Corvalment®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT KORVALMENT® (CORVALMENT)

Composition:

Active substance: menthol solution in menthyl isovalerate;

1 capsule contains 100 mg of menthol solution in menthyl isovalerate;

Excipients: gelatin, glycerin.

Pharmaceutical form. Soft capsules.

Main physicochemical properties: soft gelatin capsules, spherical or nearly spherical in shape, with a seam, colorless or ranging from pale yellow to light brownish-yellow, filled with a transparent, colorless or slightly yellowish oily liquid with a characteristic odor of menthol.

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 (coronarolytic) action by reflex stimulation of sensory (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 essential mechanisms of the cardiovascular and nervous systems.

Pharmacokinetics.

When administered sublingually, Corvalment® is absorbed through the oral mucosa. The therapeutic effect occurs approximately within 5 minutes.

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

Clinical characteristics.

Indications.

• Mild angina attacks;
• seasickness and airsickness;
• hysteria;
• neurosis;
• headache associated with nitrate intake.

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.

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

Potentiation of the effect of antihypertensive medicinal products is possible when used simultaneously with Corvalment®.

Corvalment® reduces the intensity of headache caused by the use of nitrates.

Special precautions for use.

If chest pain does not subside after administration of the medicinal product, it is essential to consult a physician to rule out acute coronary syndrome.

The medicinal product does not contain sugar and can be used by 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/infant.

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 or operating machinery, due to possible adverse effects (dizziness and drowsiness).

Method of Administration and Dosage.

Hold the capsule in the mouth (under the tongue) until it dissolves completely. To accelerate the effect, the capsule may be crushed with teeth.

Single dose for adults – 1 capsule (100 mg).

Maximum daily dose – 6 capsules (600 mg).

Duration of treatment – up to 7 days.

Children.

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

Overdose.

Symptoms: headache, nausea, excitement, cardiac dysfunction, decreased arterial pressure, central nervous system depression, hypersensitivity reactions to components of the medicinal product (angioneurotic edema, urticaria, pruritus, rash).

Treatment: discontinuation of the medicinal product and symptomatic therapy.

Adverse reactions.

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

Allergic reactions may develop, including Quincke's edema (angioedema), urticaria, rashes, and itching.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

10 capsules in blisters.

10 capsules per blister; 3 blisters per carton.

20 capsules per blister; 1 blister per carton.

20 capsules per blister; 3 blisters per carton.

20 capsules per blister; 4 blisters per carton.

Availability category. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's location and address of its business operations.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua

INSTRUCTION

for medical use of the medicinal product

CORVALMENT®

(CORVALMENT)

Composition:

Active substance: menthol solution in menthyl ester of isovaleric acid;

1 capsule contains 100 mg of menthol solution in menthyl ester of isovaleric acid;

Excipients: gelatin, glycerin.

Pharmaceutical form. Soft capsules.

Main physicochemical properties: soft gelatin capsules, spherical or nearly spherical in shape, with a seam, colorless or ranging from pale yellow to light brownish-yellow, filled with a transparent, colorless or slightly yellowish oily liquid with a characteristic odor of menthol.

Pharmacotherapeutic group. Cardiology preparations. ATC code: C01EX.

Pharmacological properties.

Pharmacodynamics.

The medicinal product exerts a calming effect on the central nervous system and provides a moderate reflex vasodilatory (coronarodilating) action through reflex stimulation of sensitive nerve ("cold") receptors in the oral mucosa. Receptor stimulation induces the release of endorphins, enkephalins, dynorphins, and other peptides, 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, Corvalment® is absorbed through the oral mucosa. Therapeutic effect occurs approximately within 5 minutes.

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

Clinical characteristics.

Indications.

• Mild angina attacks;
• Motion sickness (sea or air travel);
• Hysteria;
• Neurosis;
• Headache associated with nitrate administration.

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.

Corvalment® enhances the sedative effect of psychotropic drugs, opioid analgesics, alcohol, and anesthetic agents when used concomitantly.

Potentiation of the effect of antihypertensive drugs may occur when used simultaneously with Corvalment®.

Corvalment® reduces the severity of headache caused by nitrates.

Special precautions.

If chest pain persists after taking the medicinal product, immediate medical consultation is required to rule out acute coronary syndrome.

The medicinal product is sugar-free and can be used by patients with diabetes mellitus.

Use during pregnancy or breastfeeding.

The use of the medicinal product during pregnancy or breastfeeding is possible only if, in the physician’s opinion, the expected benefit to the mother outweighs the potential risk to the fetus/child.

Ability to affect reaction speed when driving or operating machinery.

Caution is advised during the first hours after administration when driving or operating machinery requiring high attention, due to possible adverse effects (dizziness and drowsiness).

Method of administration and dosage.

Hold the capsule in the mouth (under the tongue) until completely dissolved. To accelerate the effect, the capsule may be crushed with teeth.

Single dose for adults – 1 capsule (100 mg).

Maximum daily dose – 6 capsules (600 mg).

Duration of treatment – up to 7 days.

Children.

There is no experience with the use of this medicinal product in pediatric patients.

Overdose.

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

Treatment: discontinue the medicinal product and provide symptomatic therapy.

Adverse reactions.

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

Allergic reactions may develop, including Quincke's edema (angioedema), urticaria, rashes, and itching.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

10 capsules in blisters.

10 capsules per blister; 3 blisters per carton.

20 capsules per blister; 1 blister per carton.

20 capsules per blister; 3 blisters per carton.

20 capsules per blister; 4 blisters per carton.

Availability category. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's location and address of its business operations.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua