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BETALOC I.V. INJECTION

Active substance(s): METOPROLOL TARTRATE / METOPROLOL TARTRATE / METOPROLOL TARTRATE

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28047294

Package leaflet: information for the patient

Betaloc® IV Injection

metoprolol tartrate
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Betaloc IV is and what it is used for
2. What you need to know before you use Betaloc IV
3. How to use Betaloc IV
4. Possible side effects
5. How to store Betaloc IV
6. Contents of the pack and other information
1. What Betaloc IV Injection is and what it is used for
Betaloc IV Injection contains a medicine called metoprolol tartrate.
This belongs to a group of medicines called beta-blockers.
Betaloc IV Injection is used:
• To treat uneven heart beat (arrhythmia).
• After a heart attack.
It works by making your heart beat more slowly and with less force.
2. What you need to know before you use Betaloc IV
Do not have Betaloc IV 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 propanolol).
• 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 IV 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 IV Injection. If you
are not sure, talk to your doctor or nurse before having Betaloc IV Injection.
Warnings and precautions
Talk to your doctor or nurse before using Betaloc IV 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.
• If you have a type of chest pain (angina) called Prinzmetal's
angina.
• If you have poor blood circulation or controlled heart failure.
• If you have first-degree heart block.
• If you have problems with your liver.
• If you have diabetes. Your treatment for diabetes may need to be
adjusted.
• If you have thyrotoxicosis (a condition caused by an overactive
thyroid gland). Your medicine may hide the symptoms of
thyrotoxicosis.
• If you have or have ever had psoriasis (a skin condition).
If you are not sure if any of the above apply to you, talk to your
doctor before having Betaloc IV Injection.
Other medicines and Betaloc IV 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 IV Injection can affect the way some other medicines work
and some medicines can have an effect on Betaloc IV 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 IV Injection together, do not stop taking
clonidine unless your doctor tells you to do so. If you have to
stop taking clonidine or Betaloc IV 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).







 edicines for depression.
M
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 using Betaloc IV Injection.
This is because you can get low blood pressure (hypotension) if you are
given certain anaesthetics while you are taking Betaloc IV Injection.
Betaloc IV Injection with food, drink and alcohol
Before having Betaloc IV 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 IV Injection may cause harm to the foetus and early labour.
• If you become pregnant while having Betaloc IV Injection, talk to
your doctor as soon as possible.
Driving and using machines
If you feel dizzy or tired after using this medicine, do not drive or use
any tools or machines.
3. How to use Betaloc IV Injection
Adults
Betaloc IV 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 IV 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 IV 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.

Please turn over

Medical Information Leaflet

Betaloc® I.V. Injection 1 mg/ml
metoprolol tartrate

1.

Name of the Medicinal Product
Betaloc I.V. Injection.

2.

Qualitative and Quantitative Composition
Each ampoule of 5 ml contains 5 mg Metoprolol tartrate Ph. Eur.
Excipient(s) with known effect
For the full list of excipients, see section 6.1.

3.

Pharmaceutical Form
Solution for Injection.

4. Clinical Particulars
4.1 Therapeutic indications
Control of tachyarrhythmias, especially supraventricular tachyarrhythmias.
Early intervention with Betaloc I.V. 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 I.V. 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 I.V. Injection
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: Intravenous Betaloc I.V. 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 I.V. 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.

Decompensated cardiac failure (pulmonary oedema, hypoperfusion or hypotension).
Continuous or intermittent inotropic therapy acting through beta-receptor agonism.


Bradycardia (<45bpm).

Sick sinus syndrome (unless a permanent pacemaker is in place).

Cardiogenic shock.

Severe peripheral arterial circulatory disorder.

Untreated phaeochromocytoma.

Metabolic acidosis.
Known hypersensitivity to any component of Betaloc I.V. Injection or other beta-blockers.
Betaloc I.V. Injection is also contraindicated when suspected acute myocardial infarction is complicated by
bradycardia (<45bpm), first-degree heart block 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 I.V. Injection, as with other beta-blockers:

should not be withdrawn abruptly during oral treatment. When possible, Betaloc I.V. 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 I.V. 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 contraindicated 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. Injection 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.
Injection 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. Injection 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. Injection, 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 nonselective 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. Injection is commenced.
T he 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. Injection 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.

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

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28047294

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. Injection 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 I.V. 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 intrauterine death,
abortion and early labour. It is therefore suggested that appropriate maternofoetal monitoring
be performed in pregnant women treated with Betaloc I.V. Injection. As with all beta-blockers,
Betaloc I.V. 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 I.V. Injection has, however, been used in
pregnancy-associated hypertension under close supervision, after 20 weeks gestation. Although
Betaloc I.V. Injection crosses the placental barrier and is present in cord blood, 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.

System Organ Class
Eye disorders

Frequency
Rare

Ear and labyrinth disorders Very rare
Cardiac disorders
Common
Uncommon
Rare
Vascular disorders

Respiratory, thoracic and
mediastinal disorders

Gastrointestinal disorders

Hepatobiliary disorders
Skin and subcutaneous
tissue disorders

Common
Rare
Very rare
Common
Uncommon
Rare
Common
Uncommon
Rare
Very rare
Uncommon
Rare
Very rare
Very rare

Bronchospasm
Rhinitis
Nausea, abdominal pain, diarrhoea, constipation
Vomiting
Dry mouth
Hepatitis
Rash (in the form of psoriasiform urticaria and
dystrophic skin lesions), increased sweating
Loss of hair
Photosensitivity reactions, aggravated psoriasis
Arthralgia

Uncommon
Rare

Muscle cramps
Impotence/sexual dysfunction

4.7 Effects on ability to drive and use machines
Betaloc I.V. Injection has minor influence on the ability to drive and use machines. However, it
should be taken into account that occasionally dizziness or fatigue may occur.

Musculoskeletal and
connective tissue disorders

4.8 Undesirable effects
The following events have been reported as adverse events in clinical trials or reported from routine use.

Reproductive system and
breast disorders
General disorders and
Very common
administration site disorders
Common
Uncommon
Investigations
Uncommon
Rare

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
Infections and infestations

Frequency
Very rare

Blood and lymphatic system Very rare
disorders
Psychiatric disorders
Uncommon
Rare
Very rare
Nervous system disorders Common
Uncommon
Very rare

Undesirable Effect
Gangrene in patients with pre existing severe
peripheral circulatory disorders
Thrombocytopenia
Depression, insomnia, nightmares
Nervousness, anxiety
Confusion, hallucinations
Dizziness, headache
Concentration impairment, somnolence,
paraesthesiae
Amnesia/memory impairment, taste disturbances

Undesirable Effect
Disturbances of vision, dry and/or irritated eyes,
conjunctivitis
Tinnitus
Bradycardia, palpitations
Deterioration of heart failure symptoms,
cardiogenic shock in patients with acute
myocardial infarction*, first degree heart block
Disturbances of cardiac conduction, cardiac
arrhythmias, increased existing AV block
Postural disorders (very rarely with syncope)
Raynauds phenomenon
Increase of pre-existing intermittent claudication
Dyspnoea on exertion

Fatigue
Cold hands and feet
Precordial pain, oedema
Weight gain
Liver function test abnormalities, positive antinuclear 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 indicated for use in acute myocardial
infarction.

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 the Yellow
Card Scheme.Website: www.mhra.gov.uk/yellowcard.
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.
5.

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

6. Pharmaceutical Particulars
6.1 List of excipients
Sodium chloride and water for injections.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
4 years.
6.4 Special precautions for storage
Protect from light. Store below 25 °C.
6.5 Nature and contents of container
5 ml glass ampoule.
6.6 Special precautions for disposal
No special requirements.
7.

8.

Marketing Authorisation Holder
AstraZeneca UK Limited,
600 Capability Green,
Luton, LU1 3LU, UK.
Marketing Authorisation Number
PL 17901/0106
This leaflet was last revised in July 2016.
© AstraZeneca 2016
Betaloc is a trade mark of the AstraZeneca group of companies.
CV 16 0075

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)
• Y
 ou may notice that your pulse rate becomes slower while you
are having Betaloc IV Injection. If this happens tell your doctor as
soon as possible. Your doctor may need to lower your dose of
Betaloc IV Injection or you may need to stop having it gradually.
• P
 ounding heart beat.
 izziness (particularly when standing up, may sometimes cause
• D
fainting).
• Headache.
 hortness of breath on effort.
• S
• F
 eeling sick (nausea).
• Stomach ache.
• D
 iarrhoea or constipation.
• C
 old hands and feet.
Uncommon (may affect up to 1 in 100 people).
• Depression.
• D
 ifficulty going to sleep.
• Nightmares.
• Difficulty concentrating.
• Feeling sleepy.
• S
 ensation of burning, prickling or numbness.
• H
 eart changes shown on an ECG.
• S
 evere drop in blood pressure during a heart attack (cardiogenic
shock)
 eeling of tightness in the airways.
• F
• B
 eing sick (vomiting).
• Skin rash.
• Increased sweating.
• Muscle cramps.
• Chest pain.
• Swelling.
• Weight gain.
Rare (may affect up to 1 in 1,000 people)
• F
 eeling anxious or nervous.
• D
 isturbances of vision.
• D
 ry or irritated eyes.
• U
 neven heart beat.
• N
 umbness and spasm in your fingers (Raynaud’s disease).
• A
 llergic reactions. The signs may include runny nose and red or
watery eyes.
• Dry mouth.

• T
 hinning 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 IV 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 take 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this medicine.
5. How to store Betaloc IV Injection
• The doctor and hospital pharmacist are responsible for storing,
using and disposing of Betaloc IV Injection correctly.
• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C. Store your medicine where it is
protected from light.
• This medicine should be used immediately after opening.
• Do not use your medicine after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
6. Contents of the pack and other information
What Betaloc IV Injection contains
The active substance is metoprolol tartrate. Each 5 ml (millilitre)
ampoule contains 5 mg (milligrams) of metoprolol tartrate (this is
equal to 1 mg of metoprolol tartrate per ml).

The other ingredients are sodium chloride and water for injections.
What Betaloc IV Injection looks like and contents of the pack
Betaloc IV Injection comes in ampoules. Each ampoule contains 5 ml of
a clear colourless liquid.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Betaloc IV Injection is held by
AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK.
Betaloc IV Injection is manufactured by CENEXI, 52 rue Marcel et
Jacques Gaucher, 94120 FONTENAY-SOUS-BOIS, France.

To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following
information:
Product name
Betaloc IV Injection
Reference number 17901/0106
This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in July 2016.
© AstraZeneca 2016.
Betaloc is a trade mark of the AstraZeneca group of companies.
CV 16 0075

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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