CAPSICUM TINCTURE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PEPPER TINCTURE (Capsici Tincture Normata)

Composition:

Active substance: tincture of capsicum fruit (Fructus Capsici) (1:10) (extractant – 90% ethanol);

1 vial contains tincture of capsicum fruit (Fructus Capsici) (1:10) (extractant – 90% ethanol) – 20 ml or 25 ml or 50 ml.

Pharmaceutical form. Tincture.

Main physico-chemical properties: yellowish-orange liquid. Sediment may occur.

Pharmacotherapeutic group. Products used locally for joint and muscular pain. ATC code M02A B.

Pharmacological properties.

Pharmacodynamics.

The drug exerts a local irritant effect and acts locally on the skin similarly to mustard plaster.

Clinical characteristics.

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

Contraindications. Individual hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use.

Avoid contact of the product with eyes. In case of contact with eyes, rinse thoroughly with plenty of running water. Do not apply the product to areas with acute skin inflammation or damaged skin.

Use during pregnancy or breastfeeding.

The safety and clinical efficacy of the tincture during pregnancy or breastfeeding have not been studied; therefore, the product 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 only. Rub the affected painful areas with the tincture 1–2 times daily until a sensation of warmth or mild tingling is felt. 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 degree of inflammation and the patient's skin sensitivity to the drug.

Children.

The 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.

Adverse reactions.

The product is usually well tolerated, but in individual cases, allergic reactions may occur due to hypersensitivity: burning sensation, skin redness, itching, rash at the application site.

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

20 ml, 25 ml or 50 ml in bottles sealed with stoppers or dropper stoppers and caps. One bottle of 20 ml, 25 ml or 50 ml, sealed with a dropper stopper and cap, or 50 ml sealed with a stopper and cap, in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer: JSC Pharmaceutical Factory "Viola".

Manufacturer's address.

75 Amosova Academician Street, Zaporizhzhia, 69063, Ukraine.

Marketing Authorization Holder: JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder:

75 Amosova Academician Street, Zaporizhzhia, 69063, Ukraine.