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DICLOFENAC SODIUM 1% EMULGEL

Active substance(s): DICLOFENAC DIETHYLAMINE

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PATIENT INFORMATION LEAFLET
®

®

VOLTAROL EMULGEL
DICLOFENAC SODIUM 1% EMULGEL®
DICLOFENAC SODIUM 1% GEL

This medicine is not recommended for use in children
under 14 years of age.

Take special care with Voltarol Emulgel


(diclofenac diethylammonium)



Your medicine is available using any of the above three names but
will be referred to as Voltarol 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.
2.
3.
4.
5.
6.

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
Further information

1. What Voltarol Emulgel is and what it is
used for
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)

osteoarthritis.

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 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.



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.

3. How to use Voltarol Emulgel





Adults
1.
2.

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.

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.

Always use Voltarol 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 in your eyes. If this happens,
rinse your eyes well with clean water. See your doctor or
pharmacist if any discomfort persists.

3.
4.
5.
6.

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 plaster.
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, unless
your hands are the site being treated. Replace the cap.
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 immediately.

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 forgotten
application.
If you have any further questions on the use of this product, ask
your pharmacist.

Page 1 of 2

4. Possible side effects

6. Further information

Like all medicines, Voltarol Emulgel can cause side effects,
although not everybody gets them.

What Voltarol Emulgel contains

Some rare and very rare side effects might be
serious

If you experience any of the following signs of allergy, STOP using
Voltarol 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).

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
the pack
Voltarol Emulgel is a white to off white gel with the odour of
ethanol, available in 50g & 100g aluminium tubes.

Manufacturer

Common side effects (may affect between 1 and 10 in
every 100 people)

Voltarol Emulgel is manufactured by: Novartis Pharma GmbH,
90327 Nürnberg, Germany.
Or
Novartis Consumer Health GmbH, Zielstattstraße 40,
81379 München, Germany.

Very rare side effects (may affect less than 1 in every
10,000 people)

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 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.

Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0295

POM

Leaflet revision and issue dated: 24.03.16
Voltarol® & Emulgel® are registered trademarks of Novartis AG.

5. How to store Voltarol Emulgel








Do not store above 25°C. Protect from heat. Protect from
light.
Do not use after the expiry date, which is printed on the
carton, and tube label.
Keep your medicine out of the sight and reach of children.
Return any unused medicine to your pharmacist for safe
disposal.
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.

Page 2 of 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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