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DEPAKOTE 250 MG TABLETS

Active substance(s): VALPROATE SEMISODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Depakote 250 mg Tablets
valproate semisodium





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.
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.
Your medicine is available in another strength.
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. Do not pass it on to
others. It may harm them, even if their symptoms 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. See
section 4.
What is in this leaflet
1. What Depakote is and what it is used for
2. What you need to know before you take Depakote
3. How to take Depakote
4. Possible side effects
5. How to store Depakote
6. Contents of the pack and other information
1. What Depakote is and what it is used for
The name of your medicine is Depakote 250mg Tablets (called
Depakote in this leaflet). Depakote contains a medicine called
valproate semisodium. This belongs to a group of medicines called
mood stabilisers. It works by stabilising the levels of chemicals in your
brain that affect your mood.
Depakote can be used to manage or control mania (feeling highly
excited, enthusiastic, being over-active and easily irritated or
distracted) caused by bipolar disorder. Bipolar disorder is where the
mood changes between feeling very high (mania) and very low
(depression).
Depakote can be used when lithium can not be used.
2. What you need to know before you take Depakote
Do not take Depakote
ͯ
You are allergic (hypersensitive) to valproate semisodium or any of
the other ingredients of Depakote (see Section 6: Contents of the
pack and other information)
ͯ
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue
ͯ
You have liver problems
ͯ
You or a family member has ever had liver problems caused by
taking a medicine
ͯ
You have a rare illness called porphyria which affects your
metabolism
ͯ
If you have a genetic problem caused by a mitochondrial disorder
(e.g. Alpers-Huttenlocher syndrome)
Do not take this medicine if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before taking Depakote.
Warnings and precautions
A small number of people being treated with mood stabilisers such as
valproate semisodium 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
Depakote if:
 You are changing from another medicine that contains valproate
 The person taking this medicine is less than 18 years old
 You have fits (epilepsy), brain disease or a metabolic condition
affecting your brain.
 You have kidney problems
 You have problems with your pancreas
 You have an illness called ‘systemic lupus erythematosus’. This is
a disease of the immune system which affects the skin, bones,
joints and internal organs
 You have a metabolic condition which results in too much
ammonia in the blood (shown in blood tests)
 You have diabetes or are being tested for diabetes. This medicine
may affect the results of urine tests
 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
or pharmacist before taking Depakote.
Weight gain
Taking Depakote may make you put on weight. Talk to your doctor
about how this will affect you.
Other medicines and Depakote
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. This is because Depakote
can affect the way some other medicines work. Also, some medicines
can affect the way Depakote works.
In particular, do not take and check with your doctor if you are
taking any of the following:
• Some medicines used for pain and inflammation called ‘salicylates’
such as aspirin.
The following medicines can affect the way Depakote works or
Depakote can affect the way some of these medicines work:
• Some medicines used to treat fits (epilepsy) such as
phenobarbital, primidone, phenytoin, carbamazepine, topiramate,
lamotrigine and felbamate. Your doctor may change the dose of
one of your medicines and monitor your treatment closely
• Medicines for depression







Medicines used to calm emotional and mental conditions such as
diazepam and olanzapine
Zidovudine - used for HIV infection
Carbapenem agents (antibiotics used to treat bacterial infections)
such as panipenem, imipenem, meropenem, rifampicin and
erythromycin. The combination of Depakote and carbapenems
should be avoided because it may decrease the effect of your
medicine
Some medicines used for malaria such as mefloquine or
chloroquine
Medicines used for thinning the blood such as warfarin. Your
doctor may change your dose of the blood thinning medicine and
monitor your treatment closely.
Temozolomide - used for cancer
Cimetidine - used for stomach ulcers
Colestyramine - used for lowering blood cholesterol levels

Taking Depakote with food and drink
Alcohol intake is not recommended during treatment.
Pregnancy, breast feeding and fertility
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 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 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 your bipolar
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.
Breast-feeding
If you are breast-feeding or planning to breast-feed, talk to your doctor
or pharmacist before taking any medicine.
Driving and using machines
You may feel sleepy, confused or dizzy while taking this medicine.
If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Depakote
Your medicine contains the colour called Sunset yellow aluminium
lake E110. They may cause allergic reactions including asthma in
some people. You are more likely to have an allergy if you are also
allergic to aspirin.
3. How to take Depakote
Always take Depakote exactly as your doctor has told you. Your doctor
will decide your daily dose. You should check with your doctor or
pharmacist if you are not sure. Depakote treatment must be started
and supervised by a doctor specialised in the treatment of bipolar
disorders.
How to take your medicine
• Take this medicine by mouth
• Swallow the tablets whole with a drink of water. Do not crush or
chew them
• This medicine can be taken with or after a meal
• If you feel the effect of your medicine is too weak or too strong, do
not change the dose yourself, but ask your doctor
How much to take
The normal dose is:
Adults including the elderly
• Starting dose is 750mg on the first day. This is usually taken
as 2 or 3 divided doses
• The usual dose is then increased to between 1000mg and
2000mg each day
• Your doctor may decide to increase your dose depending on
your illness
If you have kidney problems
• Your doctor may decide to lower your dose
Children and adolescents
Children and adolescents under 18 years of age:
Depakote should not be used in children and adolescents under 18
years of age for the treatment of mania
Tests
Your doctor may do regular blood tests and liver function tests before
and during your treatment with this medicine.
If you take more Depakote than you should
If you or someone else has taken more Depakote than you should, talk
to a doctor or go to your nearest hospital casualty department straight
away. Remember to take the medicine pack with you. This is so the
doctor knows what you have taken.
The following effects may happen: being sick, headache, blurred
eyesight due to pupils of the eyes becoming smaller, lack of reflexes,
confusion and tiredness. You may also have weak or ‘floppy’ muscles,
fits (seizures), loss of consciousness, behavioural changes and
breathing difficulties such as fast breathing, shortness of breath or
chest pain.
If you forget to take Depakote
If you forget to take a dose at the right time, take it as soon as you
remember. Do not take a double dose to make up for a forgotten dose.
If you stop taking Depakote
Keep taking your medicine until your doctor tells you to stop. Do not
stop taking Depakote just because you feel better. If you stop, your
illness may return.
When your doctor says that you can stop taking Depakote, your dose
will be lowered gradually. Your doctor will help you to do this.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, Depakote can cause side effects, although not
everybody gets them. Side effects are more likely to happen at the
start of treatment.
Allergic reactions
If you have an allergic reaction, stop taking Depakote and see a doctor
or go to a hospital straight away. The signs may include: rash, joint
pain, fever (systemic lupus erythematosus), swallowing or breathing
problems, swelling of your lips, face, throat or tongue. Hands, feet or
genitals may also be affected. More severe allergic reactions can lead
to lymph node enlargement and possible impairment of other organs.
Stop taking Depakote and see your doctor or go to a hospital
straight away if you notice a combination of any of the following
serious side effects:
The following side effects may be signs of problems with your
liver or pancreas and may show as a sudden illness:
• Feeling weak, general feeling of being unwell
• Loss of or decreased appetite (anorexia)
• Feeling drowsy, confused or tired
• Swelling of the feet and legs (oedema)
• Nausea (feeling sick)
• Vomiting (being sick)
• Stomach pain. Sometimes may be severe and reach through to
your back
• Recurrence of fits (seizures) for patients with epilepsy
• Yellowing of the eyes or skin

The following side effects may be signs of problems with your
blood cells
• Bruising more easily, spontaneous bruising or bleeding
• Frequent infections such as fever, severe chills, sore throat or
mouth ulcers
• Getting more infections than usual
• Feeling weak, tired, faint, dizzy or having an unusually pale skin
These could be caused by a blood disorder called ‘thrombocytopenia’.
It can be due to a fall in the number of white blood cells, bone marrow
depression or another condition that affects red blood cells, white
blood cells and platelets (pancytopenia) or how the blood clots.
Other serious side effects which need urgent medical attention:
• Fits (seizures), loss or reduction of consciousness, seeing or
hearing things that are not there (hallucinations)
• Memory problems, reduced ability to perform mental tasks, being
unable to concentrate
• Difficulty in speaking or slurred speech
• Muscle weakness, lack of co-ordination, muscle twitching or
sudden jerks and shaking
• Difficulty in walking or unusual involuntary movements, such as
unusual eye movements
• Blistering, peeling, bleeding, scaling or fluid filled patches on any
part of your skin. This includes your lips, eyes, mouth, nose,
genitals, hands or feet. You may also have flu-like symptoms and
fever, joint aches and pains, swollen joints, headaches, chest pain
and shortness of breath
• Underactive thyroid gland, which may cause tiredness or weight
gain (hypothyroidism)
• Breathing difficulty and pain due to inflammation of the lungs
(pleural effusion)
• Rapid, uncontrollable movement of the eyes
Tell your doctor as soon as possible if you have any of the
following side effects:
• Unusual behaviour including being very alert, and sometimes also
aggressive, hyper-active and showing bad behaviour
• Water retention which may cause swollen arms or legs
• Bleeding a lot from a wound
Tell your doctor or pharmacist if any of the following side effects
get serious or lasts longer than a few days
• Hair, including body or facial hair, grows more than normal
• Temporary hair loss
• Acne
• Diarrhoea
• Night sweats or joint pain
• Irregular periods or a lack/absence of menstrual periods
• Breast enlargement in men
• Loss of hearing
• Bed wetting
• Weight gain
• Headache
• Aggression, agitation, disturbance in attention, abnormal
behaviour, restlessness/hyperactivity, and learning disorder
• Tingling or numbness in the hands and feet
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.
Tests
Blood and urine tests may show changes in the way the kidney is
working. This includes an increase in the amounts of sugar, amino
acids, uric acid and phosphates. Blood tests may show changes in the
amount of blood cells or levels of liver enzymes.
Male Fertility
Taking Depakote can be a contributing factor in male infertility.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/ yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Depakote
Keep out of the sight and reach of children.
Do not use Depakote after the expiry date which is stated on the label
after EXP. The expiry date refers to the last day of that month.
If your tablets show any sign of discolouration or any other sign of
deterioration, seek the advice of your pharmacist who will advise you.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment
What Depakote 250mg Tablets contain
Each 250mg tablet contains 269.1 mg of the active substance,
valproate semisodium (equivalent to 250 mg of valproic acid)
The other ingredients are: silicone dioxide, maize starch
pregelatinised, povidone, titanium dioxide E171, talc, hypromellose
phalate, diacetylated monoglycerides, sunset yellow aluminium lake
E110 and vanillin.
6. Contents of the pack and other information
What Depakote looks like and contents of the pack
Depakote 250mg Tablets are oval, orange gastro resistant tablets
supplied in blister packs containing 30 and 90 tablets.
Manufacturer: Sanofi-aventis SA,
Riells i Viabrea, Spain.
Procured within the EU
Product licence holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride G75 0TD, UK.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place East Kilbride G75 0TD, UK.
POM
PL: 19065/0507
This leaflet was revised 28/04/2016
E0507/1(D)
Depakote® is as registered trade mark of sanofi-aventis

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valproate semisodium 250 Tablets

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.
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.
Your medicine is available in another strength.
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. Do not pass it on to
others. It may harm them, even if their symptoms 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. See
section 4.
What is in this leaflet
1. What Valproate semisodium is and what it is used for
2. What you need to know before you take Valproate semisodium
3. How to take Valproate semisodium
4. Possible side effects
5. How to store Valproate semisodium
6. Contents of the pack and other information
1. What Valproate semisodium is and what it is used for
The name of your medicine is Valproate semisodium 250 Tablets
(called Valproate semisodium in this leaflet). Valproate semisodium
250 tablets contains a medicine called valproate semisodium. This
belongs to a group of medicines called mood stabilisers. It works by
stabilising the levels of chemicals in your brain that affect your mood.
Valproate semisodium can be used to manage or control mania
(feeling highly excited, enthusiastic, being over-active and easily
irritated or distracted) caused by bipolar disorder. Bipolar disorder is
where the mood changes between feeling very high (mania) and very
low (depression).
Valproate semisodium can be used when lithium can not be used.
2. What you need to know before you take Valproate semisodium
Do not take Valproate semisodium
ͯ
You are allergic (hypersensitive) to valproate semisodium or any of
the other ingredients of Valproate semisodium (see Section 6:
Contents of the pack and other information)
ͯ
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue
ͯ
You have liver problems
ͯ
You or a family member has ever had liver problems caused by
taking a medicine
ͯ
You have a rare illness called porphyria which affects your
metabolism
ͯ
If you have a genetic problem caused by a mitochondrial disorder
(e.g. Alpers-Huttenlocher syndrome)
Do not take this medicine if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before taking Valproiate
semisodium.
Warnings and precautions
A small number of people being treated with mood stabilisers such as
valproate semisodium 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 Valproate
semisodium if:
 You are changing from another medicine that contains valproate
 The person taking this medicine is less than 18 years old
 You have fits (epilepsy), brain disease or a metabolic condition
affecting your brain.
 You have kidney problems
 You have problems with your pancreas
 You have an illness called ‘systemic lupus erythematosus’. This is
a disease of the immune system which affects the skin, bones,
joints and internal organs
 You have a metabolic condition which results in too much
ammonia in the blood (shown in blood tests)
 You have diabetes or are being tested for diabetes. This medicine
may affect the results of urine tests
 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
or pharmacist before taking Valproate semisodium.
Weight gain
Taking Valproic acid may make you put on weight. Talk to your doctor
about how this will affect you.
Other medicines and Valproate semisodium
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. This is because Valproate
semisodium can affect the way some other medicines work. Also,
some medicines can affect the way Valproate semisodium works.
In particular, do not take and check with your doctor if you are
taking any of the following:
• Some medicines used for pain and inflammation called ‘salicylates’
such as aspirin.
The following medicines can affect the way Valproate
semisodium works or Valproate semisodium can affect the way
some of these medicines work:
• Some medicines used to treat fits (epilepsy) such as
phenobarbital, primidone, phenytoin, carbamazepine, topiramate,
lamotrigine and felbamate. Your doctor may change the dose of
one of your medicines and monitor your treatment closely












Medicines for depression
Medicines used to calm emotional and mental conditions such as
diazepam and olanzapine
Zidovudine - used for HIV infection
Carbapenem agents (antibiotics used to treat bacterial infections)
such as panipenem, imipenem, meropenem, rifampicin and
erythromycin. The combination of Valproate semisodium and
carbapenems should be avoided because it may decrease the
effect of your medicine
Some medicines used for malaria such as mefloquine or
chloroquine
Medicines used for thinning the blood such as warfarin. Your
doctor may change your dose of the blood thinning medicine and
monitor your treatment closely.
Temozolomide - used for cancer
Cimetidine - used for stomach ulcers
Colestyramine - used for lowering blood cholesterol levels

Taking Valproate semisodium with food and drink
Alcohol intake is not recommended during treatment.
Pregnancy, breast feeding and fertility
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 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 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 your bipolar
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.
Breast-feeding
If you are breast-feeding or planning to breast-feed, talk to your doctor
or pharmacist before taking any medicine.
Driving and using machines
You may feel sleepy, confused or dizzy while taking this medicine.
If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Valproate
semisodium
Your medicine contains the colour called ‘Sunset yellow aluminium
lake E110’ They may cause allergic reactions including asthma in
some people. You are more likely to have an allergy if you are also
allergic to aspirin.
3. How to take Valproate semisodium
Always take Valproate semisodium exactly as your doctor has told
you. Your doctor will decide your daily dose. You should check with
your doctor or pharmacist if you are not sure. Valproate semisodium
treatment must be started and supervised by a doctor specialised in
the treatment of bipolar disorders.
How to take your medicine
• Take this medicine by mouth
• Swallow the tablets whole with a drink of water. Do not crush or
chew them
• This medicine can be taken with or after a meal
• If you feel the effect of your medicine is too weak or too strong, do
not change the dose yourself, but ask your doctor
How much to take
The normal dose is:
Adults including the elderly
• Starting dose is 750mg on the first day. This is usually taken
as 2 or 3 divided doses
• The usual dose is then increased to between 1000mg and
2000mg each day
• Your doctor may decide to increase your dose depending on
your illness
If you have kidney problems
• Your doctor may decide to lower your dose
Children and adolescents
Children and adolescents under 18 years of age:
Valproate semisodium should not be used in children and adolescents
under 18 years of age for the treatment of mania
Tests
Your doctor may do regular blood tests and liver function tests before
and during your treatment with this medicine.
If you take more Valproate semisodium than you should
If you or someone else has taken more Valproate semisodium than
you should, talk to a doctor or go to your nearest hospital casualty
department straight away. Remember to take the medicine pack with
you. This is so the doctor knows what you have taken.
The following effects may happen: being sick, headache, blurred
eyesight due to pupils of the eyes becoming smaller, lack of reflexes,
confusion and tiredness. You may also have weak or ‘floppy’ muscles,
fits (seizures), loss of consciousness, behavioural changes and
breathing difficulties such as fast breathing, shortness of breath or
chest pain.
If you forget to take Valproate semisodium
If you forget to take a dose at the right time, take it as soon as you
remember. Do not take a double dose to make up for a forgotten dose.
If you stop taking Valproate semisodium
Keep taking your medicine until your doctor tells you to stop. Do not
stop taking Valproic acid just because you feel better. If you stop, your
illness may return.
When your doctor says that you can stop taking Valproate
semisodium, your dose will be lowered gradually. Your doctor will help
you to do this.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

The following side effects may be signs of problems with your
blood cells
• Bruising more easily, spontaneous bruising or bleeding
• Frequent infections such as fever, severe chills, sore throat or
mouth ulcers
• Getting more infections than usual
• Feeling weak, tired, faint, dizzy or having an unusually pale skin
These could be caused by a blood disorder called ‘thrombocytopenia’.
It can be due to a fall in the number of white blood cells, bone marrow
depression or another condition that affects red blood cells, white
blood cells and platelets (pancytopenia) or how the blood clots.
Other serious side effects which need urgent medical attention:
• Fits (seizures), loss or reduction of consciousness, seeing or
hearing things that are not there (hallucinations)
• Memory problems, reduced ability to perform mental tasks, being
unable to concentrate
• Difficulty in speaking or slurred speech
• Muscle weakness, lack of co-ordination, muscle twitching or
sudden jerks and shaking
• Difficulty in walking or unusual involuntary movements, such as
unusual eye movements
• Blistering, peeling, bleeding, scaling or fluid filled patches on any
part of your skin. This includes your lips, eyes, mouth, nose,
genitals, hands or feet. You may also have flu-like symptoms and
fever, joint aches and pains, swollen joints, headaches, chest pain
and shortness of breath
• Underactive thyroid gland, which may cause tiredness or weight
gain (hypothyroidism)
• Breathing difficulty and pain due to inflammation of the lungs
(pleural effusion)
• Rapid, uncontrollable movement of the eyes
Tell your doctor as soon as possible if you have any of the
following side effects:
• Unusual behaviour including being very alert, and sometimes also
aggressive, hyper-active and showing bad behaviour
• Water retention which may cause swollen arms or legs
• Bleeding a lot from a wound
Tell your doctor or pharmacist if any of the following side effects
get serious or lasts longer than a few days
• Hair, including body or facial hair, grows more than normal
• Temporary hair loss
• Acne
• Diarrhoea
• Night sweats or joint pain
• Irregular periods or a lack/absence of menstrual periods
• Breast enlargement in men
• Loss of hearing
• Bed wetting
• Weight gain
• Headache
• Aggression, agitation, disturbance in attention, abnormal
behaviour, restlessness/hyperactivity, and learning disorder
• Tingling or numbness in the hands and feet
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.
Tests
Blood and urine tests may show changes in the way the kidney is
working. This includes an increase in the amounts of sugar, amino
acids, uric acid and phosphates. Blood tests may show changes in the
amount of blood cells or levels of liver enzymes.
Male Fertility
Taking Valproic acid can be a contributing factor in male infertility.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/ yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Valproate semisodium
Keep out of the sight and reach of children.
Do not use Valproate semisodium after the expiry date which is stated
on the label after EXP. The expiry date refers to the last day of that
month.
If your tablets show any sign of discolouration or any other sign of
deterioration, seek the advice of your pharmacist who will advise you.

4. Possible side effects
Like all medicines, Valproate semisodium can cause side effects,
although not everybody gets them. Side effects are more likely to
happen at the start of treatment.

Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment

Allergic reactions
If you have an allergic reaction, stop taking Valproate semisodium and
see a doctor or go to a hospital straight away. The signs may include:
rash, joint pain, fever (systemic lupus erythematosus), swallowing or
breathing problems, swelling of your lips, face, throat or tongue.
Hands, feet or genitals may also be affected. More severe allergic
reactions can lead to lymph node enlargement and possible
impairment of other organs.

What Valproate semisodium 250 Tablets contain
Each 250 mg tablet contains 269.1 mg of the active substance,
valproate semisodium (equivalent to 250mg of valproic acid)

Stop taking Valproate semisodium and see your doctor or go to a
hospital straight away if you notice a combination of any of the
following serious side effects:
The following side effects may be signs of problems with your
liver or pancreas and may show as a sudden illness:
• Feeling weak, general feeling of being unwell
• Loss of or decreased appetite (anorexia)
• Feeling drowsy, confused or tired
• Swelling of the feet and legs (oedema)
• Nausea (feeling sick)
• Vomiting (being sick)
• Stomach pain. Sometimes may be severe and reach through to
your back
• Recurrence of fits (seizures) for patients with epilepsy
• Yellowing of the eyes or skin

The other ingredients are: silicone dioxide, maize starch
pregelatinised, povidone, titanium dioxide, talc, hypromellose phalate,
diacetylated monoglycerides, sunset yellow aluminium lake E110 and
vanillin.
6. Contents of the pack and other information
What Valproate semisodium looks like and contents of the pack
Valproate semisodium 250 Tablets are oval, orange gastro resistant
tablets supplied in blister packs containing 30 and 90 tablets.
Manufacturer: Sanofi-aventis SA,
Riells i Viabrea, Spain.
Procured within the EU
Product licence holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride G75 0TD, UK.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place East Kilbride G75 0TD, UK.
POM
PL: 19065/0507
This leaflet was revised 28/04/2016
E0507/1 (V)

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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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