DICLOFENAC 1% GEL

Active substance: DICLOFENAC DIETHYLAMINE

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500850/PL1d

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 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 have:
• an allergy (hypersensitivity) to any of the ingredients in
®
®
the product (see Section 6 ‘What Voltarol Emulgel
contains’).
• ever had an allergic reaction to diclofenac or other
medicines used to treat pain, fever or inflammation,
such as aspirin, ibuprofen or acetylsalicylic acid.
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.
• 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
Voltarol® Emulgel® should not be used if you are pregnant or
breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.

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
Diclofenac 1% 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 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.
continued overleaf

4) POSSIBLE SIDE EFFECTS
Like all medicines, Voltarol® Emulgel® can cause side effects,
although not everybody gets them. If you experience any of
the following signs of an allergic reaction (likely to affect
®
fewer than 1 person out of 10,000) stop using Voltarol
®
Emulgel and tell your doctor or pharmacist immediately:
• Skin rash with blisters, hives
• Wheezing, shortness of breath or asthma/feeling of
tightness in the chest
• Swelling of the face, lips, tongue or throat that may
cause difficulty in swallowing, breathing or speaking.
Other side effects which may occur are usually mild, passing
and harmless (if you are concerned, tell your doctor or
pharmacist as soon as you can):
• Skin rash, itching, reddening or smarting (sharp,
stinging pain) of the skin are common after use (likely
to affect 1 to 10 people out of 100).
• In very rare cases, your skin may be more sensitive to
the sun. Possible signs are sunburn with itching,
swelling and blistering (likely to affect fewer than 1
person out of 10,000).
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.
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 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
1 g contains 11.6 mg diclofenac diethylammonium
corresponding to 10 mg 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 and Manufacturer
Procured from within the EU by the Product Licence Holder
Ginova Ltd and repackaged by Ginova UK Ltd both at St
James’ House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by Novartis Consumer Health SA, Basle,
Switzerland.
Voltarol® Emulgel®
PL No: 18067/0296

POM

This leaflet was last revised on 17th April 2013.
®
®
Voltarol and Emulgel are registered trademarks of
Novartis AG.

500850/PL1d

500852/PL1d

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 is 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 have:
• an allergy (hypersensitivity) to any of the ingredients in
®
®
the product (see Section 6 ‘What Voltaren Emulgel
contains’).
• ever had an allergic reaction to diclofenac or other
medicines used to treat pain, fever or inflammation,
such as aspirin, ibuprofen or acetylsalicylic acid.
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.
• 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).
Pregnancy and breast-feeding
Voltaren® Emulgel® should not be used if you are pregnant or
breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.

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
Diclofenac 1% 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.
®
®
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.
continued overleaf

4) POSSIBLE SIDE EFFECTS
Like all medicines, Voltaren® Emulgel® can cause side effects,
although not everybody gets them. If you experience any of
the following signs of an allergic reaction (likely to affect
®
fewer than 1 person out of 10,000) stop using Voltaren
®
Emulgel and tell your doctor or pharmacist immediately:
• Skin rash with blisters, hives
• Wheezing, shortness of breath or asthma/feeling of
tightness in the chest
• Swelling of the face, lips, tongue or throat that may
cause difficulty in swallowing, breathing or speaking.
Other side effects which may occur are usually mild, passing
and harmless (if you are concerned, tell your doctor or
pharmacist as soon as you can):
• Skin rash, itching, reddening or smarting (sharp,
stinging pain) of the skin are common after use (likely
to affect 1 to 10 people out of 100).
• In very rare cases, your skin may be more sensitive to
the sun. Possible signs are sunburn with itching,
swelling and blistering (likely to affect fewer than 1
person out of 10,000).
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.
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 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 Voltaren Emulgel contains
1 g contains 11.6 mg diclofenac diethylammonium
corresponding to 10 mg 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 and Manufacturer
Procured from within the EU by the Product Licence Holder
Ginova Ltd and repackaged by Ginova UK Ltd both at St
James’ House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by Novartis Consumer Health SA, Basle,
Switzerland.
Voltaren® Emulgel®
PL No: 18067/0296

POM

This leaflet was last revised on 17th April 2013.
®
®
Voltaren and Emulgel are registered trademarks of
Novartis AG.

500852/PL1d

500854/PL1d

Diclofenac 1% Emulgel®
(diclofenac diethylammonium)

Driving and using machines
Diclofenac 1% Emulgel®, when used as directed, is not
expected to have any effect on your ability to drive or use
machines.

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 Diclofenac 1% Emulgel is and what it is used
for
2) Before you use Diclofenac 1% Emulgel®
3) How to use Diclofenac 1% Emulgel®
4) Possible side effects
5) How to store Diclofenac 1% Emulgel®
6) Further information
1) WHAT DICLOFENAC 1% EMULGEL® IS AND WHAT IT
IS USED FOR
Diclofenac 1% Emulgel® contains the active substance
diclofenac which belongs to a group of medicines called nonsteroidal 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 1%
®
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 1% EMULGEL®
DO NOT use Diclofenac 1% Emulgel® if you have:
• an allergy (hypersensitivity) to any of the ingredients in
the product (see Section 6 ‘What Diclofenac 1%
Emulgel® contains’).
• ever had an allergic reaction to diclofenac or other
medicines used to treat pain, fever or inflammation,
such as aspirin, ibuprofen or acetylsalicylic acid.
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 1% Emulgel®
• Do not apply the gel to skin that has (i) a rash or
eczema (ii) cuts or open wounds.
• 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 1% Emulgel if you are already taking
diclofenac tablets or other NSAID pain/inflammation tablets
(e.g. aspirin or ibuprofen).
Pregnancy and breast-feeding
®
Diclofenac 1% Emulgel should not be used if you are
pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.

Important information about some of the ingredients of
®
Diclofenac 1% Emulgel
The gel formulation contains propylene glycol which may
cause mild localised skin irritation in some people.
3) HOW TO USE DICLOFENAC 1% EMULGEL®
• Always use Diclofenac 1% 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 1% 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 1%
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 Diclofenac 1% 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 1% Emulgel® than you should
If you or a child accidentally swallows Diclofenac 1%
Emulgel®, contact your doctor or accident and emergency
department immediately.
®

If you forget to use Diclofenac 1% Emulgel
If you miss your application of Diclofenac 1% 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.
continued overleaf

4) POSSIBLE SIDE EFFECTS
Like all medicines, Diclofenac 1% Emulgel® can cause side
effects, although not everybody gets them. If you experience
any of the following signs of an allergic reaction (likely to
affect fewer than 1 person out of 10,000) stop using
®
and tell your doctor or
Diclofenac 1% Emulgel
pharmacist immediately:
• Skin rash with blisters, hives
• Wheezing, shortness of breath or asthma/feeling of
tightness in the chest
• Swelling of the face, lips, tongue or throat that may
cause difficulty in swallowing, breathing or speaking.
Other side effects which may occur are usually mild, passing
and harmless (if you are concerned, tell your doctor or
pharmacist as soon as you can):
• Skin rash, itching, reddening or smarting (sharp,
stinging pain) of the skin are common after use (likely
to affect 1 to 10 people out of 100).
• In very rare cases, your skin may be more sensitive to
the sun. Possible signs are sunburn with itching,
swelling and blistering (likely to affect fewer than 1
person out of 10,000).
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.
5) HOW TO STORE DICLOFENAC 1% EMULGEL®
Keep out of the sight and reach of children.
Do not store above 30°C.
Protect from heat.
Do not use Diclofenac 1% Emulgel® after the expiry date
stated on the carton and tube.
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 1% Emulgel® contains
1 g contains 11.6 mg diclofenac diethylammonium
corresponding to 10 mg 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 1% Emulgel ’ for
propylene glycol).
What Diclofenac 1% Emulgel® looks like and contents of
the pack
®
Diclofenac 1% Emulgel is a white to off white, soft,
homogeneous, cream-like, aqueous, emulsion gel.
It comes in a 100 g tube.
Product Licence Holder and Manufacturer
Procured from within the EU by the Product Licence Holder
Ginova Ltd and repackaged by Ginova UK Ltd both at St
James’ House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by Novartis Consumer Health SA, Basle,
Switzerland.
Diclofenac 1% Emulgel
PL No: 18067/0296

®

POM

th
This leaflet was last revised on 17 April 2013.

Emulgel® is a registered trademark of Novartis AG.

500854/PL1d

800855/PL1d

Diclofenac 1% Gel
(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 Diclofenac 1% Gel is and what it is used for
2) Before you use Diclofenac 1% Gel
3) How to use Diclofenac 1% Gel
4) Possible side effects
5) How to store Diclofenac 1% Gel
6) Further information
1) WHAT DICLOFENAC 1% GEL IS AND WHAT IT IS USED
FOR
Diclofenac 1% 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 is used
to relieve pain and reduce inflammation and swelling in painful
conditions affecting the joints and muscles. Diclofenac 1% 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 1% GEL
DO NOT use Diclofenac 1% Gel if you have:
• an allergy (hypersensitivity) to any of the ingredients in
the product (see Section 6 ‘What Diclofenac 1% Gel
contains’).
• ever had an allergic reaction to diclofenac or other
medicines used to treat pain, fever or inflammation,
such as aspirin, ibuprofen or acetylsalicylic acid.
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 1% Gel
• Do not apply the gel to skin that has (i) a rash or
eczema (ii) cuts or open wounds.
• 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 1% Gel if you are already taking
diclofenac tablets or other NSAID pain/inflammation tablets
(e.g. aspirin or ibuprofen).
Pregnancy and breast-feeding
Diclofenac 1% Gel should not be used if you are pregnant or
breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines
Diclofenac 1% 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 1% Emulgel®
The gel formulation contains propylene glycol which may
cause mild localised skin irritation in some people.
3) HOW TO USE DICLOFENAC 1% GEL
• Always use Diclofenac 1% 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 1% 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 1% 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.
Do not use Diclofenac 1% 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 1% Gel than you should
If you or a child accidentally swallows Diclofenac 1% Gel,
contact your doctor or accident and emergency department
immediately.
If you forget to use Diclofenac 1% Gel
If you miss your application of Diclofenac 1% 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.
If you have any further questions on the use of this product,
ask your pharmacist.
continued overleaf

4) POSSIBLE SIDE EFFECTS
Like all medicines, Diclofenac 1% Gel can cause side effects,
although not everybody gets them. If you experience any of
the following signs of an allergic reaction (likely to affect
fewer than 1 person out of 10,000) stop using Diclofenac
1% Gel and tell your doctor or pharmacist immediately:
• Skin rash with blisters, hives
• Wheezing, shortness of breath or asthma/feeling of
tightness in the chest
• Swelling of the face, lips, tongue or throat that may
cause difficulty in swallowing, breathing or speaking.
Other side effects which may occur are usually mild, passing
and harmless (if you are concerned, tell your doctor or
pharmacist as soon as you can):
• Skin rash, itching, reddening or smarting (sharp,
stinging pain) of the skin are common after use (likely
to affect 1 to 10 people out of 100).
• In very rare cases, your skin may be more sensitive to
the sun. Possible signs are sunburn with itching,
swelling and blistering (likely to affect fewer than 1
person out of 10,000).
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.
5) HOW TO STORE DICLOFENAC 1% GEL
Keep out of the sight and reach of children.
Do not store above 30°C.
Protect from heat.
Do not use Diclofenac 1% Gel after the expiry date stated on
the carton and tube.
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 1% Gel contains
1 g contains 11.6 mg diclofenac diethylammonium
corresponding to 10 mg 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 1% Gel’ for
propylene glycol).
What Diclofenac 1% Gel looks like and contents of the
pack
Diclofenac 1% Gel is a white to off white, soft, homogeneous,
cream-like, aqueous, emulsion gel.
It comes in a 100 g tube.
Product Licence Holder and Manufacturer
Procured from within the EU by the Product Licence Holder
Ginova Ltd and repackaged by Ginova UK Ltd both at St
James’ House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by Novartis Consumer Health SA, Basle,
Switzerland.
Diclofenac 1% Gel
PL No: 18067/0296

POM

This leaflet was last revised on 17th April 2013.

800855/PL1d

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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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