Burinex 5 mg Tablets

  • Name:

    Burinex 5 mg Tablets

  • Company:
    info
  • Active Ingredients:

    Bumetanide

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/04/19

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Summary of Product Characteristics last updated on medicines.ie: 3/4/2019

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Karo Pharma AB

Karo Pharma Corporate Logo - klar_1552387562

Company Products

Medicine NameActive Ingredients
Medicine Name Burinex 1 mg Tablets Active Ingredients Bumetanide
Medicine Name Burinex 5 mg Tablets Active Ingredients Bumetanide
Medicine Name Centyl K Tablets Active Ingredients Bendroflumethiazide, Potassium Chloride
Medicine Name Low Centyl K Active Ingredients Bendroflumethiazide, Potassium Chloride
Medicine Name Pivmecillinam hydrochloride Karo Pharma 400 mg film-coated tablets Active Ingredients Pivmecillinam Hydrochloride
1 - 0 of 5 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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.

Updated on 3 April 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 3 April 2019

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Updated on 22 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 November 2017

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 21 November 2017 SPC

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 4.1 the words 'in adults' are added to the indication
- 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 18 April 2017 SPC

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 6.5 the 28 tablet pack has been replaced with a 30 tablet pack.
- In Section 10 the date of revision has been updated.

Updated on 9 February 2017 SPC

Reasons for updating

  • 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
  • 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 23 December 2016 SPC

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 25°C.


10. Date of Revision of THE Text          

March 2015December 2016

Updated on 7 April 2015 SPC

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 4.3: QRD update
Section 4.4: QRD update (addition of sub-headings for clarity)
Section 4.8: QRD update
Section 5.1: QRD update
Section 6.1: Editorial update
Section 6.6: QRD update
Section 9: QRD update

Updated on 10 February 2012 SPC

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 SPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided