DICLOFENAC 1% GEL

Active substance: DICLOFENAC DIETHYLAMINE

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500854/PL1e

®

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 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.
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 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.

Diclofenac 1% 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 1% 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.
®

Diclofenac 1% Emulgel should only be used under medical
advice during breast-feeding as diclofenac passes into breast
®
milk in small amounts. However, Diclofenac 1% 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
®
Diclofenac 1% 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, 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.

®

2) BEFORE YOU USE DICLOFENAC 1% EMULGEL
®
DO NOT use Diclofenac 1% 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 1% 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 1% 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 Diclofenac 1% Emulgel if you are already taking
diclofenac tablets or other NSAID pain/inflammation tablets
(e.g. aspirin or ibuprofen).

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.

continued overleaf

®

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.
4) POSSIBLE SIDE EFFECTS
®
Like all medicines, Diclofenac 1% 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 Diclofenac 1% 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 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
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 1% Emulgel
PL No: 18067/0296

®

POM
th

This leaflet was last revised on 7 May 2014.
®

Emulgel is a registered trademark of Novartis AG.

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 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 or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

500854/PL1e

800855/PL1e

Diclofenac 1% Gel
(diclofenac diethylammonium)

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.

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 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:
• 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 1% 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 1% 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 1% Gel if you are already taking
diclofenac tablets or other NSAID pain/inflammation tablets
(e.g. aspirin or ibuprofen).

Diclofenac 1% 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 1% 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 1% Gel should only be used under medical advice
during breast-feeding as diclofenac passes into breast milk in
small amounts. However, Diclofenac 1% 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 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% Gel
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.

continued overleaf

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.

6) FURTHER INFORMATION
What Diclofenac 1% Gel contains
1 g contains 11.6 mg diclofenac diethylammonium
corresponding to 10 mg diclofenac sodium.

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.

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).

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.

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.

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.

It comes in a 100 g tube.

If you have any further questions on the use of this product,
ask your pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Diclofenac 1% Gel 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 1% 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).

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 1% Gel
PL No: 18067/0296

POM
th

This leaflet was last revised on 7 May 2014.

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 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 or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

800855/PL1e

500850/PL1e

®

®

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
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
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 7 May 2014.
®

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/PL1e

500852/PL1e

®

®

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
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
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 7 May 2014.
®

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/PL1e

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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