- valproate semisodium
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 are: PL 04425/0200, PL 04425/0199.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Depakote® 250mg and 500mg Tablets
valproic acid (as valproate semisodium)
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▼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.
Depakote, valproate semisodium, can seriously harm an unborn child taken during pregnancy. If you are a female able to have a baby you must use an effective method of birth control (contraception) without interruption during your entire treatment with Depakote. Your doctor will discuss this with you but you should also follow the advice in section 2 of this leaflet.
Schedule an urgent appointment with your doctor if you want to become pregnant or think you are pregnant.
Do not stop taking Depakote unless your doctor tells you to as your condition may become worse.
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 Depakote is and what it is used for
2.What you need to know before you take Depakote
3.How to take Depakote
4.Possible side effects
5.How to store Depakote
6.Contents of the pack and other information
1. What Depakote is and what it is used for
The name of your medicine is Depakote 250mg or 500mg Tablets (called Depakote in this leaflet).Depakote contains a medicine called valproate semisodium. This belongs to a group of medicines called mood stabilisers. It works by stabilising the levels of chemicals in your brain that affect your mood.
Depakote can be used to manage or control mania (feeling highly excited, enthusiastic, being over-active and easily irritated or distracted) caused by bipolar disorder. Bipolar disorder is where the mood changes between feeling very high (mania) and very low (depression).
Depakote can be used when lithium cannot be used.
2. What you need to know before you take Depakote
Do not take Depakote and tell your doctor if:
If you are a woman able to have a baby you must not take Depakote unless you use an effective method of birth control (contraception) at all times during your treatment with Depakote. Do not stop taking Depakote 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 Depakote.
Warnings and precautions
Talk to your doctor or pharmacist before taking Depakote if:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Depakote.
Taking Depakote may make you put on weight. Talk to your doctor about how this will affect you.
Other medicines and Depakote
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 Depakote can affect the way some other medicines work. Also, some medicines can affect the way Depakote works.
In particular, do not take and check with your doctor if you are taking any of the following:
The following medicines can affect the way Depakote works or Depakote can affect the way some of these medicines work:
Taking Depakote 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
Please choose the situations which apply to you and read the descriptions below:
I AM STARTING TREATMENT WITH DEPAKOTE
If this is the first time you have been prescribed Depakote 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 Depakote. Talk to your doctor or family planning clinic if you need advice on birth control (contraception).
I AM TAKING DEPAKOTE AND NOT PLANNING TO HAVE A BABY
If you are continuing treatment with Depakote but you don’t plan to have a baby make sure you are using an effective method of birth control (contraception) without interruption during your entire treatment with Depakote. Talk to your doctor or family planning clinic if you need advice on birth control (contraception).
I AM TAKING DEPAKOTE 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 Depakote 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 bipolar disorder 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 Depakote, switch you to another medicine, or stop treatment with Depakote 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 DEPAKOTE
Do not stop taking Depakote, 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 so that alternative treatment options can be evaluated. 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:
If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
You may feel sleepy, confused or dizzy while taking this medicine. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Depakote
Your medicine contains colours called ‘sunset yellow aluminium lake (E110)’ and ‘ponceau 4R aluminium lake (E124)’. They may cause allergic reactions including asthma in some people. You are more likely to have an allergy if you are also allergic to aspirin.
3. How to take Depakote
Always take Depakote exactly as your doctor has told you. Your doctor will decide your daily dose. You should check with your doctor or pharmacist if you are not sure.
Depakote treatment must be started and supervised by a doctor specialised in the treatment of bipolar disorders.
How to take your medicine
How much to take
Adults (including the elderly)
If you have kidney problems
Children and adolescents under 18 years of age
Your doctor may do regular blood tests and liver function tests before and during your treatment with this medicine.
If you take more Depakote than you should
If you or someone else has taken more Depakote than you should, talk to a doctor or go to your nearest hospital casualty department straight away. Remember to take the medicine pack with you. This is so the doctor knows what you have taken.
The following effects may happen: being sick, headache, blurred eyesight due to pupils of the eyes becoming smaller, lack of reflexes, confusion and tiredness. You may also have 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 forget to take Depakote
If you forget to take a dose at the right time, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.
If you stop taking Depakote
Keep taking your medicine until your doctor tells you to stop. Do not stop taking Depakote just because you feel better. If you stop, your illness may return.
When your doctor says that you can stop taking Depakote, your dose will be lowered gradually. Your doctor will help you to do this.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Depakote can cause side effects, although not everybody gets them. Side effects are more likely to happen at the start of treatment.
If you have an allergic reaction, stop taking Depakote and see a doctor or go to a hospital straight away. The signs may include: rash, joint pain, fever (systemic lupus erythematosus), swallowing or breathing problems, swelling of your lips, face, throat or tongue. Hands, feet or genitals may also be affected. More severe allergic reactions can lead to lymph node enlargement and possible impairment of other organs.
Stop taking Depakote and see your doctor or go to a hospital straight away if you notice a combination of any of the following serious side effects:
The following side effects may be signs of problems with your liver or pancreas and may show as a sudden illness:
The following side effects may be signs of problems with your blood cells:
These could be caused by a blood disorder called ‘thrombocytopenia’. It can be due to a fall in the number of white blood cells, bone marrow depression or another condition that affects red blood cells, white blood cells and platelets (pancytopenia) or how the blood clots.
Other serious side effects which need urgent medical attention:
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:
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.
Depakote can change levels of liver enzymes, salts or sugars shown up on blood and urine tests.
Taking Depakote 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 Depakote
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Depakote after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
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 to protect the environment.
6. Contents of the pack and other information
What Depakote 250mg Tablets contain
What Depakote 500mg Tablets contain
What Depakote Tablets look like and contents of the pack
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
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 November 2019
© Sanofi, 2000-2019
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
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+44 (0)845 372 7101
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