Hansaterm 4.8 mg medicated transdermal patch

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hansaterm ® 4.8 mg medicated patch

Soft extract of Cayenne pepper

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use of the medicine contained in this leaflet or those indicated by your pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 3 weeks.

Leaflet contents

1. What Hansaterm 4.8 mg medicated patch is and what it is used for
2. What you need to know before using Hansaterm 4.8 mg medicated patch
3. How to use Hansaterm 4.8 mg medicated patch
4. Possible adverse effects
5. How to store Hansaterm 4.8 mg medicated patch
6. Contents of the pack and other information

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

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

2. What you need to know before using Hansaterm 4.8 mg medicated patch

Do not use Hansaterm 4.8 mg medicated patch

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

Warnings and precautions

Talk to your doctor or pharmacist before using Hansaterm 4.8 mg medicated patch:

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

In addition, keep the following in mind:

• The patch must not be applied near the eyes, mouth, tongue, or lips.
• Scratching the application site should be avoided to prevent skin damage.
• Avoid applying other sources of heat during treatment. Treatment should be discontinued if excessive heat is felt.

Children

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

Use of Hansaterm 4.8 mg medicated patch with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• The patch is not intended to be used together with other products (e.g., other rubefacients [products causing skin redness due to increased blood flow] or pain relief gels) on the same application area.
• Interactions with other products applied to the same treatment area may occur even several hours after removing the patch.

Pregnancy and breastfeeding

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

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

Driving and using machines

There are no reasons to believe that the use of Hansaterm 4.8 mg medicated patch may affect the ability to drive or operate machinery.

Hansaterm 4.8 mg medicated patch contains wool fat

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

3. How to use Hansaterm 4.8 mg medicated adhesive patch

Follow exactly the instructions for use provided in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Dosage

Use a maximum of 1 patch per day.

Method of administration

The patch must be applied only to dry and intact skin.

Remove the protective liner from the patch and apply the patch directly to the painful area, with the adhesive side in contact with the skin.

The patch should be left in place for a minimum of 4 hours and a maximum of 8 hours.

To remove the patch, lift one corner and carefully peel it off. After handling or touching the patch, hands should be washed thoroughly with soap and water.

Any residue remaining on the skin after patch removal can be removed using vegetable oil, moisturizing cream, or cold water.

A minimum interval of 12 hours should elapse before applying a new patch to the same application site.

Duration of treatment

If necessary, new patches may be applied if pain persists, up to a maximum treatment duration of three weeks. Please consult your doctor if symptoms continue.

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

Overdose with this patch is highly unlikely.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

The active ingredient in the patch causes increased blood circulation, resulting in marked redness of the skin and a sensation of warmth. This reaction is part of the normal effect of the product and usually subsides shortly after removing the patch.

**Rare adverse effects (**may affect up to 1 in 1,000 people):

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

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse 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 must be securely closed and then discarded in the trash. After handling the adhesive patch, hands should be washed thoroughly with soap and water. Contact with the eyes, 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 refers to the last day of the month indicated.

Do not store above 25°C.

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

6. Contents of the pack and other information

Composition of Hansaterm 4.8 mg medicated adhesive patch

• The active substance 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 80% (v/v) ethanol.

• The other components are:

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

Appearance of the product and contents of the pack

Hansaterm 4.8 mg medicated adhesive patch is a perforated rectangular patch (18 x 12 cm) with a viscose fabric support. It is marketed in packaging containing 1 or 2 patches.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Beiersdorf AG
Beiersdorfstrasse 1-9
22529 Hamburg
Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany Rheumaplast 4.8 mg medicated patch
Belgium Hansamedic Wärmepflaster 4.8 mg medicated patch
Hansamedic Emplâtre Chauffant 4.8 mg medicated patch
Hansamedic Warmtepleister 4.8 mg patch
Greece ΛΕΟΝΤΟΣ ?μπλαστρο 4.8 mg
Luxembourg Hansamedic Wärmepflaster 4.8 mg medicated patch
Portugal Hansaplast 4.8 mg medicated patch
Spain Hansaterm 4.8 mg medicated adhesive patch

Date of the most recent review of this leaflet: July 2021