Corvalol® n

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CORVALOL®N (CorvalolUM® n)

Composition:

Active substances: ethyl ether of α-bromoisovaleric acid, menthol solution in menthyl isovalerate, peppermint oil, hop oil;

1 ml of solution (25 drops) contains ethyl ether of α-bromoisovaleric acid, calculated as 100 % substance – 20 mg, menthol solution in menthyl isovalerate – 55 mg, peppermint oil (Menthaoil) – 1.42 mg, hop oil (Oleum Humuli) – 0.2 mg;

Excipients: sodium acetate trihydrate, diluted acetic acid, ethanol 96 %, purified water.

Pharmaceutical form. Oral drops.

Main physico-chemical properties: clear colorless or slightly yellowish liquid with a characteristic aromatic odor.

Pharmacotherapeutic group. Hypnotics and sedatives. Combinations of hypnotics and sedatives, excluding barbiturates. ATC code N05C X.

Pharmacological properties.

Pharmacodynamics.

Corvalol® N is a sedative and spasmolytic agent, whose action as a combination drug is determined by its constituent components.

The ethyl ether of α-bromoisovaleric acid exerts a reflex sedative and spasmolytic effect due to stimulation primarily of oral and nasopharyngeal mucosal receptors, reduction of reflex excitability in central nervous system centers, enhancement of neuronal inhibition in the cerebral cortex and subcortical structures, as well as reduction in activity of central vasomotor centers and direct local spasmolytic action on smooth muscle of blood vessels.

Valerian acid, or menthol dissolved in menthyl ester of isovaleric acid, produces a sedative effect and a moderate coronary vasodilating action through its influence on sensory nerve receptors of the oral mucosa.

Peppermint oil contains essential oils, including approximately 50% menthol and 4–9% menthol esters. These components can stimulate "cold" receptors in the oral mucosa, resulting in reflex vasodilation of coronary and cerebral vessels, as well as exerting a calming and mild cholagogue effect. Peppermint oil also possesses antiseptic and spasmolytic properties and helps relieve meteorism. By stimulating receptors in the gastric and intestinal mucosa, it enhances intestinal peristalsis.

Hops oil exerts reflex vasodilating and spasmolytic effects and helps alleviate symptoms of meteorism.

Pharmacokinetics.

After oral administration, absorption of the drug begins immediately through the mucous membrane of the oral cavity. The effect develops within 15–45 minutes and lasts for 3–6 hours.

Clinical characteristics.

Indications.

• Neuroses with increased irritability;
• as part of complex therapy for arterial hypertension and vegetative-vascular dystonia;
• mild coronary vessel spasms, tachycardia;
• intestinal spasms.

Contraindications.

• Hypersensitivity to the components of the medicinal product;
• pronounced arterial hypotension;
• acute myocardial infarction.

Interaction with other medicinal products and other types of interactions.

Corvalol® N enhances the sedative effect of psychotropic agents, opioid analgesics, alcohol, and anesthetics when used concomitantly.

Concomitant use of Corvalol® N with antihypertensive agents may potentiate their effects.

Corvalol® N reduces the intensity of headache caused by nitrate intake.

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.

Prolonged use is not recommended due to the risk of bromide accumulation in the body and development of bromism.

This medicinal product contains 70% v/v ethanol (alcohol).

The minimum dose (15 drops) contains 330 mg of ethanol, equivalent to 8.4 ml of beer or 3.5 ml of wine. Harmful for patients suffering from alcoholism. Caution should be exercised when administering to pregnant women and breastfeeding mothers, as well as in patients with liver disorders and in patients with epilepsy.

The product contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

Use during pregnancy or breastfeeding

The use of this medicinal product 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/infant.

Ability to affect reaction speed when driving or operating machinery

The product contains 70% v/v alcohol, which may impair coordination and speed of psychomotor reactions. Additionally, adverse effects such as dizziness and drowsiness may occur in the first hours after administration. Therefore, caution is advised for individuals operating complex machinery or driving vehicles.

Dosage and Administration.

Corvalol® N should be taken orally, regardless of food intake, 2–3 times daily, 15–30 drops at a time, with water or on a piece of sugar. If necessary (pronounced tachycardia and coronary vessel spasm), the single dose may be increased to 40–50 drops.

The duration of treatment is determined by the physician, depending on the clinical effect and tolerability of the drug.

Children. There is no experience with the use of this medication for the treatment of children.

Overdose.

Prolonged use is not recommended due to the potential for bromide accumulation in the body and the development of bromism.

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

Treatment: discontinue the drug and provide symptomatic therapy.

Adverse Reactions.

Corvalol® N is generally well tolerated. In individual cases, the following adverse effects may occur:

From the nervous system: drowsiness, dizziness, decreased concentration;

From the gastrointestinal tract: abdominal discomfort, mild nausea;

From the immune system: development of allergic reactions, including angioedema, urticaria, rashes, itching;

Other: transient arterial hypotension, lacrimation.

Prolonged use of preparations containing bromine may lead to bromism, characterized by the following symptoms: central nervous system depression, depressive mood, apathy, confusion, ataxia, purpura, rhinitis, conjunctivitis, acne. These phenomena resolve upon dose reduction or discontinuation of the drug.

Shelf life. 5 years.

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

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 25 ml in a bottle. 1 bottle per carton.

Supply category. Over-the-counter.

Manufacturer: JSC "Farmak".

Manufacturer's address and place of business.
74, Kyrylivska Street, Kyiv, 04080, Ukraine.