PATIENT INFORMATION LEAFLET

Hansaterm®4.8 mg medicated adhesive plaster

Soft extract of Cayenne pepper

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

Follow exactly the administration instructions contained in this leaflet or those given by your pharmacist.

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

Hansaterm 4,8 mg adhesive medicated dressing is used topically to relieve muscle pain, for example lower back pain, in adults and adolescents 12 years of age and older.

Do not use Hansaterm 4,8 mg adhesive medicated plaster

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

Warnings and precautions

Consult your doctor or pharmacist before starting to useHansaterm 4,8 mg adhesive medicated plaster:

• in severe cases when your condition is accompanied byskin redness,swellingora feeling of intense heat in the joints,
• if you havepermanent joint pain,
• if you havesevere back painthat radiates to the legs and/or isassociated with neurological symptoms(e.g., numbness, tingling).

Also, note the following:

• The plaster should not be appliednear the eyes, mouth, tongue, or lips.
• It is recommendednot to scratch the area of application, to avoid skin injuries.
• Avoid applying other heat sourcesduring treatment. Treatment should be discontinued if excessive heat is felt.

Children

This medication is not recommended for children under 12 years old, as there is no experience with children.

Use of Hansaterm 4,8 mg adhesive medicated plaster with other medications

Inform your doctor or pharmacist if you are using, have used recently, or might have to use any other medication

• The plaster 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 area of application.
• Interactions with other products applied in the same treatment area may occur even after several hours of removing the plaster.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant, consult your doctor before using this medication.

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

Driving and operating machines

There is no reason to believe that using Hansaterm 4,8 mg adhesive medicated plaster can affect your ability to drive or operate machines.

Hansaterm 4,8 mg adhesive medicated plaster contains wool fat

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

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

Dose

It will be used asa maximum of 1 patch per day.

Administration form

The patch should be applied only ondry and healthy skin.

Remove the protective paper from the patch and place the patch on theaffected area,with the adhesive side on 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 a corner and remove it carefully. After handling and touching the patch, wash your hands with water and soap.

Any remaining residue 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 on the same application area.

Treatment duration

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

If you use more Hansaterm 4,8 mg adhesive medicated patch than you should

Overdosing with this patch is very unlikely.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The active ingredient in the dressing 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 generally subsides shortly after removing the dressing.

Adverse effects that are rare (may affect up to 1 in 1000 people):

Reactions of cutaneous hypersensitivity (allergic) may occur with redness, itching, and the appearance of blisters at the site of application. If this occurs, the dressing should be removed and treatment suspended.

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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

After removal, the adhesive patch should be introduced into a plastic bag that will be sealed well and discarded. After handling the adhesive patch, hands should be washed with water and soap. Contact with the eyes, mouth, tongue, and lips should be avoided.

Do not use this medication after the expiration date appearing on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

After the first opening of the packaging, the patch should be used within a period of 3 months.

Composition of Hansaterm 4,8 mg medicated adhesive plaster

• The active ingredient is:

Soft extract of Cayenne pepper.

Each medicated adhesive plaster 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 at 80% (v/v).

• The other components are:

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

Appearance of the product and content of the packaging

Hansaterm 4,8 mg medicated adhesive plaster is a perforated rectangular plaster (18x12 cm) with a viscose fabric support. It is marketed in a package with 1 or 2 plasters.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Beiersdorf AG

Beiersdorfstrasse 1-9

22529 Hamburg

Germany

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

Germany Rheumaplast 4,8 mg medicated plaster

Belgium Hansamedic Warm Plaster 4,8 mg medicated plaster

Hansamedic Emplâtre Chauffant 4,8 mg medicated plaster

Hansamedic Warmtepleister 4,8 mg plaster

Greece ΛΕΟΝΤΟΣ ?μπλαστρο 4,8 mg

Luxembourg Hansamedic Wärmepflaster 4,8 mg medicated plaster

Portugal Hansaplast 4,8 mg medicated plaster

Spain Hansaterm 4,8 mg medicated adhesive plaster

Last review date of this leaflet: July 2021 .