Patient leaflet - SODIUM VALPROATE CRESCENT ORAL SOLUTION BP 200 MG / 5ML
1. what sodium valproate is and what it is used for
Sodium Valproate contains the active ingredient sodium valproate, which belongs to a group of medicines known as anticonvulsants.
Sodium Valproate is a medicine for the treatment of:
- epilepsy or fits
- women of child bearing age suffering from severe epilepsy or those not responding to other treatment.
- Sodium Valproate is used in the treatment of mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive. Mania occurs in an illness called ‘bipolar disorder’. Sodium Valproate can be used when lithium can not be used.
Sodium Valproate may be taken either on its own as your only treatment for epilepsy or you may take it together with another epilepsy therapy.
You must talk to a doctor if you do not feel better or if you feel worse within a few days of taking this medicine.
2. what you need to know before you take sodium valproate
Do not take Sodium Valproate:
- if you are allergic to Sodium Valproate or any of the other ingredients of this medicine (listed in section 6).
- Bipolar disorder
o For bipolar disorder, you must not use Sodium Valproate if you are pregnant.
o For bipolar disorder, if you are a woman able to have a baby, you must not take Sodium Valproate, unless you use effective method of birth control (contraception) during your entire treatment with Sodium Valproate. Do not stop taking Sodium Valproate 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”).
- Epilepsy
o For epilepsy, you must not use Sodium Valproate if you are pregnant, unless nothing else works for you.
o For epilepsy, if you are a woman able to have a baby, you must not take Sodium Valproate unless you use effective method of birth control (contraception) during your entire treatment with Sodium Valproate). Do not stop taking Sodium Valproate 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”).
- if you have a rare illness called porphyria which affects your metabolism
- if you have ever had problems with your liver or have a family history of liver problems.
- if you have a genetic problem causing a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
Warnings 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 Sodium Valproate
- if you are diabetic, as Sodium Valproate may affect tests on your urine giving an indication that
ketones are present in the urine when this is not the case
- if you have any sudden abdominal pain, nausea, vomiting or loss of appetite, as your doctor may
want to do some blood tests
- if you are likely to become pregnant
- if you are likely to increase your weight, as whilst taking your solution your appetite may be
increased so you must take care to avoid weight gain. Please regularly check your body weight when you are on this medicine.
- if you have kidney problems – you may need a lower dose.
- if you have any metabolic disorder, particularly a urea cycle disorder which is passed on in
families there is a risk of increased amounts of ammonia in the blood.
- if you have an illness called “lupus” – a disease of the immune system which affects skin, bones,
joints, lungs and kidneys
- if you are taking salicylates
- if you know that there is a genetic problem causing a mitochondrial disorder in your family.
Children and adolescents
Children and adolescents under 18 years of age:
Sodium Valproate should not be used for children and adolescents below 18 years of age for the treatment of mania.
Your doctor may want you to have blood tests before you start and during the first six months of your treatment to:
- check for blood or liver problems, especially in children under 3 years of age, or patients who suffer from severe seizures, have brain disease and/or learning disabilities, or have a history of liver disease.
- to check your blood cell counts as these may be affected by using sodium valproate.
- Your doctor may do regular blood tests and liver function tests before and during your treatment
with this medicine.
Other medicines and Sodium Valproate
Tell your doctor or pharmacist if you are taking, if you have recently taken or might take any other medicines.
- Anti-psychotic agents – for mental health problems. Sodium Valproate may increase the effects of these drugs. In particular, when taken with the medicine olanzapine the following effects may occur: neutropenia (a blood problem which reduces the chance of fighting infection), tremor, dry mouth, increased appetite and weight gain, problems with speech, sleepiness or extreme tiredness
- Drugs for depression, including monoamine oxidase inhibitors.
- Benzodiazepines – used as sleeping tablets and for anxiety
- Medicines for thinning the blood such as warfarin and aspirin
- Other medicines for epilepsy, for example, phenytoin, topiramate, carbamazepine, Phenobarbital, primidone, felbamate and lamotrigine
- Carbapenem agents (antibiotic used to treat bacterial infection). The combination of valproic acid and carbapenems should be avoided because it may decrease the effect of sodium valproate.
- Colestyramine (for high blood fat levels)
- Cimetidine – for stomach ulcers
- Erythromycin, rifampicin (antibiotics used for bacterial infections)
- Mefloquine chloroquine – used to prevent and treat malaria. Taking these with Sodium Valproate may increase the chance of a fit. Before travelling to a malaria area, ask your doctor or pharmacist about the best malaria prevention tablets for you.
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 oral solution.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Important advice for women
Bipolar disorder
- For bipolar disorder, you must not use Sodium Valproate if you are pregnant.
- For bipolar disorder, if you are a woman able to have a baby, you must not take Sodium Valproate, unless you use effective method of birth control (contraception) during your entire treatment with Sodium Valproate). Do not stop taking Sodium Valproate or your contraception, until you have discussed this with your doctor. Your doctor will advise you further.
Epilepsy
- For epilepsy, you must not use Sodium Valproate if you are pregnant, unless nothing else works for you.
- For epilepsy, if you are a woman able to have a baby, you must not take Sodium Valproate unless you use effective method of birth control (contraception) during your entire treatment with Sodium Valproate. Do not stop taking Sodium Valproate or your contraception, until you have discussed this with your doctor. Your doctor will advise you further.
The risks of valproate when taken during pregnancy (irrespective of the disease for which valproate is used)
- 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.
- It can cause serious birth defects and can affect the way in which the child develops as it grows. 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.
- Eye malformations have been reported in children exposed to valproate during pregnancy in association with other congenital malformations. These eye malformations may affect vision.
- 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 to 3 babies in ever 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).
- 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 baby you must not stop taking your medicine or your method of contraception until you have discussed this with your doctor.
- If you are a parent or a caregiver of a female child treated with valproate, you should contact the
doctor once your child using valproate experiences menarche.
- 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.
Please choose and read the situations which apply to you from the situations described below: o I AM STARTING TREATMENT WITH SODIUM VALPROATE
o I AM TAKING SODIUM VALPROATE AND NOT PLANNING TO HAVE A BABY
o I AM TAKING SODIUM VALPROATE AND PLANNING TO HAVE A BABY
o I AM PREGNANT AND I AM TAKING SODIUM VALPROATE
I AM STARTING TREATMENT WITH SODIUM VALPROATE
If this is the first time you have been prescribed Sodium Valproate 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 contraception without interruption throughout your treatment with Sodium Valproate. Talk to your doctor or family planning clinic if you need advice on contraception.
Key messages:
- Pregnancy must be excluded before start of treatment with Sodium Valproate with the result of a pregnancy test, confirmed by your doctor.
- You must use an effective method of birth control (contraception) during your entire treatment with Sodium Valproate.
- You must discuss the appropriate 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.
- You must get regular (at least annual) appointments with a specialist experienced in the management of bipolar disorder or epilepsy. During this visit your doctor will make sure you are well aware and have understood all the risks and advices 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.
I AM TAKING SODIUM VALPROATE AND NOT PLANNING TO HAVE A BABY
If you are continuing treatment with Sodium Valproate but you are not planning to have a baby make sure you are using an effective method of contraception without interruption during your entire treatment with Sodium Valproate. Talk to your doctor or family planning clinic if you need advice on contraception.
Key messages:
- You must use an effective method of birth control (contraception) during your entire treatment with Sodium Valproate.
- You must discuss contraception (birth control) with your doctor. Your doctor will give you information on preventing pregnancy, and may refer you to a specialist for advice on birth control.
- You must get regular (at least annual) appointments with a specialist experienced in the management of bipolar disorder or epilepsy. During this visit your doctor will make sure you are well aware and have understood all the risks and advices 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.
I AM TAKING SODIUM VALPROATE 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 Sodium Valproate or your 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 or 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 Sodium Valproate or switch you to another medicine, or stop treatment with Sodium Valproate, a long time before you become pregnant – this is to make sure your illness is stable.
Ask your doctor 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 it unlikely that it will reduce the risk of birth defects associated with valproate use.
Key messages:
- Do not stop taking Sodium Valproate unless your doctor tells you to.
- Do not stop using your methods of birth control (contraception) before you have talked to your doctor and worked together on a plan to ensure your condition is controlled and the risks to your baby are reduced.
- First schedule an appointment with your doctor. During this visit your doctor will make sure you are well aware and have understood all the risks and advices related to the use of valproate during pregnancy.
- Your doctor will try to switch you to another medicine, or stop treatment with Sodium Valproate a long time before you become pregnant.
- Schedule an urgent appointment with your doctor if you are pregnant or think you might be pregnant.
I AM PREGNANT AND I AM USING SODIUM VALPROATE
Do not stop taking Sodium Valproate, 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 or epilepsy, so that alternative treatment options can be evaluated.
In the exceptional circumstances when Sodium Valproate 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 could 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.
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 unless your doctor tells you to.
- Make sure you are referred to a specialist experienced in the treatment of epilepsy or bipolar disorder to evaluate the need for alternative treatment options.
- You must get thorough counselling on the risks of Sodium Valproate during pregnancy, including teratogenicity and developmental effects in children.
- Make sure you are referred to a specialist for prenatal monitoring in order to detect possible occurrences of malformations.
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.
Breast-feeding
Very little Sodium Valproate 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.
Driving and using machines
- You may feel sleepy:
- When you first start taking Sodium Valproate
If you are taking it with other medicines, such as other antiepileptic drugs or benzodiazepines.
If this happens to you, do not drive or use any tools or machines.
Sodium Valproate contains Sorbitol, Sodium propyl hydroxybenzoate (E217) and Sodium methyl hydroxybenzoate (E219)
- This medicine contains a significant amount of Sorbitol. The higher dose of this medicine is not suitable for people with hereditary fructose intolerance as it can cause stomach upset and diarrhoea.
- Sodium propyl hydroxybenzoate (E217) and Sodium methyl hydroxybenzoate (E219). These may cause a rash and other skin reactions such as contact dermatitis, which may not appear at the beginning of treatment. Rarely there have been reports of a rash appearing straight away, with wheezing or breathing problems. Talk to a doctor straight away if this happens.
3. how to take sodium valproate
Sodium Valproate treatment must be started and supervised by a doctor specialised in the treatment of epilepsy or bipolar disorders.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Taking sodium valproate on its own for epilepsy (fits):
- Adults
Initially, 600mg (three 5ml spoonfuls) in divided doses.
Your doctor will increase this amount by 200mg (one 5ml spoonful) every three days until your epilepsy is controlled. The maintenance dose is usually between 1000mg and 2000mg (five to ten 5ml spoonfuls) a day taken in divided doses, but it can sometimes be as high as 2500mg.
- Older people
Your dosage will be determined by your doctor, according to the control of your epilepsy. symptoms.
- Children over 20 kg
The initial dose is 400mg (two 5ml spoonfuls) a day. Your doctor will then increase and adjust the dose for your child based on the child’s body weight until your child’s epilepsy is controlled.
- Children under 20 kg
Your doctor will calculate the appropriate dose according to your child’s body weight.
Patients with kidney problems
- Your doctor may decide to adjust your or your child’s dose.
Mania
The daily dosage should be established and controlled individually by your doctor.
Initial dose
- The recommended initial daily dose is 750 mg.
Mean daily dose
- The recommended daily doses usually range between 1000 mg and 2000 mg.
Taking Sodium Valproate together with another therapy
You may be taking other drugs to control your epilepsy at the same time as sodium valproate. If you are, your doctor may give you a different dose of sodium valproate.
If you take more Sodium Valproate than you should
If you (or someone else) swallow a lot of the solution all together, or if you think a child has swallowed any of the solution, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause nausea, vomiting, dizziness, breathing difficulties or unconsciousness.
Please take this leaflet, any remaining solution, and the container with you to the hospital or doctor so that they know which solution was consumed.
If you forget to take your medicine, take it as soon as you remember, unless it is nearly time to take the next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sodium Valproate
DO NOT stop taking your medicine without talking to your doctor first even if you feel better, as this may lead to a recurrence of your symptoms.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop taking the solution and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:
- an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
Other side effects
Tell your doctor immediately if the following happens, as you may have to stop taking the solution:
Very common: may affect more than 1 in 10 people
- Weight gain – as your appetite may be increased
- Nausea (Feeling unwell) this usually disappears after a few days without your stopping treatment. You may not get this side effect if you take Sodium Valproate with or after your food or by taking enteric coated Sodium Valproate.
- Stomach pain, this usually disappears after a few days without stopping your treatment. You may not get this side effect if you take Sodium Valproate with or after your food or by taking enteric coated Sodium Valproate.
- Loose stool, this usually disappears after a few days without stopping your treatment. You may not get this side effect if you take Sodium Valproate with or after your food or by taking enteric coated Sodium Valproate.
Common: may affect up to 1 in 10 people
- Liver problems- abnormal result of liver enzyme test. It happens particularly early in treatment, and may be a temporary liver problem which disappears after reduction in dosage of sodium Valproate.
- Nail and nail bed disorders
Rare: may affect up to 1 in 1,000 people
- Decreased blood cell count (This can be identified from a blood test). But blood cell counts return to normal on discontinuation of this medicine
- Allergic reactions (signs of an allergic reaction include: swallowing or swelling of your throat or tongue)
- Obesity
- Sedation (Feeling sleepy) – it is a temporary problem that occurs early in treatment.
- Extrapyramidal disorders. The symptoms you may feel are like feeling shaky (tremor), or unsteady when walking or jerky muscle movements, restlessness
- Feeling tired, confused, having hallucinations (feeling things that are not real) or changes in mood
- Very unusual behaviour including being very alert, and sometimes also aggressive, hyper-active and showing bad behaviour. This can be associated with more frequent or severe fits, and loss of drive. This is more likely if phenobarbital is taken at the same time or if the Sodium Valproate dose has been suddenly increased
- Abnormal liver function
- Rash, acne. These happen rarely, but more often in people also taking lamotrigine.
- Drug Rash with Eosinophilia and systemic symptoms (DRESS) syndrome
- Hearing problems
- Swelling of the feet and legs (oedema)
- Swelling of tissues, usually in the lower limbs, due to the accumulation of fluids
- Double vision
Very rare: may affect up to 1 in 10,000 people
- Abnormally low level of sodium in the blood (this can be identified from a blood test). This can make you feel tired, weak, dizzy or faint
- Prolonged unconsciousness (coma)
- Shaking and rigidity of muscles
- Temporary loss of mental abilities such as thinking, remembering, and reasoning (Dementia) associated with muscle weakness impairment of speech and vision (cerebral atrophy).
- Pancreatitis. Symptoms you may feel are like intense abdominal pain which aggravates after eating, swollen and tender abdomen, feeling unwell, vomiting, fever and increased pulse rate.
- Inability to control the flow of urine
- Skin disorder characterized by blistering and peeling of the top layer of skin.
- Changes in women's periods
- Increased breast growth in men.
Not known: frequency cannot be estimated from the available data
- Blood clotting problems (bleeding for longer than normal), bruising or bleeding for no reason.
- Changes in the amount of ammonia in the blood (this can be identified from blood test)
- Inflamed blood vessels (vasculitis) – you may notice pain, redness or itching.
- Increased appetite
- Liver failure
- Death due to severe liver damage
- Loss of hair which is usually temporary. When it grows back it may be more curly than before.
- Disorder in muscle movement
- Bone marrow failure
- Kidney problems,
- Uncontrolled bleeding in new born babies whose mothers have taken Valproate during pregnancy.
- 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.
Additional side effects in children
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.
Reporting of side effects
If you get any side effects, talk to your doctor 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 at: 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store below 25°C.
Keep the container tightly closed in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Sodium Valproate contains
- The active ingredient is sodium valproate.In each 5ml of solution is sodium valproate 200mg.
- The other ingredients are sodium methyl p-hydroxy benzoate, sodium propyl p-hydroxy benzoate, glycerol, cherry flavour, erythrosine (E127) and sorbitol solution (inactive ingredients).
What Sodium Valproate looks like and contents of the pack
Sodium Valproate Oral Solution is a pink clear liquid with a cherry smell.
- It comes in bottles of 300 ml and 1 litre