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VOLTAROL 12 HOUR EMULGEL P 2.32% GEL

Active substance(s): DICLOFENAC DIETHYLAMINE / DICLOFENAC DIETHYLAMINE / DICLOFENAC DIETHYLAMMONIUM SALT / DICLOFENAC DIETHYLAMINE / DICLOFENAC DIETHYLAMMONIUM SALT

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Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

AWF 24923 – OTDC 408380
VOLTAROL EMULGEL 2% 12 HOUR 30G GB_317014_PIL
145 x 297 mm – PN-Notice-V11 – P07 – Recto/Verso
XXX
Black
Helvetica Neue LT Pro
8 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

Diadeis 420074 – AD – 12.04.2017

Draft H

WARNING: Wrong display / print > switch overprint ON

Recto

11.5 mm

145 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

297 mm

Read all of this leaflet carefully because it
contains important information for you.
Always use Voltarol 12 Hour Joint Pain Relief 2.32%
Gel exactly as described in this leaflet or as your
pharmacist has told you.
You should check with your doctor or pharmacist
if you are not sure.
Ř This medicine is available without prescription.
However, you still need to use Voltarol 12 Hour
Joint Pain Relief 2.32% Gel carefully to get the
best results from it. Note that this leaflet is
revised on a regular basis with the latest
information on your medicine. Please refer to the
date at the end of the leaflet.
Ř Keep this leaflet. You may need to read it again.
Ř Ask your pharmacist if you need more information
or advice.
Ř You must contact a doctor if your signs of illness
worsen or do not improve after 7 days.
Ř If you get any side effects which worry you (even
side effects not listed in this leaflet), talk to your
doctor or pharmacist.
In this leaflet
1. What Voltarol 12 Hour Joint Pain Relief 2.32% Gel
is and what it is used for
2. What you need to know about Voltarol 12 Hour
Joint Pain Relief 2.32% Gel
3. How to use Voltarol 12 Hour Joint Pain Relief
2.32% Gel
4. Possible side effects
5. How to store Voltarol 12 Hour Joint Pain Relief
2.32% Gel
6. What is in the pack and further information

1. What Voltarol 12 Hour Joint Pain Relief
2.32% Gel is and what it is used for

Pharma code XXX

Voltarol 12 Hour Joint Pain Relief 2.32% Gel
contains the active substance diclofenac which
belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
It is specially formulated for rubbing into the skin.
Voltarol 12 Hour Joint Pain Relief 2.32% Gel is used
to relieve pain and reduce inflammation and
swelling in a number of painful conditions affecting
the joints and muscles. Voltarol 12 Hour Joint Pain
Relief 2.32% Gel can be used to treat:
Ř muscle and joint injuries (e.g. sprains, strains,
bruises, backache, sports injuries), relieving pain
and helping recovery back to normal function;
Ř tendonitis (e.g. tennis elbow), swelling around
elbow or knee.
Voltarol 12 Hour Joint Pain Relief 2.32% Gel
is intended for use in adults and children aged
14 years and older.

2. What you need to know about Voltarol
12 Hour Joint Pain Relief 2.32% Gel:

11.5 mm

72 mm

Do not use Voltarol 12 Hour Joint Pain Relief
2.32% Gel if you:
Ř are allergic (hypersensitive) to diclofenac or other
medicines used to treat pain, fever or
inflammation, such as ibuprofen or aspirin
(a substance also used to prevent blood clotting),
or any of the other ingredients of this medicine
(see Section 6 and end of Section 2). If you are
not sure, ask your doctor or pharmacist.
Symptoms of an allergic reaction may include:
wheezing or shortness of breath (asthma); skin

rash with blisters or hives; swelling of the face
or tongue; runny nose.
Ř are using any other medicine containing
diclofenac or are taking oral NSAIDs such
as aspirin or ibuprofen.
Ř have severe joint pain of recent onset that is not
related to an injury or period of overuse.
Ř feel ill, have a temperature or any other
symptoms that accompany the pain.
Ř are in the last 3 months of pregnancy.
If any of these apply to you, do not use
Voltarol 12 Hour Joint Pain Relief 2.32% Gel.
Take special care with Voltarol 12 Hour Joint
Pain Relief 2.32% Gel
Ř Do not apply the gel to skin that has (i) a rash
or eczema (ii) cuts or open wounds. Stop the
treatment if a skin rash develops after applying
the product. Avoid applying on large areas of skin
and over a prolonged period of time, unless under
medical advice.
Ř Voltarol 12 Hour Joint Pain Relief 2.32% Gel is for
external use only. Do not use it in the mouth. Do
not swallow it. Wash your hands after use unless
they are the area to be treated. Be careful not to
get Voltarol 12 Hour Joint Pain Relief 2.32% Gel
in your eyes. If this happens, rinse your eyes well
with clean water. See your doctor or pharmacist
if any discomfort persists.
Ř A brace or wrap commonly used for injuries like
sprains can be used, but do not use the gel under
airtight (plastic) bandages.
Ř If you have a stomach or duodenal ulcer
(or a history of), tell your doctor or pharmacist
before using the gel.
Ř If you have or have ever had asthma speak to
your doctor or pharmacist before using the gel.
If you have any questions, talk to your doctor
or pharmacist before using Voltarol 12 Hour
Joint Pain Relief 2.32% Gel.
This medicine is not recommended for use
in children under 14 years of age.
Taking other medicines with Voltarol 12 Hour
Joint Pain Relief 2.32% Gel
Please tell your doctor or pharmacist if you are
taking, or have recently taken, or want to start
taking any other medicines, including those
obtained without a medical prescription.
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 using
this medicine.
Voltarol 12 Hour Joint Pain Relief 2.32% Gel must
not be used during the last 3 months of pregnancy,
as it could harm your unborn child or cause
problems at delivery. Voltarol 12 Hour Joint Pain
Relief 2.32% Gel should only be used under
medical advice during the first 6 months of
pregnancy and the dose should be kept as low and
duration of treatment as short as possible.
Voltarol 12 Hour Joint Pain Relief 2.32% Gel should
only be used under medical advice during breastfeeding as diclofenac passes into breast milk in
small amounts. However, Voltarol 12 Hour Joint Pain
Relief 2.32% Gel should not be applied on the
breasts of nursing mothers nor elsewhere on large

9 mm

127 mm

9 mm

Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

AWF 24923 – OTDC 408380
VOLTAROL EMULGEL 2% 12 HOUR 30G GB_317014_PIL
145 x 297 mm – PN-Notice-V11 – P07 – Recto/Verso
XXX
Black
Helvetica Neue LT Pro
8 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

Diadeis 420074 – AD – 12.04.2017

Draft H

WARNING: Wrong display / print > switch overprint ON

Verso

11.5 mm

145 mm

3. How to use Voltarol 12 Hour Joint Pain
Relief 2.32% Gel

Pharma code XXX
297 mm

Always use this medicine exactly as described in
this leaflet or as your pharmacist has told you. You
should check with your doctor or pharmacist if you
are not sure.
How much Voltarol 12 Hour Joint Pain Relief
2.32% Gel to use
For adults and adolescents 14 years and over.
Apply the gel 2 times a day (preferably morning and
evening) on the painful area.
How to apply Voltarol 12 Hour Joint Pain Relief
2.32% Gel
1. To remove the seal before first use, unscrew and
remove the cap. Use the reverse side of the cap
to insert, twist and remove the seal from the tube.
2. Gently squeeze out a small amount of gel from
the tube and apply to the painful or swollen area,
slowly rubbing into the skin. The amount
needed will vary depending upon the size of the
painful or swollen area; an amount ranging
in size from a 1 penny to a 2 pence piece will
usually be sufficient (2–4g). You may notice
a slight cooling effect when you rub the gel in.
Only use the smallest amount of Voltarol 12 Hour
Joint Pain Relief 2.32% Gel needed to relieve
your pain but never use more than 8g per day
and 56g in one week.
3. Unless the hands are the site being treated, wash
your hands after rubbing in the gel, to avoid
accidental contact with the mouth and eyes
(see Section 2).
Voltarol 12 Hour Joint Pain Relief 2.32% Gel is for
external use only.
How long to use Voltarol 12 Hour Joint Pain
Relief 2.32% Gel for
Do not use Voltarol 12 Hour Joint Pain Relief
2.32% Gel for more than 14 days unless longer
treatment is recommended by a doctor.
If the pain and swelling do not improve within
7 days, or if they get worse, tell your doctor.
In children aged 14 years and over, if this product
is required for more than 7 days for pain relief or
if the symptoms worsen the patient/parents of the
adolescent is/are advised to consult a doctor.
If you use more Voltarol 12 Hour Joint Pain
Relief 2.32% Gel than you should
Ř If you use more gel than you should, wipe off the
surplus gel with a tissue.
Ř If you or a child accidentally swallows the gel,
contact your doctor immediately.
If you forget to use Voltarol 12 Hour Joint Pain
Relief 2.32% Gel
If you miss your application of Voltarol 12 Hour Joint
Pain Relief 2.32% Gel at the correct time, apply it
when you remember and then carry on as normal.
Do not apply a double quantity to make up for the
forgotten application. If you have any further
questions on the use of this product, ask your
doctor or pharmacist.

Some rare and very rare side effects might
be serious
If you experience any of the following signs of
allergy, STOP using Voltarol 12 Hour Joint Pain
Relief 2.32% Gel and tell a doctor or pharmacist
immediately:
Ř Skin rash with blisters; hives. (These side effects
are likely to affect 1 to 10 people in every
10,000).
Ř Wheezing, shortness of breath or feeling of
tightness in the chest (asthma). (These side
effects are likely to affect less than 1 person
in every 10,000).
Ř Swelling of the face, lips, tongue or throat. (These
side effects are likely to affect less than 1 person
in every 10,000).
Other side effects which may occur are usually
mild, passing and harmless (if you are concerned,
tell a doctor or pharmacist).
Common side effects
(likely to affect between 1 and 10 in every
100 patients)
Ř Skin rash, itching, reddening or smarting of the
skin
Very rare side effects
(likely to affect less than 1 in every 10,000 patients)
Ř The skin may be more sensitive to the sun.
Possible signs are sunburn with itching, swelling
and blistering.
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
www.mhra.gov.uk/yellowcard.
g
y
By reporting side effects you can help provide more
information on the safety of this medicine.

72 mm

areas of skin or for a prolonged period of time.
Consult your doctor or pharmacist for further
information if you are pregnant or breast-feeding.
Effects of other ingredients (excipients)
Voltarol 12 Hour Joint Pain Relief 2.32% Gel
contains:
Ř propylene glycol, which may cause a mild
localised skin irritation in some people.
Ř butylhydroxytoluene, which may cause local
skin reactions (e.g. contact dermatitis) or irritation
to the eyes and mucous membranes.

5. How to store Voltarol 12 Hour Joint Pain
Relief 2.32% Gel
Ř Keep this medicine out of the sight and reach
of children.
Ř Do not use Voltarol 12 Hour Joint Pain Relief
2.32% Gel after the expiry date which is stated
on the carton and tube after EXP.
Ř Do not store above 30 °C.
Ř Do not dispose of medicines 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. What is in the pack and further
information

Like all medicines, Voltarol 12 Hour Joint Pain Relief
2.32% Gel can cause side effects, although not
everybody gets them.

GB 317014 – XXXXXX

11.5 mm

4. Possible side effects

What Voltarol 12 Hour Joint Pain Relief
2.32% Gel contains
The active substance is diclofenac
diethylammonium. Each gram of gel contains
23.2mg of diclofenac diethylammonium.
The other ingredients (excipients) are
butylhydroxytoluene, carbomer, cocoyl
caprylocaprate, diethylamine, isopropyl alcohol,
liquid paraffin, macrogol cetostearyl ether, oleyl
alcohol, propylene glycol, perfume and purified
water (see end of Section 2 for further information).
What Voltarol 12 Hour Joint Pain Relief
2.32% Gel looks like and contents of the pack
Voltarol 12 Hour Joint Pain Relief 2.32% Gel is
a white to practically white, cooling, non-greasy,
non-staining cream-like gel.
The product comes in packs of 30g, 50g and 100g.
Marketing Authorisation Holder and
Manufacturer
GlaxoSmithKline Consumer Healthcare (UK) Trading
Limited, Brentford, TW8 9GS, U.K.
This leaflet was last approved in: April 2017

9 mm

127 mm

9 mm

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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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