DICLOFENAC SODIUM 1% GEL
Active substance(s): DICLOFENAC DIETHYLAMINE
DICLOFENAC SODIUM 1% EMULGEL®
DICLOFENAC SODIUM 1% GEL
Your medicine is available using any of the above three
names but will be referred to as Voltarol Emulgel throughout
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
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
What Voltarol Emulgel is and what it is used for
Before you use Voltarol Emulgel
How to use Voltarol Emulgel
Possible side effects
How to store Voltarol Emulgel
1. What Voltarol Emulgel is and what it is
Voltarol 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 can be used to treat:
muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)
tendonitis (e.g. tennis elbow)
2. Before you use Voltarol Emulgel
DO NOT use Voltarol Emulgel if you:
are in the last 3 months of your pregnancy (see also
Pregnancy and Breast-feeding section).
have an allergy (hypersensitivity) to any of the
ingredients in the product (see Section 6 ‘What Voltarol
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
This medicine is not recommended for use in children
under 14 years of age.
Important information about some of the
ingredients of Voltarol Emulgel
The gel formulation contains propylene glycol, which may
cause mild localised skin irritation in some people.
3. How to use Voltarol Emulgel
Take special care with Voltarol 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 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 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.
Voltarol 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.
Consult your doctor or pharmacist for further information if
you are pregnant or breast-feeding.
Driving and using machines
Voltarol Emulgel, when used as directed, is not expected to
have any effect on your ability to drive or use machines.
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Always use Voltarol Emulgel exactly as your doctor has
The gel is for external use only. Do not use it in your
mouth. Inform your doctor immediately in case of
Do not put Voltarol Emulgel in your eyes. If this
happens, rinse your eyes well with clean water. See
your doctor or pharmacist if any discomfort persists.
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.
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.
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
Be careful not to get the gel in your eyes. If this
happens, rinse your eyes with clean water and tell your
Wash your hands after rubbing in Voltarol Emulgel,
unless your hands are the site being treated. Replace the
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 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 than you should
If you or a child accidentally swallows Voltarol Emulgel,
contact your doctor or accident and emergency department
If you forget to use Voltarol Emulgel
If you miss your application of Voltarol 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
5. How to store Voltarol Emulgel
If you have any further questions on the use of this product,
ask your pharmacist.
4. Possible side effects
Like all medicines, Voltarol Emulgel can cause side effects,
although not everybody gets them.
Some rare and very rare side effects might be
If you experience any of the following signs of allergy, STOP
using Voltarol Emulgel and tell a doctor or pharmacist
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
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
Common side effects (may affect between 1 and 10 in
every 100 people)
Do not store above 25°C. Protect from heat. Protect
Do not use this medicine after the expiry date which is
marked on the carton and blister strips. This refers to
the last day of that month.
Keep your medicine out of the sight and reach of
Return any unused medicine to your pharmacist for safe
If your medicine appears to be discoloured or shows any
other signs of deterioration, please return this to your
pharmacist who will advise you further.
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.
6. Further information
What Voltarol Emulgel contains
Each gram of gel contains 11.6mg of
diclofenac diethylammonium salt corresponding to
10mg diclofenac sodium.
The gel also includes the following inactive ingredients:
diethylamine, carbomer, cetomacrogol, cocoyl caprylocaprate,
isopropyl alcohol, liquid paraffin, propylene glycol,
purified water, and crème perfume.
What Voltarol Emulgel looks like and contents of
Voltarol Emulgel is a white to off white gel with the odour of
ethanol, available in 50g & 100g aluminium tubes.
Very rare side effects (may affect less than 1 in every
Voltarol Emulgel is manufactured by:
Novartis Pharma GmbH, 90327 Nürnberg, Germany.
Novartis Consumer Health GmbH, Zielstattstraße 40,
81379 München, Germany.
Reporting of side effects
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Skin rash, itching, reddening or smarting of the skin.
The skin may be more sensitive to the sun. Possible signs are
sunburn with itching, swelling and blistering.
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.
Product Licence holder:
BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster,
PL No: 08929/0295
Leaflet revision and issue dated: 18.08.16
Voltarol® & Emulgel® are registered trademarks of
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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.