Skip to Content

DICLOFENAC DIETHYLAMMONIUM 1.16% W/W EMULGEL

Active substance(s): DICLOFENAC DIETHYLAMINE

View full screen / Print PDF » Download PDF ⇩
Transcript
500854/PL1f

Diclofenac diethylammonium 1.16% w/w Emulgel

®

Patient Information Leaflet
The name of your medicine is Diclofenac diethylammonium
®
1.16% w/w Emulgel . Throughout this leaflet it will be referred
®
to as Diclofenac diethylammonium Emulgel .

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 Diclofenac diethylammonium 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.

Read all of this leaflet carefully because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- 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.

®

Diclofenac diethylammonium Emulgel must not be used
during the last 3 months of pregnancy, as it could harm your
unborn child or cause problems at delivery. Diclofenac
®
diethylammonium 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.

In this leaflet
®
1) What Diclofenac diethylammonium Emulgel is and
what it is used for
®
2) Before you use Diclofenac diethylammonium Emulgel
®
3) How to use Diclofenac diethylammonium Emulgel
4) Possible side effects
®
5) How to store Diclofenac diethylammonium Emulgel
6) Further information

®

Diclofenac diethylammonium Emulgel should only be used
under medical advice during breast-feeding as diclofenac
passes into breast milk in small amounts. However,
®
Diclofenac diethylammonium 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.

®

1) WHAT DICLOFENAC DIETHYLAMMONIUM EMULGEL
IS AND WHAT IT IS USED FOR
®
Diclofenac diethylammonium 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 used to
relieve pain and reduce inflammation and swelling in painful
conditions affecting the joints and muscles. Diclofenac
®
diethylammonium Emulgel can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)
• tendonitis (e.g. tennis elbow)
• osteoarthritis.
2) BEFORE YOU USE DICLOFENAC DIETHYLAMMONIUM
®
EMULGEL
®
DO NOT use Diclofenac diethylammonium Emulgel if you:
• are in the last 3 months of your pregnancy (see also
pregnancy and lactation section)
• have an allergy (hypersensitivity) to any of the
ingredients in the product (see Section 6 ‘What
®
Diclofenac diethylammonium Emulgel contains’).
• have ever had an allergic reaction to diclofenac or
other medicines used to treat pain, fever or
inflammation, such as aspirin (acetylsalicylic 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.
This medicine is not recommended for use in children
under 14 years of age.
Take special care with Diclofenac diethylammonium
®
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.

Driving and using machines
®
Diclofenac diethylammonium 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
®
Diclofenac diethylammonium Emulgel
The gel formulation contains propylene, which may cause
mild localised skin irritation in some people.
3) HOW TO USE DICLOFENAC DIETHYLAMMONIUM
®
EMULGEL
®
• Always use Diclofenac diethylammonium Emulgel
exactly as your doctor has told you.
• 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 Diclofenac diethylammonium Emulgel in
your eyes. If this happens, rinse your eyes well with
clean water. See your doctor or pharmacist if any
discomfort persists.
Adults
1. Take the tube out of the carton. Before first use, pierce
the sealing membrane of the tube with the spiked top
of the cap. 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. 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.
4. Be careful not to get the gel in your eyes. If this
happens, rinse your eyes with clean water and tell your
doctor.
5. Wash your hands after rubbing in Diclofenac
®
diethylammonium Emulgel , unless your hands are the
site being treated. Replace the cap.
6. Allow at least four hours between applications of the
gel. Do not apply more than 4 times in any 24 hour
period.
Continued overleaf

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

Do not use Diclofenac diethylammonium Emulgel for more
than:
• 2 weeks for muscle and joints injuries (e.g. sprains,
strains, bruises) or tendonitis.
• If you are using the gel for arthritis, your doctor may
wish to review your treatment regularly.
If symptoms do not improve within this time, or they get
worse, consult 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 Diclofenac diethylammonium Emulgel
than you should
If you or a child accidentally swallows Diclofenac
®
diethylammonium Emulgel , contact your doctor or accident
and emergency department immediately.
If you forget to use Diclofenac diethylammonium
®
Emulgel
If you miss your application of Diclofenac diethylammonium
®
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, Diclofenac diethylammonium Emulgel can
cause side effects, although not everybody gets them.

6) FURTHER INFORMATION
®
What Diclofenac diethylammonium Emulgel contains
The active substance is diclofenac diethylammonium 1.16%
w/w corresponding to 1% w/w diclofenac sodium.
The other ingredients are: diethylamine, carbomer, cocyl
caprylocaprate, isopropyl alcohol, liquid paraffin, perfume
crème 45, propylene glycol, cetomacrogol 1000 and deionised water (see end of Section 2 ‘Important information
about some of the ingredients of Diclofenac diethylammonium
®
Emulgel ’ for propylene glycol).
®

What Diclofenac diethylammonium Emulgel looks like
and contents of the pack
®
Diclofenac diethylammonium Emulgel is a white to off white,
soft, homogeneous, cream-like, aqueous, emulsion gel.
It comes in a 100 g tube.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Novartis Consumer Health SA, Basle, Switzerland.
Diclofenac diethylammonium 1.16% w/w Emulgel
PL No: 18067/0296
POM

®

th

This leaflet was last revised on 26 October 2015.
®

Emulgel is a registered trademark of Novartis AG.

Some rare and very rare side effects might be serious
If you experience any of the following signs of allergy,
®
STOP using Diclofenac diethylammonium 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.
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.
5) HOW TO STORE DICLOFENAC DIETHYLAMMONIUM
®
EMULGEL
Keep out of the sight and reach of children.
Do not store above 30°C. Protect from heat.
®
Do not use Diclofenac diethylammonium 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.

500854/PL1f

800855/PL1f

Diclofenac diethylammonium 1.16% w/w Gel
Patient Information Leaflet
The name of your medicine is Diclofenac diethylammonium
1.16% w/w Gel. Throughout this leaflet it will be referred to as
Diclofenac diethylammonium Gel.
Read all of this leaflet carefully because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- 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.
In this leaflet
1) What Diclofenac diethylammonium Gel is and what it is
used for
2) Before you use Diclofenac diethylammonium Gel
3) How to use Diclofenac diethylammonium Gel
4) Possible side effects
5) How to store Diclofenac diethylammonium Gel
6) Further information
1) WHAT DICLOFENAC DIETHYLAMMONIUM GEL IS AND
WHAT IT IS USED FOR
Diclofenac diethylammonium Gel 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 used to
relieve pain and reduce inflammation and swelling in painful
conditions affecting the joints and muscles. Diclofenac
diethylammonium Gel can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)
• tendonitis (e.g. tennis elbow)
• osteoarthritis.
2) BEFORE YOU USE DICLOFENAC DIETHYLAMMONIUM
GEL
DO NOT use Diclofenac diethylammonium Gel if you:
• are in the last 3 months of your pregnancy (see also
pregnancy and lactation section)
• have an allergy (hypersensitivity) to any of the
ingredients in the product (see Section 6 ‘What
Diclofenac diethylammonium Gel contains’).
• have ever had an allergic reaction to diclofenac or
other medicines used to treat pain, fever or
inflammation, such as aspirin (acetylsalicylic 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.
This medicine is not recommended for use in children
under 14 years of age.
Take special care with Diclofenac diethylammonium 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.
• 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.
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 Diclofenac diethylammonium Gel 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.
Diclofenac diethylammonium Gel must not be used during the
last 3 months of pregnancy, as it could harm your unborn
child or cause problems at delivery. Diclofenac
diethylammonium 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.
Diclofenac diethylammonium Gel should only be used under
medical advice during breast-feeding as diclofenac passes
into breast milk in small amounts. However, Diclofenac
diethylammonium 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 breastfeeding.
Driving and using machines
Diclofenac diethylammonium Gel, 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
Diclofenac diethylammonium Gel
The gel formulation contains propylene glycol, which may
cause mild localised skin irritation in some people.
3) HOW TO USE DICLOFENAC DIETHYLAMMONIUM GEL
• Always use Diclofenac diethylammonium Gel exactly
as your doctor has told you.
• 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 Diclofenac diethylammonium Gel in your
eyes. If this happens, rinse your eyes well with clean
water. See your doctor or pharmacist if any discomfort
persists.
Adults
1. Take the tube out of the carton. Before first use, pierce
the sealing membrane of the tube with the spiked top
of the cap. 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. 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.
4. Be careful not to get the gel in your eyes. If this
happens, rinse your eyes with clean water and tell your
doctor.
5. Wash your hands after rubbing in Diclofenac
diethylammonium Gel, unless your hands are the site
being treated. Replace the cap.
6. 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.
Continued overleaf

Do not use Diclofenac diethylammonium Gel for more than:
• 2 weeks for muscle and joints injuries (e.g. sprains,
strains, bruises) or tendonitis.
• If you are using the gel for arthritis, your doctor may
wish to review your treatment regularly.
If symptoms do not improve within this time, or they get
worse, consult 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 Diclofenac diethylammonium Gel than
you should
If you or a child accidentally swallows Diclofenac
diethylammonium Gel, contact your doctor or accident and
emergency department immediately.

6) FURTHER INFORMATION
What Diclofenac diethylammonium Gel contains
The active substance is diclofenac diethylammonium 1.16%
w/w corresponding to 1% w/w diclofenac sodium.
The other ingredients are: diethylamine, carbomer, cocyl
caprylocaprate, isopropyl alcohol, liquid paraffin, perfume
crème 45, propylene glycol, cetomacrogol 1000 and deionised water (see end of Section 2 ‘Important information
about some of the ingredients of Diclofenac diethylammonium
Gel’ for propylene glycol).
What Diclofenac diethylammonium Gel looks like and
contents of the pack
Diclofenac diethylammonium Gel is a white to off white, soft,
homogeneous, cream-like, aqueous, emulsion gel.
It comes in a 100 g tube.

If you forget to use Diclofenac diethylammonium Gel
If you miss your application of Diclofenac diethylammonium
Gel 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.

Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.

If you have any further questions on the use of this product,
ask your pharmacist.

Manufacturer
Novartis Consumer Health SA, Basle, Switzerland.

4) POSSIBLE SIDE EFFECTS
Like all medicines, Diclofenac diethylammonium Gel can
cause side effects, although not everybody gets them.

Diclofenac diethylammonium 1.16% w/w Gel
PL No: 18067/0296
POM
th

This leaflet was last revised on 26 October 2015.
Some rare and very rare side effects might be serious
If you experience any of the following signs of allergy,
STOP using Diclofenac diethylammonium Gel 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.
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.
5) HOW TO STORE DICLOFENAC DIETHYLAMMONIUM
GEL
Keep out of the sight and reach of children.
Do not store above 30°C.
Protect from heat.
Do not use Diclofenac diethylammonium Gel 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.
800855/PL1f

500850/PL1f

®

®

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

(diclofenac diethylammonium)
Patient Information Leaflet
Read all of this leaflet carefully because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- 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.
In this leaflet
®
®
1) What Voltarol Emulgel is and what it is used for
®
®
2) Before you use Voltarol Emulgel
®
®
3) How to use Voltarol Emulgel
4) Possible side effects
®
®
5) How to store Voltarol Emulgel
6) Further information
®

®

1) WHAT VOLTAROL EMULGEL IS AND WHAT IT IS
USED FOR
®
®
Voltarol 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 used to
relieve pain and reduce inflammation and swelling in painful
®
®
conditions affecting the joints and muscles. Voltarol Emulgel
can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)
• tendonitis (e.g. tennis elbow)
• osteoarthritis.
®

®

2) BEFORE YOU USE VOLTAROL EMULGEL
®
®
DO NOT use Voltarol Emulgel if you:
• are in the last 3 months of your pregnancy (see also
pregnancy and lactation section)
• have an allergy (hypersensitivity) to any of the
ingredients in the product (see Section 6 ‘What
®
®
Voltarol Emulgel contains’).
• have ever had an allergic reaction to diclofenac or
other medicines used to treat pain, fever or
inflammation, such as aspirin (acetylsalicylic 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.
This medicine is not recommended for use in children
under 14 years of age.
®

®

Take special care with Voltarol 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.
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 if you are already taking
diclofenac tablets or other NSAID pain/inflammation tablets
(e.g. aspirin or ibuprofen).

®

®

®

®

Voltarol 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 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 Emulgel should only be used under medical advice
during breast-feeding as diclofenac passes into breast milk in
®
®
small amounts. However, Voltarol 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 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 Emulgel
The gel formulation contains propylene glycol, which may
cause mild localised skin irritation in some people.
®

®

3) HOW TO USE VOLTAROL EMULGEL
®
®
• Always use Voltarol Emulgel exactly as your doctor
has told you.
• 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 Emulgel in your eyes. If this
happens, rinse your eyes well with clean water. See
your doctor or pharmacist if any discomfort persists.
Adults
1. Take the tube out of the carton. Before first use, pierce
the sealing membrane of the tube with the spiked top
of the cap. 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. 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.
4. Be careful not to get the gel in your eyes. If this
happens, rinse your eyes with clean water and tell your
doctor.
®
®
5. Wash your hands after rubbing in Voltarol Emulgel ,
unless your hands are the site being treated. Replace
the cap.
6. 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.

Continued overleaf

®

®

Do not use Voltarol Emulgel for more than:
• 2 weeks for muscle and joints injuries (e.g. sprains,
strains, bruises) or tendonitis.
• If you are using the gel for arthritis, your doctor may
wish to review your treatment regularly.
If symptoms do not improve within this time, or they get
worse, consult 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 Emulgel than you should
®
®
If you or a child accidentally swallows Voltarol Emulgel ,
contact your doctor or accident and emergency department
immediately.
®

®

If you forget to use Voltarol Emulgel
®
®
If you miss your application of Voltarol 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 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 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).

6) FURTHER INFORMATION
®
®
What Voltarol Emulgel contains
The active substance is diclofenac diethylammonium 1.16%
w/w corresponding to 1% w/w diclofenac sodium.
The other ingredients are: diethylamine, carbomer, cocyl
caprylocaprate, isopropyl alcohol, liquid paraffin, perfume
crème 45, propylene glycol, cetomacrogol 1000 and deionised water (see end of Section 2 ‘Important information
®
®
about some of the ingredients of Voltarol Emulgel ’ for
propylene glycol).
®

®

What Voltarol Emulgel looks like and contents of the
pack
®
®
Voltarol Emulgel is a white to off white, soft, homogeneous,
cream-like, aqueous, emulsion gel.
It comes in a 100 g tube.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Novartis Consumer Health SA, Basle, Switzerland.
®

®

Voltarol Emulgel
PL No: 18067/0296

POM
th

This leaflet was last revised on 26 October 2015.
®

Voltarol and Emulgel
Novartis AG.

®

are registered trademarks of

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.
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.
®

®

5) HOW TO STORE VOLTAROL EMULGEL
Keep out of the sight and reach of children.
Do not store above 30°C.
Protect from heat.
®
®
Do not use Voltarol 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.

500850/PL1f

500852/PL1f

®

®

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.

Voltaren Emulgel

(diclofenac diethylammonium)
Patient Information Leaflet
Read all of this leaflet carefully because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- 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.
In this leaflet
®
®
1) What Voltaren Emulgel is and what it is used for
®
®
2) Before you use Voltaren Emulgel
®
®
3) How to use Voltaren Emulgel
4) Possible side effects
®
®
5) How to store Voltaren Emulgel
6) Further information
®

®

1) WHAT VOLTAREN EMULGEL IS AND WHAT IT IS
USED FOR
®
®
Voltaren 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 used to
relieve pain and reduce inflammation and swelling in painful
®
conditions affecting the joints and muscles. Voltaren
®
Emulgel can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)
• tendonitis (e.g. tennis elbow)
• osteoarthritis.
®

®

2) BEFORE YOU USE VOLTAREN EMULGEL
®
®
DO NOT use Voltaren Emulgel if you:
• are in the last 3 months of your pregnancy (see also
pregnancy and lactation section)
• have an allergy (hypersensitivity) to any of the
ingredients in the product (see Section 6 ‘What
®
®
Voltaren Emulgel contains’).
• have ever had an allergic reaction to diclofenac or
other medicines used to treat pain, fever or
inflammation, such as aspirin (acetylsalicylic 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.
This medicine is not recommended for use in children
under 14 years of age.
®

®

Take special care with Voltaren 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.
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 Voltaren Emulgel if you are already taking
diclofenac tablets or other NSAID pain/inflammation tablets
(e.g. aspirin or ibuprofen).

®

®

®

®

Voltaren Emulgel must not be used during the last 3 months
of pregnancy, as it could harm your unborn child or cause
®
®
problems at delivery. Voltaren 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.
Voltaren Emulgel should only be used under medical advice
during breast-feeding as diclofenac passes into breast milk in
®
®
small amounts. However, Voltaren 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
®
®
Voltaren 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
®
®
Voltaren Emulgel
The gel formulation contains propylene glycol, which may
cause mild localised skin irritation in some people.
®

®

3) HOW TO USE VOLTAREN EMULGEL
®
®
• Always use Voltaren Emulgel exactly as your doctor
has told you.
• 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 Voltaren Emulgel in your eyes. If this
happens, rinse your eyes well with clean water. See
your doctor or pharmacist if any discomfort persists.
Adults
1. Take the tube out of the carton. Before first use, pierce
the sealing membrane of the tube with the spiked top
of the cap. 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. 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.
4. Be careful not to get the gel in your eyes. If this
happens, rinse your eyes with clean water and tell your
doctor.
®
®
5. Wash your hands after rubbing in Voltaren Emulgel ,
unless your hands are the site being treated. Replace
the cap.
6. 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.

Continued overleaf

®

®

Do not use Voltaren Emulgel for more than:
• 2 weeks for muscle and joints injuries (e.g. sprains,
strains, bruises) or tendonitis.
• If you are using the gel for arthritis, your doctor may
wish to review your treatment regularly.
If symptoms do not improve within this time, or they get
worse, consult 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 Voltaren Emulgel than you should
®
®
If you or a child accidentally swallows Voltaren Emulgel ,
contact your doctor or accident and emergency department
immediately.
®

®

If you forget to use Voltaren Emulgel
®
®
If you miss your application of Voltaren 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, Voltaren 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 Voltaren 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).

6) FURTHER INFORMATION
®
®
What Voltaren Emulgel contains
The active substance is diclofenac diethylammonium 1.16%
w/w corresponding to 1% w/w diclofenac sodium.
The other ingredients are: diethylamine, carbomer, cocyl
caprylocaprate, isopropyl alcohol, liquid paraffin, perfume
crème 45, propylene glycol, cetomacrogol 1000 and deionised water (see end of Section 2 ‘Important information
®
®
about some of the ingredients of Voltaren Emulgel ’ for
propylene glycol).
®

®

What Voltaren Emulgel looks like and contents of the
pack
®
®
Voltaren Emulgel is a white to off white, soft, homogeneous,
cream-like, aqueous, emulsion gel.
It comes in a 100 g tube.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Novartis Consumer Health SA, Basle, Switzerland.
®

®

Voltaren Emulgel
PL No: 18067/0296

POM
th

This leaflet was last revised on 26 October 2015.
®

Voltaren and Emulgel
Novartis AG.

®

are registered trademarks of

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.
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.
®

®

5) HOW TO STORE VOLTAREN EMULGEL
Keep out of the sight and reach of children.
Do not store above 30°C.
Protect from heat.
®
®
Do not use Voltaren 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.
500852/PL1f

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.

Hide