Epilim Chrono 500mg Controlled Release Tablets
WARNING
Valproate can cause birth defects and problems with early development of the child if it is taken during pregnancy. If you are a female of childbearing age you should use an effective method of contraception throughout your treatment.
Your doctor will discuss this with you but you should also follow the advice in section 2 of this leaflet. Tell your doctor at once if you become pregnant or think you might be pregnant.
1. What Epilim Chrono is and what it is used for
2. What you need to know before you take Epilim Chrono
PACKAGE LEAFLET: INFORMATION FOR THE USER Epilim® Chrono 200mg, 300mg and 500mg Controlled Release Tablets
(sodium valproate/valproic acid)
This product is available as the above name and strengths but will be referred to as Epilim Chrono throughout this leaflet.
This product is available in multiple strengths and all strengths will be referred to throughout this leaflet.
▼ 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
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again
• If you have further questions, please ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Epilim Chrono is and what it is used for
2. What you need to know before you take Epilim Chrono
3. How to take Epilim Chrono
4. Possible side effects
5. How to store Epilim Chrono
6. Contents of the pack and other information
What Epilim Chrono is
The name of your medicine is Epilim Chrono 200, 300 and 500mg Controlled Release Tablets (called Epilim Chrono in this leaflet). “Controlled release” means that the active ingredient sodium valproate is slowly released from the tablets over a period of time.
What Epilim Chrono contains
Epilim Chrono contains sodium valproate. It belongs to a group of medicines called anti-convulsants or anti-epileptic agents.
It works by helping to calm the brain down.
What Epilim Chrono is used for
Epilim Chrono is used to treat epilepsy (fits) in adults and children.
Do not take Epilim Chrono and tell your doctor if:
• You are allergic (hypersensitive) to sodium valproate or any of the other ingredients of Epilim Chrono (see Section 6: Contents of the pack and other information)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You have liver problems or you or your family have a history of liver problems
• You have a rare illness called porphyria
• If you have a genetic problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
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 Chrono.
Warning and precautions
A small number of people being treated with anti-epileptics such as sodium valproate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Talk to your doctor or pharmacist before taking Epilim Chrono if:
• You have diabetes. This medicine may affect the results of urine tests
• You have kidney problems. Your doctor may give you a lower dose
• You have fits (epilepsy), brain disease or a metabolic condition affecting your brain
• You have a ‘urea cycle disorder' where too much ammonia builds up in the body
• You have an illness called “systemic lupus erythematosus (SLE)” - a disease of the immune system which affects skin, bones, joints and internal organs
• You know that there is a genetic problem caused by a mitochondrial disorder in your family.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Epilim Chrono
Weight gain
Taking Epilim Chrono 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 Epilim Chrono and during your treatment.
Other medicines and Epilim Chrono
Please tell your doctor 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 Chrono can affect the way some other medicines work. Also some medicines can affect the way Epilim Chrono works.
The following medicines can increase the chance of you getting side effects, when taken with Epilim Chrono:
• Some medicines used for pain and inflammation (salicylates) such as aspirin.
• Some other medicines used to treat fits (epilepsy) - see page 2, section 3, “Patients taking other medicines for ‘fits'”. This includes medicines such as phenobarbital, primidone, phenytoin, carbamazepine, topiramate, lamotrigine and felbamate.
Epilim Chrono may increase the effect of the following medicines:
• Medicines used for thinning the blood (such as warfarin)
• Zidovudine used to treat HIV infection
• Temozolomide used to treat cancer
• Medicines for depression
• Monoamine oxidase inhibitors (MAOI) such as moclobemide, selegiline, linezolid
• Medicines used to calm emotional and mental conditions such as diazepam and olanzapine
The following medicines can affect the way Epilim Chrono works:
• Some medicines used for the prevention and treatment of malaria such as mefloquine and chloroquine
• Cimetidine used for stomach ulcers
• Carbapenem agents (antibiotics used to treat bacterial infections) such as imipenem, meropenem, rifampicin and erythromycin. The combination of Epilim Chrono and carbapenems should be avoided because it may decrease the effect of your medicine.
• Colestyramine used to lower blood fat (cholesterol) levels
Taking Epilim Chrono with food and drink
Alcohol intake is not recommended during treatment.
Pregnancy, breast feeding and fertility
Important advice for women
• Valproate can be harmful to unborn children when taken by a woman during pregnancy.
• Valproate carries a risk if taken during pregnancy. The higher the dose, the higher the risks but all doses carry a risk.
• It can cause serious birth defects and can affect the way in which the child develops as it grows. Birth defects which have been reported include spina bifida (where the bones of the spine are not properly developed); facial and skull malformations; heart, kidney, urinary tract and sexual organ malformations; limb defects.
• If you take valproate during pregnancy you have a higher risk than other women of having a child with birth defects that require medical treatment. Because valproate has been used for many years we know that in women who take valproate around 10 babies in every 100 will have birth defects. This compares to 2-3 babies in every 100 born to women who don't have epilepsy.
• It is estimated that up to 30-40% of preschool children whose mothers took valproate during pregnancy may have problems with early childhood development. Children affected can be slow to walk and talk , intellectually less able than other children, and have difficulty with language and memory.
• Autistic spectrum disorders are more often diagnosed in children exposed to valproate and there is some evidence children may be more likely to develop symptoms of Attention Deficit Hyperactivity Disorder (ADHD).
• If you are a woman capable of becoming pregnant your doctor should only prescribe valproate for you if nothing else works for you.
• Before prescribing this medicine to you, your doctor will have explained what might happen to your baby if you become pregnant whilst taking valproate. If you decide later you want to have a child you should not stop taking your medicine until you have discussed this with your doctor and agreed a plan for switching you onto another product if this is possible.
• 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.
FIRST PRESCRIPTION
If this is the first time you have been prescribed valproate your doctor will have explained the risks to an unborn child if you become pregnant. Once you are of childbearing age, you will need to make sure you use an effective method of contraception throughout your treatment. Talk to your doctor or family planning clinic if you need advice on contraception.
Key messages:
• Make sure you are using an effective method of contraception.
• Tell your doctor at once if you are pregnant or think you might be pregnant.
CONTINUING TREATMENT AND NOT TRYING FOR A BABY
If you are continuing treatment with valproate but you don't plan to have a baby make sure you are using an effective method of contraception. Talk to your doctor or family planning clinic if you need advice on contraception.
Key messages:
• Make sure you are using an effective method of contraception
• Tell your doctor at once if you are pregnant or think you might be pregnant.
CONTINUING TREATMENT AND CONSIDERING TRYING FOR A BABY
If you are continuing treatment with valproate and you are now thinking of trying for a baby you must not stop taking either your valproate or your contraceptive medicine until you have discussed this with your prescriber. You should talk to your doctor well before you become pregnant so that you 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 doctor may decide to change the dose of valproate or switch you to another medicine before you start trying for a baby.
If you do become pregnant you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing.
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:
• Do not stop using your contraception before you have talked to your doctor and worked together on a plan to ensure your epilepsy is controlled and the risks to your baby are reduced.
• Tell your doctor at once when you know or think you might be pregnant
UNPLANNED PREGNANCY WHILST CONTINUING TREATMENT
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. If you are taking valproate and you think you are pregnant or might be pregnant contact your doctor at once. Do not stop taking your medicine until your doctor tells you to.
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:
• Tell your doctor at once if you know you are pregnant or think you might be pregnant.
• Do not stop taking valproate unless your doctor tells you to.
Make sure you read the patient booklet and sign the Acknowledgement of Risk form which should be given to you and discussed with you by your doctor or pharmacist
