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 TOPROL-XL?
TOPROL-XL contains the active ingredient metoprolol succinate. TOPROL-XL is used to
treat heart failure. It is used in combination with other medicines to treat your
condition.
2. What should I know before I use TOPROL-XL?
Do not use TOPROL-XL if you have ever had an allergic reaction to TOPROL-XL or any
of the ingredients listed at the end of the CMI, have or have had asthma, difficulty
in breathing, wheezing, bronchitis or other lung problems in the past, have a history
of allergic problems, including hayfever, have low blood pressure, have a very slow
heartbeat, certain other heart conditions, have phaeochromocytoma which is not being
treated already with other medicines, have a severe blood vessel disorder causing
poor circulation in the arms and legs or 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
including those not requiring prescription, or are pregnant or plan to become pregnant
or are breastfeeding.
3. What if I am taking other medicines?
4. How do I use TOPROL-XL?
The usual starting dose is half a 23.75 mg or a whole 23.75 mg tablet once a day for
one to two weeks. The dose is then usually doubled every second week up to a maximum
dose of 190 mg once daily or to the highest tolerated dose.
TOPROL-XL tablets may be broken in half or swallowed whole with a glass of water as
directed by your doctor. TOPROL-XL tablets should not be chewed or crushed. More
instructions can be found in Section
4. How do I use TOPROL-XL? in the full CMI.
5. What should I know while using TOPROL-XL?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using TOPROL-XL.
Be sure to keep all of your doctor's appointments so that your progress can be checked.
If you have to have any medical tests while you are taking TOPROL-XL, tell your doctor.
If you feel a worsening of your condition in the early stages of taking TOPROL-XL,
tell your doctor immediately.
If you are being treated for diabetes, make sure you check your blood sugar level
regularly and report any changes to your doctor.
Tell your doctor immediately if you become pregnant while taking TOPROL-XL or develop
any severe allergic reaction to foods, medicines or insect stings.
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Things you should not do
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Do not stop using this medicine suddenly without checking with your doctor.
Do not use TOPROL-XL to treat any other complaints unless your doctor tells you to.
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Looking after your medicine
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Keep your tablets in the blister pack until it is time to take them.
Keep the tablets in a cool dry place where the temperature stays below 30°C.
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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 could require
urgent medical attention or hospitalisation.
Active ingredient: metoprolol succinate
Consumer Medicine Information (CMI)
This leaflet provides important information about using TOPROL-XL. 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 TOPROL-XL.
Where to find information in this leaflet:
1. Why am I using TOPROL-XL?
TOPROL-XL contains the active ingredient metoprolol succinate. TOPROL-XL belongs to a group of medicines called beta-blockers. It works by affecting
the body's response to some nerve impulses, especially in the heart. As a result,
it decreases the heart's need for blood and oxygen and therefore reduces the amount
of work the heart has to do. It also helps the heart to beat more regularly.
TOPROL-XL tablets are used to treat heart failure. It is used in combination with
other medicines to treat your condition.
2. What should I know before I use TOPROL-XL?
Warnings
Do not use TOPROL-XL if:
you are allergic to metoprolol succinate, or any of the ingredients listed at the
end of this leaflet, or any other beta-blocker medicine or substances such as foods,
preservatives or dyes.
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 or have had asthma, difficulty in breathing, wheezing, bronchitis or other
lung problems 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
Check with your doctor if you:
are not sure whether any of the above apply to you
have any other medical conditions, especially the following:
asthma or other lung problems, even if you have had them in the past
allergic problems, including hayfever
diabetes
very slow heart beat (less than 45-50 beats/minute)
severe blood vessel disorder causing poor circulation in the arms and legs
liver problems
kidney problems
certain types of angina
any other heart problems
phaeochromocytoma, a rare tumour of the adrenal gland
hyperthyroidism (an overactive thyroid gland)
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, TOPROL-XL is not recommended for use during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
The active ingredient in TOPROL-XL passes into breast milk and therefore there is
a possibility that the breast-fed baby may be affected.
Children and adolescents
Do not give TOPROL-XL to children.
The safety and effectiveness of TOPROL-XL 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 TOPROL-XL 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
digoxin, a medicine used to treat heart failure
medicines used to treat diabetes
medicines used to treat bacterial infections, for example rifampicin
cimetidine, a medicine used to treat stomach ulcers
medicines used to treat depression
warfarin, a medicine used to prevent blood clots
monoamine-oxidase inhibitors (MAOIs)
These medicines may be affected by TOPROL-XL or may affect how well it works. You
may need to take different amounts of your medicine, or you may need to take different
medicines. Your doctor will advise you.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking TOPROL-XL.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TOPROL-XL.
4. How do I use TOPROL-XL?
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist.
How much to take
The usual starting dose is half a 23.75 mg or a whole 23.75 mg tablet once a day for
one to two weeks. The dose is then usually doubled every second week up to a maximum
dose of 190 mg once daily or to the highest tolerated dose.
TOPROL-XL tablets may be broken in half or swallowed whole with a glass of water as
directed by your doctor. TOPROL-XL tablets should not be chewed or crushed.
If you are taking other medicines your doctor may need to change the dose of them
to obtain the best results for you.
When to take TOPROL-XL
Take your medicine at about the same time each day, preferably together with the morning
meal.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
How long to take TOPROL-XL
Continue taking your medicine for as long as your doctor tells you. This medicine
helps to control your condition, but does not cure it.
It is important to keep taking your medicine even if you feel well.
DO NOT STOP TAKING TOPROL-XL TABLETS SUDDENLY.
The dose needs to be reduced slowly over 7 to 14 days to make sure that your condition
does not get worse.
Your doctor will tell you how to gradually reduce the dose before stopping completely.
If you forget to use TOPROL-XL
TOPROL-XL should be used regularly at the same time each day. If you miss your dose
at the usual time, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do or have trouble remembering when to take your medicine,
ask your doctor or pharmacist.
If you use too much TOPROL-XL
If you think that you have used too much TOPROL-XL, you may need urgent medical attention.
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.
If you take too many TOPROL-XL tablets your blood pressure may drop too far. You will
feel faint or may
faint, and your heart rate will also slow down. You may also have nausea, vomiting
and shortness of breath. In extreme cases, serious heart and lung problems may occur.
5. What should I know while using TOPROL-XL?
Things you should do
Be sure to keep all of your doctor's appointments so that your progress can be checked.
Call your doctor straight away if you:
become pregnant while taking TOPROL-XL.
have a severe allergic reaction to foods, medicines or insect stings.
If you have a history of allergies, there is a chance that TOPROL-XL may cause allergic
reactions to be worse and harder to treat.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
You may feel light-headed or dizzy when you begin to take TOPROL-XL. This is because
your blood pressure has fallen suddenly.
Standing up slowly, especially when you get up from bed or chairs, will help your
body get used to the change in position and blood pressure. If this problem gets worse
or continues, talk to your doctor.
If you feel a worsening of your condition in the early stages of taking TOPROL-XL,
tell your doctor immediately.
Some people may experience an apparent worsening of their condition in the early stages
of treatment with TOPROL-XL. It is important to tell your doctor if this happens to
you, although it is usually temporary. If your condition continues to worsen, you
should see your doctor as soon as possible.
Make sure you drink enough water during exercise and hot weather when you are taking
TOPROL-XL, especially if you sweat a lot.
If you do not drink enough water while taking TOPROL-XL, you may feel faint or light-headed
or sick. This is because your blood pressure is dropping too much. If you continue
to feel unwell, tell your doctor.
If you are being treated for diabetes, make sure you check your blood sugar level
regularly and report any changes to your doctor.
TOPROL-XL may change how well your diabetes is controlled. It may also cover up some
of the symptoms of low blood sugar (hypoglycaemia). TOPROL-XL may increase the time
your body takes to recover from low blood sugar. Your doses of diabetic medicines,
including insulin, may need to change.
Dress warmly during cold weather, especially if you will be outside for a long time
(for example when playing winter sports).
TOPROL-XL, like other beta-blocker medicines, tends to decrease blood circulation
in the skin, fingers and toes. It may make you more sensitive to cold weather, especially
if you have circulation problems.
If you are about to be started on any new medicine, remind any doctor, dentist or
pharmacist you visit that you are taking TOPROL-XL.
If you plan to have surgery (even at the dentist) that needs an anaesthetic, tell
your doctor or dentist that you are taking TOPROL-XL.
If you have to have any medical tests while you are taking TOPROL-XL, tell your doctor.
TOPROL-XL may affect the results of some tests.
Things you should not do
Do not stop taking TOPROL-XL without checking with your doctor.
Your doctor may want you to gradually reduce the amount of TOPROL-XL you are taking
before stopping completely. This may help reduce the possibility of your condition
worsening or other heart complications occurring.
Do not give TOPROL-XL to anyone else even if they have the same condition as you.
Do not use TOPROL-XL to treat any other complaints unless your doctor tells you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TOPROL-XL
affects you.
As with other beta-blocker medicines, TOPROL-XL may cause dizziness, light-headedness,
tiredness, or drowsiness in some people. Make sure you know how you react to TOPROL-XL
before you drive a car, operate machinery, or do anything else that could be dangerous
if you are dizzy or light-headed.
Drinking alcohol
Tell your doctor if you drink alcohol.
Be careful drinking alcohol while you are taking TOPROL-XL.
If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them. If you take TOPROL-XL out of the blister pack it will not keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place where the temperature stays below 30°C away from moisture,
heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
When to discard your medicine
Do not use TOPROL-XL if the expiry date (EXP) printed on the pack has passed or if
the packaging is torn or shows signs of tampering.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
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.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
If you get any side effects, do not stop taking TOPROL-XL without first talking to
your doctor.
If you are over 65 years of age you may have an increased chance of getting 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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headache, tiredness, drowsiness, weakness, or lack of energy
aches and pains, painful joints
nausea (feeling sick), vomiting
stomach upset, diarrhoea or constipation, weight gain
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
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, light headedness or fainting especially on standing up, which may be a
sign of 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
sunburn happening more quickly than usual
abnormal thinking or hallucinations
buzzing or ringing in the ears, deafness
irritated eyes or blurred vision
problems with sexual function
constant "flu-like" symptoms with tiredness or lack of energy
unusual bleeding or bruising.
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 in swallowing
or breathing, which may be signs of a serious allergic reaction
yellowing of the skin or eyes (jaundice), generally feeling unwell.
These 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.
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 TOPROL-XL contains
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Active ingredient
(main ingredient)
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metoprolol succinate
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Other ingredients
(inactive ingredients)
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ethylcellulose
phyprolose
hypromellose
microcrystalline cellulose
synthetic paraffin
macrogol 6000
silicon dioxide
sodium stearylfumarate
titanium dioxide
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Do not take this medicine if you are allergic to any of these ingredients.
What TOPROL-XL looks like
TOPROL-XL 23.75 mg tablets are white to off-white, oval, scored on both sides and
marked A/Beta Symbol on one side. This tablet can be divided into equal doses. TOPROL-XL
23.75 mg comes in a blister pack of 15 tablets (AUST R 97785).
TOPROL-XL 47.5 mg tablets are white to off-white, round, scored on one side and marked
A/mO on the other side. The score line is only there to help you break the tablet
if you have difficulty swallowing it whole. TOPROL-XL 47.5 mg comes in a blister pack
of 30 tablets (AUST R 97786).
TOPROL-XL 95 mg tablets are white to off-white, round, scored on one side and marked
A/mS on the other side. The score line is only there to help you break the tablet
if you have difficulty swallowing it whole. TOPROL-XL 95 mg comes in a blister pack
of 30 tablets (AUST R 97787).
TOPROL-XL 190 mg tablets are white to off-white, oval, scored on one side and marked
A/mY on the same side. The score line is only there to help you break the tablet if
you have difficulty swallowing it whole. TOPROL-XL 190 mg comes in a blister pack
of 30 tablets (AUST R 97788).
Who distributes TOPROL-XL
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
This leaflet was prepared in September 2024.
TOPROL-XL is a trade mark of the AstraZeneca group of companies.
© AstraZeneca, 2024
VV-RIM-01353688 v5.0