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DICLOFENAC DIETHYLAMMONIUM 1.16PERCENT W/W GEL

Active substance(s): DICLOFENAC DIETHYLAMMONIUM SALT

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Voltarol® 1.16%w/w 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 1.16%w/w
Emulgel but will be referred to as Voltarol Emulgel
throughout this leaflet.

In this leaflet
1.
2.
3.
4.
5.
6.

What Voltarol Emulgel is and what it is used for
Before you use Voltarol Emulgel
How to use Voltarol Emulgel
Possible side effects
How to store Voltarol Emulgel
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 breast-feeding’ 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 and
benzyl benzoate, 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 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).

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 direct sunlight.
Do not use this gel after the expiry date which is
stated on the carton and tube label after ‘Exp’. The
expiry date refers to the last day of that month
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 Voltarol Emulgel contains
The active ingredient in Voltarol Emulgel is diclofenac
diethylammonium.
Each gram gel contains 11.6mg of diclofenac
diethylammonium corresponding to 10mg of diclofenac
sodium.
The other ingredients are diethylamine, carbomer,
macrogol cetostearyl ether, cocoyl caprylocaprate,
isopropyl alcohol, liquid paraffin, perfume creme 45
(contains benzyl benzoate), propylene glycol and
purified water.

What Voltarol Emulgel looks like and contents of
the pack
Voltarol Emulgel is a white to off-white, soft,
homogenous, cream in an aluminium tube with a white
plastic screw cap.
It is available in 100g aluminium tube.

Manufactured by: Novartis Consumer Health GmbH,
DE-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 1.16%w/w Emulgel ;
PL 18799/2902
Leaflet date: 30.06.2016

POM

Diclofenac diethylammonium 1.16%w/w gel
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
diethylammonium 1.16%w/w gel but will be referred to
as Diclofenac diethylammonium throughout this leaflet.

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

1. What Diclofenac diethylammonium is and what
it is used for
Diclofenac diethylammonium 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 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
DO NOT use Diclofenac diethylammonium if
you:
are in the last 3 months of your pregnancy (see also
pregnancy and breast-feeding section)
have an allergy (hypersensitivity) to any of the
ingredients in the product (see Section 6 ‘What
Diclofenac diethylammonium 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
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 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 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 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 should only be used under
medical advice during breast-feeding as diclofenac
passes into breast milk in small amounts. However,
Diclofenac diethylammonium 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, 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
The gel formulation contains propylene glycol and
benzyl benzoate, which may cause mild localised skin
irritation in some people.

3. How to use Diclofenac diethylammonium
Always use Diclofenac diethylammonium 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 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, 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 diethylammonium 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
than you should
If you or a child accidentally swallows Diclofenac
diethylammonium, contact your doctor or accident and
emergency department immediately.

If you forget to use Diclofenac diethylammonium
If you miss your application of Diclofenac
diethylammonium 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 can
cause side effects, although not everybody gets
them.

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
Keep out of the sight and reach of children.
Do not store above 30˚C.
Protect from direct sunlight.
Do not use this gel after the expiry date which is
stated on the carton and tube label after ‘Exp’. The
expiry date refers to the last day of that month
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 diethylammonium contains
The active ingredient in Diclofenac diethylammonium is
diclofenac diethylammonium.
Each gram gel contains 11.6mg of diclofenac
diethylammonium corresponding to 10mg of diclofenac
sodium.
The other ingredients are diethylamine, carbomer,
macrogol cetostearyl ether, cocoyl caprylocaprate,
isopropyl alcohol, liquid paraffin, perfume crème 45
(contains benzyl benzoate), propylene glycol and
purified water.

What Diclofenac diethylammonium looks like and
contents of the pack
Diclofenac diethylammonium is a white to off-white, soft,
homogenous, cream in an aluminium tube with a white
plastic screw cap.
It is available in 100g aluminium tube.

Some rare and very rare side effects might
be serious

Manufactured by: Novartis Consumer Health GmbH,

If you experience any of the following signs of allergy,
STOP using Diclofenac diethylammonium and tell a
doctor or pharmacist immediately:

Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare, Unit 4,

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).

DE-81379 Munich, Germany.

Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Diclofenac diethylammonium 1.16%w/w gel;
PL 18799/2902
Leaflet date: 30.06.2016

POM

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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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