EPIVAL CR 500MG PROLONGED-RELEASE TABLETS

Active substance: SODIUM VALPROATE

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Prolonged-release Tablets
Active substance: Sodium valproate

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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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Epival CR is and what it is used for
2. Before you take Epival CR Prolonged-release Tablets
3. How to take Epival CR Prolonged-release Tablets
4. Possible side effects
5. How to store Epival CR Prolonged-release Tablets
6. Further information

1. WHAT EPIVAL CR IS AND
WHAT IT IS USED FOR
This medicine is an anticonvulsant (medication against
epilepsy/fits). It is also used for the treatment of mania.
Sodium valproate, the active substance in Epival CR
Prolonged-release Tablets, is effective against certain types
of convulsions.
From the prolonged-release tablets, sodium valproate is
released slowly into your body, thus acting over many
hours.
What are Epival CR Prolonged-release Tablets used
for?
Epival CR is used in the treatment of
– various forms of epilepsy (fits)
– mania, where you may feel very excited, elated, agitated,
enthusiastic or hyperactive. Mania occurs in an illness
called “bipolar disorder”. Epival CR can be used when
lithium cannot be used.

2. BEFORE YOU TAKE
EPIVAL CR PROLONGEDRELEASE TABLETS
Do not take Epival CR
– if you are allergic (hypersensitive) to sodium valproate or
any of the other ingredients of Epival CR Prolongedrelease Tablets
– if you have an active liver disease
– if close family-members have severe liver function
disturbances or if there is a history of such disturbances
in your family
– if you have a severe disturbance of the pancreas
function
– if you suffer from hepatic porphyria (a rare meta­ olic
b
disease).
Take special care with Epival CR
Prolonged-release Tablets

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– if you suffer from “systemic lupus erythematosus” (a rare
allergic condition which causes joint pain, skin rashes
and fever): You should consult your doctor before you
start taking Epival CR Prolonged-release Tablets.
– if you need to go in for surgery: Inform the treating
physician before any type of surgery that you are taking
Epival CR, because sodium valproate may prolong the
bleeding time. Blood tests may have to be done.
– if there is a possibility that you suffer from “urea cycle
enzymatic deficiency” (a rare metabolic disorder): You
may have to undergo tests before starting treatment
with Epival CR.
– A small number of people being treated with antiepileptics such as sodium valproate have had thoughts
of harming or killing themselves. If at any time you have
these thoughts, immediately contact your doctor
Children and adolescents under 18 years of age:
Epival CR should not be used in children and adolescents
under 18 years of age for the treatment of mania.
Other important things you should know before
taking Epival CR:
– Liver damage
In rare cases severe liver damage resulting in death has
been reported. Patients most at risk are children under
the age of three years who suffer from severe seizure
disorders, particularly in association with mental
retardation and/or congenital metabolic disorders. The
frequency of such liver diseases generally decreases
significantly in patients older than 10 years. Liver
damage mostly occurred during the first 6 months of
therapy, particularly between weeks 2 and 12 of
treatment and usually when other anti-epileptic drugs
were given at the same time.
Especially during the first 6 months of treatment,
patients at risk should therefore have their liver function
checked regularly, and their treatment must be closely
monitored.
Signs of severe liver damage may include: increase in
seizures, feeling unwell, weakness, loss of appetite,
vomiting, pain in the upper abdomen, oedema (swelling
of the fingers, legs and toes), lethargy, drowsiness,
jaundice (yellowing of the skin or whites of the eyes). If
you notice any such symptoms, please consult a doctor
immediately.
Similar symptoms may also occur in connection with
a disease of the pancreas.
The risk of liver failure may increase if salicylates (e.g.
aspirin) are taken at the same time. This risk is particularly
high in infants and toddlers. Children under 12 years
should not be given Epival CR in combination with
acetylsalicylic acid at all. In adolescents, this combination
should only be used after careful evaluation of the
benefits and risks by their doctor, because it could
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Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Epival CR and other medicines may influence each
other in their effects:
– The effect of certain medicines for depression, medicines
used to calm emotional and mental conditions (so-called
neuroleptics, MAO-inhibitors, benzodiazepines such as
lorazepam and diazepam) may be enhanced by Epival
CR.
– The combination with clonazepam (for the treatment of
epilepsy) may induce absence seizures: your doctor will
adjust the dose of your medication and monitor your
treatment carefully.
– Other medicines used to treat fits/epilepsy (e.g.
phenobarbital, primidone, phenytoin, carba­ azepine,
m
lamotrigine, felbamate) and Epival CR may increase or
reduce each other’s effects.
– The effect of fluoxetine (an antidepressant) may be
enhanced by Epival CR, whereas the effect of Epival CR
may be reduced.
– Certain antibiotics (e.g. erythromycin) may increase the
effect of Epival CR, others (e.g. meropenem, panipenem,
imipenem) may reduce its effect.
– Cimetidine (used to treat stomach ulcers) may enhance
the effect of Epival CR.
– Cholestyramine (used to treat high blood fat levels) may
decrease the effect of Epival CR.
– The effect of certain anticoagulants (used to thin the
blood, e.g. warfarin) may be increased by Epival CR.
– The effect of acetylsalicylic acid (e.g. aspirin) may be
enhanced by Epival CR and vice versa.
– Medicines against malaria (mefloquine, chloroquine) may
reduce the effect of Epival CR.
– The effect of zidovudine (used to treat HIV-infections)
may be enhanced by Epival CR.
– The effect of temozolomide (for tumour treatment) may
be increased by Epival CR.
In particular, tell your doctor or nurse if you are taking
any of the following medicines:
Carbapenem agents (antibiotic used to treat bacterial
infections). The combination of valproic acid and
carbapenems should be avoided because it may decrease
the effect of sodium valproate.
The potential liver-damaging effect of Epival CR may be
increased if you ingest alcohol or use other treatments that
could have a negative effect on the liver.
Epival CR does not appear to influence the effect of oral
contraceptives.

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Epival ® CR

300 mg
Epival ® CR

500 mg


increase the bleeding tendency and enhance the effects
of Epival CR.
– Patients who suffered from bone marrow damage in
the past may need special monitoring by their doctor
during treatment.
– A possible weight gain during therapy was reported.
Consult your doctor in order to discuss a suitable
strategy against this risk.
– Urine tests to diagnose diabetes may be falsepositive because of Epival CR. Please inform your doctor
before such tests that you are taking Epival CR.
– If you require a blood test to have your thyroid
function checked, please inform your doctor about this,
because treatment with Epival CR may lead to a false
diagnosis of hypothyroidism (insufficient production of
thyroid hormone).
– Occasionally tablet parts may appear in the stools
as a visible white residue. However, this does not reduce
the effect of the medicine, as the active substance is
completely released from the tablet system (matrix) while
the drug passes through the intestine.

Taking Epival CR Prolonged-release
Tablets with food and drink
During treatment with Epival CR you should not drink
alcoholic beverages, as sodium valproate may potentiate
the effects of alcohol.
Pregnancy and breast-feeding
You should not take this medicine if you are pregnant or
a women of child-bearing age unless explicitly advised by
your doctor. If you are a woman of child-bearing age, you
have to use effective contraception during treatment.
If you are planning to become pregnant, it is important that
you discuss this with your doctor. He/she will inform you
about the benefits and possible risks of Epival CR
treatment. Treatment with Epival CR must not be stopped
without medical advice. The risk of abnormal developments
is higher in children of mothers treated with Epival CR. To
minimise this risk, your doctor will review and adjust your
treatment if possible already before you become pregnant.
If indicated, your doctor will prescribe the additional use of
folic acid. Pregnancy should be carefully monitored.
Your doctor will decide whether you may breast-feed your
baby.
The doctor may consider it necessary to have blood tests
done in the newborn baby.
Driving and using machines
Use of this drug may affect reactivity and the patient's
ability to drive, particularly if other medicines against
epilepsy/fits or medicines with a calming effect are taken
and in combination with alcohol.
Successful seizure control over a period of several months
may enable patients to actively participate in road traffic.
Your treating physician will inform you whether you may
drive a vehicle.

3. HOW TO TAKE
EPIVAL CR PROLONGEDRELEASE TABLETS

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Always take Epival CR Prolonged-release Tablets exactly as
your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
DOSAGE AND DURATION OF TREATMENT
Dosage and duration of treatment are individually adjusted
by your doctor.
In general, treatment is started with a lower dose, which is
then gradually increased by your doctor until your optimal
dose is reached.
The daily dose may be taken either once daily or in two
divided doses.
If you have the feeling that the effect of Epival CR
Prolonged-release Tablets is too weak or too strong, please
consult your doctor or pharmacist.
The duration of treatment and the dose may vary from one
person to another; they will therefore be decided by your
doctor depending on the course of your illness.
GI25420GB, Epival CR 300/500 mg Tab.

06.07.12 11:32

Epilepsy
In general, the treatment of epilepsy is a long-term
treatment.
Monotherapy
Adults:
The usual dose is between 1000 and 2000 mg daily; if
necessary, a higher daily dose (up to 2500 mg per day) may
be prescribed by your doctor.
Children over 20 kg body weight:
The dose is based on the child’s weight. In general, 20 to
30 mg sodium valproate per kg body weight per day are
administered (for example in case of 30 kg body weight and
an average dose of 25 mg/kg: 2½ tablets of 300 mg per
day).
If necessary, the doctor may prescribe daily doses higher
than 30 mg per kg body weight.
For children under 20 kg body weight, other presentations
of Epival CR (for example an oral solution or a syrup) are
available and may be prescribed instead of tablets.
The following table serves as a general dosage guideline for
orientation:
Age
Body Weight
Average Dose
approx.
3 – 6 months
150 mg per day
5.5 – 7.5 kg
approx.
150 – 300
6 – 12 months
7.5 – 10 kg
mg per day
approx.
300 – 450
1 – 3 years
10 – 15 kg
mg per day
approx.
450 – 600
3 – 6 years
15 – 20 kg
mg per day
approx.
600 – 1200 mg
7 – 11 years
20 – 40 kg
per day
approx.
1000 – 1500 mg
12 – 17 years
40 – 60 kg
per day
Adults (including
approx. 60 kg 1200 – 2100 mg
elderly patients)
and higher
per day
Patients with disturbed kidney and/or liver function:
Your doctor may prescribe a lower dose.
Combination therapy
If you are also taking other medicinal products to treat your
illness, your doctor will adjust the dose accordingly.
Mania
The daily dosage should be established and controlled
individually by your doctor.
Initial dose
The recommended initial daily dose is 750 mg.
Mean daily dose
The recommended daily doses usually range between
1000 mg and 2000 mg.
ADMINISTRATION
Take the tablets with sufficient amounts of fluid.
If gastro-intestinal side-effects (e.g. nausea) occur at the
beginning of treatment, you should take the tablets during
or after meals.
The tablets may be divided into halves, but must not be
chewed or crushed.
If you take more Epival CR Prolongedrelease Tablets than you should
Symptoms of an acute overdose may include nausea,
vomiting, dizziness, sometimes also serious, or even fatal,
side-effects affecting the central nervous system and
breathing. If you take more tablets than you should or if
a child has taken the medicine by accident, consult your
doctor or go to the nearest accident and emergency
department immediately. Take this leaflet and any remaining
tablets with you so the doctor will know what you have
taken.

cells (possibly causing frequent infections, fever, severe
chills, sore throat or mouth ulcers), reduction in the
number of red blood cells or in the total number of blood
cells (which can make you feel tired, short of breath or
look pale), or conditions inhibiting blood clotting
(coagulation) thus leading to more frequent bruises or to
bleeding more or longer than usual.
– Changes in mood (depression), confusion (occasionally
followed by disturbed consciousness or associated with
hallucinations or convulsions (fits)), lethargy, feeling less
responsive than normal, twitching of the eyes, or loss of
brain function (usually temporary)
– Disturbance or lack of coordination affecting balance
and manner of walking, limb or eye movements and / or
speech; dizziness/spinning sensation
– Drowsiness: this is often experienced when other
medication used to treat epilepsy is given at the same
time.
– Dementia and memory loss (usually reversible)
– Trembling, particularly at higher dosages
– Pins and needles (tingling or numbness of the hands and
feet)
– Parkinson-like symptoms (such as reduced capacity of
movement, trembling, increased muscular tension), or
involuntary movements
– Increased alertness, hyperactivity, aggression and
inappropriate behaviour
– Porphyria (a rare metabolic disease which may be
associated with red coloration of the urine, abdominal
spasms and pain as well as vomiting).
Tell your doctor or pharmacist, if any of the following
side effects get serious or last longer than a few days,
or if you notice any side effects not listed in this
leaflet:
– Vasculitis (inflammation of the blood vessels), which may
present as pain, reddening or itching
– Menstruation disorders, e.g. irregular periods or missed
periods, cysts on the ovaries, breast enlargement in
men, increased growth of face or body hair, acne
– Oedema (swelling of the hands, ankles and feet)
– Nystagmus (rapid, uncontrollable movements of the
eyes)
– Tinnitus (buzzing, hissing, whistling, ringing or other
persistent noise in the ears), hearing loss
– Headache
– Increased appetite leading to weight gain
– Lack of appetite, weight loss, constipation, increased
saliva
– Feeling sick, stomach ache or diarrhoea, especially at
the beginning of treatment; this can usually be helped by
taking the tablets with or after food (see under 3:
“Administration”).
– Temporary hair loss has been noted in some patients.
Regrowth normally begins within six months, although
the hair may become curlier than before.
– Kidney problems leading to sugar/glucose in the urine
and other abnormalities, bedwetting in children, or
increased need to pass urine
– Skin changes, e.g. rash.
Other side effects:
– Changes in liver function may occur at the beginning of
treatment – detected by a blood test.
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.
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

5. HOW TO STORE
EPIVAL CR PROLONGEDRELEASE TABLETS

If you forget to take Epival CR
Prolonged-release Tablets
If you forgot to take a dose at the right time, take it as soon
as you remember. However, if you are already nearing the
time for your next scheduled dose, you should skip the
forgotten dose and then continue treatment as prescribed.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Epival CR
Prolonged-release Tablets
Do not interrupt or stop the treatment with Epival CR
Prolonged-release Tablets without consulting your doctor.
This could have a negative effect on your treatment and
might induce more seizures. Please discuss any signs of
intolerance or changes in the course of your illness with
your treating physician.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Epival CR Prolonged-release Tablets can
cause side effects, although not everybody gets them.
Please note that the following list includes all reported side
effects – even those that occur very rarely.
Tell your doctor straight away, if you notice any of the
following serious side effects – you may need urgent
medical treatment:
– Allergic reaction: Signs may include rash, swallowing or
breathing problems, swelling of your lips, face, throat or
tongue. In a very small number of patients, serious skin
reactions may occur and may sometimes even be lifethreatening and may include blistering or bleeding of the
skin around the lips, nose, eyes and genitals, or skin
lesions affecting also the palms or the soles of your feet.
These skin reactions may be accompanied by a feeling
of being generally unwell, flu-like symptoms, fever and
aching muscles.
– Increased amount of ammonia in the blood: Signs may
be vomiting, problems with balance and coordination
and feeling lethargic or less alert.
– Deep loss of consciousness (coma) may occur in very
few patients.
– Liver problems and problems of the pancreas: These
may show as a sudden illness with signs including
feeling sick, being sick repeatedly, being very tired and
weak, stomach pain, jaundice (yellowing of the skin or
whites of the eyes), loss of appetite, or a general feeling
of being unwell.
Tell your doctor as soon as possible, if you have any
of the following side effects:
– If you notice an increased tendency to bleed, or if you
seem to get bruises or infections more easily. This could
be due to certain conditions affecting the blood cells,
e.g. a severe reduction in the number of white blood

Keep out of the reach and sight of children.
Tightly close the container after each use.
Do not use Epival CR after the expiry date which is stated
on the container. 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 Epival CR 300 / 500 mg Prolonged-release
Tablets contain
– The active substance is sodium valproate. 1 prolongedrelease tablet contains 300 / 500 mg sodium valproate.
– The other ingredients are:
Tablet core: citric acid monohydrate, ethylcellulose,
ammonio methacrylate copolymer (type B) (contains sorbic
acid), purified talc, colloidal hydrated silica, magnesium
stearate.
Film-coating: ammonio methacrylate copolymer (type
A & B) (contains sorbic acid), purified talc, carmellose
sodium, titanium dioxide (E 171), triethyl citrate, vanillin.
What Epival CR 300 / 500 mg Prolonged-release
Tablets look like and contents of the pack
White, oval-shaped prolonged-release tablets, with score
line and engraving “CC3” / “CC5” on one side. The tablets
can be divided into equal halves.
50 tablets.
Marketing Authorisation Holder and manufacturer
G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
This leaflet was last approved in April 2012
Reg.no.:


PL 21597/0005 (300 mg)
PL 21597/0006 (500 mg)

The following information is intended for medical or
healthcare professionals only:
Advice for doctors on management of overdose:
Hospital management of overdose including induced
vomiting, gastric lavage, assisted ventilation and other
measures supporting vital functions are recommended.
Haemodialysis and haemoperfusion have been used
successfully. Intravenous naloxone has also been used,
sometimes in association with activated charcoal given
orally.

09.2012/913/GB

P r ä pa r at e n a m e n /S tä r k e :

A r t .-N r .:

GI25420GB, Epival CR 300/500 mg Tab.

E p i va l CR 300/500

GI25420GB



C o d e -N r .:

mg



Darreichungsform:

09.2012/913/GB ♦
♦ F o r m at : 140 x 420

Produktion: i n t e r n

GI25420GB_Epival_Tab_Fla.indd 2

Tabletten ♦

A b pa c k u n g s a r t :

F l a sc h e

H e lv e t i c a 8,0 / 8,4 P u n k t , n a r r o w
G r o ss b r i ta n n i e n / GB ♦ P a c k m i t t e l a r t : G e b r a u c h s i n f o .
♦ D at u m /V e r s i o n : 6. 7. 2012 – 1 ♦ F a r b e :
Schwarz
Schrift:

Land:

mm



06.07.12 11:32

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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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