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DEPAKOTE 500 MG TABLETS

Active substance(s): VALPROATE SEMISODIUM / VALPROIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Depakote® 250mg Tablets
Depakote® 500mg 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

 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

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.

Taking Depakote with food and drink

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.

Pregnancy, breast feeding and fertility
Important advice for women

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
 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.

Alcohol intake is not recommended during treatment.

 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

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:

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.

 Memory problems, reduced ability to perform mental tasks, being unable to
concentrate
 Difficulty in speaking or slurred speech
 Muscle weakness, lack of co-ordination, muscle twitching or sudden jerks and
shaking
 Difficulty in walking or unusual involuntary movements, such as unusual eye
movements
 Blistering, peeling, bleeding, scaling or fluid filled patches on any part of your
skin. This includes your lips, eyes, mouth, nose, genitals, hands or feet. You
may also have flu-like symptoms and fever, joint aches and pains, swollen
joints, headaches, chest pain and shortness of breath
 Underactive thyroid gland, which may cause tiredness or weight gain
(hypothyroidism)
 Breathing difficulty and pain due to inflammation of the lungs (pleural effusion)
 Rapid, uncontrollable movement of the eyes
Tell your doctor as soon as possible if you have any of the following side
effects:
 Unusual behaviour including being very alert, and sometimes also aggressive,
hyper-active and showing bad behaviour
 Water retention which may cause swollen arms or legs
 Bleeding a lot from a wound
Tell your doctor or pharmacist if any of the following side effects get
serious or lasts longer than a few days
 Hair, including body or facial hair, grows more than normal
 Temporary hair loss
 Acne
 Diarrhoea
 Night sweats or joint pain
 Irregular periods or a lack/absence of menstrual periods
 Breast enlargement in men
 Loss of hearing
 Bed wetting
 Weight gain
 Headache
 Aggression, agitation, disturbance in attention, abnormal behaviour,
restlessness/hyperactivity, and learning disorder
 Tingling or numbness in the hands and feet

Bone Disorders
There have been reports of bone disorders including osteopenia and
osteoporosis (thinning of the bone) and fractures. Check with your doctor or
pharmacist if you are on long-term antiepileptic medication, have a history of
osteoporosis, or take steroids.

Tests
Blood and urine tests may show changes in the way the kidney is working. This
includes an increase in the amounts of sugar, amino acids, uric acid and
phosphates.
Blood tests may show changes in the amount of blood cells or levels of liver
enzymes.

Male Fertility

If you take more Depakote than you should

Taking Depakote can be a contributing factor in male infertility.

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.

Reporting of side effects

If you forget to take Depakote

5. How to store 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.

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.

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.

 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.
 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
What Depakote 250mg Tablets contain

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)

 Each tablet contains 269.1mg of valproate semisodium equivalent to 250mg of
valproic acid.
 The other ingredients are: silicone dioxide, povidone, titanium dioxide (E171),
vanillin, hypromellose phthalate, diacetyl monoglyceride, maize starch
pregelatinised, sunset yellow aluminium lake (E110), talc.

What Depakote 500mg 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),
talc, hypromellose phthalate, diacetyl monoglyceride, maize starch
pregelatinised, ponceau 4R aluminium lake (E124), indigotine aluminum lake
(E132), vanillin.

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 90 tablets.
Depakote 500mg 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 SANOFI
This leaflet does not contain all the information about your medicine. If you have
any questions or are no sure about anything, ask your doctor or pharmacist.
Date of leaflet preparation: 17/08/2016
PIL-0877-0878-S0001

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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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