VALIDOL-LUBNIFARM

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALILOL-LUBNYFARM

Composition:

Active ingredient: 1 tablet contains a solution of menthol in menthyl ester of isovaleric acid – 60 mg;

Excipients: refined granulated sugar, calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: intact, regular, cylindrical, circular tablets with flat upper and lower surfaces, beveled edges, scored for division, white or white with a yellowish tinge, characteristic odor of menthol and cooling taste. Gray specks and powdery deposits on the surface of tablets are permissible.

Pharmacotherapeutic group.
Combined cardiac preparations. ATC code C01EX.

Pharmacological properties.

Pharmacodynamics.

The drug exerts a calming effect on the central nervous system and also causes a moderate reflex vasodilatory (coronary-dilating) effect by reflex stimulation of sensory nerves ("cold" receptors) in the oral mucosa. Stimulation of these receptors induces the release of endorphins, enkephalins, dynorphins, and other opioid peptides, which play an important role in reducing pain perception, normalizing vascular permeability, and regulating other essential mechanisms of cardiovascular and nervous system function. Under the influence of the drug, physiologically active compounds such as histamine, kinins, etc., are released.

Pharmacokinetics.

When administered sublingually, the drug is absorbed through the oral mucosa. The therapeutic effect begins approximately 5 minutes after administration.

Following absorption, the drug undergoes biotransformation in the liver and is excreted in the urine as glucuronides.

Clinical characteristics.

Indications.

Mild angina attacks, neuroses, hysteria, motion sickness (sea and air sickness) – symptomatic therapy; headache associated with nitrate intake.

Contraindications.

Hypersensitivity to the components of the drug. Severe arterial hypotension, acute myocardial infarction.

Interaction with other medicinal products and other forms of interaction.

Reduces the intensity of headache caused by nitrates. Potentiation of sedative and antihypertensive effects may occur when used concomitantly with other psychotropic and antihypertensive agents, opioid analgesics, anesthetics, and alcohol.

Special precautions for use.

If chest pain does not subside after taking the medication, it is essential to consult a physician immediately to rule out acute coronary syndrome.

The product contains sugar, which should be taken into account for patients with diabetes mellitus.

Use during pregnancy or breastfeeding.

The use of this medication during pregnancy or breastfeeding is possible only if, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the fetus/child.

Ability to influence reaction rate when driving or operating machinery.

Caution is required during the first hours after taking the medication when driving or operating machinery, as dizziness, drowsiness, and reduced psychomotor reaction speed may occur.

Dosage and Administration.

Hold tablets in the mouth (under the tongue) until completely dissolved. The single dose for adults is 1–2 tablets; the daily dose is 2–4 tablets.

If necessary, the daily dose may be increased. The maximum daily dose is 600 mg.

Duration of treatment—up to 7 days.

Children.

There is no experience with the use of the drug for treatment in children.

Overdose.

Symptoms: headache, nausea, excitation, cardiac arrhythmia, decreased arterial pressure, central nervous system depression.

Treatment: discontinue the drug and provide symptomatic therapy.

Side effects.

Abdominal discomfort; hypersensitivity reactions, including angioneurotic edema, urticaria, itching, rash.

With prolonged use, mild nausea, lacrimation, dizziness, transient arterial hypotension, drowsiness may rarely occur, which quickly resolve spontaneously.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

6 or 10 tablets per blister pack.

10 tablets per blister, 1, 5, or 10 blisters per cardboard package.

Availability. Over-the-counter (without prescription).

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and place of business.

16 Barvinkova Street, Lubny, Poltava region, 37500, Ukraine.