Burinex 1 mg Tablets
*Company:
Karo Pharma ABStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 February 2023
File name
SmPC-202005-Burinex 1 mg-ie.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Uploading anew to comply with the correct format.
Updated on 21 February 2023
File name
PL-202005-Burinex 1 mg-ie.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Uploading anew to comply with the correct format.
Updated on 19 December 2020
File name
SmPC-202005-Burinex 1 mg-ie.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 December 2020
File name
PL-202005-Burinex 1 mg-ie.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 09 July 2019
File name
SmPC-201903-Burinex 1 mg-ie.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 July 2019
File name
SmPC-201903-Burinex 1 mg-ie.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 April 2019
File name
PL-201903-Burinex 1 mg-ie.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 03 April 2019
File name
PL-201903-Burinex 1 mg-ie.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 27 March 2019
File name
PL-201903-Burinex 1 mg-ie.pdf
Reasons for updating
- New PIL for new product
Updated on 22 November 2017
File name
PIL_8461_601.pdf
Reasons for updating
- New PIL for new product
Updated on 22 November 2017
Reasons for updating
- Joint PIL superseded by individual PILs
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
Updated on 21 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 November 2017
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- In Section 4.2 the statement regarding no clinical trials in children has been replaced with a statement regarding limited information in children
- In Section 5.2 information regarding elimination in paediatric patients is added
- The date of revision has been updated
Updated on 11 May 2017
Reasons for updating
- Improved presentation of PIL
Updated on 18 April 2017
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- In Section 10 the date of revision has been updated.
Updated on 18 April 2017
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 09 February 2017
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.3: Editorial update in line with the QRD.
Section 4.4: Addition of the following;
Hypomagnesaemia
Administration of proton pump inhibitors has been associated with development of hypomagnesaemia. Hypomagnesaemia may be exacerbated with co-administration of bumetanide and particular attention to magnesium levels should be given when this combination is used.
Section 4.4 (Renal Impairment), 4.6, 4.7, 4.8 & 5.2: Replacing the product name 'Burinex' with the name of the active substance 'bumetanide'.
Section 10: Date of revision is February 2017.
Updated on 08 February 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
- Change to other sources of information section
- Correction of spelling/typing errors
Updated on 03 January 2017
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
6.4 Special precautions for storage
Keep the blisters in the outer carton in order to protect from light.
Store below 30°C.
10. Date of Revision of the Text
March 2015December 2016
Updated on 21 December 2016
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 07 April 2015
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 1: QRD update
Section 2: Editorial update
Section 4.1: QRD update
Section 4.2: QRD + editorial update
Section 4.4: QRD update (addition of sub-headings for clarity)
Section 4.8: QRD update
Section 5.1: QRD update
Section 6.6: QRD update
Section 9: QRD update
Updated on 27 March 2015
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 22 March 2012
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
- Change due to user-testing of patient information
Updated on 10 February 2012
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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
The following text has been added to this section:
Fertility
There are no clinical studies with bumetanide regarding fertility
Section 4.7 Effects on the ability to drive and use machines
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.
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.
Updated on 15 November 2010
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
3 years
10. DATE OF (PARTIAL) REVISION OF TEXT
November 2010
Updated on 25 August 2010
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 12 February 2009
Reasons for updating
- Addition of legal category
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 27 August 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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
Updated on 27 August 2008
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 27 August 2008
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 01 August 2006
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 July 2006
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 27 April 2005
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 March 2005
Reasons for updating
- Change to warnings or special precautions for use
Updated on 02 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 02 December 2003
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 November 2003
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Addition of legal category
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 June 2003
Reasons for updating
- Addition of legal category
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)