HANSATERM 4.8 mg MEDICATED ADHESIVE DRESSING

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hansaterm® 4.8 mg medicated adhesive patch

Soft extract of Cayenne pepper

Read the entire package leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 weeks.

Contents of the package leaflet

1. What Hansaterm 4.8 mg medicated adhesive patch is and what it is used for
2. What you need to know before starting to use Hansaterm 4.8 mg medicated adhesive patch
3. How to use Hansaterm 4.8 mg medicated adhesive patch
4. Possible side effects
5. Storage of Hansaterm 4.8 mg medicated adhesive patch
6. Contents of the pack and further information

1. What Hansaterm 4.8 mg medicated adhesive patch is and what it is used for

Hansaterm 4.8 mg medicated adhesive patch is used topically to relieve muscle pain, such as lower back pain, in adults and adolescents over 12 years of age.

2. What you need to know before starting to use Hansaterm 4.8 mg medicated adhesive patch

Do not use Hansaterm 4.8 mg medicated adhesive patch

• if you are allergic to Cayenne pepper, to other sources of capsaicinoids (e.g., pepper plants) or to any of the other components of this medicine (listed in section 6).
• on damaged skin and over wounds.

Warnings and precautions

Consult your doctor orpharmacist before starting to use Hansaterm 4.8 mg medicated adhesive patch:

• in more severe cases when your condition is accompanied by redness of the skin, swellingor a sensation of intense heat in the joints,
• if you have permanent joint discomfort,
• if you have severe back painthat radiates to the legs and/or is associated with neurological symptoms(e.g., numbness, tingling sensation).

Additionally, note the following:

• The patch should not be applied near the eyes, mouth, tongue, or lips.
• It is recommended not to scratch the application areato avoid skin lesions.
• Avoid applying other heat sourcesduring treatment. The treatment should be interrupted if excessive heat is felt.

Children

This medicine is not recommended for use in children under 12 years of age, as there is no experience in children.

Using Hansaterm 4.8 mg medicated adhesive patch with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

• The patch is not intended to be used in conjunction with other products (e.g., other rubefacients [products that redden the skin due to increased blood flow] or pain-relieving gels) in the same application area.
• Interactions with other products applied to the same treatment area may occur even after several hours of removing the patch.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

The active ingredient of the patch (soft extract of Cayenne pepper) may pass into breast milk.

Driving and using machines

There is no reason to believe that the use of Hansaterm 4.8 mg medicated adhesive patch may alter the ability to drive or use machines.

Hansaterm 4.8 mg medicated adhesive patch contains lanolin

This medicine contains lanolin (wool fat). Lanolin may cause local skin reactions (such as contact dermatitis).

3. How to use Hansaterm 4.8 mg medicated adhesive patch

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Dose

Use a maximum of 1 patchper day.

Method of administration

The patch should be applied only to dry and healthy skin.

Remove the protective paper from the patch and place the patch over the painful area, with the adhesive side on the skin.

The patch should be left on for at least 4 hours and a maximum of 8 hours.

To remove the patch, lift a corner and remove it carefully. After handling and touching the patch, wash your hands with soap and water.

Any residue that may remain on the skin after removing the patch can be removed with vegetable oil, a moisturizing cream, or cold water.

A minimum interval of 12 hours should be allowed before using a new patch in the same application area.

Duration of treatment

If necessary, if the pain continues, new patches can be applied, up to a maximum of three weeks of treatment duration. Please consult your doctor if symptoms persist.

If you use more Hansaterm 4.8 mg medicated adhesive patch than you should

Overdose with this patch is very unlikely.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The active ingredient of the patch produces an increase in blood circulation with pronounced redness of the skin and a sensation of heat. This reaction is part of the normal effect of the preparation and usually subsides shortly after removing the patch.

Rare side effects (may affect up to 1 in 1000 people):

Cutaneous hypersensitivity reactions (allergic) with redness, itching, and blistering at the application site may occur. If this happens, the patch should be removed and treatment discontinued.

If during the first few days of treatmenta burning sensation or excessive itching or stinging occurs, the patch should be removed and treatment discontinued.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hansaterm 4.8 mg medicated adhesive patch

Keep this medicine out of the sight and reach of children.

After removal, the adhesive patch should be placed in a plastic bag, which should be tightly closed and thrown away. After handling the adhesive patch, wash your hands with soap and water. Contact with the eyes or mouth, tongue, and lips should be avoided.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

After opening the package, the patch should be used within 3 months.

6. Contents of the pack and further information

Composition of Hansaterm 4.8 mg medicated adhesive patch

• The active ingredient is:

Soft extract of Cayenne pepper.

Each medicated adhesive patch contains 112-167 mg of soft extract of Cayenne pepper (4-7:1), corresponding to 4.8 mg of capsaicinoids, calculated as capsaicin. The solvent of the extract is ethanol 80% (v/v).

• The other ingredients are:

liquid glucose; purified water; 2,2’-methylene-bis-(6-tert-butyl-4-methylphenol); mixture of iris root powder/rice flour; rubber; poly(butadiene-block-styrene) (76.5:23.5); cis-1,4-polyisoprene; talc (E553b); beta-pinene homopolymer; poly(2-methylbut-2-eno-co-penta-1,3-diene); hydrogenated colophony ester with glycerol; light liquid paraffin; lanolin; viscose fabric (patch backing); siliconized paper on one side (protective paper).

Appearance and packaging of the product

Hansaterm 4.8 mg medicated adhesive patch is a rectangular perforated patch (18x12 cm) with a viscose fabric backing. It is marketed in a package containing 1 or 2 patches.

Only certain pack sizes may be marketed.

Marketing authorization holder and manufacturer

Beiersdorf AG

Beiersdorfstrasse 1-9

22529 Hamburg

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Rheumaplast 4.8 mg wirkstoffhaltiges Pflaster

Belgium Hansamedic Wärmepflaster 4.8 mg wirkstoffhaltiges Pflaster

Hansamedic Emplâtre Chauffant 4.8 mg emplâtre médicamenteux

Hansamedic Warmtepleister 4.8 mg Pleister

Greece ΛΕΟΝΤΟΣ ?μπλαστρο 4.8 mg

Luxembourg Hansamedic Wärmepflaster 4.8 mg wirkstoffhaltiges Pflaster

Portugal Hansaplast 4.8 mg emplastro medicamentoso

Spain Hansaterm 4.8 mg apósito adhesivo medicamentoso

Date of the last revision of this package leaflet: July 2021