Burinex 5 mg Tablets

Section 4.2 Posology and method of administration

The following text has been added to this section:

The dosage recommendations for adults apply, but in the elderly bumetanide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Depending on the liver or renal function, the dose should be titrated according to the patient’s response and required therapeutic effect (see section 4.4).

The following contraindications have been removed:

Although Burinex® can be used to induce diuresis in renal insufficiency, any marked increase in blood urea or the development of oliguria or anuria during treatment of sever progresing renal disease are indications for stopping treatment with Burinex®.

As with other diuretics, Burinex® should not be administered concurrently to patients taking lithium salts.

Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

A caution with regard to administration to patients with severe liver insufficiency has been removed.

A caution with regard to administration to patients with disorders which render their electrolyte balance precarious has been removed.

The following text has been removed:

Excessively rapid mobilisation of oedema, particularly in elderly patients, amy give rise to sudden changes in cardiovascular pressure-flow relationships with circulatory collapse. This should be borne in mind during treatment with high oral doses of Burinex®. Burinex® may aggravate severe pre-existing electrolyte imbalance, particularly in patients on a low salt diet.

Patients with chronic renal failure on high doses of bumetanide should remain under constant hospital supervision.

Bone marrow depression rarely complicates treatment necessitating withdrawal of the drug.

Known hypersensitivity to thiazides as a potential risk of hypersensitivity to bumetanide has been removed.

Caution should be exercised when bumetanide is used in patients with porphyria.

The following text has been added:

This warning was previously a contraindication, but has been change to a warning:

Burinex® tablets contain lactose as an excipient and patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicinal product.

Additional detail regarding the signs of digitalis toxicity have been added to the section.

With regard to lithium, the following text has been added 'Lower lithium levels may be required'.

With regard to antihypertensives, it is now stated that first doe hypotension may occur.

With regard to NSAIDs, the following text has been added: 'The effects of concurrent use should be monitored (e.g. Blood pressure, signs of renal failure). Diuretics may enhance the nephrotoxicity of NSAIDs.

The following has been added:

The potassium depleting effect of bumetanide may be increased by other potassium depleting agents.

The following has been removed:

Phenytoin decreases the diuretic effect of bumetanide due to a possible decreased absorption from the intestine.

The following text has been added to this section:

There are no clinical studies with bumetanide regarding fertility

The following text has been added to this section:

However, the patient should be informed that dizziness may occur during treatment and take this into account while driving or using machines.

The frequencies have been revised as per MedDRA SOC system.

The proportion of patients who can be expected to experience an undesirable effect has changed from 10-20% to 12%.

Each undesirable effect now states the frequency at which they occur, this was omitted from earlier SmPCs.