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DICLOFENAC DIETHYLAMMONIUM 2.32% W/W GEL

Active substance(s): DICLOFENAC DIETHYLAMMONIUM SALT

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Voltarol® 12 Hour Emulgel® P
2.32% Gel

2965
15.05.17[4]

(diclofenac diethylammonium)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully because it contains important
information for you.
Always use Voltarol 12 Hour Emulgel P 2.32% Gel exactly as described in
this leaflet or as your pharmacist has told you. You should check with your
doctor or pharmacist if you are not sure.
- This medicine is available without prescription. However, you still need to
use Voltarol 12 Hour Emulgel P carefully to get the best results from it.
Note that this leaflet is revised on a regular basis with the latest information
on your medicine. Please refer to the date at the end of the leaflet.
- Keep this leaflet, you may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your sign of illness worsen or do not improve
after 7 days.
- If you get any side effects which worry you (even side effects not listed in
this leaflet), talk to your doctor or pharmacist.
This medicine is available using the above name but will be referred to as
Voltarol 12 Hour Emulgel P throughout the following.
In this leaflet
1. What Voltarol 12 Hour Emulgel P is and what it is used for
2. What you need to know about Voltarol 12 Hour Emulgel P
3. How to use Voltarol 12 Hour Emulgel P
4. Possible side effects
5. How to store Voltarol 12 Hour Emulgel P
6. What is in the pack and further information
1. WHAT VOLTAROL 12 HOUR EMULGEL P IS AND WHAT IT IS USED
FOR
Voltarol 12 Hour Emulgel P 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.
Voltarol 12 Hour Emulgel P is used to relieve pain and reduce inflammation
and swelling in a number of painful conditions affecting the joints and
muscles. Voltarol 12 Hour Emulgel P can be used to treat:
- muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports
injuries), relieving pain and helping recovery back to normal function;
- tendonitis (e.g. tennis elbow), swelling around elbow or knee.
Voltarol 12 Hour Emulgel P is intended for use in adults and children aged
14 years and older.
2. WHAT YOU NEED TO KNOW ABOUT VOLTAROL 12 HOUR
EMULGEL P:
Do not use Voltarol 12 Hour Emulgel P if you:
- are allergic (hypersensitive) to diclofenac or other medicines used to treat
pain, fever or inflammation, such as ibuprofen or aspirin (a substance also
used to prevent blood clotting), or any of the other ingredients of this
medicine (see Section 6 and end of Section 2). If you are not sure, ask
your doctor or pharmacist.
Symptoms of an allergic reaction may include: wheezing or shortness of
breath (asthma); skin rash with blisters or hives; swelling of the face or
tongue; runny nose.
- are using any other medicine containing diclofenac or are taking oral
NSAIDs such as aspirin or ibuprofen.
- have severe joint pain of recent onset that is not related to an injury or
period of overuse.
- feel ill, have a temperature or any other symptoms that accompany the
pain.
- are in the last 3 months of pregnancy.
If any of these apply to you, do not use Voltarol 12 Hour Emulgel P.
Take special care with Voltarol 12 Hour Emulgel P
- 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.
- Voltarol 12 Hour Emulgel P is for external use only. Do not use it in the
mouth. Do not swallow it. Wash your hands after use unless they are the
area to be treated. Be careful not to get Voltarol 12 Hour Emulgel P in
your eyes. If this happens, rinse your eyes well with clean water. See your
doctor or pharmacist if any discomfort persists.
- A brace or wrap commonly used for injuries like sprains can be used, but
do not use the gel under airtight (plastic) bandages.
- If you have a stomach or duodenal ulcer (or a history of), tell your doctor
or pharmacist before using the gel.
- If you have or have ever had asthma speak to your doctor or pharmacist
before using the gel.

If you have any questions, talk to your doctor or pharmacist before
using Voltarol 12 Hour Emulgel P.
This medicine is not recommended for use in children under 14 years
of age.
Taking other medicines with Voltarol 12 Hour Emulgel P
Please tell your doctor or pharmacist if you are taking, or have recently
taken, or want to start taking any other medicines, including those obtained
without a medical prescription.
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
using this medicine.
Voltarol 12 Hour Emulgel P must not be used during the last 3 months of
pregnancy, as it could harm your unborn child or cause problems at
delivery. Voltarol 12 Hour Emulgel P 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 12 Hour
Emulgel P should only be used under medical advice during breast-feeding
as diclofenac passes into breast milk in small amounts. However, Voltarol
12 hour Emulgel P 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 breast-feeding.
Effects of other ingredients (excipients) Voltarol 12 Hour Emulgel P
contains:
- propylene glycol, which may cause a mild localised skin irritation in
some people.
- butylhydroxytoluene, which may cause local skin reactions (e.g. contact
dermatitis) or irritation to the eyes and mucous membranes.
3. HOW TO USE VOLTAROL 12 HOUR EMULGEL P
Always use this medicine exactly as described in this leaflet or as your
pharmacist has told you. You should check with your doctor or pharmacist if
you are not sure.
How much Voltarol 12 Hour Emulgel P to use
For adults and adolescents 14 years and over.
Apply the gel 2 times a day (preferably morning and evening) on the painful
area.
How to apply Voltarol 12 Hour Emulgel P
1. To remove the seal before first use, unscrew and remove the cap. Use
the reverse side of the cap to insert, twist and remove the seal from the
tube.
2. Gently squeeze out a small amount of gel from the tube and apply to the
painful or swollen area, slowly rubbing into the skin. The amount needed will
vary depending upon 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
(2–4 g). You may notice a slight cooling effect when you rub the gel in. Only
use the smallest amount of Voltarol 12 Hour Emulgel P needed to relieve
your pain but never use more than 8 g per day and 56g in one week.
3. Unless the hands are the site being treated, wash your hands after
rubbing in the gel, to avoid accidental contact with the mouth and eyes (see
Section 2).
Voltarol 12 Hour Emulgel P is for external use only.
How long to use Voltarol 12 Hour Emulgel P for
Do not use Voltarol 12 Hour Emulgel P for more than 14 days unless longer
treatment is recommended by a doctor.
If the pain and swelling do not improve within 7 days, or if they get worse,
tell 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 12 Hour Emulgel P than you should
- If you use more gel than you should, wipe off the surplus gel with a tissue.
- If you or a child accidentally swallows the gel, contact your doctor
immediately.
If you forget to use Voltarol 12 Hour Emulgel P
If you miss your application of Voltarol 12 Hour Emulgel P at the correct
time, apply it when you remember and then carry on as normal.
Do not apply a double quantity to make up for the forgotten application. If
you have any further questions on the use of this product, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Voltarol 12 Hour Emulgel P 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
12 Hour Emulgel P and tell a doctor or pharmacist immediately:
- Skin rash with blisters; hives. (These side effects are likely to affect 1 to
10 people in every 10,000).
- Wheezing, shortness of breath or feeling of tightness in the chest
(asthma). (These side effects are likely to affect less than 1 person in
every 10,000).
- Swelling of the face, lips, tongue or throat. (These side effects are likely to
affect less than 1 person in every 10,000).
Other side effects which may occur are usually mild, passing and harmless
(if you are concerned, tell a doctor or pharmacist).
Common side effects
(likely to affect between 1 and 10 in every 100 patients)
- Skin rash, itching, reddening or smarting of the skin
Very rare side effects
(likely to affect less than 1 in every 10,000 patients)
- 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 12 HOUR EMULGEL P
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use Voltarol 12 Hour Emulgel P 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.
If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
6. WHAT IS IN THE PACK AND FURTHER INFORMATION
What Voltarol 12 Hour Emulgel P contains
The active substance is diclofenac diethylammonium.
Each gram of gel contains 23.2mg of diclofenac diethylammonium.
The other ingredients are isopropyl alcohol, oleyl alcohol, propylene glycol,
cocoyl caprylocaprate, liquid paraffin, macrogol cetostearyl ether, carbomer,
diethylamine, perfume (eucalyptus), butylhydroxytoluene (E 321), purified
water.
What Voltarol 12 Hour Emulgel P looks like and contents of the pack
Voltarol 12 Hour Emulgel P is a white, cooling, non-greasy, non-staining
cream-like gel, packed inside an aluminium laminated tube with plastic
screw cap. This is supplied in a carton and comes in packs of 50 g, 2 x 50 g,
100 g and 180 g.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Voltarol is manufactured by Novartis Consumer Health GmbH,
Zielstattstrasse 40, D- 81379 Munich, Germany. Procured from within the
EU by Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close,
Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
P

PL 20636/2965

Leaflet revision and issue date (Ref) 15.05.17[4]
Voltarol and Emulgel are trademarks of Novartis AG.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

Voltarol® Extra Strength Emulgel®
P 2.32% Gel

2965
15.05.17[4]

(diclofenac diethylammonium)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully because it contains important
information for you.
Always use Voltarol Extra Strength Emulgel P 2.32% Gel exactly as
described in this leaflet or as your pharmacist has told you. You should
check with your doctor or pharmacist if you are not sure.
- This medicine is available without prescription. However, you still need to
use Voltarol Extra Strength Emulgel P carefully to get the best results from it.
Note that this leaflet is revised on a regular basis with the latest information on
your medicine. Please refer to the date at the end of the leaflet.
- Keep this leaflet, you may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your sign of illness worsen or do not improve
after 7 days.
- If you get any side effects which worry you (even side effects not listed in
this leaflet), talk to your doctor or pharmacist.
This medicine is available using the above name but will be referred to as
Voltarol Extra Strength Emulgel P throughout the following.
In this leaflet
1. What Voltarol Extra Strength Emulgel P is and what it is used for
2. What you need to know about Voltarol Extra Strength Emulgel P
3. How to use Voltarol Extra Strength Emulgel P
4. Possible side effects
5. How to store Voltarol Extra Strength Emulgel P
6. What is in the pack and further information
1. WHAT VOLTAROL EXTRA STRENGTH EMULGEL P IS AND WHAT IT
IS USED FOR
Voltarol Extra Strength Emulgel P contains the active substance diclofenac
which belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
It is specially formulated for rubbing into the skin.
Voltarol Extra Strength Emulgel P is used to relieve pain and reduce
inflammation and swelling in a number of painful conditions affecting the
joints and muscles. Voltarol Extra Strength Emulgel P can be used to treat:
- muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports
injuries), relieving pain and helping recovery back to normal function;
- tendonitis (e.g. tennis elbow), swelling around elbow or knee.
Voltarol Extra Strength Emulgel P is intended for use in adults and children
aged 14 years and older.
2. WHAT YOU NEED TO KNOW ABOUT VOLTAROL EXTRA STRENGTH
EMULGEL P:
Do not use Voltarol Extra Strength Emulgel P if you:
- are allergic (hypersensitive) to diclofenac or other medicines used to treat
pain, fever or inflammation, such as ibuprofen or aspirin (a substance also
used to prevent blood clotting), or any of the other ingredients of this
medicine (see Section 6 and end of Section 2). If you are not sure, ask
your doctor or pharmacist.
Symptoms of an allergic reaction may include: wheezing or shortness of
breath (asthma); skin rash with blisters or hives; swelling of the face or
tongue; runny nose.
- are using any other medicine containing diclofenac or are taking oral
NSAIDs such as aspirin or ibuprofen.
- have severe joint pain of recent onset that is not related to an injury or
period of overuse.
- feel ill, have a temperature or any other symptoms that accompany the pain.
- are in the last 3 months of pregnancy.
If any of these apply to you, do not use Voltarol Extra Strength
Emulgel P.
Take special care with Voltarol Extra Strength Emulgel P
- 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.
- Voltarol Extra Strength Emulgel P is for external use only. Do not use it in
the mouth. Do not swallow it. Wash your hands after use unless they are
the area to be treated. Be careful not to get Voltarol Extra Strength
Emulgel P in your eyes. If this happens, rinse your eyes well with clean
water. See your doctor or pharmacist if any discomfort persists.
- A brace or wrap commonly used for injuries like sprains can be used, but
do not use the gel under airtight (plastic) bandages.
- If you have a stomach or duodenal ulcer (or a history of), tell your doctor
or pharmacist before using the gel.
- If you have or have ever had asthma speak to your doctor or pharmacist
before using the gel.

If you have any questions, talk to your doctor or pharmacist before
using Voltarol Extra Strength Emulgel P.
This medicine is not recommended for use in children under 14 years
of age.
Taking other medicines with Voltarol Extra Strength Emulgel P
Please tell your doctor or pharmacist if you are taking, or have recently
taken, or want to start taking any other medicines, including those obtained
without a medical prescription.
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
using this medicine.
Voltarol Extra Strength Emulgel P must not be used during the last 3 months
of pregnancy, as it could harm your unborn child or cause problems at
delivery. Voltarol Extra Strength Emulgel P 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 Extra
Strength Emulgel P should only be used under medical advice during
breast-feeding as diclofenac passes into breast milk in small amounts.
However, Voltarol Extra Strength Emulgel P 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 breast-feeding.
Effects of other ingredients (excipients) Voltarol Extra Strength
Emulgel P contains:
- propylene glycol, which may cause a mild localised skin irritation in
some people.
- butylhydroxytoluene, which may cause local skin reactions (e.g. contact
dermatitis) or irritation to the eyes and mucous membranes.
3. HOW TO USE VOLTAROL EXTRA STRENGTH EMULGEL P
Always use this medicine exactly as described in this leaflet or as your
pharmacist has told you. You should check with your doctor or pharmacist if
you are not sure.
How much Voltarol Extra Strength Emulgel P to use
For adults and adolescents 14 years and over.
Apply the gel 2 times a day (preferably morning and evening) on the painful
area.
How to apply Voltarol Extra Strength Emulgel P
1. To remove the seal before first use, unscrew and remove the cap. Use
the reverse side of the cap to insert, twist and remove the seal from the
tube.
2. Gently squeeze out a small amount of gel from the tube and apply to the
painful or swollen area, slowly rubbing into the skin. The amount needed will
vary depending upon 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
(2–4 g). You may notice a slight cooling effect when you rub the gel in. Only
use the smallest amount of Voltarol Extra Strength Emulgel P needed to
relieve your pain but never use more than 8 g per day and 56g in one week.
3. Unless the hands are the site being treated, wash your hands after
rubbing in the gel, to avoid accidental contact with the mouth and eyes (see
Section 2).
Voltarol Extra Strength Emulgel P is for external use only.
How long to use Voltarol Extra Strength Emulgel P for
Do not use Voltarol Extra Strength Emulgel P for more than 14 days unless
longer treatment is recommended by a doctor.
If the pain and swelling do not improve within 7 days, or if they get worse,
tell 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 Extra Strength Emulgel P than you should
- If you use more gel than you should, wipe off the surplus gel with a tissue.
- If you or a child accidentally swallows the gel, contact your doctor
immediately.
If you forget to use Voltarol Extra Strength Emulgel P
If you miss your application of Voltarol Extra Strength Emulgel P at the
correct time, apply it when you remember and then carry on as normal.
Do not apply a double quantity to make up for the forgotten application. If
you have any further questions on the use of this product, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Voltarol Extra Strength Emulgel P 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
Extra Strength Emulgel P and tell a doctor or pharmacist immediately:
- Skin rash with blisters; hives. (These side effects are likely to affect 1 to
10 people in every 10,000).
- Wheezing, shortness of breath or feeling of tightness in the chest
(asthma). (These side effects are likely to affect less than 1 person in
every 10,000).
- Swelling of the face, lips, tongue or throat. (These side effects are likely to
affect less than 1 person in every 10,000).
Other side effects which may occur are usually mild, passing and harmless
(if you are concerned, tell a doctor or pharmacist).
Common side effects
(likely to affect between 1 and 10 in every 100 patients)
- Skin rash, itching, reddening or smarting of the skin
Very rare side effects
(likely to affect less than 1 in every 10,000 patients)
- 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 EXTRA STRENGTH EMULGEL P
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use Voltarol Extra Strength Emulgel P 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.
If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
6. WHAT IS IN THE PACK AND FURTHER INFORMATION
What Voltarol Extra Strength Emulgel P contains
The active substance is diclofenac diethylammonium.
Each gram of gel contains 23.2mg of diclofenac diethylammonium.
The other ingredients are isopropyl alcohol, oleyl alcohol, propylene glycol,
cocoyl caprylocaprate, liquid paraffin, macrogol cetostearyl ether, carbomer,
diethylamine, perfume (eucalyptus), butylhydroxytoluene (E 321), purified
water.
What Voltarol Extra Strength Emulgel P looks like and contents of the
pack
Voltarol Extra Strength Emulgel P is a white, cooling, non-greasy, nonstaining cream-like gel, packed inside an aluminium laminated tube with
plastic screw cap. This is supplied in a carton and comes in packs of 50 g,
2 x 50 g, 100 g and 180 g.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Voltarol is manufactured by Novartis Consumer Health GmbH,
Zielstattstrasse 40, D- 81379 Munich, Germany. Procured from within the
EU by Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close,
Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
P

PL 20636/2965

Leaflet revision and issue date (Ref) 15.05.17[4]
Voltarol and Emulgel are trademarks of Novartis AG.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

Diclofenac Diethylammonium
2.32% w/w Gel

2965
15.05.17[4]

PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully because it contains important
information for you.
Always use Diclofenac Diethylammonium 2.32% w/w Gel exactly as
described in this leaflet or as your pharmacist has told you. You should
check with your doctor or pharmacist if you are not sure.
- This medicine is available without prescription. However, you still need to
use Diclofenac Diethylammonium 2.32% w/w Gel carefully to get the best
results from it. Note that this leaflet is revised on a regular basis with the
latest information on your medicine. Please refer to the date at the end of
the leaflet.
- Keep this leaflet, you may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your sign of illness worsen or do not improve
after 7 days.
- If you get any side effects which worry you (even side effects not listed in
this leaflet), talk to your doctor or pharmacist.
In this leaflet
1. What Diclofenac Diethylammonium 2.32% w/w Gel is and what it is used
for
2. What you need to know about Diclofenac Diethylammonium 2.32% w/w Gel
3. How to use Diclofenac Diethylammonium 2.32% w/w Gel
4. Possible side effects
5. How to store Diclofenac Diethylammonium 2.32% w/w Gel
6. What is in the pack and further information
1. WHAT DICLOFENAC DIETHYLAMMONIUM 2.32% W/W GEL IS AND
WHAT IT IS USED FOR
Diclofenac Diethylammonium 2.32% w/w Gel contains the active substance
diclofenac which belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
It is specially formulated for rubbing into the skin.
Diclofenac Diethylammonium 2.32% w/w Gel is used to relieve pain and
reduce inflammation and swelling in a number of painful conditions affecting
the joints and muscles. Diclofenac Diethylammonium 2.32% w/w Gel can be
used to treat:
- muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports
injuries), relieving pain and helping recovery back to normal function;
- tendonitis (e.g. tennis elbow), swelling around elbow or knee.
Diclofenac Diethylammonium 2.32% w/w Gel is intended for use in adults
and children aged 14 years and older.
2. WHAT YOU NEED TO KNOW ABOUT DICLOFENAC
DIETHYLAMMONIUM 2.32% W/W GEL:
Do not use Diclofenac Diethylammonium 2.32% w/w Gel if you:
- are allergic (hypersensitive) to diclofenac or other medicines used to treat
pain, fever or inflammation, such as ibuprofen or aspirin (a substance also
used to prevent blood clotting), or any of the other ingredients of this
medicine (see Section 6 and end of Section 2). If you are not sure, ask
your doctor or pharmacist.
Symptoms of an allergic reaction may include: wheezing or shortness of
breath (asthma); skin rash with blisters or hives; swelling of the face or
tongue; runny nose.
- are using any other medicine containing diclofenac or are taking oral
NSAIDs such as aspirin or ibuprofen.
- have severe joint pain of recent onset that is not related to an injury or
period of overuse.
- feel ill, have a temperature or any other symptoms that accompany the pain.
- are in the last 3 months of pregnancy.
If any of these apply to you, do not use Diclofenac Diethylammonium
2.32% w/w Gel.
Take special care with Diclofenac Diethylammonium 2.32% w/w 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.
- Diclofenac Diethylammonium 2.32% w/w Gel is for external use only. Do
not use it in the mouth. Do not swallow it. Wash your hands after use
unless they are the area to be treated. Be careful not to get Diclofenac
Diethylammonium 2.32% w/w Gel in your eyes. If this happens, rinse your
eyes well with clean water. See your doctor or pharmacist if any
discomfort persists.
- A brace or wrap commonly used for injuries like sprains can be used, but
do not use the gel under airtight (plastic) bandages.
- If you have a stomach or duodenal ulcer (or a history of), tell your doctor
or pharmacist before using the gel.
- If you have or have ever had asthma speak to your doctor or pharmacist
before using the gel.

If you have any questions, talk to your doctor or pharmacist before
using Diclofenac Diethylammonium 2.32% w/w Gel.
This medicine is not recommended for use in children under 14 years
of age.
Taking other medicines with Diclofenac Diethylammonium 2.32% w/w
Gel
Please tell your doctor or pharmacist if you are taking, or have recently
taken, or want to start taking any other medicines, including those obtained
without a medical prescription.
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
using this medicine.
Diclofenac Diethylammonium 2.32% w/w Gel must not be used during the
last 3 months of pregnancy, as it could harm your unborn child or cause
problems at delivery. Diclofenac Diethylammonium 2.32% w/w Gel should
only be used under medical advice during the first 6 months of pregnancy
and the dose should be kept as low and duration of treatment as short as
possible. Diclofenac Diethylammonium 2.32% w/w Gel should only be used
under medical advice during breast-feeding as diclofenac passes into breast
milk in small amounts. However, Diclofenac Diethylammonium 2.32% w/w
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 breast-feeding.
Effects of other ingredients (excipients) Diclofenac Diethylammonium
2.32% w/w Gel contains:
- propylene glycol, which may cause a mild localised skin irritation in
some people.
- butylhydroxytoluene, which may cause local skin reactions (e.g. contact
dermatitis) or irritation to the eyes and mucous membranes.
3. HOW TO USE DICLOFENAC DIETHYLAMMONIUM 2.32% W/W GEL
Always use this medicine exactly as described in this leaflet or as your
pharmacist has told you. You should check with your doctor or pharmacist if
you are not sure.
How much Diclofenac Diethylammonium 2.32% w/w Gel to use
For adults and adolescents 14 years and over.
Apply the gel 2 times a day (preferably morning and evening) on the painful
area.
How to apply Diclofenac Diethylammonium 2.32% w/w Gel
1. To remove the seal before first use, unscrew and remove the cap. Use
the reverse side of the cap to insert, twist and remove the seal from the
tube.
2. Gently squeeze out a small amount of gel from the tube and apply to the
painful or swollen area, slowly rubbing into the skin. The amount needed will
vary depending upon 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
(2–4 g). You may notice a slight cooling effect when you rub the gel in. Only
use the smallest amount of Diclofenac Diethylammonium 2.32% w/w Gel
needed to relieve your pain but never use more than 8 g per day and 56g in
one week.
3. Unless the hands are the site being treated, wash your hands after
rubbing in the gel, to avoid accidental contact with the mouth and eyes (see
Section 2).
Diclofenac Diethylammonium 2.32% w/w Gel is for external use only.
How long to use Diclofenac Diethylammonium 2.32% w/w Gel for
Do not use Diclofenac Diethylammonium 2.32% w/w Gel for more than 14
days unless longer treatment is recommended by a doctor.
If the pain and swelling do not improve within 7 days, or if they get worse,
tell 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 2.32% w/w Gel than you
should
- If you use more gel than you should, wipe off the surplus gel with a tissue.
- If you or a child accidentally swallows the gel, contact your doctor
immediately.

If you forget to use Diclofenac Diethylammonium 2.32% w/w Gel
If you miss your application of Diclofenac Diethylammonium 2.32% w/w Gel
at the correct time, apply it when you remember and then carry on as
normal.
Do not apply a double quantity to make up for the forgotten application. If
you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Diclofenac Diethylammonium 2.32% w/w 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 Diethylammonium 2.32% w/w Gel and tell a doctor or pharmacist
immediately:
- Skin rash with blisters; hives. (These side effects are likely to affect 1 to
10 people in every 10,000).
- Wheezing, shortness of breath or feeling of tightness in the chest
(asthma). (These side effects are likely to affect less than 1 person in
every 10,000).
- Swelling of the face, lips, tongue or throat. (These side effects are likely to
affect less than 1 person in every 10,000).
Other side effects which may occur are usually mild, passing and harmless
(if you are concerned, tell a doctor or pharmacist).
Common side effects
(likely to affect between 1 and 10 in every 100 patients)
- Skin rash, itching, reddening or smarting of the skin
Very rare side effects
(likely to affect less than 1 in every 10,000 patients)
- 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 2.32% W/W GEL
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use Diclofenac Diethylammonium 2.32% w/w 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.
If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
6. WHAT IS IN THE PACK AND FURTHER INFORMATION
What Diclofenac Diethylammonium 2.32% w/w Gel contains
The active substance is diclofenac diethylammonium.
Each gram of gel contains 23.2mg of diclofenac diethylammonium.
The other ingredients are isopropyl alcohol, oleyl alcohol, propylene glycol,
cocoyl caprylocaprate, liquid paraffin, macrogol cetostearyl ether, carbomer,
diethylamine, perfume (eucalyptus), butylhydroxytoluene (E 321), purified
water.
What Diclofenac Diethylammonium 2.32% w/w Gel looks like and
contents of the pack
Diclofenac Diethylammonium 2.32% w/w Gel is a white, cooling, nongreasy, non-staining cream-like gel, packed inside an aluminium laminated
tube with plastic screw cap. This is supplied in a carton and comes in packs
of 50 g, 2 x 50 g, 100 g and 180 g.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Diclofenac Diethylammonium 2.32% w/w Gel is manufactured by Novartis
Consumer Health GmbH, Zielstattstrasse 40, D- 81379 Munich, Germany.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
P

PL 20636/2965

Leaflet revision and issue date (Ref) 15.05.17[4]

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