Patient Leaflet Updated 19-Mar-2018 | Zentiva
Sodium Valproate 200mg & 500mg Gastro-Resistant Tablets
PATIENT INFORMATION LEAFLET
SODIUM VALPROATE ZENTIVA 200MG AND 500MG GASTRO-RESISTANT TABLETS
▼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.
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.
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 sodium valproate is and what is it used for
2. What you need to know before you take sodium valproate
3. How to take sodium valproate
4. Possible side effects
5. How to store sodium valproate
6. Contents of the pack and other information
1. WHAT SODIUM VALPROATE IS AND WHAT IT IS USED FOR
The name of your medicine is Sodium Valproate Zentiva 200mg or 500mg Gastro-resistant Tablets (called sodium valproate throughout this leaflet). This belongs to a group of medicines called anti-convulsants or anti-epileptic agents. It works by controlling the activity of the brain which causes fits or seizures.
It is used to treat epilepsy (fits) in adults and children.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SODIUM VALPROATE
Do not take sodium valproate and tell your doctor if:
Talk to your doctor or pharmacist before taking sodium valproate if:
Talk to your doctor or pharmacist before taking sodium valproate if you have these conditions. Do this even if you no longer have them, but have had them in the past.
Sodium valproate can increase your appetite and may make you put on weight. Talk to your doctor about how this will affect you.
Your doctor may wish to do blood tests before you start taking sodium valproate and during the first six months of treatment.
Warnings and precautions
Other medicines and sodium valproate
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because sodium valproate can affect the way some other medicines work. Also some medicines can affect the way sodium valproate works.
In particular, check with your doctor or pharmacist if you are taking any of the following medicines:
Taking sodium valproate with food and drink
Take sodium valproate with or after food. This will help to stop the feelings of sickness that may happen after taking the tablets.
Alcohol intake is not recommended during treatment.
Pregnancy, breast feeding and fertility
Important advice for women
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.
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.
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.
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.
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.
Very little sodium valproate gets into the breast milk. However, talk to your doctor about whether you should breastfeed your baby. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may feel sleepy:
If this happens to you, do not drive or use any tools or machines.
Important information about some the ingredients of sodium valproate tablets
These tablets contain:
3. HOW TO TAKE SODIUM VALPROATE
Always take sodium valproate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Sodium valproate treatment must be started and supervised by a doctor specialised in the treatment of epilepsy.
Taking this medicine
How much to take
Children over 20kg:
Children under 20kg:
People with kidney problems
If you or your child have kidney problems, your doctor may prescribe a lower dose.
Do not change the dose you have been prescribed without first discussing with your doctor.
When treatment is first started
At first you may be prescribed a lower dose. This is because some patients need less sodium valproate than others to control their fits. Your doctor will then increase the dosage until your condition is controlled.
Make sure you keep your regular appointments for a check-up. They are very important as your dose may need to be changed. If you go into hospital or visit another doctor or a dentist, tell them you are taking sodium valproate.
If you take more sodium valproate than you should
An overdose of this medicine may be dangerous. If you think you may have taken more sodium valproate tablets than you should (or someone else has taken some), talk to a doctor, pharmacist or go to the nearest hospital casualty department straight away. Take the carton and any sodium valproate tablets left with you so that the doctors know what you have taken.
The following effects may happen: 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 take sodium valproate
If you forget to take a dose at the right time, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking sodium valproate
Do not stop taking sodium valproate without first discussing this with your doctor, even if you feel better. This is because stopping suddenly may lead to your fits coming back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, sodium valproate can cause side effects, although not everybody gets them. Usually they are not serious, and may stop if you change to another medicine.
Stop taking sodium valproate and see a doctor or go to a hospital straight away if:
Tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment.
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
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:
Very common side effects (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Frequency unknown (cannot be estimated from available data)
These effects usually get better when you stop taking sodium valproate.
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.
Sodium valproate may decrease blood sodium. This can make you feel tired, weak, dizzy or faint. You may also feel or be sick and have muscle cramps.
Less commonly you may be bloated with swelling and tightness of the hands and feet, feel confused and have fits. Sometimes it can cause changes in the blood. Here you may notice unusual bleeding or bruising more easily, severe stomach pains, feeling shaky or problems with balance.
Taking sodium valproate can be a contributing factor in male infertility.
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 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 SODIUM VALPROATE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Sodium Valproate Tablets contain
Each tablet contains 200mg or 500mg of sodium valproate as the active substance.
The other ingredients are: Povidone, talc, magnesium stearate, calcium silicate, polyvinyl acetate phthalate, citric acid, hypromellose, macrogol 6000, diethyl phthalate, stearic acid, titanium dioxide (E171), amaranth lake (E123), indigo carmine lake (E132) and hydroxypropyl cellulose.
What Sodium Valproate Tablets look like and contents of the pack
Sodium Valproate 200mg and 500mg Tablets are round, lilac gastro-resistant tablets. They are available in blister packs of 100 tablets.
The Marketing Authorisation Holder is:
The Manufacturer is:
This leaflet was last revised in March 2018.
© 2018 Winthrop Pharmaceuticals.
© 2018 Zentiva.
There are two organisations that will also be happy to try and answer any general questions on epilepsy. They can be contacted at: