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.
Name change:
Betaloc 50mg Tablets
Betaloc 100mg Tablets
Section 2
Additional text:
Betaloc Tablets 50mg:
Each tablet contains Metoprolol tartrate 50mg
Each tablet contains 17.5mg lactose monohydrate
Betaloc Tablets 100mg:
Each tablet contains Metoprolol tartrate 100mg
Each tablet contains 35mg lactose monohydrate
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, the use of gastric lavage, activated charcoal and a laxative to prevent absorption of any drug still present in the gastrointestinal tract, 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 9
Renewal authorisation:
Betaloc 50mg: 26th May 2005
Betaloc 100mg: 29th May 2005
New revision date of text: 28th May 2010
New additional text – last paragraph. Lactose warning.
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose‑galactose malabsorption should not take this medicine.
New additional text 3rd paragraph
Digitalis glycosides, in association with beta‑blockers, may increase atrioventricular conduction time and may induce bradycardia.
In the adverse events for the cardiovascular system there is new additional text in “uncommon” with a reference.
Uncommon: Deterioration of heart failure symptoms, cardiogenic shock in patients with acute myocardial infarction*, first‑degree heart block, oedema, precordial pain.
*Excess frequency of 0.4% compared with placebo in a study of 46,000 patients with acute myocardial infarction where the frequency of cardiogenic shock was 2.3% in the metoprolol group and 1.9% in the placebo group in the subset of patients with low shock risk index. The shock risk index was based on the absolute risk of shock in each individual patient derived from age, sex, time delay, Killip class, blood pressure, heart rate, ECG abnormality, and prior history of hypertension. The patient group with low shock risk index corresponds to the patients in which metoprolol is recommended for use in acute myocardial infarction.
Change of text in last paragraph
Current text: The use of haemodialysis or haemoperfusion may be considered.