Doppelherz^® Aktiv Lecithin-complex (Capsules) Instructions for Use

Marketing Authorization Holder

Queisser Pharma, GmbH & Co. KG (Germany)

Dosage Form

Doppelherz® Aktiv Lecithin-complex

Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Composition of capsules as active substances includes Lecithin, vitamins B1, B2, B6, B12 and E, Nicotinamide, Folic acid.

Release form and packaging
30 capsules

Indications

• This dietary supplement is indicated as an adjunct to support the normal function of the nervous system during periods of high mental and psychological stress, fatigue, and concentration difficulties.
• It is used to help maintain cognitive performance, including memory and learning capacity, particularly in adults experiencing age-related cognitive decline.
• The formulation provides essential phospholipids and B-vitamins to contribute to the structural integrity of nerve cell membranes and support energy metabolism within the nervous system.
• It may be used to support overall mental vitality and well-being in individuals with inadequate dietary intake of the contained nutrients.

Therapeutic Category

Dietary supplement for support of function of nervous system

Dosage Regimen

The recommended dosage for adults and adolescents over 12 years is one capsule daily, taken with a sufficient amount of fluid, preferably during a meal.

The capsule should be swallowed whole and not chewed. It is important to adhere to the recommended daily dose; do not exceed the stated intake.

The duration of use is not limited; however, long-term continuous use should be discussed with a healthcare professional. The product is intended for use as part of a balanced and varied diet and a healthy lifestyle.

Adverse Reactions

Based on the composition and reported experience, adverse reactions are rare and typically mild. In very rare cases, gastrointestinal discomfort such as nausea or a feeling of fullness may occur, which is often associated with the high phospholipid content.

Isolated cases of allergic skin reactions, such as rash or itching, have been reported, potentially linked to sensitivity to one of the active ingredients or excipients.

Due to the high content of vitamin B2 (riboflavin), a harmless yellow discoloration of the urine may be observed; this is a normal physiological effect and not a cause for concern.

If any unusual or severe reactions occur, discontinue use and consult a physician. Reporting suspected adverse reactions is important for ongoing safety monitoring.

Drug Interactions

While significant interactions are not commonly expected with dietary supplements, the potential for interaction exists due to the high doses of certain vitamins. Concomitant use with Levodopa for Parkinson’s disease should be avoided, as vitamin B6 in doses above 5 mg per day can reduce the efficacy of Levodopa when it is not administered with a decarboxylase inhibitor.

The absorption of Folic acid may be reduced by concurrent use with drugs such as cholestyramine, sulfasalazine, and high-dose non-steroidal anti-inflammatory drugs (NSAIDs). Conversely, Folic acid can affect the plasma concentration and efficacy of antiepileptic drugs like phenytoin and phenobarbital, potentially necessitating dosage adjustment.

It is crucial to inform your doctor or pharmacist about all the medicines you are taking, including other vitamin B complex supplements, to avoid unintentional overdose and potential interactions.

Contraindications

• Hypersensitivity to any of the active substances (Lecithin, Thiamine, Riboflavin, Pyridoxine, Cyanocobalamin, Tocopherol, Nicotinamide, Folic acid) or to any of the excipients listed in the full product composition.
• Patients with known fructose intolerance, as the product may contain sorbitol, which can cause gastrointestinal disturbances in sensitive individuals.
• Individuals with hereditary metabolic disorders affecting B-vitamin utilization, such as vitamin B12-dependent megaloblastic anemia without concurrent cyanocobalamin deficiency, should avoid this product unless under strict medical supervision.
• Use in children under 12 years of age is contraindicated due to the lack of data on safety and efficacy in this population group and the high vitamin dosage relative to their body weight and requirements.

Overdose

Acute overdose with a single dose is unlikely to cause serious harm due to the formulation; however, chronic intake of doses significantly exceeding the recommended daily amount can lead to hypervitaminosis and associated adverse effects.

Prolonged and excessive intake of vitamin B6 (pyridoxine) at doses far above the recommended level may lead to sensory neuropathy, characterized by symptoms such as numbness and tingling in the extremities. Very high doses of vitamin E can potentially increase the risk of bleeding, especially in patients on anticoagulant therapy.

In case of suspected massive overdose, seek medical attention or contact a poison control center immediately. Treatment is generally symptomatic and supportive. There is no specific antidote. Store the product securely to prevent accidental ingestion by children.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.