Doppelherz^® Aktiv Vitamins for the Eyes with Lutein (Capsules) Instructions for Use

Marketing Authorization Holder

Queisser Pharma, GmbH & Co. KG (Germany)

Dosage Form

Doppelherz® Aktiv Vitamins for the Eyes with Lutein

Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Composition: vitamin A (retinol) – 800 mcg, vitamin C (ascorbic acid) – 250 mg, vitamin E (tocopherol) – 36 mg, lutein – 6 mg, zeaxanthin – 300 mcg, zinc (gluconate) – 2.5 mg.

Release form and packaging
30 capsules.

Therapeutic Category

Dietary supplement for maintaining the function of the organ of vision

Indications

• This dietary supplement is indicated to support the health and function of the eyes and to help maintain visual acuity.
• It is used as an additional source of lutein, zeaxanthin, vitamins A, C, E, and zinc, which contribute to the protection of retinal cells from oxidative stress and help maintain normal vision.
• It is recommended for individuals whose eyes are subjected to increased strain, for example, from prolonged work at a computer, reading, or exposure to bright light.
• It may be beneficial for supporting eye health as part of a balanced diet and a healthy lifestyle.

Contraindications

• Hypersensitivity or individual intolerance to any of the components of the dietary supplement.
• Pregnancy and breastfeeding – use is not recommended due to the high content of vitamin A, which can have teratogenic effects in high doses.
• Patients with severe kidney or liver disease should consult a physician before use.
• This product is not intended for use by children or adolescents under 18 years of age.

Dosage Regimen

The recommended dosage for adults and children over 12 years of age is one capsule per day, taken with a sufficient amount of fluid, preferably with a meal.

The capsule should be swallowed whole and not chewed. Do not exceed the recommended daily dose. The duration of use is not limited, but it is advisable to consult a doctor for long-term continuous use.

For optimal absorption, it is recommended to take the capsule with a meal that contains a small amount of fat, as some components (such as vitamin A and lutein) are fat-soluble.

Adverse Reactions

When used at the recommended dosage, adverse reactions are very rare. In isolated cases, hypersensitivity reactions, such as skin rash, itching, or redness, may occur.

Due to the content of vitamin A, exceeding the recommended dose may lead to symptoms of hypervitaminosis A, which include headache, dizziness, nausea, vomiting, and skin peeling. Long-term intake of high doses of vitamin A can lead to more serious health issues, including liver damage.

High doses of vitamin C (ascorbic acid) may cause gastrointestinal discomfort, such as diarrhea or abdominal cramps. If any undesirable effects occur, discontinue use and consult a physician.

Drug Interactions

The components of this dietary supplement may interact with certain medications. Vitamin A may enhance the toxic effects of retinoids used in dermatology (e.g., isotretinoin, acitretin), therefore concomitant use is not recommended.

Vitamin C may affect the excretion of certain drugs by acidifying the urine and should be used with caution in patients taking salicylates, certain anticoagulants, or drugs whose efficacy is pH-dependent. High doses of vitamin E may potentially enhance the effect of anticoagulant drugs (e.g., warfarin) and increase the risk of bleeding.

Zinc can reduce the absorption of certain antibiotics (e.g., tetracyclines, fluoroquinolones) and bisphosphonates. To avoid this interaction, it is recommended to take the dietary supplement at least 2 hours before or 4-6 hours after taking these medications. Always inform your doctor about all the dietary supplements and medications you are taking.

Overdose

In case of accidental intake of a significantly higher dose than recommended, seek medical attention immediately. Symptoms of acute overdose are primarily related to the vitamin A content and may include severe headache, dizziness, blurred vision, nausea, vomiting, and drowsiness.

Chronic overdose resulting from long-term intake of doses exceeding the recommendation can lead to the development of hypervitaminosis A, characterized by dry skin, hair loss, joint pain, liver damage, and increased intracranial pressure. Treatment is symptomatic and supportive; specific antidotes are not available. Gastric lavage may be considered if the overdose is recent.

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.