CONVULEX CAPSULES 300MG

Active substance: VALPROIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Convulex ® 150 mg capsules
Convulex ® 300 mg capsules
Convulex ® 500 mg capsules

In this leaflet:
1. What Convulex is and what it is used for
2. Before you take Convulex
3. How to take Convulex
4. Possible side effects
5. How to store Convulex
6. Further information
1. WHAT CONVULEX IS AND WHAT IT IS
USED FOR
Convulex is an antiepileptic, i.e. a medicine
which is used to treat epilepsy (fits). Its active
ingredient is valproic acid.
2. BEFORE YOU TAKE CONVULEX
Do not take Convulex
– if you are allergic (hypersensitive) to valproic
acid or any of the other ingredients of
Convulex (see 6 “Further information”).
– if you have liver problems.
– if you have a family history of liver problems.
– if you suffer from porphyria (a rare metabolic
condition).

+#+++

Take special care with Convulex
– if you experience abdominal pain, nausea
and/or vomiting: Contact your doctor
immediately, as these may be symptoms of
pancreatitis (inflammation of the pancreas).
The risk of this potentially life-threatening
condition is especially high in young children,
in patients receiving combination treatment
and in those with severe liver function disorder.
– Convulex may cause marked and progressive
weight gain. This is a very common side
effect. Consult your doctor about appropriate
strategies to minimize this risk.
Tell your doctor before starting Convulex
– you have lupus (an immune system
if
condition affecting skin, bones and joints,
lungs, kidneys).
– if you are diabetic. Valproic acid may give an
indication that ketones are present in the urine
when this is not the case.
– if you have kidney problems. You may need
a lower dose.
– you suffer from urea cycle enzymatic
if
deficiency (a rare metabolic disorder).
Talk to your doctor even if you no longer have
these conditions, but have had them in the past.
Your doctor may advise blood tests before you
start taking Convulex and during the first six
months of treatment.
Taking other medicines
Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
If taken with some other medicines, the effects
of Convulex or the effects of the other medicines
may be changed.
Please tell your doctor if you are taking any of
the following:
– salicylates, e.g. aspirin.

antidepressants
including
monoamine
oxidase inhibitors.
– anticoagulants, used to thin the blood (e.g.
warfarin).

benzodiazepines, used as sleeping tablets
and to treat anxiety.

other
antiepileptics,
e.g.
phenytoin,
carbamazepine, phenobarbital, lamotrigine,
primidone, felbamate.
– cholestyramine, used to treat high blood lipid
(fat) levels.
– cimetidine, used to treat stomach ulcers.

antibiotics, e.g. erythromycin, carbapenem,
imipenem, panipenem and meropenem.

medicines to prevent and treat malaria,
e.g. mefloquine and chloroquine. They
may increase the likelihood of a fit. Before
travelling to a high-risk malaria area, seek
advice from your doctor or pharmacist on the
most appropriate prevention medicines.
– zidovudine, used to treat HIV and AIDS.
– temozolomide, used to treat cancer.
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Taking Convulex with food and drink
Convulex may be taken with food and drink.
The capsules are usually taken after meals.
Pregnancy and breast-feeding
Pregnancy
It is essential that you discuss your epilepsy
treatment with your doctor well before you
intend to become pregnant. Women who take
valproic acid during the first month of pregnancy
to control their epilepsy have a small risk
(1–2%) of having a baby with spina bifida, an
abnormality of the spinal cord. There is also an
increased risk of other congenital abnormalities.
These can usually be detected in the first part
of pregnancy by normally used screening tests.
Taking folic acid 5 mg daily as soon as you stop
contraception may lower the risk of having a
baby with spina bifida. Rarely there may also be
clotting problems in the newborn if the mother
has taken valproic acid during pregnancy. It
is important not to stop your valproic acid
suddenly as this may result in fits, which may
harm you or your unborn baby.
Infants born to mothers who took valproic acid
during pregnancy may develop less quickly
than normal. This may also be because of the
mother’s epilepsy but the exact cause is not
known.

+#+++

+#+++

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 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.
If you have to undergo any type of surgery,
including
dental
procedures
where
anaesthesia is required, tell the doctor that you
are taking Convulex.
Convulex does not appear to influence the effect
of oral contraceptives.

Breast feeding:
Very little Convulex gets into the breast milk, but
you should discuss with your doctor whether
you should breast feed your baby.
Driving and using machines
When you first start taking Convulex, or if you
are taking it with other medicines, you may
notice some drowsiness.
Do not drive or use any tools or machines until
you know if you are affected by the intake of
Convulex.
3. HOW TO TAKE CONVULEX
Always take Convulex exactly as your doctor
has told you. Check with your doctor if you are
not sure.
Swallow the capsules whole, after meals, with
a drink of water, unless your doctor advises
differently. Do not crush or chew the capsules.
Adults
The usual dose of Convulex is between
1000 and 2000 mg per day but may be increased
to 2500 mg per day. Usually, this quantity is
evenly divided and taken in 2 separate doses,
e.g. half in the morning and half in the evening.
Children over 20 kg
The usual dose of Convulex is based on the
child’s weight. The usual dose is between
20 and 30 mg for each kg of body weight but
may be increased to 35 mg for each kg of body
weight per day. Usually, this quantity is evenly
divided and taken in 2 separate doses, e.g. half
in the morning and half in the evening.
Children under 20 kg
The usual dose of Convulex is based on the
child’s weight. The usual dose is 20 mg for
each kg of body weight. Usually, this quantity is
evenly divided and taken in 2 separate doses,
e.g. half in the morning and half in the evening.

+#+++

Active substance: Valproic acid

When Convulex is first commenced, you may
be prescribed a lower dose. This is because
some patients need less Convulex than others
to control their fits. Your doctor will increase the
dosage until your condition is controlled. As
a result of this it is very important that you follow
the instructions your doctor has given you about
how much to take. Blood tests may be needed.
If you have a kidney disease, your doctor may
prescribe a lower dose.
If you are taking other medicines to control
your epilepsy at the same time as Convulex,
your doctor may gradually reduce the dose of
these antiepileptics while increasing the dose of
Convulex in small units per day, based on your
body weight.
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Make sure you keep your regular check up
appointments with your doctor. They are very
important as your dosage may need to be
changed.
If you take more Convulex than you should
An overdose of this medicine may be dangerous.
If you think you have taken more Convulex than
you should, talk to a doctor or pharmacist, or
go to the nearest hospital casualty department
immediately.
If you forget to take Convulex
If you forget to take a dose at the right time, take
it as soon as you remember, unless it is nearly
time for your next dose. Then go on as before.
Do not take a double dose to make up for
a forgotten dose.
If you stop taking Convulex
If you wish to stop taking Convulex, talk to your
doctor first.
Do not stop taking Convulex just because you
feel better, as this may lead to an immediate
relapse and your condition may get worse.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Convulex 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.
It is very important that you immediately
contact your doctor if you develop any of the
following symptoms, because urgent medical
measures may be necessary:
– Certain changes in the blood, which may lead
to an increased risk of weakness, bleeding or
bruising, and can make infections more likely.
– Severe or persisting abdominal pain, nausea
and/or vomiting (these may be symptoms of
severe liver damage or of an inflammation
of the pancreas, which may take a lifethreatening course).

Vomiting, disturbed coordination of move­
ments and progressive clouding of conscious­
ness (these may be signs of increased
ammonia levels in the blood).

Serious (sometimes life-threatening) skin
reactions with blistering of the skin, mouth,
eyes or genitals.
Tell your doctor or pharmacist, if you develop
any of the following side effects:
Very common side effects (affecting more than
1 person in 10):
– During treatment, increased appetite leading
to weight gain, which may be marked in some
cases.
Common side effects (affecting less than
1 person in 10):
– Drowsiness. This side effect is mostly seen
when other antiepileptics are used at the
same time; more rarely it also occurs if
Convulex only is taken.

Trembling, particularly at higher dosages,
abnormal sensations (e.g. tickling or tingling
sensation).
Uncommon side effects (affecting less than
1 person in 100):

Disturbed coordination of movements and
dizziness, particularly at higher dosages

Confusion (occasionally followed by
disturbed consciousness or associated with
hallucinations or convulsions)
– Headache
– Weight loss
– minor gastrointestinal irritation (e.g. nausea)
at the beginning of treatment; this can usually
be overcome by taking the capsules with
or after food (see under 3. “How to take
Convulex”).
– Excessive formation of saliva.
– Oedema (swelling of the fingers, legs and
toes).
– Vasculitis (inflammation of the blood vessels),
which may present as pain, reddening or
itching of the skin.
Rare side effects (affecting less than 1 person
in 1,000):

Lethargy, temporary disturbance of brain
functions, twitching of the eyes.

Impairment of hearing, usually temporary.
However, it is not known if this occurs due to
the treatment with valproic acid.
– Reversible Fanconi´s syndrome (a rare kidney
disorder).
– Skin changes, e.g. rash.
– Changes in women’s periods and cysts on the
ovaries; elevated testosterone levels in both

sexes (leading to e.g. increased growth of
face or body hair).

Systemic lupus erythematosus (an allergic
condition, which causes joint pain, skin rashes
and fever).
– Porphyria (a rare metabolic disease which
may be associated with red coloration of the
urine, abdominal spasms and pain as well as
vomiting).
Very rare side effects (affecting less than
1 person in 10,000):
– Temporary loss of consciousness, Parkinsonlike symptoms such as reduced capacity of
movement, trembling, increased muscular
tension, involuntary movements, reversible
dementia (impaired memory).
– Acne and excessive growth of facial or body
hair.
– Increased breast growth in men.
The following side effects have also been
reported with no frequency given:
– Noises in one or both ears.

Vomiting, diarrhoea, lack of appetite,
constipation.
– Involuntary discharge of urine in children.
– Temporary hair loss has been noted in some
patients. Regrowth normally begins within six
months, although the hair may become curlier
than before.
– Temporary elevation of liver test values (which
can be seen in blood tests) may occur at the
beginning of treatment.
– Depression.
– An increase in alertness may occur. This is
generally considered a positive effect, but
occasionally symptoms such as hyperactivity,
aggression and inappropriate behaviour have
been reported.
– 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 CONVULEX
Do not store above 25 °C.
Store in the original container in order to protect
from light.
Keep out of the reach and sight of children.
Do not use Convulex after the expiry date which
is stated on the blister and on the carton after
“use before”. 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 Convulex contains
– The active substance is valproic acid.
One Convulex capsule 150 contains 150 mg
valproic acid.
One Convulex capsule 300 contains 300 mg
valproic acid.
One Convulex capsule 500 contains 500 mg
valproic acid.
– The other ingredients are gelatine, glycerol
85%, dry substance of Karion 83, titanium
dioxide (E 171), red ferric oxide (E 172), hydro­
chloric acid, methacrylic acid-ethyl­crylate
a
copolymer (1:1)-dispersion 30%, triethyl
citrate, macrogol 6000, glycerol monostearate
44-55 Type II, shellac and black ferric oxide
(E 172).
What Convulex looks like and contents of the
pack
Convulex capsules are oval, old-rose coloured
soft-gelatine capsules in blister packs and are
supplied in cartons of 100.
Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Manufacturer
Gerot Pharmazeutika GmbH
Arnethgasse 3
A-1160 Vienna
Austria
Leaflet revised April 2012

02.2012/54/GB

GI19126GB, Convulex 150/300/500 mg Kap.

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

C o n u v l e x 150/300/500
A r t .N r .:

GI19126GB



Produktion: i n t e r n

GI19126GB_Cx_Kap_Bli.indd 2

mg



Darreichungsform:

K a ps e l n ♦

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

Blister

H e lv e t i c a 9,0 / 10,0 P u n k t
N r .:
♦ L a n d : 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 r m at i o n
F o r m at : 160 x 420 m m
♦ D at u m /V e r s i o n : 6. 7. 2012 – 3 ♦ F a r b e :
Schwarz
Schrift:

Code





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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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