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ELASTOPLAST BACK PAIN 4.8MG MEDICATED PLASTER

Active substance(s): CAYENNE PEPPER SOFT EXTRACT 4-7:1

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PACKAGE LEAFLET:

high temperature of the joints,
• if you have ongoing joint trouble,
• if you have severe back pain
radiating into the legs and/or
associated with neurological
syndromes (e.g. numbness,
tingling).

INFORMATION FOR THE USER

Elastoplast Back Pain
4.8 mg Medicated Plaster
Soft extract of cayenne pepper

180 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 Elastoplast Back Pain 4.8 mg
Medicated Plaster 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 after 3 weeks.
• If any of the side effects gets
serious, or if you notice any
side effects not listed in this
leaflet,please tell your doctor or
pharmacist.

In addition please observe the
following:
• The plaster should not be applied
near the eyes, mouth, tongue or
lip.
• It is recommended not to scratch
the application site to avoid
damage to the skin (see also: "Do
not use Elastoplast Back Pain 4.8
mg Medicated Plaster").
• Avoid application of additional
sources of heat during
treatment. Treatment should be
discontinued if excessive warmth
is experienced.

In this leaflet
1. What Elastoplast Back Pain 4.8 mg
Medicated Plaster is and what it is
used for
2. Before you use Elastoplast Back
Pain 4.8 mg Medicated Plaster
3. How to use Elastoplast Back Pain
4.8 mg Medicated Plaster
4. Possible side effects

Using other medicines
• The plaster is not intended to be
applied at the same time as other
products [e.g. other
rubefacient (agents that
redden the skin due to
increased blood flow) or
pain relieving gels] at the
same application site.
• Interactions with other products
applied at the same application
site may even occur several
hours after the plaster has been
removed.
• Please tell your doctor or
pharmacist if you are taking or

5. How to store Elastoplast Back Pain
4.8 mg Medicated Plaster
6. Further information

have recently taken any other
medicines, including medicines
obtained without a prescription.

1. WHAT ELASTOPLAST BACK
PAIN 4.8 mg MEDICATED
PLASTER IS AND WHAT IT IS
USED FOR
Elastoplast Back Pain 4.8 mg
Medicated Plaster is for the external
treatment of muscle pain (eg. lower
back pain) to be used in adults
and adolescents over the age of
12 years. The active ingredient in
the plaster (soft extract of cayenne
pepper) stimulates blood flow
produces a sensation of warmth
and reduces the perception of pain
at the site of application.

Children
Because there is no experience
available, use of this medicinal
product is not recommended in
children below the age of 12 years.

180 mm

2. BEFORE YOU USE
ELASTOPLAST BACK PAIN
4.8 MG MEDICATED PLASTER
Do not use Elastoplast Back Pain
4.8 mg Medicated Plaster
• if you are allergic (hypersensitive)
to cayenne pepper, to other
capsaicinoid sources (e.g.
paprika plants) or any of the other
ingredients of the plaster.
• on broken skin and wounds.
Take special care with Elastoplast
Back Pain 4.8 mg Medicated
Plaster
You should consult your doctor
before using the plaster if any of the
following points apply to you:
• in those more serious cases when
your condition is accompanied by
reddening, swelling or a feeling of

Data Matrix
xxxxx
xxxxx
xx
ECC 200

Pregnancy and breast-feeding
Do not use the plaster if you are
pregnant, planning to be pregnant or
breastfeeding without first consulting
your doctor.
Driving and using machines
There is no reason to believe that the
use of Elastoplast Back Pain 4.8 mg
Medicated Plaster will impair the
ability to drive or use machines.
Important information about some
of the ingredients of Elastoplast
Back Pain 4.8 mg Medicated
Plaster
The medicinal product contains wool
fat (lanolin) which may contain traces
of butylated hydroxytoluene (E321)
which may cause local skin reactions
(e.g. contact dermatitis) or irritation to
the eyes and mucous membranes.
3. HOW TO USE ELASTOPLAST
BACK PAIN 4.8 MG MEDICATED
PLASTER
A maximum of 1 plaster per day
should be used.
The plaster should be used on dry,
unbroken skin only.
Peel the plaster cover off. Apply the
plaster with the adhesive side on the

130 mm

skin over the painful area.
The plaster should be left in place for
at least 4 and up to 8 hours.
To remove the plaster, raise one
corner and carefully pull it off. Hands
should be washed with soap and
water after handling the plaster.
Any remnants remaining on the skin
after detachment of the plaster can
be removed with vegetable oil, a
moisturising cream or cold water.
There should be an interval of at
least 12 hours before a new plaster
is applied on the same application
area.
Duration of treatment
New plasters should be applied until
the pain subsides, if necessary, up
to 3 weeks duration. Please consult
your doctor if symptoms persist.
If you use more Elastoplast Back
Pain 4.8 mg Medicated Plaster
than you should
Overdose with this plaster is
extremely unlikely.
If you have any further questions
on the use of this product, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Elastoplast Back
Pain 4.8 mg Medicated Plaster can
cause side effects, although not
everybody gets them.
(The active ingredient of the plaster
causes increased blood circulation
with marked reddening of the skin
and a sensation of warmth. This

reaction is part of the normal effect
of the preparation and subsides as a
rule within a short time after removal
of the plaster.
In rare cases (1 to 10 out of 10,000
patients treated): Skin hypersensitivity
(allergic) reactions may occur,
causing redness, itching and
blistering at the plaster application
site. If this occurs, the plaster should
be removed and treatment should be
discontinued.
If during the first few days of
treatment a burning sensation or
any stinging or itching occurs which
is excessive, the plaster should be
removed and treatment discontinued.
If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE ELASTOPLAST
BACK PAIN 4.8 MG MEDICATED
PLASTER
Keep out of the reach and sight of
children.
After removal the plaster should
be placed in a plastic bag, which
should be sealed securely and be
disposed of via household waste.
Hands should be washed with
soap and water after handling the
plaster. Contact with the eyes or
mouth/tongue/lips must be avoided.
Do not use Elastoplast Back Pain
4.8 mg Medicated Plaster after the
expiry date which is stated on the
pack after Exp. Date. The expiry date
refers to the last day of that month.

This medicinal product does
not require any special storage
conditions.
After first opening of the sealed
envelope it should be used within 3
months.
6. FURTHER INFORMATION
What Elastoplast Back Pain 4.8 mg
Medicated Plaster contains:
The active substance is:
Soft extract of cayenne pepper.
Each plaster contains 112 – 167
mg soft extract of cayenne pepper
(4-7:1) corresponding to 4.8 mg
capsaicinoids, calculated as
capsaicin. Extract solvent is ethanol
80% (v/v).
The other ingredients are:
Liquid glucose; purified water;
2,2’-methylene-bis-(6-tert-butyl-4-m
ethylphenol); 2,2’-(propane-1,2-diyldiiminodimethyl) diphenol; orris root
powder/rice flour mixture;
caoutchouc; poly(butadiene-blockstyrene) (76.5:23.5); cis-1,4-polyisoprene; talcum (E553b); beta-pinene
homopolymer; poly (2-methylbut-2ene-co-penta-1,3-diene); glycerol
ester of hydrogenated colophony;
light liquid paraffin; wool fat (lanolin)
(contains butylated hydroxytoluene
(E321)).
The backing material is made from
viscose fabric and the covering
consists of paper siliconised on one
side.
What Elastoplast Back Pain 4.8 mg
Medicated Plaster looks like and

contents of the pack
Elastoplast Back Pain 4.8 mg
Medicated Plaster is a rectangular
perforated plaster (18 x 12 cm) with
viscose fabric carrier. It is available
in a pack with 1 or 2 medicated
plasters.

Marketing Authorisation Holder
and Manufacturer
Beiersdorf AG
D-20245 Hamburg
Germany
This medicinal product is
authorised in the member states
of the EEA under the following
names:
Belgium: Hansamedic 4,8 mg pleister
France:

Elastotherm 4,8 mg,
emplâtre médicamenteux

Germany: Rheumaplast 4,8 Mg
Wirkstoffhaltiges Pflaster
Greece:

ΛΕΟΝΤΟΣ Φαρμακούχο
Έμπλαστρο ψαρμακούχο
4,8mg

Ireland:

Elastoplast Back Pain
4.8 mg Medicated Plaster

Portugal: Hansaplast® 4,8 mg
Emplastro Medicamentoso
Spain:

Hansatermâ 4,8 mg
Apósito Adhesivo
Medicamentoso

This leaflet was last approved in
11/2008.

NART xxxxx-xxxxx-xx

130 mm

DRVxxxxx.01

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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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