Doppelherz^® Cardiovital (Tablets) Instructions for Use

Marketing Authorization Holder

Queisser Pharma, GmbH & Co. KG (Germany)

ATC Code

C01EB04 (Hawthorn glycosides)

Active Substance

Crataegi folium cum flore (DAB German Pharmacopoeia)

Dosage Form

Doppelherz® Cardiovital

Coated tablets, 300 mg: 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Coated tablets, brown in color with dark specks, round, biconvex; the coating is transparent.

Excipients: lactose monohydrate, powdered cellulose, highly dispersed silicon dioxide, copovidone, high-chain glycerides, povidone, corn starch, sodium croscarmellose, talc, magnesium stearate.

Coating composition: shellac, methacrylic acid-ethyl acrylate copolymer (1:1), sodium dodecyl sulfate, polysorbate 80, macrogol 6000, talc, simethicone emulsion.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation used for heart failure

Pharmacotherapeutic Group

Cardiotonic agent of plant origin

Pharmacological Action

A cardiotonic agent of plant origin. It has a moderate cardiotonic effect, improving the function of the heart muscle.

It possesses spasmolytic properties. By selectively dilating the coronary vessels and cerebral vessels, it exerts a hypotensive effect and helps normalize venous pressure.

It exhibits sedative properties.

Pharmacokinetics

Data on the pharmacokinetics of the drug Doppelherz^® Cardiovital are not provided.

Indications

• As part of complex therapy for chronic heart failure of functional classes I and II according to the NYHA classification.

ICD codes

Dosage Regimen

Administer orally with a sufficient amount of liquid. The standard dosage is one tablet taken two to three times daily.

The typical duration of a treatment course is six weeks. Conduct subsequent courses if deemed necessary by a physician based on clinical evaluation.

Adverse Reactions

Observe for adverse reactions primarily from the cardiovascular system and skin. With prolonged use at high doses, bradycardia and arterial hypotension may occur.

Monitor for potential allergic reactions, including urticaria and pruritus. Discontinue use immediately if signs of hypersensitivity appear.

Drug Interactions

Exercise caution with concomitant use of cardiac glycosides, such as digoxin or strophanthin. A pharmacodynamic interaction leads to an additive inotropic effect on the heart muscle.

Consider potential interactions with antihypertensive agents and central nervous system depressants due to the drug’s own hypotensive and mild sedative properties. Monitor for enhanced effects.

Contraindications

• Do not use in patients with a known hypersensitivity to the active substance, hawthorn, or any of the excipients listed in the composition.
• This product is contraindicated during pregnancy due to a lack of sufficient safety data.
• Avoid use throughout the entire period of lactation (breastfeeding).
• Do not administer to children or adolescents under 18 years of age as safety and efficacy have not been established in this population.

Overdose

No specific cases of overdose have been reported to date. Given the pharmacological profile, symptoms of severe overdose could theoretically include pronounced bradycardia and a significant drop in blood pressure.

In case of suspected overdose, immediately discontinue the medication and initiate symptomatic and supportive care. There is no known specific antidote.

Use in Pregnancy and Lactation

The drug Doppelherz^® Cardiovital is contraindicated for use during pregnancy and the breastfeeding period.

Storage Conditions

The drug should be stored in a dry place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug 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.