10):
Common side effects (affecting less than 1 person in 10):
Uncommon side effects (affecting less than 1 person in 100):
Rare side effects (affecting less than 1 person in 1,000):
Very rare side effects (affecting less than 1 person in 10,000):
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:
By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not store above 25 °C.
Store in the original container in order to protect from light.
Do not use Convulex after the expiry date which is stated on the blister and on the carton after “use before”. The expiry date refers to the last day of that month.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Convulex capsules are oval, old-rose coloured gastro-resistant soft-gelatine capsules in blister packs and are supplied in cartons of 30 and 100.
Not all pack sizes may be marketed.
Leaflet revised January 2020