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CONVULEX 500MG CAPSULES

Active substance(s): VALPROIC ACID

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Convulex® 500mg Capsules

2955
03.03.17[2]

(valproic acid)
PATIENT INFORMATION LEAFLET



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.
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.
This medicine is available using the above name but will be referred to as
Convulex throughout the following. This medicine is also available in other
strengths.
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.
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 anti-epileptics 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 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.
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.
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.
Key messages:
- Do not stop using your contraception before you have talked to your
doctor and worked together on 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 and sign the Acknowledgement
of Risk form 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.

- Porphyria (a rare metabolic disease which may be associated with red
coloration of the urine, abdominal spasms and pain as well as vomiting).
- Obesity

Convulex treatment must be started and supervised by a doctor specialised
in the treatment of epilepsy or bipolar disorders.

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.

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 occurs if Convulex only is taken.
- Trembling, particularly at higher dosages, abnormal sensations (e.g.
ticking or tingling sensation).
- Nail and nail bed disorder.
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).

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 30°C.
Do not use Convulex after the expiry date which is stated on the blister and
on the carton. 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.
If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Convulex contains
- The active substance is valproic acid
Each gastro-resistant soft capsule contains 500 mg valproic acid.
- The other ingredients are gelatin, glycerol 85%, dry substance of Karion
83, titanium dioxide (E 171), red ferric oxide (E 172), hydrochloric acid
25%, methacrylic acid - ethylacrylate copolymer (1:1) - dispersion 30%,
triethyl citrate, macrogol 6000 and glycerol monostearate 44-55 Type II
Ink composition: shellac, black ferric oxide (E172), titanium dioxide
(E171).
What Convulex looks like and contents of the pack
Convulex capsules are oval, old-rose coloured soft-gelatine capsules
marked with 500.
Available in blister packs and are supplied in cartons of 100 Capsules.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by G.L. Pharma GmbH, Schlossplatz 1, A-8502, Lannach,
Austria. Procured from within the EU by Product Licence holder Star
Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2955

Leaflet revision and issue date (Ref) 03.03.17[3]
Convulex is a trademark of G.L. Pharma.

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