S471590453_09_a3removesphos.indd

The relentless, focused binding of FOSRENOL.1-4 For sustained phosphate control — meal after meal, day after day, week after week.1, 5, 6 FOSRENOL removes phosphate, removes phosphate, removes phosphate, removes pho
Fosrenol* 500mg, 750mg and 1000mg Chewable
be exercised in these patients, and monitoring of liver function may be required. oedema; pain; thirst; blood aluminium increased; increase in GGT; increases in Patients with renal insuffi ciency may develop hypocalcaemia. Serum calcium levels hepatic transaminases; alkaline phosphatase increased; weight decrease. Prescribing Information
should therefore be monitored at regular intervals for this patient population and Legal category: POM. Marketing Authorisation Holder: Shire
(Please refer to the current full Summary of Product appropriate supplements given. The risk/benefi t for longer term administration (over Pharmaceutical Contracts Ltd., Hampshire International Business Park, Chineham, Characteristics [SmPC] before prescribing) Presentation: Chewable tablets
2 years) should be careful y considered as experience with therapy beyond 2 years Basingstoke, Hampshire RG24 8EP, UK. Marketing Authorisation Number:
containing 500mg, 750mg or 1000mg of lanthanum (as lanthanum carbonate is limited. Interactions: Fosrenol may increase gastric pH. Therefore it is
PL 08081/0037-9. Date of Preparation: January 2007. Further information
hydrate). Excipients are dextrates (hydrated), colloidal anhydrous silica and recommended that compounds that are known to interact with antacids should not is available from: Shire Pharmaceuticals Ltd, Hampshire International Business
magnesium stearate. Indication: Fosrenol is indicated as a phosphate binding
be taken within 2 hours of dosing with Fosrenol (e.g. chloroquine, hydroxychloroquine Park, Chineham, Basingstoke, Hampshire RG24 8EP.
FOSRENOL monotherapy is indicated for the control of phosphataemia in chronic renal agent for use in the control of hyperphosphataemia in chronic renal failure patients and ketoconazole). Interactions with drugs such as tetracycline, doxycycline and the failure patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Dosage
fl oxacins are theoretically possible. Therefore it is recommended that they are not Adverse events should be reported to the Yellow Card Scheme.
and administration: For oral use. Adults, including elderly (> 65 years): Fosrenol
taken within 2 hours of dosing with Fosrenol. Pregnancy and lactation: Fosrenol
Information about adverse event reporting via this scheme can be
results for up to 6 years of treatment. Nephrol Clin Pract. 2008; 11-(1):c15c23. 2. Autissier
should be taken with or immediately after food, with the daily dose divided between is not recommended in pregnancy. The risk/benefi t for continuing/discontinuing found at www.yellowcard.gov.uk. Adverse events should also be
et al. Infl uence of Bile Acids on the Phosphate-binding Effi cacy of Lanthanum Carbonate and meals. The tablets should be chewed and not swallowed whole. The dose of Fosrenol either Fosrenol or breast feeding should be careful y considered. Undesirable
reported to Shire Pharmaceuticals Ltd on +44 (0)1256 894000.
Sevelamer Hydrochloride. Poster presented at the 38th Annual Meeting of the American should be titrated every 2-3 weeks until an acceptable serum phosphate level is effects: Common adverse reactions (>1/100, <1/10 patients) include
Healthcare Professionals from other countries should report
Society of Nephrology, Philadelphia, Pennysylvania, 8-13 November 2005. 3. Fosrenol
reached. Control of serum phosphate level has been demonstrated at doses starting gastrointestinal reactions (such as abdominal pain, constipation, diarrhoea, adverse events in accordance with their local requirements.
Summary of Product Characteristics, 2007. 4. Finn et al. 25-hydroxyvitamin D and
from 750mg. The maximum daily dose studied, in a limited number of patients, is dyspepsia, fl atulence, nausea and vomiting); hypocalcaemia. Uncommon adverse 1,25-dihydroxyvitamin D levels in patients with CKD Stages 3 and 4 are not affected by 3750mg. Patients who respond to lanthanum therapy usually achieve acceptable reactions (>1/1000, <1/100 patients) include gastroenteritis; laryngitis; The prescribing information above is for the UK. Product presentations and lanthanum carbonate: results from a randomized multicentre trial. 5. Hutchison AJ, Maes B,
serum phosphate levels at doses of 1500-3000mg lanthanum per day. Children and eosinophilia; hyperparathyroidism; hypercalcaemia; hyperglycaemia; indications may differ from those in your own country. Please consult your local Vanwal eghem J, et al. Long-term effi cacy and tolerability of lanthanum carbonate: results Adolescents (< 18 years): Not recommended. Contra-indications: Hypersensitivity
hyperphosphataemia; hypophosphataemia; anorexia; appetite increased; dizziness; from a 3-year study. Nephrol Clin Pract. 2006; 102(2):c61-c71. 6. Finn WF; on behalf of
to lanthanum carbonate hydrate or to any of the excipients. Hypophosphataemia. headache; taste alteration; vertigo; eructation; indigestion; irritable bowel syndrome; the SDP 405-307 Lanthanum Study Group. Lanthanum carbonate versus standard therapy Special warnings and precautions: Patients with acute peptic ulcer, ulcerative
dry mouth; oesophagitis; stomatitis; loose stools; tooth disorder; gastrointestinal References:
for the treatment of hyperphosphatemia: safety and effi cacy in chronic maintenance colitis, Crohn’s disease or bowel obstruction were not included in clinical studies with disorder NOS; alopecia; itching; pruritus; erythematous rash; sweating increased; 1. Hutchison AJ, Barnet ME, Krause R, Kwan JT, Siami GA; on behalf of the SPD405-309
hemodialysis patients. Clin Nephrol. 2006; 65(3): 191-202.
Fosrenol. No data is available in patients with hepatic impairment. Caution should arthralgia; myalgia; osteoporosis; asthenia; chest pain; fatigue; malaise; peripheral Lanthanum Study Group. Long-term effi cacy and safety profi le of lanthanum carbonate: Date of preparation: July 2009. Item no: INT/FOS/09/0016.

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