• 500 mg calcium carbonate

• hypromellose
• crospovidone
• Silica, colloidal
• cellulose, microcrystalline
• Povidone K30
• Magnesium stearate (vegetable)
• lactose-1 water
• Macrogol 6000
• Polyoxyethylene (8) monostearate
• titanium dioxide
• talc

indication

• The drug is a phosphate binder.
• Field of use:
  • Elevated serum phosphate (hyperphosphataemia) in chronic renal failure, particularly in patients on dialysis.

dosage

• Always take the medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• The dosage depends on the height of the serum phosphate level.
• The recommended dose is:
  • Adult
    • The dosage is always in consultation with the doctor treating you. When determining the individual and daily doses, the phosphate content and the number of meals must be taken into account.
    • The dose range is 1-3 tablets 3 times a day, for example 1 tablet with breakfast, 3 tablets with lunch and 2 tablets with dinner. The maximum dose of 7 tablets (equivalent to 1400 mg calcium) should not be exceeded.
  • Children and adolescents (under 18 years)
    • There are no data on use in children and adolescents under 18 years of age. Therefore, its use cannot be recommended for these patients.

• Duration of use:
  • Therapy with the preparation for phosphate binding in patients with chronic kidney failure is a long-term therapy and requires regular medical monitoring.
  • Please talk to your doctor or pharmacist if you have the impression that the effect of the preparation is too strong or too weak.

• If you take more of the medicine than you should:
  • Calcium overdose can lead to high levels of calcium in the blood (hypercalcaemia). Please contact your doctor if you accidentally take too many tablets. Symptoms of overdose may include but are not limited to muscle weakness, abdominal pain, constipation, nausea, vomiting, excessive thirst, abnormal heart rhythm, and loss of consciousness.

• If you forget to take the medicine:
  • Do not take a double dose if you have forgotten the previous one, in this case continue with the prescribed dose.
  • Under no circumstances should it be taken after a meal.

• If you stop taking the medicine:
  • Do not interrupt or stop taking it without consulting your doctor.

• If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

way

• The film-coated tablets should be swallowed whole, possibly with some liquid, immediately before or with meals.

side effects

• Like all medicines, this can cause side effects, although not everyone gets them.
• Possible side effects:
  • Not known (cannot be estimated from the available data)
    • Feeling of fullness as gaseous carbonic acid (carbon dioxide) is released by the stomach acid
    • Reduced absorption of phosphate due to the formation of poorly soluble salts
  • With renal insufficiency and long-term use:
    • Not known (cannot be estimated from the available data)
      • increase in calcium levels in the blood (hypercalcaemia)
      • Increased excretion of calcium in the urine (hypercalciuria)
      • Hypoacidity of the blood (metabolic alkalosis)
      • Soft tissue and vascular calcifications
  • If the calcium levels in the blood are elevated, the dose must be reduced. In the case of dialysis patients, the calcium content of the dialysis fluid can also be temporarily reduced.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

interactions

• Taking the medicine with other medicines:
  • Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
  • Vitamin D increases the effect of the preparation (increase in absorption). Serum calcium and serum phosphate must be monitored regularly, particularly during concomitant therapy with vitamin D and vitamin D derivatives. In hemodialysis patients, the calcium content of the dialysate may need to be reduced.
  • Certain water tablets (thiacid-type diuretics) decrease calcium excretion. If this preparation is taken at the same time as such medicinal products, the blood calcium level should therefore be monitored.
  • If the intake raises blood calcium levels, it increases sensitivity to certain medicines that increase the strength of the heart (cardiac glycosides) and increases the risk of cardiac arrhythmias. The preparation reduces the absorption and thus the effectiveness of numerous drugs. This applies to certain antibiotics (e.g. tetracycline, ciprofloxacin, norfloxacin, cefpodoxime axetil, cefuroxime axetil), the antifungal agent ketoconazole, iron, fluoride and estramustine.
  • There should therefore be a gap of at least 2 hours between taking the medicine and taking these preparations.
  • The effectiveness of the heart drug quinidine is influenced by the preparation in an unpredictable way.
• Taking with food and drink:
  • Please note that dairy products have a high calcium content, which increases the effect of the preparation. A liter of milk contains 1200 mg of calcium.

Contraindications

• The medicine must not be taken
  • if you are allergic to calcium carbonate or any of the other ingredients of this medicine.
  • if the calcium concentration in the blood is too high (hypercalcaemia).
    • An increase in the calcium concentration occurs regularly with an overactive parathyroid gland (hyperparathyroidism). It can also be present with vitamin D overdose; certain tumors such as lung cancer (bronchial carcinoma), breast cancer (mammary carcinoma), kidney cancer (hypernephroma), certain forms of blood cancer (plasmocytoma) and in bone metastases, certain lung diseases (sarcoidosis, Boeck's disease); Immobilization of limbs (immobilisation osteoporosis).
  • with reduced serum phosphate (hypophosphataemia).
  • with calcium-containing kidney stones.
  • in the absence of free hydrochloric acid in the gastric juice.

pregnancy and breast feeding period

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking/using this medicine.
• Reports of adverse effects of calcium during pregnancy and lactation in humans have not become known. During pregnancy, serum calcium levels must be carefully monitored because prolonged hypercalcaemia can lead to physical malformations and mental retardation in the child.

patient notes

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before taking this medicine.
  • Special care is required when taking the drug:
    • with impaired kidney function, kidney stones and kidney calcification (nephrocalcinosis).
    • with increased excretion of calcium in the urine (hypercalciuria).
    • if you have a reduced phosphate concentration in the blood (hypophosphataemia).
    • with additional intake of calcium or alkalis (basic substances) with food or with other medicines. Elevated concentrations of calcium together with alkaline substances can lead to milk-alkaline syndrome (Burnett's syndrome). If high doses are taken, the calcium level in the blood and urine should therefore be monitored
  • Also ask your doctor for advice if you have a family history of calcium containing kidney stones.
  • If the kidneys are still functioning, taking the drug increases the excretion of calcium in the urine. In the first few months after starting intake, this also increases the tendency to precipitate calcium salts and, under certain circumstances, to form stones in the kidneys and urinary bladder. This can be avoided by drinking plenty of fluids.
  • Therapy with the preparation requires regular monitoring of serum calcium and serum phosphate levels.
    The serum calcium level should be kept within the normal range during therapy . The calcium x phosphate product should by no means exceed 5.3 mmol ² /l ²
    , in which case therapy should be discontinued.
• Driving and using machines:
  • No studies on the effects on the ability to drive and use machines have been performed.