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VOLTARENE EMULGEL P

Active substance(s): DICLOFENAC DIETHYLAMMONIUM SALT

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Voltarol® Emulgel® P
Voltarene® Emulgel® P
Diclofenac diethylammonium 1.16% w/w gel
(diclofenac diethylammonium)
Your medicine is known by one of the above names, but will be referred to
as Voltarol Emulgel P throughout this leaflet.

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 gets 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
breast-feeding 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
The gel formulation contains propylene glycol which may cause mild
localised skin irritation in some people.

3) How to use 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.
Adults and adolescents 14 years and over:
Before using for the first time, open as follows:
 aluminium tube: Unscrew cap and pierce the aluminium seal with the
spiked top of the cap. Do not use if seal is broken.
 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.
 dispenser: Remove the lid from the top of the dispenser.
How to apply:
Gently squeeze out a small amount of gel from the tube or press firmly and
evenly on the nozzle of the dispenser 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 an
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.
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 the package 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 P
 Keep out of the sight and reach of children.
 Do not use Voltarol Emulgel P after the expiry date printed on the carton,
label or can label.
 Do not store above 30°C. Protect from heat. Do not pierce or burn, even
after use.
 If the gel becomes discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.

 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 100ml of gel contains the active ingredient,
diethylammonium salt equivalent to 1g diclofenac sodium.

diclofenac

The gel also contains the following ingredients: diethylamine, carbomer
974P, macrogol cetostearyl ether, cocyl caprylocaprate, isopropyl alcohol,
liquid paraffin heavy, perfume cream 45, propylene glycol and purified
water. (see end of Section 2 ‘Important information about some of the
ingredients of Voltarol Emulgel P’ for propylene glycol.
What Voltarol Emulgel P looks like and contents of the pack
Voltarol Emulgel P is available as a white pressurised can fitted with an
actuator and a plastic cap. Each pressurised can contains 100ml of a white
emulsion in an aqueous gel.
PL 10383/1396

Voltarol Emulgel P / Votarene Emulgel P / Diclofenac
diethylammonium 1.16% w/w gel
P

Who makes and repackages your medicine?
Your medicine is manufactured by Novartis Sante Familiale S.A.S., 14
Boulevard Richelieu, 92 500 Rueil-Malmaison, France. Procured from
within the EU and repackaged by Product Licence Holder: Primecrown Ltd,
4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 14.04.2016
Voltarol®, Voltarene® and Emulgel® are all registered trademarks of
Novartis AG, Basel, Switzerland.

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Source: Medicines and Healthcare Products Regulatory Agency

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

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