PHYTOSEPT®

INSTRUCTION for medical use of the medicinal product FITOSEPT® (FITOSEPT)

Composition:

Active substance: 1 ml of the preparation contains 0.025 ml of tincture of capsicum pepper fruits (Capsicum annuum) (1:10) (extractant – 90% ethanol);

Excipient: 96% ethanol.

Pharmaceutical form. Solution for oral cavity.

Main physicochemical properties: clear liquid, light yellow-orange to light reddish-orange in color.

Pharmacotherapeutic group.

Other agents for local use in dentistry.

ATC code A01AD11.

Pharmacological properties.

Pharmacodynamics.

The medicinal product exerts an antiseptic and refreshing effect, due to the pharmacological properties of the substances contained in its composition.

Biologically active substances contained in capsicum fruit (aromatic amine capsaicin, essential oil), when applied locally, produce a local irritant and counterirritant action, cause local enhancement of blood circulation and tissue hyperemia at the site of application, promote the release of endogenous biologically active substances, and exhibit moderate antibacterial activity.

Pharmacokinetics.

The pharmacokinetics of the drug has not been studied.

Clinical characteristics.

Indications.

For mouth rinsing in periodontitis, in case of toothache.

Contraindications.

Hypersensitivity to any component of the drug; impaired integrity of the mucous membrane.

Interaction with other medicinal products and other forms of interaction.

Unknown.

If it is necessary to use any other medicinal products simultaneously, consult a physician.

Special precautions.

Do not swallow.

Use during pregnancy or breastfeeding.

Since the medicinal product contains ethanol, it is not recommended for use in women during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Driving or engaging in other potentially hazardous activities should be avoided, as adverse reactions such as dizziness and drowsiness may occur.

Method of Administration and Dosage.

For rinsing the mouth in case of periodontosis and toothache, dissolve 1 teaspoon of the preparation in 200 ml of warm boiled water.

The duration of treatment depends on the form and severity of the disease, concomitant therapy, and the therapeutic effect achieved, and is determined individually by the physician.

Children. Do not use in children.

Overdose.

Possible development of increased sensitivity to the preparation and intensification of adverse effects.

Side effects.

Allergic reactions, dizziness, drowsiness, and mucous membrane irritation may occasionally occur.

If any adverse reactions occur, discontinue use of the medication and consult a physician.

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC.

Keep out of reach of children.

Packaging.

100 ml in bottles.

100 ml in a bottle in a cardboard pack.

Prescription status. Prescription only.

Manufacturer.

JSC "FITOFARM".

Manufacturer's address and place of business.

Ukraine, 84500, Donetsk region, city of Bakhmut, Sybitskova Street, 2.

Marketing Authorization Holder.

JSC "FITOFARM".

Address of the Marketing Authorization Holder.

Ukraine, 02092, city of Kyiv, Almatynska Street, building 12.