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VOLTAROL PAIN-EZE EMULGEL

Active substance(s): DICLOFENAC DIETHYLAMMONIUM SALT / DICLOFENAC DIETHYLAMMONIUM SALT

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Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

AWF 27575 – OTDC 458606
VOLTAREN EMULGEL 1% NO MESSI 100G NEW GB_318360_PIL
145 x 297 mm – PN-Notice-V11 – P07 – Recto/Verso
XXX
Black
Helvetica Neue LT Pro
8 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

Diadeis426508 – KR – 27.04.2017

Draft B

WARNING: Wrong display / print > switch overprint ON

Recto

11.5 mm

145 mm

Patient Information Leaflet

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 Back and Muscle Pain Relief 1.16% Gel must not
be used during the last 3 months of pregnancy, as it could
harm your unborn child or cause problems at delivery.
Voltarol Back and Muscle Pain Relief 1.16% Gel 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 Back and Muscle Pain Relief 1.16% Gel should
only be used under medical advice during breast-feeding
as diclofenac passes into breast milk in small amounts.
However, Voltarol Back and Muscle Pain Relief 1.16% Gel
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 Back and Muscle Pain Relief 1.16% Gel, 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 Back and Muscle Pain Relief 1.16% Gel
The gel formulation contains propylene glycol and benzyl
benzoate, which may cause mild localised skin irritation
in some people.
3. How to use Voltarol Back and Muscle Pain Relief
1.16% Gel
• 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.
• 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 Back and Muscle Pain Relief 1.16%
Gel in your eyes. If this happens, rinse your eyes well
with clean water. See your doctor or pharmacist if any
discomfort persists.
Adults and adolescents 14 years and over
1. Take the tube out of the carton:
a. For the aluminium tube: Before first use, pierce the
sealing membrane of the tube with the spiked top
of the cap. Do not use if seal is broken
b. For the laminated tube: Unscrew and remove cap.
When using for the first time, reverse the cap,
engage with the nozzle, twist and remove the seal
from the tube. Do not use if seal is broken.
c. For laminated tube with push/pull cap applicator:
To remove the seal before first use, remove the
transparent protective cover and then unscrew the
applicator. Use the star-shape groove located at the
side of the applicator to remove the tamper evidence
seal of the tube. Screw the applicator back on the
tube before dispensing the gel.
To open, pull the white part of the applicator. Gently
squeeze the tube to push the gel to the surface of
the applicator and gently rub the gel into the skin
at the painful or swollen area. The slight pressure
of rubbing in the gel will automatically close the
applicator.
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. In addition to applying the gel, the guidelines (known
as “RICE”) may be useful to help healing of sprains.
See the end of this leaflet.
4. 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.
11.5 mm

72 mm

Pharma code XXX

297 mm

Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription. However,
you still need to use Voltarol Back and Muscle Pain Relief
1.16% Gel carefully to get the best results from it.
• 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 symptoms worsen
or do not improve within 7 days.
• If any of the side effects gets serious, or if you notice
any side effect not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet
1. What Voltarol Back and Muscle Pain Relief 1.16% Gel
is and what it is used for
2. Before you use Voltarol Back and Muscle Pain Relief
1.16% Gel
3. How to use Voltarol Back and Muscle Pain Relief
1.16% Gel
4. Possible side effects
5. How to store Voltarol Back and Muscle Pain Relief
1.16% Gel
6. Further information
1. What Voltarol Back and Muscle Pain Relief
1.16% Gel is and what it is used for
Voltarol Back and Muscle Pain Relief 1.16% Gel
contains the active substance diclofenac which belongs
to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs). It is specially formulated
for rubbing into the skin and is used to relieve pain and
reduce inflammation and swelling in painful conditions
affecting the joints and muscles. Voltarol Back and
Muscle Pain Relief 1.16% Gel can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)
• tendonitis (e.g. tennis elbow)
2. Before you use Voltarol Back and Muscle Pain
Relief 1.16% Gel
DO NOT use Voltarol Back and Muscle Pain Relief
1.16% Gel if you:
• have an allergy (hypersensitivity) to any of the
ingredients in the product (see Section 6 ‘What Voltarol
Back and Muscle Pain Relief 1.16% Gel contains’).
• have ever had an allergic reaction to diclofenac or other
medicines used to treat pain, fever or inflammation,
such as aspirin (acetylsalicyclic 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.
• are in the last 3 months of your pregnancy (see also
pregnancy and breast-feeding section).
• are using any other medicine containing diclofenac
or are taking oral NSAIDs such as aspirin or ibuprofen.
This medicine is not recommended for use in children
under 14 years of age.
Take special care with Voltarol Back and Muscle Pain
Relief 1.16% Gel
• 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.
• If you have or have ever had asthma speak to 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 Back and Muscle Pain Relief 1.16% Gel
if you are already taking diclofenac tablets or other NSAID
pain/inflammation tablets (e.g. aspirin or ibuprofen).

9 mm

127 mm

9 mm

Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

AWF 27575 – OTDC 458606
VOLTAREN EMULGEL 1% NO MESSI 100G NEW GB_318360_PIL
145 x 297 mm – PN-Notice-V11 – P07 – Recto/Verso
XXX
Black
Helvetica Neue LT Pro
8 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

Diadeis426508 – KR – 27.04.2017

Draft B

WARNING: Wrong display / print > switch overprint ON

Verso

11.5 mm

145 mm

2. Unscrew the
applicator cap




4. Screw the applicator
cap back on the tube

5. Pull white part
to open

6. Squeeze the tube
to release required
amount of Gel

7. Apply to skin, closing
cap on application

8. Clean the applicator
with cotton towel or
absorbent paper until
visually dry and clean

Stop using the injured joint as much as
possible in the first 48 hours. If you are
unable to use the joint, e.g. put any
REST
weight at all on an ankle, it may be
broken, so see a doctor as soon as
possible so that an X-ray can be done
To decrease both swelling and pain, take
a bag of ice (or frozen vegetables), wrap
ICE
it in a towel, and apply for 10-20 minutes
(longer may cause frostbite). Do this every
hour, or at least 3 times a day.
Lightly wrap your joint/the affected area
with an elastic bandage, make sure it
COMPRESSION
is not so tight that it cuts off circulation
to your limb.
If possible raise the affected limb as
ELEVATION
much as possible in the first 48 hours
to reduce swelling and pain
This leaflet was last revised in April 2017.

GB 318360 – XXXXXX

11.5 mm

This medicine is not recommended for use in children
under 14 years of age.
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.
Do not use Voltarol Back and Muscle Pain Relief 1.16%
Gel for more than:
• 7 days unless longer treatment is recommended
by a doctor.
If the pain and swelling do not improve within 7 days, or
worsen, speak to your doctor. If symptoms do not improve
within this time, or they get worse, consult your doctor.
If you use more Voltarol Back and Muscle Pain Relief
1.16% Gel than you should
If you or a child accidentally swallows Voltarol Back and
Muscle Pain Relief 1.16% Gel, contact your doctor or
accident and emergency department immediately.
If you forget to use Voltarol Back and Muscle Pain
Relief 1.16% Gel
If you miss your application of Voltarol Back and Muscle
Pain Relief 1.16% Gel 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 Back and Muscle Pain Relief
1.16% Gel can cause side effects, although not everybody
gets them.
Some rare and very rare side effects might be serious
If you experience any of the following signs of allergy,
STOP using Voltarol Back and Muscle Pain Relief 1.16%
Gel and tell a doctor or pharmacist immediately:
Skin rash with blisters; hives (may affect between 1 and
10 in every 10,000 people).

297 mm

3. Using the key on the
applicator cap to remove
the star seal on the tube

Pharma code XXX

1. Pull off the transparent
protective cover

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 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.
g
y
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Voltarol Back and Muscle Pain Relief
1.16% Gel
Keep out of the reach and sight of children.
Do not store above 30 °C.
Do not use Voltarol Back and Muscle Pain Relief 1.16%
Gel 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.
6. Further information
What Voltarol Back and Muscle Pain Relief 1.16%
Gel contains
The active substance is diclofenac diethylammonium
(1.16%) equivalent to 1g of diclofenac sodium in each
100 g of gel.
The other ingredients are carbomers, cetomacrogol,
cocoyl caprylocaprate, diethylamine, 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 Back and Muscle Pain Relief 1.16% Gel’ for
propylene glycol).
What Voltarol Back and Muscle Pain Relief 1.16% Gel
looks like and contents of the pack
Voltarol Back and Muscle Pain Relief 1.16% Gel is a white,
cooling, non-greasy, non-staining cream-like gel, packed
inside an aluminium or aluminium laminated tube with
plastic screw cap or a cap applicator. This is supplied in
a carton and comes in packs of 10g, 30g, 40g, 50g, 60g
or 100g (not all pack sizes may be marketed). Aluminium
laminated tube with cap applicator comes in a pack of
100g.
Marketing authorisation holder and Manufacturer
GlaxoSmithKline Consumer Healthcare (UK) Trading
Limited, Brentford, TW8 9GS, U.K.
RICE advice:
In addition to applying the gel, these guidelines (known
as “RICE”) may be useful to help healing of sprains.
Day 1 to Day 3

72 mm

5. Be careful not to get the gel in your eyes. If this
happens, rinse your eyes with clean water and tell
your doctor.
6. Wash your hands after rubbing in Voltarol Back and
Muscle Pain Relief 1.16% Gel, unless your hands are
the site being treated. Replace the cap. For laminated
tube with push/pull cap applicator: After use, clean the
applicator with cotton towel or absorbent paper until
visually dry and clean. Do not immerse or rinse under
water. Do not use any solvent or detergent to clean the
surface of the applicator. After cleaning, place the
transparent protective cap back on the tube before
storage. Do not reuse the applicator with another tube.
7. Allow at least four hours between applications of the
gel. Do not apply more than 4 times in any 24 hour
period.
For Laminated tube with push/pull cap applicator

9 mm

127 mm

9 mm

Expand view ⇕

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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