CAPSICUM TINCTURE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CAYENNE PEPPER TINCTURE

Composition:

Active substance: tincture of finely cut cayenne pepper fruits (Capsici fructus);

1 bottle contains tincture of finely cut cayenne pepper fruits (Capsici fructus)
(1 : 10) (extractant − 90% ethanol) 50 ml;

Excipients: none.

Pharmaceutical form. Tincture.

Main physicochemical properties: yellowish-orange or reddish-orange liquid.

Pharmacotherapeutic group.

Agents used locally for joint and muscular pain. ATC code M02A B.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances contained in capsicum fruit (aromatic amine, capsaicin, essential oil) have local irritant properties and, when applied to the skin, act similarly to mustard plasters.

Clinical characteristics.

Indications. Capsicum tincture is used as a local irritant and counterirritant in myalgia, neuralgia, lumbago, arthritis, and rheumatism.

Contraindications. Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use.

Avoid getting the medication into the eyes. If contact occurs, rinse thoroughly with plenty of running water. Do not apply the medication to areas with acute skin inflammation or damaged skin.

Use during pregnancy or breastfeeding. Safety and clinical efficacy of the tincture during pregnancy or breastfeeding have not been studied; therefore, the medication should not be used during these periods.

Ability to influence reaction rate when driving or operating machinery. Not studied.

Method of administration and dosage.

For external use in adults and children aged 12 years and older.

Rub the tincture into the painful areas 1–2 times daily until a sensation of warmth or mild tingling occurs. To enhance the effect of the drug, it is recommended to apply a dry warming dressing to the affected areas.

The duration of treatment depends on the severity of the inflammatory process and the skin's sensitivity to the drug.

Children. Safety and efficacy of the drug in children have not been established; therefore, the drug should not be administered to children under 12 years of age.

Overdose. Cases of overdose have not been reported.

Side effects.

In individual cases, with increased individual sensitivity, allergic reactions may occur: sensation of warmth, burning, skin redness, rash at the application site, itching, and skin peeling.

If any unusual reactions occur, it is essential to consult a physician regarding further use of the medication!

Shelf life. 4 years.

Do not use the medication after the expiry date stated on the packaging!

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 50 ml in bottles.

Availability category.

Over-the-counter (without prescription).

Manufacturer. JSC "FITOPHARM".

Manufacturer's address and location of business activity.

84500, Bakhmut, Sibirtseva St., 2, Donetsk region, Ukraine.

Marketing Authorization Holder. JSC "FITOPHARM".

Address of the Marketing Authorization Holder.

12 Almatinska St., Kyiv, 02092, Ukraine.