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VOLTAROL EMULGEL 1%W/W

Active substance: DICLOFENAC DIETHYLAMINE

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VOLTAROL® EMULGEL® 1% W/W
diclofenac sodium

MOCK UP

PATIENT INFORMATION LEAFLET

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.

The name of your medicine is Voltarol® Emulgel® 1% W/W. Throughout the remainder of this
leaflet your medicine will be referred to as Voltarol® Emulgel®.




Read all of this leaflet carefully because it contains important information for
you.

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.

• 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.

1. What Voltarol® Emulgel® is and what it is used for
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2. Before you use Voltarol Emulgel .
3. How to use Voltarol® Emulgel®.
4. Possible side effects
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5. How to store Voltarol Emulgel .
6. Further information

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1. What Voltarol Emulgel is and what it is used for
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muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries)
tendonitis (e.g. tennis elbow)
osteoarthritis.
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2. Before you use Voltarol Emulgel

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DO NOT use Voltarol® Emulgel® if you have:

an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 ‘What
Voltarol® Emulgel® contains’).

ever had an allergic reaction to diclofenac or other medicines used to treat pain, fever or
inflammation, such as aspirin, ibuprofen or acetylsalicylic acid. 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.
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
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Voltarol Emulgel should not be used if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
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If you forget to use Voltarol® Emulgel®.

4. Possible side effects

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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 is used to relieve pain and reduce
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inflammation and swelling in painful conditions affecting the joints and muscles. Voltarol
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Emulgel can be used to treat:




If you or a child accidentally swallows Voltarol® Emulgel®, contact your doctor or accident and
emergency department immediately.
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.

In this leaflet

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If you use more Voltarol® Emulgel® than you should

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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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Like all medicines, Voltarol Emulgel can cause side effects, although not everybody gets
them.
If you experience any of the following signs of an allergic reaction (likely to affect fewer than 1
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person out of 10,000) stop using Voltarol Emulgel and tell your doctor or pharmacist
immediately:




Skin rash with blisters, hives
Wheezing, shortness of breath or asthma/feeling of tightness in the chest
Swelling of the face, lips, tongue or throat that may cause difficulty in swallowing, breathing
or speaking.

Other side effects which may occur are usually mild, passing and harmless (if you are
concerned, tell your doctor or pharmacist as soon as you can):



Skin rash, itching, reddening or smarting (sharp, stinging pain) of the skin are common
after use (likely to affect 1 to 10 people out of 100).
In very rare cases, your skin may be more sensitive to the sun. Possible signs are sunburn
with itching, swelling and blistering (likely to affect fewer than 1 person out of 10,000).

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.

5. How to store Voltarol® Emulgel®.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store below 30°C. Protect from heat.
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Do not use Voltarol 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.

6. Further information
What Voltarol® Emulgel® contains
Active Substance
The active substance is diclofenac diethylammonium (1.16%) equivalent to 1 g of diclofenac
sodium in each 100 g of gel in the 100 g tube.

Other Ingredients
The other ingredients are diethylamine, carbopol, ceto macrogol, a caprylic/capric acid fatty
alcohol ester, isopropanolol, liquid paraffin, perfume, propylene glycol and water.

What Voltarol® Emulgel® looks like and contents of the pack

Important information about some of the ingredients of Voltarol®
Emulgel®.

Voltarol® Emulgel® is a white, perfumed, non-greasy emulsion in an aqueous gel, packed inside
a plastic tube. This is supplied in a carton and comes in a packs of 100 g

The gel formulation contains propylene glycol and benzyl benzoate, which may cause mild
localised skin irritation in some people.

Voltarol Emulgel is manufactured by Novartis Pharma GmbH, Wehr, Germany and is
procured within the E.U. and repackaged by the Product Licence holder Stephar (UK) Limited,
3 Waveney Park, Hewett Road, Great Yarmouth, Norfolk, NR31 0NN.

3. How to use Voltarol® Emulgel®





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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.

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.

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VOLTAROL and EMULGEL are the registered trademarks of Novartis AG.
PRODUCT LICENCE NUMBER:
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Voltarol Emulgel - PL 10256/0259
POM

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.

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Print Date: xx/xx/xxxx

Leaflet Ref: VOLTAROL EMU/S
Revision Date: 18.03.2013-L
© STEPHAR (UK) LTD

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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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