PEPPER FIVE TINCTURE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PEPPERMINT TINCTURE (TINCTURA MENTHAE PIPERITAE)

Composition:

Active substance: tincture of peppermint leaves (Folium Menthae piperitae) (1 : 20) (extractant – 90% ethanol);

One vial contains: tincture of peppermint leaves (Folium Menthae piperitae) (1 : 20) (extractant – 90% ethanol) – 23.75 ml; peppermint oil – 1.25 ml, or tincture of peppermint leaves (Folium Menthae piperitae) (1 : 20) (extractant – 90% ethanol) – 47.50 ml; peppermint oil – 2.50 ml.

Pharmaceutical form. Tincture.

Main physicochemical properties: clear green liquid with the odor and taste of peppermint. Formation of sediment upon storage is permissible.

Pharmacotherapeutic group. Antiemetic and antinausea agents. ATC code A04AD.

Pharmacological properties.

Pharmacodynamics.

Peppermint oil (containing up to 70% menthol and its esters) and other biologically active substances present in peppermint leaves (menthone, oleanolic and ursolic acids, flavonoid glycosides), by stimulating sensitive receptors of the oral cavity and gastric mucosa, reflexively reduce nausea and prevent vomiting. Additionally, they exert a mild spasmolytic, sedative, and choleretic effect.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications. Nausea, vomiting, digestive disorders, angina pectoris, neuralgic pains.

Contraindications. Hypersensitivity to any of the components of the medicinal product. Bronchial asthma and spasmophilia.

Special safety precautions.

Patients with gastroesophageal reflux (heartburn) should avoid using the medicinal product, as heartburn may increase.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use.

Use during pregnancy or breastfeeding.

Do not use during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Since the medicinal product contains ethanol, it is advisable to refrain from driving or operating potentially hazardous machinery.

Dosage and Administration.

Take orally before meals. For adults and children aged 12 years and older: 10–15 drops of the tincture 3–4 times daily.

The duration of treatment is determined individually by a physician and depends on the course of the disease and individual sensitivity to the drug.

Children.

Do not use in children under 12 years of age due to the presence of ethyl alcohol in the formulation.

Overdose.

Improper use of peppermint preparations may cause chest pain. Treatment is symptomatic.

Side effects.

Allergic reactions are possible (including hyperemia, rash, itching, skin swelling, urticaria, contact dermatitis).

If side effects occur, discontinue use of the product and consult a doctor.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children. Precipitation may occur during storage.

Packaging.

25 ml in glass bottles stoppered with corks or dropper caps with caps, or 50 ml in glass bottles stoppered with dropper caps and caps, in a carton or without a carton. 25 ml or 50 ml in polymer bottles stoppered with dropper caps and caps, in a carton or without a carton.

Supply category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

75 Amosova Akademika Street, Zaporizhzhia, 69063, Ukraine.

Marketing authorization holder. JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder.

75 Amosova Akademika Street, Zaporizhzhia, 69063, Ukraine.