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VOLTAROL 12 HOUR EMULGEL P 2.32% GEL

Active substance(s): DICLOFENAC DIETHYLAMINE

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Order – AWF
Reference
Format
Pharma code
Colour

AWF 24261 - OTDC 395257
VOLT EMULG 2% GB_316597Z_PIL
145 X 297 mm - PN-Notice-V11 P07 - Recto/Verso
XXX
PANTONE Reflex Blue U

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

Helvetica Neue LT Pro
9.5 pt (all, approx - outlined), 8.5 pt (body text)

Draft Z

NCH Nyon - CH
GB XXXXXX
Sonoco-Trident - TR1060727/1/DIS - 08/01/2016

Recto

11.5 mm

145 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully because
it contains important information for you.
Always use Voltarol 12 Hour Emulgel P 2.32% Gel
exactly as described in this leaflet or as your
pharmacist has told you. You should check with your
doctor or pharmacist if you are not sure.
• This medicine is available without prescription.
However, you still need to use Voltarol 12 Hour
Emulgel P carefully to get the best results from
it. Note that this leaflet is revised on a regular
basis with the latest information on your medicine.
Please refer to the date at the end of the leaflet.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice.
• You must contact a doctor if your signs of illness
worsen or do not improve after 7 days.
• If you get any side effects which worry you (even
side effects not listed in this leaflet), talk to your
doctor or pharmacist.

297 mm

In this leaflet
1. What Voltarol 12 Hour Emulgel P is and
what it is used for
2. What you need to know about Voltarol 12 Hour Emulgel P
3. How to use Voltarol 12 Hour Emulgel P
4. Possible side effects
5. How to store Voltarol 12 Hour Emulgel P
6. What is in the pack and further information

1. What Voltarol 12 Hour Emulgel P is and
what it is used for

Pharma code XXX

Take special care with Voltarol 12 Hour Emulgel P
• 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.
• Voltarol 12 Hour Emulgel P is for external use
only. Do not use it in the mouth. Do not swallow
it. Wash your hands after use unless they are
the area to be treated. Be careful not to get
Voltarol 12 Hour Emulgel P in your eyes. If this
happens, rinse your eyes well with clean water.
See your doctor or pharmacist if any discomfort
persists.
• A brace or wrap commonly used for injuries like
sprains can be used, but do not use the gel under
airtight (plastic) bandages.
• If you have a stomach or duodenal ulcer
(or a history of), tell your doctor or pharmacist
before using the gel.
• If you have or have ever had asthma speak to your
doctor or pharmacist before using the gel.
If you have any questions, talk to your doctor or
pharmacist before using Voltarol 12 Hour Emulgel P.
This medicine is not recommended for use
in children under 14 years of age.

Voltarol 12 Hour Emulgel P 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.
Voltarol 12 Hour Emulgel P is used to relieve pain and
reduce inflammation and swelling in a number of painful
conditions affecting the joints and muscles.
Voltarol 12 Hour Emulgel P can be used to treat:
• muscle and joint injuries (e.g. sprains, strains,
bruises, backache, sports injuries), relieving pain
and helping recovery back to normal function;
• tendonitis (e.g. tennis elbow), swelling around
elbow or knee.
Voltarol 12 Hour Emulgel P is intended for use in adults
and children aged 14 years and older.

2. What you need to know about
Voltarol 12 Hour Emulgel P:
Do not use Voltarol 12 Hour Emulgel P if you:
• are allergic (hypersensitive) to diclofenac
or other medicines used to treat pain, fever
or inflammation, such as ibuprofen or aspirin
(a substance also used to prevent blood clotting),
or any of the other ingredients of this medicine
(see Section 6 and end of Section 2). If you are
not sure, ask your doctor or pharmacist.
Symptoms of an allergic reaction may include:
wheezing or shortness of breath (asthma); skin rash
with blisters or hives; swelling of the face or tongue;
runny nose.
• are using any other medicine containing diclofenac
or are taking oral NSAIDs such as aspirin or ibuprofen.
• have severe joint pain of recent onset that is not
related to an injury or period of overuse.
• feel ill, have a temperature or any other symptoms
that accompany the pain.
• are in the last 3 months of pregnancy.

Taking other medicines with Voltarol
12 Hour Emulgel P
Please tell your doctor or pharmacist if you are taking,
or have recently taken, or want to start taking any
other medicines, including those obtained without
a medical prescription.
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 using this
medicine.
Voltarol 12 Hour Emulgel P must not be used during
the last 3 months of pregnancy, as it could harm
your unborn child or cause problems at delivery.
Voltarol 12 Hour Emulgel P 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 12 Hour Emulgel P should only be used
under medical advice during breast-feeding as
diclofenac passes into breast milk in small amounts.
However, Voltarol 12 hour Emulgel P 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 breast-feeding.
Effects of other ingredients (excipients)
Voltarol 12 Hour Emulgel P contains:
• propylene glycol, which may cause a mild
localised skin irritation in some people.
• butylhydroxytoluene, which may cause local
skin reactions (e.g. contact dermatitis) or irritation
to the eyes and mucous membranes.
11.5 mm

72 mm

If any of these apply to you, do not use
Voltarol 12 Hour Emulgel P.

9 mm

127 mm

9 mm

Order – AWF
Reference
Format
Pharma code
Colour

AWF 24261 - OTDC 395257
VOLT EMULG 2% GB_316597Z_PIL
145 X 297 mm - PN-Notice-V11 P07 - Recto/Verso
XXX
PANTONE Reflex Blue U

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

Helvetica Neue LT Pro
9.5 pt (all, approx - outlined), 8.5 pt (body text)

Draft Z

NCH Nyon - CH
GB XXXXXX
Sonoco-Trident - TR1060727/1/DIS - 08/01/2016

Verso

11.5 mm

145 mm

3. How to use Voltarol 12 Hour Emulgel P
Always use this medicine exactly as described in this
leaflet or as your pharmacist has told you. You should
check with your doctor or pharmacist if you are not sure.

Common side effects
(likely to affect between 1 and 10 in every
100 patients)
• Skin rash, itching, reddening or smarting of the skin

For adults and adolescents 14 years and over.
Apply the gel 2 times a day (preferably morning and
evening) on the painful area.

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.

Pharma code XXX

How to apply Voltarol 12 Hour Emulgel P
1. To remove the seal before first use, unscrew and
remove the cap. Use the reverse side of the cap
to insert, twist and remove the seal from the tube.
2. Gently squeeze out a small amount of gel from the
tube and apply to the painful or swollen area, slowly
rubbing into the skin. The amount needed will vary
depending upon 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 (2–4 g).
You may notice a slight cooling effect when you rub
the gel in. Only use the smallest amount of Voltarol
12 Hour Emulgel P needed to relieve your pain
but never use more than 8 g per day and 56 g
in one week.
3. Unless the hands are the site being treated, wash
your hands after rubbing in the gel, to avoid accidental
contact with the mouth and eyes (see Section 2).
Voltarol 12 Hour Emulgel P is for external use only.

72 mm

Very rare side effects
(likely to affect less than 1 in every 10,000 patients)
• The skin may be more sensitive to the sun.
Possible signs are sunburn with itching, swelling
and blistering.

How much Voltarol 12 Hour Emulgel P to use

5. How to store Voltarol 12 Hour Emulgel P
• Keep this medicine out of the reach and sight
of children.
• Do not use Voltarol 12 Hour Emulgel P after the
expiry date which is stated on the carton and tube
after EXP.
• Do not store above 30 °C.
• Do not dispose of medicines 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. What is in the pack and further information

Do not use Voltarol 12 Hour Emulgel P for more than
14 days unless longer treatment is recommended
by a doctor.
If the pain and swelling do not improve within 7 days,
or if they get worse, tell 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.

What Voltarol 12 Hour Emulgel P contains
The active substance is diclofenac diethylammonium.
Each gram of gel contains 23.2mg of diclofenac
diethylammonium.
The other ingredients (excipients) are
butylhydroxytoluene, carbomers, cocoyl
caprylocaprate, diethylamine, isopropyl alcohol,
liquid paraffin, macrogol cetostearyl ether, oleyl
alcohol, propylene glycol, perfume and purified
water (see end of Section 2 for further information).

If you use more Voltarol 12 Hour Emulgel P than
you should
• If you use more gel than you should, wipe off the
surplus gel with a tissue.
• If you or a child accidentally swallows the gel,
contact your doctor immediately.

What Voltarol 12 Hour Emulgel P looks like and
contents of the pack
Voltarol 12 Hour Emulgel P is a white to practically white,
cooling, non-greasy, non-staining cream-like gel.
The product comes in packs of 30g, 50g and 100g.

If you forget to use Voltarol 12 Hour Emulgel P
If you miss your application of Voltarol 12 Hour
Emulgel P at the correct time, apply it when you
remember and then carry on as normal.
Do not apply a double quantity to make up for
the forgotten application. If you have any further
questions on the use of this product, ask your
doctor or pharmacist.

Marketing Authorisation Holder
Novartis Consumer Health UK Ltd
Watchmoor Park, Camberley, Surrey
GU15 3YL, UK

4. Possible side effects

This leaflet was last approved in: December 2015

297 mm

How long to use Voltarol 12 Hour Emulgel P for

Manufacturer
Novartis Consumer Health UK Ltd
Watchmoor Park, Camberley, Surrey
GU15 3YL, UK

Like all medicines, Voltarol 12 Hour Emulgel P can
cause side effects, although not everybody gets them.

GB XXXXXX - GB 316597

11.5 mm

Some rare and very rare side effects might be
serious
If you experience any of the following signs of allergy,
STOP using Voltarol 12 Hour Emulgel P and tell
a doctor or pharmacist immediately:
• Skin rash with blisters; hives. (These side effects
are likely to affect 1 to 10 people in every 10,000).
• Wheezing, shortness of breath or feeling
of tightness in the chest (asthma).
(These side effects are likely to affect less than
1 person in every 10,000).
• Swelling of the face, lips, tongue or throat.
(These side effects are likely to affect less than
1 person in every 10,000).
Other side effects which may occur are usually mild,
passing and harmless (if you are concerned, tell
a doctor or pharmacist).

9 mm

127 mm

9 mm

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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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