Active substance: DICLOFENAC FREE ACID

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Material item code 1406729a
LFT Voltarol Dispersible Tab 50mg GB
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13 Jun 2013
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VOLTAROL® Dispersible
Tablets 50 mg
(diclofenac sodium)
Patient Information Leaflet
What you need to know about Voltarol
Dispersible Tablets
Your doctor has decided that you need this medicine to
help treat your condition.
Please read this leaflet carefully before you start to
take your medicine. It contains important information.
Keep the leaflet in a safe place because you may want
to read it again.
If you have any other questions, or if there is
something you don’t understand, please ask your
doctor or pharmacist.
This medicine has been prescribed for you. Never give
it to someone else. It may not be the right medicine
for them even if their symptoms seem to be the same
as yours.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.

In this leaflet:
1.  hat Voltarol Dispersible Tablets are, and what they
are used for
2.  hings to consider before you start to take Voltarol
Dispersible Tablets
3. How to take Voltarol Dispersible Tablets
4. Possible side effects
5. How to store Voltarol Dispersible Tablets
6. Further information

1.  hat Voltarol Dispersible Tablets are, and what
they are used for
Diclofenac sodium, the active ingredient in Voltarol
Dispersible Tablets, is one of a group of medicines
called non-steroidal anti–inflammatory drugs (NSAIDs).
NSAIDs reduce pain and inflammation.
Voltarol Dispersible Tablets act quickly and so are used
to treat short term painful conditions affecting the
joints and muscles. They are especially useful for the
treatment of sprains, strains and back pain. They
should not be taken for more than three months.

2.  hings to consider before you start to take
Voltarol Dispersible Tablets
Some people MUST NOT take Voltarol Dispersible
Tablets. Talk to your doctor if:
you think you may be allergic to diclofenac sodium,
aspirin, ibuprofen or any other NSAID, or to any of
the other ingredients of Voltarol Dispersible Tablets.
(These are listed at the end of the leaflet.) Signs of a
hypersensitivity reaction include swelling of the face
and mouth (angioedema), breathing problems, runny
nose, skin rash or any other allergic type reaction

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you have now, or have ever had, a stomach (gastric)
or duodenal (peptic) ulcer, or bleeding in the
digestive tract (this can include blood in vomit,
bleeding when emptying bowels, fresh blood in
faeces or black, tarry faeces)
you have had stomach or bowel problems after you
have taken other NSAIDs
• you have severe heart, kidney or liver failure
• you are more than six months pregnant.
You should also ask yourself these questions before
taking Voltarol Dispersible Tablets:
•  you suffer from any stomach or bowel disorders
including ulcerative colitis or Crohn’s disease?
•  you have kidney or liver problems, or are
you elderly?
• Do you have a condition called porphyria?
•  you suffer from any blood or bleeding disorder?
If you do, your doctor may ask you to go for regular
check-ups while you are taking these tablets.
• Have you ever had asthma?
• Are you breast-feeding?
•  you have heart problems, or have you had a
stroke, or do you think you might be at risk of these
conditions (for example, if you have high blood
pressure, diabetes, or high cholesterol or are you
a smoker)?
• Do you have Lupus (SLE) or any similar condition?
If the answer to any of these questions is YES, discuss
your treatment with your doctor or pharmacist because
Voltarol Dispersible Tablets might not be the right
medicine for you.

Are you taking other medicines?
Some medicines can interfere with your treatment.
Tell your doctor or pharmacist if you are taking any of
the following:
• Medicines to treat diabetes
• Anticoagulants (blood thinning tablets like warfarin)
• Diuretics (water tablets)
• Lithium (used to treat some mental problems)
Methotrexate (for some inflammatory diseases and
some cancers)
Ciclosporin or tacrolimus (used to treat some
inflammatory diseases and after transplants)
Trimethoprim (a medicine used to prevent or treat
urinary tract infections)
• Quinolone antibiotics (for infections)
Any other NSAID or COX-2 (cyclo-oxgenase-2)
inhibitor, for example aspirin or ibuprofen
Mifepristone (a medicine used to terminate pregnancy)
Cardiac glycosides (for example digoxin), used to treat
heart problems
• Medicines known as SSRIs used to treat depression
• Oral steroids (an anti-inflammatory drug)
Medicines used to treat heart conditions or high blood
pressure, for example beta- blockers or ACE inhibitors.
Voriconazole (a medicine used to treat fungal infections)
• Phenytoin (a medicine used to treat seizures)
• Colestipol/cholestyramine (used to lower cholesterol).
Always tell your doctor or pharmacist about all the
medicines you are taking. This means medicines you
have bought yourself as well as medicines on prescription
from your doctor.

Are you pregnant or planning to become pregnant?
Although not common, abnormalities have been
reported in babies whose mothers have taken NSAIDs
during pregnancy. You should not take Voltarol
Dispersible Tablets during the last 3 months of
pregnancy as it may affect the baby’s circulation.
Are you trying for a baby? Taking Voltarol Dispersible
Tablets may make it more difficult to conceive. You
should talk to your doctor if you are planning to
become pregnant, or if you have problems getting
Will there be any problems with driving or
using machinery?
Very occasionally people have reported that Voltarol
Dispersible Tablets have made them feel dizzy, tired or
sleepy. Problems with eyesight have also been reported.
If you are affected in this way, you should not drive or
operate machinery.
Other special warnings
You should take the lowest dose of Voltarol Dispersible
Tablets for the shortest possible time, particularly if
you are underweight or elderly.
There is a small increased risk of heart attack or
stroke when you are taking any medicine like Voltarol.
The risk is higher if you are taking high doses for a
long time. Always follow the doctor’s instructions on
how much to take and how long to take it for.
Whilst you are taking these medicines your doctor
may want to give you a check up from time to time.
•  you have a history of stomach problems when you
are taking NSAIDs, particularly if you are elderly, you
must tell your doctor straight away if you notice any
unusual symptoms.


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Because it is an anti-inflammatory medicine, Voltarol
Dispersible Tablets may reduce the symptoms of
infection, for example headache, and high
temperature. If you feel unwell and need to see a
doctor, remember to tell him or her that you are
taking Voltarol Dispersible Tablets.
Voltarol Dispersible Tablets are not suitable
for children.
The tablets contain erythrosine and may be unsuitable
for some people.

3. How to take Voltarol Dispersible Tablets
The doctor will tell you how many Voltarol Dispersible
Tablets to take and when to take them. Always follow
his/her instructions carefully. The dose will be on the
pharmacist’s label. Check the label carefully. If you
are not sure, ask your doctor or pharmacist. Keep
taking your tablets for as long as you have been told,
unless you have any problems. In that case, check with
your doctor.
Take the tablets before or with food.
Drop the tablets into a glass of water, and stir. Drink the
pink, blackcurrant-flavoured liquid at once. To make sure
you get all of the medicine, rinse the glass round with a
small amount of water and drink this as well.
The usual doses are:
One tablet two or three times a day.
Your doctor may advise you to take a dose that is lower
than the usual adult dose if you are elderly. Your doctor
may also want to check closely that the Voltarol
Dispersible Tablets are not affecting your stomach.
GB 1406729a

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Code direction (778)



These tablets are not suitable for children.
The doctor may also prescribe another drug to protect
the stomach to be taken at the same time, particularly
if you have had stomach problems before, or if you are
elderly, or taking certain other drugs as well.
What if you forget to take a dose?
If you forget to take a dose, take one as soon as you
remember. If it is nearly time for your next dose,
though, just take the next dose and forget about the
one you missed. Do not double up on the next dose to
make up for the one missed. Do not take more than
150 mg (three tablets) in 24 hours.
What if you take too many tablets?
If you, or anyone else, accidentally takes too much, tell
your doctor or your nearest hospital casualty
department. Take your medicine pack with you so that
people can see what you have taken.

4. Possible side effects
Voltarol Dispersible Tablets are suitable for most
people, but, like all medicines, they can sometimes
cause side effects.
Some side effects can be serious
Stop taking Voltarol Dispersible Tablets and tell your
doctor straight away if you notice:
Stomach pain, indigestion, heartburn, wind, nausea
(feeling sick) or vomiting (being sick)
Any sign of bleeding in the stomach or intestine, for
example, when emptying your bowels, blood in vomit
or black, tarry faeces
Allergic reactions which can include skin rash, itching,
bruising, painful red areas, peeling or blistering
Wheezing or shortness of breath (bronchospasm)

Swollen face, lips, hands or fingers
Yellowing of your skin or the whites of your eyes
Persistent sore throat or high temperature
•  unexpected change in the amount of urine
produced and/or its appearance.
If you notice that you are bruising more easily than
usual or have frequent sore throats or Infections, tell
your doctor.
The side effects listed below have also been reported.
Common side effects (These may affect between 1 and
10 in every 100 patients):
Stomach pain, heartburn, nausea, vomiting, diarrhoea,
indigestion, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood.
Rare side effects (These may affect between 1 in every
1000 to 1 in every 10,000 patients):
Stomach ulcers or bleeding (there have been very
rare reported cases resulting in death, particularly in
the elderly)
Gastritis (inflammation, irritation or swelling of the
stomach lining)
• Vomiting blood
Diarrhoea with blood in it or bleeding from the
back passage
Black, tarry faeces or stools
• Drowsiness, tiredness
Hypotension (low blood pressure, symptoms of which
may include faintness, giddiness or light headedness)
Skin rash and itching

Fluid retention, symptoms of which include
swollen ankles
Liver function disorders, including hepatitis
and jaundice.
Very rare side effects (These may affect less than 1 in
every 10,000 patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual
disturbances such as blurred or double vision, hearing
loss or impairment, tinnitus (ringing in the ears),
sleeplessness, nightmares, mood changes, depression,
anxiety, mental disorders, disorientation, and loss of
memory, fits, headaches together with a dislike
of bright lights, fever and a stiff neck, disturbances
in sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers,
inflammation of the inside of the mouth or lips, taste
changes, lower gut disorders (including inflammation
of the colon or worsening of ulcerative colitis or
Crohn’s disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain,
hypertension (high blood pressure), inflammation of
blood vessels (vasculitis), inflammation of the lung
(pneumonitis), heart disorders, including congestive
heart failure or heart attack, blood disorders (including
anaemia), stroke.
Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure,
presence of blood or protein in the urine.

Effects on skin or hair:
Serious skin rashes including Stevens-Johnson
syndrome and Lyell’s syndrome and other skin rashes
which may be made worse by exposure to sunlight.
Hair loss.
Other side effects that have also been reported include:
Inflammation of the pancreas, impotence.
Facial swelling, inflammation of the lining of the brain
(meningitis), stroke, throat disorders, confusion,
hallucinations, malaise (general feeling of discomfort),
inflammation of the nerves in the eye.
Do not be alarmed by this list – most people take
Voltarol Dispersible Tablets without any problems.
If any of the symptoms become troublesome, or if you
notice anything else not mentioned here, please go
and see your doctor. He/she may want to give you a
different medicine.

5. How to store Voltarol Dispersible Tablets
Store in a dry place, below 30°C. Keep the tablets in
their original pack.
Keep out of the reach and sight of children.
Do not take Voltarol Dispersible Tablets after the expiry
date which is printed on the outside of the pack.
If your doctor tells you to stop taking the tablets, please
take any unused tablets back to your pharmacist to be
destroyed. Do not throw them away with your normal
household water or waste. This will help to protect
the environment.

6. Further information
Voltarol Dispersible Tablets contain 50 mg of the active
ingredient, diclofenac sodium. The tablets also contain
the inactive ingredients avicel, croscarmellose sodium,
sodium starch glycollate, sodium saccharin,
hydrogenated castor oil, talc, aerosol, blackcurrant
flavouring and red colouring.
They come in aluminium blister packs containing
either 3 or 21 tablets. Not all of the pack sizes may
be marketed.
The Product licence holder is
Novartis Pharmaceuticals UK Limited trading as
Geigy Pharmaceuticals, Frimley Business Park,
Frimley, Camberley, Surrey GU16 7SR, England.
Voltarol Dispersible Tablets
are manufactured by
Novartis Pharmaceuticals UK Limited,
Frimley Business Park
Frimley Camberley
Surrey GU16 7SR
United Kingdom
This leaflet was revised in June 2013
If you would like any more information, or would like the
leaflet in a different format, please contact
Medical Information at Novartis Pharmaceuticals UK Ltd,
telephone number 01276 698370.
VOLTAROL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited



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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.