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SODIUM VALPROATE WOCKHARDT 200MG GASTRO-RESISTANT TABLETS

Active substance(s): SODIUM VALPROATE / SODIUM VALPROATE / SODIUM VALPROATE

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PACKAGE LEAFLET INFORMATION FOR THE USER

Sodium Valproate 200mg and 500mg
Gastro-Resistant Tablets

sodium valproate
This medicine is subject to additional monitoring.
This will allow quick identification of new safety information.
You can help by reporting any side effects you may get.
See the end of section 4 for how to report side effects.
WARNING
Valproate can cause birth defects and problems with
early development of the child if it is taken during
pregnancy. If you are a female of childbearing age
you should use an effective method of contraception
throughout your treatment.
Your doctor will discuss this with you but you should
also follow the advice in section 2 of this leaflet.
Tell your doctor at once if you become pregnant or
think you might be pregnant.
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
or pharmacist.
- This medicine has been prescribed for you personally
and you should not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Sodium Valproate Tablets are and what they
are used for
2. What you need to know before you take Sodium
Valproate Tablets
3. How to take Sodium Valproate Tablets
4. Possible side effects
5. How to store Sodium Valproate Tablets
6. Contents of the pack and other information

1. WHAT SODIUM VALPROATE TABLETS ARE
AND WHAT THEY ARE USED FOR
What Sodium Valproate Tablets are
The name of your medicine is Sodium Valproate 200mg
and 500mg Gastro-Resistant Tablets.
Gastro-Resistant Tablets are “enteric coated” this means that
the tablets have a protective coating that allows it to reach
the intestines (gut) without being dissolved in the stomach
first. This helps stop it from causing a stomach upset.
In the rest of this leaflet it is called Sodium Valproate
Tablets.
What Sodium Valproate Tablets contain
Sodium Valproate Tablets contains sodium valproate.
This belongs to a group of medicines called
anticonvulsants or anti-epileptic agents. It works by
helping to calm the brain down.
What Sodium Valproate Tablets are used for
Sodium Valproate Tablets are used to treat epilepsy (fits)
in adults and children.

2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE SODIUM VALPROATE TABLETS
Do not take Sodium Valproate Tablets and tell your
doctor if:
• you are allergic (hypersensitive) to sodium valproate
or any of the other ingredients of Sodium Valproate
Tablets (see Section 6: Contents of the pack and other
information)
Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face, throat
or tongue
• you have liver problems or you or your family have
a history of liver problems
• you have a rare illness called porphyria.
• you have a known metabolic disorder, i.e a urea cycle
disorder
• you have a genetic problem caused by a mitochondrial
disorder (e.g. Alpers-Huttenlocher syndrome)
Do not take this medicine if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before
taking Sodium Valproate Tablets.
Warnings and precautions
A small number of people being treated with anti-epileptics
such as sodium valproate have had thoughts of harming or
killing themselves. If at any time you have these thoughts,
immediately contact your doctor. As with other antiepileptic
drugs, convulsions may become worse or happen more
frequently whilst taking this medicine. If this happens
contact your doctor immediately.
Talk to your doctor or pharmacist before taking this
medicine if:
• you have diabetes. This medicine may affect the results of
urine tests
• you have kidney problems. Your doctor may give you
a lower dose
• you have fits (epilepsy), brain disease or a metabolic
condition affecting your brain
• you have a ‘urea cycle disorder’ where too much
ammonia builds up in the body

• you have an illness called ‘systemic lupus
erythematosus (SLE)’ – a disease of the immune system
which affects skin, bones, joints and internal organs
• you know that there is a genetic problem caused by
a mitochondrial disorder in your family.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Sodium Valproate Tablets.
Tell your doctor immediately if you
• Develop stomach pain and feel sick or start vomiting
since this may indicate inflammation of the pancreas.
• Have unexplained bruises or unusual bleeding
e.g. nose bleeding or bleeding from your gums. Do not
take aspirin if this occurs.
Weight gain
Taking Sodium Valproate Tablets may make you put on
weight. Talk to your doctor about how this will affect you.
Your Doctor will monitor your weight during treatment.
Blood tests
Your doctor may wish to do blood tests before you start
taking Sodium Valproate Tablets and during your treatment.
Other medicines and Sodium Valproate Tablets
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines. This includes
medicines you buy without a prescription, including herbal
medicines. This is because Sodium Valproate Tablets can
affect the way some other medicines work. Also some
medicines can affect the way Sodium Valproate Tablets work.
The following medicines can increase the chance
of you getting side effects, when taken with Sodium
Valproate Tablets:
• Some medicines used for pain and inflammation
(salicylates) such as aspirin
• Some other medicines used to treat fits (epilepsy) –
see Section 3: “Patients taking other medicines for ‘fits.’”
This includes medicines such as phenobarbital,
primidone, phenytoin, carbamazepine, topiramate,
lamotrigine, clonazepam and felbamate
Sodium Valproate Tablets may increase the effect
of the following medicines:
• Medicines used for thinning the blood (such as warfarin)
• Zidovudine used to treat HIV infection
• Temozolomide used to treat cancer
• Medicines for depression, such as amitriptyline or
nortriptyline
• Monoamine oxidase inhibitors (MAOI) such as
moclobemide, selegiline, linezolid
• Medicines used to calm emotional and mental
conditions such as diazepam, olanzapine, clozapine,
lorazepam and bupropion
• Ethosuximide and oxcarbazepine, used to treat epilepsy
• Sodium benzoate, used as a preservative
• Sodium phenylbutyrate, used to treat urea cycle
disorders.
The following medicines can affect the way Sodium
Valproate Tablets work:
• Some other medicines used to treat fits (epilepsy)
• Some medicines used for the prevention and treatment
of malaria such as mefloquine and chloroquine
• Cimetidine used for stomach ulcers
• Carbapenem agents (antibiotics used to treat bacterial
infections) such as imipenem, meropenem, rifampicin
and erythromycin. The combination of Sodium Valproate
Tablets and carbapenems should be avoided because
it may decrease the effect of your medicine.
• Colestyramine used to lower blood fat (cholesterol) levels.
• Antacids containing magnesium or aluminium
hydroxides, used for indigestion.
Taking Sodium Valproate Tablets with food, drink
and alcohol
Alcohol intake is not recommended during treatment.
Pregnancy and breast feeding and fertility
IMPORTANT ADVICE FOR WOMEN
• Valproate can be harmful to unborn children when taken
by a woman during pregnancy.
• Valproate carries a risk if taken during pregnancy.
The higher the dose, the higher the risks but all doses
carry a risk.
• It can cause serious birth defects and can affect the way
in which the child develops as it grows. Birth defects
which have been reported include spina bifida (where
the bones of the spine are not properly developed);
facial and skull malformations; heart, kidney, urinary
tract and sexual organ malformations; limb defects.
• If you take valproate during pregnancy you have a
higher risk than other women of having a child with
birth defects that require medical treatment. Because
valproate has been used for many years we know that
in women who take valproate around 10 babies in every
100 will have birth defects. This compares to 2-3 babies
in every 100 born to women who don’t have epilepsy.
• It is estimated that up to 30-40% of preschool children
whose mothers took valproate during pregnancy may
have problems with early childhood development.
Children affected can be slow to walk and talk,
intellectually less able than other children, and have
difficulty with language and memory.
• Autistic spectrum disorders are more often diagnosed in
children exposed to valproate and there is some evidence
children may be more likely to develop symptoms of
Attention Deficit Hyperactivity Disorder (ADHD).

• If you are a woman capable of becoming pregnant your
doctor should only prescribe valproate for you if nothing
else works for you.
• Before prescribing this medicine to you, your doctor will
have explained what might happen to your baby if you
become pregnant whilst taking valproate. If you decide
later you want to have a child you should not stop taking
your medicine until you have discussed this with your
doctor and agreed a plan for switching you onto another
product if this is possible.
• Ask your doctor about taking folic acid when trying
for a baby. Folic acid can lower the general risk of
spina bifida and early miscarriage that exists with all
pregnancies. However, it is unlikely that it will reduce
the risk of birth defects associated with valproate use.
FIRST PRESCRIPTION
If this is the first time you have been prescribed valproate
your doctor will have explained the risks to an unborn child
if you become pregnant. Once you are of childbearing age,
you will need to make sure you use an effective method
of contraception throughout your treatment. Talk to your
doctor or family planning clinic if you need advice on
contraception.
Key messages:
• Make sure you are using an effective method of
contraception.
• Tell your doctor at once if you are pregnant or think you
might be pregnant.
CONTINUING TREATMENT AND NOT TRYING FOR
A BABY
If you are continuing treatment with valproate but you don’t
plan to have a baby make sure you are using an effective
method of contraception. Talk to your doctor or family
planning clinic if you need advice on contraception.
Key messages:
• Make sure you are using an effective method of
contraception
• Tell your doctor at once if you are pregnant or think you
might be pregnant.
CONTINUING TREATMENT AND CONSIDERING
TRYING FOR A BABY
If you are continuing treatment with valproate and you are
now thinking of trying for a baby you must not stop taking
either your valproate or your contraceptive medicine until
you have discussed this with your prescriber. You should
talk to your doctor well before you become pregnant so that
you can put several actions in place so that your pregnancy
goes as smoothly as possible and any risks to you and your
unborn child are reduced as much as possible.
Your doctor may decide to change the dose of valproate
or switch you to another medicine before you start trying
for a baby.
If you do become pregnant you will be monitored very
closely both for the management of your underlying
condition and to check how your unborn child is developing.
Ask your doctor about taking folic acid when trying for
a baby. Folic acid can lower the general risk of spina bifida
and early miscarriage that exists with all pregnancies.
However, it is unlikely that it will reduce the risk of birth
defects associated with valproate use.
Key messages:
• Do not stop using your contraception before you have
talked to your doctor and worked together on a plan to
ensure your epilepsy is controlled and the risks to your
baby are reduced.
• Tell your doctor at once when you know or think you
might be pregnant.
UNPLANNED PREGNANCY WHILST CONTINUING
TREATMENT
Babies born to mothers who have been on valproate
are at serious risk of birth defects and problems with
development which can be seriously debilitating.
Liver damage, low blood sugar levels (hypoglycaemia)
and withdrawal symptoms have also been reported in
newborns if the mother has taken sodium valproate during
pregnancy. Withdrawal symptoms include irritability,
jitteriness, abnormal increase in muscle tone, fits and
feeding problems. If you are taking valproate and you
think you are pregnant or might be pregnant contact your
doctor at once. Do not stop taking your medicine until your
doctor tells you to.
Ask your doctor about taking folic acid. Folic acid can
lower the general risk of spina bifida and early miscarriage
that exists with all pregnancies.
However, it is unlikely that it will reduce the risk of birth
defects associated with valproate use.
Key messages:
• Tell your doctor at once if you know you are pregnant
or think you might be pregnant.
• Do not stop taking valproate unless your doctor tells you to.
Make sure you read the patient booklet and sign
the Acknowledgement of Risk form which should be
given to you and discussed with you by your doctor
or pharmacist.
Breast-feeding
Very little Sodium Valproate Tablets gets into the breast
milk. However, talk to your doctor about whether you
should breast-feed your baby. Ask your doctor or
pharmacist for advice before taking any medicine.

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Market

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Date

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Artwork No.

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Driving and using machines
You may feel sleepy when taking Sodium Valproate
Tablets. 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.
Important information about some of the
ingredients in this medicine
Sodium
Sodium Valproate 200mg Tablets contain 1.20 mmol and
Sodium Valproate 500mg Tablets contain 3.01 mmol of
sodium per dose. This needs to be taken into consideration
by patients on a controlled sodium diet.

3. HOW TO TAKE SODIUM VALPROATE
TABLETS

Always take Sodium Valproate Tablets exactly as your
doctor has told you. You should check with your doctor or
pharmacist if you are not sure. Sodium Valproate Tablets
treatment must be started and supervised by a doctor
specialised in the treatment of epilepsy.
Taking this medicine
• Your doctor will decide how much Sodium Valproate
Tablets to give you or your child depending on your or
your child’s body weight
• Take this medicine by mouth
• Take Sodium Valproate Tablets with or after food.
This will help to stop the feelings of sickness that may
happen after taking Sodium Valproate Tablets
• Do not crush or chew the tablets
• If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself but ask your
doctor
How to take this medicine
• The dose is normally split and given half in the morning
and half in the evening.
How much to take
Adults (including the elderly)
• The starting dose is 600mg daily. Your doctor should
gradually increase this dose by 200mg every 3 days
depending on your condition.
• The usual dose is between 1000mg and 2000mg
(20-30mg per kilogram of body weight) each day
• This may be increased to 2,500mg each day depending
on your illness.
Children over 20 kilograms
• The starting dose should be 400mg daily. Your doctor
should increase this dose depending on your child’s illness
• The usual dose is then between 20mg and 30mg for
each kilogram of body weight each day
• This may be further increased to 35mg for each
kilogram of body weight each day depending on your
child’s illness
Children under 20 kilograms
• The usual dose is 20mg for each kilogram of body
weight each day
• Depending on the child’s condition your child’s doctor
may decide to increase this dose
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 Tablets.
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
Tablets by 5 to 10mg for each kilogram of body weight each
day depending on which other medicines you are taking
If you take more Sodium Valproate Tablets than you
should
If you take too many tablets contact your doctor,
pharmacist or nearest hospital casualty department
straight away. Take the medicine pack with you. This is so
the doctor knows what you have taken.
The following effects may happen: feeling sick or being sick,
pupils of the eye becoming smaller, dizziness, sleepiness,
loss of consciousness, weak muscles, poor reflexes,
breathing problems, headaches, fits (seizures), confusion,
memory loss and unusual or inappropriate behaviour.
If you forget to take Sodium Valproate Tablets
If you forget to take a dose, take it as soon as you
remember. However, if it nearly time for the next dose,
skip the missed dose. Do not take a double dose to make
up for a forgotten dose.
Stopping Sodium Valproate Tablets
Keep taking Sodium Valproate Tablets until your doctor
tells you to stop. If your doctor advises you to stop taking
Sodium Valproate Tablets, (perhaps in order to start
another medicine for your epilepsy) this will be done
gradually to maintain control of your fits. Do not stop
taking Sodium Valproate Tablets without talking to your
doctor first and never suddenly stop taking your Sodium
Valproate Tablets if you are pregnant since this may result
in fits which may harm you or your unborn child.
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
Tablets 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 taking
Sodium Valproate Tablets.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines Sodium Valproate Tablets 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 taking Sodium Valproate Tablets.
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. This can happen in adults or
children and can be life threatening.
• Severe liver damage and reduced liver function,
including liver failure resulting in death.
Your doctor may tell you to stop taking Sodium Valproate
Tablets 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).
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, hyper-active 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 Tablets 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.
• An increase in the number and severity of convulsions
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. This may be helped by taking
the tablets with food
• Swollen gums
• 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 or altered in
texture
• 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 in the hands and 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
You may need to have periodic blood tests to check the
function of your liver and pancreas. If liver or pancreas
damage occurs during treatment, your doctor may tell you to
stop taking Sodium Valproate Tablets.
Side effects specific to children
Reye’s-like syndrome may develop. Symptoms include
vomiting, fever, floppiness (hypotonia) and coma.
Children may develop symptoms of a blood disorder called
Von Willebrand’s disease, which can cause prolonged
bleeding, bleeding from gums or bruising.
Male fertility
Taking Sodium Valproate Tablets 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE SODIUM VALPROATE
TABLETS
Keep this medicine out of the sight and reach of
children.
Do not take this medicine if the expiry date on the carton
has passed. The expiry date refers to the last day of that
month. Sodium Valproate Tablets should not be taken if
they show signs of deterioration such as discoloration.
Store below 25°C.
Store in the original container or package in order to
protect from light and moisture.
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 Tablets contain
• Each tablet contains 200mg or 500mg of the active
substance sodium valproate.
• The other ingredients are microcrystalline cellulose
anhydrous, methylated colloidal anhydrous silica,
enzymatically hydrolysed gelatine, calcium behenate,
talc, triacetin, titanium dioxide (E171), macrogol and
methylacrylic acid copolymer.
What Sodium Valproate Tablets look like and
contents of the pack
Sodium Valproate 200mg Gastro-Resistant Tablets are
white to faintly yellowish, round, bevel edged gastroresistant tablets.
Sodium Valproate 500mg Gastro-Resistant Tablets are
white, oval gastro-resistant tablets.
Tablets are supplied in polypropylene or polyethylene
containers or glass bottles of 100 tablets and blister packs
of 10, 50, 60 or 100 tablets.
Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: Desitin Arzneimittel, Hamburg, Germany.
This leaflet was last revised in 06/2017
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:
Product Name
Reference number
Sodium Valproate 200mg Gastro- 29831/0189
Resistant Tablets
Sodium Valproate 500mg Gastro- 29831/0190
Resistant Tablets
This is a service provided by the Royal National Institute of
Blind People.

103995/10

Measure bar should be 150mm at 100% scale

artwork.leicester@cirrus-artwork.com

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

Customer

Wockhardt UK Limited

Colours Used

Description

Sodium Valproate tablet common leaflet

Process Black

Item Code

103995/10

Profile

See uploaded pdf

Size

297 x 210mm

Min. Point Size

8pt (Main Body) / 8pt (Variables)

Market

UK

Language

English

Proof By

MPI

Proof No.

3

Date

14/06/2017

Artwork No.

857372

Pharma
Code

Keyline (non-printing)

N/A

Expand Transcript

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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