2. What should I know before I take NEBIVOLOL VIATRIS?
Do not take NEBIVOLOL VIATRIS if you have ever had an allergic reaction to NEBIVOLOL
VIATRIS or any of the ingredients listed at the end of the CMI.
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?
4. How do I take NEBIVOLOL VIATRIS?
Follow all directions given to you by your doctor. They will determine your dose.
Take your medicine at about the same time each day. Swallow the tablets whole with
a full glass of water. Do not crush or chew the tablets. 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. More instructions can be found in Section
4. How do I take NEBIVOLOL VIATRIS? in the full CMI.
5. What should I know while taking NEBIVOLOL VIATRIS?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking NEBIVOLOL VIATRIS.
Keep all of your doctor's appointments so that your progress can be checked
Tell your doctor if you believe that NEBIVOLOL VIATRIS is not helping your condition.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
|
|
Things you should not do
|
Do not stop taking this medicine suddenly or lower the dosage without checking with
your doctor.
Do not take NEBIVOLOL VIATRIS to treat any other complaints unless your doctor tells
you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how NEBIVOLOL VIATRIS affects
you as this medicine may cause dizziness, light-headedness or drowsiness in some people.
|
|
Drinking alcohol
|
Tell your doctor if you drink alcohol.
If you drink alcohol, symptoms such as dizziness or light-headedness may be worse.
|
|
Looking after your medicine
|
Keep your tablets in the pack until it is time to take them.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
|
6. Are there any side effects?
The most common side effects of NEBIVOLOL VIATRIS are headache, tiredness, nausea
or vomiting, stomach upset, wind, diarrhoea, constipation, and coldness or numbness
in the hands or feet. Call your doctor straight away or go straight to the Emergency
Department at your nearest hospital if you experience swelling of the face, lips,
tongue or throat that may cause difficulty swallowing or breathing; chest tightness,
shortness of breath or difficulty breathing; swelling of the feet and ankles; or chest
pain or changes in heart rate.
Active ingredient(s):
nebivolol hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking NEBIVOLOL VIATRIS. Keep this
leaflet with the medicine. You may need to read it again. 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 NEBIVOLOL VIATRIS.
Where to find information in this leaflet:
1. Why am I taking NEBIVOLOL VIATRIS?
NEBIVOLOL VIATRIS contains the active ingredient nebivolol hydrochloride. NEBIVOLOL VIATRIS belongs to a group of medicines called beta-blockers.
NEBIVOLOL VIATRIS is used to treat high blood pressure (essential hypertension) or
chronic heart failure. It is usually used in combination with other medicines.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you. Your doctor may have prescribed it for another reason.
High Blood Pressure (Hypertension)
NEBIVOLOL VIATRIS can be used to treat high blood pressure. It works by blocking the
transmission of messages to the beta receptors in the heart which slows down the activity
of the heart. It also relaxes the blood vessels and reduces the resistance that the
heart has to pump against. The blood pressure lowering effects occur after 1 to 2
weeks, although it may take up to 4 weeks for the full effect to occur.
Chronic Heart Failure
NEBIVOLOL VIATRIS can also be used to treat chronic heart failure, in addition to
other medicines. It slows down the heart rate and makes it beat more regularly. It
also reduces the pressure the heart has to pump against and therefore reduces the
amount of work that the heart has to do. This improves the symptoms of chronic heart
failure and reduces the likelihood of you being hospitalised and/or dying from your
heart condition.
2. What should I know before I take NEBIVOLOL VIATRIS?
Warnings
Do not use NEBIVOLOL VIATRIS if:
you are allergic to nebivolol hydrochloride, or any of the ingredients listed at the
end of this leaflet.
always check the ingredients to make sure you can use this medicine.
you have liver problems.
you have acute heart failure or cardiogenic shock, a serious heart condition causing
low blood pressure.
you have a history of slow heart rate or uneven heart beating.
you have certain other heart conditions.
you have asthma, bronchitis or other lung disease with tightening of the airways.
you have untreated phaeochromocytoma, a rare tumour of the adrenal gland.
you have metabolic acidosis, where there is too much acid in the blood.
you have hypotension, low blood pressure.
you have a severe blood vessel disorder causing poor circulation in the arms and legs.
Check with your doctor if you:
have any other medical conditions, such as:
low blood pressure or poor circulation
a slow heartbeat, lower than 60 beats per minute
asthma or breathing difficulties
angina, chest pain or any other heart problems, or your heart failure has just occurred
or recently worsened
diabetes
a history of psoriasis, a skin disease with thickened patches of red skin, often with
silvery scales
a severe blood vessel disorder causing poor circulation in the arms and legs
thyroid disorders
liver problems
kidney problems
phaeochromocytoma, a rare tumour of the adrenal gland
a lactose intolerance
or 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
Do not take this medicine if you are pregnant.
It may affect or harm your developing baby if you take it during pregnancy, as it
can reduce blood flow to the placenta.
Check with your doctor if you are pregnant or intend to become pregnant.
Talk NEBIVOLOL VIATRIS should not be used during pregnancy unless clearly necessary.
If NEBIVOLOL VIATRIS is required during pregnancy, your doctor may recommend close
monitoring. Your baby must be closely monitored for signs of low blood sugar (hypoglycaemia)
and slow heart rate (bradycardia) which are generally expected within the first three
days of life.
Do not breastfeed if you are taking this medicine.
The active ingredient in NEBIVOLOL VIATRIS passes into breast milk and there is a
possibility that your baby may be affected.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Children under the age of 18 years
Do not give NEBIVOLOL VIATRIS to a child under the age of 18 years.
Safety and effectiveness in children younger than 18 years have 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 may interfere with NEBIVOLOL VIATRIS and affect how it works.
Those used to treat irregular or abnormal heartbeat (e.g. quinidine, flecainide, disopyramide,
lidocaine, mexiletine, amiodarone)
Those used to treat high blood pressure (e.g. clonidine, guanfacine, moxonidine, methyldopa,
amlodipine, felodipine, nifedipine, nicardipine, nimodipine, reserpine, guanethidine).
Calcium channel blockers for high blood pressure or heart problems (e.g. verapamil,
diltiazem).
Insulin and tablets used to treat diabetes.
Those used to treat depression and anxiety (e.g. paroxetine, fluoxetine, phenothiazine,
thioridazine, sedatives, antipsychotics).
Those used to treat excessive stomach acid (e.g. cimetidine). You should take NEBIVOLOL
VIATRIS during a meal, and the antacid between meals.
Digoxin, a medicine used to treat heart failure.
Other beta-blocker medicines (including beta-blocker eye drops) used to treat asthma,
blocked nose or certain eye disorders such as glaucoma or dilation of the pupil.
Anaesthetics.
Baclofen, an antispasmodic drug.
Amifostine, a protective medicine used during cancer treatment.
Those used to treat diabetes such as insulin or oral antidiabetic medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect NEBIVOLOL VIATRIS.
4. How do I take NEBIVOLOL VIATRIS?
How much to take
High blood pressure (hypertension)
For the treatment of high blood pressure, the usual starting dose is one 5 mg tablet
once daily. Your doctor may start you with a lower dose of NEBIVOLOL VIATRIS
Chronic heart failure
For the treatment of chronic heart failure, your doctor will start you on a low dose
of NEBIVOLOL VIATRIS, and gradually increase the dose depending on how you respond
to this medicine.
The usual starting dose is one 1.25 mg tablet once daily. Your doctor will gradually
increase your dose stepwise over a number of weeks, one tablet at a time until you
reach the best dose for you.
The highest dose you should take is 10 mg once daily.
When you take NEBIVOLOL VIATRIS for the first time, and whenever your doctor increases
your dose, you should be observed by a doctor for at least 2 hours until the effect
of the medicine on you is known.
Follow the instructions provided and take NEBIVOLOL VIATRIS until your doctor tells
you to stop.
When to take NEBIVOLOL VIATRIS
NEBIVOLOL VIATRIS should be taken about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
It does not matter if you take NEBIVOLOL VIATRIS before or after food or with food.
If you need to take an antacid, take it at least 2 hours before or 2 hours after your
dose of NEBIVOLOL VIATRIS.
How to take NEBIVOLOL VIATRIS
Swallow the tablets whole with a full glass of water.
Do not crush or chew the tablets.
If you forget to take NEBIVOLOL VIATRIS
NEBIVOLOL VIATRIS should be taken regularly at the same time each day. If you miss
your dose at the usual time, follow the instructions below.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to. Otherwise, take it as soon as you remember, and then
go back to taking NEBIVOLOL VIATRIS as you would normally.
Repeated skipping of doses should be avoided.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you use too much NEBIVOLOL VIATRIS
If you think that you have taken too much NEBIVOLOL VIATRIS, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26
in Australia, or 0800 764 766 in New Zealand ), 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.
Symptoms of an overdose may include feeling faint or fainting and shortness of breath.
Your blood pressure may drop too far and your heart rate might slow down too much.
In extreme cases, serious heart and lung problems may occur.
5. What should I know while taking NEBIVOLOL VIATRIS?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking NEBIVOLOL VIATRIS.
Remind any doctor, dentist or pharmacist you visit that you are taking NEBIVOLOL VIATRIS.
If you are going to have surgery, tell the surgeon, anaesthetist or dentist that you
are taking this medicine.
NEBIVOLOL VIATRIS may affect other medicines used during surgery. Your surgeon and
anaesthetist should know well ahead of the date of your surgery so they can allow
for your condition and medications.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may check your eyes, thyroid, lipid and blood glucose levels.
If you have any medical test, tell your doctor that you are taking NEBIVOLOL VIATRIS.
This medicine may affect the results of some tests.
Tell your doctor if you believe that NEBIVOLOL VIATRIS is not helping your condition.
Your doctor may need to change the dose.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Your doctor may think it is not working effectively and change your treatment unnecessarily.
If you are being treated for diabetes, make sure you check your blood sugar level
regularly and report any changes to your doctor.
NEBIVOLOL VIATRIS has no effect on blood sugar, may change how well your diabetes
is controlled. It may also cover up some of the symptoms of low blood sugar, called
hypoglycaemia, such as palpitations, fast heartbeat and could increase the risk of
severe hypoglycaemia when used with a certain type of antidiabetic medication called
sulfonylureas (e.g. gliclazide, glibenclamide, glipizide, or glimepiride).
NEBIVOLOL VIATRIS may make hypoglycaemia last longer. Your dose of diabetic medicines,
including insulin, may need to change.
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 NEBIVOLOL VIATRIS. This
is because your blood pressure has fallen suddenly. Standing up slowly, especially
when you get up from bed or from sitting, will help your body adjust to the change
in position and blood pressure. If this problem continues or gets worse, tell your
doctor.
Make sure you drink enough water during exercise and in hot weather when you are taking
NEBIVOLOL VIATRIS, especially if you sweat a lot.
If you do not drink enough water while taking this medicine you may feel faint or
light-headed. This is because your blood pressure is dropping too much.
If you continue to feel unwell, talk to your doctor.
Call your doctor straight away if you:
If you become pregnant while taking this medicine.
Things you should not do
Do not stop taking your medicine or lower the dosage without checking with your doctor.
This medicine helps control your condition but does not cure it. It is important to
keep taking your medicine even if you feel well. Continue taking NEBIVOLOL VIATRIS
for as long as your doctor tells you.
If you stop taking it suddenly, your condition may worsen or you may have unwanted
side effects. If possible, your doctor will gradually reduce the amount you take each
day before stopping the medicine completely.
Do not take NEBIVOLOL VIATRIS to treat any other complaints unless your doctor tells
you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how NEBIVOLOL
VIATRIS affects you.
NEBIVOLOL VIATRIS may cause dizziness, light-headedness, or drowsiness in some people.
If you have any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may worsen symptoms such as dizziness or light- headedness.
Be careful getting up from a lying or sitting position.
You may feel dizzy or light-headed if you get up too quickly. Getting up slowly may
help.
Looking after your medicine
Keep your tablets in a cool dry place where the temperature stays below 25C.
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may 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 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.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
Do not take this medicine after the expiry date or if the packaging is torn or shows
signs of tampering or the tablets do not look quite right.
If the medicine has expired or is damaged, or if your doctor tells you to stop taking
this medicine, take it to any pharmacy for safe disposal.
6. Are there any side effects?
All medicines can have side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
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.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
General body-related
Headache, tiredness
Coldness or numbness in the hands or feet
Changes to the colour of fingers and toes in response to cold or stress
Feeling of light-headedness or dizziness when getting out of bed or standing up
Stomach and bowel-related
Nausea
Vomiting
Stomach upset
Wind
Diarrhoea
Constipation
Mind-related:
Disturbed sleep or nightmares
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Allergic reaction-related
Swelling of the face, lips, tongue or throat that may cause difficulty swallowing
or breathing
Rashes, itching or hives on the skin
General body-related:
Chest tightness, shortness of breath or difficulty breathing.
Low blood pressure
Swelling of the hands, feet or ankles
Severe light-headedness, dizziness or fainting
Tingling or ‘pins and needles’
Heart-related:
Slow heartbeat
Chest pain
Changes in heart rate
Mind-related
Abnormal thinking, depression or hallucinations
Sex-related
Impotence
Skin-related
Skin rashes and itching
Worsening of psoriasis
Eye-related
Dry eyes
Problems with eyesight
Muscle-related
An increase in cramp-like pain in one or both legs that develops on walking
|
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.
|
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. This medicine is not
addictive.
What NEBIVOLOL VIATRIS contains
|
Active ingredient
|
Each tablet contains 1.25 mg, 5 mg or 10 mg of nebivolol (as nebivolol hydrochloride).
|
|
Other ingredients
|
lactose monohydrate
crospovidone
copovidone
pregelatanised maize starch
magnesium stearate
|
|
Potential allergens
|
This medicine contains sugars as lactose.
|
Do not take this medicine if you are allergic to any of these ingredients.
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking NEBIVOLOL VIATRIS.
This medicine does not contain gluten, tartrazine or other azo dyes.
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.
What NEBIVOLOL VIATRIS looks like
1.25 mg tablet
White to off-white, round biconvex tablets debossed "APO" over "1.25" on one side
and single score on the other side (AUST R 281797).
5 mg tablet
White to off-white, round biconvex tablets debossed "APO" over "N5" on one side and
cross scored on the other side (AUST R 281800).
10 mg tablet
White to off-white, round biconvex tablets debossed "APO" on one side and "N10" on
the other side
(AUST R 281796).
Who distributes NEBIVOLOL VIATRIS
Sponsored by
Helix Pharmaceuticals Pty Ltd
C/-EGA Corporate Advisors Pty Ltd
Level 12, 468 St Kilda Road
Melbourne, VIC 300
Australia
Distributed by
Alphapharm Pty Ltd trading as Viatris
Carole Park QLD 4300 Australia
Ph: 1800 274 276
This leaflet was prepared in December 2025.