VOLTAROL PAIN-EZE TABLETS

Active substance: DICLOFENAC POTASSIUM

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AWF 19792 - OTDC 334169
VOLT PAIN EZE 12.5 MG GB_924493B_PIL
315 x 160 mm - Recto/Verso
352
P Reflex Blue U
Helvetica Neue LT Pro
8 pt (all) 8 pt (body text)
Famar L’Aigle - FR
FM-H8022552
Sonoco-Trident - 546133/7/AWK - 22/07/2014

WARNING: Wrong display / print > switch overprint ON

160 mm

RECTO
PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking Voltarol
Pain-eze Tablets.
It contains important information for you. Follow the
instructions below to get the best results.
• Keep this leaflet, you may need to read it again
• Ask a doctor or a pharmacist if you need more information or
advice
• Contact a doctor if your symptoms worsen or do not improve
within 3 days
• If any of the side effects get serious or if you notice any
side effect not listed in this leaflet, please tell your doctor or
pharmacist
In this leaflet
1. What Voltarol Pain-eze Tablets are and what they are used
for
2. Before you take Voltarol Pain-eze Tablets
3. How to take Voltarol Pain-eze Tablets
4. Possible side effects
5. How to store Voltarol Pain-eze Tablets
6. Further information

1. What Voltarol Pain-eze Tablets are and
what they are used for
Voltarol Pain-eze Tablets contain diclofenac which belongs to
a group of medicines called “non-steroidal anti-inflammatory
drugs” (NSAIDs). This medicine is a pain reliever which also
reduces inflammation (swelling) and fever.
Voltarol Pain-eze Tablets provide relief from:
• muscular pain, joint (rheumatic) pain, backache, headache,
dental pain, period pain.
• symptoms of colds and flu. This medicine also reduces fever.

Do not take Voltarol Pain-eze Tablets if you:
• have established heart disease and/or cerebrovascular
disease e.g. if you have had a heart attack, stroke, ministroke (TIA), or blockages to blood vessels to the heart or brain
or an operation to clear or bypass blockages
• have or have had problems with your blood circulation
(peripheral arterial disease)
• are allergic to diclofenac or to any of the other ingredients (listed
at the end of this leaflet, section 6)
• have ever had an allergic reaction to medicines used to treat
pain, inflammation or fever, such as diclofenac, ibuprofen or
aspirin (a substance also used to prevent blood clotting).
Reactions may include: asthma, wheezing, skin rash, face
swelling, runny nose. If you are not sure, ask your doctor or
pharmacist
• currently have or have ever had a stomach or intestinal ulcer,
bleeding or perforation which may show up as a severe
indigestion
• have noticed blood in your stools or black stools (symptoms
of gastrointestinal bleeding)
• suffer from severe kidney or liver disease
• suffer from severe heart failure
• are breast feeding
• are in the last 3 months of pregnancy
If any of these apply to you, consult your doctor and do not
take these tablets.

FM-H8022552

Make sure your doctor or pharmacist knows, before you
take diclofenac:
• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, raised
cholesterol or raised triglycerides

Pharmacode 352

Take special care and ask a doctor or pharmacist before
use if you:
• have ever had gastrointestinal problems such as stomach
ulcer, bleeding or black stools or vomiting blood or what
looks like coffee granules. If you have had stomach
discomfort or heartburn after taking pain relievers or antiinflammatory medicines in the past
• have or have had asthma, liver, kidney or bowel problems
• are intolerant to some sugars
• are on a controlled potassium diet
• have a bleeding disorder or other blood disorders, including a
rare liver condition called hepatic porphyria
• are at risk of being dehydrated (e.g. by sickness, diarrhoea,
or before or after major surgery)
Side effects may be minimised by using the lowest effective
dose for the shortest duration necessary.

Other precautions
• Medicines such as diclofenac may be associated with a small
increased risk of heart attack (myocardial infarction) or stroke.
Any risk is more likely with high doses and prolonged
treatment. Do not exceed the recommended dose or
duration of treatment.
• Diclofenac belongs to a group of medicines which may impair
fertility in women. This effect is reversible on stopping the
medicine. It is unlikely that Voltarol Pain-eze Tablets, used
occasionally, will affect your chances of becoming pregnant,
however, tell your doctor before taking this medicine if you have
problems becoming pregnant.
• Voltarol Pain-eze Tablets may reduce the symptoms of an
infection (e.g. headache, high temperature) and may therefore
make it more difficult to detect. If you feel unwell and need to
see a doctor, remember to tell them that you are taking Voltarol
Pain-eze Tablets.
• Prolonged use of any type of painkiller for headaches can
make them worse. If you think that this may be the case,
please contact your doctor for advice.
Elderly
As with other pain relievers, elderly people may be more
sensitive to the effects of Voltarol Pain-eze Tablets than other
adults. Follow the instructions carefully and take the lowest
number of tablets that provides relief of symptoms. It is
especially important for elderly patients to report undesirable
effects promptly to their doctor.
Children
Do not give Voltarol Pain-eze Tablets to children under 14 years
of age.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including any you have
bought without a prescription.
• Lithium or a class of antidepressant drugs called SSRIs such as
fluoxetine or paroxetine (to treat depression)
• Digoxin (a medicine used for heart problems)
• ACE inhibitors or beta-blockers (for high blood pressure and
heart failure)
• Methotrexate (to treat some kinds of cancer or arthritis)
• Medicines used to treat diabetes, except insulin
• Diuretics (to increase the amount of urine)
• Medicines used to prevent blood-clotting (“blood thinners” or
anticoagulants)
• Other anti-inflammatory medicines or pain killers such as
aspirin, ibuprofen or naproxen (includes cyclo-oxygenase-2
selective inhibitors (COX2) like celecoxib)
• Corticosteroids (for relief of inflamed areas of the body)
• Ciclosporin, tacrolimus (immunosuppressant for patients who
have received organ transplants)
• Some medicines used against infection (quinolone
antibacterials)
• Sulfinpyrazone (a medicine used to treat gout) or voriconazole
(a medicine used to treat fungal infections)
• Phenytoin (a medicine used to treat seizures)
• Colestipol and cholestyramine (medicines used to regulate
cholesterol)
Pregnancy
If you are pregnant or think that you may be pregnant, tell your
doctor and do not take Voltarol Pain-eze Tablets.
As with other anti-inflammatory medicines, the use of
diclofenac, the active substance in Voltarol Pain-eze Tablets,
may make it more difficult to become pregnant. This is
reversible on stopping the medicine. You should inform your
doctor if you are planning to become pregnant or if you have
problems becoming pregnant.
Breast-feeding
Do not take Voltarol Pain-eze Tablets if you are breast-feeding
as it might be harmful for your infant. Tell your doctor if you are
breast-feeding.
Driving and using machines
Usually this medicine has no influence on the ability to drive
or use machines. However, in rare cases, you may experience
vision disorders, dizziness or drowsiness. If you notice such
effects, do not drive or use machines. Tell your doctor as soon
as possible.
Important information about some of the ingredients
Voltarol Pain-eze Tablets contain lactose. If you have been told by
your doctor that you have an intolerance to some sugars, ask
your doctor before taking this medicine.

3. How to take Voltarol Pain-eze Tablets
For adults and children aged 14 years and over
It is important that you use the lowest dose that controls your
pain and that you do not take Voltarol Pain-eze Tablets for
longer than necessary.
Take an initial dose of 2 tablets when symptoms appear. If
needed, continue with 1 or 2 tablets every 4 to 6 hours. Do not
take more than 6 tablets per day. Do not take Voltarol Pain-eze
Tablets for more than 3 days.
Swallow the tablets whole with a drink of water.

315 mm

2. Before you take Voltarol Pain-eze Tablets

If any of these apply to you, tell your doctor
or pharmacist before you take these tablets.

Order - AWF
Reference
Format
Pharma code
Colour
Font
Minimum font size
Reference MKT
Production site
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Proof B

AWF 19792 - OTDC 334169
VOLT PAIN EZE 12.5 MG GB_924493B_PIL
315 x 160 mm - Recto/Verso
352
P Reflex Blue U
Helvetica Neue LT Pro
8 pt (all) 8 pt (body text)
Famar L’Aigle - FR
FM-H8022552
Sonoco-Trident - 546133/7/AWK - 22/07/2014

WARNING: Wrong display / print > switch overprint ON

160 mm

VERSO

If you forget to take Voltarol Pain-eze Tablets
If you miss a dose, take the next dose as soon as you
remember. If it is nearly time for your next dose, take the next
tablet at the usual time. Do not take a double dose to make up
for a forgotten tablet.
Do not take too much
If symptoms persist or worsen, tell your doctor to ensure that
they are not due to a serious illness. Do not take more than the
recommended dose.
If you take more Voltarol Pain-eze Tablets than you should
If you have taken too many tablets, tell your doctor or
pharmacist or go to the hospital emergency unit at once. You
may require medical attention. If possible, take the medicine
with you.

4. Possible side effects
Like all medicines, Voltarol Pain-eze Tablets can sometimes cause
side effects, although not everybody gets them.
If you experience any of the side-effects, STOP taking Voltarol
Pain-eze Tablets IMMEDIATELY and seek medical advice. These
include the following:
• swelling of the face or throat
• drowsiness
• rash
• blistering of the skin, mouth, eyes and genitals (StevensJohnson syndrome)
• blood disorders including reduction in blood platelets, which
increases the risk of bleeding or bruising (Thrombocytopenia)
• gastrointestinal bleeding, stomach and intestine ulcer (with or
without bleeding or perforation), bloody or black stools
• constipation
• taste disorders
• tingling or numbness of the hands or feet, trembling
• blurred vision, double vision, ringing in the ears, impaired
hearing
• palpitations
• change in mood, difficulty sleeping, feeling confused.
Medicines such as diclofenac may be associated with a
small increased risk of heart attack (also called “myocardial
infarction”) or stroke.

Medicines such as diclofenac may be associated with a small
increased risk of heart attack (also called “myocardial infarction”)
or stroke.
If you experience any of these, STOP taking Voltarol Pain-eze
Tablets and tell a doctor straightaway.
Other side effects
Other side effects which may occur are usually mild. Some of
the effects have been reported with higher doses of diclofenac,
the active substance in Voltarol Pain-eze, used for longer
duration. If you find these are troubling you, talk to a doctor
or pharmacist.
Some side effects are common
These side effects may affect between 1 and 10 in every 100
people.
• Headache, dizziness
• Nausea, vomiting, diarrhoea, indigestion, abdominal pain,
flatulence
• Loss of appetite
• Change in liver function (e.g. level of transaminases)
• Skin rash
• Vertigo

Some side effects are very rare
These side effects may affect less than 1 in every 10,000 people.
• Disorientation, memory impairment
• Depression, irritability, psychotic disorder, anxiety, trembling
• Difficulty sleeping, nightmare
• Tingling or numbness of the hands or feet
• Taste disorders
• Vision and hearing disorders
• Constipation, mouth sores, ulcer of the oesophagus (the tube
that carries food from the throat to the stomach), palpitations
• Hair loss
• Redness, swelling and blistering of the skin (due to increased
sensitivity to sun)
• Blood disorders including reduction in blood platelets, which
increases the risk of bleeding or bruising (Thrombocytopenia),
decrease in the number of white blood cells, which increases
the risk of infection (leukopenia), reduction in the number of
red blood cells which can make the skin appear yellow and
cause weakness or breathlessness (haemolytic anemia), the
bone marrow not able to produce enough new blood cells to
replace old blood cells (aplastic anaemia), severe reduction in
number of white blood cells which makes infections more
likely (agranulocytosis)
• Tinnitus (ringing in the ear)
• Aseptic meningitis
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
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: “http://www.mhra.gov.uk/yellowcard” 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 Voltarol Pain-eze Tablets
• Keep out of the reach and sight of children.
• Do not store above 25°C.
• Do not take the tablets after the expiry date which is stated on the
carton after EXP (abbreviation used for expiry date). The expiry
date refers to the last day of that month.
• 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. Further information
What Voltarol Pain-eze Tablets contain
• The active substance is diclofenac potassium. Each tablet
contains 12.5 mg of diclofenac potassium.
• The other ingredients are: silica, lactose, maize starch,
sodium starch glycolate, polyvidone, magnesium stearate,
microcrystalline cellulose, hypromellose, titanium dioxide
(E171) and stearic acid.
What Voltarol Pain-eze Tablets look like and contents of the
pack
Voltarol Pain-eze Tablets are small, white, film-coated tablets,
available in packs of 18 tablets.
Marketing Authorisation Holder
Novartis Consumer Health, Camberley, GU15 3YL, UK
Manufacturer
Famar l’Aigle, 61303 L’Aigle, France
This leaflet was last revised in: July 2014

GB 924493
FM-H8022552

315 mm

Some rare or very rare side effects could likely be serious.
These side effects may affect up to between 1 and 10 in every
10,000 people.
• Severe stomach pain, bloody or black stools. Vomiting blood.
These may be sign and symptoms of ulceration, bleeding and
perforation of the stomach or intestines.
• Allergic reaction with swelling of the face, lips, mouth, tongue
or throat often associated with rash and itching, which may
cause difficulty to swallow, hypotension (low blood pressure),
fainting.
• Wheezing and feelings of tightness in the chest (signs of
asthma).
• Chest pain (signs of heart attack).
• Sudden and severe headache, nausea, dizziness, numbness,
inability to speak or difficulty in speaking, paralysis (signs of
stroke).
• Stiff neck (sign of aseptic meningitis).
• Red or purple skin (possible signs of blood vessel
inflammation), skin rash with blisters, blistering of the lips, eyes
and mouth, skin inflammation with flaking or peeling.
• Any change in the appearance or amount of urine, for
example blood in urine, excess of protein in the urine, severe
decreased urine output (signs of kidney disorders).
• Swelling of arms, hands, legs and feet (oedema).
• Yellowing of the skin or eyes (signs of hepatitis/liver
inflammation).
• Unusual bleeding or bruising.
• Breathlessness, tiredness, swollen feet and ankles (signs of
heart failure).
• Convulsions.
• Hypertension (high blood pressure).

Some side effects are rare
These side effects may affect between 1 and 10 in every 10,000
people.
• Drowsiness
• Stomach pain
• Swelling of arms, hands, legs and feet (oedema)
• Hypotension and shock (symptoms of anaphylactic and
anaphylactoid reaction)
• Shortness of breath (symptom of asthma)
• Gastrointestinal bleeding, stomach and intestine ulcer (with or
without bleeding or perforation), bloody or black stools
• Yellowing of the skin (Liver disorder)
• Inflammation of the colon (colitis)
• Hives (urticaria)

Order - AWF
Reference
Format
Pharma code
Colour
Font
Minimum font size
Reference MKT
Production site
Reference SITE
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Proof Z

AWF 18323 - OTDC 310362
VOLT PAIN EZE 12.5 MG TAB GB_922795Z_PIL
148 x 210 mm - Recto/Verso - Page 1
169
P Reflex Blue U
Helvetica Neue LT Pro
6.5 pt
Novartis Pharma Wehr - DE
2140956
Sonoco-Trident - 540694/6/DIS - 13/01/2014

WARNING: Wrong display / print > switch overprint ON

Recto
Page 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

86 mm

Pharma Code Direction

Pharma code 169

Read all of this leaflet carefully before you start taking
Voltarol Pain-eze Tablets.
It contains important information for you. Follow the
instructions below to get the best results.

2. Before you take Voltarol Pain-eze
Tablets

1. What Voltarol Pain-eze Tablets are
and what they are used for

Do not take Voltarol Pain-eze Tablets if you:
• have established heart disease and/or cerebrovascular
disease e.g. if you have had a heart attack, stroke,
mini-stroke (TIA), or blockages to blood vessels to the
heart or brain or an operation to clear or bypass blockages
• have or have had problems with your blood circulation
(peripheral arterial disease)
• are allergic to diclofenac or to any of the other ingredients
(listed at the end of this leaflet, section 6)
• have ever had an allergic reaction to medicines used
to treat pain, inflammation or fever, such as diclofenac,
ibuprofen or aspirin (a substance also used to prevent
blood clotting). Reactions may include: asthma, wheezing,
skin rash, face swelling, runny nose. If you are not
sure, ask your doctor or pharmacist
• currently have or have ever had a stomach or intestinal
ulcer, bleeding or perforation which may show up as
a severe indigestion
• have noticed blood in your stools or black stools
(symptoms of gastrointestinal bleeding)
• suffer from severe kidney or liver disease
• suffer from severe heart failure
• are breast feeding
• are in the last 3 months of pregnancy
If any of these apply to you, consult your doctor and
do not take these tablets.

Voltarol Pain-eze Tablets contain diclofenac which
belongs to a group of medicines called “non-steroidal
anti-inflammatory drugs” (NSAIDs). This medicine is a
pain reliever which also reduces inflammation (swelling)
and fever.

Make sure your doctor or pharmacist knows, before
you take diclofenac:
• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure,
raised cholesterol or raised triglycerides

• Keep this leaflet, you may need to read it again
• Ask a doctor or a pharmacist if you need more
information or advice
• Contact a doctor if your symptoms worsen or do not
improve within 3 days
• If any of the side effects get serious or if you notice
any side effect not listed in this leaflet, please tell
your doctor or pharmacist
In this leaflet
1. What Voltarol Pain-eze Tablets are and what they are
used for
2. Before you take Voltarol Pain-eze Tablets
3. How to take Voltarol Pain-eze Tablets
4. Possible side effects
5. How to store Voltarol Pain-eze Tablets
6. Further information

Voltarol Pain-eze Tablets provide relief from:
• muscular pain, joint (rheumatic) pain, backache,
headache, dental pain, period pain.
• symptoms of colds and flu. This medicine also
reduces fever.

Take special care and ask a doctor or
pharmacist before use if you:
• have ever had gastrointestinal problems such as
stomach ulcer, bleeding or black stools or vomiting

Please turn the page

Order - AWF
Reference
Format
Pharma code
Colour
Font
Minimum font size
Reference MKT
Production site
Reference SITE
Pre-press

Proof Z

AWF 18323 - OTDC 310362
VOLT PAIN EZE 12.5 MG TAB GB_922795Z_PIL
148 x 210 mm - Recto/Verso - Page 2
169
P Reflex Blue U
Helvetica Neue LT Pro
6.5 pt
Novartis Pharma Wehr - DE
2140956
Sonoco-Trident - 540694/6/DIS - 13/01/2014

WARNING: Wrong display / print > switch overprint ON

Verso
Page 2







blood or what looks like coffee granules. If you have
had stomach discomfort or heartburn after taking pain
relievers or anti-inflammatory medicines in the post
have or have had asthma, liver, kidney or bowel
problems.
are intolerant to some sugars
are on a controlled potassium diet
have a bleeding disorder or other blood disorders,
including a rare liver condition called hepatic porphyria
are at risk of being dehydrated (e.g. by sickness,
diarrhoea, or before or after major surgery)

Side effects may be minimised by using the lowest
effective dose for the shortest duration necessary.
If any of these apply to you, tell your doctor
or pharmacist before you take these tablets.
Other precautions
• Medicines such as diclofenac may be associated with
a small increased risk of heart attack (myocardial
infarction) or stroke. Any risk is more likely with high
doses and prolonged treatment. Do not exceed
the recommended dose or duration of treatment.
• Diclofenac belongs to a group of medicines which may
impair fertility in women. This effect is reversible on
stopping the medicine. It is unlikely that Voltarol Pain-eze
Tablets, used occasionally, will affect your chances of
becoming pregnant, however, tell your doctor before taking
this medicine if you have problems becoming pregnant.
• Voltarol Pain-eze Tablets may reduce the symptoms
of an infection (e.g. headache, high temperature) and
may therefore make it more difficult to detect. If you
feel unwell and need to see a doctor, remember to tell
them that you are taking Voltarol Pain-eze Tablets.
• Prolonged use of any type of painkiller for headaches
can make them worse. If you think that this may be
the case, please contact your doctor for advice.
Elderly
As with other pain relievers, elderly people may be
more sensitive to the effects of Voltarol Pain-eze Tablets
than other adults. Follow the instructions carefully and
take the lowest number of tablets that provides relief of
symptoms. It is especially important for elderly patients
to report undesirable effects promptly to their doctor.
Children
Do not give Voltarol Pain-eze Tablets to children under
14 years of age.
Taking other medicines
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including any
you have bought without a prescription.
• Lithium or a class of antidepressant drugs called SSRIs
such as fluoxetine or paroxetine (to treat depression)
• Digoxin (a medicine used for heart problems)
• ACE inhibitors or beta-blockers (for high blood
pressure and heart failure)
• Methotrexate (to treat some kinds of cancer or arthritis)
• Medicines used to treat diabetes, except insulin

• Diuretics (to increase the amount of urine)
• Medicines used to prevent blood-clotting
(“blood thinners” or anticoagulants)
• Other anti-inflammatory medicines or pain killers such
as aspirin, ibuprofen or naproxen (includes cyclooxygenase-2 selective inhibitors (COX2) like celecoxib).
• Corticosteroids (for relief of inflamed areas of the body)
• Ciclosporin, tacrolimus (immunosuppressant for
patients who have received organ transplants)
• Some medicines used against infection (quinolone
antibacterials).
• Sulfinpyrazone (a medicine used to treat gout) or voriconazole (a medicine used to treat fungal infections)
• Phenytoin (a medicine used to treat seizures)
• Colestopol and cholestyramine (medicines used to
regulate cholesterol)
Pregnancy
If you are pregnant or think that you may be pregnant,
tell your doctor and do not take Voltarol Pain-eze Tablets.
As with other anti-inflammatory medicines, the use of
diclofenac, the active substance in Voltarol Pain-eze
Tablets, may make it more difficult to become pregnant.
This is reversible on stopping the medicine. You should
inform your doctor if you are planning to become
pregnant or if you have problems becoming pregnant.
Breast-feeding
Do not take Voltarol Pain-eze Tablets if you are breastfeeding as it might be harmful for your infant. Tell your
doctor if you are breast-feeding.
Driving and using machines
Usually this medicine has no influence on the ability to
drive or use machines. However, in rare cases, you may
experience vision disorders, dizziness or drowsiness. If
you notice such effects, do not drive or use machines.
Tell your doctor as soon as possible.
Important information about some of the ingredients
Voltarol Pain-eze Tablets contain lactose. If you have been
told by your doctor that you have an intolerance to some
sugars, ask your doctor before taking this medicine.

3. How to take Voltarol Pain-eze
Tablets
For adults and children aged 14 years and over
It is important that you use the lowest dose that controls
your pain and that you do not take Voltarol Pain-eze
Tablets for longer than necessary.
Take an initial dose of 2 tablets when symptoms appear.
If needed, continue with 1 or 2 tablets every 4 to 6
hours. Do not take more than 6 tablets per day. Do not
take Voltarol Pain-eze Tablets for more than 3 days.
Swallow the tablets whole with a drink of water.

Please turn the page

Order - AWF
Reference
Format
Pharma code
Colour
Font
Minimum font size
Reference MKT
Production site
Reference SITE
Pre-press

Proof Z

AWF 18323 - OTDC 310362
VOLT PAIN EZE 12.5 MG TAB GB_922795Z_PIL
148 x 210 mm - Recto/Verso - Page 3
169
P Reflex Blue U
Helvetica Neue LT Pro
6.5 pt
Novartis Pharma Wehr - DE
2140956
Sonoco-Trident - 540694/6/DIS - 13/01/2014

WARNING: Wrong display / print > switch overprint ON

Recto
Page 3

If you forget to take Voltarol Pain-eze Tablets
If you miss a dose, take the next dose as soon as you
remember. If it is nearly time for your next dose, take
the next tablet at the usual time. Do not take a double
dose to make up for a forgotten tablet.
Do not take too much
If symptoms persist or worsen, tell your doctor to ensure
that they are not due to a serious illness. Do not take
more than the recommended dose.
If you take more Voltarol Pain-eze Tablets than you
should
If you have taken too many tablets, tell your doctor or
pharmacist or go to the hospital emergency unit at once.
You may require medical attention. If possible, take the
medicine with you.

4. Possible side effects
Like all medicines, Voltarol Pain-eze Tablets can sometimes
cause side effects, although not everybody gets them.
If you experience any of the side-effects, STOP taking
Voltarol Pain-eze Tablets IMMEDIATELY and seek medical
advice. These include the following:
• swelling of the face or throat
• drowsiness
• rash
• blistering of the skin, mouth, eyes and genitals
(Stevens-Johnson syndrome)
• blood disorders including reduction in blood platelets,
which increases the risk of bleeding or bruising
(Thrombocytopenia)
• gastrointestinal bleeding, stomach and intestine ulcer
(with or without bleeding or perforation), bloody or
black stools
• constipation
• taste disorders
• tingling or numbness of the hands or feet, trembling
• blurred vision, double vision, ringing in the ears,
impaired hearing
• palpitations
• change in mood, difficulty sleeping, feeling confused.
Medicines such as diclofenac may be associated
with a small increased risk of heart attack (also called
“myocardial infarction”) or stroke.
Some rare or very rare side effects could likely be serious.
These side effects may affect up to between 1 and 10 in
every 10,000 people.
• Severe stomach pain, bloody or black stools. Vomiting
blood. These may be sign and symptoms of ulceration,
bleeding and perforation of the stomach or intestines.
• Allergic reaction with swelling of the face, lips, mouth,
tongue or throat often associated with rash and itching,
which may cause difficulty to swallow, hypotension
(low blood pressure), fainting.
• Wheezing and feelings of tightness in the chest (signs
of asthma).

• Chest pain (signs of heart attack).
• Sudden and severe headache, nausea, dizziness,
numbness, inability to speak or difficulty in speaking,
paralysis (signs of stroke).
• Stiff neck (sign of aseptic meningitis).
• Red or purple skin (possible signs of blood vessel
inflammation), skin rash with blisters, blistering of the lips,
eyes and mouth, skin inflammation with flaking or peeling.
• Any change in the appearance or amount of urine,
for example blood in urine, excess of protein in the
urine, severe decreased urine output (signs of kidney
disorders).
• Swelling of arms, hands, legs and feet (oedema).
• Yellowing of the skin or eyes (signs of hepatitis/liver
inflammation).
• Unusual bleeding or bruising.
• Breathlessness, tiredness, swollen feet and ankles
(signs of heart failure).
• Convulsions.
• Hypertension (high blood pressure).
Medicines such as diclofenac may be associated with a
small increased risk of heart attack (also called “myocardial
infarction”) or stroke.
If you experience any of these, STOP taking Voltarol
Pain-eze Tablets and tell a doctor straightaway.
Other side effects
Other side effects which may occur are usually mild.
Some of the effects have been reported with higher
doses of diclofenac, the active substance in Voltarol
Pain-eze, used for longer duration. If you find these are
troubling you, talk to a doctor or pharmacist.
Some side effects are common
These side effects may affect between 1 and 10 in every
100 people.
• Headache, dizziness
• Nausea, vomiting, diarrhoea, indigestion, abdominal
pain, flatulence
• Loss of appetite
• Change in liver function (e.g. level of transaminases)
• Skin rash
• Vertigo
Some side effects are rare
These side effects may affect between 1 and 10 in every
10,000 people.
• Drowsiness
• Stomach pain
• Swelling of arms, hands, legs and feet (oedema)
• Hypotension and shock (symptoms of anaphylactic
and anaphylactoid reaction)
• Shortness of breath (symptom of asthma)
• Gastrointestinal bleeding, stomach and intestine ulcer
(with or without bleeding or perforation), bloody or
black stools
• Yellowing of the skin (Liver disorder)
• Inflammation of the colon (colitis)
• Hives (urticaria)

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AWF 18323 - OTDC 310362
VOLT PAIN EZE 12.5 MG TAB GB_922795Z_PIL
148 x 210 mm - Recto/Verso - Page 4
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P Reflex Blue U
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Novartis Pharma Wehr - DE
2140956
Sonoco-Trident - 540694/6/DIS - 13/01/2014

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Some side effects are very rare
These side effects may affect less than 1 in every 10,000
people.
• Disorientation, memory impairment
• Depression, irritability, psychotic disorder, anxiety,
trembling
• Difficulty sleeping, nightmare
• Tingling or numbness of the hands or feet
• Taste disorders
• Vision and hearing disorders
• Constipation, mouth sores, ulcer of the oesophagus
(the tube that carries food from the throat to the
stomach), palpitations
• Hair loss
• Redness, swelling and blistering of the skin (due to
increased sensitivity to sun)
• Blood disorders including reduction in blood
platelets, which increases the risk of bleeding or
bruising (Thrombocytopenia), decrease in the number
of white blood cells, which increases the risk of
infection (leukopenia), reduction in the number of red
blood cells which can make the skin appear yellow
and cause weakness or breathlessness (haemolytic
anemia), the bone marrow not able to produce
enough new blood cells to replace old blood cells
(aplastic anaemia), severe reduction in number of
white blood cells which makes infections more likely
(agranulocytosis)
• Tinnitus (ringing in the ear)
• Aseptic meningitis

83.6 mm

If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
Also you can help to make sure that medicines remain as
safe as possible by reporting any unwanted side effects
via the internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100 3352
(available from 10 a.m. to 2 p.m. Mondays to Fridays) or
fill in a paper form available from your local pharmacy.

5. How to store Voltarol Pain-eze Tablets
• Keep out of the reach and sight of children.
• Do not store above 25°C.
• Do not take the tablets after the expiry date which is stated
on the carton after EXP (abbreviation used for expiry
date). The expiry date refers to the last day of that month.
• 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. Further information
What Voltarol Pain-eze Tablets contain
• The active substance is diclofenac potassium. Each
tablet contains 12.5 mg of diclofenac potassium.
• The other ingredients are: silica, lactose, maize starch,
sodium starch glycolate, polyvidone, magnesium
stearate, microcrystalline cellulose, hypromellose,
titanium dioxide (E171) and stearic acid.
What Voltarol Pain-eze Tablets look like and contents
of the pack
Voltarol Pain-eze Tablets are small, white, film-coated
tablets, available in packs of 18 tablets.
Marketing Authorisation Holder and Manufacturer
Novartis Consumer Health, Camberley, GU15 3YL, UK
This leaflet was last approved on: October 2013

GB 922795 - 2140956

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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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