Cratal (Tablets) Instructions for Use

Marketing Authorization Holder

Borshchagovsky CPPC NPC, PJSC (Ukraine)

ATC Code

C01EB (Other drugs for the treatment of heart diseases)

Active Substances

Taurine (Rec.INN registered by WHO)

Crataegus fruit (BHP British Herbal Pharmacopoeia)

Leonuri herba (SP State Pharmacopoeia)

Dosage Form

Cratal

Coated tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets are oval, biconvex, from light gray or light brown to dark brown in color, with inclusions from light brown to dark brown in color.

Excipients: potato starch, colloidal silicon dioxide, magnesium stearate.

10 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation used for functional disorders of the cardiovascular system

Pharmacotherapeutic Group

Cardiotonic agent of plant origin

Pharmacological Action

Cratal is a combined preparation, the action of which is determined by the properties of its constituent components. The preparation Cratal includes extracts of hawthorn fruit and motherwort, as well as a component with metabolic action – Taurine. According to the results of preclinical studies, Cratal has a mild cardiotonic, antianginal, antioxidant and antiarrhythmic, antihypoxic, antiaggregant action.

The preparation inhibits the renin-angiotensin and stimulates the kallikrein-kinin system, inhibits lipid peroxidation processes, and has a positive effect on the production of cyclic adenosine monophosphate (cAMP).

It improves blood supply and the functional state of the myocardium, increases the “coronary reserve”, improves the contractility of the heart muscle, contributes to the reduction of blood pressure and normalization of heart rate, and increases tolerance to physical exertion.

It also reduces the severity of signs of cardiac glycoside intoxication.

Pharmacokinetics

No data available.

Indications

• As part of complex therapy for neurocirculatory dystonia.

ICD codes

Dosage Regimen

Administer Cratal orally.

Take 1 tablet three times daily, before meals.

The standard course of treatment is 3 to 4 weeks.

For patients with diabetes mellitus, monitor blood glucose concentration closely, especially at the start of therapy.

Adjust doses of insulin or other hypoglycemic agents as necessary to prevent hypoglycemia.

Refrain from driving vehicles or operating machinery during treatment, as the preparation may impair concentration and psychomotor speed.

Do not exceed the prescribed dosage.

Discontinue use and consult a physician if severe adverse reactions occur.

Adverse Reactions

Possible allergic reactions, dyspeptic phenomena, decreased blood pressure.

Contraindications

• Age under 18 years.
• Pregnancy;
• Lactation period;
• Hypersensitivity to the components of the preparation.

With caution diabetes mellitus.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

Due to the fact that Taurine, which is part of the preparation, has a hypoglycemic effect, when prescribing Cratal to patients with diabetes mellitus, constant monitoring of blood glucose concentration is necessary, especially at the initial stage of therapy.

In some cases, it is necessary to adjust the doses of insulin or oral hypoglycemic drugs to avoid the development of hypoglycemia.

Influence on the ability to drive vehicles and mechanisms

Throughout the entire treatment period, patients taking Cratal should refrain from driving vehicles, working with mechanisms, and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms dyspeptic phenomena, drowsiness are possible.

Treatment symptomatic.

Drug Interactions

It is possible to use the preparation Cratal in combination with long-acting nitrates, vasodilators, calcium antagonists, beta-blockers, cardiac glycosides and diuretics.

It should be taken into account that Cratal enhances the antianginal effects of nitrates, calcium antagonists, beta-blockers, antihypoxants, and neuroprotectors.

Cratal increases the sensitivity of the myocardium to the action of cardiac glycosides and slow calcium channel blockers, which requires correction of their doses.

Storage Conditions

Store the preparation in a dry, light-protected place at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Do not use after the expiration date.

Dispensing Status

The preparation is dispensed 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.