Special warnings and precautions for use

When treating patients with suspected or definite myocardial infarction the haemodynamic status of the patient should be carefully monitored after each of the three 5 mg intravenous doses. The second or third dose should not be given if the heart rate is <40 beats/min, the systolic blood pressure is <90 mmHg and the P-Q time is >0.26 sec, or if there is any aggravation of dyspnoea or cold sweating.

Betaloc injection, as with other beta blockers:

•       should not be withdrawn abruptly during oral treatment. When possible, Betaloc i.v. should be withdrawn gradually over a period of 10 – 14 days, in diminishing doses to 25 mg daily for the last 6 days. During its withdrawal patients should be kept under close surveillance, especially those with known ischaemic heart disease. The risk for coronary events, including sudden death, may increase during the withdrawal of beta-blockade.

•       must be reported to the anaesthetist prior to general anaesthesia. It is not generally recommended to stop Betaloc i.v. treatment in patients undergoing surgery. If withdrawal of metoprolol is considered desirable, this should, if possible, be completed at least 48 hours before general anaesthesia. Routine initiation of high-dose metoprolol to patients undergoing non-cardiac surgery should be avoided, since it has been associated with bradycardia, hypotension, stroke and increased mortality in patients with cardiovascular risk factors. However in some patients it may be desirable to employ a beta-blocker as premedication. In such cases an anaesthetic with little negative inotropic activity should be selected to minimise the risk of myocardial depression.

•       although contra-indicated in severe peripheral arterial circulatory disturbances (see Section 4.3), may also aggravate less severe peripheral arterial circulatory disorders.

•       may be administered when heart failure has been controlled. Digitalisation and/or diuretic therapy should also be considered for patients with a history of heart failure, or patients known to have a poor cardiac reserve. Betaloc i.v. should be used with caution in patients where cardiac reserve is poor. •may cause patients to develop increasing bradycardia, in such cases the Betaloc i.v. dosage should be reduced or gradually withdrawn.

•       due to the negative effect on conduction time, should only be given with caution to patients with first-degree heart block.

•       may increase the number and duration of angina attacks in patients with Prinzmetal’s angina, due to unopposed alpha-receptor mediated coronary artery vasoconstriction. Betaloc i.v. is a beta₁-selective beta-blocker; consequently, its use may be considered although utmost caution must be exercised.

•       metoprolol should be administered with caution to patients with diabetes mellitus, especially those who are receiving insulin or oral hypoglycaemic agents. Beta-blockers, including metoprolol, may mask some important warning signs that occurs with hypoglycaemia such as the tachycardia; other symptoms such as dizziness and sweating may not be significantly suppressed, and sweating may even be increased. During treatment with metoprolol, there is the risk of masking hypoglycaemia or interfering with carbohydrate metabolism. Both effects may even be higher with non-selective β-blockers. Beta-blockers could further increase the risk of severe hypoglycaemia when used concurrently with sulfonylureas. Diabetic patients should be advised to carefully monitor blood glucose levels (see Section 4.5).

•       may mask the symptoms of thyrotoxicosis.

•       may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions. Although cardioselective beta-blockers may have less effect on lung function than non-selective beta-blockers, as with all beta-blockers, these should be avoided in patients with reversible obstructive airways disease unless there are compelling clinical reasons for their use. When administration is necessary, these patients should be kept under close surveillance. The use of a beta₂-bronchodilator (e.g. terbutaline) may be advisable in some patients. The dosage of the beta₂-agonist may require an increase when treatment with Betaloc i.v. is commenced.

The label shall state - “Use with caution in patients who have a history of wheezing, asthma or any other breathing difficulties, see enclosed user leaflet.”

Like all beta-blockers, careful consideration should be given to patients with psoriasis before Betaloc i.v. is administered.

In patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly.

In labile and insulin-dependent diabetes it may be necessary to adjust the hypoglycaemic therapy.

Intravenous administration of calcium antagonists of the verapamil type should not be given to patients treated with beta-blockers.

The initial treatment of severe malignant hypertension should be so designed as to avoid sudden reduction in diastolic blood pressure with impairment of autoregulatory mechanisms.

This medicinal product contains less than 1 mmol sodium (23mg) per ampoule, that is to say essentially ‘sodium-free’.

Interaction with other medicinal products and other forms of interaction

Metoprolol is a metabolic substrate for the Cytochrome P450 isoenzyme CYP2D6. Drugs that act as enzyme-inducing and enzyme-inhibiting substances may exert an influence on the plasma level of metoprolol. Enzyme inducing agents (e.g. rifampicin) may reduce plasma concentrations of Betaloc i.v. whereas enzyme inhibitors (e.g. cimetidine, alcohol and hydralazine) may increase plasma concentrations. Patients receiving concomitant treatment with sympathetic ganglion blocking agents, other beta blockers (i.e. eye drops), or Mono Amine Oxidase (MAO) inhibitors should be kept under close surveillance.

If concomitant treatment with clonidine is to be discontinued, Betaloc i.v. should be withdrawn several days before clonidine.

Increased negative inotropic and chronotropic effects may occur when metoprolol is given together with calcium antagonists of the verapamil and diltiazem type. In patients treated with beta-blockers intravenous administration of calcium antagonists of the verapamil-type should not be given.

Beta-blockers may enhance the negative inotropic and negative dromotropic effect of antiarrhythmic agents (of the quinidine type and amiodarone).                         

Digitalis glycosides, in association with beta-blockers, may increase atrioventricular conduction time and may induce bradycardia.

In patients receiving beta-blocker therapy, inhalation anaesthetics enhance the cardiodepressant effect.

Concomitant treatment with indometacin and other prostaglandin synthetase inhibiting drugs may reduce the antihypertensive effect of beta-blockers.

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.

Betaloc i.v. will antagonise the beta₁-effects of sympathomimetic agents but should have little influence on the bronchodilator effects of beta₂-agonists at normal therapeutic doses.

Metoprolol may impair the elimination of lidocaine.

As with other beta-blockers, concomitant therapy with dihydropyridines e.g.nifedipine, may increase the risk of hypotension, and cardiac failure may occur in patients with latent cardiac insufficiency.

The dosages of oral antidiabetic agents and also of insulin may have to be readjusted in patients receiving beta-blockers.

 As beta-blockers may affect the peripheral circulation, care should be exercised when drugs with similar activity e.g. ergotamine are given concurrently.

The effects of Betaloc i.v. and other drugs with an antihypertensive effect on blood pressure are usually additive. Care should be taken when combining with other antihypertensive drugs or drugs that might reduce blood pressure such as tricyclic antidepressants, barbiturates and phenothiazines.However, combinations of antihypertensive drugs may often be used with benefit to improve control of hypertension.

Antidiabetic drugs and insulin

Beta blockers may interfere with the normal hemodynamic response to hypoglycaemia. In diabetic patients who use insulin, beta blocker treatment may be associated with increased or prolonged hypoglycaemia. Regular monitoring of blood glucose is therefore necessary. Moreover, the concomitant use of beta-blockers with sulfonylureas could increase the risk of severe hypoglycaemia (see Section 4.4). The dosages of oral antidiabetics may have to be readjusted in patients receiving beta-blockers (see Section 4.4).

Date of revision of the text

10th Aug 2026

Warnings and precautions

Talk to your doctor or nurse before using Betaloc Injection if:

·      You have asthma, wheezing or any other similar breathing problems, or you get allergic reactions, for example to insect stings, foods or other substances. If you have ever had asthma or wheezing, do not have this medicine without first checking with your doctor.

·      You have a type of chest pain (angina) called Prinzmetal's angina.

·      You have poor blood circulation or controlled heart failure.

·      You have first-degree heart block.

·      You have problems with your liver.

·      You have diabetes and are on medication to treat diabetes (see section “Other medicines and Betaloc Injection”), this medicine could interfere with sugar metabolism or mask the signs and symptoms of low blood sugar levels (hypoglycaemia), particularly accelerated heartbeats (tachycardia). Inform your doctor if you use insulin or another antidiabetic as your doctor should monitor your blood glucose levels at shorter intervals. 

·      You have thyrotoxicosis (a condition caused by an overactive thyroid gland). Your medicine may hide the symptoms of thyrotoxicosis.

·      You have or have ever had psoriasis (a skin condition).

Other medicines and Betaloc Injection

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Betaloc Injection can affect the way some other medicines work and some medicines can have an effect on Betaloc Injection.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

·      Clonidine (for high blood pressure or migraine). If you are taking clonidine and Betaloc Injection together, do not stop taking clonidine unless your doctor tells you to do so. If you have to stop taking clonidine or Betaloc Injection, your doctor will give you careful instructions about how to do it.

·      Medicines called Mono-Amine Oxidase Inhibitors (MAOIs).

·      Verapamil, diltiazem or nifedipine (for high blood pressure or chest pain).

·      Quinidine, amiodarone or digoxin (for heart problems).

·      Hydralazine (for high blood pressure).

·      Medicines for stomach ulcers (such as cimetidine).

·      Medicines for infections caused by bacteria (such as rifampicin).

·      Adrenaline, also known as epinephrine (a medicine that stimulates the heart).

·      Medicines for pain, inflammation and arthritis (such as indometacin and celecoxib).

·      Medicines for depression.

·      Medicines for mental illness (such as phenothiazine).

·      Barbiturates (a type of sedative).

·      Anti-histamines (medicines for hay fever and allergies).

·      Other beta-blocker medicines used as eye drops (such as timolol).

·      Medicines used to treat diabetes (insulin or oral antidiabetics). In diabetics, who are being treated with insulin, Betaloc Injection may be associated with an increased or prolonged lowering of blood glucose levels (hypoglycaemia). In particular, Betaloc Injection could increase the risk of severe hypoglycaemia when used with certain type of antidiabetic drugs called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide). Your doctor may adjust the dosage of your anti-hyperglycaemic medicine as appropriate.

·      Lidocaine (a local anaesthetic).

·      Ergotamine medicines (for migraines).

This leaflet was last revised in Aug 2026

6.3                Shelf life

Unopened pack: 5 years.

The product should be used immediately after opening.

10.         Date of revision of the text

 February 2024

6.3      Shelf life

Unopened pack: 5 years.

The product should be used immediately after opening.

This leaflet was last revised in February 2024

Section 2- Editorial changes to bring in line with QRD template

Section 4.2- Editorial changes to bring in line with QRD template

Section 4.4- correction in spelling of haemodynamic

Section 4.6 Editorial changes to bring in line with QRD template

Section 5.1 Correction in spelling of pharmacotherapeutic

Section 9 Editorial changes to bring in line with QRD template

Section 10 Change to revision date

- QRD update – editorial changes to number of sections in the SmPC

- Section 4.6 updated in line with QRD template, addition of following: ‘In general, beta-blockers reduce placental perfusion, which has been associated has been associated with growth retardation, intrauterine death, abortion and early labour. It is therefore suggested that appropriate maternofoetal monitoring be performed in pregnant women treated with Betaloc’

-section 4.8 ADR wording updated with correct address for HPRA

-section 10 updated date of revision

Section 4.3 addition of ‘unless a permanent pacemaker is in place’ after sick sinus syndrome and formatting changes

Section 4.8 Addition of adverse event reporting statement

Section 4.9 Amendment to symptoms and management text for overdose

Section 10 – Update to "Date of Revision"

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

Change of text to section:

For single use only. Discard any unused contents.

Section 9

Renewal authorisation:

2^nd May 2008

Section 10

New revision date of text: 19^th May 2010

Section 4.5- 6^th & 7^th 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;  12^th September 2006