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Valproic Acid 145mg, Sodium Valproate 333mg Ta blets Taj Phar ma : Us es, Side Effe cts, Intera ctions,

Pictures , Warning s, Valproic A cid-S odium Valproate Dosage & Rx I nfo | Valproic Acid -Sodium Valproate Uses , Side Effects - Ca ncer, Val proic Acid-Sodium Valproate : Indications, Side E ffe cts, War nings , Valproic Acid-Sodium Valproate - Dr ug Informati on - Taj P harma, Valpr oic Aci d-Sodium Valproate dose Taj phar maceuticals Valpr oic Aci d-Sodium Valproate interactions, Taj Phar ma ceutical Valproi c Acid -Sodium Valpr oate contraindicati ons, Valproi c Acid -Sodium Valproate price, Valpr oic Aci d-Sodium Valproate Taj Phar ma anti-convul sants Val proic Acid 145mg, Sodium Valproate 333mg Ta blets PIL- Taj P harma . Stay conne cted to all updated on Valproi c Acid -Sodi um Valproate Taj P harma ceuti cals Taj phar mace uticals Hyderabad. Patient Informati on Lea flets, PI L.

1.WHAT VALPROIC ACID/SODIUM  You have a genetic problem caused by a


℞VALPROIC ACID AND mitochondrial disorder (e.g. Alpers-
VALPROATE TABLETS IS AND WHAT IT
SODIUM VALPROATE IS USED FOR

Huttenlocher syndrome).
You are pregnant, unless nothing else works
What Valproic Acid/Sodium Valproate Tablets
TABLETS contains
for you (see ‘Pregnancy, breast-feeding and
fertility – Important advice for women’
145MG/333MG Valproic Acid/Sodium Valproate Tablets contains below).
Package leaflet: Information for the patient sodium valproate. It belongs to a group of
Valproic Acid 145mg, Sodium Valproate 333mg medicines called anti-convulsants or anti-epileptic If you are a woman able to have a baby you must
agents. It works by helping to calm the brain not take Valproic Acid/Sodium Valproate Tablets
Tablets.
down. unless you use an effective method of birth control
Read all of this leaflet carefully before you start (contraception) at all times during your treatment
What Valproic Acid/Sodium Valproate Tablets is
taking this medicine because it contains with Valproic Acid/Sodium Valproate Tablets. Do
used for not stop taking Valproic Acid/Sodium Valproate
important information for you.
- Keep this leaflet. You may need to read it again. Valproic Acid/Sodium Valproate Tablets is used to Tablets or your contraception until you have
- If you have any further questions, ask your treat epilepsy (fits) in adults and children. discussed this with your doctor. Your doctor will
doctor or pharmacist. advise you further (see below under ‘Pregnancy,
- This medicine has been prescribed for you only. 2. WHAT YOU NEED TO KNOW breast-feeding and fertility – Important advice for
Do not pass it on to others. It may harm them, BEFORE YOU TAKE VALPROIC women’).
even if their signs of illness are the same as yours. ACID/SODIUM VALPROATE TABLETS Do not take this medicine if any of the above apply
- If you get any side effects, talk to your doctor or Do not take Valproic Acid/Sodium Valproate to you. If you are not sure, talk to your doctor or
pharmacist. This includes any possible side effects Tablets and tell your doctor if: pharmacist before taking Valproic Acid/Sodium
not listed in this leaflet (see section 4). Valproate Tablets.
 You are allergic (hypersensitive) to sodium
What is in this leaflet Warnings and precautions
1. What Valproic Acid/Sodium Valproate Tablets is valproate or any of the other ingredients of
Valproic Acid/Sodium Valproate Tablets
and what it is used for  A small number of people being treated with
(listed in section 6).
2. What you need to know before you take antiepileptics such as sodium valproate have
Signs of an allergic reaction include: a rash,
Valproic Acid/Sodium Valproate Tablets had thoughts of harming or killing
3. How to take Valproic Acid/Sodium Valproate swallowing or breathing problems, swelling of
your lips, face, throat or tongue. themselves. If at any time you have these
Tablets thoughts, immediately contact your doctor.
4. Possible side effects  You have liver problems or you or your family
have a history of liver problems.  As with other anti-epileptic drugs, convulsions
5. How to store Valproic Acid/Sodium Valproate
 You have a rare illness called porphyria. may become worse or happen more
Tablets
 You have a known metabolic disorder, i.e. a frequently whilst taking this medicine. If this
6. Contents of the pack and other information happens contact your doctor immediately.
urea cycle disorder.
Valproic Acid 145mg, Sodium Valproate 333mg Ta blets Taj Phar ma : Us es, Side Effe cts, Intera ctions, Pictures , Warning s, Valproic A cid-S odium Valproate Dosage & Rx I nfo | Valproic Acid -Sodium Valproate Uses , Side Effects - Ca ncer, Val proic Acid-Sodium Valproate : Indications, Side E ffe cts, War nings , Valproic Acid-Sodium Valproate - Dr ug Informati on - Taj P harma, Valpr oic Aci d-Sodium Valproate dose Taj phar maceuticals Valpr oic Aci d-Sodium Valproate interactions, Taj Phar ma ceutical Valproi c Acid -Sodium Valpr oate contraindicati ons, Valproi c Acid -Sodium Valproate price, Valpr oic Aci d-Sodium Valproate Taj Phar ma anti-convul sants Val proic Acid 145mg, Sodium Valproate 333mg Ta blets PIL- Taj P harma . Stay conne cted to all updated on Valproi c Acid -Sodi um Valproate Taj P harma ceuti cals Taj phar mace uticals Hyderabad. Patient Informati on Lea flets, PI L.

Talk to your doctor or pharmacist before taking Other medicines and Valproic Acid/Sodium  Medicines used to calm emotional and mental
Valproic Acid/Sodium Valproate Tablets if: Valproate Tablets health problems (including schizophrenia,
bipolar disorder and depression) such as
Please tell your doctor or pharmacist if you are
 You have diabetes. This medicine may affect quetiapine, diazepam and olanzapine.
taking or have recently taken any other medicines.
the results of urine tests.  Nimodipine.
This includes medicines you buy without a
 You have a carnitine palmitoyltransferase  Propofol – used for anaesthesia.
prescription, including herbal medicines. This is
type II deficiency. because Valproic Acid/Sodium Valproate Tablets
 You have kidney problems. Your doctor may can affect the way some other medicines work. The following medicines can affect the way
give you a lower dose. Also some medicines can affect the way Valproic Valproic Acid/Sodium Valproate Tablets works:
 You have a brain disease or a metabolic Acid/Sodium Valproate Tablets works.
condition affecting your brain.  Oestrogen-containing products (including
 You have a ‘urea cycle disorder’ where too The following medicines can increase the chance some birth control pills).
much ammonia builds up in the body. of you getting side effects, when taken with  Some medicines used for the prevention and
 You have an illness called ’systemic lupus Valproic Acid/Sodium Valproate Tablets: treatment of malaria such as mefloquine and
erythematosus (SLE)’ – a disease of the chloroquine.
immune system which affects skin, bones,  Some medicines used for pain and  Cimetidine used for stomach ulcers.
joints and internal organs. inflammation (salicylates) such as aspirin.  Protease inhibitors such as lopinavir and
 You know that there is a genetic problem  Some other medicines used to treat fits ritonavir – used for HIV infection and AIDS.
caused by a mitochondrial disorder in your (epilepsy) – see page 2, section 3, ’Patients  Carbapenem agents (antibiotics used to treat
family. taking other medicines for fits’. This includes bacterial infections) such as imipenem,
medicines such as phenobarbital, primidone, meropenem, rifampicin and erythromycin.
If you are not sure if any of the above apply to you, phenytoin, carbamazepine, rufinamide, The combination of Valproic Acid/Sodium
talk to your doctor or pharmacist before taking topiramate, acetazolamide, lamotrigine and Valproate Tablets and carbapenems should be
Valproic Acid/Sodium Valproate Tablets. felbamate. avoided because it may decrease the effect of
your medicine.
Weight gain Valproic Acid/Sodium Valproate Tablets may  Cholestyramine used to lower blood fat
Taking Valproic Acid/Sodium Valproate Tablets increase the effect of the following medicines: (cholesterol) levels.
may make you put on weight. Talk to your doctor
about how this will affect you.  Medicines used for thinning the blood (such as Taking Valproic Acid/Sodium Valproate Tablets
warfarin). with food and drink
Blood tests  Zidovudine used to treat HIV infection.
Alcohol intake is not recommended during
Your doctor may wish to do blood tests before you  Temozolomide used to treat cancer.
treatment.
start taking Valproic Acid/Sodium Valproate  Medicines for depression.
Tablets and during your treatment.  Monoamine oxidase inhibitors (MAOI) such as Pregnancy, breast-feeding and fertility
moclobemide, selegiline, linezolid.
Important advice for women
Valproic Acid 145mg, Sodium Valproate 333mg Ta blets Taj Phar ma : Us es, Side Effe cts, Intera ctions, Pictures , Warning s, Valproic A cid-S odium Valproate Dosage & Rx I nfo | Valproic Acid -Sodium Valproate Uses , Side Effects - Ca ncer, Val proic Acid-Sodium Valproate : Indications, Side E ffe cts, War nings , Valproic Acid-Sodium Valproate - Dr ug Informati on - Taj P harma, Valpr oic Aci d-Sodium Valproate dose Taj phar maceuticals Valpr oic Aci d-Sodium Valproate interactions, Taj Phar ma ceutical Valproi c Acid -Sodium Valpr oate contraindicati ons, Valproi c Acid -Sodium Valproate price, Valpr oic Aci d-Sodium Valproate Taj Phar ma anti-convul sants Val proic Acid 145mg, Sodium Valproate 333mg Ta blets PIL- Taj P harma . Stay conne cted to all updated on Valproi c Acid -Sodi um Valproate Taj P harma ceuti cals Taj phar mace uticals Hyderabad. Patient Informati on Lea flets, PI L.

 You must not use Valproic Acid/Sodium take valproate around 10 babies in every 100 general risk of spina bifida and early
Valproate Tablets if you are pregnant, unless will have birth defects. This compares to 2-3 miscarriage that exists with all pregnancies.
nothing else works for you. babies in every 100 born to women who don’t However, it is unlikely that it will reduce the
 If you are a woman able to have a baby, you have epilepsy. risk of birth defects associated with valproate
must not take Valproic Acid/Sodium  It is estimated that up to 30-40% of preschool use.
Valproate Tablets unless you use an effective children whose mothers took valproate during
method of birth control (contraception) pregnancy may have problems with early Please choose the situations which apply to you
during your entire treatment with Valproic childhood development. Children affected can and read the descriptions below:
Acid/Sodium Valproate Tablets. be slow to walk and talk, intellectually less
 Do not stop taking Valproic Acid/Sodium able than other children, and have difficulty  I AM STARTING TREATMENT WITH
Valproate Tablets or your birth control with language and memory. VALPROIC ACID/SODIUM VALPROATE
(contraception), until you have discussed this  Autistic spectrum disorders are more often TABLETS
with your doctor. Your doctor will advise you diagnosed in children exposed to valproate  I AM TAKING VALPROIC ACID/SODIUM
further. and there is some evidence children may be VALPROATE TABLETS AND NOT
more likely to develop symptoms of Attention PLANNING TO HAVE A BABY
The risks of valproate when taken during Deficit Hyperactivity Disorder (ADHD)  I AM TAKING VALPROIC ACID/SODIUM
pregnancy  Before prescribing this medicine to you, your VALPROATE TABLETS AND PLANNING TO
doctor will have explained what might happen HAVE A BABY
 Talk to your doctor immediately if you are to your baby if you become pregnant whilst  I AM PREGNANT AND I AM TAKING
planning to have a baby or are pregnant. taking valproate. If you decide later you want VALPROIC ACID/SODIUM VALPROATE
 Valproate carries a risk if taken during to have a child you should not stop taking TABLETS
pregnancy. The higher the dose, the higher your medicine or your method of birth control
the risks but all doses carry a risk. (contraception) until you have discussed this
I AM STARTING TREATMENT WITH VALPROIC
with your doctor.
 It can cause serious birth defects and can ACID/SODIUM VALPROATE TABLETS
affect the way in which the child develops as it  If you are a parent or a caregiver of a female
grows. Birth defects which have been child treated with valproate, you should If this is the first time you have been prescribed
reported include spina bifida (where the bones contact their doctor once your child Valproic Acid/Sodium Valproate Tablets your
of the spine are not properly developed); experiences their first period (menarche). doctor will have explained the risks to an unborn
facial and skull malformations; heart, kidney,  Some birth control pills (oestrogen-containing child if you become pregnant. Once you are able
urinary tract and sexual organ malformations; birth control pills) may lower valproate levels to have a baby, you will need to make sure you use
limb defects. in your blood. Make sure you talk to your an effective method of birth control
 If you take valproate during pregnancy you doctor about the method of birth control (contraception) without interruption throughout
have a higher risk than other women of having (contraception) that is the most appropriate your treatment with Valproic Acid/Sodium
a child with birth defects that require medical for you. Valproate Tablets. Talk to your doctor or family
treatment. Because valproate has been used  Ask your doctor about taking folic acid when planning clinic if you need advice on birth control
for many years we know that in women who trying for a baby. Folic acid can lower the (contraception).
Valproic Acid 145mg, Sodium Valproate 333mg Ta blets Taj Phar ma : Us es, Side Effe cts, Intera ctions, Pictures , Warning s, Valproic A cid-S odium Valproate Dosage & Rx I nfo | Valproic Acid -Sodium Valproate Uses , Side Effects - Ca ncer, Val proic Acid-Sodium Valproate : Indications, Side E ffe cts, War nings , Valproic Acid-Sodium Valproate - Dr ug Informati on - Taj P harma, Valpr oic Aci d-Sodium Valproate dose Taj phar maceuticals Valpr oic Aci d-Sodium Valproate interactions, Taj Phar ma ceutical Valproi c Acid -Sodium Valpr oate contraindicati ons, Valproi c Acid -Sodium Valproate price, Valpr oic Aci d-Sodium Valproate Taj Phar ma anti-convul sants Val proic Acid 145mg, Sodium Valproate 333mg Ta blets PIL- Taj P harma . Stay conne cted to all updated on Valproi c Acid -Sodi um Valproate Taj P harma ceuti cals Taj phar mace uticals Hyderabad. Patient Informati on Lea flets, PI L.

Key messages: entire treatment with Valproic Acid/Sodium (contraception) until you have discussed this with
Valproate Tablets. Talk to your doctor or family your doctor. Your doctor will advise you further.
 Pregnancy must be excluded before start of planning clinic if you need advice on birth control
Babies born to mothers who have been on
treatment with Valproic Acid/Sodium (contraception).
valproate are at serious risk of birth defects and
Valproate Tablets with the result of a Key messages: problems with development, which can be
pregnancy test, confirmed by your doctor. seriously debilitating. Your doctor will refer you to
 You must use an effective method of birth
 You must use an effective method of birth a specialist experienced in the management of
control (contraception) during your entire epilepsy, so that alternative treatment options can
control (contraception) during your entire
treatment with Valproic Acid/Sodium be evaluated early on. Your specialist can put
treatment with Valproic Acid/Sodium
Valproate Tablets. several actions in place so that your pregnancy
Valproate Tablets.
 You must discuss appropriate methods of goes as smoothly as possible and any risks to you
 You must discuss birth control (contraception)
birth control (contraception) with your doctor. and your unborn child are reduced as much as
with your doctor. Your doctor will give you
Your doctor will give you information on possible.
information on preventing pregnancy, and
preventing pregnancy, and may refer you to a
may refer you to a specialist for advice on Your specialist may decide to change the dose of
specialist for advice on birth control
birth control (contraception). Valproic Acid/Sodium Valproate Tablets, switch
(contraception).
 You must get regular (at least annual)
 You must get regular (at least annual) you to another medicine, or stop treatment with
appointments with a specialist experienced in Valproic Acid/Sodium Valproate Tablets a long
appointments with a specialist experienced in
the management of epilepsy. During this visit time before you become pregnant – this is to
the management of epilepsy. During this visit
your doctor will make sure you are well aware make sure your illness is stable.
your doctor will make sure you are well aware
of and have understood all the risks and
of and have understood all the risks and
advice related to the use of valproate during Ask your doctor about taking folic acid when
advice related to the use of valproate during
pregnancy. trying for a baby. Folic acid can lower the general
pregnancy.
 Tell your doctor if you want to have a baby. risk of spina bifida and early miscarriage that exists
 Tell your doctor if you want to have a baby.
 Tell your doctor immediately if you are with all pregnancies. However, it is unlikely that it
 Tell your doctor immediately if you are will reduce the risk of birth defects associated with
pregnant or think you might be pregnant.
pregnant or think you might be pregnant. valproate use.
I AM TAKING VALPROIC ACID/SODIUM Key messages:
I AM TAKING VALPROIC ACID/SODIUM
VALPROATE TABLETS AND PLANNING TO
VALPROATE TABLETS AND NOT PLANNING
HAVE A BABY
TO HAVE A BABY  Do not stop taking Valproic Acid/Sodium
If you are planning to have a baby, first schedule Valproate Tablets unless your doctor tells you
If you are continuing treatment with Valproic to.
an appointment with your doctor.
Acid/Sodium Valproate Tablets but you are not
 Do not stop using your birth control
planning to have a baby make sure you are using Do not stop taking Valproic Acid/Sodium (contraception) before you have talked to
an effective method of birth control Valproate Tablets or your birth control your doctor and worked together on a plan to
(contraception) without interruption during your
Valproic Acid 145mg, Sodium Valproate 333mg Ta blets Taj Phar ma : Us es, Side Effe cts, Intera ctions, Pictures , Warning s, Valproic A cid-S odium Valproate Dosage & Rx I nfo | Valproic Acid -Sodium Valproate Uses , Side Effects - Ca ncer, Val proic Acid-Sodium Valproate : Indications, Side E ffe cts, War nings , Valproic Acid-Sodium Valproate - Dr ug Informati on - Taj P harma, Valpr oic Aci d-Sodium Valproate dose Taj phar maceuticals Valpr oic Aci d-Sodium Valproate interactions, Taj Phar ma ceutical Valproi c Acid -Sodium Valpr oate contraindicati ons, Valproi c Acid -Sodium Valproate price, Valpr oic Aci d-Sodium Valproate Taj Phar ma anti-convul sants Val proic Acid 145mg, Sodium Valproate 333mg Ta blets PIL- Taj P harma . Stay conne cted to all updated on Valproi c Acid -Sodi um Valproate Taj P harma ceuti cals Taj phar mace uticals Hyderabad. Patient Informati on Lea flets, PI L.

ensure your condition is controlled and the management of your underlying condition and to will also receive a Patient Card from your
risks to your baby are reduced. check how your unborn child is developing. You pharmacist to remind you of valproate risks in
 First schedule an appointment with your and your partner should receive counselling and pregnancy.
doctor. During this visit your doctor will make support regarding the valproate exposed
Newborn babies of mothers who took valproate
sure you are well aware of and have pregnancy.
during pregnancy may have:
understood all the risks and advice related to
Ask your doctor about taking folic acid. Folic acid
the use of valproate during pregnancy.
 Your doctor will try to switch you to another
can lower the general risk of spina bifida and early  Blood clotting problems (such as blood not
miscarriage that exists with all pregnancies. clotting very well). This may appear as
medicine or stop treatment with Valproic
However, it is unlikely that it will reduce the risk of bruising or bleeding which takes a long time
Acid/Sodium Valproate Tablets a long time
birth defects associated with valproate use. to stop.
before you become pregnant.
 Schedule an urgent appointment with your Key messages:  Hypoglycaemia (low blood sugar).
doctor if you are pregnant or think you might  Hypothyroidism (underactive thyroid gland,
be pregnant. which can cause tiredness or weight gain).
 Schedule an urgent appointment with your
 Withdrawal syndrome (including agitation,
doctor if you are pregnant or think you might
I AM PREGNANT AND I AM USING VALPROIC irritability, hyperexcitability, jitteriness,
be pregnant.
hyperkinesia, muscle problems, tremor,
ACID/SODIUM VALPROATE TABLETS  Do not stop taking Valproic Acid/Sodium
convulsions and feeding problems). In
Valproate Tablets unless your doctor tells you
Do not stop taking Valproic Acid/Sodium particular, this may occur in newborns whose
to.
Valproate Tablets unless your doctor tells you to mothers have taken valproate during the last
 Make sure you are referred to a specialist
as your condition may become worse. trimester of their pregnancy.
experienced in the treatment of epilepsy to
Schedule an urgent appointment with your doctor evaluate the need for alternative treatment
if you are pregnant or think you might be options. Breast-feeding
pregnant. Your doctor will advise you further.  You must get thorough counselling on the Very little Valproic Acid/Sodium Valproate Tablets
risks of Valproic Acid/Sodium Valproate gets into the breast milk.
Babies born to mothers who have been on
Tablets during pregnancy, including
valproate are at serious risk of birth defects and However, talk to your doctor about whether you
malformations and developmental effects in
problems with development which can be should breast-feed your baby.
children.
seriously debilitating. You will be referred to a
 Make sure you are referred to a specialist for Ask your doctor or pharmacist for advice before
specialist experienced in the management of
prenatal monitoring in order to detect taking any medicine.
epilepsy so that alternative treatment options can
possible occurrences of malformations.
be evaluated. Driving and using machines
In the exceptional circumstances when Valproic Make sure you read the Patient Guide that you You may feel sleepy when taking Valproic
Acid/Sodium Valproate Tablets is the only will receive from your doctor. Your doctor will Acid/Sodium Valproate Tablets. If this happens to
available treatment option during pregnancy, you discuss the Annual Risk Acknowledgement you, do not drive or use any tools or machines.
will be monitored very closely both for the Form and will ask you to sign it and keep it. You
Valproic Acid 145mg, Sodium Valproate 333mg Ta blets Taj Phar ma : Us es, Side Effe cts, Intera ctions, Pictures , Warning s, Valproic A cid-S odium Valproate Dosage & Rx I nfo | Valproic Acid -Sodium Valproate Uses , Side Effects - Ca ncer, Val proic Acid-Sodium Valproate : Indications, Side E ffe cts, War nings , Valproic Acid-Sodium Valproate - Dr ug Informati on - Taj P harma, Valpr oic Aci d-Sodium Valproate dose Taj phar maceuticals Valpr oic Aci d-Sodium Valproate interactions, Taj Phar ma ceutical Valproi c Acid -Sodium Valpr oate contraindicati ons, Valproi c Acid -Sodium Valproate price, Valpr oic Aci d-Sodium Valproate Taj Phar ma anti-convul sants Val proic Acid 145mg, Sodium Valproate 333mg Ta blets PIL- Taj P harma . Stay conne cted to all updated on Valproi c Acid -Sodi um Valproate Taj P harma ceuti cals Taj phar mace uticals Hyderabad. Patient Informati on Lea flets, PI L.

Taking other medicines used to treat fits or calm How much to take Patients taking other medicines for fits
emotional and mental health problems may (epilepsy)
increase sleepiness. Adults (including the elderly)
 You or your child may be taking other
3. HOW TO TAKE VALPROIC  The starting dose is 600mg daily. Your doctor medicines for epilepsy at the same time as
ACID/SODIUM VALPROATE TABLETS will gradually increase this dose by 200mg Valproic Acid/Sodium Valproate Tablets. If so,
Always take Valproic Acid/Sodium Valproate every 3 days depending on your condition. your doctor should gradually initiate
Tablets exactly as your doctor has told you. You  The usual dose is generally 1000-2000mg (20- treatment depending on your or your child’s
should check with your doctor or pharmacist if you 30mg per kilogram of body weight) each day. condition.
are not sure.  This may be increased to 2500mg each day  Your doctor may increase the dose of Valproic
depending on your illness. Acid/Sodium Valproate Tablets by 5-10mg for
Valproic Acid/Sodium Valproate Tablets treatment
must be started and supervised by a doctor each kilogram of body weight each day
Children over 20 kilograms depending on which other medicines you are
specialised in the treatment of epilepsy.
taking.
Taking this medicine  The starting dose should be 400mg daily.
Your doctor should increase this dose If you take more Valproic Acid/Sodium
 Your doctor will decide how much Valproic depending on your child’s illness. Valproate Tablets than you should
Acid/Sodium Valproate Tablets to give you or  The usual dose is then 20-30mg for each
your child depending on your or your child’s kilogram of body weight each day. If you take more Valproic Acid/Sodium Valproate
body weight.  This may be further increased to 35mg for Tablets than you should, tell a doctor or go to a
hospital casualty department straight away. Take
 Take this medicine by mouth. each kilogram of body weight each day
the medicine pack with you. This is so the doctor
 Take Valproic Acid/Sodium Valproate Tablets depending on your child’s illness.
knows what you have taken.
with or after food. This will help to stop the
feelings of sickness that may happen after Children under 20 kilograms The following effects may happen: feeling sick or
taking Valproic Acid/Sodium Valproate being sick, pupils of the eye become smaller,
Tablets.  Valproic Acid/Sodium Valproate Tablets is not dizziness, loss of consciousness, weak muscles and
 Do not crush or chew the tablets. recommended in children that weigh less than poor reflexes, breathing problems, headaches, fits
 If you feel the effect of your medicine is too 20 kilograms. Epilim Liquid (sugar free) or (seizures), confusion, memory loss and unusual or
weak or too strong, do not change the dose Epilim Syrup is recommended instead. inappropriate behaviour.
yourself but ask your doctor.
If you forget to take Valproic Acid/Sodium
Patients with kidney problems Valproate Tablets
How to take this medicine
 Your doctor may decide to adjust your or your If you forget to take a dose, take it as soon as you
 This medicine can be taken once or twice daily child’s dose. remember. However, if it is nearly time for the
next dose, skip the missed dose. Do not take a
double dose to make up for a forgotten dose.
Valproic Acid 145mg, Sodium Valproate 333mg Ta blets Taj Phar ma : Us es, Side Effe cts, Intera ctions, Pictures , Warning s, Valproic A cid-S odium Valproate Dosage & Rx I nfo | Valproic Acid -Sodium Valproate Uses , Side Effects - Ca ncer, Val proic Acid-Sodium Valproate : Indications, Side E ffe cts, War nings , Valproic Acid-Sodium Valproate - Dr ug Informati on - Taj P harma, Valpr oic Aci d-Sodium Valproate dose Taj phar maceuticals Valpr oic Aci d-Sodium Valproate interactions, Taj Phar ma ceutical Valproi c Acid -Sodium Valpr oate contraindicati ons, Valproi c Acid -Sodium Valproate price, Valpr oic Aci d-Sodium Valproate Taj Phar ma anti-convul sants Val proic Acid 145mg, Sodium Valproate 333mg Ta blets PIL- Taj P harma . Stay conne cted to all updated on Valproi c Acid -Sodi um Valproate Taj P harma ceuti cals Taj phar mace uticals Hyderabad. Patient Informati on Lea flets, PI L.

If you stop taking Valproic Acid/Sodium reactions can lead to lymph node aching muscles. This may be something called
Valproate Tablets enlargement and possible impairment of ‘Toxic epidermal necrolysis’.
other organs.  Bruising more easily and getting more
Keep taking until your doctor tells you to stop. Do
 Liver problems and problems of the pancreas infections than usual. This could be a blood
not stop taking Valproic Acid/Sodium Valproate
may show as a sudden illness which may problem called ‘thrombocytopenia’. It can also
Tablets just because you feel better. If you stop
happen in the first six months of treatment. be due to a fall in the number of white blood
your fits may come back.
This happens in a very small number of people cells, bone marrow depression or another
Tests taking Valproic Acid/Sodium Valproate condition that affects red blood cells, white
Tablets. It includes feeling and being sick blood cells and platelets (pancytopenia) or
Make sure you or your child keep your regular many times; being very tired, sleepy and how the blood clots.
appointments for a check-up. They are very weak; stomach pain including very bad upper  Blood clotting problems (bleeding for longer
important as your or your child’s dose may need to stomach pain; jaundice (yellowing of the skin than normal), bruising or bleeding for no
be changed. Valproic Acid/Sodium Valproate or whites of the eyes); loss of appetite; reason.
Tablets can change the levels of liver enzymes swelling (especially of the legs and feet but  Changes in mood, loss of memory, lack of
shown up in blood tests. This can mean that your may include other parts of the body); concentration and deep loss of consciousness
or your child’s liver is not working properly. If you worsening of your fits or a general feeling of (coma).
or your child go into hospital or visit another being unwell. Your doctor may tell you to stop  Underactive thyroid gland, which may cause
doctor or a dentist, tell them you are taking taking Valproic Acid/Sodium Valproate tiredness or weight gain (hypothyroidism).
Valproic Acid/Sodium Valproate Tablets. Tablets immediately if you have these  Breathing difficulty and pain due to
If you have any further questions on the use of this symptoms. inflammation of the lungs (pleural effusion).
product, ask your doctor or pharmacist.  You have a skin rash or skin lesions with a
pink/red ring and a pale centre which may be Tell your doctor as soon as possible if you have
4.POSSIBLE SIDE EFFECTS itchy, scaly or filled with fluid. The rash may any of the following side effects:
Like all medicines, Valproic Acid/Sodium appear especially on the palms or soles of
Valproate Tablets can cause side effects, although your feet. These could be signs of a serious
 Changes in behaviour including being very
not everybody gets them. allergy to the medicine called ‘erythema
alert, and sometimes also aggressive,
multiforme’.
Tell your doctor straight away if you notice any hyperactive and unusual or inappropriate
 Blistering or bleeding of the skin around the
of the following serious side effects – you may behaviour. This is more likely if other
lips, eyes, mouth, nose and genitals. Also flu-
need urgent medical treatment: medicine to treat fits such as phenobarbital
like symptoms and fever. This may be
and topiramate are taken at the same time or
something called ‘Stevens-Johnson
if the Valproic Acid/Sodium Valproate Tablets
 You have an allergic reaction. The signs syndrome’.
starting dose is high or has been suddenly
include: a rash, joint pain, fever (systemic  Severe blistering rash where layers of the skin increased.
lupus erythematosus), swelling of your lips, may peel off to leave large areas of raw
 Changes in the amount of ammonia in the
face, throat or tongue. Hands, feet or genitals exposed skin over the body. Also a feeling of
blood. Symptoms of this condition are being
may also be affected. More severe allergic being generally unwell, fever, chills, and
Valproic Acid 145mg, Sodium Valproate 333mg Ta blets Taj Phar ma : Us es, Side Effe cts, Intera ctions, Pictures , Warning s, Valproic A cid-S odium Valproate Dosage & Rx I nfo | Valproic Acid -Sodium Valproate Uses , Side Effects - Ca ncer, Val proic Acid-Sodium Valproate : Indications, Side E ffe cts, War nings , Valproic Acid-Sodium Valproate - Dr ug Informati on - Taj P harma, Valpr oic Aci d-Sodium Valproate dose Taj phar maceuticals Valpr oic Aci d-Sodium Valproate interactions, Taj Phar ma ceutical Valproi c Acid -Sodium Valpr oate contraindicati ons, Valproi c Acid -Sodium Valproate price, Valpr oic Aci d-Sodium Valproate Taj Phar ma anti-convul sants Val proic Acid 145mg, Sodium Valproate 333mg Ta blets PIL- Taj P harma . Stay conne cted to all updated on Valproi c Acid -Sodi um Valproate Taj P harma ceuti cals Taj phar mace uticals Hyderabad. Patient Informati on Lea flets, PI L.

sick, problems with balance and co- growth on the face, breasts or chest, acne or Valproic Acid/Sodium Valproate Tablets can
ordination, feeling lethargic or less alert. thinning hair. change levels of liver enzymes, salts or sugars
 Feeling shaky (tremor), sleepy or unsteady  Skin rash caused by narrow or blocked blood shown up on blood and urine tests.
when walking or jerky muscle movements. vessels (vasculitis)
Male fertility
 Feeling tired or confused with loss of  Changes in women’s periods and increased
consciousness sometimes accompanied by hair growth in women Taking Valproic Acid/Sodium Valproate Tablets
hallucinations or fits.  Breast enlargement in men can be a contributing factor in male infertility.
 Blisters with the skin flaking away.  Swelling of the feet and legs (oedema)
 Rapid, uncontrollable movement of the eyes.  Obesity, weight gain – as your appetite may Reporting of side effects
 An increase in the number and severity of be increased If you get any side effects, talk to your doctor,
convulsions.  Kidney disease, kidney problems, blood in the pharmacist or nurse. This includes any possible
urine, bedwetting or increased need to pass side effects not listed in this leaflet.By reporting
Tell your doctor or pharmacist if any of the urine, urinary incontinence (unintentional side effects you can help provide more
following side effects get serious or lasts longer passing of urine) information on the safety of this medicine.
than a few days, or if you notice any side effects  Headache
not listed in this leaflet:  Seeing or hearing things that are not there 5.HOW TO STORE VALPROIC
(hallucinations) ACID/SODIUM VALPROATE TABLETS
 Feeling sick (nausea), being sick (vomiting),  Aggression, agitation, disturbance in
attention, abnormal behaviour, Keep out of the sight and reach of children.
stomach ache or diarrhoea, especially when
starting treatment. This may be helped by restlessness/hyperactivity, and learning Do not take this medicine after the expiry date
taking the tablets with food. disorder shown on the blister and carton after EXP. The
 Swelling of gums or sore mouth  Tingling or numbness in the hands and feet expiry date refers to the last day of that month.
 Fainting  Lowering of normal body temperature
 Do not remove the tablets from the foil until just
 Hearing loss Abnormal blood clotting factors
 before you take them. Do not cut the blister strips.
 Double vision Muscle pain and weakness (rhabdomyolysis)
Store in a dry place below 30°C.
 Nail and nail bed disorders
 Skin problems such as rashes. These happen Bone disorders Medicines should not be disposed of via household
rarely, but more often in people also taking wastewater or household waste. Ask your
There have been reports of bone disorders
lamotrigine. pharmacist how to dispose of medicines no longer
including osteopenia and osteoporosis (thinning of
 Hair disorders (changes in texture, colour or required. These measures will help protect the
the bone) and fractures. Check with your doctor or
growth), hair loss which is usually temporary. environment.
pharmacist if you are on long-term anti-epileptic
When it grows back it may be more curly than
medication, have a history of osteoporosis, or take 6. CONTENTS OF THE PACK AND
before.
steroids. FURTHER INFORMATION
 Increased levels of some hormones
(androgens), which may lead to increased hair Tests
Valproic Acid 145mg, Sodium Valproate 333mg Ta blets Taj Phar ma : Us es, Side Effe cts, Intera ctions, Pictures , Warning s, Valproic A cid-S odium Valproate Dosage & Rx I nfo | Valproic Acid -Sodium Valproate Uses , Side Effects - Ca ncer, Val proic Acid-Sodium Valproate : Indications, Side E ffe cts, War nings , Valproic Acid-Sodium Valproate - Dr ug Informati on - Taj P harma, Valpr oic Aci d-Sodium Valproate dose Taj phar maceuticals Valpr oic Aci d-Sodium Valproate interactions, Taj Phar ma ceutical Valproi c Acid -Sodium Valpr oate contraindicati ons, Valproi c Acid -Sodium Valproate price, Valpr oic Aci d-Sodium Valproate Taj Phar ma anti-convul sants Val proic Acid 145mg, Sodium Valproate 333mg Ta blets PIL- Taj P harma . Stay conne cted to all updated on Valproi c Acid -Sodi um Valproate Taj P harma ceuti cals Taj phar mace uticals Hyderabad. Patient Informati on Lea flets, PI L.

What Valproic Acid/Sodium Valproate Tablets


contain
Each controlled release tablet contains a mixture
of 333mg sodium valproate and 145mg valproic
acid, equivalent to 500mg of the active substance,
sodium valproate.
The other ingredients are: hypromellose (E464),
ethylcellulose, hydrated silica, titanium dioxide
(E171), erythrosine BS aluminium lake (E127),
indigo carmine aluminium lake FD and C Blue No 2
(E132), iron oxide black (E172), macrogol 400.

What Valproic Acid/Sodium Valproate Tablets


look like and contents of the pack
Valproic Acid/Sodium Valproate Tablets tablets
are oval shaped and lilac coloured. The tablets are
supplied in blister packs of 30 or 100.
Packaging: 10x3.

Manufactured in India by:


TAJ PHARMACEUTICALS LTD.
Mumbai, India
At:388/34, Changodar Industrial Estate
Changodar- 382 210
Dist- Ahmedabad. Gujarat (India)
MFG. LIC NO: G/25A/4795-A
This leaflet was last revised in March 2019

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