Instructions for Validol-Darnitsa tablets 60 mg No. 10 in a pack
Composition
active ingredient: menthol solution in menthyl ester of isovaleric acid;
1 tablet contains a solution of menthol in menthyl ester of isovaleric acid 60 mg;
excipients: crystalline sugar, calcium stearate.
Dosage form
Pills.
Main physicochemical properties: tablets of white or white with a yellowish tinge, flat-cylindrical shape, with a score and a bevel, with a characteristic menthol odor. Grayish inclusions and a powdery coating are allowed on the surface of the tablets.
Pharmacotherapeutic group
Cardiological drugs. ATX code C01E X.
Pharmacological properties
Pharmacodynamics
Validol is a complex substance formed when menthol is dissolved in the menthyl ester of isovaleric acid. When used sublingually, the effect of the drug is due to the effects of menthol and isovaleric acid ester. The first, by irritating sensitive nerve endings on the oral mucosa, has a reflex vasodilating (including coronary dilating) effect. The second, stimulates the formation and release of enkephalins, endorphins, dynorphins and peptides in the central nervous system that regulate the sensation of pain. As a result of using the drug, regional blood circulation improves, the severity of pain decreases. The drug has a calming effect.
Pharmacokinetics
The drug is rapidly absorbed in the oral cavity and reaches maximum concentration in the systemic bloodstream within a few minutes. The effect of the drug with sublingual administration develops after 5 minutes.
Partially transformed in the liver. Transformation products are excreted from the body through the intestines with bile. The drug is excreted unchanged from the body with urine and exhaled air.
Indication
Mild angina attacks; sea and air sickness; hysteria; neurosis; headache associated with the use of nitrates.
Contraindication
Hypersensitivity to the components of the drug, severe arterial hypotension, acute myocardial infarction.
Interaction with other medicinal products and other types of interactions
Nitrates – simultaneous use of the drug with nitrates reduces the headache that occurs with the use of the latter.
Validol-Darnitsa enhances the effect of sedatives, psychotropic drugs, opioid analgesics, alcohol, and anesthetics when used simultaneously.
Antihypertensive drugs – potentiation of the effect of antihypertensive drugs is possible when used simultaneously with Validol-Darnitsa.
Application features
In cases where pain in the heart area does not go away after using the drug, acute coronary syndrome should be excluded. When using the drug as part of combination therapy for angina attacks, in the absence of effect in the first 5 minutes, nitrates should be prescribed.
The medicine contains sugar, so it should be prescribed with caution to patients with diabetes.
Ability to influence reaction speed when driving vehicles or other mechanisms
Caution is required in the first hours after using the drug when driving vehicles or performing work that requires increased attention, as dizziness, drowsiness, and decreased psychomotor reaction speed are possible.
Use during pregnancy or breastfeeding
The use of the drug during pregnancy or breastfeeding is possible if, in the opinion of the doctor, the expected positive effect for the mother outweighs the potential risk to the fetus/child.
Method of administration and doses
Keep the tablets in your mouth (under the tongue) until completely dissolved.
A single dose for adults is 1–2 tablets; daily dose is 2–4 tablets.
If necessary, the daily dose can be increased. The maximum daily dose is 600 mg. The duration of treatment is up to 7 days.
Children
There is no experience with the use of the drug in children.
Overdose
Symptoms: headache, nausea, agitation, cardiac dysfunction, decreased blood pressure, central nervous system depression, hypersensitivity reactions to the components of the drug (angioedema, urticaria, itching, rash).
Treatment: in case of overdose, the drug should be discontinued and symptomatic therapy should be carried out.
Adverse reactions
With prolonged use, in rare cases, nausea, abdominal discomfort, tearing, dizziness, drowsiness, and short-term arterial hypotension may occur, which quickly resolve on their own.
Hypersensitivity reactions may develop, including angioedema, urticaria, itching, rashes, flushing, and hypersensitivity reactions from the respiratory system.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature of 8 ºС to 15 ºС.
Keep out of reach of children.
Packaging
10 tablets in a contour blister pack; 1 contour blister pack in a pack.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and its business address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
