DEPAKOTE 500MG TABLETS

Active substance: VALPROATE SEMISODIUM

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Format : 170 x 315 mm D.collée
Plant barcode : 762
Colours : 2
- REFLEX BLUE
- BLACK
Fonts : Ocean Sans Pro San (9pt)
Assembly Card : UHLMANN 1040
Layout of Cutting :
Technical Card :
Technical Constraint :
Reason for change: DV 1237759 CCDS v15

5. How to store Depakote

Depakote® 250mg and 500mg Tablets
Valproic acid (as valproate semisodium)

Keep this medicine in a safe place where children
cannot see or reach it.
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
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

‚

6. Contents of the pack and other information

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.

What Depakote looks like and contents of the pack
Depakote 250mg Tablets are oval orange gastroresistant tablets supplied in Aluminium/aluminium
blister packs containing 30, 60 or 90 tablets.
Depakote 500mg Tablets are oval lilac pink gastroresistant tablets supplied in Aluminium/aluminium
blister packs containing 30, 60 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS
UK
Tel: 0845 372 7101
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com

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 or
500mg 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.

Manufacturer
Sanofi-aventis SA, Carretera C-35 (La Batlloria-Hostalric),
Km 65.09
17404 Riells i Viabrea (Girona)
This leaflet does not contain all the information about
your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in December 2014
© Sanofi, 2000-2014

PAG 4

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help

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.

What Depakote 500mg Tablets contain
• Each 500mg tablet contains 538.2mg of the active
substance, valproate semisodium (equivalent to
500mg of valproic acid)
• The other ingredients are: silicone dioxide,
pregelatinised starch, povidone, titanium dioxide
(E171), hypromellose , polyethylene glycol 6000,
Methacrylic acid- ethyl acrylate copolymer (1:1),
triethyl citrate, vanillin, ponceau 4R aluminium lake
(E124), indigotine aluminium lake (E132)

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.
Take special care with Depakote
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.

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.

What Depakote 250mg Tablets contain
• Each 250mg tablet contains 269.1mg of the active
substance, valproate semisodium (equivalent to
250mg of valproic acid)
• The other ingredients are: silicone dioxide,
pregelatinised starch, povidone, titanium dioxide
(E171), hypromellose , polyethylene glycol 6000,
Methacrylic acid- ethyl acrylate copolymer (1:1),
triethyl citrate, , vanillin, sunset yellow aluminium
lake (E110).

Avance bobina

Code :
678836
Update : V6- 07/01/2015
Local code :
Current item code: 678718
Product/Item type : PRO DEPAKOTE 250/500
Country : GB
Artwork by : M.Pacho
Plant : Riells
Supplier code :

2. What you need to know before you take
Depakote

170 x 315 mm
678836

Technical Data

For sanofi use only

sanofi
Riells Packaging Team

Do not take Depakote
xx 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)
xx Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face,
throat or tongue
xx You have liver problems
xx You or a family member has ever had liver problems
caused by taking a medicine
xx You have a rare illness called porphyria which affects
your metabolism

PAG 1

Check with your doctor or pharmacist before taking
your medicine if:
SS You are changing from another medicine that
contains valproate
SS The person taking this medicine is less than 18 years
old
SS You have fits (epilepsy), brain disease or a metabolic
condition affecting your brain.
SS You have kidney problems
SS You have problems with your pancreas
SS 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
SS You have a metabolic condition which results in too
much ammonia in the blood (shown in blood tests)
SS You have diabetes or are being tested for diabetes.
This medicine may affect the results of urine tests
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.

PAG 2

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 (E110)’ and ‘ponceau 4R aluminium
lake (E124)’. 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

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.

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

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

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
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

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.

PAG 3

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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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