VOLTAROL PAIN-EZE EXTRA STRENGTH 25MG TABLETS

Active substance: DICLOFENAC POTASSIUM

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AWF 18319 - OTDC 310304
VOLT EXTRA STRENGTH 0025 MG 0009 TABS GB_922794Z_PIL
297 x 148 mm - Recto/Verso
XXX
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Helvetica Neue LT Pro
8 pt (all), 8 pt (body copy)

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Novartis Pharma Kurtkoy - TR
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• are pregnant or think that you may be pregnant
• are breastfeeding
• are taking any other anti-inflammatory pain relievers or
aspirin with a daily dose above 75mg
If any of these apply to you, consult your doctor and do not
take these tablets.
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
Read all of this leaflet carefully before you start taking
Voltarol Pain-eze Extra Strength 25mg 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 Extra Strength 25mg Tablets are and
what they are used for
2. Before you take Voltarol Pain-eze Extra Strength 25mg Tablets
3. How to take Voltarol Pain-eze Extra Strength 25mg Tablets
4. Possible side effects
5. How to store Voltarol Pain-eze Extra Strength 25mg Tablets
6. Further information
1. What Voltarol Pain-eze Extra Strength 25mg Tablets are
and what they are used for
Voltarol Pain-eze Extra Strength 25 mg 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 Extra Strength 25 mgTablets 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 Pain-eze Extra Strength 25mg
Tablets
Do not take Voltarol Pain-eze Extra Strength 25mg 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
• have (or have had two or more episodes of) a stomach ulcer,
perforation or bleeding 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)

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, liver, kidney or bowel problems.
• if you are taking other pain relievers or anti-inflammatory
medicines
• 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 Extra Strength 25mg Tablets,

PHARMACODE XXX

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Extra Strength 25mg 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 Extra Strength 25mg Tablets.
Elderly
As with other pain relievers, elderly people may be more sensitive to the
effects of Voltarol Pain-eze Extra Strength 25mg 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 Extra Strength 25mg 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.
It is particularly important to tell your doctor or pharmacist if
you are taking any of the following medicines:
• 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-oxygen
ase-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).

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Order - AWF
Reference
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AWF 18319 - OTDC 310304
VOLT EXTRA STRENGTH 0025 MG 0009 TABS GB_922794Z_PIL
297 x 148 mm - Recto/Verso
XXX
P Reflex Blue U
Helvetica Neue LT Pro
8 pt (all), 8 pt (body copy)

Sonoco-Trident - 540612/5/DIS - 16/12/2013

Novartis Pharma Kurtkoy - TR
XXXXXX

WARNING: Wrong display / print > switch overprint ON

PHARMACODE XXX

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3. How to take Voltarol Pain-eze Extra Strength 25mg
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 Extra Strength
25mg Tablets for longer than necessary.
Take an initial dose of 1 tablet when symptoms appear.
If needed, continue with 1 tablet after 4 to 6 hours. Do not take
more than 3 tablets per day. Do not take Voltarol Pain-eze Extra
Strength 25mg Tablets for more than 3 days.
Swallow the tablets whole with a drink of water.
If you take more Voltarol Pain-eze Extra Strength 25mg
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.

If you forget to take Voltarol Pain-eze Extra Strength 25mg
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
Do not take Voltarol Pain-eze Extra Strength 25mg Tablets for
more than 3 days. 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.
4. Possible side effects
Like all medicines, Voltarol Pain-eze Extra Strength 25mg
Tablets can sometimes cause side effects, although not everybody
gets them.
If you suffer from any of the following rare or very rare
side effects at any time during your treatment, STOP
TAKING the medicine and seek medical help immediately:
• blood in the stools/faeces or black tarry stools,
vomiting blood or dark particles that look like coffee grounds
• 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
• 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.
STOP TAKING the medicine and tell your doctor if you
experience:
• Indigestion or heartburn
• Abdominal pain (pains in your stomach) or other abnormal
stomach symptoms

Tell your doctor if you experience any of the following
symptoms:
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).

• 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.

Rare side effects
• Drowsiness,
• Urticaria (itching skin rash)

What Voltarol Pain-eze Extra Strength 25mg Tablets contain
• The active substance is diclofenac potassium. Each tablet
contains 25 mg of diclofenac potassium.
• The other ingredients are: magnesium stearate, povidone,
silica colloidal anhydrous, Aerosil 200 (silica aerogel)
Calcium phosphate, Maize starch, Polyvinylpyrrolidone K30,
Sodium carboxymethyl starch, Avicel PH 101 (cellulose), Iron
oxide, red 17266, Polyethylene glycol 8000, Sucrose, cryst,
Talc, Titanium dioxide.
What Voltarol Pain-eze Extra Strength 25mg Tablets look
like and contents of the pack
Voltarol Pain-eze Extra Strength 25mg Tablets are small,
pale red sugar-coated tablets available in packs of 9 tablets.
Marketing Authorisation Holder and Manufacturer
Novartis Consumer Health, Park View, Watchmoor Park
Camberley, GU15 3YL

Very rare side effects
(likely to affect less than 1 person out of 10,000):





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,
• 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.
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.

6. Further information

This leaflet was last approved on: October 2013

5. How to store Voltarol Pain-eze Extra Strength 25mg
Tablets
• Keep out of the reach and sight of children.
• Do not store above 30°C.

GB 922794 - XXXXXX

PHARMACODE XXX

Pregnancy
If you are pregnant or think that you may be pregnant, tell your
doctor and do not take Voltarol Pain-eze Extra Strength 25mg Tablets.
As with other anti-inflammatory medicines, the use of diclofenac,
the active substance in Voltarol Pain-eze Extra Strength 25mg
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 Extra Strength 25mg 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 Extra Strength 25mg Tablets contain sucrose.
If you have been told by your doctor that you have an intolerance
to some sugars, ask your doctor before taking this medicine.

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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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