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AstraZeneca Pharmaceuticals (Ireland) Ltd
College Park House, 20 Nassau Street, Dublin 2,
Telephone: +353 1 609 7100
Fax: +353 1 679 6650
Medical Information e-mail: Irelandinfo@astrazeneca.com
Summary of Product Characteristics last updated on medicines.ie: 26/01/2011
SPC Bricanyl Turbohaler

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.

Updated on 26/01/2011 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   13-Aug-2010
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 12/02/2010 and displayed until 26/01/2011
Reasons for adding or 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
Date of revision of text on the SPC:   25-Jan-2010
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 21/09/2005 and displayed until 12/02/2010
Reasons for adding or 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
Updated on 06/11/2003 and displayed until 21/09/2005
Reasons for adding or 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
Updated on 29/05/2003 and displayed until 06/11/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Terbutaline Sulphate