Active ingredient
- sodium valproate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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
Package leaflet: Information for the patient
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https://www.medicines.org.uk/emc/product/1771/rmms
▼ 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)
WARNING
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 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 Episenta unless your doctor 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 doctor once they experience their first period (menarche).
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
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
1. What Episenta is and what it is used for
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
2. What you need to know before you take Episenta
Do not take Episenta
Bipolar disorder
Epilepsy
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 Episenta.
Warnings and precautions
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 doctor.
As with other antiepileptic drugs, convulsions may become worse or happen more frequently whilst taking this medicine. If this happens contact your doctor immediately.
Talk to your doctor or pharmacist before taking Episenta if:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Episenta.
Weight gain
Taking Episenta may make you put on weight. Talk to your doctor about how this will affect you.
Blood tests
Your doctor may wish to do blood tests before you start taking Episenta and during your treatment.
Children and adolescents
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.
Other medicines and Episenta
Tell your doctor, pharmacist or nurse 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.
Taking Episenta with food and drink
Alcohol intake is not recommended during treatment.
Pregnancy, breast-feeding and fertility
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 women
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 this is the first time you have been prescribed Episenta 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 Episenta. Talk to your doctor or family planning clinic if you need advice on contraception.
Key messages:
I AM TAKING EPISENTA AND NOT PLANNING TO HAVE A BABY
If you are continuing treatment with Episenta 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 Episenta. Talk to your doctor or family planning clinic if you need advice on 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 doctor.
Do not stop taking Episenta 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 bipolar disorder or 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 Episenta or switch you to another medicine, or stop treatment with Episenta, 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.
Key messages:
I AM PREGNANT AND I AM USING EPISENTA
Do not stop taking Episenta, 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 bipolar disorder or epilepsy, so that alternative treatment options can be evaluated.
In the exceptional circumstances when 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 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.
Key messages:
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.
Breast-feeding
A small amount of sodium valproate, the active substance of Episenta, gets into the breast milk. Talk to your doctor about whether you should breast-feed your baby.
Fertility
Episenta may decrease your fertility. However, single reports have shown that this effect is reversible after discontinuation of the medicine.
Driving and using machines:
You may experience drowsiness when you first start taking Episenta, or if you are taking it with other medicines, such as other antiepileptic drugs or benzodiazepines. If affected you should not drive or operate machinery.
Important information about some of the ingredients of Episenta
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.
3. How to take Episenta
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Episenta treatment must be started and supervised by a doctor specialised in the treatment of epilepsy or bipolar disorders.
Dosage
Epilepsy
Your doctor 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 doctor 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 doctor. Initial dose: The recommended initial daily dose is 750 mg. Mean daily dose: The recommended daily doses usually range between 1,000 mg 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.
Patients with kidney problems
Your doctor may decide to adjust your dose.
Patients taking other medicines for fits (epilepsy)
You or your child may be taking other medicines for epilepsy at the same time as Episenta. If so, your doctor 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 take more Episenta than you should
If you take more Episenta than you should or if someone else accidentally takes your medicine contact your nearest casualty department or tell your doctor or pharmacist immediately. Remember to take the pack, this leaflet and any remaining sachets with you.
If you forget to take Episenta
Take it as soon as you remember. If your next dose is due within 2 hours, take a single dose now and do not take the next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Episenta
Do not stop taking Episenta without consulting your doctor. If you stop, your seizures may return. You should continue to take Episenta for as long as your doctor tells you to.
Tests
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 doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
Tell your doctor as soon as possible if you have any of the following side effects:
Tell your doctor 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 doctor 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, salts or sugars shown up on blood and urine tests.
Male fertility
Taking Episenta can be a contributing factor in male infertility.
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.
If you, or your carer, notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
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.
Reporting of side effects
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 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.
5. How to store Episenta
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.
6. Contents of the pack and other information
What Episenta contains
What Episenta looks like and contents of the pack
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.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in 12/2021.
Fairbourne Drive , Atterbury , Milton Keynes , Bucks, MK10 9RG, UK
+44 (0) 1908 488817
+44 (0) 1908 488817