Doppelherz^® Aktiv L-carnitine + Magnezium (Tablets) Instructions for Use

Marketing Authorization Holder

Queisser Pharma, GmbH & Co. KG (Germany)

Dosage Form

Doppelherz® Aktiv L-carnitine + Magnesium

Tablets

Dosage Form, Packaging, and Product Composition

1 tablet contains L-carnitine 300.0 mg, magnesium oxide – 175 mg.

Form of release
Tablets with a mass of 1175 mg.

Therapeutic Category

Dietary supplement – an additional source of L-carnitine and magnesium

Dosage Regimen

The recommended dosage for adults and children over 12 years of age is 1 tablet once daily.

The tablet should be swallowed whole with a sufficient amount of liquid, preferably during a meal. Do not chew the tablet.

The duration of use is not limited; however, it is recommended to consult a physician for prolonged continuous use exceeding 2-3 months to assess the ongoing need and appropriateness.

It is important to adhere to the recommended daily dose. Exceeding the stated dose does not lead to enhanced beneficial effects and may increase the risk of adverse reactions.

Adverse Reactions

Like all supplements, this product can cause adverse reactions, although not everybody gets them.

Adverse reactions are generally mild and transient. The most commonly reported adverse reactions are related to the gastrointestinal system and may include diarrhea, soft stools, nausea, or abdominal discomfort. These effects are often dose-dependent and may subside with continued use or by taking the tablet with a meal.

In rare cases, allergic skin reactions such as rash or itching may occur. L-carnitine supplementation, particularly at high doses, has been associated with a “fishy” body odor in some individuals, which is a result of metabolite formation.

If you experience any adverse reactions that are severe or persistent, or any reactions not listed here, you should discontinue use and consult your doctor or pharmacist.

Indications

This dietary supplement is intended to be used as an additional source of L-carnitine and magnesium for the following purposes:

• To help reduce feelings of tiredness and fatigue and support normal energy-yielding metabolism.
• To contribute to the normal functioning of the nervous system and psychological function.
• To support muscle function, including the reduction of muscle cramps and weakness, particularly associated with magnesium deficiency.
• To contribute to the maintenance of normal bone health.
• To support metabolic processes, particularly fat metabolism, as L-carnitine plays a crucial role in the transport of fatty acids into the mitochondria for energy production.

The product is intended for use in individuals with an increased need for these nutrients or whose dietary intake is insufficient.

Drug Interactions

Before taking this supplement, inform your healthcare professional about all the medicines you are currently taking, including prescription, over-the-counter, and other herbal products.

Magnesium can interfere with the absorption of several orally administered drugs. It is recommended to maintain a time gap of at least 2-3 hours between taking this supplement and the following medications: tetracycline antibiotics (e.g., doxycycline), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), bisphosphonates (e.g., alendronate), thyroid hormones (e.g., levothyroxine), and iron supplements.

Concomitant use with potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene) or ACE inhibitors may lead to an increased risk of hypermagnesemia (elevated magnesium levels in the blood), especially in patients with renal impairment.

While no specific interactions are widely reported for L-carnitine at this dosage, it may potentially influence the effects of thyroid hormone medication or blood-thinning medications (anticoagulants like warfarin). Monitoring by a physician is advised in such cases.

Contraindications

This product is contraindicated and must not be used under the following conditions:

• Hypersensitivity (allergy) to L-carnitine, magnesium, or any of the excipients listed in the full product composition.
• Patients with severe renal impairment (kidney failure) or end-stage renal disease, due to the risk of magnesium accumulation and toxicity (hypermagnesemia).
• Patients with myasthenia gravis, as high doses of magnesium can worsen muscle weakness associated with this condition.
• Individuals with a known severe bradycardia (very slow heart rate) or atrioventricular block.

The safety of this product for children under 12 years of age has not been established; therefore, its use in this age group is contraindicated.

Pregnant or breastfeeding women should consult their doctor before using this or any other dietary supplement.

Overdose

Exceeding the recommended daily dose can lead to symptoms of overdose, primarily related to magnesium.

Symptoms of magnesium overdose may include severe diarrhea, nausea, vomiting, marked muscle weakness, confusion, extreme drowsiness, a significant drop in blood pressure, and bradycardia (slow heart rate). In severe cases, respiratory depression, cardiac arrest, and coma can occur, especially in individuals with pre-existing kidney problems.

There is no specific antidote for magnesium overdose. Treatment is symptomatic and supportive. In cases of severe overdose, immediate medical attention is required. Medical management may include the administration of calcium gluconate intravenously to antagonize the effects of magnesium, along with measures to support respiration and circulation.

In case of suspected overdose, even in the absence of immediate symptoms, you should contact a poison control center or a healthcare professional without delay.

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.