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VOLTAROL 1% EMUGEL

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Voltarol® 1% 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.
The name of your medicine is Voltarol 1% Emulgel but
will be referred to as Voltarol Emulgel throughout this
leaflet.

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
is 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).
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 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.
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 any of the side effects get serious or if you
notice any side effects not listed in this leaflet,
STOP USING the gel and tell your doctor or
pharmacist immediately.
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
Protect from light.
Keep out of the sight and reach of children.
Return any unused gel to your pharmacist for safe
disposal. Only keep it of your doctor tells you to.
If the gel becomes discoloured or shows any signs
of deterioration, seek the advice of your
pharmacist.
Medicines should not be disposed of via
wastewater of household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

If you or a child accidentally swallows Voltarol
Emulgel, contact your doctor or accident and
emergency department immediately.

6. Further information
What Voltarol Emulgel contains

If you forget to use Voltarol Emulgel

Each gram of gel contains 11.6mg of diclofenac
diethylammonium salt corresponding to 10mg of
diclofenac sodium.
The gel also contains the following inactive ingredients:
diethylamine, carbomer 974, macrogol cetostearyl
ether, octane / decanoic acid fatty alcohol ester,
isopropyl alcohol, liquid paraffin, perfume crème 45,
propylene glycol dist and purified water.

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).
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.

What Voltarol Emulgel looks like and contents of
the pack
Voltarol Emulgel comes as white and golden yellow
tamper evident sealed tube with a white plastic screw
on cap. It contains a whitish, smooth gel with the odour
of Isopropyl alcohol. It is available in 100g aluminium
tube.
Manufactured by: Novartis Consumer Health GmbH,
81379 Munich, Germany.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
Voltarol 1% Emugel

PL No: 18799/1813

POM

Leaflet date: 29.01.2014
Voltarol and Emulgel are trademarks of Novartis AG

Diclofenac sodium® 1% Emulgel®
(diclofenac diethylammonium salt)

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.
The name of your medicine is Diclofenac sodium 1%
Emulgel but will be referred to as Diclofenac sodium
throughout this leaflet.

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

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

3. How to use Diclofenac sodium
Always use Diclofenac sodium 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 sodium 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
sodium, 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.
Do not use Diclofenac sodium 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 sodium than you
should
If you or a child accidentally swallows Diclofenac
sodium Emulgel, contact your doctor or accident and
emergency department immediately.

If any of the side effects get serious or if you
notice any side effects not listed in this leaflet,
STOP USING the gel and tell your doctor or
pharmacist immediately.
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 sodium
Protect from light.
Keep out of the sight and reach of children.
Return any unused gel to your pharmacist for safe
disposal. Only keep it of your doctor tells you to.
If the gel becomes discoloured or shows any signs
of deterioration, seek the advice of your
pharmacist.
Medicines should not be disposed of via
wastewater of 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 Diclofenac sodium contains

If you miss your application of Diclofenac sodium 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.

Each gram of gel contains 11.6mg of diclofenac
diethylammonium salt corresponding to 10mg of
diclofenac sodium.
The gel also contains the following inactive ingredients:
diethylamine, carbomer 974, macrogol cetostearyl
ether, octane / decanoic acid fatty alcohol ester,
isopropyl alcohol, liquid paraffin, perfume crème 45,
propylene glycol dist and purified water.

4. Possible side effects

What Diclofenac sodium looks like and contents
of the pack

If you forget to use Diclofenac sodium

Like all medicines, Diclofenac sodium 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 Diclofenac sodium 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.

Diclofenac sodium comes as white and golden yellow
tamper evident sealed tube with a white plastic screw
on cap. It contains a whitish, smooth gel with the odour
of Isopropyl alcohol. It is available in 100g aluminium
tube.
Manufactured by: Novartis Consumer Health GmbH,
81379 Munich, Germany.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
Diclofenac sodium 1% Emugel
PL No: 18799/1813

POM

Leaflet date: 29.01.2014
Diclofenac sodium and Emulgel are trademarks of
Novartis AG

+ Expand Transcript

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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