Selamerex, 800 mg 180 pcs

A drug for the treatment of hyperphosphatemia, a polymer of allylamine carbonate, not absorbed from the gastrointestinal tract. By binding phosphates in the digestive tract, it reduces their concentration in blood serum.

The drug does not contain Ca²⁺ and therefore does not cause the hypercalcemia seen with other phosphate withdrawal medications that contain Ca²⁺.

The effect on blood phosphorus concentrations is maintained when the drug is taken for 1 year.

Indications

hyperphosphatemia in chronic renal failure in patients on hemodialysis or peritoneal dialysis – as part of complex therapy, including Ca2+ preparations, colecalciferol or its analogues;

hyperphosphatemia in adults on hemodialysis.

Selamerex® should be used as part of a combination therapy aimed at preventing bone damage due to kidney disease, which includes calcium supplements, 1.25-hydroxyvitamin D3, or one of its analogues.

Pharmacological effect

A drug for the treatment of hyperphosphatemia, a polymer of allylamine carbonate, not absorbed from the gastrointestinal tract. By binding phosphates in the digestive tract, it reduces their concentration in the blood serum.

The drug does not contain Ca2+ and therefore does not cause hypercalcemia, observed with the use of other drugs that remove phosphates, which contain Ca2+.

The effect on the concentration of phosphorus in the blood persists when taking the drug for 1 year.

Special instructions

If the patient forgets to take one dose of the drug, it should be skipped. The next dose is taken at the usual time with meals. Do not take a double dose or try to make up for a missed dose.

When using the drug Selamerex®, a deficiency of vitamins A, D, E, K, and folic acid in the blood may occur. Therefore, additional administration of these vitamins may be required.

If the patient is taking medications to treat arrhythmia or epilepsy, it is necessary to consult a doctor about taking Selamerex®.

Impact on the ability to drive vehicles and operate machinery

There was no effect on the ability to drive vehicles and other mechanisms that require increased concentration.

Active ingredient

Sevelamer

Composition

1 film-coated tablet contains sevelamer carbonate as the active substance, calculated as dry matter 800 mg.

Excipients:

lactose monohydrate – 286.25 mg,

colloidal silicon dioxide – 5.50 mg,

zinc stearate – 8.25 mg.

Shell composition:

macrogol and polyvinyl alcohol copolymer – 19.80 mg, talc – 13.20 mg.

Pregnancy

The safety of sevelamer has not been established in pregnant women. There was no evidence in animal studies that sevelamer caused embryotoxicity. Selamerex® should be prescribed to pregnant women only if there is a clear need and after a careful risk-benefit analysis for the mother and fetus.

The safety of sevelamer has not been established for nursing mothers. Selamerex® should be prescribed to breastfeeding women only if there is a clear need and after a careful risk-benefit analysis for mother and child.

Contraindications

hypophosphatemia;
intestinal obstruction;
hypersensitivity to sevelamer or to the excipients of the drug;
children under 18 years of age (the safety and effectiveness of the drug in children under 18 years of age have not been studied).

With caution:

Inflammatory diseases of the gastrointestinal tract, impaired motility of the gastrointestinal tract (including constipation), surgical operations on the gastrointestinal tract (history), dysphagia, difficulty swallowing, simultaneous use with antiarrhythmic and antiepileptic drugs, pregnancy, breastfeeding.

Side Effects

The frequency of side effects noted when taking sevelamer is given in accordance with the WHO classification: very often (>1/10), often (>1/100 and <1/10).

From the digestive system: very often – nausea, vomiting, abdominal pain, constipation, diarrhea, dyspepsia; often – flatulence.

From the side of the central nervous system: very often – headache.

From the cardiovascular system: very often – increased or decreased blood pressure.

From the skin: very often – itching; often – rash.

Other: very often – pain of various localizations; often – pharyngitis.

Intestinal obstruction has been very rarely observed in clinical practice.

Side effects occur more often in patients with end-stage chronic renal failure.

Interaction

Reduces the bioavailability of ciprofloxacin by 50%. Medicines for which decreased bioavailability may be clinically significant should be taken 1 hour before or 3 hours after taking CELAMEREX®.

The effect of cyclosporine, mycophenolate mofetil and tacrolimus may be reduced when taking CELAMEREX®.

Thyroid hormone deficiency may rarely develop in some people taking CELAMEREX® with levothyroxine.

Overdose

No cases of overdose in patients have been reported.

Storage conditions

In a dry place, at a temperature not exceeding 25 °C.

Shelf life

2 years.

Manufacturer

Polpharma JSC, Poland