CORVALOL® K

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CORVALOL® K (Corvalol® K)

Composition:

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

1 capsule contains ethyl ether of α-bromoisovaleric acid 16.63 mg, menthol solution in menthyl ether of isovaleric acid 45.74 mg, hop oil 0.17 mg, peppermint oil 1.18 mg;

Excipients: sunflower oil, sucralose, glycerol monostearate, colloidal anhydrous silicon dioxide;

Capsule shell composition: gelatin, glycerin, liquid maltitol, microcrystalline cellulose-guar gum, potato starch, xylitol, lemon flavor, purified water.

Pharmaceutical form. Soft capsules.

Main physicochemical properties: soft gelatin capsules of oval shape, light yellow to light brown in color. The capsule contents – oily suspension with characteristic odor.

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

Pharmacological Properties

Pharmacodynamics

Corvalol® K 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 reflex sedative and spasmolytic effects due to stimulation primarily of oral and nasopharyngeal receptors, reduction of reflex excitability in central nervous system structures, enhancement of neuronal inhibition in the cerebral cortex and subcortical regions, suppression of activity in central vasomotor centers, as well as direct local spasmolytic action on smooth muscle of blood vessels.

Validol, 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, approximately 50% menthol and 4–9% menthol esters. These components stimulate oral "cold" receptors, inducing reflex vasodilation of coronary and cerebral vessels, and exerting a calming and mild choleretic effect. Peppermint oil possesses antiseptic and spasmolytic properties and the ability to relieve meteorism. By stimulating gastric and intestinal mucosal receptors, it enhances intestinal peristalsis.

Hops extract exerts reflex vasodilatory and spasmolytic effects and helps relieve symptoms of meteorism.

Pharmacokinetics

When administered sublingually, drug absorption begins immediately through the oral mucosa. The effect starts within 5 minutes and lasts for 3–6 hours.

Clinical characteristics.

Indications.

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

Contraindications.

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

Interaction with other medicinal products and other forms of interactions.

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

Possible potentiation of antihypertensive drugs may occur when they are used simultaneously with Corvalol® K.

Corvalol® K reduces 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 bromine accumulation in the body and development of bromine poisoning.

Use during pregnancy or breastfeeding.

The use of this drug during pregnancy or breastfeeding is possible only 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 speed when driving vehicles or operating machinery.

Adverse effects (dizziness and drowsiness) may occur in the first hours after administration. Therefore, caution should be exercised by individuals who operate complex machinery or drive vehicles while using this drug.

Dosage and Administration.

Corvalol® K, capsules, are administered sublingually. The capsule should be held under the tongue until completely dissolved. To accelerate the effect, the capsule may be crushed with the teeth.

Take independently of food intake, 2–3 times daily, 1 capsule at a time. If necessary (pronounced tachycardia and coronary vessel spasm), the single dose may be increased to 2 capsules.

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

Children.

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

Overdose.

Prolonged use is not recommended due to the possible accumulation of bromine in the body and development of bromine poisoning.

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

Treatment: discontinuation of the drug and symptomatic therapy.

Adverse reactions.

Corvalol® K 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 Quincke's edema, urticaria, rash, 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. 1 year 6 months.

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 25 °C. Keep out of reach of children.

Packaging.

10 capsules in a blister. 1 or 3 blisters per carton.

Availability. Over-the-counter.

Manufacturer.

JSC "Farmak".

Manufacturer's address and location of business activity.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.