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FOSRENOL CHEWABLE TABLETS 500MG [SIN13594P]

Active ingredients: FOSRENOL CHEWABLE TABLETS 500MG

Last updated 26 October 2025

Product Info

FOSRENOL CHEWABLE TABLETS 500MG

[SIN13594P]

Product information

Active Ingredient and Strength

LANTHANUM (AS LANTHANUM CARBONATE HYDRATE 954 MG) - 500 MG

Dosage Form

TABLET, CHEWABLE

Manufacturer and Country

HAMOL LIMITED - UNITED KINGDOM

Registration Number

SIN13594P

Licence Holder

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

V03AE03

INDICATIONS
Treatment of hyperphosphataemia in adults with chronic renal failure on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

DOSAGE AND ADMINISTRATION
Patients should adhere to recommended diets in order to control phosphate and fluid intake. Tablets must be chewed completely and not swallowed whole. To aid with chewing the tablets may be crushed.

Adults, including elderly (>65 years)
For patients taking FOSRENOL for the first time, the starting dose may be determined individually based on serum phosphate concentration as indicated below:

Table caption

Pre-treatment serum phosphate level

Recommended initial daily dose of FOSRENOL

>1.8 and ≤2.4 mmol/L

750 mg

>2.4 and ≤2.9 mmol/L

1500 mg

>2.9 mmol/L

2250 mg

FOSRENOL should be taken with or immediately after food, with the daily dose divided between meals, i.e. three times daily. Serum phosphate levels should be monitored and the dose of FOSRENOL titrated every 2–3 weeks until an acceptable serum phosphate level is reached, with regular monitoring thereafter.
Control of serum phosphate level has been demonstrated at doses from 750 mg with most patients achieving acceptable serum phosphate levels at 1500 – 3000 mg lanthanum per day.

Hepatic impairment
The effect of hepatic impairment on FOSRENOL pharmacokinetics has not been formally assessed. Due to its mechanism of action and the lack of liver metabolism, doses in hepatic impairment should not be modified, but patients should be monitored carefully (see PRECAUTIONS and PHARMACOLOGY, Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Children and Adolescents
The safety and efficacy of FOSRENOL has not been established in patients below the age of 18 years.

CONTRAINDICATIONS
Hypersensitivity to lanthanum or any of the excipients in the product.
Hypophosphataemia.
FOSRENOL is contraindicated in patients with bowel obstruction, ileus and faecal impaction.