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SODIUM VALPROATE 100MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): SODIUM VALPROATE

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The intravenous solution is suitable for infusion by PVC, polyethylene or glass containers.
Sodium valproate injection should be replaced by oral valproate therapy as soon as practicable.
Use with Children: Daily requirement for children is usually in the range 20 – 30mg/kg body weight
per day and method of administration is as above. Where adequate control is not achieved within
this range, the dose may be increased to 40 mg/kg/day but only in patients in whom plasma valproic
acid levels can be monitored. Above 40 mg/kg/day clinical chemistry and haematological parameters
should be monitored.
Use in elderly: Although the pharmacokinetics of sodium valproate are modified in the elderly, they
have limited clinical significance and dosage should be determined by seizure control. The volume
of distribution is increased in the elderly and because of decreased binding to serum albumin, the
proportion of free drug is increased. This will affect the clinical interpretation of plasma valproic
acid levels.
In patients with renal insufficiency: It may be necessary to decrease dosage. Dosage should
be adjusted according to clinical monitoring since monitoring of plasma concentrations may be
misleading (see section 5.2 Pharmacokinetic Properties of the SmPC).
In patients with hepatic insufficiency: Salicylates should not be used concomitantly with sodium
valproate since they employ the same metabolic pathway (see section 4.4 Special Warnings and
Precautions for Use and 4.8 Undesirable Effects of the SmPC).
Liver dysfunction, including hepatic failure resulting in fatalities, has occurred in patients whose
treatment included valproic acid (see section 4.3 Contraindications and 4.4 Special Warnings and
Precautions for Use of the SmPC).
Salicylates should not be used in children under 16 years (see aspirin/salicylate product information
on Reye’s syndrome). In addition in conjunction with sodium valproate, concomitant use in children
under 3 years can increase the risk of liver toxicity (see section 4.4 Special Warnings of the SmPC).
Female children, female adolescents, women of childbearing potential and pregnant women:
Sodium valproate injection should be initiated and supervised by a specialist experienced in the
management of epilepsy. Treatment should only be initiated if other treatments are ineffective or
not tolerated (see sections 4.4 and 4.6) and the benefit and risk should be carefully reconsidered at
regular treatment reviews. Preferably sodium valproate should be prescribed as monotherapy and at
the lowest effective dose, if possible as a prolonged release formulation to avoid high peak plasma
concentrations. The daily dose should be divided into at least two single doses.

664543

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
Sodium Valproate 100mg/ml Solution for Injection or Infusion
Please refer to the Summary of Product Characteristics (SmPC) for further details on this product.
Qualitative and Quantitative Composition
Each ml of solution contains 100 mg sodium valproate. Each 4 ml ampoule contains 400 mg sodium
valproate. Each 10 ml ampoule contains 1000 mg sodium valproate.
For a full list of excipients; see Pharmaceutical Particulars section below.
Pharmaceutical Form
Solution for injection or infusion. A clear, colourless solution.
Posology and Method of Administration
Sodium Valproate 100mg/ml Solution for Injection or Infusion
Please refer to the Summary of Product Characteristics (SmPC) for further details on this product.
Qualitative and Quantitative Composition
Each ml of solution contains 100 mg sodium valproate. Each 4 ml ampoule contains 400 mg sodium
valproate. Each 10 ml ampoule contains 1000 mg sodium valproate.
For a full list of excipients; see Pharmaceutical Particulars section below.
Pharmaceutical Form
Solution for injection or infusion. A clear, colourless solution.
Posology and Method of Administration
Sodium valproate injection may be given by direct slow intravenous injection or by infusion using a
separate intravenous line in normal saline, dextrose 5%, or dextrose saline.
Dosage
Dosage requirements vary according to age and body weight. Each vial of sodium valproate injection
is for single dose injection only. For instructions on preparation and dilution of sodium valproate
injection before administration see section 6.6. Special precautions for disposal and other handling
of the SmPC.
Patients already satisfactorily treated with oral sodium valproate may be continued at their current
dosage using continuous or repeated infusion. Other patients may be given a slow intravenous
injection over 3-5 minutes, usually 400-800mg depending on body weight (up to 10mg/kg) followed
by continuous or repeated infusion up to a maximum of 2500mg/day.
Sodium valproate injection should not be administered via the same IV line as other IV additives.

Artwork No.

• Monoamine oxidase inhibitors (MAOI) such as moclobemide,
selegiline, linezolid
• Medicines used to calm emotional and mental conditions such
as diazepam and olanzapine.
This medicine is
subject to additional
The following medicines can affect the way Sodium Valproate
monitoring.
Injection works:
This will allow quick
• Some medicines used for the prevention and treatment of
identification of new safety
malaria such as mefloquine and chloroquine
information. You can help by
• Cimetidine used for stomach ulcers
reporting any side effects
• Carbapenem agents (antibiotics used to treat bacterial
you may get. See the end of
infections) such as imipenem, meropenem, rifampicin and
section 4 for how to report
erythromycin. The combination of Sodium Valproate Injection
side effects.
and carbapenems should be avoided because it may decrease
the effect of your medicine.
• Colestyramine used to lower blood fat (cholesterol) levels.
Sodium Valproate Injection with food, drink and alcohol
WARNING
Alcohol intake is not recommended during treatment.
Valproate can cause birth defects and problems with early
development of the child if it is given during pregnancy. If you are Pregnancy, breast feeding and fertility
Important advice for women
a female of childbearing age you should use an effective method
• Valproate can be harmful to unborn children when given to a
of contraception throughout your treatment.
woman during pregnancy.
Your doctor will discuss this with you but you should also follow
• Valproate carries a risk if given during pregnancy. The higher the
the advice in section 2 of this leaflet. Tell your doctor at once if
dose, the higher the risks but all doses carry a risk.
you become pregnant or think you might be pregnant.
• It can cause serious birth defects and can affect the way in which
Read all of this leaflet carefully before you are given this
the child develops as it grows. Birth defects which have been
medicine because it contains important information for you.
reported include spina bifida (where the bones of the spine are not
- Keep this leaflet. You may need to read it again.
properly developed); facial and skull malformations; heart, kidney,
- If you have any further questions, ask your doctor or pharmacist.
urinary tract and sexual organ malformations; limb defects.
- This medicine has been prescribed for you personally and you
• If you are given valproate during pregnancy you have a higher risk
should not pass it on to others. It may harm them, even if their
than other women of having a child with birth defects that require
symptoms are the same as yours.
medical treatment. Because valproate has been used for many
- If you get any side effects, talk to your doctor or pharmacist.
years we know that in women who are given valproate around
This includes any possible side effects not listed in this leaflet.
10 babies in every 100 will have birth defects. This compares to
See section 4.
2-3 babies in every 100 born to women who don’t have epilepsy.
What is in this leaflet
• It is estimated that up to 30-40% of preschool children whose
1. What Sodium Valproate Injection is and what it is used for
mothers received valproate during pregnancy may have
2. What you need to know before you are given Sodium Valproate Injection
problems with early childhood development. Children affected
3. How Sodium Valproate Injection is given
can be slow to walk and talk, intellectually less able than other
4. Possible side effects
children, and have difficulty with language and memory.
5. How to store Sodium Valproate Injection
• Autistic spectrum disorders are more often diagnosed in
6. Contents of the pack and other information
children exposed to valproate and there is some evidence
children may be more likely to develop symptoms of Attention
1. WHAT SODIUM VALPROATE INJECTION IS AND WHAT
Deficit Hyperactivity Disorder (ADHD).
IT IS USED FOR
• If you are a woman capable of becoming pregnant your doctor
What Sodium Valproate Injection is
should only prescribe valproate for you if nothing else works for you.
The name of your medicine is Sodium Valproate 100mg/ml Solution • Before prescribing this medicine to you, your doctor will have
for Injection or Infusion (called Sodium Valproate Injection in this
explained what might happen to your baby if you become
leaflet).
pregnant whilst having valproate. If you decide later you want
What Sodium Valproate Injection contains
to have a child you should not stop having your medicine until
Sodium Valproate Injection contains a medicine called sodium
you have discussed this with your doctor and agreed a plan for
valproate. This belongs to a group of medicines called
switching you onto another product if this is possible.
anti-convulsants or anti-epileptic agents. It works by helping
• Ask your doctor about taking folic acid when trying for a baby.
to calm the brain down.
Folic acid can lower the general risk of spina bifida and early
miscarriage that exists with all pregnancies. However, it is
What Sodium Valproate Injection is used for
unlikely that it will reduce the risk of birth defects associated
Sodium Valproate Injection is used to treat epilepsy (fits) in adults
with valproate use.
and children. The injection is given when it is not possible to have
FIRST PRESCRIPTION
your medicine by mouth.
If this is the first time you have been prescribed valproate your
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
doctor will have explained the risks to an unborn child if you
SODIUM VALPROATE INJECTION
become pregnant. Once you are of childbearing age, you will
Do not have Sodium Valproate Injection and tell your doctor
need to make sure you use an effective method of contraception
or nurse if:
throughout your treatment. Talk to your doctor or family planning
• you are allergic (hypersensitive) to sodium valproate or any of
clinic if you need advice on contraception.
the other ingredients of Sodium Valproate Injection (listed in see
Key messages:
section 6)
• Make sure you are using an effective method of contraception.
Signs of an allergic reaction include: a rash, swallowing or
• Tell your doctor at once if you are pregnant or think you might
breathing problems, swelling of your lips, face, throat or tongue
be pregnant.
• you have liver problems or you or your family have a history of
CONTINUING TREATMENT AND NOT TRYING FOR A BABY
liver problems
If you are continuing treatment with valproate but you don’t plan
• you have a rare illness called porphyria.
to have a baby make sure you are using an effective method of
• you have a genetic problem caused by a mitochondrial disorder contraception. Talk to your doctor or family planning clinic if you
(e.g. Alpers-Huttenlocher syndrome)
need advice on contraception.
Do not have this medicine if any of the above apply to you. If you
Key messages:
are not sure, talk to your doctor or nurse before having Sodium
• Make sure you are using an effective method of contraception
Valproate Injection.
• Tell your doctor at once if you are pregnant or think you might
Warnings and precautions
be pregnant.
A small number of people being treated with anti-epileptics such
CONTINUING TREATMENT AND CONSIDERING TRYING FOR A BABY
as sodium valproate have had thoughts of harming or killing
If you are continuing treatment with valproate and you are now
themselves. If at any time you have these thoughts, immediately
thinking of trying for a baby you must not stop having your valproate
contact your doctor.
or taking your contraceptive medicine until you have discussed this
Check with your doctor or nurse before you are given this medicine if: with your prescriber. You should talk to your doctor well before you
• you have diabetes. This medicine may affect the results of urine
become pregnant so that you can put several actions in place so
tests
that your pregnancy goes as smoothly as possible and any risks to
• you have kidney problems. Your doctor may give you a lower dose you and your unborn child are reduced as much as possible.
• you have fits (epilepsy), brain disease or a metabolic condition
Your doctor may decide to change the dose of valproate or switch
affecting your brain
you to another medicine before you start trying for a baby.
• you have a ‘urea cycle disorder’ where too much ammonia
If you do become pregnant you will be monitored very closely both
builds up in the body
the management of your underlying condition and to check how
• you have an illness called ‘systemic lupus erythematosus (SLE)’ for
your
unborn child is developing.
– a disease of the immune system which affects skin, bones,
Ask
your
doctor about taking folic acid when trying for a baby. Folic
joints and internal organs
acid can lower the general risk of spina bifida and early miscarriage
• you know that there is a genetic problem caused by a
that exists with all pregnancies. However, it is unlikely that it will
mitochondrial disorder in your family.
reduce the risk of birth defects associated with valproate use.
If you are not sure if any of the above apply to you, talk to your
Key messages:
doctor or pharmacist before having Sodium Valproate Injection
• Do not stop using your contraception before you have talked
Weight gain
to your doctor and worked together on a plan to ensure your
Having Sodium Valproate Injection may make you put on weight.
epilepsy is controlled and the risks to your baby are reduced.
Talk to your doctor about how this will affect you.
• Tell your doctor at once when you know or think you might be
Blood tests
pregnant.
Your doctor may wish to do blood tests before you start having
UNPLANNED
PREGNANCY WHILST CONTINUING TREATMENT
Sodium Valproate Injection and during your treatment.
Babies born to mothers who have been on valproate are at serious
Other medicines and Sodium Valproate Injection
risk of birth defects and problems with development which can be
Tell your doctor or nurse if you are taking or have recently taken
seriously debilitating. If you are having valproate and you think you
any other medicines. This includes medicines you buy without a
are pregnant or might be pregnant contact your doctor at once.
prescription, including herbal medicines. This is because Sodium
Do not stop having your medicine until your doctor tells you to.
Valproate Injection can affect the way some other medicines work.
Also some medicines can affect the way Sodium Valproate Injection Ask your doctor about taking folic acid. Folic acid can lower the
general risk of spina bifida and early miscarriage that exists with
work.
all pregnancies.
The following medicines can increase the chance of you getting
However, it is unlikely that it will reduce the risk of birth defects
side effects, when taken with Sodium Valproate Injection:
associated with valproate use.
• Some medicines used for pain and inflammation (salicylates)
Key messages:
such as aspirin
• Some other medicines used to treat fits (epilepsy) – see Section 3: • Tell your doctor at once if you know you are pregnant or think
you might be pregnant.
“Patients taking other medicines for ‘fits.’” This includes medicines
• Do not stop having valproate unless your doctor tells you to.
such as phenobarbital, primidone, phenytoin, carbamazepine,
Make sure you read the patient booklet and sign the
topiramate, lamotrigine and felbamate
Acknowledgement of Risk form which should be given to you and
Sodium Valproate Injection may increase the effect of the
discussed with you by your doctor or pharmacist.
following medicines:
Breast-feeding
• Medicines used for thinning the blood (such as warfarin)
Very little Sodium Valproate Injection gets into breast milk. However,
• Zidovudine used to treat HIV infection
talk to your doctor about whether you should breast-feed your baby.
• Temozolomide used to treat cancer
Ask your doctor or nurse for advice before taking any medicine.
• Medicines for depression

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PACKAGE LEAFLET INFORMATION FOR THE PATIENT
Sodium Valproate 100mg/ml Solution for Injection or Infusion

Clearly mark any amendments on one proof and return to MPS

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

artwork.leicester@multipkg.com
Profile

6pt (Main Body) / 7.5pt (Variables)

475 x 150mm

n-a

Measure bar should be 150mm at 100% scale

Size

UK

Wockhardt UK Limited

Min. Point Size

English

Customer

Market

Sodium valproate leaflet

Language

chris.jenney

Description

Proof By

1

105857/5

Proof No.

13/06/2016

Item Code

Date

47
Process Black

Colours Used

Keyline (non-printing)

Text free area (non-printing)
Pharmacode: 47

MPS Read Direction

Wockhardt Travel Direction

105857/5

Pharma
Code

after opening. If not used immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would normally be not longer than 24 hours at 2 to 8°C, unless dilution
has taken place in controlled and validated aseptic conditions.
Special Precautions for Storage
Do not freeze.
Nature and contents of container
Clear glass 5ml-capacity ampoules (PhEur Type I, One Point Cut with black spot), containing 4ml
of solution and clear glass 10ml-capacity ampoules (PhEur Type I, One Point Cut with red spot)
containing 10ml of solution.
The ampoules are packed in a PVC tray and cardboard box in packs of 1, 5 or 10 ampoules per pack.
Not all pack sizes may be marketed.
Special precautions for disposal and other handling
For infusion the product may be diluted in 0.9% saline or 5% dextrose. Tests with the recommended
infusion solutions over seven days at 20 - 22ºC show compatibility.
Prior to use sodium valproate solution for injection and the diluted solution should be visually
inspected. Only clear solutions without particles should be used.
The contents of the ampoule are for single use only. Any unused product or waste material should be
disposed of in accordance with local requirements.
Marketing Authorisation Holder
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK
Marketing Authorisation Number: PL 29831/0506; MA 154/10201
Date of Revision of Text: 06/2016

105857/5

664543

Combined Therapy: When starting sodium valproate injection in patients already on other
anticonvulsants these should be tapered slowly. Initiation of sodium valproate injection therapy
should then be gradual, with target dose reached after about two weeks. In certain cases it may be
necessary to raise the dose by 5 to 10mg/kg/day when used in combination with anticonvulsants
which induce liver enzyme activity, e.g. phenytoin, phenobarbital and carbamazepine. Once known
enzyme inducers have been withdrawn it may be possible to maintain seizure control on a reduced
dose of sodium valproate injection.
When barbiturates are being administered concomitantly and particularly if sedation is observed
(particularly in children) the dosage of barbiturates should be reduced.
N.B. In children requiring doses higher than 40 mg/kg/day clinical chemistry and haematological
parameters should be monitored.
Optimum dosage is mainly determined by seizure control and routine measurement of plasma levels
is unnecessary. However, a method for measurement of plasma levels is available and may be
helpful where there is poor control or side effects are suspected (see section 5.2 Pharmacokinetic
Properties of the SmPC).
Pharmaceutical Particulars
List of Excipients
Disodium hydrogen phosphate dodecahydrate
Sodium dihydrogen phosphate dihydrate
Phosphoric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections
Incompatibilities
Sodium valproate Intravenous should not be administered via the same line as other IV additives. This
medicinal product must not be mixed with other medicinal products except those mentioned in the
section entitled ‘Special precautions for disposal and other handling’.
Shelf Life
Unopened: 3 years.
After dilution according to the directions detailed in the section entitled ‘Special precautions for
disposal and other handling’: Chemical and physical in-use stability has been demonstrated for seven
days at 20 - 22°C. From a microbiological point of view, the product should be used immediately

Product Name
Reference number
Sodium Valproate
29831/0506
100mg/ml Solution for Injection or Infusion
This is a service provided by the Royal National Institute of Blind
People.
For Malta, please call +44 1978 661261.
This medicinal product is authorised in the Member States of
the EEA under the following names:
United Kingdom and Malta: Sodium Valproate 100mg/ml Solution
for Injection or Infusion
This leaflet was last revised in 06/2016

Artwork No.

Tell your doctor as soon as possible if you have any of the
following side effects:
• Changes in behaviour including being very alert, and sometimes
also aggressive, hyperactive and unusual or
inappropriate behaviour.
This is more likely if other
medicine to treat fits
such as phenobarbital
and topiramate are taken
at the same time or if
the Sodium Valproate
Injection starting dose is
high or has been suddenly
increased.
• Changes in the amount
of ammonia in the blood. Symptoms of this condition are being
sick, problems with balance and co-ordination, feeling lethargic
or less alert.
• Feeling shaky (tremor), sleepy or unsteady when walking or
jerky muscle movements
• Feeling tired or confused with loss of consciousness sometimes
accompanied by hallucinations or fits.
• Blisters with the skin flaking away.
• Rapid, uncontrollable movement of the eyes
Tell your doctor or pharmacist if any of the following side
effects gets serious or lasts longer than a few days, or if you
notice any side effects not listed in this leaflet:
• Feeling sick, stomach ache or diarrhoea, especially when
starting treatment.
• Fainting
• Hearing loss
• Skin problems such as rashes. These happen rarely, but more
often in people also taking lamotrigine
• Acne
• Hair loss which is usually temporary. When it grows back it may
be more curly than before
• Hair, including body or facial hair grows more than normal in
women
• Skin rash caused by narrow or blocked blood vessels (vasculitis)
• Changes in women’s periods and increased hair growth in women
• Breast enlargement in men
• Swelling of the feet and legs (oedema)
• Weight gain, leading to obesity in rare cases - as your appetite
may be increased
• Kidney problems, bedwetting or increased need to pass urine
• Headache
• Aggression, agitation, disturbance in attention, abnormal
behaviour, restlessness/hyperactivity and learning disorder
• Tingling or numbness of the hands or feet
• Nail and nail bed disorders are common
Bone Disorders
There have been reports of bone disorders including osteopenia
and osteoporosis (thinning of the bone) and fractures. Check with
your doctor or pharmacist if you are on long-term antiepileptic
medication, have a history of osteoporosis, or take steroids.
Blood tests
Sodium Valproate Injection can change levels of liver enzymes,
salts or sugars shown up on blood and urine tests.
Male fertility
Sodium Valproate Injection can be a contributing factor in male
infertility.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting
systems listed below:
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta:
ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE SODIUM VALPROATE INJECTION
This medicine will be kept by your doctor or pharmacist in a safe
place where children cannot see or reach it.
Do not have this medicine if the expiry date on the carton has
passed. The expiry date refers to the last day of that month.
Do not freeze. Only clear solutions free of particles should be used.
The contents of the ampoule are for single use only.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Sodium Valproate Injection contains
The active ingredient is sodium valproate 100mg per ml.
The other ingredients are Disodium hydrogen phosphate
dodecahydrate, sodium dihydrogen phosphate dihydrate,
phosphoric acid, sodium hydroxide and water for injections.
What Sodium Valproate Injection looks like and contents of
the pack
Sodium Valproate Injection is a clear colourless solution. It is available
in glass ampoules containing either 4ml (400mg sodium valproate)
or 10ml (1000mg sodium valproate) of the solution for injection.
Each pack contains 1, 5 or 10 ampoules. Not all pack sizes may be
marketed.
Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North,
Wrexham Industrial Estate, Wrexham, LL13 9UF, UK
Other sources of information:
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Driving and using machines
You may feel sleepy after having Sodium Valproate Injection. If this
happens to you, do not drive or use any tools or machines. Taking
other medicines used to treat fits or calm emotional and mental
health problems may increase sleepiness.
3. HOW SODIUM VALPROATE INJECTION IS GIVEN
Sodium Valproate Injection is always given to you by a doctor or nurse.
This is because it needs to be given as a slow injection or infusion into
the vein. If you are not sure why you are being given Sodium Valproate
Injection or have any questions about how much Sodium Valproate
Injection is being given to you, speak to your doctor or nurse.
Your doctor will stop giving you Sodium Valproate Injection and
change you to oral therapy (by mouth) as soon as possible.
Sodium Valproate Injection treatment must be started and
supervised by a doctor specialised in the treatment of epilepsy
How much will be given to you
• Your doctor will decide how much Sodium Valproate Injection
to give you depending on your illness. The amount of Sodium
Valproate Injection given to you or your child will depend on you
or your child’s age or body weight
• If you have been taking Sodium Valproate by mouth your doctor
may decide to give you the same amount of Sodium Valproate
Injection by continuous or repeated infusion.
If you have not had Sodium Valproate Injection before, the doctor
will use the following doses:
Adults (including the elderly)
• The starting dose is usually between 400mg and 800mg daily
(up to 10mg per kilogram of body weight)
• This is given as a slow intravenous injection over 3-5 minutes
• This is followed by a continuous or repeated infusion, up to a
maximum dose of 2500mg each day.
Children
• The usual dose is between 20mg and 30mg for each kilogram
of body weight each day
• This may be increased to 40mg for each kilogram of body
weight each day depending on your child’s illness.
Patients with kidney problems
• Your doctor may decide to adjust your or your child’s dose
Patients taking other medicines for ‘fits’ (epilepsy)
• You or your child may be taking other medicines for epilepsy at
the same time as Sodium Valproate Injection. If so, your doctor
should gradually initiate treatment depending on you or your
child’s condition
• Your doctor may increase the dose of Sodium Valproate
Injection by 5 to 10mg for each kilogram of body weight each
day depending on which other medicines you are taking.
If have more Sodium Valproate Injection than you should
It is unlikely that your doctor or nurse will give you too much
medicine. Your doctor will be checking your progress and checking
the medicine that you are given. Always ask if you are not sure why
you are getting a dose of medicine.
Having too much Sodium Valproate Injection can lead to the following
symptoms: feeling sick or being sick, pupils of the eye become
smaller, dizziness, loss of consciousness, weak muscles and poor
reflexes, breathing problems, headaches, fits (seizures), confusion,
memory loss and unusual or inappropriate behaviour.
If you forget to have Sodium Valproate Injection
Your doctor or nurse will have instructions on when to give you this
medicine. It is unlikely that you will not be given the medicine as it
has been prescribed. However, if you think you may have missed a
dose, then talk to your doctor or nurse.
If you stop receiving Sodium Valproate Injection
It is important for you to keep having Sodium Valproate Injection until
your doctor decides to stop them. If you stop, your fits may come back.
Tests
Make sure you or your child keep your regular appointments for a
check-up. They are very important as your or your child’s dose may
need to be changed. Sodium Valproate Injection can change the
levels of liver enzymes shown up in blood tests. This can mean that
your or your child’s liver is not working properly. If you or your child
go into hospital or visit another doctor or a dentist, tell them you
are having Sodium Valproate Injection.
If you have any further questions about receiving this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Sodium Valproate Injection can cause side
effects, although not everybody gets them.
Tell your doctor straight away if you notice any of the following
serious side effects – you may need urgent medical treatment:
• You have an allergic reaction. The signs may include: a rash,
joint pain, fever (systemic lupus erythematosus), swallowing or
breathing problems, swelling of your lips, face, throat or tongue.
Hands, feet or genitals may also be affected. More severe
allergic reactions can lead to lymph node enlargement and
possible impairment of other organs.
• Liver problems and problems of the pancreas may show as
a sudden illness which may happen in the first six months of
treatment. This happens in a very small number of people having
Sodium Valproate Injection. It includes feeling and being sick
many times, being very tired, sleepy and weak, stomach pain
including very bad upper stomach pain, jaundice (yellowing
of the skin or whites of the eyes), loss of appetite, swelling
(especially of the legs and feet but may include other parts of the
body), worsening of your fits or a general feeling of being unwell.
Your doctor may stop giving you Sodium Valproate Injection
immediately if you have these symptoms.
• You have a skin rash or skin lesions with a pink/red ring and
a pale centre which may be itchy, scaly or filled with fluid.
The rash may appear especially on the palms or soles of
your feet. These could be signs of a serious allergy to the
medicine called ‘erythema multiforme.’
• Blistering or bleeding of the skin around the lips, eyes, mouth,
nose and genitals. Also flu-like symptoms and fever. This may
be something called ‘Stevens-Johnson syndrome.’
• Severe blistering rash where layers of the skin may peel off
to leave large areas of raw exposed skin over the body. Also a
feeling of being generally unwell, fever, chills and aching muscles.
This may be something called ‘Toxic epidermal necrolysis.’
• Bruising more easily and getting more infections than usual. This
could be a blood problem called ‘thrombocytopenia’. It can also
be due to a fall in the number of white blood cells, bone marrow
depression or another condition that affects red blood cells, white
blood cells and platelets (pancytopenia) or how the blood clots.
• Blood clotting problems (bleeding for longer than normal),
bruising or bleeding for no reason.
• Changes in mood, loss of memory, lack of concentration and
deep loss of consciousness (coma).
• Underactive thyroid gland, which may cause tiredness or weight
gain (hypothyroidism)
• Breathing difficulty and pain due to inflammation of the lungs
(pleural effusion)

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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