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VOLTAROL EXTRA STRENGTH EMULGEL 2.32% GEL

Active substance(s): DICLOFENAC DIETHYLAMINE

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Order – AWF
Reference
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Pharma code
Colour
Font
Min. font size
Reference MKT
Production site
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AWF 16125 – OTDC 274100
VOLTAREN 12 HOUR GEL 30 G GB_303553_PIL
145 x 297 mm – Recto/Verso
XXX
P Reflex Blue U
Helvetica Neue LT Pro
8.5 pt
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

NDMT CF – 13.02.2013

Draft Z

WARNING: Wrong display / print > switch overprint ON

11.5

Recto 9

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully because
it contains important information for you.
Always use Voltarol 12 Hour Emulgel 2.32 % Gel
exactly as described in this leaflet. You should check
with your doctor or pharmacist if you are not sure.
• This medicine is available without prescription.
However, you still need to use Voltarol 12 Hour
Emulgel 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.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice.
• You must contact a doctor if your signs of illness
worsen or do not improve after 7 days.
• If you get any side effects which worry you (even
side effects not listed in this leaflet), talk to your
doctor or pharmacist.

• feel ill, have a temperature or any other symptoms
that accompany the pain.
• are in the last 3 months of pregnancy.
If any of these apply to you, do not use Voltarol
12 Hour Emulgel.
Take special care with Voltarol 12 hour Emulgel
• 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.
• Voltarol 12 Hour Emulgel 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
Emulgel in your eyes. If this happens, rinse your
eyes well with clean water.
See your doctor or pharmacist if any discomfort
persists.
• A brace or wrap commonly used for injuries like
sprains can be used, but do not use the gel under
airtight (plastic) bandages.
• If you have or have ever had asthma speak to your
doctor or pharmacist before using the gel.
• If you have a stomach or duodenal ulcer (or a
history of), tell your doctor or pharmacist before
using the gel.

Pharma code XXX

297

In this leaflet
1. What Voltarol 12 Hour Emulgel is and what
it is used for
2. What you need to know about Voltarol
12 Hour Emulgel
3. How to use Voltarol 12 Hour Emulgel
4. Possible side effects
5. How to store Voltarol 12 Hour Emulgel
6. What is in the pack and further information

1. What Voltarol 12 Hour Emulgel is and
what it is used for

If you have any questions, talk to your doctor or
pharmacist before using Voltarol 12 Hour Emulgel

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

This medicine is not recommended for use
in children under 14 years of age.
Taking other medicines with Voltarol
12 Hour Emulgel
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 Emulgel 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 Emulgel 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 Emulgel should only be used under
medical advice during breast-feeding as diclofenac
passes into breast milk in small amounts. However,
Voltarol 12 hour Emulgel 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.

2. What you need to know about Voltarol
12 Hour Emulgel

Effects of other ingredients (excipients)
Voltarol 12 Hour Emulgel contains:
• propylene glycol, which may cause a mild
localised skin irritation in some people.

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Do not use Voltarol 12 Hour Emulgel if you:
• 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.
• are using any other medicine containing diclofenac
or are taking oral NSAIDs such as aspirin or ibuprofen.
• have severe joint pain of recent onset that is not
related to an injury or period of overuse.

9
145

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

AWF 16125 – OTDC 274100
VOLTAREN 12 HOUR GEL 30 G GB_303553_PIL
145 x 297 mm – Recto/Verso
XXX
P Reflex Blue U
Helvetica Neue LT Pro
8.5 pt
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

NDMT CF – 13.02.2013

Draft Z

WARNING: Wrong display / print > switch overprint ON

11.5

Verso

• 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).

• butylhydroxytoluene, which may cause local skin
reactions (e.g. contact dermatitis) or irritation
to the eyes and mucous membranes.

3. How to use Voltarol 12 Hour Emulgel
Always use this medicine exactly as described in this
leaflet. You should check with your doctor or pharmacist
if you are not sure.

Common side effects
(likely to affect between 1 and 10 in every
100 patients)
• Skin rash, itching, reddening or smarting of the skin

How much Voltarol 12 Hour Emulgel 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.

Very rare side effects
(likely to affect less than 1 in every
10,000 patients)
• The skin may be more sensitive to the sun.
Possible signs are sunburn with itching, swelling
and blistering.
If you get any side effects which worry you (even
side effects not listed in this leaflet), talk to your
doctor or pharmacist.

5. How to store Voltarol 12 Hour Emulgel
• Keep this medicine out of the reach and sight
of children.
• Do not use Voltarol 12 Hour Emulgel after the expiry
date which is stated on the carton and tube
after EXP.
• Do not store above 30 °C.
• 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

297

How long to use Voltarol 12 Hour Emulgel for
Do not use Voltarol 12 Hour Emulgel for more than
7 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.

What Voltarol 12 Hour Emulgel contains
The active substance is diclofenac diethylammonium.
Each gram of gel contains 23.2 mg of diclofenac
diethylammonium.
The other ingredients (excipients) are butylhydroxytoluene, carbomers, 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).

If you use more Voltarol 12 Hour Emulgel than you
should
• If you use more gel than you should, wipe off the
surplus gel with a tissue.
• If you or a child accidentally swallows the gel,
contact your doctor immediately.

What Voltarol 12 Hour Emulgel looks like and
contents of the pack
Voltarol 12 Hour Emulgel is a white to practically white,
cooling, non-greasy, non-staining cream-like gel.
The product comes in packs of 30g and 50g.
Not all pack sizes may be marketed.

If you forget to use Voltarol 12 Hour Emulgel

Marketing Authorisation Holder
Novartis Consumer Health UK Ltd
Watchmoor Park, Camberley, Surrey
GU15 3YL UK

If you miss your application of Voltarol 12 Hour
Emulgel 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.

Manufacturer
Novartis Consumer Health UK Ltd
Watchmoor Park, Camberley, Surrey
GU15 3YL UK

4. Possible side effects
Like all medicines, Voltarol 12 Hour Emulgel can cause
side effects, although not everybody gets them.

This leaflet was last approved on:
February 2013

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 Emulgel and tell a doctor
or pharmacist immediately:
• Skin rash with blisters; hives. (These side effects
are likely to affect 1 to 10 people in every 10,000).
• 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).

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GB 303553 - XXXXXX

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Pharma code XXX

How to apply Voltarol 12 Hour Emulgel
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– 4 g).
You may notice a slight cooling effect when you rub
the gel in. Only use the smallest amount of Voltarol
12 Hour Emulgel needed to relieve your pain but
never use more than 8 g per day and 56 g 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 Emulgel is for external use only.

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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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