Bricanyl Turbohaler

  • Name:

    Bricanyl Turbohaler

  • Company:
    info
  • Active Ingredients:

    Terbutaline sulfate

  • Legal Category:

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

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

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Summary of Product Characteristics last updated on medicines.ie: 18/3/2019

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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Medicine Name Bricanyl Turbohaler Active Ingredients Terbutaline sulfate
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Medicine Name Komboglyze 2.5mg-1000mg Tablets Active Ingredients Metformin Hydrochloride, Saxagliptin hydrochloride
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1 - 0 of 56 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 19 March 2019 PIL

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 18 March 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • 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 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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 2 – qualitative and quantitative composition of product updated

Section 3 – Pharmaceutical form and description of product updated

Section 4.2 – Editorial update to align with QRD template

Section 4.3 – Updated in line with QRD template

Section 4.4 – Information relating to the inclusion of lactose monohydrate added.

Section 4.8 – Updated with information relating to lactose.

Section 5.2 – Pharmacokinetic properties information updated.

Section 6.1 – Lactose monohydrate added as an excipient.

Section 6.5 – number of metered doses updated from 100 to 120 doses.

Section 6.6 – Updated in line with QRD template.

Section 7 – Marketing Authorisation Holder updated.

Section 8 – Marketing Authorisation Number updated.

Section 10 – Date of revision updated.

Updated on 3 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 January 2018 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 12 November 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 12 November 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5.1 - Pharmacodynamic 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

Section 2 update to spelling of ‘sulfate’

Section 5.1 update to spelling of ‘sulfate’

Section 10 update to date of revision

Updated on 11 November 2015 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 2 June 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • 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 2 editorial changes to reflect latest QRD template
- Section 4.2 editorial changes to reflect latest QRD template

-section 4.3 editorial changes to reflect latest QRD template

-section 4.4 editorial changes to reflect latest QRD template

-section 4.5 updated informaton on halogenated anaesthetics and potassium depleting agents plus editorial changes to reflect latest QRD template

-section 4.6 editorial changes to reflect latest QRD template

-section 4.7 editorial changes to reflect latest QRD template

-section 4.8 editorial changes to reflect latest QRD template and ADR reporting statement

-section 5.1 editorial changes to reflect latest QRD template

-section 6.3 editorial changes to reflect latest QRD template

-section 6.6 editorial changes to reflect latest QRD template

-section 9 editorial changes to reflect latest QRD template

-section 10 update to revision date

Updated on 27 May 2015 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 19 February 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • 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 4.4- addition of cross reference to 4.9

Section Section 4.9- information on accumulation of dry powder in the mouthpiece

Section 10 – Update to "Date of Revision"

Updated on 7 May 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 17 April 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.4

 

Paragraph inserted after paragraph 1.

 

With each inhalation a fraction of the delivered dose will be deposited in the oral cavity. To minimize unnecessary systemic exposure to terbutaline, the patients should be advised to, when possible, rinse their mouth after each use.

 

 

Section 10

 

Date of revision changed to 5th April 2012

 

Updated on 13 April 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 26 January 2011 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.5

Additional paragraph added at end of section, reads as,

 

There are some data which indicate that there is a risk of interaction between monoamine oxidase inhibitors, tricyclic antidepressants and terbuatline.”

 

Section 10

13th August 2010

Updated on 24 January 2011 PIL

Reasons for updating

  • Change to drug interactions

Updated on 12 February 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • 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 4.4

Addition of text:

If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should urgently seek further medical advice. Consideration should be given to the requirements for additional therapy (including increased dosages of anti-inflammatory medication). Severe exacerbations of asthma should be treated as an emergency in the usual manner.

As for all beta2-agonists caution should be observed in patients with thyrotoxicosis.

Cardiovascular effects may be seen with sympathomimetic drugs, including Bricanyl. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with beta agonists. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Bricanyl should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.

Due to the positive inotropic effect of beta2-agonists, these drugs should not be used in patients with hypertrophic cardiomyopathy.

Deletion of text:

If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should urgently seek further medical advice. Consideration should be given to the requirements for additional therapy (including increased dosages of anti-inflammatory medication). Severe exacerbations of asthma should be treated as an emergency in the usual manner.

Due to the positive inotropic effect of b2-agonists, these drugs should not be used in patients with hypertrophic cardiomyopathy.

Section 4.8

Replacement of section with:

The frequency of adverse reactions is low at the recommended dose. Terbutaline given by inhalation is unlikely to produce significant systemic effects when given in recommended doses. Most of the adverse reactions are characteristic of sympathomimetic amines. The majority of these effects have reversed spontaneously within the first 1-2 weeks of treatment.

Frequency Classification

Adverse Drug Reaction

 

System Organ Class (SOC)

Preferred term (PT)

Very Common ≥1/10

Nervous System Disorders

Tremor

Headache

Common <1/10 and ≥1/100

Cardiac Disorders

 

Tachycardia

Palpitations

 

Musculoskeletal and Connective Tissue Disorders

 

Muscle spasms

 

Metabolism and Nutrition Disorders

Hypokalaemia

Unknown*

Cardiac Disorders

 

Arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia and extrasystoles

Myocardial ischaemia

 

Gastrointestinal Disorders

 

Nausea

 

Psychiatric Disorders

 

 

Sleep disoreder and Behavioural disturbances, such as agitation and restlessness

Nervous System Disorders

Psychomotor hyperactivity

Respiratory, Thoracic and Mediastinal Disorders

Bronchospasm**

 

 

Skin and Subcutaneous Tissue Disorders

Urticaria

Rash

 


* Reported spontaneously in post-marketing data and therefore frequency regarded as unknown
** Drugs for inhalation may through unspecified mechanisms cause bronchospasm

Section 5.3

Deletion of text:

Terbutaline has been used extensively over many years for the relief of bronchospasm without identifying any areas of concern.

Section 9

Change of date to:

7th February 1989 / 4th December 2009

Section 10

Change of date to:

25th January 2010

Updated on 11 February 2010 PIL

Reasons for updating

  • Change to side-effects
  • Addition of manufacturer

Updated on 31 July 2009 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 9 February 2006 PIL

Reasons for updating

  • Change to instructions about overdose
  • Change to date of revision
  • Change of active ingredient

Updated on 21 September 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • 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)

Updated on 29 July 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 6 November 2003 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Updated on 29 May 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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