Phosex
Summary of product characteristics
1. Name of the medicinal product
Phosex 1000 mg tablet
2. Qualitative and quantitative composition
1 tablet containsCalcium 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
TabletOval yellow tablet embossed “PHOS-EX” on one side with a score-line on the reverse
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 useInitially 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determine efficacy and prevent hypercalcaemia.If hypercalcaemia occurs, the dosage should be reduced or the treatment withdrawn temporarily, depending on the degree of hypercalcaemia.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 non-prescription 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 >3.0 mmol/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.
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemiaATC code: V03A EPhosphate 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.
6.1. List of excipients
Macrogol 8000Sodium starch glycolate (type A)Calcium stearateLemon meringue flavour containing lemon oil, citral, aldehyde C-9, lime oil, orange oil, vanillin, ethyl vanillin, malto-dextrin, tricalcium phosphateYellow 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, 500 tablets.Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorisation holder
Pharmacosmos A/SRoervangsvej 30DK-4300 HolbaekDenmark
8. Marketing authorisation number(s)
PL 18380/0003
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 29 June 2001Date of last renewal: 22 December 2007
10. Date of revision of the text
October 2011
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 useInitially 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 non-prescription 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 >3.0 mmol/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.
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Drug Licencing
Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).