Skip to Content

VOLTAROL EMULGEL P

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

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

AWF 24924 – OTDC 408388
VOLTAROL EMULGEL 1% OSTEO GEL 100G GB_317017_PIL
145 x 210 mm – PN-Notice-V11 – Recto/Verso
XXX
Black
Helvetica Neue LT Pro
7.2 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

Diadeis 420072 – AD – 11.04.2017

Draft H

WARNING: Wrong display / print > switch overprint ON

Recto

11.5 mm

145 mm

PATIENT INFORMATION LEAFLET

210 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 Osteoarthritis Joint Pain
Relief 1.16% Gel carefully to get the best results from it.
Ř Keep this leaflet, you may need to read it again.
Ř Ask your pharmacist if you need more information or advice.
Ř You must contact a doctor if your symptoms worsen or do not
improve within 7 days.
Ř 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 Osteoarthritis Joint Pain Relief 1.16% Gel is and
what it is used for
2. Before you use Voltarol Osteoarthritis Joint Pain Relief
1.16% Gel
3. How to use Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel
4. Possible side effects
5. How to store Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel
6. Further information

1. What Voltarol Osteoarthritis Joint Pain Relief
1.16% Gel is and what it is used for
Pharma code XXX

Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel 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 inflammation and swelling in painful conditions affecting the
joints and muscles. Voltarol Osteoarthritis Joint Pain Relief 1.16%
Gel can be used to treat:
Ř muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)
Ř tendonitis (e.g. tennis elbow)
Ř mild arthritis (symptoms of mild arthritis include joint pain at
rest, joint pain on movement, joint swelling or stiffness (after
sleep or long rest)).

2. Before you use Voltarol Osteoarthritis Joint
Pain Relief 1.16% Gel

3. How to use Voltarol Osteoarthritis Joint 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.

11.5 mm

72 mm

DO NOT use Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel if you:
Ř have an allergy (hypersensitivity) to any of the ingredients in the
product (see Section 6 ‘What Voltarol Osteoarthritis Joint Pain
Relief 1.16% Gel contains’).
Ř have ever had an allergic reaction to diclofenac or other
medicines used to treat pain, fever or inflammation, such
as aspirin 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.
Ř are using any other medicine containing diclofenac or are taking
oral NSAIDs such as aspirin or ibuprofen.
Ř have severe joint pain of recent onset that is not related
to an injury or period of overuse.
Ř feel ill, have a temperature or any other symptoms that
accompany the pain.

Ř are in the last 3 months of your pregnancy (see also pregnancy
and breast-feeding section).
This medicine is not recommended for use in children under
14 years of age.
Take special care with Voltarol Osteoarthritis Joint Pain Relief
1.16% Gel
Ř 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.
Ř Avoid applying on large areas of skin and over a prolonged
period of time, unless under medical advice.
Ř Be careful when sunbathing or using sun lamps as your skin
may be more sensitive to sunlight.
Ř If you have a stomach or duodenal ulcer (or a history of), tell
your doctor or pharmacist before using the gel.
Ř 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 Osteoarthritis Joint Pain Relief 1.16% Gel 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 Osteoarthritis Joint Pain Relief 1.16% Gel must not be used
during the last 3 months of pregnancy, as it could harm your
unborn child. Voltarol Osteoarthritis Joint 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 Osteoarthritis Joint 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 Osteoarthritis Joint 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.
Driving and using machines
Voltarol Osteoarthritis Joint 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 Osteoarthritis Joint Pain Relief 1.16% Gel
The gel formulation contains propylene glycol and benzyl benzoate,
which may cause mild localised skin irritation in some people.

9 mm

127 mm

9 mm

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

AWF 24924 – OTDC 408388
VOLTAROL EMULGEL 1% OSTEO GEL 100G GB_317017_PIL
145 x 210 mm – PN-Notice-V11 – Recto/Verso
XXX
Black
Helvetica Neue LT Pro
7.2 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

Diadeis 420072 – AD – 11.04.2017

Draft H

WARNING: Wrong display / print > switch overprint ON

Verso

11.5 mm

145 mm

Some rare and very rare side effects might be serious
If you experience any of the following signs of allergy, STOP using
Voltarol Osteoarthritis Joint 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).
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.
Some side effects have unknown frequency (cannot be
estimated from available information): local application site
irritation, skin discolouration.
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 this 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.

72 mm

Pharma code XXX

5. How to store Voltarol Osteoarthritis Joint Pain
Relief 1.16% Gel
Keep out of the sight and reach of children.
Do not store above 30 °C. The dispenser is a pressurised container,
protect from direct sunlight and do not pierce or burn even when
empty.
Do not use Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel after
the expiry date stated on the carton and tube, or dispenser.
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.

210 mm

Adults and adolescents 14 years and over:
Before using for the first time, open as follows:
Ř aluminium tube: Unscrew cap and pierce the aluminium seal
with the spiked top of the cap. Do not use if seal is broken.
Ř laminated tube: Unscrew cap and remove. Reverse the cap,
engage with the nozzle, twist and remove the plastic seal from
the tube. Do not use if seal is broken.
Ř dispenser: Remove the lid from the top of the dispenser.
How to apply:
Gently squeeze out a small amount of gel from the tube or press
firmly and evenly on the nozzle of the dispenser and apply to the
painful or swollen area, slowly rubbing into the skin.
When and how much to use:
Ř Apply 3 to 4 times a day. Allow at least 4 hours between
applications of the gel. Do not apply more than 4 times in any
24 hour period.
Ř 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 (2 to 4g) will usually be sufficient.
Ř You may notice a slight cooling effect when you rub the gel in.
Ř Only use the smallest amount of Voltarol Osteoarthritis Joint
Pain Relief 1.16% Gel needed to relieve your pain but never use
more than 16g per day and 112g in one week.
How and where to use:
Ř You can apply the gel to a maximum of 2 joints (such as your
knees or elbows). If you need to apply it to more than 2 joints,
consult your doctor.
Ř 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.
Ř The gel is for external use only. Do not use it in your mouth.
Ř Be careful not to get the gel in your eyes. If this happens, rinse
your eyes with clean water and tell your doctor.
Ř Wash your hands after rubbing in Voltarol Osteoarthritis Joint
Pain Relief 1.16% Gel, unless your hands are the site being
treated.
For how long should you use Voltarol Osteoarthritis Joint Pain
Relief 1.16% Gel?
Do not use Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel for
more than:
Ř 14 days unless longer treatment is recommended by a doctor.
Ř For arthritis pain, you may need to apply the gel for up to 7 days
(to allow its effect to build up on the joint) before you notice
an improvement in your pain.
Ř If the pain and swelling do not improve within 7 days, or worsen,
speak to your doctor.
Ř 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.
Children under 14 years:
This medicine is not recommended for use in children under
14 years of age.
If you use more Voltarol Osteoarthritis Joint Pain Relief
1.16% Gel than you should
If you or a child accidentally swallows Voltarol Osteoarthritis Joint
Pain Relief 1.16% Gel, contact your doctor or accident and
emergency department immediately.
If you forget to use Voltarol Osteoarthritis Joint Pain Relief
1.16% Gel
If you miss your application of Voltarol Osteoarthritis Joint 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.

6. Further information
What Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel
contains
The active substance is diclofenac diethylammonium (1.16%)
equivalent to 1g of diclofenac sodium in each 100g of gel.
The other ingredients are diethylamine, isopropyl alcohol, liquid
paraffin, propylene glycol, perfume (containing benzyl benzoate),
carbomers, cetomacrogol, cocoyl caprylocaprate, purified water
(see end of Section 2 ‘Important information about some of the
ingredients of Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel’
for propylene glycol).
What Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel looks
like and contents of the pack
Voltarol Osteoarthritis Joint 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 in a pressurised dispenser. This is supplied in a carton and
comes in packs of 10, 30, 50g, 75ml, 100g, 120g, 150g and 180g
(not all pack sizes may be marketed).
Marketing authorisation holder and Manufacturer
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
Brentford, TW8 9GS, U.K.
This leaflet was last revised in March 2017.

4. Possible side effects
GB 317017 - XXXXXX

11.5 mm

Like all medicines, Voltarol Osteoarthritis Joint Pain Relief
1.16% Gel can cause side effects, although not everybody gets
them.

9 mm

127 mm

9 mm

Expand Transcript

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.

Hide