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VOLTAROL 1.16% EMULGEL

Active substance(s): DICLOFENAC DIETHYLAMMONIUM SALT

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Order – AWF
Reference
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Pharma code
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AWF 24260 - OTDC 393585
VOLT EMULG 100 G GB_316596Z_PIL
148 x 210 mm - Recto/Verso
XXX
Process Black

Font
Minimum font size
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Production site
Reference SITE
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Helvetica Neue LT Pro
8 pt
Novartis Wehr - DE
XXXXXX
Sonoco-Trident - TR1060531/1/DIS - 23/12/2015

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10

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Draft Z

Voltarol® 1.16% Emulgel® gel
Diclofenac diethylammonium

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

• 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 and
benzyl benzoate, which may cause mild localised skin
irritation in some people.

• 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. 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

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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.

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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.

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.

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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.

12
148

AWF 24260 - OTDC 393585
VOLT EMULG 100 G GB_316596Z_PIL
148 x 210 mm - Recto/Verso
XXX
Process Black

Font
Minimum font size
Reference MKT
Production site
Reference SITE
Pre-press

Helvetica Neue LT Pro
8 pt

Draft Z

Novartis Wehr - DE
XXXXXX
Sonoco-Trident - TR1060531/1/DIS - 23/12/2015

12

10

VERSO

Order – AWF
Reference
Format
Pharma code
Colour

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 the package 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 reach and sight of children.
Do not store above 30°C.
Do not use Voltarol Emulgel after the expiry date
stated on the carton and tube.
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.

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.

Pharma code XXX

210

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.

6. Further information
What Voltarol Emulgel contains
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 and 0.2g of
diclofenac sodium in each 20 g of gel in the 20 g tube.
The other ingredients are diethylamine, carbomers,
macrogol cetostearyl ether, cocoyl caprylocaprate,
isopropyl alcohol, propylene glycol, liquid paraffin,
perfume (contains benzyl benzoate), purified water
(see end of Section 2 ‘Important information about
some of the ingredients of Voltarol Emulgel’ for
propylene glycol).

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.

What Voltarol Emulgel looks like and contents of the pack
Voltarol Emulgel is a white, cooling, non-greasy, nonstaining cream-like gel, packed inside an aluminium
tube with plastic screw cap. This is supplied in a carton
and comes in packs of 20 g and 100 g

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

Marketing authorisation holder and manufacturer
Novartis Consumer Health, Park View, Riverside Way,
Watchmoor Park, Camberley, Surrey, GU15 3YL, England
This leaflet was last approved in December 2015

GB 316596 - XXXXXX

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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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