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: PL04425/0685.
Epilim 400mg Powder and Solvent for solution for injection/infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Epilim® 400mg Powder and Solvent for solution for injection/infusion
sodium valproate
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Phone 0800 035 2525 for help
▼ 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.
WARNING
Epilim Injection, sodium valproate, can seriously harm an unborn baby when taken during pregnancy. If you are a female able to have a baby you should use an effective method of birth control (contraception) without interruption during your entire treatment with Epilim Injection. 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 Injection 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 Epilim Injection, you must also read section 2 of this leaflet carefully and contact your child’s doctor once they experience their first period.
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 Epilim Injection is and what it is used for
2. What you need to know before you take Epilim Injection
3. How Epilim Injection is given
4. Possible side effects
5. How to store Epilim Injection
6. Contents of the pack and other information
1. What Epilim Injection is and what it is used for
What Epilim Injection is
The name of your medicine is Epilim 400mg Powder and Solvent for solution for injection/infusion (called Epilim Injection in this leaflet).
What Epilim Injection contains
Epilim Injection 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.
What Epilim Injection is used for
Epilim Injection is used to treat epilepsy (fits) in adults and children. The injection is given when it is not possible to have your medicine by mouth.
2. What you need to know before you take Epilim Injection
Do not have Epilim Injection and tell your doctor or nurse if:
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
If you are a woman able to have a baby you must not take Epilim Injection unless you use an effective method of birth control (contraception) at all times during your treatment with Epilim Injection. Do not stop taking Epilim Injection or your contraception until you have discussed this with your doctor. Your doctor will advise you further (see below under ‘Pregnancy, breast-feeding and fertility – Important advice for women’).
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before having Epilim Injection.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before having Epilim Injection if:
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Epilim Injection.
Weight gain
Having Epilim Injection 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 having Epilim Injection and during your treatment.
Other medicines and Epilim Injection
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Epilim Injection can affect the way some other medicines work.
Also some medicines can affect the way Epilim Injection works.
The following medicines can increase the chance of you getting side effects, when taken with Epilim Injection:
Epilim Injection may increase the effect of the following medicines:
The following medicines can affect the way Epilim Injection works:
Taking Epilim Injection with food and drink
Alcohol intake is not recommended during treatment.
Pregnancy, breast-feeding and fertility
Important advice for women
The risks of valproate when taken during pregnancy
However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
Please choose the situations which apply to you and read the descriptions below:
I AM STARTING TREATMENT WITH EPILIM INJECTION
If this is the first time you have been prescribed Epilim Injection 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 birth control (contraception) without interruption throughout your treatment with Epilim Injection.
Talk to your doctor or family planning clinic if you need advice on birth control (contraception).
Key messages:
I AM TAKING EPILIM INJECTION AND NOT PLANNING TO HAVE A BABY
If you are continuing treatment with Epilim Injection but you are not planning to have a baby make sure you are using an effective method of birth control (contraception) without interruption during your entire treatment with Epilim Injection. Talk to your doctor or family planning clinic if you need advice on birth control (contraception).
Key messages:
I AM TAKING EPILIM INJECTION 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 Injection or your birth control (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 Epilim Injection, switch you to another medicine, or stop treatment with Epilim Injection a long time before you become pregnant – this is to make sure your illness is stable.
Ask your doctor about taking folic acid when trying for 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 EPILIM INJECTION
Do not stop taking Epilim Injection 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 Epilim Injection 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.
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 doctor, nurse or pharmacist to remind you of valproate risks in pregnancy.
Newborn babies of mothers who took valproate during pregnancy may have:
Breast-feeding
Very little Epilim Injection gets into the breast milk. However, talk to your doctor about whether you should breast-feed your baby.
Ask your doctor, nurse or pharmacist for advice before taking or having any medicine.
Driving and using machines
You may feel sleepy when taking Epilim Injection. 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.
3. How Epilim Injection is given
Epilim Injection is always given to you by a doctor or nurse. This is because it needs to be given as a slow injection or infusion into the vein.
If you are not sure why you are being given Epilim Injection or have any questions about how much Epilim Injection is being given to you, speak to your doctor or nurse.
Your doctor will stop giving you Epilim Injection and change you to Epilim tablets, granules, syrup or liquid as soon as possible.
Epilim Injection treatment must be started and supervised by a doctor specialised in the treatment of epilepsy.
How much will be given to you
If you have not had Epilim Injection before, the doctor will use the following doses:
Adults (including the elderly)
Children
Patients with kidney problems
Patients taking other medicines for fits (epilepsy)
If you have more Epilim Injection than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor will be checking your progress and checking the medicine that you are given. Always ask if you are not sure why you are getting a dose of medicine.
Using too much Epilim Injection can lead to the following symptoms: feeling sick or being sick, pupils of the eye become smaller, dizziness, loss of consciousness, weak muscles and poor reflexes, breathing problems, headaches, fits (seizures), confusion, memory loss and unusual or inappropriate behaviour.
If you forget to have Epilim Injection
Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you think you may have missed a dose, then talk to your doctor or nurse.
If you stop using Epilim Injection
It is important for you to keep having Epilim injection until your doctor decides to stop them. If you stop, your fits may come back.
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. Epilim Injection 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 Epilim Injection.
If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
4. Possible side effects
Like all medicines, Epilim Injection 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, nurse 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, nurse or pharmacist if you are on long-term anti-epileptic medication, have a history of osteoporosis, or take steroids.
Tests
Epilim Injection can change levels of liver enzymes, salts or sugars shown up on blood and urine tests.
Male fertility
Epilim Injection can be a contributing factor in male infertility.
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, nurse or pharmacist. 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.
5. How to store Epilim Injection
This medicine will be kept by your doctor or nurse out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the vial and the carton after EXP.
The expiry date refers to the last day of that month.
Only clear solutions free of particles should be used.
Once diluted, Epilim Injection should be stored in a refrigerator between 2-8°C and used within 24 hours. Any solution remaining after 24 hours should be discarded.
Medicines should not be disposed of via household wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What Epilim Injection contains
Each vial contains 400mg of the active substance, sodium valproate.
What Epilim Injection looks like and contents of the pack
Epilim is a freeze-dried powder in a colourless glass vial with an aluminium cap. The vial is supplied packed in a carton along with one ampoule containing 4ml of water for injection.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer :
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, nurse or pharmacist.
This leaflet was last revised in October 2020
© Sanofi, 1993 - 2020
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
790554
Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
+44 (0)800 035 2525