Phosphate Sandoz

PHOSPHATE SANDOZ^® Effervescent Tablets

Each effervescent tablet contains 1.936g of sodium acid phosphate anhydrous.

Excipients with known effect:

Each tablet contains:

• 123mg potassium

• 469mg sodium

• 136mg sucrose

For the full list of excipients, see section 6.1.

Effervescent Tablet

White, round, effervescent tablets

Hypercalcaemia associated with such conditions as hyperparathyroidism, multiple myelomatosis and malignancy.

Hypophosphataemia associated with vitamin D resistant rickets and vitamin D resistant hypophosphataemic osteomalacia.

Posology

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, adolescents and children 5 years and over

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.

Method of administration

PHOSPHATE SANDOZ should be dissolved in 1/3 to 1/2 a tumblerful of water (50-70ml) and taken orally.

• Hypersensitivity to sodium acid phosphate anhydrous or to any of the excipients listed in section 6.1

In cases of impaired renal function associated with hypercalcaemia and in cases where restricted sodium intake is required, e.g. congestive cardiac failure, hypertension or pre-eclamptic toxaemia, the sodium (20.4mmol / 469mg per tablet) and potassium (3.1mmol / 123mg 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.

This medicinal product contains 123mg potassium per tablet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

This medicinal product contains 469mg sodium per tablet, equivalent to 23% of the WHO recommended maximum daily intake of 2g sodium for an adult.

The maximum daily dose of this product is equivalent to 141% of the WHO recommended maximum daily intake for sodium. PHOSPHATE SANDOZ is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Concurrent administrations of antacids, containing agents such as aluminium hydroxide, may result in displacement of calcium from binding to oral phosphate, thus reducing efficacy.

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.

PHOSPHATE SANDOZ has no or negligible influence on the ability to drive and use machines.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Excessive dosage has been reported to produce hypocalcaemia in isolated cases. This has proved reversible when dosage has been adjusted.

Pharmacotherapeutic group: Other mineral products, ATC code: A12CX

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.

Absorption

Approximately two thirds of ingested phosphate is absorbed from the gastro-intestinal 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.

Elimination

Virtually all absorbed phosphate is eventually excreted in the urine, the remainder being excreted in the faeces.

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.

Potassium bicarbonate

Sodium bicarbonate

Sodium saccharin

Orange flavour 52.570 TP

Polyethylene glycol 4000

Sugar icing CP

Citric acid anhydrous

Water

None.

3 years

Do not store above 25°C. Store in the original tube in order to protect from moisture. Keep the tube tightly closed.

Polypropylene tubes of 20 effervescent tablets in cartons of 5 tubes (100 tablets).

None.

Alturix Limited

287 Upper Fourth Street

Milton Keynes

MK9 1EH

PL 44490/0002

28^th April 1998

12/01/2022