CORVALCAPS EXTRA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KORVALKAPS EXTRA (CORVALCAPSEXTRA)

Composition:

Active substances: ethyl ether of alpha-bromoisovaleric acid, phenobarbital;

1 capsule contains ethyl ether of alpha-bromoisovaleric acid 18.4 mg, phenobarbital 18.4 mg;

Excipients: peppermint oil, hop oil, cyclodextrin, magnesium stearate;

Capsule shell: gelatin, titanium dioxide (E 171).

Pharmaceutical form. Hard capsules.

Main physicochemical properties: hard gelatin capsules with white body and cap. The capsule contents are granular powder or compacted mass of white or almost white color.

Pharmacotherapeutic group.

Sedatives and hypnotics. Combined barbiturate preparations. ATC code N05CB02.

Pharmacological Properties.

Pharmacodynamics.

Corvalcaps Extra is a sedative and spasmolytic agent whose effects are determined by its constituent components.

The ethyl ether of α-bromoisovaleric acid exerts reflex sedative and spasmolytic actions, primarily due to stimulation of receptors in the oral cavity and nasopharynx, reduction of reflex excitability in central nervous system centers, enhancement of inhibitory processes in neurons of 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.

Phenobarbital suppresses activating influences from the reticular formation centers of the midbrain and medulla oblongata on the cerebral cortex, thereby reducing excitatory impulses to the cerebral cortex and subcortical structures. Reduction of these activating influences results, depending on the dose, in sedative, tranquilizing, or hypnotic effects.

Corvalcaps Extra reduces excitatory influences on vasomotor centers and on coronary and peripheral blood vessels, lowering overall arterial pressure and relieving or preventing vascular spasms, particularly in the heart vessels.

Pharmacokinetics.

After oral administration, the bioavailability of the components is high (approximately 60–80%). The onset of action occurs within 15–45 minutes and lasts for 3–6 hours. In patients previously treated with barbituric acid derivatives, the duration of action is shortened due to accelerated hepatic metabolism of phenobarbital, as barbiturates induce liver enzymes. In elderly individuals and patients with liver cirrhosis, metabolism of Corvalcaps Extra is reduced, resulting in prolonged elimination half-life, which necessitates dose reduction and increased intervals between doses.

Clinical characteristics.

Indications.

• Neuroses with increased irritability;
• insomnia;
• as part of combination therapy for hypertension and vegetative-vascular dystonia;
• mild spasms of coronary vessels, tachycardia;
• intestinal spasms (as a spasmolytic agent).

Contraindications.

Hypersensitivity to the components of the drug, bromine; severe impairment of liver and/or kidney function; hepatic porphyria; severe heart failure.

Medicinal products containing phenobarbital are contraindicated in severe arterial hypotension, acute myocardial infarction, diabetes mellitus, depression, myasthenia, alcoholism, narcotic and drug dependence, respiratory disorders with dyspnea, obstructive syndrome.

Special precautions.

Alcohol consumption should be avoided.

The presence of phenobarbital in the medicinal product may lead to a risk of developing Stevens-Johnson syndrome and Lyell's syndrome, which is most likely during the first weeks of treatment. Prolonged use is not recommended due to the risk of drug dependence, possible accumulation of bromine in the body, and bromine poisoning. In cases where chest pain does not subside after taking the drug, medical advice should be sought to exclude acute coronary syndrome. The drug should be prescribed with caution in arterial hypotension, hyperkinesias, hyperthyroidism, adrenal insufficiency, acute and persistent pain, acute intoxication with medicinal products.

Interaction with other medicinal products and other types of interactions.

Central nervous system depressants enhance the effect of Corvalcaps Extra. The presence of phenobarbital in the medicinal product may induce liver enzymes, making its concomitant use with drugs metabolized in the liver undesirable (including indirect anticoagulants, cardiac glycosides, antimicrobial, antiviral, antifungal, antiepileptic, anticonvulsant, psychotropic, oral hypoglycemic, hormonal, immunosuppressive, cytostatic, antiarrhythmic, antihypertensive drugs with coumarin derivatives, griseofulvin, glucocorticoids, oral contraceptives), since their efficacy will be reduced due to a higher rate of metabolism. Corvalcaps Extra enhances the effect of local anesthetics, analgesics, and sedatives, which is associated with the presence of barbituric acid derivatives.

Concomitant use with valproic acid enhances its effect.

Concomitant use with methotrexate increases the latter's toxicity.

Alcohol may cause toxicity of the medicinal product.

MAO inhibitors prolong the effect of phenobarbital. Rifampicin may reduce the effect of phenobarbital.

Concomitant use of phenobarbital with gold compounds increases the risk of kidney damage.

Prolonged concomitant use of phenobarbital with nonsteroidal anti-inflammatory drugs carries a risk of gastric ulcer formation and bleeding.

Concomitant use of phenobarbital with zidovudine increases the toxicity of both drugs.

Special precautions for use.

Use during pregnancy or breastfeeding.

Corvalcaps Extra is not recommended during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

The medicinal product contains phenobarbital, which may impair coordination and psychomotor reaction speed; this should be taken into account when deciding whether to drive or operate machinery.

Dosage and Administration.

The medicinal product is taken orally, regardless of food intake, 1 capsule 2–3 times a day, swallowed with water. If necessary (pronounced tachycardia and coronary vessel spasm), the single dose may be increased to 2 capsules.

The duration of treatment with Corvalcaps Extra is determined by the physician depending on the clinical effect and the patient's tolerance of the medicinal product.

Children. Experience with use of the medicinal product in children is lacking.

Overdose.

Overdose is possible with frequent or prolonged use of the medicinal product, related to accumulation of its components. Prolonged and continuous use may lead to dependence, abstinence syndrome, and psychomotor agitation. Sudden discontinuation of the medicinal product may cause withdrawal syndrome.

Symptoms of overdose: central nervous system depression, confusion, dizziness, ataxia, drowsiness progressing nearly to deep sleep. In severe poisoning: respiratory depression, tachycardia, arrhythmias, decreased arterial pressure, collapse, coma; nausea, weakness, hypothermia, reduced diuresis.

Treatment: symptomatic.

Adverse Reactions.

In individual cases, the following adverse effects may occur:

Gastrointestinal system: constipation, feeling of heaviness in the epigastric region, with prolonged use – liver function impairment, nausea, vomiting;

Nervous system: weakness, ataxia, impaired motor coordination, nystagmus, hallucinations, paradoxical excitation, decreased attention concentration, fatigue, slowed reaction time, headache, cognitive disturbances, confusion, drowsiness, mild dizziness;

Hematopoietic system: anemia, thrombocytopenia, agranulocytosis;

Cardiovascular system: arterial hypotension, bradycardia;

Immune system: hypersensitivity reactions, including angioedema, allergic reactions (e.g. skin rash, itching, urticaria);

Skin and mucous membranes: Stevens-Johnson syndrome, toxic epidermal necrolysis;

Musculoskeletal system: with prolonged use of agents containing phenobarbital, there is a risk of impaired osteogenesis;

Other: difficulty breathing.

Prolonged intake of drugs containing bromine may lead to bromism, characterized by the following symptoms: central nervous system depression, depressive mood, confusion, ataxia, apathy, conjunctivitis, rhinitis, lacrimation, acne or purpura.

These phenomena resolve upon dose reduction or discontinuation of the drug.

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 per blister pack.

10 capsules per blister; 1 or 3 blisters per carton.

Prescription status.

Over-the-counter.

Manufacturer.

PJSC "KYIV VITAMIN PLANT".

Manufacturer’s location and address of business activity.

38 Kopylivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua.

INSTRUCTIONS

for medical use of medicinal product

CORVALCAPS EXTRA

(CORVALCAPSEXTRA)

Composition:

Active substances: ethyl ether of alpha-bromoisovalerianic acid, phenobarbital;

1 capsule contains ethyl ether of alpha-bromoisovalerianic acid 18.4 mg, phenobarbital 18.4 mg;

Excipients: peppermint oil, hops oil, cyclodextrin, magnesium stearate;

Capsule shell: gelatin, titanium dioxide (E 171).

Pharmaceutical form. Hard capsules.

Main physicochemical properties: hard gelatin capsules with white body and cap. Capsule contents – granulated powder or compressed mass of white or almost white color.

Pharmacotherapeutic group.

Hypnotics and sedatives. Combined barbiturate preparations.

ATC code N05CB02.

Pharmacological properties.

Pharmacodynamics. Corvalcaps Extra is a sedative and spasmolytic agent whose effects are determined by its constituent components.

Ethyl ether of α-bromoisovalerianic acid exerts reflex sedative and spasmolytic actions, caused primarily by irritation of oral and nasopharyngeal receptors, reduced reflex excitability in central nervous system centers, enhanced inhibitory processes in cortical and subcortical brain neurons, and decreased activity of central vasomotor centers, as well as direct local spasmolytic action on vascular smooth muscles.

Phenobarbital suppresses activating influences from the reticular formation centers of the midbrain and medulla oblongata on the cerebral cortex, thereby reducing excitatory impulses to the cerebral cortex and subcortical structures. Reduced activating input leads to sedative, tranquilizing, or hypnotic effects depending on the dose.

Corvalcaps Extra reduces excitatory influences on vasomotor centers, coronary and peripheral vessels, lowering overall arterial pressure, relieving and preventing vascular spasms, especially in the heart.

Pharmacokinetics. After oral administration, bioavailability of components is high (approximately 60–80%). Effects develop within 15–45 minutes and last for 3–6 hours. In patients previously exposed to barbiturate drugs, duration of action is shortened due to accelerated hepatic metabolism of phenobarbital, as barbiturates induce liver enzymes. In elderly patients and those with liver cirrhosis, metabolism of Corvalcaps Extra is reduced, resulting in prolonged elimination half-life, necessitating dose reduction and increased dosing intervals.

Clinical characteristics.

Indications.

• Neuroses with increased irritability;
• insomnia;
• as part of complex therapy for hypertension and vegetative-vascular dystonia;
• mild coronary vessel spasms, tachycardia;
• intestinal spasms (as a spasmolytic agent).

Contraindications.

Hypersensitivity to the drug components or to bromine; severe impairment of liver and/or kidney function, hepatic porphyria, severe heart failure.

Medicinal products containing phenobarbital are contraindicated in severe arterial hypotension, acute myocardial infarction, diabetes mellitus, depression, myasthenia, alcoholism, drug or medication dependence, respiratory disorders with dyspnea, obstructive syndrome.

Special precautions.

Avoid concomitant consumption of alcoholic beverages.

The presence of phenobarbital in the formulation may increase the risk of developing Stevens-Johnson and Lyell's syndromes, most likely during the first weeks of treatment. Prolonged use is not recommended due to the risk of drug dependence, potential bromide accumulation in the body, and bromism. If chest pain persists after taking the drug, medical consultation is required to rule out acute coronary syndrome. Use with caution in patients with arterial hypotension, hyperkinesia, hyperthyroidism, adrenal insufficiency, acute or persistent pain, or acute intoxication with medicinal agents.

Interaction with other medicinal products and other types of interactions.

Central nervous system depressants enhance the effect of Corvalcaps Extra. The presence of phenobarbital in the formulation may induce liver enzymes, making concomitant use with drugs metabolized in the liver undesirable (including indirect anticoagulants, cardiac glycosides, antimicrobial, antiviral, antifungal, antiepileptic, anticonvulsant, psychotropic, oral hypoglycemic, hormonal, immunosuppressive, cytostatic, antiarrhythmic, antihypertensive agents, drugs containing coumarin derivatives, griseofulvin, glucocorticoids, oral contraceptives), as their efficacy may be reduced due to increased metabolism. Corvalcaps Extra enhances the effects of local anesthetics, analgesics, and hypnotics, due to the presence of barbiturate derivatives.

Concomitant use with valproic acid enhances its effect.

Concomitant use with methotrexate increases its toxicity.

Alcohol may cause drug toxicity.

MAO inhibitors prolong the effect of phenobarbital. Rifampicin may reduce the effect of phenobarbital.

Concomitant use of phenobarbital with gold-containing drugs increases the risk of kidney damage.

Long-term concomitant use of phenobarbital with nonsteroidal anti-inflammatory drugs increases the risk of gastric ulceration and bleeding.

Concomitant use of phenobarbital with zidovudine increases the toxicity of both agents.

Special instructions.

Use during pregnancy or breastfeeding.

Corvalcaps Extra is not used during pregnancy and breastfeeding.

Ability to affect reaction rate when operating vehicles or machinery.

The medicinal product contains phenobarbital, which may impair coordination and psychomotor reaction speed. This should be considered when deciding whether to operate vehicles or machinery.

Administration and dosage.

The drug should be taken orally, regardless of food intake, 1 capsule 2–3 times daily, with water. If necessary (severe tachycardia or coronary vessel spasm), the single dose may be increased to 2 capsules.

Duration of Corvalcaps Extra treatment is determined by the physician based on clinical response and drug tolerance.

Children. Experience with use in children is lacking.

Overdose.

Overdose may occur with frequent or prolonged use due to accumulation of components. Long-term continuous use may lead to dependence and withdrawal syndrome. Sudden discontinuation may cause withdrawal symptoms.

Symptoms of overdose: central nervous system depression, confusion, dizziness, ataxia, drowsiness, up to deep sleep. In severe poisoning – respiratory depression, tachycardia, arrhythmias, decreased blood pressure, collapse, coma; nausea, weakness, hypothermia, reduced diuresis.

Treatment: symptomatic.

Adverse reactions.

In individual cases, the following adverse effects may occur:

Gastrointestinal system: constipation, feeling of heaviness in the epigastric region, with prolonged use – liver function impairment, nausea, vomiting;

Nervous system: weakness, ataxia, impaired motor coordination, nystagmus, hallucinations, paradoxical excitation, decreased attention concentration, fatigue, slowed reaction time, headache, cognitive disturbances, confusion, drowsiness, mild dizziness;

Hematopoietic system: anemia, thrombocytopenia, agranulocytosis;

Cardiovascular system: arterial hypotension, bradycardia;

Immune system: hypersensitivity reactions, including angioedema, allergic reactions (e.g. skin rash, itching, urticaria);

Skin and mucous membranes: Stevens-Johnson syndrome, toxic epidermal necrolysis;

Musculoskeletal system: with prolonged use of agents containing phenobarbital, there is a risk of impaired osteogenesis;

Other: difficulty breathing.

Prolonged intake of drugs containing bromine may lead to bromism, characterized by the following symptoms: central nervous system depression, depressive mood, confusion, ataxia, apathy, conjunctivitis, rhinitis, lacrimation, acne or purpura.

These phenomena resolve upon dose reduction or discontinuation of the drug.

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 per blister.

10 capsules per blister; 1 or 3 blisters per carton.

Prescription status.

Over-the-counter.

Manufacturer.

PJSC "KYIV VITAMIN PLANT".

Manufacturer’s location and address of business activity.

38 Kopylivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua.