DEPAKOTE 250MG TABLETS

Active substance: VALPROATE SEMISODIUM

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Code :
678718
Update : V2- 30/9/13
Local code :
Current item code: 678582
Product/Item type : DEPAKOTE 250/500
Country : GB
Artwork by : M.Pacho
Plant : Riells
Supplier code :

Technical Data

For sanofi use only

sanofi
Riells Packaging Team

Format : 170 x 315 mm D.collée
Plant barcode : 644
Colours : 1
- REFLEX BLUE
Fonts : Ocean Sans Pro San
Assembly Card : UHLMANN 1040
Layout of Cutting :
Technical Card :
Technical Constraint :

Reason for change: Regulatory Text

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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

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.

Is this leaflet hard to see or read?
Phone 01483 505515 for help
Read all of this leaflet carefully before you start taking
this medicine
• 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 any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What Depakote is and what it is used for
2. Before you take Depakote
3. How to take Depakote
4. Possible side effects
5. How to store Depakote
6. Further information

1. What Depakote is and what it is used for

Avance bobina

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.

2. Before you take Depakote
Do not take Depakote and tell your doctor if:
xx You are allergic (hypersensitive) to valproate semisodium
or any of the other ingredients of Depakote (see
Section 6: Further information)
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
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.

170 x 315 mm
678718

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.

PAG 4

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

Taking other medicines
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 and breast-feeding
You should not take this medicine if you are pregnant
or a woman of child-bearing age unless explicitly
advised by your doctor.
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.
Women who could become pregnant
Before you start taking Depakote, your doctor
should discuss with you the possible problems when
it is taken in pregnancy.
• Unplanned pregnancy is not desirable in women
taking Depakote
• You should use an effective method of
contraception and talk to your doctor before
planning pregnancy.
Depakote has no effect on how well the oral
contraceptive pill works.
Well before you become pregnant it is important
to discuss pregnancy with your doctor and, if you
have one, your specialist. This is to make sure
that you and your doctor agree that you should
have Depakote if you become pregnant. Women
taking Depakote during pregnancy have a higher
risk than other women of having a child with
an abnormality. The chance of abnormalities is
increased if you are also taking other medicines
for epilepsy at the same time.
These abnormalities include:
• Head and face deformities including cleft
palate (a gap or depression in the lip)
• Deformities of the bones, including hip
dislocation Malformations of the arms and
legs

PAG 1

Avance bobina

Weight gain
Taking Depakote may make you put on weight. Talk to
your doctor about how this will affect you.

• Deformities of the tube from the bladder to
the penis, where the opening is formed in a
different place
• Heart and blood vessel malformations with
heart defects
• Defects of the lining of the spinal cord
• An abnormality of the spinal cord called ‘Spina
bifida’
• Malformations of the urethra
Women who take Depakote during pregnancy may
be more likely to have a baby with spina bifida.
Taking folic acid 5mg each day as soon as you stop
contraception may lower the risk of having a baby
with spina bifida.
There is also an increased risk of other birth defects.
These other defects can usually be detected in the first
3 months of the pregnancy using routine antenatal
screening blood tests and ultrasound scans.
Pregnant mothers who take Depakote may have babies
with:
• blood clotting problems (such as blood not
clotting or not clotting very well).This may
appear as bruising or bleeding which takes a long
time to stop.
• Hypoglycaemia (low blood sugar)
• Hypothyroidism (underactive thyroid gland,
which can cause tiredness or weight gain).

Some babies born to mothers who took Depakote
during pregnancy may develop less quickly than
normal or have autistic disorders. These children
may require additional educational support.
Talk to your doctor before you stop taking Depakote
if you want to become pregnant. Do not stop taking
Depakote suddenly, as it is likely that your illness will
come back.
Women who are planning to get Pregnant
If you become pregnant, think you may be pregnant or
plan to become pregnant while taking Depakote, you
must tell your doctor straight away.
• Your doctor will give you appropriate
counselling and will suggest changes to your
treatment or dose
• He or she will also want to check your progress
while you are pregnant
It is very important that you discuss your treatment
with your doctor well before you become pregnant.
Breast-feeding
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.
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)

PAG 2

• 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

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: hydrated colloidal silica,
pregelatinised starch, povidone, titanium dioxide
(E171), talc; hypromellose phthalate, diacetylated
monoglycerides, vanillin, ponceau 4R aluminium lake
(E124), indigo carmine aluminium lake (E132)
What Depakote looks like and contents of the pack
Depakote 250mg Tablets are oval orange gastro-resistant
tablets supplied in Aluminium/aluminium blister packs
containing 30, 60 or 90 tablets.
Depakote 500mg Tablets are oval lilac pink gastro-resistant
tablets supplied in Aluminium/aluminium blister packs
containing 30, 60 or 90 tablets.
Not all pack sizes may be marketed.

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.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
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 October 2013
© Sanofi, 2000-2013

5. How to store Depakote
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. Further Information
What Depakote 250mg Tablets contain
• Each 250mg tablet contains 269.1mg of the active
substance, valproate semisodium (equivalent to 250mg
of valproic acid)
• Hydrated colloidal silica, pregelatinised starch,
povidone, titanium dioxide (E171), talc; hypromellose
phthalate, diacetylated monoglycerides, vanillin, sunset
yellow aluminium lake (E110)

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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