This tablet is indicated for the treatment of hyperphosphatemia associated with chronic renal insufficiency in patients undergoing dialysis (hemodialysis or peritoneal dialysis). It is intended for use in adult patients.

Each film-coated tablet contains:

• Calcium acetate 435 mg, equivalent to 110 mg elemental calcium
• Magnesium carbonate (heavy) 235 mg, equivalent to 60 mg elemental magnesium

Calcium acetate and magnesium carbonate act as phosphate-binding agents. They combine with dietary phosphate in the gastrointestinal tract to form poorly soluble calcium and magnesium phosphate complexes, which are then eliminated through feces. Calcium acetate exhibits optimal phosphate-binding activity at a pH of 6–8. Therefore, this formulation is also effective for phosphate binding in patients with reduced or absent gastric acidity.

Adults: 3 to 10 film-coated tablets per day, depending on the serum phosphate level. The daily dose should be subdivided according to the number of meals per the day (usually 3 a day). The recommended starting dose is 3 tablets daily. If necessary, the dosage may be raised to maximally 12 film-coated tablets per day.

Pediatric population: The safety and efficacy of this tablet in children and adolescence have not been established. Therefore, the administration of this tablet is not recommended in children and adolescents below 18 years of age.

Method of administration: To achieve the maximum phosphate binding effect, this tablet must be taken together with the meal and should not be crushed or chewed. For easy swallowing, the tablets should be taken together with some liquid. In case the tablets are too large to be swallowed by the patient, the tablets should be broken along the score line immediately before swallowing in order to avoid the development of taste of acetic acid. Because the rate and/or extent of absorption of other defined medicinal products may vary when used concomitantly with this tablet, none of the oral medicinal products should be taken within the period 2 hours before and 3 hours after administration of this tablet. This can be applied long-term.

To minimize potential drug interactions, this tablet should be taken at least 2 hours before or 3 hours after other oral medications. It may interfere with the absorption of tetracyclines, doxycycline, norfloxacin, certain cephalosporins (such as cefpodoxime and cefuroxime), quinolones (e.g., ciprofloxacin), bisphosphonates, fluorides, ketoconazole, estramustine, anticholinergics, iron supplements, digoxin, nitrofurantoin, and levothyroxine. Vitamin D and its derivatives, thiazide diuretics, and estrogens may influence calcium absorption. Elevated serum calcium levels can increase sensitivity to cardiac glycosides and raise the risk of arrhythmias. Administration of adrenaline in patients with high calcium levels may lead to severe arrhythmias. The effectiveness of calcium antagonists may also be reduced.

This product is contraindicated in patients with:

• Hypophosphatemia
• Hypercalcemia (with or without symptoms), including cases due to vitamin D overdose, paraneoplastic syndromes (such as bronchial carcinoma, breast cancer, renal cell carcinoma, plasmacytoma), bone metastases, sarcoidosis, or immobilization-induced osteoporosis
• Elevated serum magnesium levels (>2 mmol/L) and/or symptoms of hypermagnesemia
• AV block (grade III)
• Myasthenia gravis
• Hypersensitivity to the active ingredients or any excipients

Gastrointestinal disorders: Common: Soft stools, gastrointestinal irritation such as nausea, loss of appetite, fullness, belching, constipation, and diarrhea.

Metabolism and nutrition disorders: Common: Hypercalcemia (symptomatic or asymptomatic), asymptomatic hypermagnesemia. Uncommon: Moderate to severe symptomatic hypercalcemia, symptomatic hypermagnesemia. Very rare: Hyperkalemia and magnesium-related disturbances in bone mineralization.

Pregnancy: Limited data are available regarding the use of this tablet in pregnant women. Animal studies are insufficient to assess reproductive toxicity. This medication should only be used during pregnancy if clearly necessary and justified by clinical need.

Lactation: This medication is excreted into breast milk in amounts that may affect the breastfed infant. Therefore, breastfeeding is not recommended during treatment.

This tablet should be used with caution and only under continuous monitoring of serum calcium, magnesium, and phosphate in cases of severe hyperphosphatemia with a calcium-phosphate product exceeding 5.3 mmol/L, especially when:

• The condition is refractory to therapy
• Refractory hypercalcemia is present
• Clinically relevant bradycardia or AV block (grade II) with bradycardia occurs

Continuous monitoring of serum phosphate, magnesium, calcium, and calcium-phosphate product is required, particularly when used together with vitamin D preparations and thiazide diuretics. High doses or long-term use may lead to hypermagnesemia, which is usually asymptomatic but can sometimes cause systemic effects. Caution is advised when used with antacids and digitalis glycosides.

In patients with chronic renal insufficiency, hypercalcemic episodes may occur, especially when combined with vitamin D metabolites. Monitoring for vascular and soft tissue calcification is necessary. The risk can be reduced by maintaining the calcium-phosphate product below 4.5 mmol/L. Increased calcium intake may lead to the formation of calcium soaps with fatty and bile acids, potentially causing constipation. In case of diarrhea, the dose should be reduced.

Acute hypermagnesemia, whether asymptomatic or associated with systemic toxicity, can suppress both central and peripheral nervous system activity by inhibiting acetylcholine release. Systemic toxicity is generally expected when serum magnesium levels reach 2.5 mmol/L, while severe neurotoxic effects may occur at levels of 3 mmol/L or higher. At concentrations between 2.5–5.0 mmol/L, symptoms may include gastrointestinal disturbances (such as nausea, loss of appetite, constipation), bladder spasm, muscle weakness, lethargy, diminished deep tendon reflexes, and abnormalities in AV conduction and ventricular stimulation.

When serum magnesium levels rise to 5–10 mmol/L, patients may develop arterial hypotension due to vasodilation, paralytic ileus, flaccid paralysis, and coma. Levels exceeding 10 mmol/L may result in respiratory arrest and cardiac arrest.

Early signs of hypercalcemia include muscle weakness and gastrointestinal symptoms such as abdominal pain, constipation, nausea, and vomiting. Severe hypercalcemia may present with altered consciousness, including lethargy, disorientation, stupor, and coma. When serum calcium exceeds 3.5 mmol/L, a hypercalcemic crisis may occur, presenting with:

• Polyuria and polydipsia
• Nausea, anorexia, constipation, and rarely pancreatitis
• Cardiac arrhythmias, shortened QT interval, weakness, and hypertension
• Progressive muscle weakness leading to pseudo-paralysis
• Psychiatric disturbances, drowsiness, and coma

Prolonged excessive intake may lead to adynamic bone disease.

Emergency management: In addition to symptomatic treatment, hypermagnesemia should be managed by reducing magnesium levels in the dialysate and decreasing the dose of this medication. During treatment of hypercalcemia, the use of calcium-free dialysate and close monitoring of serum calcium levels are essential to prevent hypocalcemia and cardiovascular complications.

Specific mineral preparations

Store below 30°C in a dry place, protected from light and moisture. Keep out of the reach of children.