Overdose would not be expected to cause gross hypercalcaemia except in patients taking excessive doses of vitamin D.
Measures in case of overdose: Discontinuation of the medicinal product and symptomatic treatment including lowering calcium levels e.g. administration of oral phosphates and non-saline laxatives such as lactulose.
3 years
Renacet 475 mg must not be used in patients with:
Hypersensitivity to the active substance or to any of the excipients.
Hypophosphatemia, severe hypophosphatemia, hypercalcemia, hypercalciuria associated with calcium-containing kidney stones, decalcifying tumors and skeletal metastases; severe renal failure without dialysis treatment; constipation; known stenosis of the large intestine, osteoporosis due to immobilisation.
Not applicable.
Tablet core
Maize starch
Sucrose
Gelatin
Sodium starch glycolate (Type A)
Croscarmellose sodium
Magnesium stearate
Film coat
Hypromellose
Refined castor oil
Saccharin sodium
Talc
Orange flavour
Film-coated tablet
white, round, convex film-coated tablets.
The following definitions apply to the incidence of undesirable effects:
Very common (> 1/10)
Common (> 1/100 to < 1/10)
Uncommon (> 1/1,000 to < 1/100)
Rare (>1/10,000 to < 1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
General disorders | |
Uncommon: | Soft tissue calcification (e.g in the fatty tissue under the skin) usually occurring only after many years of intake and frequently associated with increased blood calcium levels. |
Cardiac/vascular disorders: | |
Uncommon: | Hypercalcemia, especially following overdosage. |
Gastrointestinal disorders: | |
Rare: | Gastrointestinal disorders such as nausea and constipation, especially in case of too high dosages. |
| If gastrointestinal side effects occur, treatment should be changed to calcium carbonate as appropriate. |
Preclinical studies with calcium acetate are very limited and reveal no special additional risks to those already mentioned in other sections of the SPC. Preclinical effects were observed only at doses considered in excess of the maximum human dose.
Hyperphosphatemia associated with chronic renal insufficiency in patients undergoing dialysis.
Pharmacotherapeutic group: | Drug for treatment of hyperphosphatemia |
ATC-Code: | A12AA12 |
Calcium is an endogenous ion of the body essential for the maintenance of a number of physiologic processes. It participates as an integral factor in the maintenance of the functional integrity of the nervous system, in the contractile mechanisms of muscle tissue, in the clotting of blood, and in the formation of the major structural material of the skeleton.
A dynamic equilibrium occurs between blood calcium and skeletal calcium, homeostasis being mainly regulated by the parathyroid hormone, by calcitonin and by vitamin D.
Variations in the concentration of ionised calcium are responsible for the symptoms of hyper/hypocalcaemia. Soluble calcium salts are commonly used in the treatment of calcium deficiency.
The pharmacokinetics of calcium and its salts are well known. Bioavailability of calcium acetate depends on the dissolution rate which is normally completed after 15 minutes. After 15 minutes the calcium acetate is released. The serum concentration of phosphate may decrease after interaction with calcium resulting in the formation of the less soluble calcium phosphate salts.
30/06/2010
Renacet 475 mg, film-coated tablets
RenaCare NephroMed GmbH
Werrastr. 1 a
35625 Hüttenberg
Germany
Phone: +49 (0) 64 03 9 21 60
Fax: +49 (0) 64 03 9 21 63
E-mail: [email protected]
This medicinal product does not require any special storage conditions.
Pack sizes:
100 film-coated tablets
200 film-coated tablets
PVDC-coated PVC / aluminium foil blisters
PL 36032/0001
Treatment with Renacet 475 mg film-coated tablets requires regular measurement of the serum calcium and serum phosphate levels. Under no circumstances should the calcium concentration multiplied by the phosphate concentration exceed 5.3 mmol/l since the frequency of extraosseous calcification increases if this value is exceeded.
To avoid an increase in serum calcium level beyond the normal range the intake of Renacet 475 mg film-coated tablets should be monitored regularly when patients are already on preparations which contain calcium.
Patients with the rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Renacet 475 mg has no effect on the ability to drive or use machines.
Dosage should be effected individually. Unless a different dose has been prescribed, adults should take no more than 14 Renacet 475 mg film-coated tablets daily.
To achieve optimal efficacy, Renacet 475 mg should be taken during or immediately after meals
The usual dose is:
with breakfast: | 1 to 2 film-coated tablets Renacet 475 mg, |
with a snack: | 1 to 2 film-coated tablets Renacet 475 mg, |
with a main meal: | 2 to 6 film-coated tablets Renacet 475 mg, |
with supper: | 2 to 4 film-coated tablets Renacet 475 mg. |
Renacet 475 mg film-coated tablets should be taken with some liquid during or immediately after meals and must not be chewed.
Experience with children is not available.
No special requirements.
30/06/2010
