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 4.3 - Contraindications
• Change to section 4.8 - Undesirable effects
• Change to section 5.2 - Pharmacokinetic properties
• 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: 11-Apr-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2 – Updated information relating to excipients of known effect in line with QRD template
Section 4.2 – Updated sub-heading in line with QRD template
Section 4.3 – Updated information in line with QRD template
Section 4.8 – Minor formatting changes
Section 5.2 – Minor formatting changes and correction of spelling for sulfate
Section 6.6 – Updated statement regarding disposal of medicinal product in line with QRD template
Section 9 – Updated date of first authorisation and renewal of authorisation in line with QRD template
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 - how to report a side effect
• Change to section 4.9 - Overdose
• Change to section 6.1 - List of excipients
• Change to section 6.2 - Incompatibilities
• Change to section 6.3 - Shelf life
• 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 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 update 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 ADR reporting statement added.

-Section 4.9 Editorial changes to reflect latest QRD template

-section 6.1  Editorial changes to reflect latest QRD template

-Section 6.2 Editorial changes to reflect latest QRD template

-Section 6.3 Editorial changes to reflect latest QRD template

- Section 6.5 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 4.1 - Therapeutic indications
• Change to section 4.2 - Posology and method of administration
• 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

Date of revision of text on the SPC: 07-Feb-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.1 removal of premature indication

Section 4.2 removal of reference to premature indication

Section 4.2 removal of all contraindications related to premature labour

Section 4.4 removal of Tocolysis section

Section 4.9 removal of information on preterm labour

Section 10 revision date updated

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 4.3 - Contraindications
• 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 4.3

Replacement of first paragraph with:

 

‘Bricanyl Tablets should not be used as a tocolytic agent in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease.’

 

Addition of text to bullet point:

 

‘intrauterine infection, severe preeclampsia’

 

Addition of text- last paragraph:

 

‘Bricanyl Tablets should not be used in patients with a history of hypersensitivity to any of the ingredients.’

Section 4.4

Replacement of text with:

 

‘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 myocardial ischaemia associated with beta agonists.

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

Tocolysis
Bricanyl should be used with caution in tocolysis and supervision of cardiorespiratory function, including ECG monitoring, should be considered. Treatment should be discontinued if signs of myocardial ischaemia (such as chest pain or ECG changes) develop. Bricanyl should not be used as a tocolytic agent in patients with significant risk factors for or pre-existing heart disease (see section 4.3, Contraindications).

During infusion treatment in pregnant women with beta₂-agonists in combination with corticosteroids, a rare complication with a pathological picture resembling pulmonary oedema has been reported.

Increased tendency to uterine bleeding has been reported in connection with Caesarean section. However, this can be effectively stopped by propranolol 1‑2 mg injected intravenously.

Respiratory indications
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.

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.’

 

Section 4.8

Replacement of text with:

 

The intensity of the adverse reactions depends on dosage and route of administration. 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:

28^th May 2002 / 15^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 4.6 - Pregnancy and Lactation
• 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 4.6 - Pregnancy and Lactation
• 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:

• New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC