VOLTAROL PAIN-EZE TABLETS

Active substance: DICLOFENAC POTASSIUM

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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 Joint Pain 12.5 mg 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 Joint Pain 12.5 mg Tablets are and
what they are used for
2. Before you take Voltarol Joint Pain 12.5 mg Tablets
3. How to take Voltarol Joint Pain 12.5 mg Tablets
4. Possible side effects
5. How to store Voltarol Joint Pain 12.5 mg Tablets
6. Further information

1. What Voltarol Joint Pain 12.5 mg
Tablets are and what they are
used for
Voltarol Joint Pain 12.5 mg Tablets contain diclofenac
which belongs to a group of medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs).
This medicine is a pain reliever which also reduces
inflammation (swelling) and fever.
Voltarol Joint Pain 12.5 mg 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.

2. Before you take Voltarol Joint Pain
12.5 mg Tablets
Do not take Voltarol Joint Pain 12.5 mg Tablets if you:
• 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)
• are pregnant or think that you may be pregnant
• are breastfeeding
• are taking any other anti-inflammatory pain relievers
or aspirin
If any of these apply to you, consult your doctor
and do not take these tablets.
Take special care and ask a doctor or
pharmacist before use if you:
• have had stomach discomfort or heartburn after
taking pain relievers or anti-inflammatory medicines
in the past
• have or have had asthma, diabetes, high
cholesterol, high blood pressure, a stroke, liver,
heart, kidney or bowel problems.
• are intolerant to some sugars
• are on a controlled potassium diet
• are a smoker
• 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)

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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
Joint Pain 12,5 mg 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 Joint Pain 12.5 mg 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
Joint Pain 12.5 mg Tablets.
Elderly
As with other pain relievers, elderly people may be more
sensitive to the effects of Voltarol Joint Pain 12.5 mg 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 Joint Pain 12.5 mg 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).

Pregnancy
If you are pregnant or think that you may be pregnant,
tell your doctor and do not take Voltarol Joint Pain
12.5 mg Tablets.
As with other anti-inflammatory medicines, the use of
diclofenac, the active substance in Voltarol Joint Pain
12.5 mg 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 Joint Pain 12.5 mg 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 Joint Pain 12.5 mg 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 Joint Pain
12.5 mg 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 Joint Pain
12.5 mg 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 Joint Pain 12.5 mg Tablets for more
than 3 days.
Swallow the tablets whole with a drink of water.
If you forget to take Voltarol Joint Pain 12.5 mg
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.

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If you take more Voltarol Joint Pain 12.5 mg 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 Joint Pain 12.5 mg Tablets
can sometimes cause side effects, although not everybody gets them.
Common side effects
(likely to affect 1 to 10 people out of 100):
• Stomach pain, pain in the gut, diarrhoea, nausea,
vomiting, flatulence,
• Headache, dizziness, vertigo,
• Skin rash,
• Change in liver function (e.g. level of transaminases).
Rare side effects
(likely to affect 1 to 10 people out of 10,000 people):
• Severe stomach pain, blood in the stools or black
stools, vomiting blood,
• Allergic reaction including swelling of the face,
mouth, tongue or throat, often associated with skin
rash, collapse,
• Wheezing and feelings of tightness in the chest,
chest pain,
• Fainting,
• High blood pressure,
• Yellowing of the skin or eyes.
If you notice any of these, stop taking Voltarol
Joint Pain 12.5 mg Tablets and tell a doctor
immediately.
• Drowsiness,
• Urticaria (itching skin rash)
Very rare side effects
(likely to affect less than 1 person out of 10,000):
• Sudden and severe headache, stiff neck, difficulty to
speak, convulsions,
• Skin rash with blisters, peeling of the skin, purple
skin lesions, blistering of the mouth or eyes,
• Swelling of arms, hands, legs and feet (oedema),
• Any change in the appearance or amount of urine,
• Unusual bleeding or bruising, high fever or persistent
sore throat.

• 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.
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.

5. How to store Voltarol Joint Pain
12.5 mg 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 Joint Pain 12.5 mg 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) macrogol,
polysorbate and maltodextrin.
What Voltarol Joint Pain 12.5 mg Tablets look like
and contents of the pack
Voltarol Joint Pain 12.5 mg Tablets are small, white,
film-coated tablets, available in packs of 10 and 18 tablets.
Not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Novartis Consumer Health, Horsham, RH12 5AB, UK
This leaflet was last approved on: December 2010

If you notice any of these, stop taking Voltarol
Joint Pain 12.5 mg Tablets and tell a doctor
immediately.
• Constipation,
• Mouth sores, taste disorders,
• Tingling or numbness of the hands or feet, trembling,
• Blurred vision, double vision, ringing in the ears,
impaired hearing,
• Palpitations,
GB_921688 - 2110620

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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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