Section 4.3
Replacement of first paragraph:
‘Bricanyl Syrup 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 last paragraph:
Bricanyl Syrup 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-stimulants 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).
|
|
|
|
|
|
|
|
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:
4th June 2002 / 12th May 2007
Section 10
Change of date:
30th March 2009
|
