Sodium Valproate can seriously harm an unborn baby when taken during pregnancy.

If you are a female able to have a baby, you must use effective method of birth control (contraception) at all times without interruptions during your entire treatment with Sodium Valproate 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 Sodium Valproate 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 Sodium Valproate Injection, you must also read section 2 of this leaflet carefully and contact your child’s doctor once they experience their first period.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Sodium Valproate Injection is and what it is used for
2. What you need to know before you are given Sodium Valproate Injection
3. How Sodium Valproate Injection is given
4. Possible side effects
5. How to store Sodium Valproate Injection
6. Contents of the pack and other information

The name of your medicine is Sodium Valproate 100mg/ml Solution for Injection or Infusion (called Sodium Valproate Injection in this leaflet).

Sodium Valproate Injection contains a medicine called sodium valproate.

This belongs to a group of medicines called anti-convulsants or antiepileptic agents. It works by helping to calm the brain down.

Sodium Valproate 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.

• you are allergic (hypersensitive) to sodium valproate or any of the other ingredients of Sodium Valproate Injection (listed in section 6)
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• you have a known metabolic disorder, i.e. a urea cycle disorder
• you have liver problems or you or your family have a history of liver problems, especially if caused by taking a medicine
• you have a rare illness called porphyria which affects your metabolism
• you have a genetic problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
• you are pregnant, unless nothing else works for you (see ‘Pregnancy, breast-feeding and fertility – Important advice for women’ below).

If you are a woman able to have a baby, you must not take Sodium Valproate Injection unless you use an effective method of birth control (contraception) at all times during your entire treatment with Sodium Valproate Injection. Do not stop taking Sodium Valproate Injection or your contraception, until you have discussed this with your specialist. Your specialist will advise you further (see below under “Pregnancy, breastfeeding 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, pharmacist or nurse before having Sodium Valproate Injection.

• 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
• As with other anti-epileptic drugs, convulsions may become worse or happen more frequently whilst taking this medicine. If this happens contact your doctor immediately.

• you have a brain disease or a metabolic condition affecting your brain
• you have problems with your pancreas
• you have diabetes or are being tested for diabetes. This medicine may affect the results of urine tests
• you have a carnitine palmitoyltransferase (CPT) type II deficiency
• you have kidney problems. Your doctor may monitor your valproate level or adjust your dose
• 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 rare 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, pharmacist or nurse before having Sodium Valproate Injection.

Having Sodium Valproate Injection may make you put on weight. Talk to your doctor or nurse about how this will affect you.

Your doctor may do blood tests and liver function tests before and during your treatment with this medicine. Sodium Valproate 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.

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Sodium Valproate Injection can affect the way some other medicines work. Also some medicines can affect the way Sodium Valproate Injection works.

In particular, check with your doctor if you are taking any of the following:

• Some medicines used for pain and inflammation (salicylates) such as aspirin
• Some other medicines used to treat fits (epilepsy) – see Section 3: ’Patients taking other medicines for fits’. This includes medicines such as phenobarbital, primidone, phenytoin, carbamazepine, rufinamide, topiramate, acetazolamide, lamotrigine and felbamate
• Medicines used to calm emotional and mental health disorders (including schizophrenia, bipolar disorder and depression) such as quetiapine, diazepam and olanzapine
• Monoamine oxidase inhibitors (MAOIs) such as moclobemide (used to treat depression and anxiety), selegiline (used to treat Parkinson’s disease), linezolid (used to treat infections)
• Anticoagulants – such as warfarin - used to thin the blood and prevent clots. Your doctor may change your dose of the blood thinning medicine and monitor your treatment closely
• Zidovudine and protease inhibitors such as lopinavir and ritonavir - used to treat HIV infection and AIDs
• Carbapenem agents (antibiotics used to treat bacterial infections) such as panipenem, imipenem, meropenem, rifampicin and erythromycin.
  The combination of Sodium Valproate Injection and carbapenems should be avoided because it may decrease the effect of your medicine
• Some medicines used to treat or prevent malaria such as mefloquine and chloroquine
• Temozolomide - used to treat cancer
• Cimetidine - used to treat stomach ulcers
• Cholestyramine - used to lower blood fat (cholesterol) levels
• Nimodipine – used to treat bleeding in the brain (subarachnoid haemorrhage)
• Propofol – used for anaesthesia
• Oestrogen-containing products (including some birth control pills)
• Metamizole – used to treat pain and fever.

Alcohol intake is not recommended during treatment.

Important advice for women

• You must not use Sodium Valproate Injection if you are pregnant, unless your specialist has determined that no alternative treatment works for you
• If you are a woman able to have a baby, you must not take Sodium Valproate Injection unless you use an effective method of birth control (contraception) at all times during your entire treatment with Sodium Valproate Injection
• Do not stop taking Sodium Valproate Injection or your birth control (contraception), until you have discussed this with your specialist. Your specialist will advise you further.

• Talk to your doctor immediately if you are planning to have a baby or are pregnant
• Valproate carries a risk if taken during pregnancy. The higher the dose, the higher the risks but all doses carry a risk, including when valproate is used in combination with other medicines to treat epilepsy.
• It can cause serious birth defects and can affect the physical and mental development of the child as it grows after birth. 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 11 babies in every 100 will have birth defects. This compares to 2-3 babies in every 100 born to women from the general population
  • The most frequently reported birth defects 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 and multiple associated malformations affecting several organs and parts of the body. Birth defects may result in disabilities which may be severe
  • Hearing problems or deafness have been reported in children exposed to valproate during pregnancy
  • Eye malformations have been reported in children exposed to valproate during pregnancy in association with other congenital malformations. These eye malformations may affect vision
• It is estimated that up to 30-40% of 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
• Autism and related disorders are more often diagnosed in children exposed to valproate during pregnancy and there is some evidence that children exposed to valproate during pregnancy are at increased risk of developing Attention Deficit Hyperactivity Disorder (ADHD)
• Before prescribing this medicine to you, your specialist will have explained what might happen to your baby if you become pregnant whilst taking valproate. If you decide later that you want to have a baby you must not stop taking your medicine or your method of birth control (contraception) until you have discussed this with your specialist
• If you are a parent or a caregiver of a female child treated with valproate, you must contact their doctor once your child using valproate experiences their first period (menarche)
• Some birth control pills (oestrogen-containing birth control pills) may lower valproate levels in your blood. Make sure you talk to your doctor about the method of birth control (contraception) that is the most appropriate for you
• Ask your doctor or nurse about taking folic acid when planning to have 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 STARTING TREATMENT WITH SODIUM VALPROATE INJECTION
• I AM TAKING SODIUM VALPROATE INJECTION AND NOT PLANNING TO HAVE A BABY
• I AM TAKING SODIUM VALPROATE INJECTION AND PLANNING TO HAVE A BABY
• I AM PREGNANT AND I AM TAKING SODIUM VALPROATE INJECTION

If this is the first time you have been prescribed valproate your specialist will have explained the risks to an unborn child if you become pregnant.

Once you are able to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Sodium Valproate Injection. Talk to your doctor or family planning clinic if you need advice on birth control (contraception).

Key messages:

• Pregnancy must be excluded before start of treatment with Sodium Valproate Injection with the result of a pregnancy test, confirmed by your specialist
• You must use an effective method of birth control (contraception) at all times during your entire treatment with Sodium Valproate Injection
• You must discuss appropriate and effective methods of birth control (contraception) with your doctor. Your doctor will give you information on preventing pregnancy, and may refer you to a specialist for advice on birth control (contraception)
• You must get regular (at least annual) appointments with a specialist experienced in the management of epilepsy. During this visit your specialist will make sure you are well aware of and have understood all the risks and advice related to the use of valproate during pregnancy
• Tell your doctor if you want to have a baby
• Tell your doctor immediately if you are pregnant or think you might be pregnant.

If you are continuing treatment with valproate but you are not planning to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Sodium Valproate Injection. Talk to your doctor or family planning clinic if you need advice on birth control (contraception).

Key messages:

• You must use an effective method of birth control (contraception) at all times during your entire treatment with Sodium Valproate Injection
• You must discuss appropriate and effective methods of birth control (contraception) with your doctor. Your doctor will give you information on preventing pregnancy, and may refer you to a specialist for advice on birth control (contraception)
• You must get regular (at least annual) appointments with a specialist experienced in the management of epilepsy. During this visit your specialist will make sure you are well aware of and have understood all the risks and advice related to the use of valproate during pregnancy
• Tell your doctor if you want to have a baby
• Tell your doctor immediately if you are pregnant or think you might be pregnant.

If you are planning to have a baby, first schedule an appointment with your doctor.

Do not stop taking Sodium Valproate Injection or your birth control (contraception), until you have discussed this with your specialist. Your specialist 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 are 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 valproate, switch you to another medicine, or stop treatment with Sodium Valproate Injection a long time before you become pregnant – this is to make sure your illness is stable.

Ask your doctor or nurse about taking folic acid when planning to have 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 taking Sodium Valproate Injection unless your specialist tells you to
• Do not stop using your birth control (contraception) before you have talked to your specialist and worked together on a plan to ensure your epilepsy is controlled and the risks to you and your baby are reduced
• First schedule an appointment with your specialist. During this visit your specialist will make sure you are well aware of and have understood all the risks and advice related to the use of valproate during pregnancy
• Your specialist will try to switch you to another medicine, or stop treatment with Sodium Valproate Injection a long time before you become pregnant
• Schedule an urgent appointment with your doctor if you are pregnant or think you might be pregnant.

Do not stop taking Sodium Valproate Injection, unless your specialist 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 Sodium Valproate 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 or nurse 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:

• Schedule an urgent appointment with your doctor if you are pregnant or think you might be pregnant
• Do not stop taking Sodium Valproate Injection unless your specialist tells you to
• Make sure you are referred to a specialist experienced in the treatment of epilepsy to evaluate the possibility of alternative treatment options
• You must get thorough counselling on the risks of Sodium Valproate Injection during pregnancy, including malformations and physical and mental development disorders in children
• Make sure you are referred to a specialist for prenatal monitoring to examine for potential malformations.

Make sure you read the Patient Guide that you will receive from your doctor, pharmacist or nurse. Your specialist 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, pharmacist or nurse to remind you of valproate risks in pregnancy.

• Blood clotting problems (such as blood not clotting very well). This may appear as bruising or bleeding which takes a long time to stop
• Hypoglycaemia (low blood sugar)
• Hypothyroidism (underactive thyroid gland, which can cause tiredness or weight gain)
• Withdrawal syndrome (including agitation, irritability, hyperexcitability, jitteriness, hyperkinesia, muscle problems, tremor, convulsions and feeding problems). In particular, this may occur in newborns whose mothers have taken valproate during the last trimester of their pregnancy.

Very little Sodium Valproate Injection gets into breast milk. However, talk to your doctor about whether you should breast-feed your baby. Ask your doctor, pharmacist or nurse for advice before taking or having any medicine.

You may feel sleepy when taking Sodium Valproate 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.

• Your doctor will decide how much Sodium Valproate Injection to give you depending on your illness. The amount of Sodium Valproate Injection given to you or your child will depend on you or your child’s age or body weight
• If you have been taking Sodium Valproate by mouth your doctor may decide to give you the same amount of Sodium Valproate Injection by continuous or repeated infusion.

Adults (including the elderly)

• The starting dose is usually 400-800mg (up to 10mg per kilogram of body weight)
• This is given as a slow intravenous injection over 3-5 minutes
• This is followed by a continuous or repeated infusion, up to a maximum of 2500mg each day.

Children

• The usual dose is 20-30mg for each kilogram of body weight each day • This may be increased to 40mg for each kilogram of body weight each day depending on your child’s illness.

• Your doctor may decide to adjust your or your child’s dose.

• You or your child may be taking other medicines for epilepsy at the same time as Sodium Valproate Injection. If so, your doctor should gradually initiate treatment depending on your or your child’s condition
• Your doctor may increase the dose of Sodium Valproate Injection by 5-10mg for each kilogram of body weight each day depending on which other medicines you are taking.

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.

The following effects may happen: feeling sick or being sick, headache, blurred vision due to pupil of the eye becoming smaller, dizziness, poor reflexes, confusion, memory loss 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.

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.

It is important for you to keep having Sodium Valproate Injection until your specialist decides to stop them. If you stop having Sodium Valproate Injection before your specialist decides to stop it, 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 have been given Sodium Valproate Injection.

Sodium Valproate Injection can change levels of liver enzymes, blood clotting factors, salts or sugars shown up on blood and urine tests.

Sodium Valproate Injection can be a contributing factor in male infertility.

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, 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, Website: 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.

The active ingredient is sodium valproate 100mg per ml.

The other ingredients are Disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid, sodium hydroxide and water for injections.

Sodium Valproate Injection is a clear colourless solution. It is available in glass ampoules containing either 4ml (400mg sodium valproate) or 10ml (1000mg sodium valproate) of the solution for injection. Each pack contains 1, 5 or 10 ampoules. Not all pack sizes may be marketed.

Other sources of information:

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Product Name Reference number

Sodium Valproate 100mg/ml Solution for Injection or Infusion 29831/0506

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