CARVELIS

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CARVELIS (CARVELIS)

Composition:

Active substances: 10 ml of the preparation contains: extract from a mixture of hawthorn leaves, flowers and fruits (Crataegi folii cum flore, fructus extractum) (1:1.6–2.2), extraction solvent: ethanol 50% (v/v) – 7.125 ml; extract from motherwort herb (Leonuri herbae extractum) (1:1.7–2.2), extraction solvent: ethanol 40% (v/v) – 1.0 ml; extract from lemon balm leaves (Melissae herbae extractum) (1:1.6–2.1), extraction solvent: ethanol 60% (v/v) – 1.0 ml; extract from valerian root (Valerianae radix extractum) (1:1.6–2.1), extraction solvent: ethanol 60% (v/v) – 0.5 ml;

Excipients: sucrose, purified water.

Pharmaceutical form. Oral drops, solution.

Main physicochemical properties. Brown liquid.

Pharmacotherapeutic group.

Psycholeptics. Sedatives and hypnotics. Other sedatives and hypnotics.

ATC code N05CM.

Pharmacological properties.

The therapeutic effect of the medicinal product is due to the synergistic combination of therapeutic effects of medicinal plants contained in its composition: dog nettle, melissa, hawthorn, and valerian.

In neuroses, including cardioneurosis, and other functional disorders of the cardiovascular system, which may be accompanied by pain, palpitations, sweating, hot flashes, and sensations of irregular heartbeat, the components of the drug eliminate pathological symptoms and normalize the function of the heart and blood vessels. Hawthorn additionally improves the heart's pumping function, enhances blood circulation in the heart and brain, while simultaneously reducing excitability.

In stressful situations, due to the protective sedative and vegetostabilizing effects of the drug, nervous tension, irritability, and restlessness are eliminated. General condition, well-being, and work capacity improve.

In insomnia, the drug does not have a direct hypnotic effect; however, it facilitates the onset of physiological sleep, deepens sleep, and improves its quality.

The drug does not cause habituation or dependence.

Clinical characteristics.

Indications.

Used to support the cardiovascular system during nervous stress (stress), neurocirculatory dystonia, cardiac neuroses, as part of complex therapy for stage I–II arterial hypertension, stage I–II angina pectoris, arrhythmia under stressful conditions, and for improving general well-being during nervous excitement in adults.

Contraindications.

Hypersensitivity to the components of the drug. Depression and other disorders accompanied by central nervous system depression. Marked arterial hypotension and bradycardia.

Special precautions.

If symptoms do not disappear and/or leg swelling occurs, or if symptoms of unknown origin appear, medical advice must be sought. In case of chest pain that may radiate to the arms, epigastric area, or neck region, or if shortness of breath develops, immediate medical attention is required.

The medicinal product Carvelis contains sucrose. In case of intolerance to certain types of sugars, consult a physician before starting the medication.

During treatment with this medicinal product, consumption of alcoholic beverages should be avoided.

Interaction with other medicinal products and other forms of interaction.

If you are taking any other medicinal products, you must consult your doctor regarding the possibility of using this drug.

Valerian preparations may enhance the effects of alcohol, sedatives, hypnotics, analgesics, spasmolytics, and anxiolytics.

Interaction with other medicinal products has not been studied to date.

Special precautions.

Use during pregnancy or breastfeeding.

Prior to starting treatment, consult a physician.

The use of Carvelis in pregnant women has not been sufficiently studied. Carvelis is not recommended for use in pregnant or breastfeeding women.

Ability to affect reaction speed when driving or operating machinery.

When taking this medicine, patients should refrain from driving vehicles or operating potentially hazardous machinery.

Caution should be exercised when administering the drug to patients with severe hepatic impairment or a history of severe liver disease.

Specific sensitivity to the smell of valerian may occur.

Dosage and Administration.

Adults should take 30 drops (1.2 ml) of Carvelis three times daily, after dissolving the drops in a small amount of liquid.

If symptoms do not improve within 2 weeks, worsen, or if adverse reactions not listed in this instruction appear, consult a physician.

Children.

Safety and efficacy of Carvelis in children (under 18 years of age) have not been established; therefore, Carvelis is not recommended for patients in this age group.

Overdose.

A single intake of a dose 2–3 times higher than the recommended dose usually does not cause adverse effects. In such cases, continue using the medication according to the instructions. However, significantly exceeding the recommended dose increases the risk of adverse reactions.

Symptoms: headache, drowsiness, lethargy, abdominal pain, nausea, decreased hearing and visual acuity, tachycardia.

Treatment: discontinue the medication, gastric lavage, administration of activated charcoal.

Side effects.

Gastrointestinal system: nausea, heartburn, spasmodic abdominal pain.

Cardiovascular system: decreased blood pressure, bradycardia.

Skin allergic reactions: redness, rash, itching, skin swelling.

Central and peripheral nervous system: dizziness, drowsiness, suppression of emotional responses, depression, general weakness, decreased mental and physical performance.

The frequency of occurrence of these adverse reactions is unknown.

If any undesirable effects occur, consult a physician.

Shelf life.

36 months. After opening the bottle, the shelf life is 6 months.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, in a light-protected and child-inaccessible place.

Packaging.

30 ml, 50 ml, or 100 ml in a bottle, 1 bottle in a cardboard box.

Supply category: Over-the-counter (without prescription).

Manufacturer.

Dr. Gustav Klein GmbH & Co. KG.

Manufacturer's address and place of business.

Steinenfeld 3, 77736 Zell am Harmersbach, Germany.