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SODIUM VALPROATE MYLAN TABLETS BP 500MG EC

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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.

Package leaflet: Information for the patient
Sodium Valproate Mylan Tablets BP 200 mg EC
Sodium Valproate Mylan Tablets BP 500 mg EC
(sodium valproate)
IMPORTANT THINGS TO KNOW ABOUT YOUR MEDICINE
Like all medicines Sodium Valproate Mylan can have unwanted effects. It is therefore important that you
and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting
treatment.
Sodium Valproate Mylan must not be used by women who are trying to become pregnant or are pregnant as
it can cause serious birth defects and developmental problems in the child, unless explicitly advised and
agreed with your doctor to do so. All female patients who are capable of becoming pregnant will need to
consider this risk and follow the advice provided in section 2. Your doctor will discuss this with you.

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

1.

What Sodium Valproate Mylan is and what it is used for

Sodium Valproate Mylan belongs to a group of medicines called anticonvulsants or antiepileptics. It works
by helping to calm the brain down.
Sodium Valproate Mylan is a medicine for the treatment of:
- epilepsy (fits) in adults and children
- 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 cannot be used.
Sodium Valproate Mylan treatment must be started and supervised by a doctor specialised in the treatment of
epilepsy or bipolar disorders.
You must talk to a doctor if you do not feel better or if you feel worse.

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2.

What you need to know before you take Sodium Valproate Mylan

Do not take Sodium Valproate Mylan if you:
- are allergic to sodium valproate or any of the other ingredients of this medicine (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips,
face, throat or tongue
- have liver disease or you or your family have a history of liver problems
- have a rare condition called porphyria (a condition that affects your blood).
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 this medicine if:
- you have kidney problems. Your doctor may want to monitor the levels of sodium valproate in your
blood and adjust your dose
- you have an illness called systemic lupus erythematosus (SLE), a disease of the immune system which
affects the skin, bones, joints and internal organs
- you have a metabolic disorder such as urea cycle disorder, where too much ammonia builds up in the
body
- you have diabetes, as this medicine can affect the results of urine tests
you are pregnant, think you may be pregnant or plan to become pregnant.
Blood tests:
Your doctor may wish to perform blood tests before you start taking sodium valproate and during your
treatment.
Weight gain:
Sodium valproate can increase your appetite and may make you put on weight. Talk to your doctor about
how this will affect you.
Children and adolescents
Children and adolescents under 18 years of age: Sodium valproate should not be used in children and
adolescents under 18 years of age for the treatment of mania.
Other medicines and Sodium Valproate Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In
particular, inform your doctor if you are taking:
- medicines used to calm emotional and mental conditions such as olanzapine, diazepam
- antidepressants including monoamine oxidase inhibitors (MAOI) eg. selegiline, moclobemide
- other medicines used to treat fits (epilepsy) such as phenobarbital, primidone, phenytoin, carbamazepine,
lamotrigine, felbamate, topiramate
- zidovudine, used to treat HIV infection
- medicines used to thin the blood such as warfarin
- temozolamide, used to treat cancer
- mefloquine or chloroquine, used to prevent and treat malaria. Taking these with sodium valproate may
increase the chance of a fit
- some medicines used for pain and inflammation (salicylates) such as aspirin
- cimetidine, used to treat stomach ulcers
- erythromycin or rifampicin, antibiotics used to treat infection
- carbapenem agents (antibiotic used to treat bacterial infections) such as imipenem, penipenem,
meropenem. The combination of valproic acid and carbapenems should be avoided because it may
decrease the effect of sodium valproate
- colestyramine, used to lower blood fat (cholesterol) levels.
Sodium Valproate Mylan with food, drink and alcohol
Take Sodium Valproate Mylan Tablets with or after food to reduce the likelihood of stomach upsets.
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Alcohol intake is not recommended during treatment.
Pregnancy and breast-feeding
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 every 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 women 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.
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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 is 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 that 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.

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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.
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
This medicine may make you feel drowsy. Do not drive or operate machinery if you feel drowsy after taking
Sodium Valproate Mylan Tablets. Taking other medicines used to treat fits or calm emotional and mental
health problems may increase sleepiness.
Sodium Valproate Mylan Tablets contain sunset yellow (E110) which can cause allergic reactions
including asthma. This allergy is more common in those people who are allergic to aspirin.

3.

How to take Sodium Valproate Mylan

Sodium Valproate Mylan treatment must be started and supervised by a doctor specialised in the treatment of
epilepsy or bipolar disorders.
Swallow the tablets whole. Do not crush or chew the tablets. Take the tablets with or after food to reduce
the likelihood of stomach upsets.
The dose of Sodium Valproate Mylan you take will depend upon your age and body weight and will be
adjusted to control your symptoms.
Epilepsy
Adults (including the Elderly): The recommended starting dose is 600 mg daily. Your doctor should
increase this dose by 200 mg every three days depending on your condition.
The recommended daily dose is between 1000 mg and 2000 mg (20 - 30 mg per kilogram of bodyweight).
The maximum dose of 2500 mg daily.
Children and adolescents over 20 kg: The recommended starting dose is 400 mg daily. Your doctor may
gradually increase this dose depending on your child’s condition to a maximum total daily dose of 35 mg per
kilogram of bodyweight.
Children and adolescents under 20 kg: The recommended starting dose is 20 mg per kilogram of
bodyweight daily. Your doctor may increase this dose depending on your child’s condition.
Patients with kidney problems: Your doctor may adjust your dose.
Mania
Adults (including the Elderly): 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.
If you take more Sodium Valproate Mylan than you should
Contact your doctor or nearest hospital casualty department immediately. Take the container and any
remaining tablets with you. The following effects may happen: feeling or being sick, pupils of the eye
become smaller, dizziness, loss of consciousness, weak muscles and poor reflexes, breathing problems,
headaches, fits (seizures), confusion, memory loss and unusual or inappropriate behaviour.
If you forget to take Sodium Valproate Mylan
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Do not take a double dose to make up for a forgotten tablet. Take the missed dose as soon as you remember
unless it is almost time for your next dose.
If you stop taking Sodium Valproate Mylan
Do not stop taking Sodium Valproate Mylan Tablets without speaking to your doctor.
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.
If you notice any of the following symptoms, stop taking sodium valproate and tell your doctor
immediately or go to your nearest hospital emergency department:
 you have an allergic reaction. The signs may include: a rash, 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.
 liver problems and problems of the pancreas may show as a sudden illness which may happen in the
first six months of treatment. This happens in a very small number of people taking sodium
valproate. It includes feeling and being sick many times, being very tired, sleepy and weak, stomach
pain including very bad upper stomach pain, jaundice (yellowing of the skin or whites of the eyes),
loss of appetite, swelling (especially of the legs and feet but may include other parts of the body),
worsening of your fits or a general feeling of being unwell. Your doctor may tell you to stop taking
sodium valproate immediately if you have these symptoms.
 you have a skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly
or filled with fluid. The rash may appear especially on the palms or soles of your feet. These could be
signs of a serious allergy to the medicine called ‘erythema multiforme’
 blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like
symptoms and fever. This may be something called ‘Stevens-Johnson syndrome’
 severe blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin
over the body. Also a feeling of being generally unwell, fever, chills and aching muscles. This may
be something called ‘Toxic epidermal necrolysis’
 bruising more easily and getting more infections than usual. This could be a blood problem called
‘thrombocytopenia’. It can also 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)
 blood clotting problems (bleeding for longer than normal), bruising or bleeding for no reason
 changes in mood, loss of memory, lack of concentration and deep loss of consciousness (coma)
These side effects are serious. You may need medical attention.
Tell your doctor as soon as possible if you have any of the following side effects:
 changes in behaviour including being very alert, and sometimes also aggressive, hyper-active and
unusual or inappropriate behaviour. This is more likely if other medicine to treat fits such as
phenobarbital and topiramate are taken at the same time or if the sodium valproate starting dose is
high or has been suddenly increased.
 changes in the amount of ammonia in the blood. Symptoms of this condition are being sick, problems
with balance and co-ordination, feeling lethargic or less alert
 feeling shaky (tremor), sleepy or unsteady when walking or jerky muscle movements
 feeling tired or confused with loss of consciousness sometimes accompanied by hallucinations or fits
 blisters with the skin flaking away.
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few
days, or if you notice any side effects not listed in this leaflet:

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feeling sick, stomach ache or diarrhoea, especially when starting treatment. This may be helped by
taking the tablets with food
fainting
hearing loss
skin problems such as rashes. These happen rarely, but more often in people also taking lamotrigine
acne
hair loss which is usually temporary. When it grows back it may be more curly than before
hair, including body or facial hair grows more than normal in women
skin rash caused by narrow or blocked blood vessels (vasculitis)
changes in women's periods and increased hair growth in women
breast enlargement in men
swelling of the feet and legs (oedema)
weight gain - as your appetite may be increased
kidney problems, bedwetting or increased need to pass urine.

Bone Disorders
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.
Blood tests
Sodium valproate can change levels of liver enzymes, salts or sugars shown up on blood and urine tests.
Male Fertility
Taking Sodium Valproate Mylan can be a contributing factor in male infertility.
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.
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Sodium Valproate Mylan

Keep this medicine out of the sight and reach of children.
Store in a dry place, at a temperature not exceeding 30°C. Keep in protective foil until taken. Protect from
direct sunlight.
Do not use this medicine after the expiry date which is stated on the carton after EXP. 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 Mylan contains
-

The active substance is sodium valproate.
The other ingredients are maize starch, magnesium stearate, colloidal silicon dioxide, sodium starch
glycollate, purified talc and microcrystalline cellulose. The enteric coating contains hydroxypropyl
methylcellulose, diethyl phthalate, cellulose acetate phthalate, titanium dioxide (E171), polyethylene
glycol, indigo carmine (E132), erythrosine (E127) and sunset yellow (E110).

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What Sodium Valproate Mylan looks like and contents of the pack
The 200 mg tablets are 10 mm normal convex violet coated tablets.
The 500 mg tablets are 13 mm normal convex violet coated tablets.
Sodium Valproate Mylan Tablets are available in foil/foil blisters of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50,
56, 60, 84, 90, 100, 112, 120, 168 and 180 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Mylan, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer: Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL
This leaflet was last revised in February 2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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