Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Tissue deposition of lanthanum has been shown with Fosrenol in animal studies. In 105 bone biopsies from patients treated with Fosrenol, some for up to 4.5 years, rising levels of lanthanum were noted over time (see section 5.1). Cases of lanthanum deposition in gastrointestinal mucosa, mainly after long term use, have been reported. Lanthanum deposition in gastroduodenal mucosa is demonstrated endoscopically as whitish lesions of different sizes and shapes. Also, various pathological features were identified in gastroduodenal mucosa with lanthanum deposition, such as chronic or active inflammation, glandular atrophy, regenerative changes, foveolar hyperplasia, intestinal metaplasia and neoplasia.

The use of Fosrenol in clinical studies beyond 2 years is currently limited. However, treatment of subjects with Fosrenol for up to 6 years has not demonstrated a change in the benefit/risk profile.

There have been cases of gastrointestinal obstruction, ileus, subileus, and gastrointestinal perforation reported in association with lanthanum, some requiring surgery or hospitalisation (see section 4.8).

Lanthanum treatment in patients predisposed to gastrointestinal obstruction, ileus, subileus and perforation; for example, those with altered gastrointestinal anatomy (e.g., diverticular disease, peritonitis, history of gastrointestinal surgery, gastrointestinal cancer and gastrointestinal ulceration), hypomotility disorders (e.g., constipation, diabetic gastroparesis) and in subjects with medications known to potentiate these effects, should only be used after careful consideration.
For all subjects, physicians and patients should remain alert for signs and symptoms of gastrointestinal disorders, especially constipation and abdominal pain/distension which may indicate bowel obstruction, ileus, or subileus during treatment with lanthanum carbonate.

Withdrawal of lanthanum carbonate is recommended in patients who develop severe constipation or other severe gastrointestinal signs and symptoms, irrespective of predisposing conditions.

Patients with acute peptic ulcer, ulcerative colitis, Crohn’s disease or bowel obstruction were not included in clinical studies with Fosrenol.

Fosrenol tablets must be chewed completely and not swallowed whole to reduce the risk of serious adverse gastrointestinal complications (see section 4.2).

Patients with renal insufficiency may develop hypocalcaemia. Fosrenol does not contain calcium.
Serum calcium levels should therefore be monitored at regular time intervals for this patient population and appropriate supplements given.

Lanthanum is not metabolised by liver enzymes, but it is most likely excreted in the bile. Conditions resulting in a marked reduction of bile flow may be associated with incrementally slower elimination of lanthanum, which may result in higher plasma levels and increased tissue deposition of lanthanum (see sections 5.2 and 5.3). As the liver is the principal organ of elimination of absorbed lanthanum monitoring of liver function tests is recommended.


Fosrenol should be discontinued if hypophosphataemia develops.
Abdominal X-rays of patients taking lanthanum carbonate may have a radio-opaque appearance typical of an imaging agent.

Patients with rare glucose-galactose malabsorption should not take this medicine.

Effects on Driving

4.7   Effects on ability to drive and use machines
Fosrenol may induce dizziness and vertigo, which may impair the ability to drive and use machines.