Doppelherz^® Aktiv Ginkgo biloba + B1 + B2 + B6 (Tablets) Instructions for Use

Marketing Authorization Holder

Queisser Pharma, GmbH & Co. KG (Germany)

Dosage Form

Doppelherz® Aktiv Ginkgo biloba + B1 + B2 + B6

Tablets: 30 pcs.

Dosage Form, Packaging, and Product Composition

Into the composition of tablets enter extract of leaves of Ginkgo biloba, vitamins B1, B2, B6.

Form of release and packaging
30 tablets.

Indications

• This dietary supplement is indicated as an adjuvant to support the functional state of the nervous system in adults.
• It is used to help maintain cognitive functions, including memory and concentration, especially during periods of high mental stress and fatigue.
• The combination of Ginkgo biloba extract and B vitamins contributes to the normal functioning of the nervous system and helps reduce feelings of tiredness and exhaustion.

It is important to understand that this product is a food supplement and not a medicine. It is intended to supplement the diet and should not be used as a substitute for a varied and balanced diet and a healthy lifestyle.

Contraindications

• Hypersensitivity or allergy to any of the components of the drug, including Ginkgo biloba extract, thiamine (vitamin B1), riboflavin (vitamin B2), pyridoxine (vitamin B6), or any of the excipients.
• Hemophilia and other disorders associated with an increased risk of bleeding, as Ginkgo biloba may affect platelet aggregation.
• Concomitant use with anticoagulant or antiplatelet medications (e.g., warfarin, acetylsalicylic acid, clopidogrel) due to a potential increased risk of bleeding, unless explicitly approved and monitored by a physician.
• Epilepsy or a history of seizures, as there are theoretical concerns about Ginkgo biloba potentially lowering the seizure threshold.
• Pregnancy and breastfeeding due to insufficient data on the safety of Ginkgo biloba extract in these populations. The use of vitamin B complex is generally considered safe, but the combination product is contraindicated.
• Children and adolescents under 18 years of age, as safety and efficacy have not been established for this age group.

Patients with pre-existing medical conditions, especially those affecting the cardiovascular or nervous system, should consult a doctor before starting this supplement.

Dosage Regimen

The recommended dosage for adults and adolescents over 12 years of age is one tablet per day.

The tablet should be taken with a sufficient amount of fluid, preferably during a meal to improve tolerance and absorption. It is important not to chew the tablet but to swallow it whole.

The duration of use is not strictly limited; however, continuous use beyond 2-3 months should be discussed with a healthcare professional to assess the ongoing need and benefit. Do not exceed the recommended daily dose, as this will not enhance the beneficial effects and may increase the risk of adverse reactions.

Adverse Reactions

Doppelherz^® Aktiv Ginkgo biloba + B1 + B2 + B6 is generally well tolerated when used at the recommended dosage. However, as with any supplement, adverse reactions can occur, though not everyone gets them.

Gastrointestinal disturbances such as mild stomach upset, nausea, or diarrhea have been rarely reported. These effects are usually transient and can often be mitigated by taking the tablet with food.

Allergic reactions are possible but uncommon. These may manifest as skin rash, itching, or urticaria. In very rare cases, more severe hypersensitivity reactions, including anaphylaxis, could occur.

Due to the Ginkgo biloba component, there is a very rare potential for headache, dizziness, or palpitations. Isolated cases of bleeding (e.g., nosebleeds, easy bruising) have been reported in association with Ginkgo biloba, particularly with long-term use or in susceptible individuals.

The B-vitamin components, particularly vitamin B2 (riboflavin), may cause a harmless bright yellow discoloration of the urine. This is a normal, pharmacologically expected effect and is not a cause for concern.

If any persistent or severe adverse effects occur, discontinue use and consult a physician or pharmacist.

Drug Interactions

Concurrent use of this supplement with other medications requires caution due to potential interactions, primarily attributed to the Ginkgo biloba extract.

Anticoagulants and Antiplatelet Agents (e.g., Warfarin, Acenocoumarol, Aspirin, Clopidogrel, NSAIDs like Ibuprofen): Ginkgo biloba may inhibit platelet aggregation and possesses anticoagulant properties. Concomitant use can potentiate the effects of these drugs, increasing the risk of bleeding and bruising. Close monitoring of bleeding time and clinical signs is essential if co-administration cannot be avoided.

Anticonvulsants (e.g., Phenytoin, Carbamazepine, Valproic Acid): Ginkgo biloba might lower the seizure threshold, potentially reducing the effectiveness of antiepileptic drugs. This combination is generally not recommended.

Antidepressants (SSRIs like Sertraline, Paroxetine, Fluoxetine): There is a potential for a synergistic effect on serotonin levels, which could theoretically increase the risk of serotonin syndrome, a rare but serious condition. Caution is advised.

Antihypertensive Drugs: While some studies suggest Ginkgo may have a mild effect on blood pressure, the interaction is not fully established. Monitoring of blood pressure is prudent when starting or stopping the supplement in hypertensive patients.

Diabetic Medications (Insulin, Oral Hypoglycemics): Ginkgo biloba may alter insulin secretion and metabolism, potentially affecting blood glucose levels. Diabetic patients should monitor their blood sugar levels more closely.

Drugs Metabolized by Cytochrome P450 Enzymes (e.g., Omeprazole, Diazepam, Simvastatin): Some components in Ginkgo biloba may induce or inhibit certain CYP enzymes, potentially altering the plasma concentrations and effects of drugs that are substrates of these enzymes.

Patients taking any prescription or over-the-counter medications should inform their doctor or pharmacist before starting this dietary supplement.

Overdose

Acute overdose with this supplement is unlikely to cause severe, life-threatening symptoms due to its composition. However, significant deviation from the recommended dose increases the risk and severity of adverse reactions.

Symptoms of overdose may include pronounced gastrointestinal discomfort, nausea, vomiting, and diarrhea. Due to the high-dose vitamin B6 component, long-term intake of doses significantly exceeding the recommended daily intake (e.g., hundreds of milligrams per day over months or years) can lead to sensory neuropathy, characterized by numbness, tingling, and altered sensation in the limbs. This risk is minimal with the dosage in this product if used as directed.

In case of suspected overdose, discontinue use immediately. Treatment is primarily symptomatic and supportive. There is no specific antidote. If a large quantity has been ingested, seek medical attention or contact a poison control center. It is important to bring the product packaging to the medical facility for identification.

Therapeutic Category

Dietary supplement for maintenance of function of nervous system

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.