Doppelherz^® Vitalotonik (Solution) Instructions for Use

Marketing Authorization Holder

Queisser Pharma, GmbH & Co. KG (Germany)

ATC Code

A13A (General tonic preparations)

Dosage Form

Doppelherz® Vitalotonik

Oral solution: bottle 20 ml, 250 ml, 500 ml, 750 ml or 1 L 1 pc.

Dosage Form, Packaging, and Composition

Oral solution in the form of a transparent light brown liquid with a tangerine odor, and a tangerine and menthol taste.

Excipients: propylene glycol – 12 g, glycerol 85% – 8 g, macrogol glycerol hydroxystearate – 600 mg, sodium saccharin dihydrate – 5 mg, sodium cyclamate – 20 mg, racemic menthol – 12 mg, vanillin – 5 mg, tangerine flavor – 150 mg, potassium sorbate – 90 mg, sorbic acid – 33 mg, caramel color – 40 mg, purified water – 81.545 g.

20 ml – dark glass bottles (1) – cardboard packs.
250 ml – dark glass bottles (1) – cardboard packs.
500 ml – dark glass bottles (1) – cardboard packs.
750 ml – dark glass bottles (1) – cardboard packs.
1 L – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with a general strengthening and sedative effect

Pharmacotherapeutic Group

Herbal remedy

Pharmacological Action

A combined herbal preparation, the action of which is determined by the complex of its constituent components.

It has a general strengthening effect (including on the cardiovascular system) and possesses a sedative effect.

Extract of hawthorn leaves and flowers has a cardiotonic and spasmolytic effect, selectively dilating coronary vessels and cerebral vessels.

Extract of hop cones exerts a sedative, anti-inflammatory, capillary-strengthening action, and contributes to the normalization of metabolic processes in the body.

Extracts of valerian root and lemon balm leaves have a sedative effect and possess spasmolytic activity.

Ginseng root extract has a tonic and general strengthening effect on the body, helps to increase working capacity and the body’s resistance to adverse environmental factors.

Pharmacokinetics

The action of Doppelherz^® Vitalotonik is the combined action of its components, therefore conducting kinetic observations is not possible; all components together cannot be tracked using markers or bioassays.

Indications

• Asthenia;
• Overfatigue;
• Neurasthenic syndrome;
• Convalescence period after past illnesses.

ICD codes

Dosage Regimen

Administer orally to adults only.

Take 20 ml (equivalent to two dessert spoons) three times daily.

Administer the dose before meals.

The standard treatment course is 1.5 to 2 months.

Extend the duration or initiate a repeated course only upon physician’s recommendation.

Do not exceed the stated dosage.

Shake the bottle gently before use.

Use the provided measuring spoon or a standard dessert spoon for accurate dosing.

Adverse Reactions

Possible: allergic reactions.

Contraindications

• Epilepsy;
• Convulsive conditions;
• Acute period of infectious diseases;
• Hepatic insufficiency;
• Age under 18 years;
• Hypersensitivity to the drug components.

Use in Pregnancy and Lactation

The drug is not recommended for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindication: hepatic insufficiency.

Pediatric Use

Contraindication: age under 18 years.

Special Precautions

The drug does not contain ethanol (dealcoholized extracts from medicinal plant materials are used to produce the drug) and sugar, which allows the drug to be used by patients with diabetes mellitus.

The drug contains herbal extracts, and therefore slight deviations in color and odor are possible, which do not affect its therapeutic efficacy.

Overdose

Data on overdose of Doppelherz^® Vitalotonik have not been provided.

Drug Interactions

Drug interaction of Doppelherz^® Vitalotonik has not been described.

Storage Conditions

The drug should be stored 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 approved for use as an over-the-counter product.

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.