Package leaflet: Information for the user

Capsagamma, 53 mg capsaicinoids calculated as capsaicin/100 g, cream
Capsici extractum spissum normatum
Please read this leaflet carefully before using this medicine because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 weeks, or if you feel worse, you should contact your doctor.

Contents of the leaflet

What Capsagamma is and what it is used for
What you need to know before using Capsagamma
How to use Capsagamma
Possible side effects
How to store Capsagamma
Contents of the pack and other information

1. What Capsagamma is and what it is 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 medicine

When not to use Capsagamma

if the patient is allergic to the active substance or to other sources of capsaicinoids (e.g. pepper, chili) or to any of the other ingredients of this medicine (listed in section 6);
do not apply to damaged skin (abrasions, wounds, rashes) or to mucous membranes and the area around the eyes.

Warnings and precautions
Before starting to use Capsagamma cream, discuss this with your doctor or pharmacist.

Do not apply this medicine near the eyes or mucous membranes.
Do not scratch the area where the cream has been applied to avoid skin damage.
During treatment, avoid exposure to sources of heat (sunlight or infrared radiation, warm compresses, or hot water).
The sensation of burning may intensify during excessive physical exertion (sweating).
Treatment should be discontinued if the burning sensation is perceived as excessive. In such a case, remove any remaining cream from the skin.
If symptoms worsen during use of this medicine, consult your doctor or pharmacist.
Use of the cream is not recommended in bedridden patients (due to increased risk of pressure ulcers).

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

Capsagamma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
Concomitant use of Capsagamma product at the same site with other topical medicines [e.g. warming gels (causing increased blood flow and skin reddening) or pain-relieving gels] is not recommended.
Interactions with other medicines applied to the same area of skin may occur up to 12 hours after application.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
There are no data available on use in pregnant women. Capsaicin can cross the placental barrier and may pass into breast milk.
Self-administration of the medicine by patients is not recommended.

Driving and operating machinery
Capsagamma medicine has no effect on the ability to drive or operate machinery.

3. How to use Capsagamma medicine

This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor, pharmacist,
or nurse.
Unless otherwise prescribed, adults and elderly patients should apply a thin layer to the skin at the painful area 2 to 4 times daily.
Allow the cream to be fully absorbed.
After application or contact with the cream, hands should be thoroughly washed with water and soap.

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

Duration of use
If symptoms persist during treatment, consult your doctor or pharmacist.
Treatment should continue until pain is relieved, if necessary for up to 3 weeks.
After 3 weeks of use, a break of at least 2 weeks should be taken before resuming treatment.
Consult your doctor or pharmacist if you feel that the effect of Capsagamma cream is too strong or too weak.

Use of more than the recommended dose of Capsagamma medicine
Use of Capsagamma medicine may produce a warming sensation on the skin. If this effect feels too strong, excess cream can be removed using cold water and soap.

Missed dose of Capsagamma cream
Do not apply a double dose of cream to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The active substance may cause localised increase in blood flow, leading to intensified
skin reddening and sensation of warmth. This reaction is part of the normal
pharmacological action of this herbal medicine.
Skin hypersensitivity and allergic reactions (e.g. urticaria, formation of blisters
or vesicles at the application site) may occur. Frequency is unknown.
If any of the above symptoms occur, treatment should be discontinued immediately.
If excessive burning, stinging or itching sensation occurs in individual cases,
treatment should be discontinued.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Capsagamma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube following: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Period of use after first opening of the container

40 g tube - 3 months
100 g tube - 6 months

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Capsagamma contains
The active substance in Capsagamma is a standardized dense extract from chili pepper fruit (Capsici extractum spissum normatum).
Each 100 g of cream contains:
2.375 – 1.032 mg of standardized dense extract from Capsicum annuum L. var. minimum (Miller) Heiser and Capsicum frutescens L, fructus (chili pepper fruit) (DER 2.8-4.9:1), corresponding to
53 mg of capsaicinoids, expressed as capsaicin.
Extraction solvent: ethanol 80% (V/V).
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 pack
Capsagamma is an ochre-coloured cream.
Pack sizes:
Aluminium tube with PP or HDPE cap, in a cardboard box.
Pack size: 40 g or 100 g.
Not all pack 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

For further information, please contact the representative of the Marketing Authorization Holder:
Woerwag Pharma Polska Sp. z o.o.
ul. Józefa Piusa Dziekońskiego 1
00-728 Warsaw
Phone (+48) 22 863 72 81