SAGE TINCTURE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SAGE TINCTURE (SALVIAE TINCTURA)

Composition:

Active substance: sage leaf tincture;

1 vial contains sage leaf tincture (Salviae folium) (1:5) (extractant — ethanol 70.0% (v/v)) — 25 ml or 40 ml;

Excipients: apart from the extractant, none.

Pharmaceutical form. Tincture.

Main physico-chemical properties: greenish-brown or brown liquid with a characteristic odor. Formation of a precipitate may occur during storage.

Pharmacotherapeutic group. Agents promoting wound and ulcer healing (scar formation). ATC code D03A X.

Pharmacological properties.

Biologically active substances of sage leaves (essential oil, tannins, saponins, phytoncides, resins) exert antimicrobial, anti-inflammatory, astringent, and disinfectant effects.

Clinical characteristics.

Indications.

• Inflammatory diseases of the mucous membranes of the oral cavity, gums (stomatitis, gingivitis, periodontosis), pharynx, tonsils (pharyngitis, tonsillitis), upper respiratory tract.
• Infected wounds, cuts, skin burns.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other types of interactions.

Tincture of sage enhances the effect of other anti-inflammatory agents.

Special precautions for use.

Use during pregnancy or breastfeeding.

Under a physician's prescription, when the benefit to the mother outweighs the potential risk to the fetus/infant.

Ability to affect reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

Shake before use.

For rinsing the oral cavity, use as a freshly prepared solution:

Dilute 1 teaspoon of "Tincture of Sage" in a glass of warm boiled water.

For local applications, dilute 20–60 drops of the tincture in 100 mL of isotonic sodium chloride solution.

The duration of treatment course depends on the nature of the disease and the therapeutic effect achieved, and is 7–14 days.

Children.

Clinical experience with the use of the medicinal product in children under 12 years of age is lacking.

Overdose.

No reports available.

Side effects.

Possible allergic reactions (including skin redness and swelling, rash, itching).

Reporting of suspected adverse reactions.

Reporting of adverse reactions following registration of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the use of this medicinal product. Medical and pharmaceutical personnel, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua/.

Shelf life. 3 years.

Do not use 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 and sight of children.

Packaging.

25 ml or 40 ml in bottles.

Supply classification.

Over-the-counter (without prescription).

Manufacturer.

PJSC "Lubnipharm".

Manufacturer's address and location of its business activity.

16, Barvinkova St., Lubny, Poltava region, 37500, Ukraine.