Mint tablets

Ukraine
Brand name Mint tablets
Form tablets
Active substance / Dosage
Prescription type over-the-counter (OTC)
ATC code
Registration number UA/8485/01/01
Manufacturer PJSC "Fitofarm"

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PEPPERMINT TABLETS

Composition:

Active substance: 1 tablet contains 2.5 mg of peppermint oil calculated as 50% menthol;

Excipients: confectionery sugar, talc, calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: white tablets with a score line and beveled edge, flat cylindrical in shape.

Pharmacotherapeutic group. Antiemetic agents and drugs eliminating nausea. ATC code A04AD.

Pharmacological properties.

Pharmacodynamics.

Peppermint tablets, by stimulating sensitive receptors of the mucous membranes of the oral cavity and stomach, reflexively reduce the sensation of nausea and prevent vomiting, as well as exert a mild spasmolytic, sedative, and choleretic effect.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Symptomatic treatment of nausea, vomiting, spasms of smooth muscles of the gastrointestinal tract, bitter taste in the mouth.

Contraindications.

Hypersensitivity to the components of the drug. Diabetes mellitus, croup, spasmophilia, bronchial asthma. Children under 3 years of age.

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 worsen.

If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Use during pregnancy or breastfeeding.

The use of the medicinal product during pregnancy is possible only when the expected benefit to the mother outweighs the potential risk to the fetus or child. If treatment is necessary, breastfeeding should be discontinued.

Effects on ability to drive vehicles or operate machinery.

The medicinal product generally does not affect the ability to drive a vehicle or engage in other activities requiring increased attention and rapid psychomotor reactions. However, if any adverse reactions occur (see "Adverse reactions"), driving vehicles or operating machinery should be avoided.

Dosage and Administration.

Administer 1–2 tablets sublingually. The maximum daily dose of the drug for adults and children aged 12 years and older is 8–10 tablets per day. For children aged 3 to 12 years, the daily dose is 3–5 tablets.

The duration of treatment depends on the therapeutic effect achieved.

Children.

Do not use in children under 3 years of age.

Overdose.

Inappropriate use of peppermint preparations may cause chest pain.

Adverse reactions.

Chest pain; allergic reactions including hyperemia, rash, itching, skin swelling, urticaria, dermatitis; in individual cases – dizziness. If adverse reactions occur, discontinue use of the medication.

The patient should consult a physician if disease symptoms do not resolve during use of the medicinal product or if adverse reactions occur that are not listed in the instructions for medical use of the medicinal product.

Shelf life.

2 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets per blister pack.

Availability classification.

Over-the-counter (without prescription).

Manufacturer.

PJSC "FITOPHARM".

Manufacturer's address and place of business.

Ukraine, 84500, Donetsk region, Bakhmut, Sybirtseva Street, 2.

Marketing Authorization Holder.

PJSC "FITOPHARM".

Address of the Marketing Authorization Holder.

Ukraine, 02100, Kyiv, Verkhovnoyi Rady Street, building 7, floor 3, room 18.