DICLOFENAC DIETHYLAMINE 1.16% W/W GEL

Active substance: DICLOFENAC DIETHYLAMMONIUM SALT

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Voltarol® Emulgel® P

2407
31.10.12[4]

(diclofenac diethylamine)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription.
However, you still need to use Voltarol Emulgel P carefully to get the best
results from it.
- 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 symptoms worsen or do not improve
within 7 days.
- If any of the side effects get serious, or if you notice any side effect not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Voltarol Emulgel P is and what it is used for
2. Before you use Voltarol Emulgel P
3. How to use Voltarol Emulgel P
4. Possible side effects
5. How to store Voltarol Emulgel P
6. Further information
1. WHAT VOLTAROL EMULGEL P IS AND WHAT IT IS USED FOR
Voltarol 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 and is
used to relieve pain and reduce inflammation and swelling in painful
conditions affecting the joints and muscles.
Voltarol Emulgel P can be used to treat:
- muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports
injuries)
- tendonitis (e.g. tennis elbow)
- mild arthritis (symptoms of mild arthritis include joint pain at rest, joint
pain on movement, joint swelling or stiffness (after sleep or long rest)).
2. BEFORE YOU USE VOLTAROL EMULGEL P
DO NOT use Voltarol Emulgel P if you:
- have an allergy (hypersensitivity) to any of the ingredients in the product
(see Section 6 ‘What Voltarol Emulgel P contains’).
- have ever had an allergic reaction to diclofenac or other medicines used
to treat pain, fever or inflammation, such as aspirin 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.
- 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 your pregnancy (see also pregnancy and
lactation section).
This medicine is not recommended for use in children under 14 years
of age.
Take special care with Voltarol 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.
- 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.
- If you have or have ever had asthma speak to 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 P if you are already taking diclofenac tablets or
other NSAID pain/inflammation tablets (e.g. aspirin or ibuprofen).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Voltarol Emulgel 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
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 Emulgel P should only be used under medical advice during
breast-feeding as diclofenac passes into breast milk in small amounts.
However, Voltarol 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 breastfeeding.
Driving and using machines
Voltarol Emulgel P, 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 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.
3. HOW TO USE VOLTAROL EMULGEL P
Adults and adolescents 14 years and over:
Before using for the first time, open as follows:
- laminated tube: Unscrew cap and remove.
Reverse the cap, engage with the nozzle, twist and remove the plastic
seal from the tube. Do not use if seal is broken.
How to apply:
Gently squeeze out a small amount of gel from the tube and apply to the
painful or swollen area, slowly rubbing into the skin.
When and how much to use:
- Apply 3 to 4 times a day. Allow at least 4 hours between applications of
the gel. Do not apply more than 4 times in any 24 hour period.
- 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 (2 to 4g) will usually be sufficient.
- You may notice a slight cooling effect when you rub the gel in.
- Only use the smallest amount of Voltarol Emulgel P needed to relieve
your pain but never use more than 16g per day and 112g in one week.
How and where to use:
- You can apply the gel to a maximum of 2 joints (such as your knees or
elbows). If you need to apply it to more than 2 joints, consult your doctor.
- 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.
- The gel is for external use only. Do not use it in your mouth.
- Be careful not to get the gel in your eyes. If this happens, rinse your eyes
with clean water and tell your doctor.
- Wash your hands after rubbing in Voltarol Emulgel P, unless your hands
are the site being treated.
For how long should you use Voltarol Emulgel P?
Do not use Voltarol Emulgel P for more than:
- 14 days unless longer treatment is recommended by a doctor.
- For arthritis pain, you may need to apply the gel for up to 7 days (to allow
its effect to build up on the joint) before you notice on improvement in
your pain.
- If the pain and swelling do not improve within 7 days, or worsen, speak to
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.
Children under 14 years:
This medicine is not recommended for use in children under 14 years of
age.
If you use more Voltarol Emulgel P than you should
If you or a child accidentally swallows Voltarol Emulgel P, contact your
doctor or accident and emergency department immediately.
If you forget to use Voltarol Emulgel P
If you miss your application of Voltarol Emulgel P 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 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
Emulgel P and tell a doctor or pharmacist immediately:
Skin rash with blisters; hives (may affect between 1 and 10 in every 10,000
people).
Wheezing, shortness of breath or feeling of tightness in the chest (asthma)
(may affect less than 1 in every 10,000 people).
Swelling of the face, lips, tongue or throat (may affect less than 1 in every
10,000 people).
Other side effects which may occur are usually mild, passing and harmless
(if you are concerned, tell a doctor or pharmacist).
Common side effects (may affect between 1 and 10 in every 100 people)
Skin rash, itching, reddening or smarting of the skin
Very rare side effects (may affect less than 1 in every 10,000 people)
the skin may be more sensitive to the sun. Possible signs are sunburn with
itching, swelling and blistering.
Some side effects have unknown frequency (cannot be estimated from
available information): local application site irritation, skin discolouration.
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.
5. HOW TO STORE VOLTAROL EMULGEL P
Keep out of the sight and reach of children.
Do not store above 30°C. Store in the original package.
Do not use Voltarol Emulgel P 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 P contains
Each 100g gel contains 1.16 g of diclofenac diethylamine, equivalent to 1 g
of diclofenac sodium.
Also contains the following inactive ingredients: carbopol 974 P,
cetomacrogol 1000, cocoyl caprylocaprate, diethylamine, isopropyl alcohol,
liquid paraffin, perfume crème 45, propylene glycol and purified water.
What Voltarol Emulgel P looks like and contents of the pack
Voltarol Emulgel P is white smooth gel with the odour of ethanol and comes
in pack of 50 g and 2 x 50 g tube.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Voltarol Emulgel P is manufactured by Novartis Consumer Health GmbH,
Zielstattstrasse 40, 81379 Munchen, Germany and is 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 No: 20636/2407

Leaflet revision and issue date: 31.10.12[4]
Voltarol and Emulgel are trademarks of Novartis AG.

Diclofenac Diethylamine
1.16% w/w gel

2407
31.10.12[4]

PATIENT INFORMATION LEAFLET
Your medicine is available using the above name but will be referred to as
Diclofenac gel throughout this leaflet.
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription.
However, you still need to use Diclofenac gel carefully to get the best
results from it.
- 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 symptoms worsen or do not improve
within 7 days.
- If any of the side effects get serious, or if you notice any side effect not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Diclofenac gel is and what it is used for
2. Before you use Diclofenac gel
3. How to use Diclofenac gel
4. Possible side effects
5. How to store Diclofenac gel
6. Further information
1. WHAT DICLOFENAC GEL IS AND WHAT IT IS USED FOR
Diclofenac 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 gel can be used to treat:
- muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports
injuries)
- tendonitis (e.g. tennis elbow)
- mild arthritis (symptoms of mild arthritis include joint pain at rest, joint
pain on movement, joint swelling or stiffness (after sleep or long rest)).
2. BEFORE YOU USE DICLOFENAC GEL
DO NOT use Diclofenac gel if you:
- have an allergy (hypersensitivity) to any of the ingredients in the product
(see Section 6 ‘What Diclofenac gel contains’).
- have ever had an allergic reaction to diclofenac or other medicines used
to treat pain, fever or inflammation, such as aspirin 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.
- 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 your pregnancy (see also pregnancy and
lactation section).
This medicine is not recommended for use in children under 14 years
of age.
Take special care with Diclofenac 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.
- If you have or have ever had asthma speak to 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 gel if you are already taking diclofenac tablets or
other NSAID pain/inflammation tablets (e.g. aspirin or ibuprofen).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Diclofenac 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
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 gel should only be used under medical advice during breastfeeding as diclofenac passes into breast milk in small amounts. However,
Diclofenac 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 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 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.
3. HOW TO USE DICLOFENAC GEL
Adults and adolescents 14 years and over:
Before using for the first time, open as follows:
- laminated tube: Unscrew cap and remove.
Reverse the cap, engage with the nozzle, twist and remove the plastic
seal from the tube. Do not use if seal is broken.
How to apply:
Gently squeeze out a small amount of gel from the tube and apply to the
painful or swollen area, slowly rubbing into the skin.
When and how much to use:
- Apply 3 to 4 times a day. Allow at least 4 hours between applications of
the gel. Do not apply more than 4 times in any 24 hour period.
- 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 (2 to 4g) will usually be sufficient.
- You may notice a slight cooling effect when you rub the gel in.
- Only use the smallest amount of Diclofenac gel needed to relieve your
pain but never use more than 16g per day and 112g in one week.
How and where to use:
- You can apply the gel to a maximum of 2 joints (such as your knees or
elbows). If you need to apply it to more than 2 joints, consult your doctor.
- 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.
- The gel is for external use only. Do not use it in your mouth.
- Be careful not to get the gel in your eyes. If this happens, rinse your eyes
with clean water and tell your doctor.
- Wash your hands after rubbing in Diclofenac gel, unless your hands are
the site being treated.
For how long should you use Diclofenac gel?
Do not use Diclofenac gel for more than:
- 14 days unless longer treatment is recommended by a doctor.
- For arthritis pain, you may need to apply the gel for up to 7 days (to allow
its effect to build up on the joint) before you notice on improvement in
your pain.
- If the pain and swelling do not improve within 7 days, or worsen, speak to
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.
Children under 14 years:
This medicine is not recommended for use in children under 14 years of
age.
If you use more Diclofenac gel than you should
If you or a child accidentally swallows Diclofenac gel, contact your doctor or
accident and emergency department immediately.
If you forget to use Diclofenac gel
If you miss your application of Diclofenac 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Diclofenac 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 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).
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.
Some side effects have unknown frequency (cannot be estimated from
available information): local application site irritation, skin discolouration.
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.
5. HOW TO STORE DICLOFENAC GEL
Keep out of the sight and reach of children.
Do not store above 30°C. Store in the original package.
Do not use Diclofenac 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 gel contains
Each 100g gel contains 1.16 g of diclofenac diethylamine, equivalent to 1 g
of diclofenac sodium.
Also contains the following inactive ingredients: carbopol 974 P,
cetomacrogol 1000, cocoyl caprylocaprate, diethylamine, isopropyl alcohol,
liquid paraffin, perfume crème 45, propylene glycol and purified water.
What Diclofenac gel looks like and contents of the pack
Diclofenac gel is white smooth gel with the odour of ethanol and comes in
pack of 50 g and 2 x 50 g tube.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Diclofenac gel is manufactured by Novartis Consumer Health GmbH,
Zielstattstrasse 40, 81379 Munchen, Germany and is 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 No: 20636/2407

Leaflet revision and issue date: 31.10.12[4]

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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