VOLTAROL EMULGEL

Active substance: DICLOFENAC DIETHYLAMMONIUM SALT

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9

11.5

RECTO

Patient Information Leaflet

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 Emulgel P 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. What Voltarol Emulgel P is and what it is used for
2. Before you use Voltarol Emulgel P
3. How to use Voltarol Emulgel P
4. Possible side effects
5. How to store Voltarol Emulgel P
6. Further information
Pharma code 1540

1. What Voltarol Emulgel P is and what it is used for
Voltarol Emulgel P 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 Emulgel P can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)
• tendonitis (e.g. tennis elbow)
• mild arthritis (symptoms of mild arthritis include joint
pain at rest, joint pain on movement, joint swelling or
stiffness (after sleep or long rest)).

• are in the last 3 months of your pregnancy (see also
pregnancy and breast-feeding section).
This medicine is not recommended for use in children
under 14 years of age.
Take special care with Voltarol Emulgel P
• 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 Emulgel P if you are already taking
diclofenac tablets or other NSAID pain/inflammation tablets
(e.g. aspirin or ibuprofen).

11.5

72

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 Emulgel P must not be used during the last 3 months
of pregnancy, as it could harm your unborn child or cause
problems at delivery. Voltarol Emulgel P 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 Emulgel P should only be used under medical advice
2. Before you use Voltarol Emulgel P
during breast-feeding as diclofenac passes into breast milk
DO NOT use Voltarol Emulgel P if you:
• have an allergy (hypersensitivity) to any of the ingredients in in small amounts. However, Voltarol Emulgel P should not
the product (see Section 6 ‘What Voltarol Emulgel P contains’). be applied on the breasts of nursing mothers nor elsewhere
on large areas of skin or for a prolonged period of time.
• have ever had an allergic reaction to diclofenac or other
Consult your doctor or pharmacist for further information if
medicines used to treat pain, fever or inflammation,
you are pregnant or breastfeeding.
such as aspirin or ibuprofen.
Symptoms of an allergic reaction to these medicines may
Driving and using machines
include: asthma, wheezing or shortness of breath; skin
Voltarol Emulgel P, when used as directed, is not expected
rash or hives; swelling of the face or tongue; runny nose.
to have any effect on your ability to drive or use machines.
• are using any other medicine containing diclofenac or
are taking oral NSAIDs such as aspirin or ibuprofen.
Important information about some of the ingredients
• have severe joint pain of recent onset that is not related
of Voltarol Emulgel P
to an injury or period of overuse.
The gel formulation contains propylene glycol and benzyl
• feel ill, have a temperature or any other symptoms that
benzoate, which may cause mild localised skin irritation in
accompany the pain.
some people.

9
145

9

11.5

VERSO

210
11.5

GB 147046 - GB 909540

9
145

Pharma code 1540

If you have any further questions on the use of this product,
ask your pharmacist.
4. Possible side effects
Like all medicines, Voltarol Emulgel P 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 Emulgel P 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.
Some side effects have unknown frequency (cannot be
estimated from available information): local application
site irritation, skin discolouration.
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 Emulgel P
Keep out of the reach and sight of children.
Do not store above 30°C. The dispenser is a pressurised
container, protect from direct sunlight and do not pierce or
burn even when empty.
Do not use Voltarol Emulgel P after the expiry date stated
on the carton and tube, or dispenser.
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 Emulgel P contains
The active substance is diclofenac diethylammonium (1.16%)
equivalent to 1g of diclofenac sodium in each 100g of gel.
The other ingredients are diethylamine, isopropyl alcohol,
liquid paraffin, propylene glycol, perfume (containing benzyl
benzoate), carbomer, macrogol cetostearyl ether, cocoyl
caprylocaprate, purified water (see end of Section 2
‘Important information about some of the ingredients of
Voltarol Emulgel P’ for propylene glycol).
What Voltarol Emulgel P looks like and contents of the pack
Voltarol Emulgel P is a white, cooling, non-greasy,
non-staining cream-like gel, packed inside an aluminium
or aluminium laminated tube with plastic screw cap, or in
a pressurised dispenser. This is supplied in a carton and
comes in packs of 10, 30, 50 g, 75ml and 100g (not all
pack sizes may be marketed).
Marketing authorisation holder and manufacturer
Novartis Consumer Health, Horsham, RH12 5AB, UK
This leaflet was last approved in November 2012.

72

3. How to use Voltarol Emulgel P
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.
Adults and adolescents 14 years and over:
Before using for the first time, open as follows:
• aluminium tube: Unscrew cap and pierce the aluminium seal
with the spiked top of the cap. Do not use if seal is broken.
• laminated tube: Unscrew cap and remove. Reverse the
cap, engage with the nozzle, twist and remove the
plastic seal from the tube. Do not use if seal is broken.
• dispenser: Remove the lid from the top of the dispenser.
How to apply:
Gently squeeze out a small amount of gel from the tube or press
firmly and evenly on the nozzle of the dispenser and apply
to the painful or swollen area, slowly rubbing into the skin.
When and how much to use:
• Apply 3 to 4 times a day. Allow at least 4 hours between
applications of the gel. Do not apply more than 4 times
in any 24 hour period.
• 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 (2 to 4g) will usually be sufficient.
• You may notice a slight cooling effect when you rub the gel in.
• Only use the smallest amount of Voltarol Emulgel P
needed to relieve your pain but never use more than
16g per day and 112g in one week.
How and where to use:
• You can apply the gel to a maximum of 2 joints (such as
your knees or elbows). If you need to apply it to more
than 2 joints, consult your doctor.
• 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.
• The gel is for external use only. Do not use it in your mouth.
• Be careful not to get the gel in your eyes. If this happens,
rinse your eyes with clean water and tell your doctor.
• Wash your hands after rubbing in Voltarol Emulgel P,
unless your hands are the site being treated.
For how long should you use Voltarol Emulgel P?
Do not use Voltarol Emulgel P for more than:
• 14 days unless longer treatment is recommended by a doctor.
• For arthritis pain, you may need to apply the gel for up
to 7 days (to allow its effect to build up on the joint)
before you notice an improvement in your pain.
• If the pain and swelling do not improve within 7 days, or
worsen, speak to 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.
Children under 14 years:
This medicine is not recommended for use in children
under 14 years of age.
If you use more Voltarol Emulgel P than you should
If you or a child accidentally swallows Voltarol Emulgel P,
contact your doctor or accident and emergency
department immediately.
If you forget to use Voltarol Emulgel P
If you miss your application of Voltarol Emulgel P 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.

12

10

RECTO

Patient Information Leaflet

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 Emulgel P 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.

210

In this leaflet
1. What Voltarol Emulgel P is and what it is used for
2. Before you use Voltarol Emulgel P
3. How to use Voltarol Emulgel P
4. Possible side effects
5. How to store Voltarol Emulgel P
6. Further information
1. What Voltarol Emulgel P is and what it is used for
Voltarol Emulgel P 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 Emulgel P can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)
• tendonitis (e.g. tennis elbow)
• mild arthritis (symptoms of mild arthritis include joint
pain at rest, joint pain on movement, joint swelling or
stiffness (after sleep or long rest)).

Take special care with Voltarol Emulgel P
• 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 Emulgel P 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 Emulgel P must not be used during the last 3 months
of pregnancy, as it could harm your unborn child or cause
problems at delivery. Voltarol Emulgel P 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 Emulgel P should only be used under medical advice
during breast-feeding as diclofenac passes into breast milk
in small amounts. However, Voltarol Emulgel P 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 Emulgel P, 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 Emulgel P
The gel formulation contains propylene glycol and benzyl benzoate,
which may cause mild localised skin irritation in some people.
3. How to use Voltarol Emulgel P
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.

10

83.6

2. Before you use Voltarol Emulgel P
DO NOT use Voltarol Emulgel P if you:
• have an allergy (hypersensitivity) to any of the ingredients in
the product (see Section 6 ‘What Voltarol Emulgel P contains’).
• have ever had an allergic reaction to diclofenac or other
medicines used to treat pain, fever or inflammation,
such as aspirin 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 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 your pregnancy (see also
pregnancy and breast-feeding section).

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

12
148

12

10

VERSO

Adults and adolescents 14 years and over:
Before using for the first time, open as follows:
• aluminium tube: Unscrew cap and pierce the aluminium
seal with the spiked top of the cap. Do not use if seal
is broken.
• laminated tube: Unscrew cap and remove. Reverse
the cap, engage with the nozzle, twist and remove the
plastic seal from the tube. Do not use if seal is broken.
• dispenser: Remove the lid from the top of the dispenser.
How to apply:
Gently squeeze out a small amount of gel from the tube or press
firmly and evenly on the nozzle of the dispenser and apply
to the painful or swollen area, slowly rubbing into the skin.

How and where to use:
• You can apply the gel to a maximum of 2 joints (such
as your knees or elbows). If you need to apply it to
more than 2 joints, consult your doctor.
• 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.
• The gel is for external use only. Do not use it in your mouth.
• Be careful not to get the gel in your eyes. If this happens,
rinse your eyes with clean water and tell your doctor.
• Wash your hands after rubbing in Voltarol Emulgel P,
unless your hands are the site being treated.

5. How to store Voltarol Emulgel P
Keep out of the reach and sight of children.
Do not store above 30°C. The dispenser is a pressurised
container, protect from direct sunlight and do not pierce
or burn even when empty.
Do not use Voltarol Emulgel P after the expiry date stated
on the carton and tube, or dispenser.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
For how long should you use Voltarol Emulgel P?
medicines no longer required. These measures will help
Do not use Voltarol Emulgel P for more than:
• 14 days unless longer treatment is recommended by a doctor. to protect the environment.
• For arthritis pain, you may need to apply the gel for up
6. Further information
to 7 days (to allow its effect to build up on the joint)
What Voltarol Emulgel P contains
before you notice an improvement in your pain.
• If the pain and swelling do not improve within 7 days, The active substance is diclofenac diethylammonium (1.16%)
equivalent to 1g of diclofenac sodium in each 100g of gel.
or worsen, speak to your doctor.
The other ingredients are diethylamine, isopropyl alcohol,
• In children aged 14 years and over, if this product is
liquid paraffin, propylene glycol, perfume (containing benzyl
required for more than 7 days for pain relief or if the
symptoms worsen the patient/parents of the adolescent bezoate), carbomer, macrogol cetostearyl ether, cocoyl
caprylocaprate, purified water (see end of Section 2
is/are advised to consult a doctor.
‘Important information about some of the ingredients of
Children under 14 years:
Voltarol Emulgel P’ for propylene glycol).
This medicine is not recommended for use in children
What Voltarol Emulgel P looks like and contents of
under 14 years of age.
the pack
Voltarol Emulgel P is a white, cooling, non-greasy,
If you use more Voltarol Emulgel P than you should
If you or a child accidentally swallows Voltarol Emulgel P, non-staining cream-like gel, packed inside an aluminium
or aluminium laminated tube with plastic screw cap, or in
contact your doctor or accident and emergency
a pressurised dispenser. This is supplied in a carton and
department immediately.
comes in packs of 10, 30, 50 g, 75ml and 100g (not all
If you forget to use Voltarol Emulgel P
pack sizes may be marketed).
If you miss your application of Voltarol Emulgel P at the
Marketing authorisation holder and manufacturer
correct time, apply it as soon as you remember then
Novartis Consumer Health, Horsham, RH12 5AB, UK
carry on as normal. Do not apply a double quantity to
make up for a forgotten application.
This leaflet was last approved in November 2012.
If you have any further questions on the use of this product,
GB 307756 - xxxxxx
ask your pharmacist.

10

86

Pharma code xxx

210

When and how much to use:
• Apply 3 to 4 times a day. Allow at least 4 hours between
applications of the gel. Do not apply more than 4 times
in any 24 hour period.
• 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 (2 to 4g) will usually be sufficient.
• You may notice a slight cooling effect when you rub the gel in.
• Only use the smallest amount of Voltarol Emulgel P
needed to relieve your pain but never use more than
16g per day and 112g in one week.

4. Possible side effects
Like all medicines, Voltarol Emulgel P 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 Emulgel P 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.
Some side effects have unknown frequency (cannot be
estimated from available information): local application
site irritation, skin discolouration.
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.

12
148

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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