Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using BETALOC INJECTION?
BETALOC INJECTION contains the active ingredient metoprolol tartrate. BETALOC INJECTION
is used to treat irregular heartbeat, also known as arrhythmia, which means that there
is a disturbance of the heart's normal rhythm or beat.
2. What should I know before I use BETALOC INJECTION?
Do not use BETALOC INJECTION if you have ever had an allergic reaction to metoprolol
tartrate or any of the ingredients listed at the end of the CMI, you have asthma,
wheezing, difficulty breathing or other lung problems, or have had them in the past,
you have a history of allergic problems, including hayfever, you have low blood pressure,
you have a very slow heartbeat (less than 45-50 beats/minute), you have certain other
heart conditions, you have phaeochromocytoma (a rare tumour of the adrenal gland)
which is not being treated already with other medicines, you have a severe blood vessel
disorder causing poor circulation in the arms and legs or if you are receiving/having
emergency treatment for shock or severely low blood pressure.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with BETALOC INJECTION and affect how it works.
4. How do I use BETALOC INJECTION?
BETALOC INJECTION is given as a slow injection into a vein.
BETALOC INJECTION must only be given by a doctor or nurse.
Your doctor will decide what dose and for how long you will receive BETALOC INJECTION.
This depends on your condition and other factors, such as your weight.
5. What should I know while using BETALOC INJECTION?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using BETALOC INJECTION.
Tell your doctor if you experience any side effects, including those not listed in
this leaflet.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how BETALOC
INJECTION affects you.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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6. Are there any side effects?
All medicines can have side effects. If you do experience side effects, most of them
are minor and temporary. However some side effects may be serious and may need urgent
medical attention or hospitalisation such as shortness of breath, being less able
to exercise, swelling of the ankles, feet or legs, chest tightness, wheezing, noisy
breathing, difficulty breathing, chest pain, changes in heart rate or palpitations,
swelling of the face, lips, tongue or throat which may cause difficulty swallowing
or breathing, yellowing of the skin or eyes (jaundice) and generally feeling unwell.
Active ingredient(s):
metoprolol tartrate
Consumer Medicine Information (CMI)
This leaflet provides important information about using BETALOC INJECTION. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using BETALOC INJECTION.
Where to find information in this leaflet:
1. Why am I using BETALOC INJECTION?
BETALOC INJECTION contains the active ingredient metoprolol tartrate. BETALOC INJECTION belongs to a group of medicines called beta-blockers.
BETALOC INJECTION is used to treat irregular heartbeat, also known as arrhythmia,
which means that there is a disturbance of the heart's normal rhythm or beat.
Arrhythmias may be caused by a number of factors, including some heart diseases, an
overactive thyroid gland, or chemical imbalances. Also, after a heart attack there
is a chance of developing arrhythmias.
BETALOC INJECTION helps to restore your heart beat to a more normal rate, particularly
if it is beating very fast.
2. What should I know before I use BETALOC INJECTION?
Warnings
Do not use BETALOC INJECTION if:
you are allergic to metoprolol tartrate, or any of the ingredients listed at the end
of this leaflet.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing
or difficulty breathing; swelling of the face, lips, tongue or other parts of the
body; rash, itching or hives on the skin or you may feel faint.
always check the ingredients to make sure you can use this medicine.
you have asthma, wheezing, difficulty breathing or other lung problems, or have had
them in the past
you have a history of allergic problems, including hayfever
you have low blood pressure
you have a very slow heartbeat (less than 45-50 beats/minute)
you have certain other heart conditions
you have phaeochromocytoma (a rare tumour of the adrenal gland) which is not being
treated already with other medicines
you have a severe blood vessel disorder causing poor circulation in the arms and legs
you are receiving/having emergency treatment for shock or severely low blood pressure.
If you are not sure whether any of these apply to you, check with your doctor.
Check with your doctor if you:
have any other medical conditions, especially the following:
asthma, wheezing, difficulty breathing or other lung problems
diabetes
an overactive thyroid gland
liver problems
kidney problems
certain types of angina
any other heart problems
phaeochromocytoma, a rare tumour of the adrenal gland
any blood vessel disorders causing poor circulation in the arms and legs
take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Like most beta-blocker medicines BETALOC INJECTION is not recommended for use during
pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
The active ingredient in BETALOC INJECTION passes into breast milk and therefore there
is a possibility that the breast-fed baby may be affected.
Children and adolescents
Do not give BETALOC INJECTION to children.
The safety and effectiveness of BETALOC INJECTION in children has not been established.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and BETALOC INJECTION may interfere with each other. These include:
other beta-blocker medicines, including beta-blocker eye drops
calcium channel blockers or calcium antagonists, medicines used to treat high blood
pressure and angina, for example verapamil and diltiazem
medicines used to treat high blood pressure, for example clonidine, hydralazine, and
prazosin
medicines used to treat abnormal or irregular heartbeat, for example amiodarone, disopyramide
and quinidine
medicines used to treat arthritis, pain, or inflammation, for example indomethacin
and ibuprofen
warfarin, a medicine used to prevent blood clots
digoxin, a medicine used to treat heart failure
medicines used to treat diabetes
cimetidine, a medicine used to treat stomach ulcers
medicines used to treat bacterial infections, for example rifampicin
medicines used to treat depression
monoamine-oxidase inhibitors (MAOIs).
These medicines may be affected by BETALOC INJECTION or may affect how well it works.
You may need to be given different amounts of your medicine, or you may need to be
given different medicines. Your doctor will advise you.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while using BETALOC INJECTION.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BETALOC INJECTION.
4. How BETALOC INJECTION is given?
How you are given BETALOC INJECTION
BETALOC INJECTION is given as a slow injection into a vein.
BETALOC INJECTION must only be given by a doctor or nurse.
Your doctor will decide what dose and for how long you will receive BETALOC INJECTION.
This depends on your condition and other factors, such as your weight.
To begin treatment, up to 5 mg of BETALOC INJECTION is given at a rate of 1 to 2mg
per minute. This dose may be repeated at 5-minute intervals until a satisfactory effect
is achieved.
Your blood pressure and heart will be monitored during the treatment.
If you use too much BETALOC INJECTION
The doctor giving you BETALOC INJECTION will be experienced in its use, so it is unlikely
that you will be given an overdose.
However, if you are accidentally given an overdose of BETALOC INJECTION you may have
nausea, vomiting, convulsions, extreme slowing of the heart beat, lowered blood pressure,
possible heart failure and breathing difficulties. In extreme cases, your skin may
turn blue, and you may get shock, unconsciousness or coma.
Your doctor has further information on how to recognise and treat an overdose. Ask
your doctor if you have any concerns.
If you believe that you have been given too much BETALOC INJECTION, you should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using BETALOC INJECTION?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using BETALOC INJECTION.
Tell your doctor if you experience any side effects, including those not listed in
this leaflet.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BETALOC
INJECTION affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
BETALOC INJECTION will be stored in the pharmacy or in the ward.
The injection is kept in a cool dry place, protected from light, where the temperature
stays below 25°C.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date or damaged, take it
to any pharmacy for safe disposal.
BETALOC INJECTION should not be used if the expiry date printed on the pack has passed
or if the packaging is torn or shows signs of tampering.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
If you are over 65 years of age you may have an increased chance of getting side effects.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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swelling, burning sensation, changes in skin colour or texture where you had the injection
swelling or pain in a vein
headache, tiredness, drowsiness
aches and pains, painful joints
nausea (feeling sick), vomiting
weakness, lack of energy
stomach upset, diarrhoea or constipation
dry mouth, changes in taste sensation
difficulty sleeping, nightmares
mood changes
confusion, short-term memory loss, inability to concentrate
increased sweating, runny or blocked nose
hair loss
weight gain.
These side effects are usually mild.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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dizziness, lightheadedness or fainting especially on standing up, which may be due
to low blood pressure
tingling or "pins and needles"
coldness, burning, numbness or pain in the arms and/or legs
skin rash or worsening of psoriasis
symptoms of sunburn happening more quickly than before
abnormal thinking or hallucinations
buzzing or ringing in the ears, deafness
irritated eyes or blurred vision
sexual problems
unusual bleeding or bruising
constant "flu-like" symptoms with tiredness or lack of energy.
Serious side effects are rare.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects. You may need urgent
medical attention.
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Very serious side effects
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Very serious side effects
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What to do
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shortness of breath, being less able to exercise
swelling of the ankles, feet or legs
chest tightness, wheezing, noisy breathing, difficulty breathing
chest pain, changes in heart rate or palpitations
swelling of the face, lips, tongue or throat which may cause difficulty swallowing
or breathing
yellowing of the skin or eyes (jaundice), generally feeling unwell.
Very serious side effects are rare.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these very serious side effects.
You may need urgent medical attention or hospitalisation.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems.
By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What BETALOC INJECTION contains
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Active ingredient
(main ingredient)
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metoprolol tartrate
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Other ingredients
(inactive ingredients)
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sodium chloride, water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What BETALOC INJECTION looks like
BETALOC INJECTION (1 mg/ mL) is a clear, colourless liquid in glass ampoules of 5
mL, in packs of 5 (Aust R 12063).
Who distributes BETALOC INJECTION
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
This leaflet was prepared in August 2024.
BETALOC® is a registered trademark of the AstraZeneca group of companies.
© AstraZeneca, 2024
VV-RIM-04911960 v3.0