BETALOC I.V. INJECTION

Active substance: METOPROLOL TARTRATE

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28043229

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.

• 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 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.

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.

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.

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).

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.
Children
Your medicine must not be given to children.
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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.
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.
Impaired Renal Function: Dose adjustment is generally not needed in
patients with impaired renal function.
Impaired Hepatic Function: 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.
Older people: Several studies indicate that age-related physiological
changes have negligible effects on the pharmacokinetics of metoprolol.
Dose adjustment is not needed in older people, 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 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. Injection 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. 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.
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.

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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 breastfed infant. There is an increased risk of cardiac and pulmonary complications
in the neonate. Betaloc I.V. Injection has, however, been used in pregnancyassociated 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.
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.
4.8 Undesirable effects
The following events have been reported as adverse events in clinical trials
or reported from routine use.
The following definitions of frequencies are used:
9HU\ FRPPRQ •  FRPPRQ • WR   XQFRPPRQ • WR
  UDUH • WR  DQG YHU\ UDUH  
System Organ Class
Frequency
Undesirable Effect
Infections and
Very rare
Gangrene in patients with pre existing
infestations
severe peripheral circulatory disorders
Blood and lymphatic
Very rare
Thrombocytopenia
system disorders
Psychiatric disorders
Uncommon
Depression, insomnia, nightmares
Rare
Nervousness, anxiety
Very rare
Confusion, hallucinations
Nervous system
Common
Dizziness, headache
disorders
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
Very rare
Tinnitus
disorders
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

System Organ Class
Frequency
Respiratory, thoracic and Common
mediastinal disorders
Uncommon
Rare
Gastrointestinal disorders Common

Hepatobiliary disorders
Skin and subcutaneous
tissue disorders

Uncommon
Rare
Very rare
Uncommon
Rare
Very rare

Musculoskeletal and
connective tissue
disorders

Very rare

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

Undesirable Effect
Dyspnoea on exertion
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
Muscle cramps
Impotence/sexual dysfunction
Fatigue
Cold hands and feet
Precordial pain, oedema
Weight gain
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 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
VXFK DV GREXWDPLQH ZLWK Ơ1 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
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Beta blocking agents, selective
ATC code: C07AB02

Mechanism of action
Metoprolol is a competitive beta-adrenoceptor antagonist. It acts preferentially
to inhibit beta-adrenoceptors (conferring some cardioselectivity), is devoid of
intrinsic sympathomimetic activity (partial agonist activity) and possesses betaadrenoceptor blocking activity comparable in potency with propranolol.
Pharmacodynamic effects
A negative chronotrophic effect on the heart is a consistent feature of
metoprolol administration. Thus, cardiac output and systolic blood pressure
rapidly decrease following acute administration.
Clinical efficacy and safety
The intention to treat trial COMMIT included 45,852 patients admitted to
hospital within 24 hours of the onset of symptoms of suspected acute
myocardial infarction with supporting ECG abnormalities (i.e. ST elevation,
ST depression or left bundle-branch block). Patients were randomly
allocated to metoprolol (up to 15 mg intravenous then 200 mg oral) or
placebo and treated until discharge or up to 4 weeks in hospital. The two
co-primary outcomes were: (1) composite of death, reinfarction or cardiac
arrest; and (2) death from any cause during the scheduled treatment period.
Neither of the co-primary outcomes was significantly reduced by metoprolol.
However, metoprolol treatment was associated with fewer people having
reinfarction and ventricular fibrillation but an increased rate of cardiogenic
shock during the first day after admission. There was substantial net hazard
in haemodynamically unstable patients. There was moderate net benefit in
those who were stable, particularly after days 0-1.
5.2 Pharmacokinetic properties
Biotransformation
Metoprolol undergoes oxidative metabolism in the liver primarily by the
CYP2D6 isoenzyme.
Elimination
Metoprolol is eliminated mainly by hepatic metabolism, the average elimination
half-life is 3.5 hours (range 1–9 hours). Rates of metabolism vary between
individuals, with poor metabolisers (approximately 10%) showing higher plasma
concentrations and slower elimination than extensive metabolisers. Within
individuals, however, plasma concentrations are stable and reproducible.
5.3 Preclinical safety data
Preclinical information has not been included because the safety profile of
metoprolol tartrate has been established after many years of clinical use.
Please refer to section 4.
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.

Marketing Authorisation Holder
AstraZeneca UK Limited,
600 Capability Green,
Luton, LU1 3LU, UK.

8.

Marketing Authorisation Number
PL 17901/0106
Leaflet updated: May 2014
© AstraZeneca 2014
Betaloc is a trade mark of the AstraZeneca group of companies.
CV 14 0052

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.
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 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.
• Pounding heart beat.
• 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 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.
Leaflet prepared: May 2014.
© AstraZeneca 2014.
Betaloc is a trade mark of the AstraZeneca group of companies.
CV 14 0052

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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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