VALIDOL-DARNITSA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALIDOL-DARNITSA (VALIDOL-DARNITSA)

Composition:

Active substance: menthol solution in isovaleric acid menthyl ester;

1 tablet contains 60 mg of menthol solution in isovaleric acid menthyl ester;

Excipients: crystalline sugar, calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: white or white with yellowish tinge tablets, flat cylindrical shape, with a score line and bevelled edges, with a characteristic menthol odor. Greyish specks and a powdery deposit on the tablet surface are permissible.

Pharmacotherapeutic group. Cardiological preparations. ATC code C01EX.

Pharmacological properties.

Pharmacodynamics.

Validol is a complex substance formed by dissolving menthol in menthyl ester of isovaleric acid. When administered sublingually, the drug's effects are due to menthol and the ester of isovaleric acid. The first component, by stimulating sensory nerve endings in the oral mucosa, exerts a reflex vasodilatory effect (including coronary vasodilation). The second component stimulates in the central nervous system the formation and release of enkephalins, endorphins, dynorphins, and peptides that regulate pain perception. As a result of drug administration, regional blood circulation improves and the intensity of pain sensations decreases. The drug has a calming effect.

Pharmacokinetics.

The drug is rapidly absorbed in the oral cavity and reaches maximum concentration in systemic circulation within a few minutes. The effect of the drug develops within 5 minutes after sublingual administration.

Partially transformed in the liver. The metabolites are excreted from the body through the intestine with bile. The unchanged drug is excreted from the body in urine and in exhaled air.

Clinical characteristics.

Indications.

Mild angina attacks.

Motion sickness (sea and air).

Hysteria.

Neurosis.

Headache associated with the use of nitrates.

Contraindications.

Hypersensitivity to the components of the medicinal product, severe arterial hypotension, acute myocardial infarction.

Interaction with other medicinal products and other forms of interaction.

Nitrates – simultaneous use of the medicinal product with nitrates reduces the headache caused by the use of the latter.

Validol-Darnitsya potentiates the effect of sedative medicinal products, psychotropic agents, opioid analgesics, alcohol, and anesthetic agents when used concurrently.

Antihypertensive medicinal products – possible potentiation of the effect of antihypertensive medicinal products may occur when they are used concomitantly with Validol-Darnitsya.

Special precautions for use.

If chest pain does not subside after administration of the medicinal product, acute coronary syndrome must be ruled out. When using the medicinal product as part of combination therapy for angina attacks, if no effect is observed within the first 5 minutes, nitrates should be administered.

The medicinal product contains sugar; therefore, it should be administered with caution to patients with diabetes mellitus.

Use during pregnancy or breastfeeding.

The use of the medicinal product 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 while driving or operating machinery.

Caution is required during the first hours after administration of the medicinal product when driving vehicles or performing work requiring high attention, 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. Treatment duration—up to 7 days.

Children.

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

Overdose.

Symptoms: headache, nausea, excitement, cardiac disturbances, decreased arterial blood pressure, central nervous system depression, hypersensitivity reactions to the drug components (angioneurotic edema, urticaria, itching, rash).

Treatment: in case of overdose, discontinue the drug and administer symptomatic therapy.

Side effects.

With prolonged use, in isolated cases nausea, abdominal discomfort, lacrimation, dizziness, drowsiness, and transient arterial hypotension may occur, which quickly resolve spontaneously.

Hypersensitivity reactions are possible, including angioneurotic edema, urticaria, pruritus, rashes, hyperemia, and hypersensitivity reactions of the respiratory tract.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature between 8 ºC and 15 ºC.

Keep out of reach of children.

Packaging.

6 or 10 tablets in a blister pack; 1 blister pack per carton; 6 or 10 tablets in blister packs.

Dispensing category. Over-the-counter.

Manufacturer: JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and place of business.

13, Borispilska Street, Kyiv, 02093, Ukraine.