Summary of Product Characteristics
last updated on the eMC:
03/07/2009
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 03/07/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 26-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4
Replacement of second sentence with:
'Care should be taken with patients suffering from thyrotoxicosis.'
Addition of paragraph 3:
'Cardiovascular effects may be seen with sympathomimetic drugs, including Bambec. 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 Bambec 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.'
Addition of last paragraph:
'Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine.'
Section 4.8
Replacement of entire section with:
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common ( ≥1/10 ), common ( ≥1/100 to <1/10 ), uncommon ( ≥1/1000 to < 1/100), rare ( ≥1/10,000 to < 1/1000), very rare ( <1/10,000 ) and unknown (cannot be estimated from available data).
Most of the adverse reactions are characteristic of sympathomimetic amines. The intensity of the adverse reactions is dose-dependent. Tolerance to the effects has usually developed within 1-2 weeks.
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Immune system disorders
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Unknown
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Hypersensitivity reactions including angoiedema, urticaria, exanthema, bronchospasm, hypotension and collapse.
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Metabolism and nutrition disorders
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Unknown
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Hypokalemia
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Psychiatric disorders
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Very Common
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Restlessness
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Common
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Sleep disturbances
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Uncommon
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Agitation
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Unknown
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Hyperactivity
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Nervous system disorders
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Very common
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Tremor, headache
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Cardiac disorders
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Common
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Palpitations
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Uncommon
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Tachycardia
Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia and extrasystoles
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Unknown
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Myocardial ischemia (see section 4.4)
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Respiratory, thoracic and mediastinal disorders
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Unknown
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Paradoxical bronchospasm
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Gastrointestinal disorders
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Unknown
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Nausea
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Musculoskeletal, connective tissue and bone disorders
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Common
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Muscle cramps
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Section 10
Change of date to:
'26th June 2009'
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Updated on 25/08/2005 and displayed until 03/07/2009
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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Change to section 10 (date of (partial) revision of the text
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Updated on 22/08/2003 and displayed until 25/08/2005
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6. 6 - Instruction for Use/Handling
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Updated on 18/07/2002 and displayed until 22/08/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 16/07/2002 and displayed until 18/07/2002
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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