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VOLTAREN EMULGEL 1%W/W

Active substance(s): DICLOFENAC DIETHYLAMINE

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VOLTAROL® EMULGEL® 1% W/W
diclofenac sodium

MOCK UP

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

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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
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1. What Voltarol Emulgel is and what it is used for
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2. Before you use Voltarol Emulgel .
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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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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:




muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries)
tendonitis (e.g. tennis elbow)
osteoarthritis.

2. Before you use Voltarol® Emulgel®
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DO NOT use Voltarol Emulgel if you have:

are in the last 3 months of your pregnancy (see also pregnancy and lactation section)

an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 ‘What
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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.
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Do not use Voltarol Emulgel if you are already taking diclofenac tablets or other NSAID
pain/inflammation tablets (e.g. aspirin or ibuprofen).

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.
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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
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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®.
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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

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

Some rare and very rare side effects might be serious

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If you experience any of the following signs of an allergy, STOP using Voltarol Emulgel and
tell your doctor or pharmacist immediately:

Skin rash with blisters, hives (may affect between 1 and 10 in very 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 your 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 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 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.
Store below 30°C. Protect from heat.

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 any medicine.
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Voltarol Emulgel must not be used during the last 3 months of pregnancy, as it could harm
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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 does should be kept as low and
duration of treatment as short as possible.
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Voltarol Emulgel should only be used under medical advice during breast-feeding as
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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 for a
prolonged period of time.
Consult your doctor or pharmacist for further information if you are pregnant or breastfeeding.

Driving and using machines
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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.

Important information about some of the ingredients of Voltarol®
Emulgel®.
The gel formulation contains propylene glycol and benzyl benzoate, which may cause mild
localised skin irritation in some people.

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.
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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
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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

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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 (see end of
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Section 2 ‘Important information about some of the ingredients of Voltarol Emulgel ’ for
propylene glycol).

What Voltarol® Emulgel® looks like and contents of the pack
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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
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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.
VOLTAROL and EMULGEL are the registered trademarks of Novartis AG.
PRODUCT LICENCE NUMBER:
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Voltarol Emulgel - PL 10256/0259
POM

Print Date: xx/xx/xxxx

Leaflet Ref: VOLTAROL EMU/S
Revision Date: 09.01.2014-M
© 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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