Doppelherz^® Energotonik (Elixir) Instructions for Use

Marketing Authorization Holder

Queisser Pharma, GmbH & Co. KG (Germany)

ATC Code

A11JC (Vitamins in combination with other drugs)

Dosage Form

Doppelherz^® Energotonik

Elixir: bottle 20 ml or 250 ml 1 pc.

Dosage Form, Packaging, and Composition

Elixir in the form of a dark brown liquid with an aromatic odor.

	100 ml
Thiamine hydrochloride (vit. B₁)	5 mg
Riboflavin (vit. B₂)	5 mg
Calcium pantothenate (vit. B₅)	16 mg
Pyridoxine hydrochloride (vit. B₆)	5 mg
Folic acid (vit. B_c)	300 mcg
Cyanocobalamin (vit. B₁₂)	3.5 mcg
Nicotinamide (vit. PP)	25 mg
Rutoside trihydrate (vit. P)	2 mg
Ammonium ferric citrate	200 mg,
Which corresponds to iron content	16.5-18.5%
Copper sulfate pentahydrate	100 mcg,
Which corresponds to copper content	25 mcg
Manganese sulfate monohydrate	100 mcg,
Which corresponds to manganese content	33 mcg
Sodium glycerophosphate	271 mg
Choline citrate	222 mg
Honey	1.2 g
Invert sugar syrup	7.36 g
White mistletoe tincture (1:5)	120 µl
Hypericum perforatum herb tincture (1:5)	200 µl
Tincture of Achillea millefolium herb (1:5)	200 µl
Hawthorn fruit tincture (1:5)	600 µl
Angelica archangelica root tincture (1:5)	175 µl
Tincture of rhizomes with roots of medicinal valerian (1:5)	160 µl
Humulus lupulus tincture (1:5)	160 µl
Citrus aurantium peel tincture (1:5)	162.5 µl
Sea salt	500 mcg
Leaf oil of Salvia officinalis	0.02 µl
Oil of Rosmarinus officinalis leaves and stems	0.02 µl
Melissa leaf oil	0.04 µl
Aromatic tincture	162.5 µl,
Prepared from cinnamon tree bark – 2.67 mg, ginger rhizomes – 1.07 mg, galangal rhizomes – 530 mcg, clove buds – 530 mcg, cardamom fruits – 530 mcg, ethanol 70% vol. – 26.67 mg

Excipients : dessert wine – 88.05 g, caramel color (E150) – 650 mg, sweet wine flavor – 44 mg, ethanol 96% vol. – 52.43 mg, citric acid monohydrate – 120 mg, vanillin – 6 mg, purified water – 5.64 g.

250 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Multivitamins with trace elements and components of natural origin

Pharmacotherapeutic Group

Multivitamin agent + other drugs

Pharmacological Action

A combined preparation, the action of which is determined by the properties of its constituent vitamins, minerals, and medicinal herbs.

It has a general strengthening and tonic effect. It helps to normalize metabolic processes in the body. It increases mental and physical performance.

It improves the functional activity of the cardiovascular and nervous systems. It increases the body’s resistance to stressful situations and adverse environmental factors.

Pharmacokinetics

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

Indications

Prevention and treatment of hypo- and avitaminosis;
Period of intensive physical and mental stress;
Increased need for vitamins after past illnesses and in the postoperative period;
As part of complex therapy for chronic diseases (to improve well-being);
With unbalanced and inadequate nutrition;
To increase performance and improve concentration.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
E50-E64	Other types of nutritional deficiencies (E50-E64)
Z54	Convalescence
Z73.0	Burn-out
Z73.3	Stress, not elsewhere classified (physical and mental strain)

ICD-11 code	Indication
5B7Z	Malnutrition, unspecified
QB7Z	Convalescence, unspecified
QD85	Burn-out
QE01	Stress, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Take the elixir orally.

Measure the dose using the provided measuring cup or a dessert spoon.

The standard single dose for adults is 20 ml.

Take the dose three to four times daily.

Always take the elixir after meals.

Do not exceed the recommended daily dosage.

Shake the bottle gently before use.

Be aware that 20 ml of the elixir contains 2.5 grams of ethanol.

For patients with diabetes, note that 20 ml contains carbohydrates equivalent to 0.32 bread units (XE).

Store the bottle at room temperature, away from light and out of the reach of children.

Discard the product after the expiration date printed on the packaging.

Adverse Reactions

Possible allergic reactions.

Rarely increased sensitivity to light (especially in people with fair skin).

Contraindications

Acute period of infectious diseases;
Increased iron content in the body and impaired iron absorption;
Pregnancy;
Lactation period (breastfeeding);
Age under 18 years;
Increased sensitivity to the components of the drug.

With caution the drug should be prescribed for epilepsy, chronic alcoholism, craniocerebral trauma, impaired liver and/or kidney function, type 2 diabetes mellitus.

Use in Pregnancy and Lactation

Doppelherz^® Energotonik is contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

The drug should be prescribed with caution in case of impaired renal function.

Use in Renal Impairment

The drug should be prescribed with caution in case of impaired liver function.

Pediatric Use

Contraindication: age under 18 years.

Special Precautions

The preparation contains 15% vol. ethanol, 20 ml of the preparation contains 2.5 g of ethanol.

When using the drug in patients with diabetes mellitus, it should be taken into account that 20 ml of the drug contains easily digestible carbohydrates equivalent to 0.32 XE.

Due to the presence of iron salts in the composition of the drug, stool may turn black.

It should be taken into account that due to the content of plant components, changes in the taste and color of the elixir are possible during storage, however, this fact does not affect the pharmacological action of the drug.

Influence on the ability to drive vehicles and mechanisms

The drug contains ethanol, which should be taken into account when driving vehicles and working with mechanisms requiring increased attention (a decrease in the speed of psychomotor reactions is possible).

Overdose

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

Drug Interactions

Drug interaction of Doppelherz^® Energotonik 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.

Medical Disclaimer