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PHOSEX 1000MG TABLETS

Active substance(s): CALCIUM ACETATE / CALCIUM ACETATE / CALCIUM ACETATE

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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withdrawn temporarily, depending on the degree of hypercalcaemia.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 C9, lime oil, orange oil, vanillin, ethyl vanillin, malto-dextrin, tricalcium
phosphate.
Yellow iron oxide (E172)

6.2

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 18380/0003

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/12/2007

10

DATE OF REVISION OF THE TEXT
18/11/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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