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VALPROATE SEMISODIUM 250 TABLETS

Active substance(s): VALPROATE SEMISODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Depakote® 250mg Tablets / Depakote® 500mg 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.
This product is available as any of the above names but will be referred to as Depakote
throughout this leaflet.
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
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 cannot be used.

 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.

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. AlpersHuttenlocher 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

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 colours called ‘sunset yellow aluminium lake’ and ‘cochineal
red aluminium lake’. 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, hyperactive 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
 This medicinal product does not require any special storage conditions.
 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
 If the medicine becomes discoloured or shows any other signs of deterioration, you
should seek the advice of your pharmacist who will advise you what to do.
6. Contents of the pack and other information
What Depakote contain
 Depakote 250mg Tablets: Each tablet contains 269.1mg of valproate semisodium
equivalent to 250mg of valproic acid.
The other ingredients are: silicon dioxide, pregelatinised corn starch, povidone, titanium
dioxide, talc, hypromellose phthalate, diacetylated monoglycerides, sunset yellow
aluminium lake and vanillin.
 Depakote 500mg Tablets: Each tablet contains 538.2mg of valproate semisodium
equivalent to 500mg of valproic acid.
The other ingredients are: silicon dioxide, pregelatinised corn starch, povidone, titanium
dioxide, talc, hypromellose phthalate, diacetylated monoglycerides, cochineal red
aluminium lake, aluminium lake of indigo and vanillin.
What Depakote looks like and contents of the pack
Depakote 250mg Tablets: are orange, oval gastro-resistant tablets supplied in aluminium
blister packs containing 30 or 90 tablets.
Depakote 500mg Tablets: are oval, lilac pink gastro-resistant tablets supplied in aluminium
blister packs containing 90 tablets.
PL: 15814/1244
PL: 15814/1249

Depakote® 250mg Tablets
Depakote® 500mg Tablets

POM

Manufactured by Sanofi-Aventis SA, Riells i Viabrea, Spain.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 01.07.2016.
Depakote is a registered trademark of Sanofi.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valproate semisodium 250 Tablets /
Valproate semisodium 500 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.

 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 Tablets 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 Tablets with food and drink
Alcohol intake is not recommended during treatment.
Pregnancy, breast feeding and fertility

This product is available as any of the above names but will be referred to as Valproate
semisodium Tablets throughout this leaflet.
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 Tablets is and what it is used for
2. What you need to know before you take Valproate semisodium Tablets
3. How to take Valproate semisodium Tablets
4. Possible side effects
5. How to store Valproate semisodium Tablets
6. Contents of the pack and other information
1. What Valproate semisodium Tablets is and what it is used for
This medicine 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 Tablets 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 Tablets can be used when lithium cannot be used.
2. What you need to know before you take Valproate semisodium Tablets
Do not take Valproate semisodium Tablets
 You are allergic (hypersensitive) to Valproate semisodium Tablets or any of the other
ingredients of Valproate semisodium Tablets (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. AlpersHuttenlocher 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 Valproate semisodium Tablets.
Warnings and precautions
A small number of people being treated with mood stabilisers such as Valproate
semisodium Tablets 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 Tablets 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 Tablets.
Weight gain
Taking Valproate semisodium Tablets may make you put on weight. Talk to your doctor
about how this will affect you.
Other medicines and Valproate semisodium Tablets
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 Tablets can affect the way some other
medicines work. Also, some medicines can affect the way Valproate semisodium Tablets
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 Tablets works or
Valproate semisodium Tablets 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

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
Tablets
Your medicine contains colours called ‘sunset yellow aluminium lake’ and ‘cochineal
red aluminium lake’. 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 Tablets
Always take Valproate semisodium Tablets 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 Tablets 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 Tablets 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 Tablets than you should
If you or someone else has taken more Valproate semisodium Tablets 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 Tablets
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 Tablets
Keep taking your medicine until your doctor tells you to stop. Do not stop taking Valproate
semisodium Tablets just because you feel better. If you stop, your illness may return.
When your doctor says that you can stop taking Valproate semisodium Tablets, 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

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, hyperactive 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 Valproate semisodium Tablets 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 Tablets
 Keep out of the sight and reach of children.
 Do not use Valproate semisodium Tablets after the expiry date which is stated on the
label after EXP. The expiry date refers to the last day of that month
 This medicinal product does not require any special storage conditions.
 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
 If the medicine becomes discoloured or shows any other signs of deterioration, you
should seek the advice of your pharmacist who will advise you what to do.

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

6. Contents of the pack and other information

Allergic reactions
If you have an allergic reaction, stop taking Valproate semisodium Tablets 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 Tablets contain
 Valproate semisodium 250 Tablets: Each tablet contains 269.1mg of valproate
semisodium equivalent to 250mg of valproic acid.
The other ingredients are: silicon dioxide, pregelatinised corn starch, povidone, titanium
dioxide, talc, hypromellose phthalate, diacetylated monoglycerides, sunset yellow
aluminium lake and vanillin.

Stop taking Valproate semisodium Tablets and see your doctor or go to a hospital
straight away if you notice a combination of any of the following serious side effects:

 Valproate semisodium 500 Tablets: Each tablet contains 538.2mg of valproate
semisodium equivalent to 500mg of valproic acid.
The other ingredients are: silicon dioxide, pregelatinised corn starch, povidone, titanium
dioxide, talc, hypromellose phthalate, diacetylated monoglycerides, cochineal red
aluminium lake, indigotine aluminium lake and vanillin.

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.

What Valproate semisodium Tablets looks like and contents of the pack
Valproate semisodium 250 Tablets: are orange, oval gastro-resistant tablets supplied in
aluminium blister packs containing 30 or 90 tablets.
Valproate semisodium 500 Tablets: are oval, lilac pink gastro-resistant tablets supplied in
aluminium blister packs containing 90 tablets.
PL: 15814/1244
PL: 15814/1249

Valproate semisodium 250 Tablets
Valproate semisodium 500 Tablets

POM

Manufactured by Sanofi-Aventis SA, Riells i Viabrea, Spain.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 01.07.2016.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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