SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

PhosLo 667 mg capsule, hard

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One capsule contains:

Calcium acetate 708.4 mg (anhydrous calcium acetate 667 mg) equivalent to 169 mg calcium.

For a full list of excipients, see Section 6.1

3 PHARMACEUTICAL FORM

Capsule, hard

Oblong tablet contained in a white cap and white body, gelatin capsule. The capsule is printed in blue ink with “PhosLo®” on the cap and “667 mg” on the body.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Prevention/treatment of hyperphosphataemia in patients with advanced renal failure on dialysis.

4.2 Posology and method of administration

For oral use

Initially 2 capsules with each meal. The dosage may be increased until the desired serum phosphate level is achieved, as long as hypercalcaemia does not occur. Most patients require 3 or 4 capsules with each meal to achieve adequate control of serum phosphorus levels.

There is no experience in children.

It is recommended that calcium concentration be checked twice a week at the beginning of the treatment adjusting the dose after this procedure. In case of hypercalcaemia, the dose should be reduced or the treatment should be interrupted.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients

Hypercalcaemia

Hypercalciuria

4.4 Special warnings and precautions for use

The use of phosphate binders in renal failure should be used in conjunction with dietary advice regarding phosphate and calcium intake and methods of dialysis appropriate to the patient.

The dose will need to be adjusted depending on phosphate intake or removal by dialysis and on the ensuing effect on serum calcium. This requires regular monitoring of both the serum phosphate and calcium levels to determine efficacy and prevent hypercalcaemia. The serum calcium times phosphate levels (CA x P) should not exceed 4.51 mmol /l . Maintenance of serum phosphorous < 1.78 mmol/l is generally considered as a clinically acceptable outcome of treatment with phosphate binders.

If hypercalcaemia occurs, the dosage should be reduced or the treatment withdrawn temporarily, depending on the degree of hypercalcaemia. The risk of hypercalcaemia needs to be considered particularly during concomitant treatment with Vitamin D preparations.

The concomitant administration of calcium and vitamin D derivatives is to be made under the supervision of a physician.

Patients should be warned about the symptoms of hypercalcaemia.

ECG and calcium monitoring is warranted when calcium containing agents are combined with cardiac glycosides.

The long-term toxicity of PhosLo has not been evaluated in clinical trials. Patients should be advised to seek medical advice before taking nonprescription antacids containing calcium carbonate or other calcium salts to avoid adding to the calcium load.

4.5 Interaction with other medicinal products and other forms of interaction

The absorption of antibiotics such as tetracyclines (PO), quinolones, some cephalosporins, ketoconazole and products that contain iron, sodium-fluoride and estramustine can be affected and consequently, the intake of PhosLo should be made 3 hours before or after treatment with these agents.

The concomitant administration of calcium and vitamin D derivatives is to be made under the supervision of a physician.

4.6 Pregnancy and lactation

For PhosLo, no clinical data on exposed pregnant and lactating women are available.

It is not known whether PhosLo can cause fetal effects on the embryo/fetus when administered during pregnancy or whether it can affect fertility. PhosLo should only be administered to pregnant and lactating women if it is clearly indicated and if serum calcium levels are controlled regularly.

4.7 Effects on ability to drive and use machines

PhosLo has no influence on the ability to drive and use machines.

4.8 Undesirable effects

In clinical studies, approximately 14% of patients experienced nausea during PhosLo therapy. It is unknown whether this was related to treatment or related to underlying disease.

Hypercalcaemia may occur during treatment with PhosLo. Mild hypercalcaemia (Serum-Ca >2.625 mmol/L) may be asymptomatic or manifest itself as constipation, diarrhoea, anorexia, nausea and vomiting. More severe hypercalcaemia (Serum-Ca >3 mmol/L) is associated with confusion, delirium, stupor and coma. Mild hypercalcaemia is easily controlled by reducing the PhosLo dose or temporarily discontinuing therapy. Severe hypercalcaemia can be treated by acute hemodialysis and discontinuation of PhosLo therapy. Decreasing dialysate calcium concentration could reduce the incidence and severity of PhosLo-induced hypercalcaemia. The long-term effect of PhosLo on the progression of vascular or soft-tissue calcification has not been determined.

Approximately 5% of patients have experienced pruritis, which may represent allergic reactions.

4.9 Overdose

Administration of PhosLo in excess of the appropriate daily dosage can cause hypercalcaemia. Mild hypercalcaemia is easily controlled by reducing the PhosLo dose or temporarily discontinuing therapy. Severe hypercalcaemia can be treated by acute hemodialysis and discontinuation of PhosLo therapy. Decreasing dialysate calcium concentration could reduce the incidence and severity of PhosLo-induced hypercalcaemia.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Alimentary tract and metabolism, mineral supplements

ATC-Code: A12AA12 Phosphate binder.

Calcium ions of calcium acetate interact with and bind to phosphates in the gastrointestinal tract to form calcium phosphate, an insoluble or partially soluble product, which is excreted in the faeces.

Both components of PhosLo, calcium and acetate, are normal physiological components of the body and are also present in food. As a naturally occurring food constituent, calcium acetate is generally regarded as safe. However, excessive intake of calcium salts can result in hypercalcaemia.

5.2 Pharmacokinetic properties

Calcium acetate is not indicated for systemic availability. The residual acetate will be metabolized through bicarbonate, which is further excreted via normal metabolic routes.

The amount of calcium involved in the binding of phosphate is variable and any unbound calcium may be absorbed. Therefore, regular monitoring of calcium levels is recommended.

5.3 Preclinical safety data

There is no information of relevance to the safety assessment in addition to that already included in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Macrogols, (8000)

Light Liquid Paraffin Gelatin

Titanium dioxide (E171)

Printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide (E171), and brilliant blue (E133).

6.2 Incompatibilities

Not Applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 25°C.

Store in the original container. Keep the container tightly closed.

6.5 Nature and contents of container

White HDPE bottle with an inserted cotton coil and a 45 mm polypropylene white ribbed threaded child resistant closure with a foam liner and a pressure sensitive adhesive for a safety seal.

Package Size: 1 bottle with 200 hard capsules

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Fresenius Medical Care Nephrologica Deutschland GmbH 61346 Bad Homburg v.d.H.

Germany

8    MARKETING AUTHORISATION NUMBER(S)

PL 29386/0006

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28/01/2012

10    DATE OF REVISION OF THE TEXT

28/01/2012