One film-coated tablet contains 660 mg calcium acetate, equivalent to 167 mg calcium. Excipients: Each film-coated tablet contains 68.3 mg sucrose

Film-coated tablet. White to yellowish, oblong-shaped tablet with a score-line. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Hyperphosphataemia in patients with chronic renal insufficiency undergoing dialysis.

Everose should always be used with close monitoring

In adults

The recommended starting dose is two tablets (334 mg calcium) three times daily. The dose is gradually increased until the desired serum phosphorus level is reached, provided that hypercalcaemia does not occur. Most patients require 3 to 4 tablets with each meal.

The dose may need to be adjusted either upwards or downwards, depending on phosphate intake and elimination of phosphate by dialysis.

In children and adolescent (less than 18 years of age)

No sufficient information is available on the relationship of age to the effects of calcium acetate in paediatric patients. Therefore, Everose cannot be recommended in these patients.

In the elderly

Normal dosage regimen is recommended in the elderly.

The tablets should only be taken together with meals to achieve the maximum phosphate-binding effect. Preferably the tablets should be swallowed whole. When a patient has difficulty swallowing the tablet due to its size, the tablet can be broken in half on the score line if necessary, so half a tablet can be taken twice directly after each other. In that case the tablets need to be divided into halves just before ingestion to avoid the development of taste of acetic acid.

In case of a missed dose, the next dose should be taken at the normal time (no attempt should be made to make up for the missed dose).

• Hypophosphataemia

• Hypercalcaemia

• Hypersensitivity to calcium acetate or to any of the excipients

Patients should be advised not to take any other oral medication within 1-2 h before and after Everose (see section 4.5).

Chronic overdose of calcium preparations in uraemic patients can cause soft tissue calcifications. The risk of hypercalcaemia is increased in cases of concomitant treatment with vitamin D- preparations.

Increased amounts of calcium salts in the gastro-intestinal tract may result in the precipitation of fatty acids and bile acids as calcium salt. This may lead to constipation.

The application of adrenaline (epinephrine) in patients with increased serum calcium level may lead to severe cardiac arrhythmias.

Serum phosphorus and calcium levels should be closely monitored at regular intervals. The calcium phosphate product should not exceed 5.25 mmol2/l2, since the incidence of soft tissue calcifications increases by exceeding this value. Monitoring should be more frequent after initiation of the therapy e.g. in weekly intervals or every 2 weeks for 3 months. After this monthly intervals are sufficient, dependent on the medical condition of the patient. In general the monitoring frequency is up to the decision of the doctor and depends on the medical profile of the patient. The prolonged exceeding of a calcium phosphate product of 5.25 mmol2/l2 should prompt a therapy change.

To avoid an increase of serum calcium above normal levels, in case of a previous therapy with calcium supplements the amount of calcium that is administered with Everose should be considered.

In case of hypercalcaemia the dose should be reduced or the treatment discontinued, depending on the degree of hypercalcaemia. For the symptoms of hypercalcaemia see section 4.8.

Calcium salts should generally be avoided in patients with calcium renal calculi, or a history of renal calculi. Calcium salts should be given cautiously to patients with diseases associated with hypercalcaemia such as sarcoidosis and some malignancies.

Patients should be warned for the possible symptoms of hypercalcaemia.

In patients where there is difficulty controlling serum phosphorous concentrations e.g. with severe hyperphosphataemia (serum levels >2.26 mmol/L), aluminium based phosphate binders may be used as a short term therapy (4 weeks).

The use of phosphate binders should be preceded by a dietary consultation with the patient concerning phosphate uptake, and may depend on the kind of dialysis treatment the patient is receiving.

This product contains sucrose. Due to the content of sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this me.

Effects of other medicinal products on Everose

On concomitant administration of thiazide diuretics (bendroflumethiazide) or vitamin D-preparations there is an increased risk of hypercalcaemia. If these drugs are prescribed simultaneously, additional serum calcium monitoring, eg, weekly may be necessary above the regular monitoring intervals as given in section 4.4.

Concurrent use of oestrogens (estradiol) or vitamin A preparations with calcium salts may increase calcium absorption.

Effects of Everose on other medicinal products

Because the rate and/or extent of absorption of other oral medications may vary when used concurrently with Everose 660 mg, patients should be advised not to take any other oral medication within 1-2 h before and after Everose.

Calcium salts can form complexes with citrates, phosphates, carbonates/bicarbonates, oxalates, tartrates, phytates or sulphates. Calcium salts affect, like other multivalent cations, the absorption of numerous anionic active substances by forming poorly soluble salts. Thus, the concurrent use of calcium containing drugs with tetracyclines, bisphosphonates, fluorides, some fluoroquinolones (ciprofloxacin, ofloxacin), some cephalosporins (cefpodoxime, cefuroxime), ketoconazole, estramustin-preparations and anticholinergics may reduce the intestinal absorption of these substances. Also the intestinal absorption of zinc and iron may be reduced.

Increased amounts of calcium salts in the gastrointestinal tract may reduce the absorption of therapeutically administered urso- and chenodesoxycholic acid due to precipitation as calcium soap.

Calcium increases the effect of digitalis glycosides (digoxin), which may result in digitalis intoxication including the risk of arrhythmia. In digitalised patients care should be taken when administering Everose, e.g. ECG monitoring is warranted.

Calcium can reduce the pharmacological effects of verapamil and probably of other calcium channel blockers.

Nephropharm, A Fresenius Medical Care Company

POM – Prescription Only Medicine

04 April 2011