EPILIM CHRONO 200 MG CONTROLLED RELEASE TABLETS

Active substance: VALPROIC ACID

View full screen / Print PDF » Download PDF ⇩

Transcript
FRONT PAGE

T04919

Epilim®
Epilim®
Epilim®

Chrono®
Chrono®
Chrono®

200 mg Controlled Release Tablets
300 mg Controlled Release Tablets
500 mg Controlled Release Tablets
(sodium valproate)

Patient information Leaflet
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 further questions, please 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 Epilim Chrono is and what it is used for
2. Before you take Epilim Chrono
3. How to take Epilim Chrono
4. Possible side effects
5. How to store Epilim Chrono
6. Further information

1.

What Epilim Chrono is and what it is used for

What Epilim Chrono is
The name of your medicine is Epilim Chrono 200, 300 and 500 mg Controlled Release
Tablets (called Epilim Chrono in this leaflet). “Controlled release” means that the active
ingredient sodium valproate is slowly released from the tablets over a period of time.
What Epilim Chrono contains
Epilim Chrono contains sodium valproate. It belongs to a group of medicines called
anti-convulsants or anti-epileptic agents. It works by helping to calm the brain down.
What Epilim Chrono is used for
Epilim Chrono is used to treat epilepsy (fits) in adults and children.

2.

Before you take Epilim Chrono

• Carbapenem agents (antibiotics used to treat bacterial infections) such as imipenem,
meropenem, rifampicin and erythromycin. The combination of Epilim Chrono and
carbapenems should be avoided because it may decrease the effect of your medicine.
• Colestyramine used to lower blood fat (cholesterol) levels
Taking Epilim Chrono with food and drink
Alcohol intake is not recommended during treatment.
Pregnancy and breast-feeding
Women who could become pregnant
You should not take this medicine if you are pregnant or a women of child-bearing
age unless explicitly advised by your doctor.
Before you start taking Epilim Chrono, your doctor should discuss with you the possible
problems when it is taken in pregnancy.
• Unplanned pregnancy is not desirable in women taking Epilim Chrono
• You should use an effective method of contraception and talk to your doctor
before planning pregnancy.
Epilim Chrono has no effect on how well the oral contraceptive pill works.
Well before you become pregnant it is important to discuss pregnancy and epilepsy with
your doctor and, if you have one, your epilepsy specialist. This is to make sure that you and
your doctor agree that you should have Epilim if you become pregnant.
Women taking Epilim 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 Epilim Chrono during pregnancy may be more likely to have a baby with
spina bifida. Taking folic acid 5 mg each day as soon as you stop contraception may
lower the risk of having a baby with spina bifida.

Do not take Epilim Chrono and tell your doctor if:
• You are allergic (hypersensitive) to sodium valproate or any of the other ingredients of
Epilim Chrono (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 or you or your family have a history of liver problems
• You have a rare illness called porphyria
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 Epilim Chrono.

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.

Take special care with Epilim Chrono
A small number of people being treated with anti-epileptics such as sodium valproate 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 this medicine if:
• You have diabetes. This medicine may affect the results of urine tests
• You have kidney problems. Your doctor may give you a lower dose
• You have fits (epilepsy), brain disease or a metabolic condition affecting your brain
• You have a ‘urea cycle disorder’ where too much ammonia builds up in the body
• You have an illness called “systemic lupus erythematosus (SLE)” – a disease of the
immune system which affects skin, bones, joints and internal organs
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking Epilim Chrono

Some babies born to mothers who took Epilim Chrono during pregnancy may develop less
quickly than normal or have autistic disorders. These children may require additional
educational support.

Weight gain
Taking Epilim Chrono may make you put on weight. Talk to your doctor about how this will
affect you.
Blood tests
Your doctor may wish to do blood tests before you start taking Epilim Chrono and during
your treatment.
Taking Epilim Chrono with 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 Epilim Chrono can affect the way some other medicines work.
Also some medicines can affect the way Epilim Chrono works.
The following medicines can increase the chance of you getting side effects, when
taken with Epilim Chrono:
• Some medicines used for pain and inflammation (salicylates) such as aspirin.
• Some other medicines used to treat fits (epilepsy) – section 3, “Patients taking other
medicines for ‘fits’”. This includes medicines such as phenobarbital, primidone,
phenytoin, carbamazepine, topiramate, lamotrigine and felbamate
Epilim Chrono may increase the effect of the following medicines:
• Medicines used for thinning the blood (such as warfarin)
• Zidovudine used to treat HIV infection
• Temozolomide used to treat cancer
• Medicines for depression
• Monoamine oxidase inhibitors (MAOI) such as moclobemide, selegiline, linezolid
• Medicines used to calm emotional and mental conditions such as diazepam and
olanzapine
The following medicines can affect the way Epilim Chrono works:
• Some medicines used for the prevention and treatment of malaria such as mefloquine
and chloroquine
• Cimetidine used for stomach ulcers

Pregnant mothers who take Epilim Chrono 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).

Talk to your doctor before you stop taking Epilim Chrono if you want to become pregnant.
Do not stop taking Epilim Chrono suddenly, as it is likely that your fits 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 Epilim Chrono, 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
Very little Epilim Chrono gets into the breast milk. However, talk to your doctor about
whether you should breast-feed your baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
You may feel sleepy when taking Epilim Chrono. If this happens to you, do not drive or use
any tools or machines. Taking other medicines used to treat fits or calm emotional and
mental health problems may increase sleepiness.

3.

How to take Epilim Chrono

Always take Epilim Chrono exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Taking this medicine
• Your doctor will decide how much Epilim Chrono to give you or your child depending
on your or your child’s body weight
• Take this medicine by mouth
• Take Epilim Chrono with or after food. This will help to stop the feelings of sickness that
may happen after taking Epilim Chrono.
• Do not crush or chew the tablets
• 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 to take this medicine
• This medicine can be taken once or twice daily
How much to take
Adults (including the elderly)
• The starting dose is 600 mg daily. Your doctor will gradually increase this dose by
200 mg every 3 days depending on your condition
• The usual dose is generally between 1000 mg and 2000 mg (20-30 mg per kilogram
of body weight) each day

BACK PAGE

• This may be increased to 2500 mg each day depending on your illness
Children over 20 kilograms
• The starting dose should be 400 mg daily. Your doctor should increase this dose
depending on your child’s illness
• The usual dose is then between 20 mg and 30 mg for each kilogram of body weight
each day
• This may be further increased to 35 mg for each kilogram of body weight each day
depending on your child’s illness
Children under 20 kilograms
Epilim Chrono is not recommended in children that weigh less than 20 kilograms.
Epilim Liquid (sugar free) or Epilim Syrup is recommended instead.
Patients with kidney problems
• Your doctor may decide to adjust your or your child’s dose
Patients taking other medicines for ‘fits’ (epilepsy)
• You or your child may be taking other medicines for epilepsy at the same time as
Epilim Chrono. If so, your doctor should gradually initiate treatment depending on your
or your child’s condition
• Your doctor may increase the dose of Epilim Chrono by 5 to 10 mg for each kilogram
of body weight each day depending on which other medicines you are taking
If you take more Epilim Chrono than you should
If you take more Epilim Chrono than you should, tell a doctor or go to a hospital casualty
department straight away. Take the medicine pack with you. This is so the doctor knows
what you have taken.
The following effects may happen: feeling sick or being sick, pupils of the eye become
smaller, dizziness, loss of consciousness, weak muscles and poor reflexes, breathing
problems, headaches, fits (seizures), confusion, memory loss and unusual or inappropriate
behaviour.
If you forget to take Epilim Chrono
If you forget to take a dose, take it as soon as you remember. However, if it is nearly time
for the next dose, skip the missed dose. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Epilim Chrono
Keep taking until your doctor tells you to stop.
Do not stop taking Epilim Chrono just because you feel better.
If you stop your fits may come back.
Tests
Make sure you or your child keep your regular appointments for a check up. They are very
important as your or your child’s dose may need to be changed. Epilim Chrono can change
the levels of liver enzymes shown up in blood tests. This can mean that your or your child’s
liver is not working properly.
If you or your child go into hospital or visit another doctor or a dentist, tell them you are
taking Epilim Chrono.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, Epilim Chrono can cause side effects, although not everybody gets
them.
Tell your doctor straight away if you notice any of the following serious side effects
– you may need urgent medical treatment:
• You have an allergic reaction. The signs include: a 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.
• Liver problems and problems of the pancreas may show as a sudden illness which
may happen in the first six months of treatment. This happens in a very small number
of people taking Epilim Chrono. It includes feeling and being sick many times, being
very tired, sleepy and weak, stomach pain including very bad upper stomach pain,
jaundice (yellowing of the skin or whites of the eyes), loss of appetite, swelling
(especially of the legs and feet but may include other parts of the body), worsening of
your fits or a general feeling of being unwell
Your doctor may tell you to stop taking Epilim Chrono immediately if you have these
symptoms
• You have a skin rash or skin lesions with a pink/red ring and a pale centre which may
be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles
of your feet. These could be signs of a serious allergy to the medicine called ‘erythema
multiforme’
• Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also
flu-like symptoms and fever. This may be something called ‘Stevens-Johnson
syndrome’
• Severe blistering rash where layers of the skin may peel off to leave large areas of raw
exposed skin over the body. Also a feeling of being generally unwell, fever, chills, and
aching muscles. This may be something called ‘Toxic epidermal necrolysis’
• Bruising more easily and getting more infections than usual. This could be a blood
problem called ‘thrombocytopenia’. It can also 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
• Blood clotting problems (bleeding for longer than normal), bruising or bleeding for no
reason
• Changes in mood, loss of memory, lack of concentration and deep loss of
consciousness (coma)
• Underactive thyroid gland, which may cause tiredness or weight gain (hypothyroidism)
• Breathing difficulty and pain due to inflammation of the lungs (pleural effusion)
Tell your doctor as soon as possible if you have any of the following side effects:
• Changes in behaviour including being very alert, and sometimes also aggressive,
hyper-active and unusual or inappropriate behaviour. This is more likely if other
medicine to treat fits such as phenobarbital and topiramate are taken at the same time
or if the Epilim Chrono starting dose is high or has been suddenly increased
• Changes in the amount of ammonia in the blood. Symptoms of this condition are being
sick, problems with balance and co-ordination, feeling lethargic or less alert

• Feeling shaky (tremor), sleepy or unsteady when walking or jerky muscle movements
• Feeling tired or confused with loss of consciousness sometimes accompanied by
hallucinations or fits
• Blisters with the skin flaking away
• Rapid, uncontrollable movement of the eyes
Tell your doctor or pharmacist if any of the following side effects get serious or lasts
longer than a few days, or if you notice any side effects not listed in this leaflet:
• Feeling sick, stomach ache or diarrhoea, especially when starting treatment. This may
be helped by taking the tablets with food or taking the Epilim Gastro-resistant Tablets
instead
• Fainting
• Hearing loss
• Skin problems such as rashes. These happen rarely, but more often in people also
taking lamotrigine
• Acne
• Hair loss which is usually temporary. When it grows back it may be more curly than
before
• Hair, including body or facial hair grows more than normal in women
• Skin rash caused by narrow or blocked blood vessels (vasculitis)
• Changes in women’s periods and increased hair growth in women
• Breast enlargement in men
• Swelling of the feet and legs (oedema)
• Weight gain – as your appetite may be increased
• Kidney problems, bedwetting or increased need to pass urine
• Headache
agitation,
disturbance
in
attention,
abnormal
behaviour,
• Aggression,
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.
Blood tests
Epilim Chrono can change levels of liver enzymes, salts or sugars shown up on blood and
urine tests.
Male Fertility
Taking Epilim Chrono can be a contributing factor in male infertility.
Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than
a few days, or if you notice any side effects not listed in this leaflet.
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 Epilim Chrono

Keep out of the sight and reach of children.
Do not store above 30°C. Store in the original package to protect from moisture. Store in a
dry place.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last
day of that month.
Do not remove the tablets from the foil until just before you take them. Do not cut the blister
strips.
Medicines should not be disposed of via household wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures will
help protect the environment.

6.

Further information

What Epilim Chrono contains
Each 200 mg controlled release tablet contains 133.2 mg sodium valproate and
58 mg valproic acid, equivalent to 200 mg of the active substance sodium valproate.
Each 300 mg controlled release tablet contains 199.8 mg sodium valproate and
87 mg valproic acid, equivalent to 300 mg of the active substance sodium valproate.
Each 500 mg controlled release tablet contains 333 mg sodium valproate and
145 mg valproic acid, equivalent to 500 mg of the active substance, sodium valproate.
The other ingredients are: hypromellose (E464), ethylcellulose, hydrated silica, titanium
dioxide (E171), erythrosine BS (E127), indigo carmine (E132), iron oxide black (E172),
macrogol 400.
What Epilim Chrono looks like and contents of the pack
Epilim Chrono tablets are violet, oblong, biconvex film coated tablets with no markings on
either side. Supplied in a carton box of 100 tablets.
Manufacturer and Product Licence Holder:
This product is manufactured by Fawdon Manufacturing Centre, Edgefield Avenue,
Fawdon, Newcastle-upon-Tyne, Tyne & Wear, NE3 3TT, UK. It is procured from within the
EU by the Product Licence Holder: Swinghope Ltd, Brandon House, Marlowe Way,
Croydon CR0 4XS and repackaged by Interport Ltd, Brandon House, Marlowe Way,
Croydon CR0 4XS.
POM
PLPI 10380/1525
PLPI 10380/1531
PLPI 10380/1532

Epilim® Chrono® 500 mg Controlled-release tablets
Epilim® Chrono® 200 mg Controlled-release tablets
Epilim® Chrono® 300 mg Controlled-release tablets

Leaflet revision date: 12/03/2014
Epilim® Chrono® is registered trademark of Sanofi-Synthelabo UK Limited.

T04919

Expand view ⇕

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
(web2)