Sodium Valproate and Valpr oic Acid 500 mg Tablets TajP harma : Uses, Side E ffects, I nteractions, Pict

ures, War nings, Sodium Valproate and Valpr oic Acid D osage & Rx Info | Sodium Valproate and Valproic A cid Use s, Side Effe cts - Antiepile ptic, Sodi um Valpr oate and Valproi c Acid : I ndications, Side E ffects, Warni ngs, Sodi um Valpr oate and Valproi c Acid - Dr ug Infor mation – Taj P harma, Sodium Valproate and Valpr oic Aci d dose Taj phar mace uticals Sodi um Valpr oate and Valproi c Acid intera ctions, Taj Pharma ce utical Sodium Valproate an d Valproic A cid contraindi cations , Sodium Valproate and Valproic Aci d price, Sodium Valproate and Valpr oic Acid Taj Phar ma A ntiepileptic Ta blets PI L - TajP harma Stay conne cted to all updated on Sodium Valproate a nd Valproi c Acid Taj Phar maceuticals Taj pharma ceuti cals Mumba i. Patient Information Lea flets, PI L.

Sodium Valproate & Valproic What is in this leaflet

acid 500mg Controlled Release 1. What Sodium Valproate &Valproicacid is

and what it is used for
Tablets 2. What you need to know before you take
(Sodium Valproate & Valproic acid) Sodium Valproate &Valproic acid
3. How to take Sodium Valproate &Valproic
Package leaflet: Information for the user acid
4. Possible side effects
WARNING 5. How to store Sodium Valproate &Valproic
Sodium Valproate &Valproicacid , sodium acid
valproate, can seriously harm an unborn baby 6. Contents of the pack and other information
when taken during pregnancy. If you are a
female able to have a baby you should use an
effective method of birth control (contraception) 1. What Sodium Valproate
without interruption during your entire treatment
with Sodium Valproate &Valproicacid . Your &Valproicacid is and what it
doctor will discuss this with you but you must is used for
also follow the advice in section 2 of this leaflet.
What Sodium Valproate &Valproicacid is
Schedule an urgent appointment with your
doctor if you want to become pregnant or if you The name of your medicine is Sodium Valproate
think you are pregnant. &Valproicacid 500mg Controlled Release
Tablets (called Sodium Valproate &Valproic
Do not stop taking Sodium Valproate acid in this leaflet). “Controlled release” means
&Valproicacid unless your doctor tells you to as that the active ingredient sodium valproate is
your condition may become worse.
slowly released from the tablets over a period of
If you are a parent or caregiver of a female child time.
treated with Sodium Valproate &Valproicacid ,
What Sodium Valproate &Valproicacid
you must also read section 2 of this leaflet
contains
carefully and contact your child‟s doctor once
they experience their first period. Sodium Valproate &Valproicacid contains
sodium valproate. It belongs to a group of
Read all of this leaflet carefully before you
medicines called anti-convulsants or anti-
start taking this medicine because it contains epileptic agents. It works by helping to calm the
important information for you brain down.
 Keep this leaflet. You may need to read it What Sodium Valproate &Valproicacid is
again. used for
 If you have further questions, please ask
Sodium Valproate &Valproicacid is used to
your doctor or pharmacist.
treat epilepsy (fits) in adults and children.
 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. 2. What you need to know
 If you get any side effects, talk to your
doctor or pharmacist. This includes any
before you take Sodium
possible side effects not listed in this leaflet. Valproate &Valproic acid
See section 4.
 Sodium Valproate and Valpr oic Acid 500 mg Tablets TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Sodium Valproate and Valpr oic Acid D osage & Rx Info | Sodium Valproate and Valproic A cid Use s, Side Effe cts - Antiepile ptic, Sodi um Valpr oate and Valproi c Acid : I ndications, Side E ffects, Warni ngs, Sodi um Valpr oate and Valproi c Acid - Dr ug Infor mation – Taj P harma, Sodium Valproate and Valpr oic Aci d dose Taj phar mace uticals Sodi um Valpr oate and Valproi c Acid intera ctions, Taj Pharma ce utical Sodium Valproate an d Valproic A cid contraindi cations , Sodium Valproate and Valproic Aci d price, Sodium Valproate and Valpr oic Acid Taj Phar ma A ntiepileptic Ta blets PI L - TajP harma Stay conne cted to all updated on Sodium Valproate a nd Valproi c Acid Taj Phar maceuticals Taj pharma ceuti cals Mumba i. Patient Information Lea flets, PI L.

Do not take Sodium Valproate &Valproicacid more frequently whilst taking this medicine.
and tell your doctor if: If this happens contact your doctor
immediately.
 You are allergic (hypersensitive) to sodium
valproate or any of the other ingredients of Talk to your doctor or pharmacist before taking
Sodium Valproate &Valproicacid (listed in Sodium Valproate &Valproicacid if:
section 6).
Signs of an allergic reaction include: a rash,  You have diabetes. This medicine may
swallowing or breathing problems, swelling affect the results of urine tests.
of your lips, face, throat or tongue.  You have a carnitinepalmitoyltransferase
 You have liver problems or you or your type II deficiency.
family have a history of liver problems.  You have kidney problems. Your doctor
 You have a rare illness called porphyria. may give you a lower dose.
 You have a known metabolic disorder, i.e. a  You have a brain disease or a metabolic
urea cycle disorder. condition affecting your brain.
 If you have a genetic problem caused by a  You have a „urea cycle disorder‟ where too
mitochondrial disorder (e.gAlpers- much ammonia builds up in the body.
Huttenlocher syndrome).  You have an illness called „systemic lupus
 You are pregnant, unless nothing else works erythematosus (SLE)‟ – a disease of the
for you (see „Pregnancy, breast-feeding and immune system which affects skin, bones,
fertility – Important advice for women‟ joints and internal organs.
below).  You know that there is a genetic problem
caused by a mitochondrial disorder in your
If you are a woman able to have a baby you family.
must not take Sodium Valproate &Valproicacid
unless you use an effective method of birth If you are not sure if any of the above apply to
control (contraception) at all times during your you, talk to your doctor or pharmacist before
treatment with Sodium Valproate &Valproic taking Sodium Valproate &Valproicacid .
acid . Do not stop taking Sodium Valproate
&Valproicacid or your contraception until you Weight gain
have discussed this with your doctor. Your Taking Sodium Valproate &Valproicacid may
doctor will advise you further (see below under make you put on weight. Talk to your doctor
„Pregnancy, breast-feeding and fertility – about how this will affect you.
Important advice for women‟).
Blood tests
Do not take this medicine if any of the above
apply to you. If you are not sure, talk to your Your doctor may wish to do blood tests before
doctor or pharmacist before taking Sodium you start taking Sodium Valproate &Valproic
Valproate &Valproicacid . acid and during your treatment.
Warnings and precautions Other medicines and Sodium Valproate
&Valproic acid
 A small number of people being treated with Please tell your doctor or pharmacist if you are
anti-epileptics such as sodium valproate taking or have recently taken any other
have had thoughts of harming or killing medicines. This includes medicines you buy
themselves. If at any time you have these without a prescription, including herbal
thoughts, immediately contact your doctor. medicines. This is because Sodium Valproate
 As with other anti-epileptic drugs, &Valproicacid can affect the way some other
convulsions may become worse or happen
 Sodium Valproate and Valpr oic Acid 500 mg Tablets TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Sodium Valproate and Valpr oic Acid D osage & Rx Info | Sodium Valproate and Valproic A cid Use s, Side Effe cts - Antiepile ptic, Sodi um Valpr oate and Valproi c Acid : I ndications, Side E ffects, Warni ngs, Sodi um Valpr oate and Valproi c Acid - Dr ug Infor mation – Taj P harma, Sodium Valproate and Valpr oic Aci d dose Taj phar mace uticals Sodi um Valpr oate and Valproi c Acid intera ctions, Taj Pharma ce utical Sodium Valproate an d Valproic A cid contraindi cations , Sodium Valproate and Valproic Aci d price, Sodium Valproate and Valpr oic Acid Taj Phar ma A ntiepileptic Ta blets PI L - TajP harma Stay conne cted to all updated on Sodium Valproate a nd Valproi c Acid Taj Phar maceuticals Taj pharma ceuti cals Mumba i. Patient Information Lea flets, PI L.

medicines work. Also some medicines can affect  Carbapenem agents (antibiotics used to treat
the way Sodium Valproate &Valproicacid bacterial infections) such as imipenem,
works. meropenem, rifampicin and erythromycin.
The combination of Sodium Valproate
The following medicines can increase the &Valproicacid andcarbapenems should be
chance of you getting side effects, when taken avoided because it may decrease the effect
with Sodium Valproate &Valproicacid : of your medicine.
 Cholestyramine used to lower blood fat
 Some medicines used for pain and (cholesterol) levels.
inflammation (salicylates) such as aspirin.
 Some other medicines used to treat fits Taking Sodium Valproate &Valproicacid
(epilepsy) – see page 2, section 3, „Patients with food and drink
taking other medicines for fits‟. This
includes medicines such as phenobarbital, Alcohol intake is not recommended during
primidone, phenytoin, carbamazepine, treatment.
rufinamide, topiramate, acetazolamide,
lamotrigine and felbamate. Pregnancy, breast-feeding and fertility
Important advice for women
Sodium Valproate &Valproicacid may
increase the effect of the following medicines:  You must not use Sodium Valproate
&Valproicacid if you are pregnant, unless
 Medicines used for thinning the blood (such nothing else works for you.
as warfarin).  If you are a woman able to have a baby, you
 Zidovudine used to treat HIV infection. must not take Sodium Valproate
 Temozolomide used to treat cancer. &Valproicacid unless you use an effective
 Medicines for depression. method of birth control (contraception)
 Monoamine oxidase inhibitors (MAOI) such during your entire treatment with Sodium
as moclobemide, selegiline, linezolid. Valproate &Valproic acid .
 Medicines used to calm emotional and  Do not stop taking Sodium Valproate
mental health problems (including &Valproicacid or your birth control
schizophrenia, bipolar disorder and (contraception), until you have discussed
depression) such as quetiapine, diazepam this with your doctor. Your doctor will
and olanzapine. advise you further.
 Nimodipine.
 Propofol – used for anaesthesia. The risks of valproate when taken during
pregnancy
The following medicines can affect the way
Sodium Valproate &Valproicacid works:  Talk to your doctor immediately if you are
planning to have a baby or are pregnant.
 Oestrogen-containing products (including  Valproate carries a risk if taken during
some birth control pills). pregnancy. The higher the dose, the higher
 Some medicines used for the prevention and the risks but all doses carry a risk.
treatment of malaria such as mefloquine and  It can cause serious birth defects and can
chloroquine. affect the way in which the child develops as
 Cimetidine used for stomach ulcers. it grows. Birth defects which have been
 Protease inhibitors such as lopinavir and reported include spina bifida (where the
ritonavir – used for HIV infection and bones of the spine are not properly
AIDS. developed); facial and skull malformations;
 Sodium Valproate and Valpr oic Acid 500 mg Tablets TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Sodium Valproate and Valpr oic Acid D osage & Rx Info | Sodium Valproate and Valproic A cid Use s, Side Effe cts - Antiepile ptic, Sodi um Valpr oate and Valproi c Acid : I ndications, Side E ffects, Warni ngs, Sodi um Valpr oate and Valproi c Acid - Dr ug Infor mation – Taj P harma, Sodium Valproate and Valpr oic Aci d dose Taj phar mace uticals Sodi um Valpr oate and Valproi c Acid intera ctions, Taj Pharma ce utical Sodium Valproate an d Valproic A cid contraindi cations , Sodium Valproate and Valproic Aci d price, Sodium Valproate and Valpr oic Acid Taj Phar ma A ntiepileptic Ta blets PI L - TajP harma Stay conne cted to all updated on Sodium Valproate a nd Valproi c Acid Taj Phar maceuticals Taj pharma ceuti cals Mumba i. Patient Information Lea flets, PI L.

heart, kidney, urinary tract and sexual organ risk of birth defects associated with
malformations; limb defects. valproate use.
 If you take valproate during pregnancy you
have a higher risk than other women of Please choose the situations which apply to
having a child with birth defects that require you and read the descriptions below:
medical treatment. Because valproate has
been used for many years we know that in  I am starting treatment with sodium
women who take valproate around 10 babies valproate & valproic acid
in every 100 will have birth defects. This  I am taking sodium valproate & valproic
compares to 2-3 babies in every 100 born to acid and not planning to have a baby
women who don‟t have epilepsy.  I am taking sodium valproate & valproic
 It is estimated that up to 30-40% of acid and planning to have a baby
preschool children whose mothers took  I am pregnant and i am taking sodium
valproate during pregnancy may have valproate & valproic acid
problems with early childhood development.
Children affected can be slow to walk and I AM STARTING TREATMENT WITH
talk, intellectually less able than other SODIUM VALPROATE & VALPROIC
children, and have difficulty with language ACID
and memory.
 Autistic spectrum disorders are more often If this is the first time you have been prescribed
diagnosed in children exposed to valproate Sodium Valproate &Valproicacid your doctor
and there is some evidence children may be will have explained the risks to an unborn child
more likely to develop symptoms of if you become pregnant. Once you are able to
Attention Deficit Hyperactivity Disorder have a baby, you will need to make sure you use
(ADHD). an effective method of birth control
 Before prescribing this medicine to you, (contraception) without interruption throughout
your doctor will have explained what might your treatment with Sodium Valproate
happen to your baby if you become pregnant &Valproicacid . Talk to your doctor or family
whilst taking valproate. If you decide later planning clinic if you need advice on birth
you want to have a child you should not stop control (contraception).
taking your medicine or your method of
Key messages:
birth control (contraception) until you have
discussed this with your doctor.
 Pregnancy must be excluded before start of
 If you are a parent or a caregiver of a female
child treated with valproate, you should treatment with Sodium Valproate
&Valproicacid with the result of a
contact their doctor once your child
pregnancy test, confirmed by your doctor.
experiences their first period (menarche).
 You must use an effective method of birth
 Some birth control pills (oestrogen-
control (contraception) during your entire
containing birth control pills) may lower
treatment with Sodium Valproate
valproate levels in your blood. Make sure
&Valproicacid .
you talk to your doctor about the method of
 You must discuss appropriate methods of
birth control (contraception) that is the most
birth control (contraception) with your
appropriate for you.
doctor. Your doctor will give you
 Ask your doctor about taking folic acid
information on preventing pregnancy, and
when trying for a baby. Folic acid can lower
may refer you to a specialist for advice on
the general risk of spina bifida and early
miscarriage that exists with all pregnancies. birth control (contraception).
 You must get regular (at least annual)
However, it is unlikely that it will reduce the
appointments with a specialist experienced
 Sodium Valproate and Valpr oic Acid 500 mg Tablets TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Sodium Valproate and Valpr oic Acid D osage & Rx Info | Sodium Valproate and Valproic A cid Use s, Side Effe cts - Antiepile ptic, Sodi um Valpr oate and Valproi c Acid : I ndications, Side E ffects, Warni ngs, Sodi um Valpr oate and Valproi c Acid - Dr ug Infor mation – Taj P harma, Sodium Valproate and Valpr oic Aci d dose Taj phar mace uticals Sodi um Valpr oate and Valproi c Acid intera ctions, Taj Pharma ce utical Sodium Valproate an d Valproic A cid contraindi cations , Sodium Valproate and Valproic Aci d price, Sodium Valproate and Valpr oic Acid Taj Phar ma A ntiepileptic Ta blets PI L - TajP harma Stay conne cted to all updated on Sodium Valproate a nd Valproi c Acid Taj Phar maceuticals Taj pharma ceuti cals Mumba i. Patient Information Lea flets, PI L.

in the management of epilepsy. During this If you are planning to have a baby, first schedule
visit your doctor will make sure you are well an appointment with your doctor.
aware of and have understood all the risks
and advice related to the use of valproate Do not stop taking Sodium Valproate
during pregnancy. &Valproicacid or your birth control
 Tell your doctor if you want to have a baby. (contraception) until you have discussed this
 Tell your doctor immediately if you are with your doctor. Your doctor will advise you
pregnant or think you might be pregnant. further.
Babies born to mothers who have been on
I AM TAKING SODIUM VALPROATE & valproate are at serious risk of birth defects and
VALPROIC ACID AND NOT PLANNING problems with development, which can be
TO HAVE A BABY seriously debilitating. Your doctor will refer you
to a specialist experienced in the management of
If you are continuing treatment with Sodium
epilepsy, so that alternative treatment options
Valproate &Valproicacid but you are not
can be evaluated early on. Your specialist can
planning to have a baby make sure you are using
put several actions in place so that your
an effective method of birth control
pregnancy goes as smoothly as possible and any
(contraception) without interruption during your
risks to you and your unborn child are reduced
entire treatment with Sodium Valproate
as much as possible.
&Valproic acid . Talk to your doctor or family
planning clinic if you need advice on birth Your specialist may decide to change the dose of
control (contraception). Sodium Valproate &Valproicacid , switch you to
another medicine, or stop treatment with Sodium
Key messages:
Valproate &Valproic acid a long time before
you become pregnant – this is to make sure your
 You must use an effective method of birth illness is stable.
control (contraception) during your entire
treatment with Sodium Valproate Ask your doctor about taking folic acid when
&Valproicacid . trying for a baby. Folic acid can lower the
 You must discuss birth control general risk of spina bifida and early miscarriage
(contraception) with your doctor. Your that exists with all pregnancies. However, it is
doctor will give you information on unlikely that it will reduce the risk of birth
preventing pregnancy, and may refer you to defects associated with valproate use.
a specialist for advice on birth control
Key messages:
(contraception).
 You must get regular (at least annual)
 Do not stop taking Sodium Valproate
appointments with a specialist experienced
in the management of epilepsy. During this &Valproicacid unless your doctor tells you
visit your doctor will make sure you are well to.
 Do not stop using your birth control
aware of and have understood all the risks
and advice related to the use of valproate (contraception) before you have talked to
during pregnancy. your doctor and worked together on a plan
 Tell your doctor if you want to have a baby. to ensure your condition is controlled and
 Tell your doctor immediately if you are the risks to your baby are reduced.
 First schedule an appointment with your
pregnant or think you might be pregnant.
doctor. During this visit your doctor will
make sure you are well aware of and have
I AM TAKING SODIUM VALPROATE &
understood all the risks and advice related to
VALPROIC ACID AND PLANNING TO
the use of valproate during pregnancy.
HAVE A BABY
 Sodium Valproate and Valpr oic Acid 500 mg Tablets TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Sodium Valproate and Valpr oic Acid D osage & Rx Info | Sodium Valproate and Valproic A cid Use s, Side Effe cts - Antiepile ptic, Sodi um Valpr oate and Valproi c Acid : I ndications, Side E ffects, Warni ngs, Sodi um Valpr oate and Valproi c Acid - Dr ug Infor mation – Taj P harma, Sodium Valproate and Valpr oic Aci d dose Taj phar mace uticals Sodi um Valpr oate and Valproi c Acid intera ctions, Taj Pharma ce utical Sodium Valproate an d Valproic A cid contraindi cations , Sodium Valproate and Valproic Aci d price, Sodium Valproate and Valpr oic Acid Taj Phar ma A ntiepileptic Ta blets PI L - TajP harma Stay conne cted to all updated on Sodium Valproate a nd Valproi c Acid Taj Phar maceuticals Taj pharma ceuti cals Mumba i. Patient Information Lea flets, PI L.

 Your doctor will try to switch you to another  Do not stop taking Sodium Valproate
medicine or stop treatment with Sodium &Valproicacid unless your doctor tells you
Valproate &Valproicacid a long time before to.
you become pregnant.  Make sure you are referred to a specialist
 Schedule an urgent appointment with your experienced in the treatment of epilepsy to
doctor if you are pregnant or think you evaluate the need for alternative treatment
might be pregnant. options.
 You must get thorough counselling on the
I AM PREGNANT AND I AM USING risks of Sodium Valproate &Valproicacid
SODIUM VALPROATE & VALPROIC during pregnancy, including malformations
ACID and developmental effects in children.
 Make sure you are referred to a specialist for
Do not stop taking Sodium Valproate prenatal monitoring in order to detect
&Valproicacid unless your doctor tells you to as possible occurrences of malformations.
your condition may become worse.
Schedule an urgent appointment with your Make sure you read the Patient Guide that you
doctor if you are pregnant or think you might be will receive from your doctor. Your doctor will
pregnant. Your doctor will advise you further. discuss the Annual Risk Acknowledgement
Form and will ask you to sign it and keep it. You
Babies born to mothers who have been on will also receive a Patient Card from your
valproate are at serious risk of birth defects and pharmacist to remind you of valproate risks in
problems with development which can be pregnancy.
seriously debilitating. You will be referred to a
specialist experienced in the management of Newborn babies of mothers who took valproate
epilepsy so that alternative treatment options can during pregnancy may have:
be evaluated.
 Blood clotting problems (such as blood not
In the exceptional circumstances when Sodium clotting very well). This may appear as
Valproate &Valproicacid is the only available bruising or bleeding which takes a long time
treatment option during pregnancy, you will be to stop.
monitored very closely both for the management  Hypoglycaemia (low blood sugar).
of your underlying condition and to check how  Hypothyroidism (underactive thyroid gland,
your unborn child is developing. You and your which can cause tiredness or weight gain).
partner should receive counselling and support  Withdrawal syndrome (including agitation,
regarding the valproate exposed pregnancy. irritability, hyperexcitability, jitteriness,
Ask your doctor about taking folic acid. Folic hyperkinesia, muscle problems, tremor,
acid can lower the general risk of spina convulsions and feeding problems). In
bifida and early miscarriage that exists with all particular, this may occur in newborns
pregnancies. However, it is unlikely that it will whose mothers have taken valproate during
reduce the risk of birth defects associated with the last trimester of their pregnancy.
valproate use.
Breast-feeding
Key messages:
Very little Sodium Valproate &Valproicacid
 Schedule an urgent appointment with your gets into the breast milk. However, talk to your
doctor if you are pregnant or think you doctor about whether you should breast-feed
might be pregnant. your baby.
 Sodium Valproate and Valpr oic Acid 500 mg Tablets TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Sodium Valproate and Valpr oic Acid D osage & Rx Info | Sodium Valproate and Valproic A cid Use s, Side Effe cts - Antiepile ptic, Sodi um Valpr oate and Valproi c Acid : I ndications, Side E ffects, Warni ngs, Sodi um Valpr oate and Valproi c Acid - Dr ug Infor mation – Taj P harma, Sodium Valproate and Valpr oic Aci d dose Taj phar mace uticals Sodi um Valpr oate and Valproi c Acid intera ctions, Taj Pharma ce utical Sodium Valproate an d Valproic A cid contraindi cations , Sodium Valproate and Valproic Aci d price, Sodium Valproate and Valpr oic Acid Taj Phar ma A ntiepileptic Ta blets PI L - TajP harma Stay conne cted to all updated on Sodium Valproate a nd Valproi c Acid Taj Phar maceuticals Taj pharma ceuti cals Mumba i. Patient Information Lea flets, PI L.

Ask your doctor or pharmacist for advice before  The starting dose is 600mg daily. Your
taking any medicine. doctor will gradually increase this dose by
200mg every 3 days depending on your
Driving and using machines condition.
You may feel sleepy when taking Sodium  The usual dose is generally 1000-2000mg
Valproate &Valproicacid . If this happens to (20-30mg per kilogram of body weight)
you, do not drive or use any tools or machines. each day.
Taking other medicines used to treat fits or calm  This may be increased to 2500mg each day
emotional and mental health problems may depending on your illness.
increase sleepiness.
Children over 20 kilograms

 The starting dose should be 400mg daily.

3. How to take Sodium Your doctor should increase this dose
Valproate &Valproic acid depending on your child‟s illness.
 The usual dose is then 20-30mg for each
Always take Sodium Valproate &Valproicacid kilogram of body weight each day.
exactly as your doctor has told you. You should  This may be further increased to 35mg for
check with your doctor or pharmacist if you are each kilogram of body weight each day
not sure. depending on your child‟s illness.
Sodium Valproate &Valproicacid treatment
must be started and supervised by a doctor Children under 20 kilograms
specialised in the treatment of epilepsy.
 Sodium Valproate &Valproicacid is not
Taking this medicine
recommended in children that weigh less
than 20 kilograms. Epilim Liquid (sugar
 Your doctor will decide how much Sodium free) or Epilim Syrup is recommended
Valproate &Valproicacid to give you or instead.
your child depending on your or your child‟s
body weight.
Patients with kidney problems
 Take this medicine by mouth.
 Take Sodium Valproate &Valproicacid
 Your doctor may decide to adjust your or
with or after food. This will help to stop the
feelings of sickness that may happen after your child‟s dose.
taking Sodium Valproate &Valproicacid .
 Do not crush or chew the tablets. Patients taking other medicines for fits
 If you feel the effect of your medicine is too (epilepsy)
weak or too strong, do not change the dose
yourself but ask your doctor.  You or your child may be taking other
medicines for epilepsy at the same time as
How to take this medicine Sodium Valproate &Valproicacid . If so,
your doctor should gradually initiate
 This medicine can be taken once or twice treatment depending on your or your child‟s
daily. condition.
 Your doctor may increase the dose of
Sodium Valproate &Valproicacid by 5-
How much to take
10mg for each kilogram of body weight
Adults (including the elderly)
 Sodium Valproate and Valpr oic Acid 500 mg Tablets TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Sodium Valproate and Valpr oic Acid D osage & Rx Info | Sodium Valproate and Valproic A cid Use s, Side Effe cts - Antiepile ptic, Sodi um Valpr oate and Valproi c Acid : I ndications, Side E ffects, Warni ngs, Sodi um Valpr oate and Valproi c Acid - Dr ug Infor mation – Taj P harma, Sodium Valproate and Valpr oic Aci d dose Taj phar mace uticals Sodi um Valpr oate and Valproi c Acid intera ctions, Taj Pharma ce utical Sodium Valproate an d Valproic A cid contraindi cations , Sodium Valproate and Valproic Aci d price, Sodium Valproate and Valpr oic Acid Taj Phar ma A ntiepileptic Ta blets PI L - TajP harma Stay conne cted to all updated on Sodium Valproate a nd Valproi c Acid Taj Phar maceuticals Taj pharma ceuti cals Mumba i. Patient Information Lea flets, PI L.

each day depending on which other digested by the body. It does not mean that the
medicines you are taking. medicine is not working.
If you have any further questions on the use of
If you take more Sodium Valproate this product, ask your doctor or pharmacist.
&Valproicacid than you should
If you take more Sodium Valproate
&Valproicacid than you should, tell a doctor or 4. Possible side effects
go to a hospital casualty department straight
away. Take the medicine pack with you. This is Like all medicines, Sodium Valproate
so the doctor knows what you have taken. &Valproicacid can cause side effects, although
not everybody gets them.
The following effects may happen: feeling sick
or being sick, pupils of the eye become smaller, Tell your doctor straight away if you notice
dizziness, loss of consciousness, weak muscles any of the following serious side effects – you
and poor reflexes, breathing problems, may need urgent medical treatment:
headaches, fits (seizures), confusion, memory
loss and unusual or inappropriate behaviour.  You have an allergic reaction. The signs
include: a rash, joint pain, fever (systemic
If you forget to take Sodium Valproate
&Valproic acid lupus erythematosus), swallowing or
breathing problems, swelling of your lips,
If you forget to take a dose, take it as soon as face, throat or tongue. Hands, feet or
you remember. However, if it is nearly time for genitals may also be affected. More severe
the next dose, skip the missed dose. Do not take allergic reactions can lead to lymph node
a double dose to make up for a forgotten dose. enlargement and possible impairment of
other organs.
If you stop taking Sodium Valproate  Liver problems and problems of the
&Valproic acid pancreas may show as a sudden illness
Keep taking until your doctor tells you to stop. which may happen in the first six months of
Do not stop taking Sodium Valproate treatment. This happens in a very small
&Valproicacid just because you feel better. If number of people taking Sodium Valproate
you stop your fits may come back. &Valproicacid . It includes feeling and
being sick many times; being very tired,
Tests sleepy and weak; stomach pain including
Make sure you or your child keep your regular very bad upper stomach pain; jaundice
appointments for a check-up. They are very (yellowing of the skin or whites of the eyes);
important as your or your child‟s dose may need loss of appetite; swelling (especially of the
to be changed. Sodium Valproate &Valproicacid legs and feet but may include other parts of
can change the levels of liver enzymes shown up the body); worsening of your fits or a
in blood tests. This can mean that your or your general feeling of being unwell.
child‟s liver is not working properly. If you or Your doctor may tell you to stop taking
your child go into hospital or visit another Sodium Valproate &Valproicacid
doctor or a dentist, tell them you are taking immediately if you have these symptoms.
Sodium Valproate &Valproicacid .  You have a skin rash or skin lesions with a
pink/red ring and a pale centre which may
You may see what appears to be part of the be itchy, scaly or filled with fluid. The rash
tablet in your stool. This is normal as the matrix may appear especially on the palms or soles
of Sodium Valproate &Valproicacid is not of your feet. These could be signs of a
 Sodium Valproate and Valpr oic Acid 500 mg Tablets TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Sodium Valproate and Valpr oic Acid D osage & Rx Info | Sodium Valproate and Valproic A cid Use s, Side Effe cts - Antiepile ptic, Sodi um Valpr oate and Valproi c Acid : I ndications, Side E ffects, Warni ngs, Sodi um Valpr oate and Valproi c Acid - Dr ug Infor mation – Taj P harma, Sodium Valproate and Valpr oic Aci d dose Taj phar mace uticals Sodi um Valpr oate and Valproi c Acid intera ctions, Taj Pharma ce utical Sodium Valproate an d Valproic A cid contraindi cations , Sodium Valproate and Valproic Aci d price, Sodium Valproate and Valpr oic Acid Taj Phar ma A ntiepileptic Ta blets PI L - TajP harma Stay conne cted to all updated on Sodium Valproate a nd Valproi c Acid Taj Phar maceuticals Taj pharma ceuti cals Mumba i. Patient Information Lea flets, PI L.

serious allergy to the medicine called  Feeling shaky (tremor), sleepy or unsteady
„erythema multiforme‟. when walking or jerky muscle movements.
 Blistering or bleeding of the skin around the  Feeling tired or confused with loss of
lips, eyes, mouth, nose and genitals. Also consciousness sometimes accompanied by
flu-like symptoms and fever. This may be hallucinations or fits.
something called „Stevens-Johnson  Blisters with the skin flaking away.
syndrome‟.  Rapid, uncontrollable movement of the eyes.
 Severe blistering rash where layers of the  An increase in the number and severity of
skin may peel off to leave large areas of raw convulsions.
exposed skin over the body. Also a feeling
of being generally unwell, fever, chills, and Tell your doctor or pharmacist if any of the
aching muscles. This may be something following side effects get serious or lasts
called „Toxic epidermal necrolysis‟. longer than a few days, or if you notice any
 Bruising more easily and getting more side effects not listed in this leaflet:
infections than usual. This could be a blood
problem called „thrombocytopenia‟. It can  Feeling sick (nausea), being sick (vomiting),
also be due to a fall in the number of white stomach ache or diarrhoea, especially when
blood cells, bone marrow depression or starting treatment. This may be helped by
another condition that affects red blood taking the tablets with food.
cells, white blood cells and platelets  Swelling of gums or sore mouth
(pancytopenia) or how the blood clots.  Fainting
 Blood clotting problems (bleeding for longer  Hearing loss
than normal), bruising or bleeding for no  Double vision
reason.  Nail and nail bed disorders
 Changes in mood, loss of memory, lack of  Skin problems such as rashes. These happen
concentration and deep loss of rarely, but more often in people also taking
consciousness (coma). lamotrigine.
 Underactive thyroid gland, which may cause  Hair disorders (changes in texture, colour or
tiredness or weight gain (hypothyroidism). growth), hair loss which is usually
 Breathing difficulty and pain due to temporary. When it grows back it may be
inflammation of the lungs (pleural effusion). more curly than before.
 Increased levels of some hormones
Tell your doctor as soon as possible if you (androgens), which may lead to increased
have any of the following side effects: hair growth on the face, breasts or chest,
acne or thinning hair.
 Changes in behaviour including being very  Skin rash caused by narrow or blocked
alert, and sometimes also aggressive, blood vessels (vasculitis)
hyperactive and unusual or inappropriate  Changes in women‟s periods and increased
behaviour. This is more likely if other hair growth in women
medicine to treat fits such as phenobarbital  Breast enlargement in men
and topiramate are taken at the same time or  Swelling of the feet and legs (oedema)
if the Sodium Valproate &Valproicacid  Obesity, weight gain – as your appetite may
starting dose is high or has been suddenly be increased
increased.  Kidney disease, kidney problems, blood in
 Changes in the amount of ammonia in the the urine, bedwetting or increased need to
blood. Symptoms of this condition are being pass urine, urinary incontinence
sick, problems with balance and co- (unintentional passing of urine)
ordination, feeling lethargic or less alert.  Headache
 Sodium Valproate and Valpr oic Acid 500 mg Tablets TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Sodium Valproate and Valpr oic Acid D osage & Rx Info | Sodium Valproate and Valproic A cid Use s, Side Effe cts - Antiepile ptic, Sodi um Valpr oate and Valproi c Acid : I ndications, Side E ffects, Warni ngs, Sodi um Valpr oate and Valproi c Acid - Dr ug Infor mation – Taj P harma, Sodium Valproate and Valpr oic Aci d dose Taj phar mace uticals Sodi um Valpr oate and Valproi c Acid intera ctions, Taj Pharma ce utical Sodium Valproate an d Valproic A cid contraindi cations , Sodium Valproate and Valproic Aci d price, Sodium Valproate and Valpr oic Acid Taj Phar ma A ntiepileptic Ta blets PI L - TajP harma Stay conne cted to all updated on Sodium Valproate a nd Valproi c Acid Taj Phar maceuticals Taj pharma ceuti cals Mumba i. Patient Information Lea flets, PI L.

 Seeing or hearing things that are not there Medicines should not be disposed of via
(hallucinations) household wastewater or household waste. Ask
 Aggression, agitation, disturbance in your pharmacist how to dispose of medicines no
attention, abnormal behaviour, longer required. These measures will help
restlessness/hyperactivity, and learning protect the environment.
disorder
 Tingling or numbness in the hands and feet
 Lowering of normal body temperature
 Abnormal blood clotting factors
6. Contents of the pack and
 Muscle pain and weakness (rhabdomyolysis) other information
What Sodium Valproate &Valproicacid
Bone disorders
contains
There have been reports of bone disorders
Each Film Coated Controlled Release Tablet
including osteopenia and osteoporosis (thinning
Contains:
of the bone) and fractures. Check with your
Sodium Valproate BP 333mg
doctor or pharmacist if you are on long-term
Valproic Acid USP 145mg
anti-epileptic medication, have a history of
Excipients q.s.
osteoporosis, or take steroids.
Colour: Red Oxide of Iron & Titanium Dioxide
Tests USP
Sodium Valproate &Valproicacid can change
The other ingredients are: hypromellose,
levels of liver enzymes, salts or sugars shown up
ethylcellulose, hydrated silica, titanium dioxide,
on blood and urine tests.
erythrosine BS aluminium lake, indigo carmine
Male fertility aluminium lake FD and C, iron oxide black,
macrogol 400.
Taking Sodium Valproate &Valproicacid can
be a contributing factor in male infertility. Contents of the pack:
Reporting of side effects Sodium Valproate &Valproicacid 500
If you get any side effects, talk to your doctor, Controlled Release tablets are supplied in blister
pharmacist or nurse. This includes any possible packs.
side effects not listed in this leaflet. Pack size: 7, 14, 28, 30, 50, 100 and 500
Controlled Release tablets.
Not all pack sizes may be marketed.
5. How to store Sodium
7. Manufactured In India By:
Valproate &Valproic acid
TAJ PHARMACEUTICALS LTD.
Keep out of the sight and reach of children. Mumbai, India
Do not take this medicine after the expiry date Unit No. 214.Old Bake House,
shown on the blister and carton after EXP. The Maharashtra chambers of Commerce Lane,
expiry date refers to the last day of that month. Fort, Mumbai - 400001
Do not remove the tablets from the foil until just at:Gujarat, INDIA.
before you take them. Do not cut the blister Customer Service and Product Inquiries:
strips. 1-800-TRY-FIRST (1-800-222-434 & 1-800-
222-825)
Store in a dry place below 30°C.
 Sodium Valproate and Valpr oic Acid 500 mg Tablets TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Sodium Valproate and Valpr oic Acid D osage & Rx Info | Sodium Valproate and Valproic A cid Use s, Side Effe cts - Antiepile ptic, Sodi um Valpr oate and Valproi c Acid : I ndications, Side E ffects, Warni ngs, Sodi um Valpr oate and Valproi c Acid - Dr ug Infor mation – Taj P harma, Sodium Valproate and Valpr oic Aci d dose Taj phar mace uticals Sodi um Valpr oate and Valproi c Acid intera ctions, Taj Pharma ce utical Sodium Valproate an d Valproic A cid contraindi cations , Sodium Valproate and Valproic Aci d price, Sodium Valproate and Valpr oic Acid Taj Phar ma A ntiepileptic Ta blets PI L - TajP harma Stay conne cted to all updated on Sodium Valproate a nd Valproi c Acid Taj Phar maceuticals Taj pharma ceuti cals Mumba i. Patient Information Lea flets, PI L.

Monday through Saturday 9:00 a.m. to 7:00 p.m.

EST
E-mail: tajgroup@tajpharma.com