2. What should I know before I use Valproate Winthrop?
Do not use if you have ever had an allergic reaction to Valproate Winthrop or any
of the ingredients listed at the end of the CMI.
Valproate Winthrop can seriously harm an unborn child when taken during pregnancy.
If you are a female able to have a baby, you must use an effective method of birth
control (contraception) during your entire treatment with Valproate Winthrop. Schedule
an urgent appointment with your doctor if you want to become pregnant or if you think
you became pregnant. Do not stop taking Valproate Winthrop unless your doctor tells
you to, as it may be dangerous for you.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Valproate Winthrop and affect how it works.
4. How do I use Valproate Winthrop?
Your doctor will tell you how much to take. This may depend on your age, your condition
and whether or not you are taking any other medicines.
5. What should I know while using Valproate Winthrop?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using Valproate Winthrop.
Plan annual appointments with your specialist.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking this medicine.
Ensure you use effective contraception and if you become pregnant while you are taking
this medicine, tell your doctor immediately
|
|
Things you should not do
|
If you suffer from mania, do not use Valproate Winthrop if you are pregnant.
If you suffer from epilepsy, do not use Valproate Winthrop if you are pregnant, unless
your doctor has determined that no other treatment works for you
Do not stop using this medicine suddenly or lower the dosage, without checking with
your doctor as your condition may become worse.
Do not take more than the recommended dose unless your doctor tells you to.
|
|
Driving or using machines
|
Valproate Winthrop may cause drowsiness, light-headedness dizziness or sleepiness,
Make sure you know how you react to it before you drive a car, operate machinery or
perform any activity that requires alertness.
Children should not ride a bike, climb trees or do anything else that could be dangerous
if they are feeling drowsy or sleepy.
|
|
Drinking alcohol
|
Avoid alcohol while you are being treated with Valproate Winthrop.
Combining Valproate Winthrop and alcohol can make you more sleepy, dizzy or lightheaded.
|
|
Looking after your medicine
|
Store tablets in a cool dry place below 30°C. Keep tablets in the blister pack.
|
6. Are there any side effects?
All medicines have some unwanted side effects. Mostly these are mild and short-lived.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Valproate Winthrop.
Tell your doctor immediately or go to the Accident and Emergency department of your
nearest hospital:
If you or your child develops a sudden illness and particularly if it includes repeated
vomiting, extreme tiredness, abdominal pain, drowsiness, weakness, loss of appetite,
upper stomach pain, nausea, jaundice (yellowing of the skin or whites of the eyes),
swelling of the legs or worsening of your epilepsy or a general feeling of being unwell
If you or your child taking Valproate Winthrop develops problems with balance and
co-ordination, feeling lethargic or less alert, vomiting,
If seizures become worse or happen more frequently
If you have any thoughts of harming yourself or committing suicide
If you think you are pregnant
Active ingredient:
sodium valproate
Consumer Medicine Information (CMI)
This leaflet provides important information about using Valproate Winthrop. Read the
entire leaflet carefully before you start taking this medicine. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Valproate Winthrop.
Where to find information in this leaflet:
1. Why am I using Valproate Winthrop?
Valproate Winthrop contains the active ingredient sodium valproate. Valproate Winthrop belongs to a group of medicines called anticonvulsants.
Valproate Winthrop is used to treat epilepsy in adults and children.
Epilepsy is a condition where you have repeated seizures (fits). There are many different
types of seizures, ranging from mild to severe. These medicines are thought to work
by controlling brain chemicals which send signals to nerves so that seizures do not
happen.
Valproate Winthrop may also be used to control mania, a mental condition with episodes
of overactivity, elation or irritability. Valproate Winthrop should not be used in
children and adolescents under 18 years of age for the treatment of mania. Valproate
Winthrop may be used alone or in combination with other medicines to treat your condition.
Your doctor, however, may have prescribed Valproate Winthrop for another reason. Valproate
Winthrop has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their symptoms seem to be the same as yours.
Ask your doctor if you have any questions about why it has been prescribed for you.
There is no evidence that Valproate Winthrop is addictive.
This medicine is available only with a doctor's prescription.
2. What should I know before I use Valproate Winthrop?
Warnings
Do not use Valproate Winthrop:
if you are pregnant, unless your doctor has determined that no other treatment works
for you
unless you use an effective method of birth control (contraception) at all times during
your treatment with Valproate Winthrop
if you are allergic to sodium valproate, or any of the ingredients listed at the end
of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you have or have had any of the following medical conditions:
liver disease (hepatic dysfunction) or severe hepatitis.
a family history of severe hepatitis, especially when caused by medicines. Medicines
used in the treatment of epilepsy, including Valproate Winthrop may have adverse effects
on the liver and the kidneys
a urea cycle disorder or a family history of urea cycle disorders.
a family history of unexplained infant deaths.
hepatic porphyria which is a rare blood disease of blood pigments.
known ornithine transcarbamylase deficiency or a family history of ornithine transcarbamylase
deficiency.
known or suspected of having a genetic problem causing a mitochondrial disorder for
example Alpers-Huttenlocher syndrome.
inborn deficiency in carnitine, a very rare metabolic disorder that is untreated.
you are pregnant, unless your doctor has determined no alternative treatment works
for you.
Check with your doctor if you:
have any other medical conditions, especially the following:
liver problems (hepatic insufficiency, hepatic damage)
impaired kidney function as your doctor may want to monitor the valproate level or
adjust your dose
urea cycle disorders because of a risk of increased ammonia level in the blood
ornithine transcarbamylase (OTC) deficiency
an inborn deficiency in carnitine (a very rare metabolic disease) that is untreated,
also called carnitine palmitoyltransferase (CPT) type II deficiency because you are
at increased risk of muscle disorders
an inborn deficiency in carnitine and are taking carnitine
have impaired dietary intake in carnitine, found in meat and dairy products, especially
in children less than 10 years old
systemic lupus erythematosus (SLE) (a disease affecting the skin, joints and kidneys)
family history of a genetic problem causing mitochondrial disorder because of a risk
of damage to your liver
put on weight as your appetite may be increased
take any medicines for any other condition
If you have not told your doctor about any of the above, tell them before you take
Valproate Winthrop.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant or intend to become pregnant.
You must not use Valproate Winthrop if you are pregnant, unless your doctor has determined
that no alternative treatment works for you.
If you are a girl or woman of childbearing age, make sure that you talk to your doctor
about the risks associated with taking Valproate Winthrop during pregnancy. Your doctor
will explain what might happen to your baby if you become pregnant whilst taking Valproate
Winthrop.
You must not take Valproate Winthrop unless you use an effective method of birth control
(contraception) at all times during your treatment with Valproate Winthrop. If you
decide later you want to have a baby, you must not stop taking Valproate Winthrop
or your contraception until you have discussed this with your doctor. Your doctor
will advise you further on alternative treatment options. Your doctor may decide to
change the dose of Valproate Winthrop or switch you to another medicine or stop treatment
with Valproate Winthrop several months before you become pregnant.
If you are a parent or carer, tell your doctor when your child using Valproate Winthrop
experiences her first period.
Valproate Winthrop can be harmful to unborn children when taken by a woman during
pregnancy. It can cause serious birth defects that require medical treatment and can
affect physical and mental development of the child as it grows after birth. Babies
are also at risk of lower weight than expected for their age at birth. The most frequently
reported birth defects include spina bifida (where the bones of the spine are not
properly developed), facial and skull malformations, heart, kidney, urinary and sexual
organ malformations, limb defects, and multiple associated malformations affecting
several organs and parts of the body.
Birth defects may result in disabilities which may be severe. As valproate has been
used for many years, it is known that in women who take valproate during pregnancy
around 11 babies in every 100 will have birth defects. This compares to 2 to 3 babies
in every 100 born to women from the general population. It is estimated that up to
30-40% of children whose mothers took valproate during pregnancy may have problems
with early childhood development. Children affected can be slow to walk and talk,
be intellectually less able than other children, and have difficulties with language
and memory.
Hearing problems or deafness as well as eye malformations in association with other
congenital malformations which may affect vision, have been reported in children exposed
to valproate during pregnancy.
Autistic spectrum disorders are more often diagnosed in children exposed to valproate
during pregnancy and there is some evidence that children exposed to valproate during
pregnancy are at increased risk of developing Attention Deficit Hyperactivity Disorder
(ADHD).
If you take valproate during pregnancy, your baby may have a lower weight than expected
for their age at birth.
There may also be blood clotting problems, hypoglycemia and hypothyroidism in the
newborn children of mothers who have taken Valproate Winthrop during pregnancy.
Children born to mothers who take Valproate Winthrop throughout their pregnancy may
be at risk of impaired cognitive development or withdrawal syndrome (agitation, irritability,
hyperexcitability, jitteriness, hyperkinesia, tonicity disorders, tremor, convulsions
and feeding problems) if Valproate Winthrop is taken during the last trimester of
pregnancy. However, do not stop taking Valproate Winthrop unless your doctor says
so as there are risks to the mother and child from uncontrolled epilepsy or uncontrolled
mania episodes.
Your doctor may want to adapt your treatment and/or prescribe dietary supplements
of folate 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.
In exceptional circumstances when Valproate Winthrop is the only available treatment
option during pregnancy, you will be monitored very closely both for the management
of your underlying condition and to check how your unborn child is developing. You
and your partner should receive counselling and support regarding the valproate exposed
pregnancy.
Your doctor will discuss the risks and benefits of taking it if you are pregnant including
when valproate is used in combination with other medicines to treat epilepsy. The
higher the dose, the higher the risks but all doses carry a risk.
Potential risk to children of fathers taking valproate in the 3 months prior to conception
A study suggests that if you take valproate in the 3 months prior to conception, your
child may have a higher risk for impaired mental and/or motor development compared
to children born to fathers who used lamotrigine or levetiracetam, other medicines
that can be used to treat your disease. In this study, around 5 children in 100 had
such disorders when born from fathers treated with valproate, and around 3 children
in 100 when born from fathers treated with the other medicines. There are no data
on this potential risk to children fathered more than 3 months after stopping valproate
treatment (the time needed for new sperm to be formed).
As a precautionary measure, your doctor will discuss with you
The potential risk when fathering a child if you are treated with valproate,
The need to use effective contraception (birth control) for you and your female partner
during the treatment and for 3 months after stopping valproate
The need to consult your doctor to discuss alternative treatment options, as soon
as you are planning to father a child and before discontinuing contraception (birth
control),
To not donate sperm during treatment and for 3 months after stopping treatment.
Do not stop your treatment without talking to your doctor. If you stop your treatment,
your symptoms may become worse. If your female partner becomes pregnant while you
used valproate in the 3 months prior to conception, both of you should contact the
doctor for counseling.
You should get regular (at least annual) appointments with your doctor. During this
visit your doctor will make sure you understand the risk and precautions associated
with valproate use.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Medicines used in the treatment of epilepsy, including Valproate Winthrop, pass into
breast milk. Your doctor will discuss the risks and benefits of taking Valproate Winthrop
if you are breastfeeding or planning to breastfeed.
Contraception use
Use an effective method of contraception and consult your doctor before planning pregnancy.
Valproate Winthrop can seriously harm an unborn child when taken during pregnancy.
If you are a girl or woman of childbearing age, you must use at least one effective
method of birth control (contraception) without interruption during your entire treatment
with Valproate Winthrop. Some birth control pills (oestrogen containing birth control
pills) may lower valproate levels in your blood. Your doctor should discuss with you
the most appropriate method of contraception for you.
Valproate Winthrop should have little effect on the oral contraceptive pill, however,
you should let your doctor know that you are taking it.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Valproate Winthrop and affect how it works.
These include:
aspirin (and other salicylates)
medicines used to prevent clots (anticoagulants) e.g. warfarin.
other medicines used to treat epilepsy e.g. phenobarbital (phenobarbitone), methylphenobarbitone,
primidone, phenytoin, carbamazepine, clonazepam, felbamate, lamotrigine, topiramate,
diazepam, lorazepam, oxcarbamazepine, rifunamide and ethosuximide
medicines used to treat depression e.g. monoamine oxidase inhibitors (MAOIs), selective
serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants
benzodiazepines (medicines used as sedatives or to treat anxiety)
oestrogen containing products or oral contraceptives. Valproate Winthrop should have
little effect on the oral contraceptive pill, however, you should let your doctor
know that you are taking it.
zidovudine or any other anti-viral medications
cannabidiol (used to treat epilepsy and other conditions)
neuroleptic agents including clozapine (a medicine used to treat schizophrenia)
quetiapine or olanzapine (medicines used to treat bipolar disorder and schizophrenia)
mefloquine (a medicine used to treat malaria)
propofol (a medicine used before and during general anaesthesia)
nimodipine (a medicine used to help blood flow to the brain)
cimetidine (used to treat stomach ulcers)
erythromycin, rifampicin and carbapenem antibiotics such as Invanz and Merrem. The
combination of Valproate Winthrop and carbapenems should be avoided because it may
decrease the effect of Valproate Winthrop.
rufinamide
colestyramine (Questran Lite)
acetazolamide (Diamox)
protease inhibitors such as lopinavir and ritonavir (used to treat HIV)
metamizole (a medicine used to treat pain and fever)
methotrexate (used to treat cancer and inflammatory diseases)
some anti-infectives that contain pivalate (e.g. pivampicillin, adefovir dipivoxil).
These medicines and others may be affected by Valproate Winthrop, or worsen adverse
reactions, or may affect how well it works. You may need different amounts of your
medicine, or you may need to take different medicines. Your doctor or pharmacist will
advise you.
Tell your doctor or pharmacist if your child is taking any other medicines before
you start giving them Valproate Winthrop, for example, aspirin or any other drugs
used to treat epilepsy. If your child is under 3 years of age, Valproate Winthrop
should not be administered together with aspirin. Valproate Winthrop can affect the
liver and rarely the pancreas in a very small number of patients. The risk of liver
damage is increased if Valproate Winthrop is taken by your child under 3 years who
is taking other antiepileptic medicine at the same time or has other neurological
or metabolic disease and severe form of epilepsy.
Children, especially young children, can be more sensitive to some of the side effects
of Valproate Winthrop.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Valproate Winthrop.
4. How do I use Valproate Winthrop?
How much to take
Your doctor will tell you how much to take. This may depend on your age, your condition
and whether or not you are taking any other medicines.
Your doctor may recommend that you start with a low dose of Valproate Winthrop and
slowly increase the dose to the lowest amount needed to control your condition.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take
Follow the instructions provided and use Valproate Winthrop until your doctor tells
you to stop.
If you take the wrong dose, Valproate Winthrop may not work as well.
Make sure you keep your regular check up appointments. They are very important, as
your dosage may need to be changed.
When to take Valproate Winthrop
Valproate Winthrop should be taken at about the same time each day.
Taking your tablets at the same time each day will have the best effect. It will also
help you remember when to take the tablets.
If you are not sure when to take it, ask your doctor. Continue taking your medicine
for as long as your doctor tells you.
Valproate Winthrop helps control your condition but does not cure it. Therefore, you
must take it every day.
How to take Valproate Winthrop
Swallow the lilac tablets whole with a glass of water or other liquid.
Do not crush or chew the tablets.
The lilac tablets have a special coating to stop them dissolving until they have gone
through the stomach and into the intestines. If you chew them the coating is destroyed.
If you forget to use Valproate Winthrop
Valproate Winthrop should be used regularly at the same time each day. If you miss
your dose at the usual time, take your next dose as usual. Contact your doctor if
you miss several doses.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed. This may increase the
chance of you getting unwanted side effects.
Always remember to take your prescribed dose otherwise you may find that either your
seizures or manic symptoms may return.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you use too much Valproate Winthrop
If you think that you have used too much Valproate Winthrop, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much Valproate Winthrop, you may experience:
reduction in consciousness possibly leading into coma
shortness of breath
muscle weakness
shrinking of the pupil in the eye
too much acid in the body, causing fast breathing, confusion, tiredness, headache,
yellowing of the skin (jaundice) and increased heart rate
dizziness, lightheadedness
collapse due to very low blood pressure
convulsions may become worse or happen more frequently
severe headache, blurred vision, blind spot or vision loss
tiredness, confusion, excessive thirst
death
5. What should I know while using Valproate Winthrop?
Things you should do
If you are about to be started on any new medicine, tell your doctor that you are
taking Valproate Winthrop.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking this medicine.
Be sure to keep all of your doctors' appointments so that your progress can be checked.
Your doctor will check your progress and may want to take some tests from time to
time. This helps prevent unwanted side effects.
Call your doctor straight away:
If you become pregnant while you are taking this medicine
If you or your child develops an allergic reaction, especially with effects on skin
and mucosa, and/or fever
Remind any doctor, dentist or pharmacist you visit that you are using Valproate Winthrop.
All mentions of suicide or violence must be taken seriously. Tell your doctor or a
mental health professional immediately if you have any suicidal thoughts or other
mental/mood changes.
Things you should not do
Do not stop using this medicine suddenly, or lower the dosage, without checking with
your doctor.
Do not take more than the recommended dose unless your doctor tells you to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not use this medicine to treat any other complaints unless your doctor tells you
to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Valproate
Winthrop affects you.
Valproate Winthrop may cause drowsiness or light-headedness in some people, especially
at the beginning of treatment or in combination with other antiepileptic medicines
or benzodiazepines. Make sure you know how you react to it before you drive a car,
operate machinery, or do anything else that could be dangerous if you are drowsy or
light-headed.
Children should not ride a bike, climb trees or do anything else that could be dangerous
if they are feeling drowsy or sleepy.
Valproate Winthrop may cause drowsiness, dizziness or sleepiness in some people and
affect alertness.
Drinking alcohol
Tell your doctor if you drink alcohol.
If you have more than 2 drinks per day, you may be putting yourself at risk of a seizure,
or fit.
The effects of alcohol could be made worse while taking Valproate Winthrop.
Combining Valproate Winthrop and alcohol can make you more sleepy, dizzy or lightheaded.
Your doctor may suggest you avoid alcohol while you are being treated with Valproate
Winthrop.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the box they may not keep well. Keep your tablets in
a cool dry place where the temperature stays below 30°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on a windowsill.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date (EXP) printed on the pack. If you take
this medicine after the expiry date has passed, it may not work as well.
Do not use it if the packaging is torn or shows signs of tampering.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
Gastrointestinal related:
nausea or vomiting
abdominal cramps or pain
changes in appetite
changes in your weight
diarrhoea
Mouth related:
bleeding, tender or enlarged gums
sore, swollen mouth, mouth ulcers and burning feeling of mouth
Head and neurology related:
headache
unusual movements, including tremor and shaking
rapid uncontrollable movements of the eye or double vision
unsteadiness when walking, dizziness or light-headedness
tingling or numbness of the hands and feet
hearing problems or deafness
depression
feeling tired or drowsy
memory impairment
confusion
hallucinations
disturbance in attention
changes in behaviour including aggression and agitation
learning disorder
Hormone related:
irregular menstrual periods
acne
male infertility
Respiratory related :
Pneumonia
Other side effects:
hair loss
nail and nail bed disorders
loss of bladder control
decrease in carnitine levels (shown in blood or muscular tests)
reduced levels of vitamin B8
bedwetting
excessive hairiness
decrease in body temperature
inflammation of small blood vessels
bone disorders and fractures
darker areas of skin and mucous membranes (hyperpigmentation)
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
These are the more common side effects of Valproate Winthrop. Mostly these are mild
and short-lived.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Gastrointestinal related:
severe upper stomach pain, often with nausea and vomiting
Blood related:
blood clotting problems
spontaneous bruising or bleeding
signs of decreased white blood cells or bone marrow problems such as fever and breathing
difficulty
signs of increased ammonia in the blood such as problems with balance and co-ordination,
feeling lethargic or less alert, vomiting
Head and neurology related:
more frequent or more severe seizures (fits)
fainting
drowsiness, change in conscious level (including coma), confusion, sluggishness or
abnormal behaviour and memory loss with or without more frequent or severe fits particularly
if phenobarbital and topiramate are taken at the same time or if the dose of Valproate
Winthrop has been suddenly increased
bizarre behaviour
suicidal thoughts
suicide attempts
Liver related:
signs of liver and pancreas problems such as vomiting, loss of appetite, generally
feeling unwell, tiredness, yellowing of the skin and/or eyes, dark urine or blood
in urine, pain in the abdomen
Other side effects:
rashes or skin lesions with a pink/red ring and a pale center which may be itchy,
scaly of filled with fluid, especially on the palms or soles of your feet
blisters with skin peeling or bleeding with sometimes flu-like symptoms such as fever,
chills or aching muscle
joint pain
passing a lot of urine and feeling thirsty (Fanconi syndrome)
swelling due to an allergy with painful itchy welts often around the eyes, lips, throat
and sometimes hands and feet
swelling of the feet and legs, weight increase due to fluid build up
syndrome with skin rash, fever, lymph node enlargement and possible impairment of
other organs. These may be signs of a condition called DRESS (Drug Rash with Eosinophilia
and Systemic Symptoms)
underactive thyroid gland which may cause tiredness or weight gain
kidney disease resulting in reduced urinary output
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects or if you have any
thoughts of harming yourself or committing suicide.
You may need urgent medical attention or hospitalisation.
|
|
Serious side effects
|
What to do
|
|
Additional side effects in children
signs of liver damage or inflammation of the pancreas (pancreatitis). Signs may include
repeated vomiting, extreme tiredness, loss of appetite, severe upper stomach pain,
nausea, jaundice (yellowing of the skin or whites of the eyes), swelling of the legs
or worsening of your epilepsy or a general feeling of being unwell
aggression
agitation
disturbance in attention
abnormal behaviour
hyperactivity
learning disorder
Some side effects of valproate occur more frequently in children or are more severe
compared to adults.
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
Your child may need urgent medical attention or hospitalisation.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
If you get any side effects, talk to your doctor or pharmacist immediately. Other
side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Valproate Winthrop contains
|
Active ingredient
(main ingredient)
|
Valproate Winthrop EC200 - 200 mg sodium valproate
Valproate Winthrop EC500 - 500 mg sodium valproate
|
|
Other ingredients
(inactive ingredients)
|
Povidone
Purified talc
Magnesium stearate
Calcium silicate
Citric acid monohydrate
Macrogol 6000
Hypromellose
Polyvinyl acetate phthalate
Hyprolose
Deithyl phthalate
Stearic acid
Amaranth aluminium lake
Indigo carmine aluminium lake
Titanium dioxide
|
|
Potential allergens
|
None
|
Do not take this medicine if you are allergic to any of these ingredients.
What Valproate Winthrop looks like
Valproate Winthrop EC200 - Lilac, biconvex, enteric-coated tablets.
Valproate Winthrop EC500 - Lilac, biconvex, enteric-coated tablets
The tablets are available in boxes of 100 tablets.
(Valproate Winthrop EC200 - AUST R 125620)
(Valproate Winthrop EC500 - AUST R 125621).
Who distributes Valproate Winthrop
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
This leaflet was prepared in September 2025
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