When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Section 2
Additional text:
Each ml of solution contains metoprolol tartrate 1 mg. Each ampoule contains 5 mg/5 ml metoprolol tartrate.
Each ml of solution contains 3.6 mg sodium, as sodium chloride. Each 5 ml ampoule contains 17.8 mg sodium, as sodium chloride.
Section 4.4
Additional text 2nd bullet point:
Acute initiation of high-dose metoprolol to patients undergoing non-cardiac surgery should be avoided, since it has been associated with bradycardia, hypotension and stroke including fatal outcome in patients with cardiovascular risk factors.
Section 4.9
Change of text to whole of section:
The symptoms of overdose may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm.
General treatment should include:
Close supervision, treatment in an intensive care ward and the use of plasma or plasma substitutes to treat hypotension and shock.
Excessive bradycardia can be countered with atropine 1-2 mg intravenously and/or a cardiac pacemaker. If necessary, this may be followed by a bolus dose of glucagon 10 mg intravenously. If required, this may be repeated or followed by an intravenous infusion of glucagon 1-10 mg/hour depending on response. If no response to glucagon occurs or if glucagon is unavailable, a beta adrenoceptor stimulant such as dobutamine 2.5 to 10 micrograms/kg/minute by intravenous infusion may be given.
Dobutamine, because of its positive inotropic effect could also be used to treat hypotension and acute cardiac insufficiency. It is likely that these doses would be inadequate to reverse the cardiac effects of beta blockade if a large overdose has been taken. The dose of dobutamine should therefore be increased if necessary to achieve the required response according to the clinical condition of the patient.
Administration of calcium ions may also be considered. Bronchospasm can usually be reversed by bronchodilators.
Section 6.2
Change of text to section:
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Section 6.6
For single use only. Discard any unused contents.
Section 9
Renewal authorisation:
2nd May 2008
New revision date of text: 19th May 2010
Section 4.5- 6th & 7th paragraph
Current Text:
The administration of adrenaline to patients undergoing beta‑blockade can result in an increase in blood pressure and bradycardia although this is less likely to occur with beta1‑selective drugs.
Betaloc Injection may impair the elimination of lignocaine
New Text:The administration of adrenaline (epinephrine) to patients undergoing beta‑blockade can result in an increase in blood pressure and bradycardia although this is less likely to occur with beta1‑selective drugs.
Section 10: New revision of text date; 12th September 2006