PEPPERMINT LEAF

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PEPPERMINT LEAVES

Composition:

Active substance: peppermint leaves;

One packet contains peppermint leaves (Menthae piperitae folium) 50 g.

Pharmaceutical form. Leaves.

Main physico-chemical properties: fragments of leaves of various shapes, with admixtures of stem pieces; color is green or brownish-green, sometimes with brownish-violet fragments (leaf veins). Odor is characteristic, penetrating.

Pharmacotherapeutic group. Antiemetic agents and drugs for relief of nausea. ATC code A04AD.

Pharmacological properties.

Pharmacodynamics. The leaves of peppermint contain essential oil composed of menthol, pinene, limonene, phellandrene, cineole, and other terpenoids. In addition, the preparation contains flavonoids, ursolic and oleanolic acids, betaine, carotene, hesperidin, tannins, organic acids, and trace elements. This complex of biologically active substances exerts choleretic, sedative, and mild hypotensive effects. Preparations from peppermint leaves enhance secretion of the digestive glands, stimulate appetite, suppress putrefactive and fermentative processes in the gastrointestinal tract, reduce the tone of smooth muscles of the intestine, biliary and urinary tracts, and promote bile secretion.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

As part of combination therapy for gastrointestinal disorders (nausea of various origins, intestinal colic, flatulence, gastrointestinal spasms); liver diseases (cholecystitis, hepatitis, cholangitis, cholelithiasis); as a mild sedative agent.

Contraindications.

Hypersensitivity to biologically active substances contained in the medicinal product. Spasmophilia, croup, bronchial asthma.

Special precautions.

Patients with gastroesophageal reflux (heartburn) should avoid using "Peppermint Leaf", as it may increase heartburn.

Interaction with other medicinal products and other types of interactions.

Not studied.

Special precautions for use.

"Peppermint Leaf" is a traditional herbal medicinal product for use according to indications supported by long-standing use.

Use during pregnancy or breastfeeding.

The safety and efficacy of the medicinal product during pregnancy or breastfeeding have not been studied; therefore, Peppermint Leaf should be prescribed during these periods only when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to influence reaction rate while driving or operating machinery.

No effect.

Administration and Dosage

Use as an infusion: Place 5 g (1 tablespoon) of leaves into an enameled container, pour 1 cup (200 ml) of hot boiled water, cover with a lid and heat on a boiling water bath for 15 minutes. Cool at room temperature for 45 minutes, strain, squeeze the residue, and add the expressed liquid to the strained infusion. Adjust the volume of the infusion to 200 ml with boiled water. Take warm, 2–3 times daily, 15 minutes before meals: adults and children aged 14 years and older – ½–⅓ cup; children aged 12–14 years – ¼ cup; children aged 7–12 years – 2 tablespoons; children aged 3–7 years – 1 tablespoon. Shake the infusion before use.

The duration of treatment is determined individually, depending on the nature of the disease, the stability of the achieved therapeutic effect, and the patient's tolerance of the drug.

The patient should consult a physician if symptoms do not improve during treatment or if adverse reactions occur that are not listed in the instructions for medical use of the drug.

Children

Peppermint leaves should not be administered to children under 3 years of age, as there is no experience with the use of this drug in this age group.

Overdose

In case of overdose, an enhanced sedative effect of the drug may occur.

Treatment is symptomatic.

Side effects.

Unreasonable use of peppermint leaf may cause chest pain.

In individual cases, allergic reactions may occur (including hyperemia, rash, itching, skin swelling, urticaria, contact dermatitis).

Shelf life. 2 years.

Storage conditions.

Store in a dry, light-protected place at a temperature not exceeding 25 °C.

The prepared infusion should be stored at a temperature from 8 °C to 15 °C for no more than 2 days.

Keep out of reach of children!

Packaging.

50 g per pack with an inner pouch.

Availability category. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Manufacturer's address / Applicant's address.

LLC "Ternopharm".

46010, Ternopil, Fabrychna St., 4, Ukraine.

Tel./Fax: (0352) 521-444, http://www.ternopharm.com.ua.