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DICLOFENAC EMULGEL 1%

Active substance(s): DICLOFENAC DIETHYLAMINE

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PATIENT INFORMATION LEAFLET

VOLTAROL® EMULGEL® / DICLOFENAC EMULGEL® 1%
(diclofenac diethylammonium)
This medicine is known by the above 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 get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Voltarol Emulgel is and what it is used for
2. Before you use Voltarol Emulgel
3. How to use Voltarol Emulgel
4. Possible side effects
5. How to store Voltarol Emulgel
6. 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 lactation 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.
This medicine is not recommended for use in children under 14 years of age.
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
breastfeeding.
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.
3. HOW TO USE VOLTAROL EMULGEL
• 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.
• 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.
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, 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 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.
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 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).
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 or pharmacist. This includes any 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
• Keep out of the sight and reach of children.
• Do not store above 30°C.
• Do not use after the expiry date printed on the carton or tube label. The expiry date refers
to the last day of that month.
• If your gel becomes discoloured or shows visible signs of deterioration, talk to your doctor
or pharmacist.
• 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
Voltarol Emulgel contains 1.16g of the active ingredient diclofenac diethylammonium
equivalent to 1g diclofenac sodium.
The gel also contains the following inactive ingredients:
diethylamine, carbomer, macrogol cetostearyl ether, cocyl caprylocaprate, isopropyl alcohol,
liquid paraffin, propylene glycol, water and perfume.
What Voltarol Emulgel looks like and contents of the pack
Voltarol Emulgel is a white, cooling, non-greasy, non-staining cream-like gel, packed inside
an aluminium tube with a plastic screw cap in white or blue, with two alternate shapes of
cap and thread. It’s available in a 100g tube.
Manufacturer
This product is manufactured by Novartis Pharma GmbH, Wehr, Germany or Novartis
Consumer Health SA, Switzerland or Novartis Hellas AEBE, Greece and procured from
within the EU by the Product Licence holder Delta Pharma (Europe) Ltd., 1 Colonial Way,
P.O. Box 233, North Watford, Herts WD24 4EW and repackaged by O.P.D. Laboratories
Ltd., Watford, Herts WD24 4PR.
PL No: 17805/0089
POM
Leaflet revision and issue date (Ref.) 06.05.2015.
Voltarol and Emulgel are registered Trade Marks of Novartis AG, Basel, Switzerland.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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