This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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Epilim Liquid 200mg/5ml
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▼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.
Epilim Liquid, sodium valproate, can seriously harm an unborn baby when taken during pregnancy. If you are a female able to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Epilim Liquid. 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 Epilim Liquid unless your specialist tells you to as your condition may become worse.
If you are a parent or caregiver of a female child treated with Epilim Liquid, you must also read section 2 of this leaflet carefully and contact your child’s doctor once they experience their first period.
1. What Epilim Liquid is and what it is used for
2. What you need to know before you take Epilim Liquid
3. How to take Epilim Liquid
4. Possible side effects
5. How to store Epilim Liquid
6. Contents of the pack and other information
The name of your medicine is Epilim Liquid 200mg/5ml (called Epilim Liquid in this leaflet).
Epilim Liquid contains a medicine called sodium valproate.
This belongs to a group of medicines called anti-convulsants or anti-epileptic agents. It works by helping to calm the brain down.
Epilim Liquid is used to treat epilepsy (fits) in adults and children.
If you are a woman able to have a baby, you must not take Epilim Liquid unless you use an effective method of birth control (contraception) at all times during your entire treatment with Epilim Liquid. Do not stop taking Epilim Liquid or your contraception until you have discussed this with your specialist. Your specialist will advise you further (see below under ‘Pregnancy, breast-feeding and fertility – Important advice for women’).
Do not take this medicine if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before taking Epilim Liquid.
Talk to your doctor or pharmacist before taking Epilim Liquid if:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Epilim Liquid.
Taking Epilim Liquid may make you put on weight. Talk to your doctor about how this will affect you.
Your doctor may do blood tests and liver function tests before and during your treatment with this medicine. Epilim Liquid can change the levels of liver enzymes shown up in blood tests. This can mean that your or your child’s liver is not working properly.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Epilim Liquid can affect the way some other medicines work. Also, some medicines can affect the way Epilim Liquid works.
In particular, check with your doctor if you are taking any of the following:
Alcohol intake is not recommended during treatment.
Important advice for women
The risks of valproate when taken during pregnancy
Please choose the situations which apply to you and read the descriptions below:
I AM STARTING TREATMENT WITH EPILIM LIQUID
If this is the first time you have been prescribed Epilim Liquid your specialist will have explained the risks to an unborn child if you become pregnant. Once you are able to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Epilim Liquid. Talk to your doctor or family planning clinic if you need advice on birth control (contraception).
I AM TAKING EPILIM LIQUID AND NOT PLANNING TO HAVE A BABY
If you are continuing treatment with Epilim Liquid but you are not planning to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Epilim Liquid. Talk to your doctor or family planning clinic if you need advice on birth control (contraception).
I AM TAKING EPILIM LIQUID 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 Epilim Liquid or your birth control (contraception) until you have discussed this with your specialist. Your specialist will advise you further.
Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development (behaviour and learning disorders), which can be seriously debilitating. Your doctor will refer you to a specialist experienced in the management of epilepsy, so that alternative treatment options are 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 Epilim Liquid, switch you to another medicine, or stop treatment with Epilim Liquid 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 TAKING EPILIM LIQUID
Do not stop taking Epilim Liquid unless your specialist 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 (behaviour and learning disorders) 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 Epilim Liquid 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 should 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 or pharmacist. Your specialist 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.
Newborn babies of mothers who took valproate during pregnancy may have:
Very little Epilim Liquid gets into the breast milk. However, talk to your doctor about whether you should breast-feed your baby. Ask your doctor or pharmacist for advice before taking any medicine.
You may feel sleepy when taking Epilim Liquid. If this happens to you, do not drive or use any tools or machines. Taking other medicines used to treat fits or calm emotional and mental health problems may increase sleepiness.
Always take Epilim Liquid exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Epilim Liquid treatment must be started and supervised by a doctor specialised in the treatment of epilepsy.
Your doctor will decide how much Epilim Liquid to give you or your child depending on you or your child’s body weight.
If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself but ask your doctor.
Adults (including the elderly)
Children over 20 kilograms
Children under 20 kilograms
Patients with kidney problems
Patients taking other medicines for fits (epilepsy)
If you or your child take more Epilim Liquid than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.
The following effects may happen: feeling sick or being sick, headache, blurred vision due to pupil of the eye becoming smaller, dizziness, poor reflexes, confusion, memory loss and tiredness. You may also have weak or ‘floppy’ muscles, fits (seizures), loss of consciousness, behavioural changes and breathing difficulties such as fast breathing, shortness of breath or chest pain.
If you or your child forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
Do not stop taking Epilim Liquid or alter your or your child’s dose without checking with your specialist. If you or your child stop taking Epilim Liquid without your specialist’s advice, your condition may get worse.
Make sure you or your child keep your regular appointments for a check up. They are very important as your or your child’s dose may need to be changed. If you or your child go into hospital or visit another doctor or a dentist, tell them you are taking Epilim Liquid.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Epilim Liquid can cause side effects, although not everybody gets them. Side effects are more likely to happen at the start of treatment.
There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term anti-epileptic medication, have a history of osteoporosis, or take steroids.
Epilim Liquid can change levels of liver enzymes, blood clotting factors, salts or sugars shown up on blood and urine tests.
Some side effects of valproate occur more frequently in children or are more severe compared to adults. These include liver damage, inflammation of the pancreas (pancreatitis), bedwetting (enuresis), renal dysfunction (Fanconi Syndrome), overgrowth of gum tissue, aggression, agitation, disturbance in attention, abnormal behaviour, hyperactivity and learning disorder.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the label and carton after “EXP”. The expiry date refers to the last day of that month.
Store below 25°C and away from direct sunlight.
Do not throw away any 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.
Epilim Liquid is a red, cherry flavoured liquid supplied in amber glass bottles of 300ml.
Each bottle is fitted with a plastic child-proof cap and includes a measuring cup marked with graduations of 5ml, 10ml, 15ml and 20ml.
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This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in January 2022
© Sanofi, 1983-2022
Other sources of information
For the most up to date patient information leaflet and important safety information on this product for girls and women of childbearing potential, scan the QR code included in this leaflet with a smartphone. The same information is also available on the following URL: qr.valproateandme.co.uk