Panangin^® Forte (Tablets) Instructions for Use

Marketing Authorization Holder

Gedeon Richter, Plc. (Hungary)

Contact Information

GEDEON RICHTER JSC (Hungary)

ATC Code

A12CX (Other mineral substances)

Active Substance

Potassium aspartate and magnesium aspartate

Dosage Form

Panangin® Forte

Film-coated tablets, 316 mg+280 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets almost white, oval, biconvex, with a slightly glossy surface, engraved with “A83” on one side, almost odorless; the cross-section is white or almost white.

Excipients: corn starch, talc, magnesium stearate, potato starch, povidone K30, colloidal silicon dioxide.

Film coating composition: talc, butyl methacrylate copolymer, titanium dioxide (color index: C.I. 77891, E171), macrogol 6000.

15 pcs. – blisters (2) – cardboard packs.
15 pcs. – blisters (4) – cardboard packs.
15 pcs. – blisters (6) – cardboard packs.

Clinical-Pharmacological Group

Drug replenishing potassium and magnesium deficiency in the body

Pharmacotherapeutic Group

Mineral supplements; other mineral supplements

Pharmacological Action

The most important intracellular cations, potassium and magnesium, play a key role in the functioning of many enzymes, in the formation of bonds between macromolecules and intracellular structures, and in the mechanism of muscle contractility.

The intra- and extracellular ratio of potassium, magnesium, calcium, and sodium ions affects myocardial contractility.

Endogenous aspartate acts as an ion conductor: it has a high affinity for cells, and due to the slight dissociation of its salts, ions in the form of complex compounds penetrate into the cell.

Potassium and magnesium aspartate improves myocardial metabolism.

A deficiency of potassium and/or magnesium ions predisposes to the development of arterial hypertension, atherosclerosis of the coronary arteries, and the occurrence of metabolic changes in the myocardium.

Pharmacokinetics

Absorption

When taken orally, Potassium aspartate and magnesium aspartate are intensively absorbed from the intestine, mainly in the small intestine.

Excretion

Potassium aspartate and magnesium aspartate are excreted by the kidneys.

Indications

For the elimination of potassium and magnesium deficiency as part of combination therapy:

• In various manifestations of coronary artery disease, including acute myocardial infarction;
• In chronic heart failure;
• In cardiac rhythm disorders (including arrhythmias caused by an overdose of cardiac glycosides).

ICD codes

Dosage Regimen

Consult a doctor before use.

Orally, without chewing and with a sufficient amount of water.

Panangin^® Forte should be taken after meals because the acidic environment of the stomach reduces its effectiveness.

Recommended daily dose: 1 tablet 3 times/day.

Maximum daily dose: 1 tablet 3 times/day.

The duration of treatment and the need for repeated courses are determined by the doctor.

If a dose is missed, a double dose should not be taken to compensate for the missed one, as this increases the risk of overdose. The next dose should be taken according to the recommended dosing regimen.

Adverse Reactions

From the digestive system: nausea, vomiting, diarrhea, discomfort or burning in the epigastric region (in patients with anacid gastritis or cholecystitis) may occur.

From the cardiovascular system: AV block, paradoxical reaction (increase in the number of extrasystoles) may occur.

From the water-electrolyte balance: hyperkalemia (nausea, vomiting, diarrhea, paresthesia), hypermagnesemia (facial flushing, feeling of thirst, decreased blood pressure, hyporeflexia, respiratory depression, convulsions) may occur.

If any of the listed adverse reactions become serious or if any adverse reactions not listed in the instructions occur, the patient should consult a doctor.

Contraindications

• Hypersensitivity to any of the components of the drug;
• Acute and chronic renal failure;
• Hyperkalemia;
• Hypermagnesemia;
• Addison’s disease;
• AV block of I-III degree;
• Shock (including cardiogenic – BP <90 mm Hg);
• Impaired amino acid metabolism;
• Myasthenia gravis;
• Hemolysis;
• Acute metabolic acidosis;
• Dehydration;
• Signs of intoxication (nausea, fever, chills) combined with abdominal pain, anemia, and jaundice of the skin associated with pathological destruction of red blood cells (hemolysis);
• Breastfeeding period;
• Age under 18 years (efficacy and safety have not been established).

With caution: pregnancy (especially the first trimester).

Use in Pregnancy and Lactation

Adequate and strictly controlled studies on the use of the drug during pregnancy and breastfeeding have not been conducted. The use of the drug during pregnancy is possible only as prescribed by the attending physician if the potential benefit to the mother outweighs the possible risk to the fetus. The drug should be used with caution during pregnancy (especially in the first trimester of pregnancy).

Potassium and magnesium aspartate penetrate into breast milk. Do not take the drug during breastfeeding. If it is necessary to use the drug during breastfeeding, breastfeeding should be discontinued.

Use in Renal Impairment

Contraindicated in acute and chronic renal failure.

Pediatric Use

Contraindicated for use under the age of 18 years (efficacy and safety have not been established).

Special Precautions

Special attention is required for patients with diseases accompanied by hyperkalemia: regular monitoring of plasma potassium levels is necessary.

Each tablet of Panangin^® Forte contains 280 mg of magnesium aspartate and 316 mg of potassium aspartate, which is twice the content of active substances in the drug Panangin^®, film-coated tablets. The daily dose of Panangin^® Forte (1 tablet 3 times/day) corresponds to the daily dose of Panangin^® (2 tablets 3 times/day). Taking a single dose of Panangin^® Forte as one tablet makes treatment more convenient for the patient.

Effect on the ability to drive vehicles and mechanisms

Studies have not been conducted. No effect on the ability to drive vehicles and operate machinery requiring increased concentration and speed of psychomotor reactions is expected.

Overdose

Overdose increases the risk of developing hyperkalemia and hypermagnesemia.

Symptoms of hyperkalemia: increased fatigue, myasthenia, paresthesia, confusion, cardiac rhythm disturbances (bradycardia, AV block, arrhythmias, cardiac arrest).

Symptoms of hypermagnesemia: decreased neuromuscular excitability, nausea, vomiting, lethargy, decreased blood pressure. With a sharp increase in the concentration of magnesium ions in the blood – inhibition of tendon reflexes, respiratory paralysis, coma.

Treatment: symptomatic therapy (intravenous administration of calcium chloride at a dose of 100 mg/min of solution), if necessary – hemodialysis.

Drug Interactions

With simultaneous use with potassium-sparing diuretics (triamterene, spironolactone), beta-blockers, cyclosporine, heparin, ACE inhibitors, NSAIDs, the risk of developing hyperkalemia increases up to the appearance of arrhythmia and asystole.

The use of potassium preparations together with corticosteroids eliminates the hypokalemia caused by them.

Under the influence of potassium, a reduction in the undesirable effects of cardiac glycosides is observed.

Panangin^® Forte enhances the negative dromotropic and bathmotropic effects of antiarrhythmic drugs.

Magnesium preparations reduce the effectiveness of neomycin, polymyxin B, tetracycline, and streptomycin.

Anesthetics enhance the inhibitory effect of magnesium preparations on the central nervous system.

With simultaneous use with atracurium, dexamethonium, succinylcholine, and suxamethonium, an increase in neuromuscular blockade is possible.

Calcitriol increases the concentration of magnesium in blood plasma; calcium preparations reduce the effect of magnesium preparations.

Pharmacokinetic interaction

Medicinal products with astringent and enveloping action reduce the absorption of potassium and magnesium aspartate from the gastrointestinal tract, so it is necessary to observe a 3-hour interval between the oral administration of Panangin^® Forte and the aforementioned medicinal products.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is available without a prescription.

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.