Kregium (Tablets) Instructions for Use

Marketing Authorization Holder

Sandoz CJS (Russia)

Manufactured By

Salutas Pharma, GmbH (Germany)

ATC Code

C01EB04 (Hawthorn glycosides)

Active Substance

Crataegi folium cum flore (DAB German Pharmacopoeia)

Dosage Form

Kregium

Coated tablets, 240 mg: 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Coated tablets light pink in color, round, biconvex, smooth.

Excipients : colloidal silicon dioxide 6 mg, microcrystalline cellulose 150.9 mg, corn starch 75 mg, sodium carboxymethylcellulose 30 mg, stearic acid 15 mg, hypromellose 5.1 mg, talc 259.613 mg.

Shell composition sucrose 106.039 mg, calcium carbonate (E170) 33.365 mg, titanium dioxide (E171) 9.217 mg, povidone-K25 6.533 mg, macrogol-6000 3.191 mg, glycol montan wax 0.06 mg, white beeswax 0.06 mg, red iron oxide E172 (iron III oxide) 0.042 mg.

10 pcs. – blisters (5) – carton packs.
10 pcs. – blisters (10) – carton packs.

Clinical-Pharmacological Group

Herbal preparation used for heart failure

Pharmacotherapeutic Group

Cardiotonic agent of plant origin

Pharmacological Action

It has a cardiotonic effect, due to the complex of biologically active components contained in the extract of hawthorn leaves and flowers, primarily flavonoids and oligomeric procyanidins.

It has been established that flavonoids reduce the entry of calcium ions into the cell and reduce their intracellular concentration, which leads to a decrease in vascular tone and vasodilation.

The following effects of the extract of hawthorn leaves and flowers have been identified: positive inotropic effect, positive dromotropic effect, negative bathmotropic effect, increase in coronary, myocardial and cerebral blood flow, decrease in total peripheral vascular resistance.

It reduces the excitability of the central nervous system (CNS) and the heart muscle, and has antiarrhythmic and hypotensive effects.

Pharmacokinetics

The action of the drug Kregium is the combined action of the active substances of the extract of hawthorn flowers and leaves, therefore, conducting pharmacokinetic studies is not possible; all components together cannot be traced using markers or bioassays.

Indications

• As part of complex therapy for chronic heart failure of functional class I-II (according to the NYHA classification).

ICD codes

Dosage Regimen

Administer orally.

Take 1 tablettwo to three times daily.

Adhere to the recommended treatment course of 6 weeks.

Consult a physician to determine the need for longer treatment.

Do not exceed a maximum treatment duration of 6 months.

Adverse Reactions

Allergic reactions exanthema, skin itching;

From the gastrointestinal tract dyspeptic phenomena (nausea, vomiting);

From the cardiovascular system bradycardia and arterial hypotension (with long-term use in high doses).

Other asthenia.

Contraindications

• Hypersensitivity to the components of the drug;
• Age under 18 years (due to the lack of sufficient clinical data);
• Rare hereditary forms of fructose intolerance, glucose-galactose malabsorption or sucrase/isomaltase deficiency (because the composition contains sucrose).

Use in Pregnancy and Lactation

The use of the drug during pregnancy and breastfeeding is contraindicated due to the lack of reliable data on the safety of using the extract of hawthorn leaves and flowers during these periods.

Pediatric Use

Contraindicated for children under 18 years of age.

Special Precautions

Precautions for use

You should consult your doctor before using Kregium. If during treatment the symptoms of the disease remain unchanged or intensify, you should consult a doctor.

Information for patients with diabetes

Each Kregium tablet contains about 106 mg of sucrose, which corresponds to 0.009 XE (bread units). When taking the recommended daily dose of the drug, this amount is insignificant even if it is necessary to follow an anti-diabetic diet.

Effect on the ability to drive vehicles and machinery

When used in recommended doses, Kregium does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require concentration and speed of psychomotor reactions.

Overdose

Symptoms no cases of overdose have been reported. With significant overdose, an increase in the frequency and severity of dose-dependent adverse effects listed in the “Adverse Reactions” section is possible.

Treatment symptomatic.

Drug Interactions

There are no reports of interaction of the drug Kregium with other drugs, however, if it is necessary to use Kregium simultaneously with other drugs, you should consult your doctor.

When hawthorn extract is used simultaneously with cardiac glycosides (digoxin, strophanthin, etc.), the cardiotonic effect is enhanced. With beta-blockers – a possible enhancement of the hypotensive effect.

Storage Conditions

At a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.