Reasons for adding or updating:

• Change to section 2 - Qualitative and quantitative composition
• Change to section 4.2 - Posology and method of administration
• Change to section 6.2 - Incompatibilities
• Change to section 6.3 - Shelf life
• Change to section 6.6 - Special precautions for disposal and other handling
• Change to section 7 - Marketing authorisation holder
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 11-Apr-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2 – Minor formatting change
Section 4.2 – Updated sub-heading in line with QRD template
Section 6.2 – Updated statement in line with QRD template
Section 6.3 – Updated shelf life (from months to years) in line with QRD template
Section 6.6 – Updated statement regarding disposal of medicinal product in line with QRD template
Section 7 – Minor editorial update to address of MAH
Section 10 – Updated date of revision of text

Reasons for adding or updating:

• Change to section 1 - Name of the medicinal product
• 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 - Fertility, 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 4.8 - Undesirable effects - how to report a side effect
• Change to section 4.9 - Overdose
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 5.2 - Pharmacokinetic properties
• Change to section 6.1 - List of excipients
• 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 first authorisation/renewal of the authorisation
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 14-May-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 1 Editorial changes to reflect latest QRD template
- Section 2 Editorial changes to reflect latest QRD template and updated spelling of ‘sulfate’

-Section 4.2 Information on anti-inflammatory therapy added and Editorial changes to reflect latest QRD template

-Section 4.3 Editorial changes to reflect latest QRD template

-Section 4.4 information on anti-inflammatory therapy added and Editorial changes to reflect latest QRD template

-Section 4.5 information on Halogenated anaesthetics

-Section 4.6 information on use at the end of pregnancy and 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 addition of adverse event reporting statement

-Section 4.9 Editorial changes to reflect latest QRD template

-Section 5.1 Editorial changes to reflect latest QRD template

-Section 5.2 Spelling of ‘sulfate’ updated.

-section 6.1  Editorial changes to reflect latest QRD template

- Section 6.4 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

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: 05-Feb-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



-Section 4.5 Update information on Potassium depleting agents and hypokalaemia

-Section 10 date of revision

Reasons for adding or updating:

• Change to section 3 - Pharmaceutical form
• Change to section 4.4 - Special warnings and precautions for use
• Change to section 4.8 - Undesirable effects
• Change to section 4.9 - Overdose
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 20-Nov-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 3- updated to include “Sterile”

Section 4.4 – addition of information on lactic acidosis

Section 4.8- lactic acidosis added as side effect and minor editorial changes

Section 4.9- cross reference to section 4.4 added

Section 10 – Update to "Date of Revision"

Reasons for adding or updating:

• Change to section 1 -Name of the Medicinal product
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 15-Jan-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1

Change name to:

Bricanyl® Respules® 2.5 mg/ml Nebuliser Solution

Section 10

Change of date to:

15th January 2010

Reasons for adding or updating:

• Correction of spelling/typing errors

Date of revision of text on the SPC: 30-Mar-2009

Legal Category:POM

Black Triangle (CHM): NO

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 9 - Date of first Authorisation/renewal of the Authorisation
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 30-Mar-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4

Replacement of text with:

 

‘Patients should be instructed in proper use and their inhalation technique checked regularly.

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.

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

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 hyperglycaemic effects of beta₂-agonists, additional blood glucose controls are recommended initially in diabetic patients.

Potentially serious hypokalaemia may result from beta₂-agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia. The hypokalaemic effect may be potentiated by concomitant treatments (see section 4.5, Interactions). It is recommended that serum potassium levels are monitored in such situations.’

Section 4.8

Replacement of text 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.

The frequency of side-effects is low at the recommended doses.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100 and <1/10), uncommon (>1/1,000 and <1/100), rare (>1/10,000 and <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Frequency Classification	Adverse Drug Reaction
	System Organ Class (SOC)	Preferred term (PT)
Very Common (>1/10)	Nervous System Disorders	Tremor Headache
Common (>1/100, <1/10)	Cardiac Disorders	Tachycardia Palpitations
	Musculoskeletal and Connective Tissue Disorders #	Muscle spasms
	Metabolism and Nutrition Disorders	Hypokalaemia (See section 4.4)
Not Known ^	Cardiac Disorders	Arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia and extrasystoles Myocardial ischaemia (See section 4.4)
	Vascular Disorders	Peripheral vasodilation
	Immune System Disorders	Hypersensitivity reactions including angioedema, bronchospasm, hypotension and collapse
	Gastrointestinal Disorders	Nausea Mouth and throat irritation
	Psychiatric Disorders	Sleep disorder and Behavioural disturbances, such as agitation and restlessness
	Respiratory, Thoracic and Mediastinal Disorders	Paradoxical bronchospasm *
	Skin and Subcutaneous Tissue Disorders	Urticaria Rash

# A few patients feel tense; this is also due to the effects on skeletal muscle and not to direct CNS stimulation.

^ Reported spontaneously in post-marketing data and therefore frequency regarded as unknown

* In rare cases, through unspecified mechanisms, paradoxical bronchospasm may occur, with wheezing immediately after inhalation. This should be immediately treated with a rapid-onset bronchodilator. Bricanyl therapy should be discontinued and after assessment, an alternative therapy initiated.

Section 9

Change of date:

4^th June 2002 / 12^th May 2007

 

Section 10

Change of date:

30^th March 2009

Reasons for adding or updating:

• Change to section 4.4 - Special Warnings and Precautions for Use
• Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
• Change to section 4.8 - Undesirable Effects
• Change to section 4.9 - Overdose
• Change to section 5.3 - Preclinical Safety Data

Reasons for adding or updating:

• Change to section 4.4 - Special Warnings and Precautions for Use
• Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
• Change to section 4.9 - Overdose
• Change to section 4.8 - Undesirable Effects
• Change to section 5.3 - Preclinical Safety Data

Reasons for adding or updating:

• Change to section 2 - qualitative and quantitative composition
• Change to section 3 - pharmaceutical form
• Change to section 4.4 - Special Warnings and Precautions for Use
• Change to section 4.8 - Undesirable Effects
• Change to section 9 - Date of Renewal of Authorisation
• Change to section 6. 4 - Special Precautions for Storage

Reasons for adding or updating:

• No reasons supplied