When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Section 4.2 Posology and method of administration
The following text has been added to this section:
Elderly:
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.
Patients with liver or renal insufficiency
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).
Section 4.3 Contraindications
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.
Section 4.4 Special Warnings and Precautions for use
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.
Section 4.5 Interaction with other medicinal products and other forms of interaction
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:
Potassium depleting agents
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.
Section 4.6 fertility, Pregnancy and Lactation
Fertility
There are no clinical studies with bumetanide regarding fertility
Section 4.7 Effects on the ability to drive and use machines
However, the patient should be informed that dizziness may occur during treatment and take this into account while driving or using machines.
Section 4.8 Undesirable effects
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.
Section 1: Strength of tablet moved behind product name i.e. Burinex® 1 mg Tablets + Burinex® 5 mg Tablets
Section 2: More details added
Section 3: More details re scoreline added
Section 5.1: ATC Code added
Section 6.1: List of excipients, Agar now called Agar Powder
Section 6.4: Change storage conditions 'protect from light' inserted
Section 6.5: Delete obsolete pack sizes
Section 6.6: Standard statement re disposal added
Section 9: Date of last renewal inserted
Section 10: Date of text revision inserted