Pepper tincture

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

Composition:

Active substance: peppermint leaf tincture;

1 bottle contains 25 ml of peppermint leaf tincture (Menthae piperitae folium) (1:5) (extractant — ethanol 45% v/v);

Excipients: apart from the extractant, none present.

Medicinal form. Tincture.

Main physicochemical properties: brown liquid or brown with a greenish tint, with a characteristic minty odor. Sediment formation during storage is permissible.

Pharmacotherapeutic group. Antiemetic agents and drugs used to relieve nausea.

ATC code A04A D.

Pharmacological properties.

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

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

For symptomatic treatment of digestive disorders, such as dyspepsia and meteorism.

Contraindications.

Age under 12 years, bronchial asthma, broncho-obstructive syndrome, spasmophilia, individual intolerance to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

Not established.

Special precautions for use.

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

Patients with cholelithiasis or other biliary tract disorders should be administered medicinal products containing peppermint leaf with particular caution. If symptoms worsen during use of the medicinal product, medical advice should be sought.

This medicinal product contains from 39% (v/v) to 44% (v/v) ethanol (alcohol), i.e. 938–1058 mg in the maximum dose (3 ml), which is equivalent to 24–27 ml of beer or 12–13 ml of wine in a single dose.
Harmful for patients suffering from alcoholism. Caution is advised when administering to pregnant women and nursing mothers, children, patients with liver disorders, and patients with epilepsy.

Peppermint tincture is a traditional herbal medicinal product used according to indications supported by long-standing use.

Use during pregnancy or breastfeeding.

Safety of use during pregnancy or breastfeeding has not been established. Due to insufficient data, use of this medicinal product during pregnancy or breastfeeding is not recommended.

There are no data available on the effect on fertility.

Ability to influence reaction speed when driving or operating machinery.

Studies on the potential effect on the ability to drive or operate machinery have not been conducted.

Dosage and Administration.

Take the medicinal product orally before meals. For adults and children aged 12 years and older, administer 1 teaspoon (2–3 ml) of the tincture 3 times daily.

The duration of treatment depends on the course of the disease and individual sensitivity to the drug.

If symptoms persist for longer than 2 weeks during use of the medicinal product, consult a physician.

Children.

"Mentha piperita tincture" is not recommended for children under 12 years of age due to the presence of ethyl alcohol in the formulation.

Overdose.

No cases of overdose have been reported.

Side effects.

Allergic reactions are possible (including hyperemia, rash, itching, skin swelling, urticaria, contact dermatitis), exacerbation of heartburn. If side effects occur, discontinue use of the medication and consult a physician.

Reporting of adverse reactions after drug registration is highly important. It enables continuous monitoring of the benefit-risk balance of this medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: 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 of children.

Packaging.

25 ml in bottles.

Availability.

Over-the-counter (without prescription).

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and location of business activity.

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