Betaloc I.V. injection – patient leaflet, side effects, dosage

1. What Betaloc Injection is and what it is used for

The name of your medicine is Betaloc 1 mg/ml Solution for Injection (called Betaloc Injection in the rest of this leaflet). Betaloc Injection contains a medicine called metoprolol tartrate. This belongs to a group of medicines called beta-blockers. Betaloc Injection is used:

• To treat uneven heart beats (arrhythmias).
• After a heart attack (myocardial infarction).

It works by making your heart beat more slowly and with less force.

2. What you need to know before you use Betaloc Injection

Do not have Betaloc Injection

• If you are allergic to metoprolol tartrate or any of the other ingredients of this medicine (listed in Section 6).
• If you are allergic to any other beta-blocker medicines (such as atenolol or propranolol).

• If you have ever had any of the following heart problems:

  • heart attack with shock
  • heart failure which is not under control (this usually makes you breathless and causes your ankles to swell)
  • second- or third-degree heart block (a condition which may be treated by a pacemaker)
  • very slow or very uneven heart beats (unless a permanent pacemaker is in place).
• If you have low blood pressure which may make you feel faint.
• If you have very poor circulation.
• If you have a tumour called phaeochromocytoma that is not being treated. This is usually near your kidney and can cause high blood pressure. If you are being treated for phaeochromocytoma your doctor will give you another medicine called an alpha-blocker, to take as well as your Betaloc Injection.

• If you have been told that you have higher than normal levels of acid in your blood (metabolic acidosis).

  If any of the above apply to you, do not have Betaloc Injection. If you are not sure, talk to your doctor or nurse before having Betaloc Injection.

  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. Your treatment for diabetes may need to be adjusted.
  • 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).

If any of the above apply to you, or if you are not sure, talk to your doctor or nurse before having Betaloc Injection.

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).
• Insulin or medicines that you take by mouth for diabetes. Your doctor may need to adjust your dose of these medicines.
• Lidocaine (a local anaesthetic).
• Ergotamine medicines (for migraines).

Operations

If you go into hospital or to the dentist to have an operation, tell the anaesthetist, medical staff or dentist that you are having Betaloc Injection. This is because you can

get low blood pressure (hypotension) if you are given certain anaesthetics while you are having Betaloc Injection.

Betaloc Injection with food, drink and alcohol

Before having Betaloc Injection, inform your doctor or nurse if you have recently had alcohol. This is because alcohol can affect how the medicine works.

Pregnancy, breast-feeding and fertility

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine. Beta-blockers including Betaloc Injection may cause harm to the foetus and early labour.
• If you become pregnant while having Betaloc Injection, talk to your doctor as soon as possible.

Driving and using machines

If you feel dizzy or tired after having this medicine, do not drive or use any tools or machines.

Betaloc Injection contains sodium

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

3. How to use Betaloc Injection

Adults

Betaloc Injection will be given to you by a doctor or a nurse. It will be given to you as an injection into your vein. Your doctor will decide how much to give you. The amount depends on your illness.

Use in children

Your medicine must not be given to children.

If you use more Betaloc Injection than you should

If you think you have been given too much of this medicine, talk to your doctor or nurse straight away.

If you stop using Betaloc Injection

Your doctor or nurse will let you know when to stop having this medicine. You may need to stop having it gradually.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Very common (may affect more than 1 in 10 people)

• Feeling tired.

Common (may affect up to 1 in 10 people)

• You may notice that your pulse rate becomes slower while you are having Betaloc Injection. If this happens tell your doctor as soon as possible. Your doctor may need to lower your dose of Betaloc Injection or you may need to stop having it gradually.

• Pounding heart beat.

  Medical Information Leaflet

  Betaloc 1 mg/ml Solution for Injection

  metoprolol tartrate

  1. 1. Name of the Medicinal Product

Betaloc 1 mg/ml Solution for Injection

1. 2. Qualitative and Quantitative Composition

Each 1 ml of solution contains 1 mg metoprolol tartrate.

Each ampoule of 5 ml contains 5 mg metoprolol tartrate.

For the full list of excipients, see section 6.1.

1. 3. Pharmaceutical Form

Solution for Injection (Injection).

Clear, colourless, liquid.

1. 4. Clinical Particulars

4.1 Therapeutic indications

Control of tachyarrhythmias, especially supraventricular tachyarrhythmias. The electrocardiogram should be monitored while undergoing treatment.

Early intervention with Betaloc Injection in acute myocardial infarction reduces infarct size and the incidence of ventricular fibrillation. Pain relief may also decrease the need for opiate analgesics.

Betaloc Injection has been shown to reduce mortality when administered to patients with acute myocardial infarction.

4.2 Posology and method of administration

Posology

The dose must always be adjusted to the individual requirements of the patient. The following are guidelines:

Cardiac arrhythmias: Initially up to 5 mg injected intravenously at a rate of 1-2 mg per minute. The injection can be repeated at 5 minute intervals until a satisfactory response has been obtained. A total dose of 10-15 mg generally proves sufficient.

Because of the risk of a pronounced drop of blood pressure, the i.v. administration of Betaloc to patients with a systolic blood pressure below 100 mmHg should only be given with special care. During anaesthesia: 2-4 mg injected slowly i.v. at induction is usually sufficient to prevent the development of arrhythmias during anaesthesia. The same dosage can also be used to control arrhythmias developing during anaesthesia. Further injections of 2 mg may be given as required to a maximum overall dose of 10 mg.

Myocardial infarction: Early intervention. To achieve optimal benefits from intravenous Betaloc, suitable patients should present within 12 hours of the onset of chest pain. Intravenous Betaloc Injection should be initiated in a coronary care or similar unit when the patient’s haemodynamic condition has stabilised. Therapy should commence with 5 mg i.v. every 2 minutes to a maximum of 15 mg total as determined by blood pressure and heart rate. The second or third dose should not be given if the systolic blood pressure is < 90 mmHg, the heart rate is < 40 beats/min and the P-Q time is > 0.26 seconds, or if there is any aggravation of dyspnoea or cold sweating.

Oral therapy should commence 15 minutes after the last injection with 50 mg every 6 hours for 48 hours. Patients who fail to tolerate the full intravenous dose should be given half the suggested oral dose.

Renal impairment: Dose adjustment is generally not needed in patients with impaired renal function.

Hepatic impairment: Dose adjustment is normally not needed in patients suffering from liver cirrhosis because metoprolol has a low protein binding (5-10%). However, in patients with severe hepatic dysfunction a reduction in dosage may be necessary.

Elderly: Several studies indicate that age-related physiological changes have negligible effects on the pharmacokinetics of metoprolol. Dose adjustment is not needed in the elderly, but careful dose titration is important in all patients.

Paediatric population: The safety and efficacy of metoprolol in children has not been established.

4.3 Contraindications

Betaloc Injection, as with other beta-blockers, should not be used in patients with any of the following:

• Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.
• Hypotension.
• AV block of second- or third-degree.

• Unstable decompensated cardiac failure (pulmonary oedema, hypoperfusion or

  hypotension).

• Continuous or intermittent inotropic therapy acting through beta-receptor agonism.
• Bradycardia (<45 bpm).
• Sick sinus syndrome (unless a permanent pacemaker is in place).
• Cardiogenic shock.
• Severe peripheral arterial circulatory disorders.
• Untreated phaeochromocytoma.
• Metabolic acidosis.

Known hypersensitivity to any component of Betaloc Injection or other beta-blockers. Betaloc Injection is also contraindicated when suspected acute myocardial infarction is complicated by bradycardia (<45 bpm), first-degree heart block (the P-Q interval is >0.24 sec) or systolic blood pressure <100 mmHg and/or severe heart failure.

4.4 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 injection

  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 injection 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.

• may mask the early signs of acute hypoglycaemia, in particular tachycardia. During

  treatment with Betaloc i.v., the risk of interfering with carbohydrate metabolism or masking hypoglycaemia is less than with non-selective beta-blockers.

  • 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’.

4.5 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.

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• Dizziness (particularly when standing up, may sometimes cause fainting).
• Headache.
• Shortness of breath on effort.
• Feeling sick (nausea).
• Stomach ache.
• Diarrhoea or constipation.
• Cold hands and feet.

Uncommon (may affect up to 1 in 100 people).

• Depression.
• Difficulty going to sleep.
• Nightmares.
• Difficulty concentrating.
• Feeling sleepy.
• Sensation of burning, prickling or numbness.
• Heart changes shown on an ECG.
• Severe drop in blood pressure during a heart attack (cardiogenic shock).
• Feeling of tightness in the airways.
• Being sick (vomiting).
• Skin rash.
• Increased sweating.
• Muscle cramps.
• Chest pain.
• Swelling.
• Weight gain.

Rare (may affect up to 1 in 1,000 people)

• Feeling anxious or nervous.
• Disturbances of vision.
• Dry or irritated eyes.
• Uneven heart beat.
• Numbness and spasm in your fingers (Raynaud’s disease).
• Allergic reactions. The signs may include runny nose and red or watery eyes.
• Dry mouth.
• Thinning of your hair.
• Being unable to get an erection (impotence).
• Liver problems (shown in a blood test).

Very rare (may affect up to 1 in 10,000 people)

• Changes to some of the cells or other parts of your blood. Your doctor may take blood samples every so often to check whether Betaloc Injection has had any effect on your blood.
• Reduced numbers of platelets in the blood. This may make you bruise more easily.
• Confusion.
• Hallucinations.
• Loss of memory or problems with memory.
• Changes to taste.
• Ringing in the ears.
• Inflammation of the liver (hepatitis).
• Skin reaction due to increased sensitivity to sunlight.

• Pain in joints.

  Conditions that may get worse

  If you have any of the following conditions, they may get worse when you start to have your medicine:

  • Being short of breath, feeling tired or having swollen ankles (if you have heart failure) may get worse for a while. This is uncommon affecting less than 1 in 100 people.
  • Psoriasis (a skin condition) and poor circulation may get worse. This is very rare affecting less than 1 in 10,000 people.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Betaloc Injection

• The doctor and hospital pharmacist are responsible for storing, using and disposing of Betaloc Injection correctly.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and ampoule label after EXP. The expiry date refers to the last day of that month.
• Do not store above 25 ºC. Keep the ampoules in the outer carton in order to protect from light.
• This medicine should be used immediately after opening.
• Do not take this medicine if the packaging is torn or damaged.
• Betaloc 1 mg/ml Solution for Injection is a clear, colourless liquid. Do not use this medicine if it does not match this description.

6. Contents of the pack and other information

What Betaloc Injection contains

The active substance is metoprolol tartrate. Each 1 ml of solution contains 1 mg metoprolol tartrate. Each ampoule of 5 ml contains 5 mg metoprolol tartrate. The other ingredients are sodium chloride and water for injections.

What Betaloc Injection looks like and contents of the pack

Betaloc Injection is a clear colourless liquid which comes in glass ampoules. Each pack contains 5 ampoules.

Marketing Authorisation Holder

Recordati Ireland Ltd., Raheens East, Ringaskiddy, Co. Cork, Ireland.

Manufacturer

CIT S.r.l., Via Primo Villa, 17, 20875 Burago di Molgora (MB), Italy.

This leaflet was last revised in January 2025

XXXX A 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.

4.6 Fertility, pregnancy and lactation

Pregnancy

Betaloc Injection should not be used in pregnancy or nursing mothers unless the physician considers that the benefit outweighs the possible hazard to the foetus/infant. In general, beta-blockers reduce placental perfusion, which 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 Injection. As with all beta-blockers, Betaloc Injection may cause side effects especially bradycardia and hypoglycaemia in the foetus, and in the newborn and breast-fed infant. There is an increased risk of cardiac and pulmonary complications in the neonate.

Betaloc Injection has, however, been used in pregnancy-associated hypertension under close supervision, after 20 weeks gestation. Although Betaloc Injection crosses the placental barrier and is present in the cord blood, as yet no evidence of foetal abnormalities has been reported. Breast-feeding

Breast-feeding is not recommended. The amount of metoprolol ingested via breast milk should not produce significant beta-blocking effects in the neonate if the mother is treated with normal therapeutic doses.

4.7 Effects on ability to drive and use machines

Betaloc Injection has a minor influence on the ability to drive and use machines. It should be taken into account that occasionally dizziness or fatigue may occur.

4.8 Undesirable effects

Metoprolol is well tolerated and adverse reactions have generally been mild and reversible. The following events have been reported as adverse events in clinical trials or reported from routine use.

The following definitions of frequencies are used:

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000) and Very rare (<1/10,000).

System Organ Class Frequency Undesirable Effect

Infections and infestations Very rare Gangrene in patients with pre existing severe

peripheral circulatory disorders Blood and lymphatic

system disorders

Very rare Thrombocytopenia

Psychiatric disorders Uncommon Depression, insomnia, nightmares

Rare Nervousness, anxiety

Very rare Confusion, hallucinations

Nervous system disorders Common Dizziness, headache

Uncommon Concentration impairment, somnolence,

paraesthesiae

Very rare Amnesia/memory impairment, taste

disturbances

Eye disorders Rare Disturbances of vision, dry and/or irritated

eyes, conjunctivitis

Ear and labyrinth disorders Very rare Tinnitus

Cardiac disorders Common Bradycardia, palpitations

Uncommon Deterioration of heart failure symptoms,

cardiogenic shock in patients with acute myocardial infarction*, first degree heart block Rare Disturbances of cardiac conduction, cardiac

arrhythmias, increased existing AV block Vascular disorders Common Postural disorders (very rarely with syncope)

Rare Raynauds phenomenon

Very rare Increase of pre-existing intermittent claudication Respiratory, thoracic and

mediastinal disorders

Common Dyspnoea on exertion

Uncommon Bronchospasm

Rare Rhinitis

Gastrointestinal disorders Common Nausea, abdominal pain, diarrhoea, constipation

Uncommon Vomiting

Rare Dry mouth

Hepatobiliary disorders Very rare Hepatitis

Skin and subcutaneous

tissue disorders

Uncommon Rash (in the form of psoriasiform urticaria and

dystrophic skin lesions), increased sweating Rare Loss of hair

Very rare Photosensitivity reactions, aggravated psoriasis Musculoskeletal and

connective tissue disorders

Very rare Arthralgia

Uncommon Muscle cramps

Reproductive system and

breast disorders

Rare Impotence/sexual dysfunction

General disorders and

administration site

disorders

Very common Fatigue

Common Cold hands and feet

Uncommon Precordial pain, oedema

Investigations Uncommon Weight gain

Rare Liver function test abnormalities, positive anti-

nuclear antibodies (not associated with SLE).

* 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 corresponding excess frequency for patients in Killip class I was 0.7% (metoprolol 3.5% and placebo 2.8%). 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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Symptoms

Symptoms of overdose may include hypotension, cardiac insufficiency, bradycardia and bradyarrhythmia, cardiac conduction disturbances and bronchospasm. Management

Care should be provided at a facility that can provide appropriate supporting measures, monitoring and supervision.

Atropine, adrenostimulating drugs or pacemaker to treat bradycardia and conduction disorders.

Hypotension, acute cardiac failure, and shock to be treated with suitable volume expansion, injection of glucagon (if necessary, followed by an intravenous infusion of glucagon), intravenous administration of adrenostimulating drugs such as dobutamine, with α₁ receptor agonistic drugs added in presence of vasodilation. Intravenous use of Ca²⁺ can also be considered.

Bronchospasm can usually be reversed by bronchodilators.

1. 5. Pharmacological Properties

Refer to sections 5.1 – 5.3 of the summary of product characteristics.

1. 6. Pharmaceutical Particulars

6.1 List of excipients

Sodium chloride

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

Unopened pack: 5 years.

The product should be used immediately after opening.

6.4 Special precautions for storage

Do not store above 25°C. Keep the ampoules in the outer carton in order to protect from light.

6.5 Nature and contents of container

Type I, 5 ml glass ampoule. Carton of five ampoules.

6.6 Special precautions for disposal and other handling

For single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

1. 7. Marketing Authorisation Holder

Recordati Ireland Ltd.,

Raheens East

Ringaskiddy

Co. Cork

Ireland.

1. 8. Marketing Authorisation Number

PL 30883/0007

This leaflet was last revised in January 2025

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