SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Phosex® 1000 mg tablet

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 tablet contains

Calcium acetate 1000 mg (calcium acetate anhydrous 986.36 mg) equivalent to 250 mg calcium.

For a full list of excipients see Section 6.1.

3 PHARMACEUTICAL FORM

Tablet

Oval yellow tablet embossed “PHOS-EX” on one side with a score-line on the reverse.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Correction of hyperphosphataemia associated with chronic renal failure in patients_undergoing dialysis.

4.2 Posology and method of administration

For oral use

Initially one tablet 3 times a day. The tablet should be swallowed whole with a meal to achieve the maximal phosphate binding effect. Where the patient cannot swallow the tablets whole they may be broken and taken with food. Tablets, whether whole or broken, should not be chewed due to their bitter taste. The dose can be increased until the desired serum phosphate level is achieved, as long as hypercalcaemia does not occur. Most patients need 4 to 6 tablets per day (1 to 2 tablets with each meal).

The maximum recommended daily dose is 12 tablets.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients Hypercalcaemia

4.4 Special warnings and precautions for use

The use of phosphate binders in renal failure should be in conjunction with dietary advice regarding phosphate 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, for example weekly, of both the serum phosphate and calcium levels to determine efficacy and prevent hypercalcaemia.

If hypercalcaemia occurs, the dosage should be reduced or the treatment withdrawn temporarily, depending on the degree of hypercalcaemia.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 suffering with progressive renal failure may exhibit signs of, and should be warned of the symptoms of hypercalcaemia, ectopic or vascular calcification, or adynamic bone disease. Regular monitoring is required since caution is needed in administering Phosex^® under these circumstances.

The long-term toxicity of Phosex® has not been evaluated in clinical trials. In particular during long-term phosphate binding therapy with calcium salts there have been reports of tissue calcifications. It is not known whether the risk of calcification is higher with Phosex^® than with other calcium salts.

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

Calcium interacts with several drugs:

- The absorption of antibiotics such as ciprofloxacin, enoxacin, norfloxacin, tetracyclines (PO) can be affected and consequently, the intake of Phosex^® should be made 3 hours before or after the antimicrobial treatment.

Vitamin D preparations may require dosage modification to avoid hypercalcaemia.

Digitalis glycosides, verapamil and gallopamil in the presence of hypercalcaemia can enhance cardiac effects and can lead to cardiac toxicity. Therefore, special precautions for use (ECG and biological surveillance) are to be taken.

4.6 Fertility, Pregnancy and lactation

No data available. It is not known whether Phosex® can cause foetal effects when administered during pregnancy or whether it can affect reproductive capacity.

Phosex® should only be administered to pregnant or lactating women if it is clearly indicated

4.7 Effects on ability to drive and use machines

No effects on the ability to drive and use machines have been observed.

4.8 Undesirable effects

Uncommon (0.1% - 1%) undesirable effects are nausea, vomiting, diarrhoea and constipation.

Hypercalcaemia can occur and the serum levels of total and ionised calcium should be monitored. Mild hypercalcaemia (Ca>2.6 mmol/L) may occur in about 1% of patients and may be asymptomatic or manifest itself as constipation, anorexia, nausea and vomiting. More severe hypercalcaemia (Ca>3.0mmol/L) may occur in about 0.1% of patients and can be associated with confusion, delirium, stupor and in very severe cases coma. Patients should be advised to consult their doctor if any of these symptoms occur.

4.9 Overdose

Overdose with calcium substances may lead to soft tissue calcifications.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemia.

ATC code: V03A E

Phosphate binder.

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

Both components of Phosex®, 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 metabolised through bicarbonate, which will be further excreted via normal metabolic routes.

The amount of calcium not 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

No specific studies are available on Phosex® calcium acetate tablets.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Macrogol 8000

Sodium starch glycolate (type A)

Calcium stearate

Lemon meringue flavour (No. 74382) containing lemon oil, citral, aldehyde C-9, lime oil, orange oil, vanillin, ethyl vanillin, malto-dextrin, tricalcium phosphate.

Yellow iron oxide (E172)

Incompatibilities

Not applicable

6.3 Shelf life

3 years.

6.4    Special precautions for storage

Do not store above 25°C.

Store Phosex® in the original container and keep the container tightly closed in order to protect from moisture.

6.5    Nature and contents of container

White HDPE bottles with polypropylene caps.

Package size: bottle with 50, 100, 180, 200 or 500 tablets Not all pack sizes may be marketed

6.6    Special precautions for disposal

No special requirements

7    MARKETING AUTHORISATION HOLDER

PHARMACOSMOS A/S ROERVANGSVEJ 30 HOLBAEK DK-4300 DENMARK

MARKETING AUTHORISATION NUMBER(S)

PL 18380/0003

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

22/12/2007

DATE OF REVISION OF THE TEXT

18/11/2011

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