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VOLTAROL 140 MG MEDICATED PLASTER

Active substance(s): DICLOFENAC SODIUM / DICLOFENAC SODIUM / DICLOFENAC SODIUM

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

AWF 24925 – OTDC 408332
VOLTAROL PATCH 140MG 0002 GB_317020_PIL
155 x 300 mm – Recto/Verso
XXX
Black
Helvetica Neue LT Pro
8 pts
XXXXXX
Fidia Bouty – IT
XXXXXX

Pre-press

Diadeis420836 – AL – 12.04.2017

Draft G

WARNING: Wrong display / print > switch overprint ON

155 mm

Recto

15 mm

125 mm

39 mm

Read all of this leaflet carefully before you start
using this medicinal product because it contains
important information for you.
Always use this medicine exactly as described in this
leaflet or as your doctor or pharmacist have told you.
– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more information
or advice.
– If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
– You must talk to a doctor if you do not feel better
or if you feel worse after 7 days.

270 mm

1. WHAT VOLTAROL 140 MG MEDICATED
PLASTER IS AND WHAT IT IS USED FOR
Voltarol 140 mg Medicated Plaster is a medicine that
relieves pain. It belongs to a group of medicines known
as non-steroidal anti-inflammatory drugs (NSAIDs).
Voltarol 140 mg Medicated Plaster is used for the local
symptomatic and short term treatment of pain associated
with acute strains, sprains or bruises on the arms and
legs as a result of injuries, e.g. sports injuries in
adolescents from 16 years of age and adults.
You must talk to a doctor if you do not feel better or if you
feel worse after 7 days.

2. WHAT YOU NEED TO KNOW BEFORE YOU
USE VOLTAROL 140 MG MEDICATED
PLASTER
Do not use Voltarol 140 mg Medicated Plaster if you
– are allergic to diclofenac or any of the other
ingredients in this medicine (listed in section 6);
– are allergic to any other non-steroidal antiinflammatory drug (NSAID, e.g. acetylsalicylic acid
or ibuprofen);
– have ever developed asthma attacks, hives or
swelling and irritation inside the nose after taking
acetylsalicylic acid or any other NSAID;
– are suffering from an active stomach or intestinal
ulcer;
– are in the last three months of pregnancy.
Voltarol 140 mg Medicated Plaster should not be used
on injured skin (e.g. skin abrasions, cuts, burns),
infected skin or skin affected by exudative dermatitis
or eczema;
Warnings and precautions
Talk to your doctor or pharmacist before using
Voltarol 140 mg Medicated Plaster
Ř if you suffer from disorders of the kidneys, heart
or liver, or if you suffer or have previously suffered
from a stomach or intestinal ulcer or intestinal
inflammation or a tendency to bleeding.
Consult a doctor or pharmacist before using
Voltarol 140 mg Medicated Plaster if any of the above
mentioned applies to you.
Take special care with Voltarol 140 mg Medicated
Plaster
Ř if you notice a skin rash. If this happens, immediately
remove the medicated plaster and stop the treatment.

3. HOW TO USE VOLTAROL 140 MG
MEDICATED PLASTER
Always use this medicine exactly as described in this
leaflet or as your doctor or pharmacist have told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is one medicated plaster twice
daily.
Attach one medicated plaster to the painful area twice
daily, in the morning and in the evening. The maximum
total daily dose is 2 medicated plasters, even if there is
more than one injured area to be treated. Treat only one
painful area at a time.
Use in children and adolescents
Voltarol 140 mg Medicated Plaster is not recommended
for use in children and adolescents under 16 years of

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300 mm

What is in this leaflet
1. What Voltarol 140 mg Medicated Plaster is and what
it is used for
2. What you need to know before you use
Voltarol 140 mg Medicated Plaster
3. How to use Voltarol 140 mg Medicated Plaster
4. Possible side effects
5. How to store Voltarol 140 mg Medicated Plaster
6. Contents of the pack and other information

Side effects can be reduced by using the lowest effective
dose for the shortest possible period of time.
IMPORTANT pprecautions
Ř If symptoms persist for longer than 7 days, you should
see a doctor.
Ř The medicated plaster must not come into contact with
or be applied to the eyes or mucous membranes.
Ř Elderly patients should use Voltarol 140 mg Medicated
Plaster with caution because they are more likely
to experience side effects.
After taking off the medicated plaster, avoid exposing the
treated area to direct sunlight or solarium radiation
in order to reduce the risk of sensitivity to light.
Children and adolescents
Voltarol 140 mg Medicated Plaster should not be used
in children and adolescents under 16 years of age
because no adequate experience is available for this
age group.
Other medicines and Voltarol 140 mg Medicated
Plaster
Please tell your doctor or pharmacist if you are taking
or have recently taken or might take any other medicines.
Do not use Voltarol 140 mg Medicated Plaster at the
same time as any other diclofenac-containing or other
non-steroidal pain-relieving and anti-inflammatory
medicines regardless of whether these are used
externally or taken by mouth.
Provided that Voltarol 140 mg Medicated Plaster is used
correctly, only a small amount of diclofenac is absorbed
into the blood. Therefore interactions with other
medicines seen with diclofenac products taken by mouth,
are unlikely.
Pregnancy and breast-feeding
Pregnancy
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.
In the first 6 months of pregnancy or if you want to
become pregnant, Voltarol 140 mg Medicated Plaster
should be used only after talking to your doctor.
In the last 3 months of pregnancy, Voltarol 140 mg
Medicated Plaster must not be used because an
increased risk of complications for the mother and the
child cannot be ruled out (see ”Do not use
Voltarol 140 mg Medicated Plaster”).
Breast-feeding
Small quantities of diclofenac pass into the breast milk.
Talk to your doctor before using Voltarol 140 mg
Medicated Plaster during breast-feeding. In any case,
if you are breast-feeding Voltarol 140 mg Medicated
Plaster should not be applied directly onto the breast
area.
Driving and using machines
Voltarol 140 mg Medicated Plaster has no influence
on your ability to drive and use machines.

15 mm

125 mm

15 mm

39 mm

For use in adolescents from 16 years of age and adults.
Active substance: diclofenac sodium

Pharma code XXX

Pharma code XXX

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

AWF 24925 – OTDC 408332
VOLTAROL PATCH 140MG 0002 GB_317020_PIL
155 x 300 mm – Recto/Verso
XXX
Black
Helvetica Neue LT Pro
8 pts
XXXXXX
Fidia Bouty – IT
XXXXXX

Pre-press

Diadeis420836 – AL – 12.04.2017

Draft G

WARNING: Wrong display / print > switch overprint ON

155 mm

Verso

15 mm

125 mm

age. There are insufficient data of efficacy and safety
available for children and adolescents below 16 years
(see section 2).
In adolescents aged 16 years and over, if this product
is required for more than 7 days for pain relief or if the
symptoms worsen, please consult a doctor.
Method of administration
For treatment on the skin (cutaneous) use only.
Do not take by mouth.
Instructions for use:
1. Cut the sachet along the dotted line and remove the
medicated plaster
To apply the plaster:
2. Remove one of the two protective
films.

3. Apply to the area to be treated and
remove the remaining protective
film.

4. Apply slight pressure with the palms
of your hand until complete adhesion
to the skin is achieved.

270 mm

If necessary, the medicated plaster can be held in place
using a net bandage.
Use the medicated plaster only on intact non-diseased
skin.
Do not use the medicated plaster together with an airtight (occlusive) bandage.
Do not wear it when bathing or showering.
Do not divide the medicated plaster, by cutting with
scissors, for example.
Duration of use
Do not use Voltarol 140 mg Medicated Plaster for longer
than 7 days.
The use of this medicine for a longer period of time
needs advice and must be discussed with a doctor.
If you have the impression that the effect of
Voltarol 140 mg Medicated Plaster is too strong or too
weak, please talk to your doctor or pharmacist.
If you apply more Voltarol 140 mg Medicated Plaster
than you should
Please tell your doctor if you experience side effects after
incorrect use of this medicine, if you apply more patches
than you should or if a patch is accidently applied to a
child. They will be able to advise you of any action that
may need to be taken.
If you forget to use Voltarol 140 mg Medicated
Plaster
You should apply a new patch to the affected area when
you remember. Do not apply more than one patch to
make up for the missed patch.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor immediately and stop using the
plaster if you notice any of the following:
sudden itchy rash (hives); swelling of the hands, feet,
ankles, face, lips, mouth or throat; difficulty breathing;
drop in blood pressure or weakness.
You may experience the following side effects:
Common side effects (may affect up to 1 in
10 people):
local skin reactions, such as skin redness, burning
sensation, itching, inflamed skin redness, skin rash,
sometimes with pustules or wheals.

5. HOW TO STORE VOLTAROL 140 MG
MEDICATED PLASTER
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which
is stated on the outer carton and the sachet after ”EXP”.
The expiry date refers to the last day of that month.
Store below 30 °C.
Store in the original package in order to protect from
desiccation and light.
Keep the sachet tightly closed in order to protect from
desiccation and light.
Do not use Voltarol 140 mg Medicated Plaster if you
notice that it is damaged.
Used plasters should be folded in half with the sticky side
inwards.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Voltarol 140 mg Medicated Plaster contains
The active substance is diclofenac sodium.
Each medicated plaster contains 140 mg diclofenac
sodium.
The other ingredients are:
Supporting
pp
g layer:
y
Polyester non-woven fabric
Adhesive layer:
y
Basic butylated methacrylate coplymer
Copolymer acrylate vinyl acetate
PEG 12 stearate
Sorbitan oleate
Liner:
Mono silicone coated paper
What Voltarol 140 mg Medicated Plaster looks like
and contents of the pack
Voltarol 140 mg Medicated Plaster are white 10x14 cm
sized self-adhesive plasters made of non-woven fabric
on one and paper on other side.
Voltarol 140 mg Medicated Plaster is available in packs
of 2, 5 and 10 plasters, each in a single sachet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketingg Authorisation Holder and Manufacturer:
GlaxoSmithKline Consumer Healthcare (UK) Trading
Limited, Brentford, TW8 9GS, U.K.
SPA Italiana Laboratori Bouty
Strada Statale n. 11 Padana Superiore, km 160
20060 Cassina de’ Pecchi (MI), Itália
This leaflet was last revised in April 2017.

GB 317020 – XXXXXXXX

15 mm

300 mm

To remove the plaster:
5. Moisten the plaster with water and
peel away an edge of the plaster
and pull smoothly away from the
skin.
6. To remove any product residues,
wash the affected area with water
gently rubbing the area with your
fingers using a circular movement.

Very rare side effects: may affect up to 1 in 10,000
people:
Hypersensitivity reactions or local allergic reactions
(contact dermatitis).
In patients externally using drugs from the same drug
group as diclofenac, there have been isolated reports
of generalised skin rash, hypersensitivity reactions such
as swelling of the skin and mucous membranes (such
as lips, mouth and throat) and anaphylactic-type (severe
allergic) reactions. Including problems with blood
circulation and light sensitivity reactions.
Absorption of diclofenac into the body by the skin is very
low compared to the drug concentration in the blood
following diclofenac taken by mouth. Therefore, the
likelihood of side effects occurring in the body as a whole
(such as stomach or kidney problems or difficulty
breathing) is very low.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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. By reporting side effects, you can help
provide more information on the safety of this medicine.

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125 mm

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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.

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