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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

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WARNING
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.
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.
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 only.
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

In this leaflet:
1. What Convulex is and what it is used for
2. What you need to know before you take Convulex
3. How to take Convulex
4. Possible side effects
5. How to store Convulex
6. Contents of the pack and other 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. What you need to know 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).
– If you have a genetic problem causing
a mitochondrial disorder (e.g. Alpers-Huttenlocher
syndrome).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Convulex.
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.

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Tell your doctor before starting Convulex
– if you have lupus (an immune system 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.
– if you suffer from urea cycle enzymatic deficiency
(a rare metabolic disorder).
– if you know that there is a genetic problem causing
a mitochondrial disorder in your family.
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.
A small number of people being treated with antiepileptics such as valproic acid have had thoughts of
harming or killing themselves. If at any time you have
these thoughts, immediately contact your doctor.
Other medicines and Convulex
Tell your doctor if you are taking, have recently taken or
might take any other medicines.
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 highrisk malaria area, seek advice from your doctor or
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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.
Convulex with food and drink
Convulex may be taken with food and drink.
The capsules are usually taken after meals.
Pregnancy, breast-feeding and fertility
Pregnancy
Important advice for women
– 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 ever 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.

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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.

pharmacist on the most appropriate prevention
medicines.
– zidovudine, used to treat HIV and AIDS.
– temozolomide, used to treat cancer.

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.

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Active substance: Valproic acid

Key messages:
– Do not stop using your contraception before you
have talked to your doctor and worked together on
GI19126GB, Convulex 150/300/500 mg Kap.

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a plan to ensure your epilepsy/bipolar disorder 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
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 which
should be given to you and discussed with you by
your doctor or pharmacist.
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.
Convulex treatment must be started and supervised
by a doctor specialised in the treatment of epilepsy or
bipolar disorders.
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.
Use in children and adolescents
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.
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.
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, this medicine 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 life-threatening course).
– Vomiting, disturbed coordination of movements
and progressive clouding of consciousness (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, Parkinson-like
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.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects
directly via the national reporting system:
Yellow Card Scheme
Website: 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 Convulex
Keep out of the sight and reach of children.
Do not store above 25 °C.
Store in the original container in order to protect from
light.
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.
Do not throw away medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other 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), hydrochloric
acid, methacrylic acid-ethylacrylate copolymer
(1:1)-dispersion 30%, triethyl citrate, macrogol 6000
and glycerol monostearate 44-55 Type II.
What Convulex looks like and contents of the pack
Convulex capsules are oval, old-rose coloured softgelatine capsules in blister packs and are supplied in
cartons of 100.
Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH
Schlossplatz 1, A-8502 Lannach, Austria
Leaflet revised March 2015.




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

A r t .N r .:

GI19126GB, Convulex 150/300/500 mg Kap.

C o n u v l e x 150/300/500

GI19126GB



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 8,0 / 8,2 P u n k t
C o d e N r .: 42.2014/251/GB
♦ L a n d : G r o ss b r i ta n n i e n / UK ♦ 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
Produktion: i n t e r n
♦ F o r m at : 160 x 420 m m ♦ D at u m /V e r s i o n : 15. 4. 2015 – 3 ♦ F a r b e :
Schwarz

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Schrift:



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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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