Depakote 250mg Tablets
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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
Do not use after the expiry date printed on the blister strip or carton after EXP. The expiry date refers to the last day of that month.
There are no special storage conditions for Depakote tablets.
KEEP ALL MEDICINES OUT OF SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please return them to your pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
If your tablets become discoloured or show any other signs of deterioration, you should seek the advice of your doctor or pharmacist who will advise you what to do.
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
Each oval, orange coloured, unmarked gastro-resistant Depakote 250mg tablet contains 269.1mg valproate semisodium (equivalent to 250 mg valproic acid) as the active ingredient.
Each oval, pink/lilac coloured, unmarked gastro-resistant Depakote 500mg tablet contains 538.2mg valproate semisodium (equivalent to 500 mg valproic acid) as the active ingredient.
Depakote tablets also contain the following inactive ingredients:
Colloidal silica hydrated, pregelatinised maize starch, povidone, diacetylated monoglycerides, hypromellose phthalate, talc, vanillin and titanium dioxide (E171).
Depakote 250mg tablets are coloured with Sunset Yellow (E110) and available in blister packs of 30 and 90 tablets.
Depakote 500mg tablets are coloured with Ponceau 4R (E124) and Indigo Carmine (E132) and available in blister packs of 90 tablets.
PL No: 6464/1997 Depakote 250mg tablets POM PL No: 6464/1998 Depakote 500mg tablets
These products are manufactured by Sanofi-Aventis, SA, Riells i Viabrea, Spain and are procured from within the EU and repackaged by the Product Licence holder:
Waymade PLC, Miles Gray Road, Basildon, Essex. SS14 3FR.
Leaflet revision and issue date (Ref.) 17.06.2014
DEPAKOTE is a registered trademark of SANOFI-SYNTHELABO
DEPAKOTE® 250mg TABLETS DEPAKOTE® 500mg TABLETS
(valproate semisodium)
(also known as divalproex sodium USAN)
Patient Information leaflet
This product is available in two different strengths 250mg and 500mg. Throughout this leaflet these products will be collectively referred to as Depakote.
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
The name of your medicine is Depakote 250mg or 500mg Tablets. 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:
• 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
• 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
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.
Check with your doctor or pharmacist before taking your medicine 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
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.
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
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• 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
• 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 (E110)' and ‘ponceau 4R (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)
• 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