Capsagamma

Package Leaflet: Information for the User

Capsagamma, 53 mg capsaicinoids as capsaicin/100 g, cream

Capsici extractum spissum normatum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 weeks or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is Capsagamma and what is it used for
• 2. Important information before using Capsagamma
• 3. How to use Capsagamma
• 4. Possible side effects
• 5. How to store Capsagamma
• 6. Contents of the package and other information

1. What is Capsagamma and what is it used for

Capsagamma is a herbal medicine used in adults to relieve muscle pain, such as lower back pain.

2. Important information before using Capsagamma

When not to use Capsagamma

• if the patient is allergic to the active substance or other sources of capsaicinoids (e.g., pepper, chili) or any of the other ingredients of this medicine (listed in section 6);
• it should not be applied to damaged skin (skin abrasions, wounds, rash) and mucous membranes, or in the eye area.

Warnings and precautions

Before starting to use Capsagamma cream, the patient should discuss it with their doctor or pharmacist.

• The medicine should not be applied near the eyes or mucous membranes.
• The area where the cream is applied should not be scratched to avoid skin damage.
• During treatment, the patient should avoid exposure to heat sources (sunlight or infrared, warm compresses, or warm water).
• The burning sensation may also increase during excessive physical exertion (sweating).
• Treatment should be discontinued if the burning sensation is felt to be excessive. In such cases, the remaining cream should be removed from the skin.
• If symptoms worsen during the use of this medicine, the patient should consult their doctor or pharmacist.
• The cream is not recommended for patients who are bedridden (due to an increased risk of pressure sores).

Children and adolescents

The cream should not be used in children and adolescents under 18 years of age due to the lack of data on safety and efficacy in this age group.

Capsagamma and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

It is not recommended to use Capsagamma at the same time as other topical medicines in the same area of the skin [e.g., warming gels (increasing blood flow and causing skin redness) or pain-relieving gels].

Interactions with other medicines used on the skin may occur even up to 12 hours after application.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before using this medicine.

There is no data on the use of Capsagamma in pregnant women. Capsaicin passes through the placental barrier and may pass into breast milk.

Patient should not use the medicine without consulting a doctor.

Driving and using machines

Capsagamma does not affect the ability to drive or use machines.

3. How to use Capsagamma

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

In case of doubt, the patient should consult their doctor, pharmacist, or nurse.

Unless otherwise instructed, adults and the elderly should apply a thin layer to the skin 2 to 4 times a day in the painful area. The cream should be allowed to absorb.

After applying or touching the cream, hands should be washed thoroughly with water and soap.

Use in children and adolescents

The cream should not be used in children and adolescents under 18 years of age due to the lack of data on safety and efficacy in this age group.

Duration of use

If symptoms persist during the use of the medicine, the patient should consult their doctor or pharmacist.

Treatment should be continued until pain relief is achieved, if necessary, for up to 3 weeks.

After 3 weeks of use, a break of at least 2 weeks should be taken.

The patient should consult their doctor or pharmacist if they feel that the effect of Capsagamma is too strong or too weak.

Using more than the recommended dose of Capsagamma

Using Capsagamma may cause a warming effect on the skin. If the patient feels that this effect is too strong, excess cream can be removed using cold water and soap.

Missing a dose of Capsagamma cream

A double dose of the cream should not be used to make up for a missed dose.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The active substance may cause local increased blood flow with intensified skin redness and a feeling of warmth. This reaction is part of the normal pharmacological effect of this herbal medicine.

Skin hypersensitivity and allergic reactions (e.g., hives, blistering, or vesicles at the application site) may occur. The frequency is unknown.

If the above symptoms occur, the use of the medicine should be discontinued immediately.

If excessive burning, stinging, or itching occurs in individual cases, treatment should be discontinued.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor or pharmacist.

Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Capsagamma

The medicine should be stored out of sight and reach of children.

The medicine should not be used after the expiry date stated on the carton and tube after EXP.

The expiry date refers to the last day of the month stated.

There are no special precautions for storage.

Shelf life after first opening the package

• Tube 40 g - 3 months
• Tube 100 g - 6 months

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Capsagamma contains

The active substance is standardized dense extract from the fruit of Capsicum annuumL. var. minimum(Miller) Heiser and Capsicum frutescensL, fructus(chilli pepper fruit).

100 g of cream contains 2.375 - 1.032 mg of standardized dense extract from Capsicum annuumL. var. minimum(Miller) Heiser and Capsicum frutescensL, fructus(chilli pepper fruit) (DER 2.8-4.9:1), equivalent to 53 mg capsaicinoids, calculated as capsaicin.

Extraction solvent: ethanol 80% (V/V).

The other ingredients are sorbitan stearate, macrogol stearate, glycerol 85%, medium-chain triglycerides, titanium dioxide, phenoxyethanol, carbomer 980, rosemary essential oil, sodium hydroxide, purified water, liquid glucose.

What Capsagamma looks like and contents of the package

Capsagamma is a cream with an ochre color.

Package size:

Aluminum tube with a PP or HDPE cap, in a cardboard box.

Package size: 40 g or 100 g.

Not all package sizes may be marketed.

Marketing authorization holder

Wörwag Pharma GmbH & Co. KG, Flugfeld-Allee 24, 71034 Böblingen, Germany

Manufacturer

C.P.M ContractPharma GmbH, Frühlingstraße 7, 83620 Feldkirchen-Westerham, Germany

To obtain more detailed information, the patient should contact the representative of the marketing authorization holder: Woerwag Pharma Polska Sp. z o.o., ul. Józefa Piusa Dziekońskiego 1, 00-728 Warszawa, tel. (+48) 22 863 72 81

Date of last revision of the package leaflet: