VOLTAREN EMULGEL

Active substance: DICLOFENAC DIETHYLAMMONIUM SALT

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This product is known by the above names but will be referred to as Voltarol Emulgel in this leaflet.

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

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

PROOF HISTORY:
v.1 - waymade - 24/09/13
v.2- waymade - 18/3/14

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.

WARNING!

Leaflet Flat Size = 148 x 400

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.

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.

DATE:

CUSTOMER
APPROVED:

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

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).

DATE:

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.

18/3/14

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.

TVT CHECKED

DATE OF PROOF:

ks
ARTWORKER:

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

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.

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.

TO UK PIL DATED APRIL 2013
REPORTING SIDE EFFECTS

6464/0164 D
CODE:

CUSTOMER: Waymade
PRODUCT:
Voltarol emugel





3. How to use Voltarol Emulgel
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.

Colour
Swatch

Black

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

VOLTAROL® EMULGEL®/VOLTAREN EMULGEL®
(diclofenac diethylammonium)
Patient Information Leaflet

WARNING!

000-0000D

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

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.

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
Keep all medicines out of the sight and reach of children.
Voltarol Emulgel/Voltaren Emulgel should not be stored above 30°C. Protect from heat.
Do not use after the expiry date printed on the carton, carton label or metal 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 your doctor tells you to stop using the gel, please take it back to the pharmacist for safe disposal.
Only keep the gel if your doctor tells you to.
• If the gel becomes discoloured or shows signs of any deterioration, you should consult your
pharmacist who will advise you what to do.

WARNING!

6. Further information.
Your medicine is called Voltarol Emulgel/Voltaren Emulgel.
Each 100g of white gel contains 1.16 grams of the diclofenac diethylammonium salt, equivalent to 1 gram of
the active ingredient, diclofenac sodium, in a pleasantly perfumed non-greasy emulsion in an aqueous gel.
Voltarol Emulgel/Voltaren Emulgel also contains the following:
diethylamine, carbopol, ceto-macrogol, capric/caprylic acid fatty alcohol ester, isopropanol, liquid paraffin,
propylene glycol, perfume crème 45, and purified water.

DATE:

CUSTOMER
APPROVED:






Voltarol Emulgel/Voltaren Emulgel is available as a metal tube containing 100 grams of gel.
PL No: 6464/0164

This product is manufactured by Novartis Pharma SA, France, and/or Novartis Pharma GmbH, Germany
and/or Novartis Consumer Health, Switzerland and is procured from within the EU and repackaged by the
Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

DATE:

Q.A.
APPROVED:

POM

18/3/14
CODE:

TO UK PIL DATED APRIL 2013
REPORTING SIDE EFFECTS

DATE OF PROOF:

TVT CHECKED

ks
ARTWORKER:

VOLTAROL and EMULGEL are registered Trademarks of NOVARTIS AG

6464/0164 D

05-0440

CUSTOMER: Waymade
PRODUCT:
Voltarol emugel

PRE-PRESS NO.:

Leaflet revision and issue date (Ref.) 18.3.2014

Colour
Swatch

Black

000-0000D

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

PROOF HISTORY:
v.1 - waymade - 24/09/13
v.2 - waymade - 18/3/13

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.

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 148 x 400

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).

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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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