VALIDOL®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALLIDOL® (Validol®)

Composition:

Active ingredient: 1 tablet contains a solution of menthol in menthyl ester of isovaleric acid (natural menthol – mint extract – 4.9%) – 0.06 g (60 mg);

Excipients: powdered sugar (sugar powder), calcium stearate.

Pharmaceutical form. Sublingual tablets.

Main physicochemical properties: flat cylindrical tablets with beveled edges and a groove, white or yellowish-white in color, with a characteristic odor of menthol. Gray specks and a powdery deposit of sugar powder on the tablet surface are permissible.

Pharmacotherapeutic group.
Cardiological preparations. ATC code C01EX.

Pharmacological properties.

Pharmacodynamics.

The medicinal product exerts a calming effect on the central nervous system and also produces a moderate reflex vasodilating (coronary-relaxing) action by reflex stimulation of sensitive nerve ("cold") receptors in the oral mucosa. Stimulation of these receptors induces the release of endorphins, enkephalins, dynorphins, and other peptides, as well as histamine and kinins, which play an important role in reducing pain sensitivity, normalizing vascular permeability, and regulating other vital mechanisms of the cardiovascular and nervous systems.

Pharmacokinetics.

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

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

Clinical characteristics.

Indications.

• Angina attacks of mild severity;
• seasickness and airsickness;
• hysteria;
• neurosis;
• 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 to rule out acute coronary syndrome.

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

Use during pregnancy or breastfeeding.

The use of the drug during pregnancy or breastfeeding is possible if, in the opinion of the physician, the expected beneficial effect for 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 drug when driving vehicles or performing tasks requiring heightened attention, as dizziness, drowsiness, and reduced psychomotor reaction speed may occur.

Method of Administration and Dosage.

Hold the 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. Maximum daily dose – 600 mg.

Duration of treatment – up to 7 days.

Children.

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

Overdose.

Symptoms: headache, nausea, excitement, cardiac disturbances, decreased arterial pressure, central nervous system depression.

Treatment: discontinuation of the drug and symptomatic therapy.

Side effects.

Rarely, with prolonged use, mild nausea, abdominal discomfort, lacrimation, dizziness, transient arterial hypotension, and drowsiness may occur; these symptoms quickly resolve spontaneously.

Allergic reactions are possible, including Quincke's edema, urticaria, rashes, and itching.

Shelf life.

2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 15 °C.

Keep out of reach of children.

Packaging.

10 tablets in a blister. 1 or 5 blisters per pack.

10 tablets in a blister, without carton packaging.

Availability. Over-the-counter.

Manufacturer. JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.