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Package leaflet: Information for the user

Sodium Valproate Ivax Oral Solution BP 200mg/5ml Sodium Valproate

YThis 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.

WARNING

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.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor 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 seem the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Sodium Valproate Ivax Oral Solution will be referred to as “Sodium Valproate” throughout this leaflet.

What is in this leaflet

1.    What Sodium Valproate is and what it is 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

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).

•    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, pharmacist or nurse 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.

•    Zidovudine - for HIV and AIDS.

•    Temozolomide - for cancer

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.

Pregnancy

Information for women who are pregnant, planning to become pregnant, or who could become pregnant

Before you start taking Sodium Valproate , your doctor should discuss with you the possible problems when it is taken in pregnancy.

•    Unplanned pregnancy is not desirable in women receiving Sodium Valproate

•    You should not take this medicine if you are pregnant or a women of child-bearing age unless explicitly advised by your doctor. If you are a woman of child-bearing age, you have to use effective contraception during treatment. Sodium Valproate has no effect on how well the oral contraceptive pill works.

Women taking Sodium Valproate during pregnancy have a higher risk than other women of having a child with an abnormality. The chance of abnormalities is increased if you are also taking other antiepileptic medicines at the same time. These abnormalities include:

•    Head and face deformities including cleft palate, a gap or depression in the lip

•    Malformations of the arms and legs

•    Deformities of the bones, including hip dislocation

•    Deformities of the tube from the bladder to the penis where the opening is formed in a different place

•    Heart and blood vessels malformations with heart defects

•    Abnormalities in the lining of nerve tubes with holes or protrusions

•    Spina bifida

Women who take Sodium Valproate during pregnancy may be more likely to have a baby with spina bifida. This is an abnormality of the spinal cord. Taking folic acid 5mg each day as soon as you stop contraception may lower the risk of having a baby with spina bifida.

There is also an increased risk of other birth defects. These other defects can usually be detected in the first 3 months of the pregnancy using routine antenatal screening blood tests and ultrasound scans. Pregnant mothers who take Sodium Valproate may have babies with blood clotting problems (such as blood not clotting or not clotting very well). This may appear as bruising or a bleeding which takes a long time to stop. Some babies born to mothers who took Sodium Valproate during pregnancy may develop less quickly than normal. These children may require additional educational support.

Talk to your doctor before stopping taking Sodium Valproate if you want to become pregnant. It is important not to stop your Sodium Valproate suddenly, as it is likely that your fits will come back.

Women who are planning to get Pregnant

If you become pregnant, think you may be pregnant or plan to become pregnant while taking Sodium Valproate , you must tell your doctor straight away.

•    Your doctor will give you appropriate counselling and will suggest changes to your treatment or dose

•    He or she will also want to check your progress while you are pregnant.

It is very important that you discuss your treatment with your doctor well before you become pregnant.

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.

Important advice for women

•    Valproate can be harmful to unborn children when taken by a woman during pregnancy.

•    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. Birth defects which have been reported 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.

•    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 2-3 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).

•    If you are a woman capable of becoming pregnant your doctor should only prescribe valproate for you if nothing else works for you.

•    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 child you should not stop taking your medicine until you have discussed this with your doctor and agreed a plan for switching you onto another product if this is possible.

•    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.

FIRST PRESCRIPTION

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.

Key messages:

•    Make sure you are using an effective method of contraception.

•    Tell your doctor at once if you are pregnant or think you might be pregnant.

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.

Key messages:

•    Make sure you are using an effective method of contraception

•    Tell your doctor at once if you are pregnant or think you might be pregnant.

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 it unlikely that it will reduce the risk of birth defects associated with valproate use.

Key messages:

•    Do not stop using your contraception before you have talked to your doctor and worked together on a plan to ensure your epilepsy/bipolar disorder is controlled and the risks to your baby are reduced.

•    Tell your doctor at once when you know or think you might be pregnant.

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.

Key messages:

•    Tell your doctor at once if you know you are pregnant or think you might be pregnant.

•    Do not stop taking valproate unless your doctor tells you to.

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.

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.

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 sodium valproate

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: a rash, swallowing or breathing problems, swelling of your lips, face, 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 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.

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: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Sodium Valproate

Keep this medicine out of the sight and reach of children.

You should keep your solution in a dry place below 25°C. Keep it in the bottle it came in. Do not put it into another bottle.

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.

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 Ivax Oral Solution contains

•    The active ingredient 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 Ivax Oral Solution 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 Not all pack sizes may be marketed.

Marketing Authorisation Holder

Norton Healthcare Limited T/A IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX

Company responsible for manufacture

TEVA UK Limited, Eastbourne BN22 9AG

This leaflet was last revised in March 2016

PL 00530/0343

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