Glod-vishfa

INSTRUCTION for medical use of the medicinal product GLOD-VISHFA (CRATAEGUS-VISHPHA)

Composition:

Active substance: hawthorn fruit tincture;

1 ml of the preparation contains hawthorn fruit tincture (Crataegi fructus) (1:10) (extraction solvent — 70% ethanol).

Pharmaceutical form. Tincture.

Main physico-chemical properties: clear liquid, ranging in color from yellow-red to reddish-brown, bitterish taste, with a faint aromatic odor; formation of a slight sediment during storage is permissible.

Pharmacotherapeutic group.

Agents used in cardiology. ATC Code C01E B04.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances contained in hawthorn fruits (flavonoids, choline, acetylcholine, tannins, phytosterols, triterpenic acids) enhance blood circulation in the coronary vessels and cerebral vessels, increase myocardial sensitivity to cardiac glycosides, and reduce myocardial excitability, resulting in a moderate enhancement of cardiac muscle contractions.

Pharmacokinetics.

The medicinal product is well absorbed when administered orally. The effect begins within 30 minutes to 1 hour.

Clinical characteristics.

Indications.

Functional disorders of the cardiovascular system activity (neurocirculatory dystonia); as an auxiliary medicinal agent in mild forms of cardiac arrhythmias (atrial fibrillation, paroxysmal tachycardia).

Contraindications.

Hypersensitivity to the components of the medicinal product. Marked arterial hypotension and bradycardia.

Interaction with other medicinal products and other forms of interaction.

The medicinal product enhances the effects of cardiac glycosides and antiarrhythmic agents. Concomitant use with alkaloid salts is not recommended due to the possibility of forming negative complexes. The drug should not be used together with cisapride. May enhance the effects of sedatives, hypnotics, and antihypertensive agents.

If simultaneous use of any medicinal products is necessary, a physician should be consulted.

Special precautions for use.

The medicinal product is not recommended to be taken during meals in order to avoid interaction with food components.

Gload-Vishfa is a traditional herbal medicinal product used according to indications supported by long-standing use.

This medicinal product contains 70 vol.% ethanol (alcohol), i.e. 690.55 mg/dose. Harmful for patients suffering from alcoholism. Caution is advised when administering to patients with liver disorders and to those with epilepsy.

Use during pregnancy or breastfeeding. The medicinal product is contraindicated during pregnancy and breastfeeding.

Ability to influence reaction speed when driving or operating machinery. The medicinal product may cause drowsiness; therefore, patients should refrain from driving or operating potentially hazardous machinery during treatment.

Method of Administration and Dosage.

Take orally before meals. The recommended dose for adults is 20 drops of the tincture 3 times a day. For children aged 12 years and older — 1 drop per year of life, 3 times a day, until a stable therapeutic effect is achieved. The duration of treatment is determined individually by a physician, depending on the nature and severity of the disease.

Consult a doctor if symptoms of the disease do not subside during treatment or if adverse reactions occur that are not listed in the instructions for medical use of the medicinal product.

Children.

The medicinal product is contraindicated in children under 12 years of age.

Overdose.

Symptoms: decreased arterial pressure, drowsiness, bradycardia.

Treatment: discontinue the drug and administer symptomatic therapy.

Side effects.

From the nervous system: drowsiness.

From the cardiovascular system: bradycardia, significant reduction in arterial pressure.

From the immune system: allergic reactions (including hyperemia, rash, itching, skin swelling).

Reporting of adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

50 mL or 100 mL in glass bottles, or 100 mL in polymer bottles.

Supply category. Over-the-counter.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity.

4, Korolova St., Stanishivka, Zhytomyr district, Zhytomyr region, 12430, Ukraine.