PHOSPHATE SANDOZ EFFERVESCENT TABLETS
Active substance(s): SODIUM ACID PHOSPHATE ANHYDROUS
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
PHOSPHATE SANDOZ® Effervescent Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHOSPHATE SANDOZ Effervescent Tablets containing 1.936g of sodium
acid phosphate anhydrous.
3.
PHARMACEUTICAL FORM
Effervescent Tablets
4.
CLINICAL PARTICULARS
4.1.
Therapeutic Indications
Hypercalcaemia associated with such conditions as hyperparathyroidism,
multiple myelomatosis and malignancy.
Hypophosphataemia associated with vitamin D resistant rickets and vitamin D
resistant hypophosphataemic osteomalacia.
4.2.
Posology and Method of Administration
PHOSPHATE SANDOZ Effervescent should be dissolved in 1/3 to 1/2 a
tumblerful of water and taken orally.
Dosage should be adjusted to suit the requirements of individual patients.
Excessive dosage has been reported to produce hypocalcaemia in isolated
cases. Particular care should therefore be taken to ensure appropriate dosage
in the elderly.
Adults
Hypercalcaemia: up to 6 tablets daily (adjustment being made according to
requirements).
Vitamin D resistant hypophosphateaemic osteomalacia: 4-6 tablets daily.
Children under 5 years
Hypercalcaemia: up to 3 tablets daily (adjustment being made according to
requirements).
Vitamin D resistant rickets: 2-3 tablets daily.
4.3.
Contra-Indications
None.
4.4.
Special Warnings and Special Precautions for Use
In cases of impaired renal function associated with hypercalcaemia and in
cases where restricted sodium intake is required, eg. congestive cardiac failure,
hypertension or pre-eclamptic toxaemia, the sodium (20.4mmol per tablet) and
potassium (3.1mmol per tablet) content of PHOSPHATE SANDOZ should be
taken into consideration. In cases of hypercalcaemia associated with impaired
renal function and hyperphosphataemia, the main effect of oral phosphate is to
bind calcium in the gut and thus reduce calcium absorption.
The effect of oral phosphate on serum phosphate is likely to be minimal, but
close monitoring of serum levels is recommended.
Soft tissue calcification and nephrocalcinosis have been reported in isolated
cases following intravenous therapy with phosphate.
This is thought to be a function of dosage and rapidity of phosphate
administration. While such effects appear less likely to occur with oral
phosphates, careful surveillance of patients is recommended, especially if on
long term therapy.
4.5. Interactions with other Medicinal Products and other Forms of
Interaction
Concurrent administrations of antacids, containing agents such as aluminium
hydroxide, may result in displacement of calcium from binding to oral
phosphate, thus reducing efficacy.
4.6.
Pregnancy and Lactation
The safety of PHOSPHATE SANDOZ in human pregnancy has not been
formally studied, but the drug has been widely used for many years without
ill-consequence.
4.7.
Effects on Ability to Drive and Use Machines
None.
4.8
Undesirable effects
Apart from gastro-intestinal upsets, nausea and diarrhoea, very few side effects have
been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the national reporting system in the United Kingdom: Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
4.9.
Overdose
Excessive dosage has been reported to produce hypocalcaemia in isolated
cases. This has proved reversible when dosage has been adjusted.
5.
PHARMACOLOGICAL PROPERTIES
5.1.
Pharmacodynamic Properties
Oral administration of inorganic phosphates produces a fall in serum calcium
in patients with hypercalcaemia. PHOSPHATE SANDOZ Effervescent
Tablets also contain sodium ions which aid the correction of the dehydration
and sodium depletion seen in hypercalcaemia.
5.2.
Pharmacokinetic Properties
Approximately two thirds of ingested phosphate is absorbed from the gastrointestinal tract; most of the absorbed phosphate is then filtered by the
glomeruli and subsequently undergoes reabsorption. Parathyroid hormone and
vitamin D stimulate absorption of phosphate from the small intestine and its
reabsorption from the proximal tubule. Virtually all absorbed phosphate is
eventually excreted in the urine, the remainder being excreted in the faeces.
5.3.
Pre-clinical Safety Data
PHOSPHATE SANDOZ Effervescent Tablets contain sodium acid phosphate,
anhydrous, sodium bicarbonate and potassium bicarbonate (all of which are
subject to pharmacopoeial monographs). The physiological, pharmacological
and clinical toxicity of potassium salts
are well documented and limited animal data are therefore available.
6.
PHARMACEUTICAL PARTICULARS
6.1.
List of Excipients
Potassium bicarbonate, sodium bicarbonate, sodium saccharin, orange flavour
52.570 TP, polyethylene glycol 4000, sugar icing CP, citric acid anhydrous,
water.
6.2.
Incompatibilities
None.
6.3.
Shelf-Life
36 months.
6.4.
Special Precautions for Storage
Do not store above 25°C. Store in the original container. Keep the container
tightly closed.
6.5.
Nature and Content of Container
Polypropylene tubes of 20 effervescent tablets in boxes of 5 tubes (100
tablets).
6.6.
Instruction for Use and Handling
None.
7
MARKETING AUTHORISATION HOLDER
HK Pharma Ltd
PO BOX 845
BEDFORD,
MK45 9EB
8.
MARKETING AUTHORISATION NUMBER(S)
PL 16784/0001
9.
DATE OF FIRST AUTHORISATION / RENEWAL OF
AUTHORISATION
28th April 1998
10
DATE OF REVISION OF THE TEXT
27/07/2015
1
NAME OF THE MEDICINAL PRODUCT
PHOSPHATE SANDOZ® Effervescent Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHOSPHATE SANDOZ Effervescent Tablets containing 1.936g of sodium
acid phosphate anhydrous.
3.
PHARMACEUTICAL FORM
Effervescent Tablets
4.
CLINICAL PARTICULARS
4.1.
Therapeutic Indications
Hypercalcaemia associated with such conditions as hyperparathyroidism,
multiple myelomatosis and malignancy.
Hypophosphataemia associated with vitamin D resistant rickets and vitamin D
resistant hypophosphataemic osteomalacia.
4.2.
Posology and Method of Administration
PHOSPHATE SANDOZ Effervescent should be dissolved in 1/3 to 1/2 a
tumblerful of water and taken orally.
Dosage should be adjusted to suit the requirements of individual patients.
Excessive dosage has been reported to produce hypocalcaemia in isolated
cases. Particular care should therefore be taken to ensure appropriate dosage
in the elderly.
Adults
Hypercalcaemia: up to 6 tablets daily (adjustment being made according to
requirements).
Vitamin D resistant hypophosphateaemic osteomalacia: 4-6 tablets daily.
Children under 5 years
Hypercalcaemia: up to 3 tablets daily (adjustment being made according to
requirements).
Vitamin D resistant rickets: 2-3 tablets daily.
4.3.
Contra-Indications
None.
4.4.
Special Warnings and Special Precautions for Use
In cases of impaired renal function associated with hypercalcaemia and in
cases where restricted sodium intake is required, eg. congestive cardiac failure,
hypertension or pre-eclamptic toxaemia, the sodium (20.4mmol per tablet) and
potassium (3.1mmol per tablet) content of PHOSPHATE SANDOZ should be
taken into consideration. In cases of hypercalcaemia associated with impaired
renal function and hyperphosphataemia, the main effect of oral phosphate is to
bind calcium in the gut and thus reduce calcium absorption.
The effect of oral phosphate on serum phosphate is likely to be minimal, but
close monitoring of serum levels is recommended.
Soft tissue calcification and nephrocalcinosis have been reported in isolated
cases following intravenous therapy with phosphate.
This is thought to be a function of dosage and rapidity of phosphate
administration. While such effects appear less likely to occur with oral
phosphates, careful surveillance of patients is recommended, especially if on
long term therapy.
4.5. Interactions with other Medicinal Products and other Forms of
Interaction
Concurrent administrations of antacids, containing agents such as aluminium
hydroxide, may result in displacement of calcium from binding to oral
phosphate, thus reducing efficacy.
4.6.
Pregnancy and Lactation
The safety of PHOSPHATE SANDOZ in human pregnancy has not been
formally studied, but the drug has been widely used for many years without
ill-consequence.
4.7.
Effects on Ability to Drive and Use Machines
None.
4.8
Undesirable effects
Apart from gastro-intestinal upsets, nausea and diarrhoea, very few side effects have
been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the national reporting system in the United Kingdom: Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
4.9.
Overdose
Excessive dosage has been reported to produce hypocalcaemia in isolated
cases. This has proved reversible when dosage has been adjusted.
5.
PHARMACOLOGICAL PROPERTIES
5.1.
Pharmacodynamic Properties
Oral administration of inorganic phosphates produces a fall in serum calcium
in patients with hypercalcaemia. PHOSPHATE SANDOZ Effervescent
Tablets also contain sodium ions which aid the correction of the dehydration
and sodium depletion seen in hypercalcaemia.
5.2.
Pharmacokinetic Properties
Approximately two thirds of ingested phosphate is absorbed from the gastrointestinal tract; most of the absorbed phosphate is then filtered by the
glomeruli and subsequently undergoes reabsorption. Parathyroid hormone and
vitamin D stimulate absorption of phosphate from the small intestine and its
reabsorption from the proximal tubule. Virtually all absorbed phosphate is
eventually excreted in the urine, the remainder being excreted in the faeces.
5.3.
Pre-clinical Safety Data
PHOSPHATE SANDOZ Effervescent Tablets contain sodium acid phosphate,
anhydrous, sodium bicarbonate and potassium bicarbonate (all of which are
subject to pharmacopoeial monographs). The physiological, pharmacological
and clinical toxicity of potassium salts
are well documented and limited animal data are therefore available.
6.
PHARMACEUTICAL PARTICULARS
6.1.
List of Excipients
Potassium bicarbonate, sodium bicarbonate, sodium saccharin, orange flavour
52.570 TP, polyethylene glycol 4000, sugar icing CP, citric acid anhydrous,
water.
6.2.
Incompatibilities
None.
6.3.
Shelf-Life
36 months.
6.4.
Special Precautions for Storage
Do not store above 25°C. Store in the original container. Keep the container
tightly closed.
6.5.
Nature and Content of Container
Polypropylene tubes of 20 effervescent tablets in boxes of 5 tubes (100
tablets).
6.6.
Instruction for Use and Handling
None.
7
MARKETING AUTHORISATION HOLDER
HK Pharma Ltd
PO BOX 845
BEDFORD,
MK45 9EB
8.
MARKETING AUTHORISATION NUMBER(S)
PL 16784/0001
9.
DATE OF FIRST AUTHORISATION / RENEWAL OF
AUTHORISATION
28th April 1998
10
DATE OF REVISION OF THE TEXT
27/07/2015
Further information
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