sanofi-aventis

Section 2- updated to state lactose monohydrate content of tablets

Section 3 updated to specify that the capules are hard capsules with a white opaque body and a blue opaque cap

Section 4.6- subheading changed to include fertility

Section 5.1 updated to include pharmaceutical group for product

Section 6.1; changes made to separate excipients for capsule content and capsule shell. Sodium amylopectin glycollate in capsule contents changed to sodium starch glycolate type c. E numbers provided to Indigotin and titanium dioxide in capsule shell.

Section 6.2- wording changes to Not applicable

Section 6.4: text changed to Store below 25°C. Keep the blister strip in the outer carton in order to protect from light.

Section 6.5- changed to specify type of packaging

Section 6.6 changed to no special requirements

Section 9- changed Date of first authorisation: 17 March 1977 Date of latest renewal: 8 February 2005 and date changed in section 10 also.

Concomitant use with risperidone

In risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97 years) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96 years) or furosemide alone (4.1%; mean age 80 years, range 67-90 years). Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.
No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use. There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be avoided in elderly patients with dementia (see section 4.3 Contraindications).

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Risperidone: Caution should be exercised and the risks and benefits of the combination or co-treatment with furosemide or with other potent diuretics should be considered prior to the decision to use. See section 4.4 Special warnings and precautions for use regarding increased mortality in elderly patients with dementia concomitantly receiving risperidone.

Section 4.3

Patients with hypovolaemia or dehydration (with or without accompanying hypotension). Patients with an impaired renal function and a creatinine clearance below 30ml/min per 1.73 m²  body surface area, acute renal failure, anuria, hepatorenal syndrome and hepatic encephalopathy, anuria or renal failure with anuria not responding to furosemide, renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents or renal failure associated with hepatic coma, hyperkalaemia, severe hypokalaemia,  severe hyponatraemia, Addison’s disease and breast feeding women.

            Section 4.4

In patients who are at high risk for radiocontrast nephropathy, furosemide is not recommended to be used for diuresis as part of the preventative measures against radiocontrast-induced nephropathy.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

            Section 4.5

The dosage of concurrently administered cardiac glycosides or, diuretics, anti-hypertensive agents, or other drugs with blood-pressure-lowering potential may require adjustment as a more pronounced fall in blood pressure must be anticipated if given concomitantly with Lasilactone.  A marked fall in blood pressure and deterioration in renal function may be seen when ACE inhibitors or angiotensin II receptor antagonists are added to furosemide therapy, or their dose level increased. The dose of Lasilactone should be reduced for at least three days, or the drug stopped, before initiating the ACE inhibitor or angiotensin II receptor antagonist or increasing their dose of an ACE inhibitor.

When Lasilactone is taken in combination with potassium salts, with drugs which reduce potassium excretion, with non-steroidal anti-inflammatory drugs or with ACE inhibitors, an increase in serum potassium concentration and hyperkalaemia may occur.

The toxic effects of nephrotoxic antibiotics drugs may be increased by concomitant administration of potent diuretics such as furosemide.

Lasilactone and sucralfate must not be taken within a brief time span two hours of each other because sucralfate decreases the absorption of furosemide from the intestine and so reduced its effect.

In common with other diuretics, serum lithium levels may be increased when lithium is given concomitantly with Lasilactone, resulting in increased lithium toxicity, including increased risk of cardiotoxic and neurotoxic effects of lithium.  Therefore, it is recommended that lithium levels are carefully monitored and where necessary the lithium dosage is adjusted in patients receiving this combination.

Impairment of renal function may develop in patients receiving concurrent treatment with furosemide and high doses of certain cephalosporins.

Concomitant use of ciclosporin and furosemide is associated with increased risk of gouty arthritis.