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VOLTAREN EMUGEL

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Voltarol® Emulgel® /
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.
This product will be called Voltarol Emulgel/Voltaren
Emulgel in this leaflet.
In this leaflet
1. What Voltarol Emulgel/Voltaren Emulgel is and what it
is used for
2. Before you use Voltarol Emulgel/Voltaren Emulgel
3. How to use Voltarol Emulgel/Voltaren Emulgel
4. Possible side effects
5. How to store Voltarol Emulgel/Voltaren Emulgel
6. Further information
1. What Voltaren Emulgel is and what it is used for
Voltarol Emulgel/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. Voltarol Emulgel/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 Voltarol Emulgel/Voltaren Emulgel
DO NOT use Voltarol Emulgel/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 Voltarol
Emulgel/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 Voltarol Emulgel/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 Voltarol Emulgel/Voltaren Emulgel 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/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/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.
Voltarol Emulgel/Voltaren Emulgel should only be used
under medical advice during breast-feeding as diclofenac
passes into breast milk in small amounts. However,
Voltarol Emulgel/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
Voltarol Emulgel/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 Voltarol Emulgel/Voltaren Emulgel
The gel formulation contains propylene glycol, which may
cause mild localised skin irritation in some people.
3. How to use Voltarol Emulgel/Voltaren Emulgel
• Always use Voltarol Emulgel/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 Voltarol Emulgel/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 Voltarol
Emulgel/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.
Do not use Voltarol Emulgel/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 Voltarol Emulgel/Voltaren Emulgel
than you should
If you or a child accidentally swallows Voltarol Emulgel/
Voltaren Emulgel, contact your doctor or accident and
emergency department immediately.
If you forget to use Voltarol Emulgel/Voltaren Emulgel
If you miss your application of Voltarol Emulgel/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, Voltarol Emulgel/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 Voltarol Emulgel/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).
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 Voltarol Emulgel/Voltaren Emulgel
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use Voltarol Emulgel/Voltaren Emulgel 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.
If the gel becomes discoloured or shows any sign of
deterioration, seek the advice of your pharmacist who will
advise you what to do.
6. Further information
What is in your medicine
100g of the Emulgel contains 1.16g of diclofenac
diethylammonium, which is equivalent to 1 g of diclofenac
sodium.
The Emulgel also contains the following inactive
ingredients: diethylamine, carbopol, cetomacrogol, a
caprylic/capric acid fatty alcohol ester, isopropanol, liquid
paraffin, perfume, water and propylene glycol.
The Emulgel is available in tubs containing 100g of the
gel.
Manufactured by:
Novartis Pharma GmbH, Wehr, Germany
Procured from within the EU by the product Licence
holder: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride G75 0TD.
PL03243/0290

0290/10 Joint

This leaflet was last approved: 27/11/2013
® Trade Mark of Novartis AG

POM

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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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