Skip to Content

UK Edition. Click here for US version.

DEPAKOTE 500 MG TABLETS

Active substance(s): VALPROATE SEMISODIUM / VALPROIC ACID / VALPROATE SEMISODIUM / VALPROIC ACID / VALPROATE SEMISODIUM / VALPROIC ACID

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package Leaflet: Information for the User
®

Depakote 250 mg Tablets
®
Depakote 500 mg Tablets
(valproate semisodium)
This medicine is available in both strengths but will be referred to as
Depakote through the remainder of this leaflet
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.
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.
2. What you need to know before you take Depakote
Do not take Depakote and tell your doctor if:
• 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
• You have a known metabolic disorder, i.e. a urea cycle disorder
• 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.
As with other antiepileptic drugs, convulsions may become worse or
happen more frequently whilst taking this medicine. If this happens
contact your doctor immediately.
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 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
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 forgot 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.

• 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
• An increase in the number and severity of convulsions
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 after EXP.
The expiry date refers to the last day of that month.
If the medicine becomes discoloured or show any signs of deterioration,
you should seek the advice of your pharmacist.
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.
6. Contents of the pack and other information

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

What Depakote 250 mg Tablets contain
Each tablet contains 269.1mg of valproate semisodium equivalent to
250mg of valproic acid.
The other ingredients are: silicone dioxide, povidone, titanium dioxide
(E171), methacrylic acid - ethyl acrylate copolymer, triethyl citrate,
polyethylene glycol, vanillin, hypromellose, maize starch pregelatinised,
sunset yellow aluminium lake (E110).
What Depakote 500 mg Tablets contain
Each tablet contains 538.2mg of valproate semisodium equivalent to
500mg of valproic acid.
The other ingredients are: silicone dioxide, povidone, titanium dioxide
(E171), hypromellose, methacrylic acid-ethyl acrylate copolymer,
polyethylene glycol, triethyl citrate, maize starch pregelatinised,
ponceau 4R aluminium lake (E124), indigotine aluminum lake (E132),
vanillin.
What Depakote looks like and contents of the pack
Depakote 250 mg Tablets are oval orange gastro-resistant tablets
supplied in Aluminium/aluminium blister packs containing 90 tablets.
Depakote 500 mg Tablets are oval lilac pink gastro-resistant tablets
supplied in Aluminium/aluminium blister packs containing 90 tablets.
Manufacturer and Product Licence Holder
This product is manufactured by Sanofi-Aventis, SA, Riells i Viabrea,
Spain. Procured from within the EU and repackaged by Mediwin Limited.
Product Licence Holder: Mediport Limited. 13 Martello Enterprise Centre,
Courtwick Lane, Littlehampton, West Sussex, BN17 7PA, United
Kingdom.
POM

PL: 18980/0877 Depakote 250 mg Tablets
PL: 18980/0878 Depakote 500 mg Tablets

Depakote® is a Registered Trademark of Pfizer Health AB
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.
Date of leaflet preparation: 20/06/2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0330 684 1100 to obtain the
leaflet in a format suitable for you.
PIL-0877-0878-S0004

Expand Transcript

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.

Hide