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: PL35533/0153.
Dyzantil 200mg, 300mg and 500mg prolonged-release tablets
Dyzantil 200mg prolonged-release tablets
Dyzantil 300mg prolonged-release tablets
Dyzantil 500mg prolonged-release 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.
Dyzantil, 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 Dyzantil.
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 Dyzantil 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 Dyzantil, you must also read section 2 of this leaflet carefully and contact your child’s doctor once they experience their first period.
1.What Dyzantil is and what it is used for
2. What you need to know before you take Dyzantil
3.How to take Dyzantil
4.Possible side effects
5.How to store Dyzantil
6.Contents of the pack and other information
The name of your medicine is Dyzantil 200, 300 and 500mg prolonged-release tablets. “Prolonged-release” means that the active ingredient sodium valproate is slowly released from the tablets over a period of time.
Dyzantil 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.
Dyzantil is used to treat epilepsy (fits) in adults and children.
If you are a woman able to have a baby you must not take Dyzantil unless you use an effective method of birth control (contraception) at all times during your treatment with Dyzantil. Do not stop taking Dyzantil 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 take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Dyzantil.
Talk to your doctor or pharmacist before taking Dyzantil if:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Dyzantil.
Taking Dyzantil 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 Dyzantil and during your treatment with this medicine. Dyzantil 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.
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 Dyzantil can affect the way some other medicines work. Also, some medicines can affect the way Dyzantil works.
In particular, check with your doctor if you are taking any of the following:
Alcohol intake is not recommended during treatment.
Important advice for women
The risks of valproate when taken during pregnancy
Please choose the situations which apply to you and read the descriptions below:
I AM STARTING TREATMENT WITH DYZANTIL
If this is the first time you have been prescribed Dyzantil 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) at all times during your entire treatment with Dyzantil. Talk to your doctor or family planning clinic if you need advice on birth control (contraception).
I AM TAKING DYZANTIL AND NOT PLANNING TO HAVE A BABY
If you are continuing treatment with Dyzantil but you are not planning to have a baby, make sure you are using an effective method of birth control (contraception) at all times during your entire treatment with Dyzantil. Talk to your doctor or family planning clinic if you need advice on birth control (contraception).
I AM TAKING DYZANTIL 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 Dyzantil 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 (behaviour and learning disorders), 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 Dyzantil, switch you to another medicine, or stop treatment with Dyzantil 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.
I AM PREGNANT AND I AM USING DYZANTIL
Do not stop taking Dyzantil 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 (behaviour and learning disorders) 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 Dyzantil 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.
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.
Newborn babies of mothers who took valproate during pregnancy may have:
Very little Dyzantil gets into the breast milk. However, talk to your doctor about whether you should breast-feed your baby. Ask your doctor or pharmacist for advice before taking any medicine.
You may feel sleepy when taking Dyzantil. 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.
Dyzantil 200 contains 18.43mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to less than 1% of the recommended maximum daily dietary intake of sodium for an adult per tablet.
Dyzantil 300 contains 27.65mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to less than 2% of the recommended maximum daily dietary intake of sodium for an adult per tablet.
Dyzantil 500 contains 46.08mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to less than 3% of the recommended maximum daily dietary intake of sodium for an adult per tablet.
Always take Dyzantil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dyzantil treatment must be started and supervised by a doctor specialised in the treatment of epilepsy.
Your doctor will decide how much Dyzantil to give you or your child depending on your or your child’s body weight. If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself but ask your doctor.
Adults (including the elderly)
Children over 20 kilograms
Children under 20 kilograms
Patients with kidney problems
If you take more Dyzantil than you should, tell a doctor or go to a hospital casualty department straight away. 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, headaches, blurred vision due to pupils of the eye becoming smaller, dizziness, poor reflexes, confusion, memory loss and tiredness. You may also have a 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 Dyzantil or alter your or your child’s dose without checking with your specialist. If you or your child stop taking Dyzantil 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. If you or your child go into hospital or visit another doctor or a dentist, tell them you are taking Dyzantil.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Dyzantil can cause side effects, although not everybody gets them. Side effects are more likely to happen at the start of treatment.
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 anti-epileptic medication, have a history of osteoporosis, or take steroids.
Dyzantil can change levels of liver enzymes, salts or sugars shown up on blood and urine tests.
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 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.
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the blister and carton after EXP. The expiry date refers to the last day of that month.
Do not remove the tablets from the foil until just before you take them. Do not cut the blister strips. Store in a dry place below 30°C. These measures help protect the tablets from moisture and light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
The other ingredients are:
14, 30, 48, 72, 90, 100 prolonged-release tablets.
Not all pack sizes may be marketed.
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 or pharmacist.
This leaflet was last revised in May 2022.
1010506 - P6.2
Other sources of information
This leaflet is available in alternative formats such as audio, CD-ROM or large print. Please contact Aspire Pharma Ltd via telephone: (+44) 01730 231148 or email: [email protected] for more information.