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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 14040/0026.
Episenta 500mg and 1000mg Prolonged Release Granules
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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.
Episenta 500 mg prolonged-release granules
Episenta 1000 mg prolonged-release granules
(sodium valproate)
(Referred to in this leaflet as Episenta)
Episenta, 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 Episenta. Your specialist will discuss this with you but you must also follow the advice in section 2 of this leaflet.
Schedule an urgent appointment with your general practitioner (GP) for a referral to a specialist if you want to become pregnant or if you think you are pregnant.
Do not stop taking Episenta 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 Episenta, you must also read section 2 of this leaflet carefully and contact your child’s GP once they experience their first period, the GP will refer your child to their specialist.
1. What Episenta is and what it is used for
2. What you need to know before you take Episenta
3. How to take Episenta
4. Possible side effects
5. How to store Episenta
6. Contents of the pack and other information
Episenta contains the active substance sodium valproate, which belongs to a group of medicines called antiepileptics which are used to control epileptic seizures and mania.
Episenta is used in the treatment of
For male patients aged under 55 years not having used valproate before and for female patients aged under 55 years: this medicine is only used when two specialists have agreed that your condition does not respond to other treatments.
Bipolar disorder
Epilepsy
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your GP, specialist or pharmacist before taking Episenta.
The risk of liver damage is increased if Episenta is taken by children under 3 years of age, in people taking other antiepileptic medicine at the same time or having other neurological or metabolic disease and severe forms of epilepsy.
A small number of people being treated with antiepileptics such as sodium valproate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your GP or specialist.
As with other antiepileptic drugs, convulsions may become worse or happen more frequently whilst taking this medicine. If this happens contact your GP or specialist immediately.
If you or your child taking Episenta develops problems with balance and co-ordination, feeling lethargic or less alert, vomiting, tell your doctor immediately. This may be due to increased amount of ammonia in the blood.
Talk to your GP, specialist or pharmacist before taking Episenta if:
If you are not sure if any of the above apply to you, talk to your GP, specialist or pharmacist before taking Episenta.
Taking Episenta may make you put on weight. Talk to your GP, specialist or pharmacist about how this will affect you.
Your GP and/or specialist may request blood tests before you start taking Episenta and during your treatment with this medicine. Episenta can change the levels of liver enzymes shown in blood tests. This can mean that your or your child’s liver is not working properly.
Children and adolescents under 18 years of age: Episenta should not be used in children and adolescents under 18 years of age for the treatment of mania.
Tell your GP, specialist 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 Episenta can affect the way some other medicines work. Also some medicines can affect the way Episenta works.
The following medicines can increase the chance of you getting side effects, when taken with Episenta:
Episenta may increase the effect of the following medicines:
The following medicines can affect the way Episenta works:
It may still be possible for you to take Episenta; your doctor will advise you on what is suitable for you.
Alcohol intake is not recommended during treatment.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Important advice for female patients aged under 55 years
Bipolar disorder
Epilepsy
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 EPISENTA
If you are a female patient aged under 55 years who is able to have a baby, this medicine can only be prescribed for you if two specialists have agreed that your condition does not respond to other treatments and the benefits of treatment outweigh the risks. If this is the first time you have been prescribed Episenta your specialist will have explained the risks to an unborn child if you become pregnant. If 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 Episenta. Talk to your GP, specialist or sexual health and contraception clinic if you need advice on birth control (contraception).
Key messages:
I AM TAKING EPISENTA AND NOT PLANNING TO HAVE A BABY
If you are a female patient aged under 55 years who is able to have a baby, this medicine can only be prescribed for you if two specialists have agreed that your condition does not respond to other treatments and the benefits of treatment outweigh the risks. If you are continuing treatment with Episenta and 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 Episenta. Talk to your GP, specialist or sexual health and contraception clinic if you need advice on birth control (contraception).
Key messages:
I AM TAKING EPISENTA AND PLANNING TO HAVE A BABY
If you are planning to have a baby, first schedule an appointment with your GP. Your GP will urgently refer you to your specialist.
Do not stop taking Episenta 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 which can be seriously debilitating and/or permanent. Your GP will refer you to a specialist experienced in the management of bipolar disorder or epilepsy, so that other 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.
For epilepsy: You must not use Episenta if you are pregnant, unless two specialists have agreed that your condition does not respond to other treatments and the benefits of treatment outweigh the risks. Your specialist may decide to change the dose of Episenta, switch you to another medicine and stop treatment with Episenta, a long time before you become pregnant – this is to make sure your illness is stable.
For bipolar disorder: You must not use Episenta if you are pregnant. Your specialist may decide to switch you to another medicine and stop treatment with Episenta a long time before you become pregnant – this is to make sure your illness is stable.
Ask your specialist 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.
Key messages:
I AM PREGNANT AND I AM USING EPISENTA
Do not stop taking Episenta, unless your specialist tells you to as your condition may become worse.
Schedule an urgent appointment with your GP. Your GP will refer you immediately to your specialist if you are pregnant or think you might be pregnant. Your specialist will then 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 and/or permanent.
Your GP will refer you to your specialist experienced in the management of bipolar disorder or epilepsy, so that other treatment options can be evaluated.
For epilepsy only: In the exceptional circumstances when two specialists have agreed that Episenta 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 specialist 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.
Key messages:
Make sure you read the patient guide that you will receive from your specialist, GP or pharmacist. If you are a female of childbearing potential, your specialist will discuss and complete the Annual Risk Acknowledgement Form with you 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:
Breast-feeding
Very little Episenta gets into the breast milk. However, talk to your GP or specialist about whether you should breast-feed your baby. Ask your GP, specialist or pharmacist for advice before taking any medicine.
Important advice for male patients
Make sure you read the Patient Guide that you will receive from your specialist, GP or pharmacist. If you are a male aged under 55 years starting treatment with valproate, your specialist will discuss and complete a risk acknowledgement form with you and will ask you to sign it and keep it.
You may feel sleepy when taking Episenta. If this happens, 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.
Episenta 500 mg: This medicine contains 69.0 mg sodium (main component of cooking/table salt) in each dose. This is equivalent to 3.5 % of the recommended maximum daily dietary intake of sodium for an adult.
Episenta 1000 mg: This medicine contains 137.9 mg sodium (main component of cooking/table salt) in each dose. This is equivalent to 7 % of the recommended maximum daily dietary intake of sodium for an adult.
Always take this medicine exactly as your specialist has told you. Check with your specialist, GP or pharmacist if you are not sure.
Episenta treatment must be started and supervised by a specialist experienced in the treatment of epilepsy or bipolar disorders.
Dosage
Epilepsy
Your specialist will decide the number of sachets you should take. This will depend on your age and weight and will be adjusted to achieve adequate control of your seizures.
The daily dosage may be taken as one single or two divided doses (half in the morning and half in the evening) before, with or after meals.
Dose for adults including the elderly
The recommended starting dose is 600 mg daily increasing by 150–300 mg every three days until the seizures are controlled.
This dose is usually within the range of 1,000 mg to 2,000 mg daily, but can be increased to a maximum of 2,500 mg daily if necessary. Your specialist may alter your dose if you are taking other antiepileptic drugs, have poor kidney function or you are an elderly patient.
Dose for children and adolescents
The dose for children will depend on their weight.
For children over 20 kg the recommended starting dose is 300 mg daily. This can be increased up to a maximum of 35 mg for each kg of bodyweight daily to control the seizures.
For children under 20 kg the usual dose is 20 mg for each kg of bodyweight which can be increased up to a maximum of 40 mg for each kg of bodyweight daily.
Manic episodes in bipolar disorder
Adults
The daily dosage should be established and controlled individually by your specialist. Initial dose: The recommended initial daily dose is 750 mg. Mean daily dose: The recommended daily doses usually range between 1,000 and 2,000 mg.
Method of administration
Episenta granules should be swallowed without chewing with plenty of liquid, e.g. a full glass of water. Tear open the sachet and sprinkle or stir the contents into soft food or a drink and swallow immediately without chewing or crushing the granules. The food or drink should be cold or at room temperature. Do not store a mixture of the granules with liquid or soft food for future use. If the granules are taken in a drink, some may stick to the glass after the drink has been finished, you should rinse the glass with a small amount of water and drink this as well. The granules should not be given in babies’ bottles as they can block the teat.
Your specialist may decide to adjust your dose.
You or your child may be taking other medicines for epilepsy at the same time as Episenta. If so, your specialist should gradually initiate treatment depending on your or your child’s condition.
Your doctor may increase the dose of Episenta by 5–10 mg for each kg of body weight each day depending on which other medicines you are taking.
If you or your child take more Episenta than you should contact your GP or specialist urgently or go to a hospital casualty department immediately. 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 Episenta or alter your or your child’s dose without checking with your specialist. If you or your child stop taking Episenta 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. Episenta 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. If you or your child go into hospital or visit another doctor or a dentist, tell them you are taking Episenta.
If you have any further questions on the use of this medicine, ask your GP, specialist or pharmacist.
Like all medicines this medicine can cause side effects, although not everybody gets them.
Tell your GP, specialist or go to a hospital straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
Tell your GP, specialist or pharmacist if any of the following side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet:
Bone disorders
There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your GP, specialist or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.
Tests
Episenta can change levels of liver enzymes, blood clotting factors, salts or sugars shown up on blood and urine tests.
You may notice the remains of the white shells of the granules in your stools (faeces). This is normal and the active part of the medicine will already have been released from the granule.
Additional side effects in children
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 GP, specialist, 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 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.
Store the sachets in the original package.
Store below 30 °C.
Keep the container tightly closed.
Do not use this medicine after the expiry date which is stated on the sachet and carton after “Expiry date:”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Episenta prolonged-release granules are white to off-white granules packed in sachets. The sachets are available in packs of 30, 50, 100 and 200 for both the 500 mg and the 1,000 mg strengths. Not all pack sizes may be marketed.
This leaflet was last revised in 01/2024.