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DICLOFENAC 1% EMULGEL

Active substance(s): DICLOFENAC DIETHYLAMINE / DICLOFENAC DIETHYLAMMONIUM SALT

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Voltaren Emulgel / Diclofenac 1% Emulgel
(Diclofenac diethylammonium)

®

Patient Information Leaflet
This product is available using any of the above names, but will
be referred to as Voltaren Emulgel throughout this 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

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 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.
Voltaren 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.

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 antiinflammatory 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.

Product: Voltaren Emulgel/ Diclofenac 1% Emulgel
Colours: Black

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).

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
Propylene glycol is an ingredient in this medicine 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.

PLPI: 17211/0091
Item Code: VOL2001G/I

Dimensions: 210mm x 297mm
Proof: 2

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.

6) FURTHER INFORMATION
What Voltaren Emulgel contains
The active substance is diclofenac diethylammonium (1.16%)
equivalent to 1 g of diclofenac sodium in each 100 g of gel in
the 100 g tube.

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, macrogol
cetostearyl ether, cocoyl caprylocaprate, isopropyl alcohol,
liquid paraffin heavy, perfume crème 45, propylene glycol and
purified water (see end of Section 2 ‘Important information
about some of the ingredients of Voltaren Emulgel’ for
propylene glycol).

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).

What Voltaren Emulgel looks like and contents of the pack
Voltaren Emulgel is a whitish, smooth gel with the odour of
isopropyl alcohol, packed inside a white and golden yellow
tamper evident sealed tube, with white plastic screw on cap.
Voltaren Emulgel/ Diclofenac 1%
Emulgel

PL No: 17211/0091

Manufacturer
This product is manufactured by Novartis Pharma Gmbh
Germany and procured from within the EU by the Product
Licence Holder Polyfarma Ltd and repackaged by Kent
Pharmaceuticals Ltd both at Repton Road, Measham, DE12
7DT, UK.
POM
Leaflet revision and issue date: 29.11.2013
®

®

Voltaren and Emulgel are registered trademarks of Novartis
AG.

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.
If any of the side effects get serious or if you notice any
side effects not listed in this leaflet, STOP USING the gel
and tell your doctor or pharmacist immediately.
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 30ºC.
• Do not use Voltaren Emulgel after the expiry date stated
on the carton and the 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.
Product: Voltaren Emulgel/ Diclofenac 1% Emulgel
Colours: Black

PLPI: 17211/0091
Item Code: VOL2001G/I

Dimensions: 210mm x 297mm
Proof: 2

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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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