180 mm    180 mm-

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Elastoplast

Elastoplast Back Pain 4.8 mg Medicated Plaster

Soft extract of cayenne pepper

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 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

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).

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.

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

Data Matrix

ECC 200

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

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-diyl-diiminodimethyl) diphenol; orris root powder/rice flour mixture; caoutchouc; poly(butadiene-block-styrene) (76.5:23.5); cis-1,4-polyiso-prene; talcum (E553b); beta-pinene homopolymer; poly (2-methylbut-2-ene-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

5.    How to store Elastoplast Back Pain

4.8    mg Medicated Plaster

6.    Further information

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.

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

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

Children

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

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

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.

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,

emplatre medicamenteux

Germany: Rheumaplast 4,8 Mg

Wirkstoffhaltiges Pflaster

Greece: AEONTOI OappaKouxo 'EpnAaaxpo ^appaKouxo 4,8mg

Ireland:    Elastoplast Back Pain

4.8 mg Medicated Plaster

Portugal: Hansaplast® 4,8 mg

Emplastro Medicamentoso

Spain:    Hansaterma 4,8 mg

Aposito Adhesivo Medicamentoso

This leaflet was last approved in 11/2008.

NART xxxxx-xxxxx-xx    DRVxxxxx.01