Cormenthol (Capsules) Instructions for Use

Marketing Authorization Holder

Gidimas, CJS (Lithuania)

Manufactured By

S.C. Biofarm S.A. (Romania)

ATC Code

C01EX (Other combined drugs for the treatment of heart diseases)

Active Substance

Levomenthol solution in menthyl isovalerate (Grouping name)

Dosage Form

Cormenthol

Sublingual capsules 100 mg: 15 pcs.

Dosage Form, Packaging, and Composition

Sublingual capsules are soft gelatin, oval in shape, from light yellow to light brownish-yellow in color; the capsule contents are a transparent colorless or yellowish oily liquid with a menthol odor.

Excipients: alpha-tocopheryl acetate (vit. E) – 0.45 mg, refined olive oil – q.s. to 160 mg.

Composition of the gelatin capsule shell: gelatin – 72 mg, purified water – 56.2384* mg, glycerol – 31.5216 mg, methylparaben (E218) – 0.24 mg.

*The specified amount is the input quantity of purified water. Water partially evaporates during the manufacturing process and its content in the finished product is less than the input quantity.

15 pcs. – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with reflex vasodilating action

Pharmacotherapeutic Group

Reflex-acting coronary dilator

Pharmacological Action

A reflex-acting coronary dilator that has a sedative effect. The reflex vasodilating action is due to the irritation of sensitive nerve endings.

It stimulates the production and release of enkephalins, endorphins, and a number of other peptides, histamine, and kinins (due to irritation of the mucous membrane receptors), which are actively involved in the regulation of vascular permeability and the formation of pain sensations.

Dextrose (if present in the used dosage form) is phosphorylated in tissues to form glucose-6-phosphate, which actively participates in various metabolic processes.

When taken sublingually, the therapeutic effect occurs on average within 5 minutes, with up to 70% of the active substance released within 3 minutes.

Pharmacokinetics

When applied sublingually, levomenthol solution in menthyl isovalerate is absorbed from the oral mucosa.

It is metabolized in the liver and excreted by the kidneys in the form of glucuronides.

When using dosage forms containing dextrose (glucose), the latter is completely absorbed by the body; it is not excreted by the kidneys (its appearance in urine is a pathological sign).

Indications

Functional cardialgia, neuroses, as an antiemetic for seasickness and airsickness.

ICD codes

Dosage Regimen

Administer the capsule sublingually. Do not swallow or chew.

Place one capsule under the tongue and allow it to dissolve completely.

The typical dosage is one capsule, taken two to three times per day.

The frequency and duration of treatment are determined by the therapeutic response.

The onset of action typically occurs within 3 to 5 minutes after administration.

If there is no effect or an insufficient effect within 5 to 10 minutes after taking a capsule, discontinue use and seek alternative therapy.

Do not exceed the recommended dosage without medical consultation.

Adverse Reactions

Possible nausea, lacrimation, dizziness, allergic reactions.

Contraindications

Hypersensitivity to the active substance, age under 18 years.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is possible if the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

Special Precautions

Caution is required when using dosage forms containing dextrose (glucose).

Concomitant use of alcohol is not recommended.

Effect on the ability to drive vehicles and operate machinery

When using the drug, patients should exercise caution when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use with drugs that have a depressant effect on the central nervous system, their effect is enhanced.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.