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VOLTAROL 12 HOUR EMULGEL 2.32% GEL

Active substance(s): DICLOFENAC DIETHYLAMINE

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

AWF 28752 – OTDC 478474
VOLTAROL EMULGEL 2% 30G GB_319181_PIL
145 x 297 mm – PN-Notice-V11 – P07 – Recto/Verso
XXX
Black
Helvetica Neue LT Pro
9 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

Diadeis429950 – AD – 18.12.2017

Draft A

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 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 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.
• 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.
In this leaflet
1. What Voltarol 12 Hour Emulgel 2.32% Gel is and
what it is used for
2. What you need to know about Voltarol 12 Hour
Emulgel 2.32% Gel
3. How to use Voltarol 12 Hour Emulgel 2.32% Gel
4. Possible side effects
5. How to store Voltarol 12 Hour Emulgel 2.32% Gel
6. What is in the pack and further information

1. What Voltarol 12 Hour Emulgel 2.32% Gel
is and what it is used for

Pharma code XXX

Voltarol 12 Hour Emulgel 2.32% Gel contains the
active substance diclofenac which belongs to
a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs). It is specially
formulated for rubbing into the skin.
Voltarol 12 Hour Emulgel 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 Emulgel 2.32% Gel
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 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 Emulgel 2.32% Gel:

11.5 mm

72 mm

Do not use Voltarol 12 Hour Emulgel 2.32% Gel
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.
• 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 2.32% Gel.
Take special care with Voltarol 12 Hour Emulgel
2.32% Gel
• 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 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 Emulgel 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.
• 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 a stomach or duodenal ulcer (or a
history of), tell your doctor or pharmacist before
using the gel.
• 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
Emulgel 2.32% Gel.
This medicine is not recommended for use
in children under 14 years of age.
Taking other medicines with Voltarol 12 Hour
Emulgel 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 Emulgel 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 Emulgel 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 Emulgel 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 Emulgel
2.32% Gel 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

9 mm

127 mm

9 mm

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

AWF 28752 – OTDC 478474
VOLTAROL EMULGEL 2% 30G GB_319181_PIL
145 x 297 mm – PN-Notice-V11 – P07 – Recto/Verso
XXX
Black
Helvetica Neue LT Pro
9 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

Diadeis429950 – AD – 18.12.2017

Draft A

WARNING: Wrong display / print > switch overprint ON

Verso

11.5 mm

145 mm

3. How to use Voltarol 12 Hour Emulgel
2.32% Gel

• Keep this medicine out of the sight and reach
of children.
• Do not use Voltarol 12 Hour Emulgel 2.32% Gel
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
What Voltarol 12 Hour Emulgel 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 Emulgel 2.32% Gel looks
like and contents of the pack
Voltarol 12 Hour Emulgel 2.32% Gel is a white to
practically white, cooling, non-greasy, non-staining
cream-like gel.
The product comes in packs of 30 g and 50 g. Not
all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
GlaxoSmithKline Consumer Healthcare (UK) Trading
Limited, Brentford, TW8 9GS, U.K.
This leaflet was last approved in:
November 2017.

GB 319181 – XXXXXX

11.5 mm

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

5. How to store Voltarol 12 Hour Emulgel
2.32% Gel

297 mm

4. Possible side effects

Pharma code XXX

Always use this medicine exactly as described
in this leaflet. You should check with your doctor
or pharmacist if you are not sure.
How much Voltarol 12 Hour Emulgel 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 Emulgel 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
Emulgel 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 Emulgel 2.32% Gel is for external
use only.
How long to use Voltarol 12 Hour Emulgel
2.32% Gel for
Do not use Voltarol 12 Hour Emulgel 2.32% Gel 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.
If you use more Voltarol 12 Hour Emulgel
2.32% Gel 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.
If you forget to use Voltarol 12 Hour Emulgel
2.32% Gel
If you miss your application of Voltarol 12 Hour
Emulgel 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.

2.32% Gel 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).
• 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)
• Skin rash, itching, reddening or smarting of the
skin
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.
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.
By reporting side effects you can help provide more
information on the safety of this medicine.

72 mm

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

9 mm

127 mm

9 mm

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

AWF 28279 – OTDC 468249
VOLTAROL EMULGEL 2% 30-50G GB_318839_PIL
145 x 297 mm – PN-Notice-V11 – P07 – Recto/Verso
XXX
Black
Helvetica Neue LT Pro
Text body: 8 pts

NCH Nyon – CH
XXXXXX

Pre-press

Diadeis Suisse SA – AD – DO-17-E0992 – 08.12.2017 – F39

9 mm

9 mm

11.5 mm

Recto

Read all of this leaflet carefully because it
contains important information for you.
Always use Voltarol Joint Pain Relief 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 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.
• 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.
In this leaflet
1. What Voltarol Joint Pain Relief 2.32% Gel is and
what it is used for
2. What you need to know about Voltarol Joint Pain
Relief 2.32% Gel
3. How to use Voltarol Joint Pain Relief 2.32% Gel
4. Possible side effects
5. How to store Voltarol Joint Pain Relief 2.32% Gel
6. What is in the pack and further information

Voltarol Joint Pain Relief 2.32% Gel contains the
active substance diclofenac which belongs to
a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs). It is specially
formulated for rubbing into the skin.
Voltarol 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 Joint Pain Relief 2.32% Gel
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 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
Joint Pain Relief 2.32% Gel:
Do not use Voltarol Joint Pain Relief 2.32% Gel
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.

11.5 mm

72 mm

Pharma code XXX

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

• have severe joint pain of recent onset that is not
related to an injury or period of overuse.
• 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 Joint Pain Relief 2.32% Gel.
Take special care with Voltarol Joint Pain Relief
2.32% Gel
• 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 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 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.
• 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 a stomach or duodenal ulcer
(or a history of), tell your doctor or pharmacist
before using the gel.
• 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 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 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 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 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 Joint Pain Relief 2.32% Gel should only be
used under medical advice during breast-feeding
as diclofenac passes into breast milk in small
amounts. However, Voltarol Joint Pain Relief 2.32%
Gel 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 breast-feeding.
Effects of other ingredients (excipients)
Voltarol Joint Pain Relief 2.32% Gel contains:
• propylene glycol, which may cause a mild
localised skin irritation in some people.

145 mm

297 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

AWF 28279 – OTDC 468249
VOLTAROL EMULGEL 2% 30-50G GB_318839_PIL
145 x 297 mm – PN-Notice-V11 – P07 – Recto/Verso
XXX
Black
Helvetica Neue LT Pro
Text body: 8 pts

NCH Nyon – CH
XXXXXX

Pre-press

Diadeis Suisse SA – AD – DO-17-E0992 – 08.12.2017 – F39

9 mm

9 mm

11.5 mm

Verso

4. Possible side effects

5. How to store Voltarol Joint Pain Relief
2.32% Gel
• Keep this medicine out of the sight and reach
of children.
• Do not use Voltarol Joint Pain Relief 2.32% Gel
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
What Voltarol 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 Joint Pain Relief 2.32% Gel looks
like and contents of the pack
Voltarol 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 30 g and 50 g. Not
all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
GlaxoSmithKline Consumer Healthcare (UK)
Trading Limited, Brentford, TW8 9GS, U.K.
This leaflet was last approved in:
November 2017.

GB 318839 – XXXXXX

11.5 mm

Like all medicines, Voltarol Joint Pain Relief 2.32%
Gel can cause side effects, although not everybody
gets them.
Some rare and very rare side effects might
be serious
If you experience any of the following signs of
allergy, STOP using Voltarol Joint Pain Relief 2.32%
Gel 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

Pharma code XXX

Always use this medicine exactly as described in
this leaflet.
You should check with your doctor or pharmacist if
you are not sure.
How much Voltarol 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 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 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 Joint Pain Relief 2.32% Gel is for external
use only.
How long to use Voltarol Joint Pain Relief 2.32%
Gel for
Do not use Voltarol Joint Pain Relief 2.32% Gel 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.
If you use more Voltarol Joint Pain Relief 2.32%
Gel 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.
If you forget to use Voltarol Joint Pain Relief
2.32% Gel
If you miss your application of Voltarol 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.

72 mm

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

effects are likely to affect less than 1 person
in every 10,000).
• 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)
• Skin rash, itching, reddening or smarting of the
skin
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.
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.
By reporting side effects you can help provide more
information on the safety of this medicine.

145 mm

297 mm

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

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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