Section 4.2 – Text transferred from section 4.4 “Use the minimum effective dosage of Migril necessary, since individual sensitivity to the arterial effects of ergotamine varies considerably”.
Amendment of text regarding use in children.
Section 4.3 – ‘Sepsis’ and ‘hyperthyroidism’ transferred from 4.4. Addition of ‘hepatic impairment’, ‘renal impairment’ and ‘porphyria’.
Section 4.4 – Addition of text regarding the co-administration of ergotamine with less potent CYP 3A4 inhibitors.
Addition of text regarding the use of Migril in patients with cardiac disease, gastrointestinal tract obstructive disease, glaucoma, prostatic hypertrophy, urinary retention and the elderly.
Section 4.5 – Section re-structured into sub-headings.
Addition of text regarding ‘quinolone and tetracycline antibacterials’ (antibacterials), ‘fluvoxamine’ (antidepressants), ‘phenytoin’ (antiepileptics), ‘diazepam’ (anxiolytics and hypnotics), ‘mexiletine’ (antiarrhythmics), ‘phenylpropanolamine’ (sympathomimetics), increased sedative effect of alcohol, MAOIs (antidepressants), ‘methysergide’, ‘eletriptan’ and ‘zolmitriptan’ (antimigraine drugs), ‘glycerol trinitrate’ (nitrates).
Text regarding alcohol transferred from 4.4
Additional text has been added regarding Sympathomimetics.
New information under the following sub-headings: ‘Disulfiram’, ‘Lithium’, ‘Oestrogens and progesterones’ ‘Theophylline’, ‘Antimuscarinincs’ ‘Anxiolytics and Hypnotics’.
Section 4.8 – Section re-structured into sub-headings.
Text transferred from section 4.4 “Doses of ergotamine as small as 2mg have caused signs of arterial insufficiency but this is a very rare occurrence” and “Repeated doses of ergotamine have occasionally been associated withy renal artery spasm and loss of renal function”.
Addition of the following undesirable effects: insomnia, dizziness, drowsiness, tremor, anxiety, palpitations, arrhythmias, hypotension, hypersensitivity reactions, blurred vision, dry mouth, vomiting, constipation, blood disorders, convulsions, headache, extrapyramidal effects, depression, confusion, hallucinations, psychomotor impairment, urinary retention, rapid and weak pulse, cerebral ischaemia, localized oedema and pruritis.
Section 4.9 – Addition of symptoms of overdosage: diarrhoea, extreme thirst, coldness, weakness, tingling and itching of the skin, a rapid and weak pulse, hypotension, shock, confusion, convulsions and unconsciousness.
Addition of the following text in ‘Acute overdosage’ section: “Fatalities have been reported. Further symptoms of peripheral vasoconstriction or of cardiovascular disturbances as seen in chronic ergotamine poisoning, may also occur but be delayed”.
Addition of the following text in ‘Treatment of acute overdosage’ section: “Activated charcoal may be used to reduce absorption”.
Amendment of text in ‘Chronic overdosage’ section
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