VOLTAROL PAIN-EZE EMULGEL

Active substance: DICLOFENAC DIETHYLAMMONIUM SALT

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Draft A

9

11.5

RECTO

Patient Information Leaflet

Do not use Voltarol Pain-eze Emulgel if you are already
taking diclofenac tablets or other NSAID pain/inflammation
tablets (e.g. aspirin or ibuprofen).

Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription. However,
you still need to use Voltarol Pain-eze Emulgel carefully to
get the best results from it.
• 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 symptoms worsen or
do not improve within 7 days.
• If any of the side effects gets serious, or if you notice
any side effect not listed in this leaflet, please tell your
doctor or pharmacist.

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 Pain-eze 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 Pain-eze
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 Pain-eze Emulgel should only be used under
medical advice during breast-feeding as diclofenac
passes into breast milk in small amounts. However,
Voltarol Pain-eze 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.

In this leaflet
1. What Voltarol Pain-eze Emulgel is and what it is used for
2. Before you use Voltarol Pain-eze Emulgel
3. How to use Voltarol Pain-eze Emulgel
4. Possible side effects
5. How to store Voltarol Pain-eze Emulgel
6. Further information

Driving and using machines
Voltarol Pain-eze Emulgel, when used as directed, is not
expected to have any effect on your ability to drive or use
machines.

1. What Voltarol Pain-eze Emulgel is and what it is
used for
297

Voltarol Pain-eze 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 and
is used to relieve pain and reduce inflammation and
swelling in painful conditions affecting the joints and
muscles. Voltarol Pain-eze Emulgel can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)
• tendonitis (e.g. tennis elbow)

Important information about some of the ingredients
of Voltarol Pain-eze Emulgel
The gel formulation contains propylene glycol and benzyl
benzoate, which may cause mild localised skin irritation
in some people.
3. How to use Voltarol Pain-eze Emulgel
• 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.
• The gel is for external use only. Do not use it in your
mouth. Inform your doctor immediately in case of
accidental swallowing.
• Do not put Voltarol Pain-eze Emulgel in your eyes. If
this happens, rinse your eyes well with clean water.
See your doctor or pharmacist if any discomfort persists.

2. Before you use Voltarol Pain-eze Emulgel
DO NOT use Voltarol Pain-eze Emulgel if you:

Pharma code XXX

• have an allergy (hypersensitivity) to any of the ingredients
in the product (see Section 6 ‘What Voltarol Pain-eze
Emulgel contains’).
• have ever had an allergic reaction to diclofenac or other
medicines used to treat pain, fever or inflammation, such
as aspirin (acetylsalicyclic acid) or ibuprofen. Symptoms
of an allergic reaction to these medicines may include:
asthma, wheezing or shortness of breath; skin rash or
hives; swelling of the face or tongue; runny nose.
• are in the last 3 months of your pregnancy (see also
pregnancy and breast-feeding section).
• are using any other medicine containing diclofenac or
are taking oral NSAIDs such as aspirin or ibuprofen.

Adults and adolescents 14 years and over
1. Take the tube out of the carton:
a. For the aluminium tube: Before first use, pierce the
sealing membrane of the tube with the spiked top
of the cap. Do not use if seal is broken
b. For the laminated tube: Unscrew and remove cap.
When using for the first time, reverse the cap,
engage with the nozzle, twist and remove the seal
from the tube. Do not use if seal is broken.
2. Gently squeeze out a small amount of gel from the tube
and apply to the painful or swollen area 3 to 4 times a
day, slowly rubbing into the skin. The amount needed
will vary depending on 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. You may notice a
slight cooling effect when you rub the gel in.
3. In addition to applying the gel, the guidelines (known
as “RICE”) may be useful to help healing of sprains.
See the end of this leaflet.
4. Do not rub the gel into cuts, open wounds or any other
area where the skin is abnormal. After rubbing the gel into
the skin, do not cover with bandages or sticking plaster.
5. Be careful not to get the gel in your eyes. If this happens,
rinse your eyes with clean water and tell your doctor.
6. Wash your hands after rubbing in Voltarol Pain-eze Emulgel,
unless your hands are the site being treated. Replace the cap.
7. Allow at least four hours between applications of the gel.
Do not apply more than 4 times in any 24 hour period.

This medicine is not recommended for use in children
under 14 years of age.

72

Take special care with Voltarol Pain-eze 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.
• Be careful when sunbathing or using sun lamps as
your skin may be more sensitive to sunlight.
• 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.

11.5

Taking other medicines
Please tell your doctor or pharmacist if you are taking, or
have recently taken, any other medicines, including those
obtained without a prescription.

9
145

Draft A

9

11.5

VERSO

6. Further information

If you forget to use Voltarol Pain-eze Emulgel
If you miss your application of Voltarol Pain-eze Emulgel
at the correct time, apply it as soon as you remember
then carry on as normal. Do not apply a double quantity to
make up for a forgotten application.
If you have any further questions on the use of this product,
ask your pharmacist.

What Voltarol Pain-eze Emulgel looks like and contents
of the pack
Voltarol Pain-eze Emulgel is a white, cooling, non-greasy,
non-staining cream-like gel, packed inside an aluminium
or aluminium laminated tube with plastic screw cap. This
is supplied in a carton and comes in packs of 10g, 30g,
50g or 100g (not all pack sizes may be marketed).

4. Possible side effects
Like all medicines, Voltarol Pain-eze Emulgel can cause
side effects, although not everybody gets them.

Marketing authorisation holder and manufacturer
Novartis Consumer Health, Horsham, RH12 5AB, UK

Some rare and very rare side effects might be serious
If you experience any of the following signs of allergy,
STOP using Voltarol Pain-eze Emulgel and tell a doctor or
pharmacist immediately:
Skin rash with blisters; hives (may affect between 1 and
10 in every 10,000 people).
Wheezing, shortness of breath or feeling of tightness in
the chest (asthma) (may affect less than 1 in every
10,000 people).
Swelling of the face, lips, tongue or throat (may affect
less than 1 in every 10,000 people).
Other side effects which may occur are usually mild,
passing and harmless (if you are concerned, tell a doctor
or pharmacist).
Common side effects (may affect between 1 and 10 in
every 100 people) Skin rash, itching, reddening or smarting of the skin
Very rare side effects (may affect less than 1 in every
10,000 people) the skin may be more sensitive to the sun.
Possible signs are sunburn with itching, swelling and
blistering.

RICE advice:
In addition to applying the gel, these guidelines (known as
“RICE”) may be useful to help healing of sprains.
Day 1 to Day 3
Stop using the injured joint as much as possible
in the first 48 hours. If you are unable to use
the joint, e.g. put any weight at all on an
REST
ankle, it may be broken, so see a doctor as
soon as possible so that an X-ray can be done
To decrease both swelling and pain, take a bag of
ice (or frozen vegetables), wrap it in a towel, and
ICE
apply for 10-20 minutes (longer may cause frostbite).
Do this every hour, or at least 3 times a day.
Lightly wrap your joint/the affected area with
COMPRESSION an elastic bandage, make sure it is not so
tight that it cuts off circulation to your limb.
If possible raise the affected limb as much as
ELEVATION
possible in the first 48 hours to reduce swelling
and pain

If any of the side effects gets serious or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

This leaflet was last approved in May 2013

11.5

GB XXXXXX - GB 305778

9
145

Pharma code XXX

What Voltarol Pain-eze Emulgel contains
The active substance is diclofenac diethylammonium
(1.16%) equivalent to 1g of diclofenac sodium in each
100 g of gel.
The other ingredients are carbomers, macrogol cetostearyl
ether, cocoyl caprylocaprate, diethylamine, isopropyl
alcohol, propylene glycol, liquid paraffin, perfume (contains
benzyl benzoate), purified water (see end of Section 2
‘Important information about some of the ingredients
of Voltarol Pain-eze Emulgel’ for propylene glycol).

If you use more Voltarol Pain-eze Emulgel than you
should
If you or a child accidentally swallows Voltarol Pain-eze
Emulgel, contact your doctor or accident and emergency
department immediately.

297

72

5. How to store Voltarol Pain-eze Emulgel
Keep out of the reach and sight of children.
Do not store above 30°C.
Do not use Voltarol Pain-eze Emulgel after the expiry
date stated on the carton and tube.
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.

This medicine is not recommended for use in children
under 14 years of age.
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.
Do not use Voltarol Pain-eze 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
worsen, speak to your doctor. If symptoms do not improve
within this time, or they get worse, consult your doctor.

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

AWF 18441 - OTDC 311901
VOLTAROL PAIN EZE EMULGEL 40G GB_304282_PIL
148 x 210 mm - Recto/Verso
XXXX
Black
Helvetica Neue LT Pro
8 pts
XXXXXX
Novartis Pharma Wehr – DE
XXXXXX

Pre-press

GSG400953 - KR - 10.09.2013

Draft A

Recto
12

10

148 mm

Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription. However,
you still need to use Voltarol Pain-eze Emulgel carefully
to get the best results from it.
• 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 symptoms worsen
or do not improve within 7 days.
• If any of the side effects gets serious, or if you notice
any side effect not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet
1. Voltarol Pain-eze Emulgel is and what it is used for
2. Before you use Voltarol Pain-eze Emulgel
3. How to use Voltarol Pain-eze Emulgel
4. Possible side effects
5. How to store Voltarol Pain-eze Emulgel
6. Further information
1. What Voltarol Pain-eze Emulgel is and what
it is used for
Voltarol Pain-eze 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 and
is used to relieve pain and reduce inflammation and
swelling in painful conditions affecting the joints and
muscles. Voltarol Pain-eze Emulgel can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)
• tendonitis (e.g. tennis elbow)
2. Before you use Voltarol Pain-eze Emulgel
DO NOT use Voltarol Pain-eze Emulgel if you:
• have an allergy (hypersensitivity) to any of the
ingredients in the product (see Section 6 ‘What
Voltarol Pain-eze Emulgel contains’).
• have ever had an allergic reaction to diclofenac or other
medicines used to treat pain, fever or inflammation, such
as aspirin (acetylsalicyclic acid) or ibuprofen. Symptoms
of an allergic reaction to these medicines may include:
asthma, wheezing or shortness of breath; skin rash
or hives; swelling of the face or tongue; runny nose.
• if you are in the last 3 months of your pregnancy
(see also pregnancy and lactation section).
• are using any other medicine containing diclofenac
or are taking oral NSAIDs such as aspirin or ibuprofen.
This medicine is not recommended for use
in children under 14 years of age.
Take special care with Voltarol Pain-eze 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.
• Be careful when sunbathing or using sun lamps
as your skin may be more sensitive to sunlight.
• 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking,
or have recently taken, any other medicines, including
those obtained without a prescription.
Do not use Voltarol Pain-eze Emulgel if you are already
taking diclofenac tablets or other NSAID pain/inflammation tablets (e.g. aspirin or ibuprofen).
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 Pain-eze 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
Pain-eze 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 Pain-eze Emulgel should
only be used under medical advice during breast-feeding
as diclofenac passes into breast milk in small amounts.
However, Voltarol Pain-eze 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.
Driving and using machines
Voltarol Pain-eze Emulgel, when used as directed, is not
expected to have any effect on your ability to drive or
use machines.
Important information about some of the ingredients
of Voltarol Pain-eze Emulgel
The gel formulation contains propylene glycol and benzyl
benzoate, which may cause mild localised skin irritation
in some people.
3. How to use Voltarol Pain-eze Emulgel
• 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.
• The gel is for external use only. Do not use it in your
mouth. Inform your doctor immediately in case
of accidental swallowing.
• Do not put Voltarol Pain-eze Emulgel in your eyes.
If this happens, rinse your eyes well with clean water.
See your doctor or pharmacist if any discomfort persists.
10

83.6 mm

210 mm

Patient Information Leaflet

12

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

AWF 18441 - OTDC 311901
VOLTAROL PAIN EZE EMULGEL 40G GB_304282_PIL
148 x 210 mm - Recto/Verso
XXXX
Black
Helvetica Neue LT Pro
8 pts
XXXXXX
Novartis Pharma Wehr – DE
XXXXXX

Pre-press

GSG400953 - KR - 10.09.2013

Verso
148 mm

Adults and adolescents 14 years and over
1. Take the tube out of the carton:
a. For the aluminium tube: Before first use, pierce the
sealing membrane of the tube with the spiked top
of the cap. Do not use if seal is broken
b. For the laminated tube: Unscrew and remove cap.
When using for the first time, reverse the cap,
engage with the nozzle, twist and remove the seal
from the tube. Do not use if seal is broken.
2. Gently squeeze out a small amount of gel from the tube
and apply to the painful or swollen area 3 to 4 times
a day, slowly rubbing into the skin. The amount needed
will vary depending on 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. You may
notice a slight cooling effect when you rub the gel in.
3. In addition to applying the gel, the guidelines (known
as “RICE”) may be useful to help healing of sprains.
See the end of this leaflet.
4. Do not rub the gel into cuts, open wounds or any other
area where the skin is abnormal. After rubbing the gel into
the skin, do not cover with bandages or sticking plaster.
5. Be careful not to get the gel in your eyes. If this happens,
rinse your eyes with clean water and tell your doctor.
6. Wash your hands after rubbing in Voltarol Pain-eze
Emulgel, unless your hands are the site being treated.
Replace the cap.
7. Allow at least four hours between applications of the gel.
Do not apply more than 4 times in any 24 hour period.
This medicine is not recommended for use in children
under 14 years of age.
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.
Do not use Voltarol Pain-eze 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 worsen, speak to your doctor. If symptoms do not improve
within this time, or they get worse, consult your doctor.
If you use more Voltarol Pain-eze Emulgel than you should
If you or a child accidentally swallows Voltarol Pain-eze
Emulgel, contact your doctor or accident and emergency
department immediately.
If you forget to use Voltarol Pain-eze Emulgel
If you miss your application of Voltarol Pain-eze Emulgel
at the correct time, apply it as soon as you remember
then carry on as normal. Do not apply a double quantity
to make up for a forgotten application.
If you have any further questions on the use of this
product, ask your pharmacist.
4. Possible side effects
Like all medicines, Voltarol Pain-eze Emulgel 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 Pain-eze Emulgel and tell a doctor
or pharmacist immediately:
Skin rash with blisters; hives (may affect between
1 and 10 in every 10,000 people).
Wheezing, shortness of breath or feeling of tightness
in the chest (asthma) (may affect less than 1 in every
10,000 people). Swelling of the face, lips, tongue
or throat (may affect less than 1 in every 10,000 people).

Other side effects which may occur are usually mild,
passing and harmless (if you are concerned, tell a doctor
or pharmacist).
Common side effects (may affect between
1 and 10 in every 100 people)
Skin rash, itching, reddening or smarting of the skin
Very rare side effects (may affect less than 1 in every
10,000 people) the skin may be more sensitive to the sun.
Possible signs are sunburn with itching, swelling and blistering.
If any of the side effects gets serious or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5. How to store Voltarol Pain-eze Emulgel
Keep out of the reach and sight of children.
Do not store above 30 °C.
Do not use Voltarol Pain-eze Emulgel after the expiry
date stated on the carton and tube.
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.
6. Further information
What Voltarol Pain-eze Emulgel contains
The active substance is diclofenac diethylammonium
(1.16%) equivalent to 1g of diclofenac sodium in each
100 g of gel.
The other ingredients are carbomers, macrogol
cetostearyl ether, cocoyl caprylocaprate, diethylamine,
isopropyl alcohol, propylene glycol, liquid paraffin,
perfume (contains benzyl benzoate), purified water
(see end of Section 2 ‘Important information about
some of the ingredients of Voltarol Pain-eze Emulgel’
for propylene glycol).
What Voltarol Pain-eze Emulgel looks like and
contents of the pack
Voltarol Pain-eze Emulgel is a white, cooling, non-greasy,
non-staining cream-like gel, packed inside an aluminium
or aluminium laminated tube with plastic screw cap.
This is supplied in a carton and comes in packs
of 10, 30, 40, 50, 60 g (not all pack sizes re marketed).
Marketing authorisation holder and manufacturer
Novartis Consumer Health, Horsham, RH12 5AB, UK
RICE advice:
In addition to applying the gel, these guidelines (known
as “RICE”) may be useful to help healing of sprains.
Day 1 to Day 3
Stop using the injured joint as much as possible
in the first 48 hours. If you are unable to use
REST
the joint, e.g. put any weight at all on an
ankle, it may be broken, so see a doctor as
soon as possible so that an X-ray can be done
To decrease both swelling and pain, take a bag of
ice (or frozen vegetables), wrap it in a towel, and
ICE
apply for 10-20 minutes (longer may cause frostbite).
Do this every hour, or at least 3 times a day.
Lightly wrap your joint/the affected area with
COMPRESSION an elastic bandage, make sure it is not so
tight that it cuts off circulation to you limb.
If possible raise the affected limb as much as
ELEVATION
possible in the first 48 hours to reduce swelling
and pain

This leaflet was last approved in August 2013.
GB 304282 - XXXXXXX
10

86 mm

Pharma code XXX

210 mm

10

12

Draft A

12

Expand view ⇕

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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