Panangin

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANANGIN (PANANGIN) Composition of the medicinal product:

Active substances: magnesium aspartate, potassium aspartate;
1 film-coated tablet contains:
140 mg magnesium aspartate (as 175 mg magnesium aspartate tetrahydrate), equivalent to 11.8 mg Mg²⁺;
158 mg potassium aspartate (as 166.3 mg potassium aspartate hemihydrate), equivalent to 36.2 mg K⁺.
Excipients: colloidal anhydrous silicon dioxide; potato starch; povidone; magnesium stearate; talc; corn starch; macrogol 6000; titanium dioxide, E 171; methacrylate copolymer base (Eudragit E 100).

Medicinal form.
Film-coated tablets.

Main physicochemical properties:
Round, biconvex, film-coated tablets, almost white in color, with a slightly shiny and slightly uneven surface, almost odorless.

Pharmacotherapeutic group.
Mineral substances.
Other mineral preparations.
ATC code: A12CX.

Pharmacological properties.
Pharmacodynamics.
Potassium and magnesium ions, as important intracellular cations, are involved in the function of various enzymes, in the binding of macromolecules to subcellular elements, and in the mechanism of muscle contraction at the molecular level. The ratio of extracellular and intracellular concentrations of potassium, calcium, sodium, and magnesium ions affects the contractile ability of the myocardium. Aspartate, an endogenous substance, acts as a carrier of potassium and magnesium ions and has a pronounced affinity for cells; its salts undergo only slight dissociation. As a result, the ions penetrate into the intracellular space in the form of complex compounds. Magnesium aspartate and sodium aspartate improve myocardial metabolism.
Deficiency of potassium and magnesium in the body increases the risk of developing arterial hypertension, atherosclerotic lesions of coronary vessels, cardiac arrhythmias, and myocardial pathology.

Pharmacokinetics.
Magnesium
The total body store of magnesium in a 70 kg human is on average 24 g (1000 mmol); more than 60% of magnesium is located in bone tissue and about 40% in skeletal muscles and other tissues. Approximately 1% of the total body magnesium is found in extracellular fluid, predominantly in blood serum. In healthy adults, serum magnesium concentration ranges between 0.7–1.10 mmol/L. The recommended daily dietary intake of magnesium is 350 mg for men and 280 mg for women. Magnesium requirements increase during pregnancy and breastfeeding. Magnesium is absorbed from the gastrointestinal tract via active transport. The kidneys are the main regulators of magnesium balance in the body. 3–5% of ionized magnesium is excreted by the kidneys. An increase in urine volume (e.g., during therapy with high-efficacy loop diuretics) leads to increased excretion of ionized magnesium. If magnesium absorption in the small intestine is reduced, subsequent hypomagnesemia leads to decreased excretion (< 0.5 mmol/day).

Potassium
The total body store of potassium in a 70 kg human is on average 140 g (3570 mmol). Total potassium stores are slightly lower in women than in men and decrease slightly with age. 2% of total body potassium is located extracellularly, while the remaining 98% is intracellular. The optimal daily dietary intake of potassium is 3–4 g (75–100 mmol). The main route of potassium excretion is renal (approximately 90% of potassium is excreted daily by the kidneys). The remaining 10% is excreted via the gastrointestinal tract. Thus, the kidneys are responsible for long-term potassium homeostasis and for maintaining serum potassium levels. In the short term, blood potassium levels are also regulated by potassium exchange between intracellular and extracellular compartments.

Clinical characteristics.
Indications.
Adjunctive therapy in chronic heart diseases (in heart failure, post-infarction period), cardiac arrhythmias, particularly ventricular arrhythmias, as recommended by a physician.
Adjunctive therapy during treatment with cardiac glycosides, as recommended by a physician.
As a dietary supplement to increase magnesium and potassium levels in the body.

Contraindications.
Hypersensitivity to the active substances or to any of the excipients of the medicinal product.
Acute and chronic renal failure, Addison’s disease, third-degree atrioventricular block, cardiogenic shock (arterial pressure < 90 mm Hg).

Interaction with other medicinal products and other types of interactions.
Oral tetracyclines, iron salts, and sodium fluoride inhibit the absorption of the medicinal product from the gastrointestinal tract. When used concomitantly with the above-mentioned medicinal products, an interval of at least 3 hours between administrations is required.
Concomitant use of the medicinal product with potassium-sparing diuretics and/or angiotensin-converting enzyme inhibitors, beta-blockers, cyclosporine, heparin, nonsteroidal anti-inflammatory drugs increases the risk of developing hyperkalemia.

Special precautions for use.
Panangin, as a preparation containing potassium and magnesium, should be used with caution in patients with myasthenia gravis and in conditions that may lead to hyperkalemia, such as impaired renal function, acute dehydration, widespread tissue damage, particularly severe burns. In these patients, serum electrolyte concentrations should be monitored regularly.
Panangin film-coated tablets should not be prescribed to patients with gastroduodenal ulcers or obstruction.

Use during pregnancy or breastfeeding.
To date, no harmful effects have been reported with the use of the medicinal product in these patient groups.

Effect on ability to drive or operate machinery.
The medicinal product does not affect the ability to drive or operate machinery.

Method of administration and dosage.
The usual daily dose for adults is 1–2 tablets three times a day. The dose may be increased to 3 tablets three times a day. Gastric juice may reduce the effectiveness of the medicinal product; therefore, it is recommended to take the tablets after meals. The duration of treatment is determined by the physician.

Children.
Use in children is not recommended due to insufficient experience with the medicinal product.

Overdose.
Cases of overdose are unknown. Given the kidneys’ ability to excrete large amounts of potassium, increased dosage of the medicinal product may lead to hyperkalemia only if associated with acute or pronounced impairment of potassium excretion. The therapeutic index of magnesium is wide, and in the absence of renal insufficiency, severe adverse effects are extremely rare. According to scientific data, oral administration of magnesium preparations may cause minor adverse effects such as diarrhea. High doses of Panangin film-coated tablets may increase defecation frequency due to magnesium content. Rapid intravenous administration may result in symptoms of hyperkalemia/hypermagnesemia.

Symptoms of hyperkalemia: general weakness, paresthesia, bradycardia, paralysis. Extremely high plasma potassium concentration may lead to death due to cardiac depression, arrhythmia, or cardiac arrest.

Symptoms of hypermagnesemia: nausea, vomiting, drowsiness, hypotension, bradycardia, weakness, slurred speech, diplopia. At very high plasma magnesium concentrations, hyporeflexia, muscle paralysis, respiratory arrest, and cardiac arrest may develop.

In case of overdose, K⁺-, Mg²⁺-aspartate should be discontinued, and symptomatic treatment is recommended (e.g., intravenous calcium chloride 100 mg/min, dialysis if necessary).

Adverse reactions.
Gastrointestinal tract: increased defecation frequency may occur when high doses of the medicinal product are used. According to some data, nausea, vomiting, and abdominal pain may also occur.

Shelf life.
5 years.

Storage conditions.
Store at a temperature not exceeding 25 °C. Keep the medicinal product out of the reach of children.

Packaging.
50 tablets in a polypropylene bottle with a tamper-evident seal, 1 bottle per cardboard box; or 20 tablets in a blister pack; 3 (20×3) or 5 (20×5) blisters per cardboard box.

Prescription status.
Over-the-counter.

Manufacturer.
JSC "Gedeon Richter".

Address of manufacturer and location of manufacturing site.
H-1103 Budapest, Demréni Street 19-21, Hungary.