Doppelherz^® Aktiv Magnesium + Calcium (Tablets) Instructions for Use

Marketing Authorization Holder

Queisser Pharma, GmbH & Co. KG (Germany)

Dosage Form

Doppelherz® Aktiv Magnesium + Calcium

Coated tablets: 30 pcs.

Dosage Form, Packaging, and Product Composition

Composition

Release form and packaging
30 coated tablets.

Therapeutic Category

Dietary supplement – additional source of magnesium and calcium

Indications

• For the compensation of magnesium and calcium deficiency in the body, which can be caused by an unbalanced diet, increased physical and mental stress, or other factors leading to insufficient intake of these essential minerals.
• As a supportive measure to maintain normal muscle function, including reducing the frequency and intensity of muscle cramps and spasms, particularly in individuals with an identified increased need for magnesium.
• To contribute to the maintenance of normal bone health and density, as calcium is a key structural component of bones and teeth, and magnesium plays a crucial role in bone metabolism.
• For supporting the normal functioning of the nervous system, as both minerals are involved in the transmission of nerve impulses and can help in managing states of fatigue and exhaustion.
• To aid in electrolyte balance and contribute to normal energy-yielding metabolism, making it suitable for athletes and physically active individuals.

Contraindications

• Hypersensitivity to any of the components of the dietary supplement. Patients with a known allergy to magnesium salts, calcium carbonate, or any excipient present in the coated tablet formulation should avoid using this product.
• Severe renal impairment or kidney failure (e.g., chronic kidney disease stage 4-5), as the ability to excrete minerals is compromised, which can lead to dangerous accumulation of magnesium and calcium in the blood (hypermagnesemia, hypercalcemia).
• Conditions associated with hypercalcemia (elevated blood calcium levels) or a predisposition to its development, such as hyperparathyroidism, sarcoidosis, certain malignancies (e.g., bone metastases), and vitamin D overdose.
• Patients with severe hypermagnesemia or conditions that predispose to it, including myasthenia gravis and other neuromuscular disorders where elevated magnesium levels could exacerbate symptoms.
• Concomitant use with certain prescription medications without medical supervision, specifically with certain types of antibiotics (e.g., tetracyclines, quinolones), bisphosphonates, levothyroxine, or cardiac glycosides (e.g., digoxin), due to potential significant interactions that may reduce the efficacy of both the supplement and the medication.
• Patients with phenylketonuria (PKU), if the product contains aspartame as a sweetener, although this specific formulation typically does not; it is essential to check the full ingredient list provided on the packaging.

Dosage Regimen

The recommended dosage for adults and children over 12 years is one coated tablet daily. The tablet should be taken with a sufficient amount of fluid (e.g., a full glass of water), preferably with a meal to enhance tolerance and absorption.

It is crucial not to exceed the recommended daily dose. The duration of continuous use should not exceed 2-3 months without consulting a physician or pharmacist for re-evaluation of the need for continued supplementation. For long-term use, medical supervision is advised to monitor mineral levels and adjust intake as necessary.

For children under 12 years of age, the use of this supplement is not recommended due to the lack of sufficient data on safety and efficacy in this population group. The dosage is specifically formulated for adult requirements.

If you miss a dose, take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten tablet.

Adverse Reactions

Like all supplements, Doppelherz Aktiv Magnesium + Calcium can cause adverse reactions, although not everybody gets them. The most commonly reported adverse effects are related to the gastrointestinal tract.

Gastrointestinal disturbances are the most frequent and may include mild diarrhea, loose stools, abdominal cramping, bloating, or flatulence. These symptoms are typically dose-dependent and often subside as the body adjusts to the supplement. Taking the tablet with food can help minimize these effects.

In rare cases, allergic reactions may occur. Signs of an allergic reaction can include skin rash, itching, urticaria (hives), swelling of the face, lips, tongue, or throat, and difficulty breathing. If any signs of an allergic reaction appear, discontinue use immediately and seek medical attention.

Very high doses significantly exceeding the recommended intake can lead to electrolyte imbalances. Symptoms of hypermagnesemia (excess magnesium) may include profound muscle weakness, severe nausea and vomiting, extreme drowsiness, confusion, and a significant drop in blood pressure and heart rate. Symptoms of hypercalcemia (excess calcium) can include constipation, nausea, vomiting, abdominal pain, bone pain, muscle weakness, increased thirst and urination, and in severe cases, kidney stones and cardiac arrhythmias.

If you experience any adverse effect that is severe, persistent, or concerns you, you should stop taking the supplement and consult a healthcare professional for advice.

Drug Interactions

Calcium and magnesium can bind to certain medications in the gastrointestinal tract, forming insoluble complexes that are not absorbed. This can significantly reduce the absorption and effectiveness of the affected drugs. To minimize this interaction, a time gap of at least 2-3 hours, and preferably 4 hours, should be maintained between taking Doppelherz Aktiv Magnesium + Calcium and the following medications: Tetracycline and Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, doxycycline), Bisphosphonates (e.g., alendronate, ibandronate, used for osteoporosis), and Thyroid hormones (e.g., levothyroxine).

Calcium supplements can potentiate the effects of certain classes of drugs. Concomitant use with cardiac glycosides (e.g., digoxin) may increase the risk of cardiac arrhythmias, requiring close monitoring of the patient’s clinical status and possibly more frequent electrocardiogram (ECG) checks. When used with thiazide diuretics (e.g., hydrochlorothiazide), which reduce calcium excretion by the kidneys, there is an increased risk of developing hypercalcemia.

Magnesium can have an additive effect with other agents that affect neuromuscular transmission. Caution is advised when taking this supplement concurrently with muscle relaxants or certain medications for myasthenia gravis, as the effects may be enhanced. High doses of magnesium may also reduce the absorption and activity of oral iron supplements and zinc. It is imperative to inform your doctor and pharmacist about all the products you are using, including prescription, over-the-counter medicines, and other dietary supplements, to prevent potential interactions.

Overdose

In the event of an accidental overdose, where a significantly larger number of tablets than the recommended daily dose has been ingested, seek immediate medical attention or contact a Poison Control Center without delay. Do not induce vomiting unless instructed to do so by a healthcare professional.

Symptoms of an acute overdose are primarily related to the effects of excessive magnesium and calcium. For magnesium, this can lead to hypermagnesemia, characterized by nausea, vomiting, severe hypotension (low blood pressure), facial flushing, urine retention, ileus (loss of bowel function), muscle weakness, lethargy, confusion, and in severe cases, respiratory depression, coma, and cardiac arrest. For calcium, hypercalcemia may manifest as anorexia, nausea, vomiting, constipation, abdominal pain, polyuria (excessive urination), polydipsia (excessive thirst), mental status changes, renal impairment, and cardiac arrhythmias.

There is no specific antidote. Treatment is supportive and symptomatic and may include gastric lavage if ingestion is recent, administration of intravenous fluids to promote renal excretion, and in severe cases of hypercalcemia, the use of loop diuretics (e.g., furosemide) and calcitonin under strict hospital supervision. For life-threatening hypermagnesemia, intravenous administration of calcium gluconate can be used as an antagonist.

To prevent overdose, always store the product in its original container, out of sight and reach of children, and adhere strictly to the recommended dosage.

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.