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 DICARZ?
DICARZ contains the active ingredient carvedilol. DICARZ is used to treat heart failure
and high blood pressure (hypertension).
2. What should I know before I use DICARZ?
Do not use if you have ever had an allergic reaction to carvedilol 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?
Some medicines may interfere with DICARZ and affect how it works.
4. How do I use DICARZ?
Take DICARZ exactly as your doctor has prescribed.
Your doctor will tell you how many DICARZ tablets to take each day. This depends on
your condition and whether or not you are taking other medicines.
5. What should I know while using DICARZ?
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Things you should do
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Remind any doctor, dentist, pharmacist, surgeon or anaesthetist you visit that you
are using DICARZ, especially if you are going to have any laboratory tests or surgery.
Drink enough water during exercise and hot weather.
Tell your doctor if you haven't taken your medicine or if you feel it is not helping
your condition.
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Things you should not do
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Do not stop using this medicine suddenly.
Do not change the dose without first checking with your doctor.
Do not run out of medicine over the weekend or on holidays.
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Driving or using machines
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DICARZ may affect your ability to drive a car or operate machinery when started or
when the dosage is increased.
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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.
Store it in a cool dry place below 25°C away from moisture, heat or sunlight.
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6. Are there any side effects?
Shortness of breath, swelling of the mouth or tongue, fluid retention, severe blisters
and bleeding in the lips, eyes, mouth, nose and genitals, itching dark urine, loss
of appetite, yellow of skin or eyes, feeling "flu-like" with no clear cause, bleeding
or bruising more easily, slow heart rate, irregular heartbeat, chest pain, feeling
dizzy or lightheaded, headache, tiredness, drowsiness, abnormal or blurry vision,
diarrhoea, nausea or vomiting, bronchitis, weight increase, unusual hair loss or thinning.
Active ingredient(s):
carvedilol
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DICARZ. 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 Dicarz.
Where to find information in this leaflet:
1. Why am I using DICARZ?
DICARZ contains the active ingredient carvedilol.
DICARZ belongs to a group of medicines called beta-blockers. These medicines work
by relaxing tightened blood vessels and slowing the heart rate. DICARZ has the additional
effect of being an antioxidant.
DICARZ is used to treat:
heart failure,
high blood pressure, which is called hypertension.
Heart Failure
Heart failure occurs when the heart can no longer pump blood strongly enough for the
body's needs. Often the heart grows in size to try to improve the blood flow but this
can make the heart failure worse.
Symptoms of heart failure include shortness of breath and swelling of the feet or
legs due to fluid build-up.
DICARZ reduces the pressure that the heart has to pump against as well as controlling
your heart rate. Over 6 months or more this will reduce the size of an oversized heart
and increase its efficiency.
DICARZ reduces the chances of you being admitted to hospital and/or dying from this
condition.
DICARZ is often used with other medicines to treat heart failure.
Hypertension
All people have blood pressure. This pressure helps to push blood all around your
body. Your blood pressure changes during the day, depending on how busy you are or
how you are feeling.
You have hypertension (high blood pressure) when your blood pressure stays higher
than is needed, even when you are calm and relaxed.
Regular blood pressure checks are the only way of knowing that you have hypertension.
There are usually no symptoms of hypertension and you may feel fine. If hypertension
is not treated, serious health problems such as stroke, heart disease and kidney failure
may occur. DICARZ helps to lower your blood pressure. Your doctor, however, may have
prescribed DICARZ for another purpose.
Ask your doctor if you have any questions about why DICARZ has been prescribed for
you.
DICARZ is not addictive.
2. What should I know before I use DICARZ?
Warnings
Do not use DICARZ if:
you are allergic to carvedilol, 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 are under 18 years of age.
you have asthma or other conditions which make you short of breath from time to time.
you have a history of allergic problems, including hayfever. Symptoms of an allergy
may include: rash, itching, watery eyes or sneezing.
you have a history of a very slow heart rate or uneven heart beating.
you have certain other heart conditions.
you have liver problems including liver failure.
you have very low blood pressure.
the package is torn or shows signs of tampering.
the expiry date (EXP) printed on the pack has passed or if the tablets appear damaged
in some way
Do not give DILATREND to people under 18 years of age. Safety and effectiveness in children have not been established.
Check with your doctor if you have other medical conditions, especially:
angina or chest pain/tightness which occurs even when you are at rest (also called
unstable angina)
low blood pressure
high blood pressure which varies widely
very poor circulation to your fingers and/or toes (also called peripheral vascular
disease)
a history of poor kidney function
chronic bronchitis or emphysema causing breathing difficulties
diabetes
sudden low blood sugar levels (also called hypoglycaemia)
thyroid disorders
severe allergic reactions causing swelling and/or difficulty breathing
a history of severe anaphylactic reactions (a whole body allergic reaction), as the
effect of medicinal product used for treatment might be reduced
a rare cancer of the adrenal gland called phaeochromocytoma which is not being treated
with other medicines
skin disease such as psoriasis (hardened patches of red skin).
Check with your doctor if you 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.
It is not known whether DICARZ is harmful to an unborn baby when taken by a pregnant
woman. Your doctor will discuss the risks and benefits of using DICARZ during your
pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
DICARZ passes into breast milk. Your doctor will discuss the risks and benefits of
taking DICARZ if you are breast-feeding.
Surgery
Check with your doctor if you plan to have surgery.
Your surgeon and anaesthetist should know well ahead of the date of your surgery so
they can allow for your condition and medications.
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 DICARZ and affect how it works. These medicines
include:
rifampicin, a medicine used to treat tuberculosis
cimetidine, a medicine used to treat stomach ulcers or reflux
digoxin, a medicine used to treat heart failure
monoamine-oxidase inhibitors (MAOIs) such as phenelzine and tranylcypromine, medicines
used to treat depression
clonidine, a medicine used to treat high blood pressure, migraine or menopausal symptoms
diltiazem, a medicine used to treat high blood pressure or angina
verapamil, a medicine used to treat high blood pressure, angina or fast heart rate
ciclosporin or tacrolimus, medicines used to treat certain problems with the immune
system
aspirin and other pain relievers or non-steroidal anti-inflammatory medicines such
as ibuprofen or naproxen medicines which may relieve asthma or help you breath better
such as salbutamol and salmeterol
fluoxetine or paroxetine, medicines used to treat depression and other conditions
drugs for when your heart doesn't beat smoothly, including disopyramide, mexiletine,
lignocaine, flecainide and amiodarone
drugs for diabetes, including insulin injections, glibenclamide, metformin, gliclazide,
glipizide
other medicines that may help lower your blood pressure.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DICARZ.
You may need to use different amounts of your medicine, or you may need to take different
medicines. Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or
avoid while taking DICARZ.
4. How do I use DICARZ?
How much to take
Take DICARZ exactly as your doctor has prescribed.
Your doctor will tell you how many DICARZ tablets to take each day. This depends on
your condition and whether or not you are taking other medicines.
Heart Failure:
The usual starting dose in heart failure is 3.125 mg twice daily.
The dose is usually increased every two weeks to 6.25 mg twice daily, 12.5 mg twice
daily and then 25 mg twice daily. However, this may be done more slowly if side effects
occur.
If the tablets slow your heart too much you may go back to a lower dose.
High Blood Pressure:
Adults: The recommended dose for initiation of therapy is 12.5 mg a day for the first two
days. Thereafter, the recommended dosage is 25 mg once a day.
If necessary, the dosage may be increased every two weeks up to the recommended maximum
daily dose of 50 mg given once a day or in divided doses (twice daily).
Elderly: The recommended dose for initiation of therapy is 12.5 mg once daily, which has provided
satisfactory control in some patients. If the response is inadequate, the dose may
be increased every two weeks up to the recommended maximum daily dose.
Your doctor will monitor you carefully each time the dose is increased.
Follow the instructions provided and use DICARZ until your doctor tells you to stop.
When to take DICARZ
DICARZ should be taken during or immediately after a meal, at about the same time
each day.
Taking your medicine at the same time each day will have the best effect. It will
also help you to remember when to take it.
If you take DICARZ on an empty stomach, it may increase the risk of some of the side
effects
How to take DICARZ
Swallow the tablets whole or halved with a glass of water.
Do not crush or chew the tablets
How long to take DICARZ
Continue taking DICARZ until your doctor tells you to stop.
Make sure you have enough to last over weekends and holidays.
It is very important that DICARZ is not ceased suddenly. If you are to stop taking
DICARZ your doctor will advise you to reduce the dose slowly over approximately two
weeks.
If you forget to take DICARZ
DICARZ should be used regularly at the same time each day.
If you miss your dose at the usual time, and 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 then go back to taking your medicine as
you would normally.
Do not take a double dose to make up for the dose you missed.
This may increase the change of you getting an unwanted side effect.
If you use too much DICARZ
If you think that you have used too much DICARZ, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, 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.
The following are some symptoms, which may or may not occur as a result of taking
too much DICARZ:
low blood pressure, causing dizziness or fainting
a very slow heart rate
difficulty breathing
vomiting
shock
seizures.
5. What should I know while using DICARZ?
Things you should do
Make sure you drink enough water during exercise and hot weather when you are taking
DICARZ, especially if you sweat a lot.
Tell your doctor that you are taking DICARZ if you are going to have any laboratory
tests.
Remind any doctor, dentist or pharmacist you visit that you are using DICARZ. You
should also tell your surgeon and anaesthetist if you are having surgery.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment
unnecessarily.
Tell your doctor if you feel the tablets are not helping your condition.
Be sure to keep all of your appointments with your doctor so that your progress can
be checked.
Your doctor may examine your eyes and test your blood glucose and kidney function
from time to time.
Call your doctor straight away if you:
feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.
become pregnant while taking DICARZ.
Things you should not do
Do not stop using this medicine suddenly.
Do not stop taking DICARZ or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
DICARZ should only be stopped by gradually reducing the amount over a two-week period.
Do not give DICARZ to anyone else even if they have the same condition as you.
Do not use DICARZ to treat other complaints unless your doctor says to.
Do not take any other medicines whether they require a prescription or not without
first telling your doctor or consulting a pharmacist.
Contact lenses
If you wear contact lenses you may notice a reduction in the amount of tear fluid
in your eyes.
Drinking grapefruit juice
When taken with grapefruit juice the amount of DICARZ absorbed by your body may be
increased.
Drinking alcohol
Talk to your doctor about drinking alcohol before taking DICARZ.
Alcohol can change how the medicine affects your condition. Your doctor may advise
you to limit your alcohol intake.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DICARZ
affects you.
DICARZ may affect your ability to drive a car or operate machinery when started or
when the dosage is increased.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the blister 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 below 25°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
If your doctor tells you to stop taking DICARZ, or the tablets have passed their expiry
date, ask your pharmacist what to do with any tablets that are left over.
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.
Less serious side effects
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Less serious side effects
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What to do
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headache (this is usually mild and happens at the start of your treatment)
tiredness, drowsiness
low blood pressure.
The signs include feeling dizzy or lightheaded especially after you stand up.
faintness
abnormal or blurry vision
slow heart rate
diarrhoea
nausea or vomiting
bronchitis
loss of control of blood sugar in diabetics
weight increase
fluid retention. The signs include overall swelling of parts of your body for example
your hands, feet, ankles and legs.
unusual hair loss or thinning
dry or irritated eyes
indigestion
stomach pain or discomfort
unusual weakness
general pain or discomfort, pain in extremities
frequent need to urinate, difficulty or pain when passing urine
depression
hallucination
asthma
excessive sweating
These are the more common side effects of DICARZ. Mostly these are mild and will decrease
as you get used to your medicine.
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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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itching, dark urine, loss of appetite, yellowing of skin or eyes, or feeling "flu-like"
with no clear cause.
shortness of breath or swelling of the mouth or tongue
irregular heartbeat, slow heartbeat or heartbeat pauses/stops, especially in older
people or people with other heart conditions
swelling of the feet or legs due to fluid build up
bleeding or bruising more easily than normal
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
fever, chills, shortness of breath and a cough which produces yellow-green phlegm
and occasionally blood
difficulty breathing, or breathlessness which usually worsens on lying down
chest tightness
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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.
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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 DICARZ contains
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Active ingredient
(main ingredient)
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Carvedilol
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Other ingredients
(inactive ingredients)
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Colloidal anhydrous silica
Crospovidone
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
OPADRY II complete film coating system YS-22-18096 White
Povidone
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Potential allergens
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This medicine contains lactose.
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Do not take this medicine if you are allergic to any of these ingredients.
This medicine does not contain gluten.
What DICARZ looks like
DICARZ is available in three tablet strengths:
Dicarz 6.25 mg - White, oval shaped, film-coated tablets, with break line on both
sides imprinted "6.25" on one side. Available in blister pack of 60 (AUST R 124079).
Dicarz 12.5 mg - White, oval shaped, film-coated tablets, with break line on both
sides, imprinted "12.5" on one side. Available in blister pack of 60 (AUST R 124081).
Dicarz 25 mg - White, oval shaped, film-coated tablets, with break line on both sides,
imprinted "25" on one side. Available in blister pack of 60 (AUST R 101742).
Who distributes DICARZ
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in September 2023.
DICARZ® is a Viatris company trade mark
DICARZ_cmi\Sep23/00