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VOLTAROL GEL PATCH 1% MEDICATED PLASTER

Active substance(s): DICLOFENAC EPOLAMINE

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code 1030 ed. V/02.14 – GB 924294

PATIENT LEAFLET: Information for the user
Read all of this leaflet carefully before start
using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness 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 theis leaflet. See sections 4.
What is in this leaflet:
1. What Voltarol Gel Patch is and what it is used for
2. What you need to know before you use Voltarol
Gel Patch
3. How to use Voltarol Gel Patch
4. Possible side effects
5. How to store Voltarol Gel Patch
6. Contents of the pack and other information.
1. WHAT Voltarol Gel Patch is and what it is
used for
Voltarol Gel Patch belongs to a group of
medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). NSAIDs reduce pain and
inflammation.
Voltarol Gel Patch is used to relieve the pain and
inflammation of tennis elbow, golfer’s elbow and
a sprained ankle.
2. What you need to know before you use
Voltarol Gel Patch
Do not use Voltarol Gel Patch:
• if you are allergic to diclofenac, acetylsalicylic
acid (aspirin) or any other NSAID
• if you are allergic to any of the other
ingredients of Voltarol Gel Patch (listed in
section 6)
• if you have asthma, breathing problems, skin
rash or a runny nose after taking
acetylsalicylic acid (aspirin) or other NSAIDs
• if you are entering or are already beyond your
6th month of pregnancy
• if you currently have a stomach ulcer (peptic ulcer)
• if you have any damaged skin including weeping
or infected areas, eczema, burns or wounds
• if you are a children or adolescent aged less
than 16 years.
If any of the above applies to you talk to your
doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before
using Voltarol Gel Patch if:
• You have heart disease
• You have kidney disease
• You have liver disease
• You have had stomach ulcers in the past
• You have inflammatory bowel disease such as

Crohn’s disease or ulcerative colitis or you are
susceptible to bleeding from your bowel
• You have asthma
• You have breathing problems, skin rash or a
runny nose after taking acetylsalicylic acid
(aspirin) or other NSAIDs
• You are taking diclofenac or other NSAIDs, as
an oral or topical preparation
• You regularly use a sun-bed or sunbathe
• You are elderly as you may be more prone to
side effects.
Children and adolescents
Do not use in case of children or adolescent aged
less than 16 years old
Other medicines and Voltarol Gel Patch
If Voltarol Gel Patch is correctly used the risk of
interaction with other medicinal products is very
low. However inform your doctor or pharmacist if
recently you used or took or you are currently
using or taking any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Voltarol Gel Patch must not be used if you are
entering or are already beyond your 6th month of
pregnancy, as it could harm your unborn child or
cause problems at delivery. Voltarol Gel Patch
should only be used under medical advice before
the 6th month of pregnancy and the dose should
be kept as low and duration of treatment as short
as possible.
Voltarol Gel Patch should only be used under
medical advice during breast-feeding as
diclofenac passes into breast milk in small
amounts. However, Voltarol Gel Patch should not
be applied on the breasts of nursing mothers nor
elsewhere on large areas of skin or for a
prolonged period of time.
Consult your doctor or pharmacist for further
information if you are pregnant or breastfeeding.
Driving and using machines
Diclofenac medicated plaster application has no
influence on the ability to drive and use machines.
Voltarol Gel Patch contains
• preservatives known as parahydroxybenzoates
which may cause allergic reactions (possibly
delayed)
• and propylene glycol, which may cause skin
irritation.
3. HOW TO USE Voltarol Gel Patch
Always use Voltarol Gel Patch exactly as your
doctor has told you.
Important:
Your doctor will choose the dose that is right
for you. Your dose will be shown clearly on
the label that your pharmacist puts on your

medicine. If it does not, or you are not sure,
ask your doctor or pharmacist.
Adults or adolescents 16 years of age and over
How many plasters to use
• Tennis elbow or golfer’s elbow
- Apply one plaster in the morning
- Remove the plaster in the evening and apply
a new one
- Remove the plaster in the morning
Repeat these steps for a maximum of 14 days.
• Ankle sprains
- Apply one plaster per day
- Remove the plaster the next day and apply a
new one
Repeat these steps for a maximum of 3 days.
Remember: Ankle sprains will normally
improve within 3 days and elbow pain within
14 days. If they do not, or if your symptoms
get worse, tell your doctor.
Use in children and adolescents (under 16
years of age)
There are insufficient data on efficacy and safety
available for children and adolescents below 16
years (see Do not use Voltarol Gel Patch).
In children aged 16 years and over, if the
symptoms worsen, the patient/parents of the
adolescent is/are advised to consult a doctor.
How to apply Voltarol Gel Patch
• Cut the top off the resealable sachet, take out
a plaster and carefully close the seal.
• Record the date on which the sachet was
opened in the space provided
• Remove the plastic backing protecting the
sticky side of the plaster.
• Apply the plaster to the skin around the painful
or swollen area. If necessary, it may be held in
place with an open weave gauze bandage or
thin strips of tape. These can be obtained from
your pharmacist.
• Do not cover the plaster with any other kind of
dressing.
• The medicated plaster should be applied only
to intact, non-diseased skin, and not to skin
wounds or open injuries, and should not be
worn when bathing or showering.
• Take care to keep the gel away from your
eyes, nose, mouth, genital and anal areas. If
gel does come into contact with these, rinse
away with water.
• The plaster should not be cut.
If you forget to use Voltarol Gel Patch
Do not apply an additional plaster to make up for
a missed dose. Simply apply your next plaster as
planned.
If you have any further questions about the use
of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Voltarol Gel Patch can cause
side effects, although not everybody gets them.

Some uncommon and very rare side effects
might be serious
If you experience any of the following signs of
allergy, STOP using Voltarol Gel Patch and tell a
doctor or a pharmacist immediately:
- Swelling of the lips, eyes or tongue,
wheezing or asthma attack which are signs
of severe allergic reaction (affect less than 1
user in 10,000),
- Rash, stinging or burning at the site where the
plaster was applied (affect 1 to 10 users in 1,000).
Other side effects which may occur are
usually mild, passing and harmless (if you are
concerned, tell a doctor or pharmacist).
Common side effects (affect 1 to 10 users in 100)
• Itchy skin.
Uncommon side effects (affect 1 to 10 users in 1,000)
• Skin rash
• Redness of the skin
• Tiny red or purple coloured spots under the skin
Rare side effects (affect 1 to 10 users in 10,000)
• Dry scaly skin
• Swelling at the site where the plaster was applied.
Very rare side effects (affect less than 1 user in
10,000)
• Skin rashes made worse by sunlight
Because Voltarol Gel Patch is applied to the skin
over the affected area, there is less risk of
unwanted effects, such as stomach problems
including pain, indigestion, or any signs of
bleeding in the stomach or intestine, that can
occur when diclofenac is taken by mouth.
However, if Voltarol Gel Patch is not used
correctly, these unwanted effects could occur.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the 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. By
reporting side effects you can help provide more
information on the safety of this medicine.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE Voltarol Gel Patch
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the sachet and carton. The
expiry date refers to the last day of that month.
Do not store above 25°C
Do not use after 3 months after the first opening
the sachet. After removing each plaster, ensure
the sachet is resealed.

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you no
longer use. These measures will help to protect
the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Voltarol Gel Patch contains
The active substance is diclofenac epolamine.
Each medicated plaster contains a total of 180
mg of diclofenac epolamine, corresponding to
140 mg diclofenac sodium (1% w/w).
The other ingredients are gelatine, povidine
(K90), sorbitol, kaolin, titanium dioxide (E171),
propylene glycol, methylparahydroxybenzoate
(E218), propylparahydroxybenzoate (E216),
disodium edetate (E385), tartaric acid, aluminium
glycinate, carmellose sodium, sodium
polyacrylate, 1,3-butylene glycol, polysorbate 80,
fragrance (propylene glycol, benzyle salicylate,
phenyl ethyl alcohol, alpha amyl cinnamic
aldehyde, hydroxycitronellal, phenylethyl
phenylacetate, cinnamyl acetate, benzyl acetate,
terpineol, cinnamic alcohol, cyclamenaldehyde.),
purified water and unwoven polyester support.
What Voltarol Gel Patch looks like and
contents of the pack
Each medicated plaster consists of a white to
pale yellow paste impregnated into a dressing
with a removable clear plastic backing protecting
an adhesive layer. Resealable sachets contain
either 2 or 5 plasters.
Voltarol Gel Patch comes in packs of 2, 5, 10 and
14 plasters per box. Not all pack sizes may be
marketed.
Marketing Authorization Holder and
Manufacturer
Marketing authorization holder
Novartis Consumer Health, Camberley, GU15 3YL,
Manufacturers
Laboratoires Genévrier,
280 rue de Goa
Z.I. Les Trois Moulins, Parc de Sophia Antipolis
06600 Antibes, France
And
Altergon Italia srl
Zona Industriale
83040 Morra De Sanctis (AV)
Italy
If this leaflet is difficult to see or read or you
would like it in a different format, please
contact Novartis Consumer Health,
Camberley, GU15 3YL United Kingdom.
This leaflet was last revised in January 2014.

GB 924294
code 1030 ed. V/02.14

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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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