Skip to Content

VOLTAROL 140 MG MEDICATED PLASTER

Active substance(s): DICLOFENAC SODIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
Order – AWF
Reference
Format
Pharma code
Colour

AWF 22308 - NPL 9-149 - OTDC 366896
VOLT FIDIA PATCH GB_932727Z_PIL
300 x 155 mm - Recto/Verso
XXX
PANTONE Reflex Blue U

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

Helvetica Neue LT Pro
Outlined (all), 7.5 pt (body text)

Proof Z

Fidia - IT
Sonoco-Trident - TR952227/1/DIS - 20/04/2015

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 Medicated plaster
is and what it is used for
Voltarol Medicated plaster is a medicine that relieves pain.
It belongs to a group of medicines known as non-steroidal
anti-inflammatory drugs (NSAIDs).
Voltarol 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 Medicated plaster
Do not use Voltarol 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 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
Medicated plaster
• 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
Medicated plaster if any of the above mentioned applies
to you.
Take special care with Voltarol Medicated Plaster
• if you notice a skin rash. If this happens, immediately
remove the medicated plaster and stop the treatment.
Side effects can be reduced by using the lowest effective
dose for the shortest possible period of time.

3. How to use Voltarol 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 Medicated plaster is not recommended for use
in children and adolescents under 16 years of 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.

15 mm

300 mm

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

IMPORTANT precautions
• If symptoms persist for longer than 7 days, you should see
a doctor.
• The medicated plaster must not come into contact with
or be applied to the eyes or mucous membranes.
• Elderly patients should use Voltarol 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 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 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 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 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 Medicated plaster should be used only
after talking to your doctor.
In the last 3 months of pregnancy, Voltarol 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 Medicated plaster”).
Breast-feeding
Small quantities of diclofenac pass into the breast milk.
Talk to your doctor before using Voltarol Medicated plaster
during breast-feeding. In any case, if you are breast-feeding
Voltarol Medicated plaster should not be applied directly onto
the breast area.
Driving and using machines
Voltarol Medicated plaster has no influence on your ability
to drive and use machines.

15 mm

15 mm
155 mm

39 mm

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

Pharma code XXX

Pharma code XXXX

Package leaflet: Information for the user

Order – AWF
Reference
Format
Pharma code
Colour

AWF 22308 - NPL 9-149 - OTDC 366896
VOLT FIDIA PATCH GB_932727Z_PIL
300 x 155 mm - Recto/Verso
XXX
PANTONE Reflex Blue U

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

Helvetica Neue LT Pro
Outlined (all), 7.5 pt (body text)

Proof Z

Fidia - IT
Sonoco-Trident - TR952227/1/DIS - 20/04/2015

155 mm

Verso

15 mm

125 mm

Instructions for use:
1. Cut the sachet along the dotted line and remove the
medicated plaster

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.

To apply the plaster:
2. Remove one of the two protective
films.

5. How to store Voltarol Medicated
plaster

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

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 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.

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 air-tight
(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 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
Medicated plaster is too strong or too weak, please talk
to your doctor or pharmacist.
If you apply more Voltarol 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 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.
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.

6. Contents of the pack and other
information
What Voltarol Medicated plaster contains
The active substance is diclofenac sodium.
Each medicated plaster contains 140 mg diclofenac sodium.
The other ingredients are:

Supporting layer:

Polyester non-woven fabric
Adhesive layer:
Basic butylated methacrylate coplymer
Copolymer acrylate vinyl acetate
PEG 12stearate
Sorbitan oleate
Liner:
Mono silicone coated paper
What Voltarol Medicated plaster looks like and contents
of the pack
Voltarol Medicated plaster are white 10x14 cm sized selfadhesive plasters made of non-woven fabric on one and
paper on other side.
Voltarol 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
Marketing Authorisation Holder:
Novartis Consumer Health UK Limited
Park view, Riverside Way
Watchmoor Park, Camberley
Surrey GU15 3YL, United Kingdom
Manufacturer:
Novartis Consumer Health GmbH
Zielstattstr. 40
81379 Munich, Germany
SPA Italiana Laboratori Bouty
Strada Statale n. 11 Padana Superiore, km 160
20060 Cassina de’ Pecchi (MI), Itália
This medicinal product is authorised in the Member
States of the EEA under the following names:
DE: Diclofenac-Natrium Sophena 140 mg Wirkstoffhaltiges
Pflaster
BE: Sophenoderm 140 mg pleister
CZ: Voltaren 140 mg léčivá náplast
DK: Diclofenac Sophena
EE: Voltaren
EL: Voltadol
FI: Diclo sodium 140 mg lääkelaastari
HU: Voltaren ActiGo140 mg gyógyszeres tapasz
LT: Voltaren 140 mg vaistinis pleistras
LV: Voltaren 140 mg ārstnieciskais plāksteris
NO: Voltarol Medicated plaster 140 mg medisinert plaster
PT: Voltaren Plast 140 mg emplastro medicamentoso
SE: Voltaren 140 mg medicinskt plåster
SK: Voltaren 140 mg liečivá náplasť
UK: Voltarol Medicated plaster 140 mg medicated plaster
This leaflet was last approved in April 2015

GB 932727

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.

15 mm

15 mm
155 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.

Hide