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MONOPRIL®
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.
MONOPRIL contains the active ingredient fosinopril sodium. MONOPRIL is used to treat
high blood pressure (hypertension) or heart failure.
For more information, see Section 1. Why am I using MONOPRIL? in the full CMI.
For more information, see Section 1. Why am I using MONOPRIL? in the full CMI.
Do not use if you have ever had an allergic reaction to fosinopril sodium or any of
the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions or allergies, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use MONOPRIL? in the full CMI.
Talk to your doctor if you have any other medical conditions or allergies, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use MONOPRIL? in the full CMI.
Some medicines may interfere with MONOPRIL and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
MONOPRIL is usually taken at a dose of 10mg to 40mg once a day. Your doctor will tell
you how much to take each day.
MONOPRIL is taken once a day at about the same time each day.
More instructions can be found in Section 4. How do I use MONOPRIL? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist, anesthetists, you visit that you are using
MONOPRIL.
Make sure you drink enough water during exercise and hot weather.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
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Things you should not do
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Do not stop using this medicine or lower the dosage without checking with your doctor.
Do not take MONOPRIL if you are pregnant or plan to become pregnant or breastfeed
Do not take a double dose to make up for the dose that you missed
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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 MONORPIL
affects you.
MONOPRIL may cause dizziness, or light-headedness in some people.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
If you drink alcohol, dizziness or light-headedness may be worse.
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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 MONOPRIL tablets in a cool dry place, in the dark, where the temperature stays
below 25°C.
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For more information, see Section 5. What should I know while using MONOPRIL? in the full CMI.
More common side effects include: felling lightheaded, dizzy or faint; headache; tiredness,
fatigue or weakness; dry cough; muscle cramps or pain; nausea or vomiting; upset stomach;
stomach pain; heartburn; diarrhoea.
Serious Side effects include: Swollen face, swollen lips, swollen mouth, swollen throat,
swollen hands or feet; fainting; yellowing skin; not urinating as much as usual; sore
throat and fever; stomach pain; chest pain; difficulty breathing; itchy skin and/or
rash; changes to your heart rhythm, inability to get or maintain an erection; severe
dizziness; gout; diabetes; infections in your urinary tract or upper respiratory tract;
hepatitis; confusion; nervousness; numbness or tingling of the hands feet or lips;
shortness or breath; weakness or heaviness of legs.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
MONOPRIL®
(MON-o-pril)
Active ingredient(s):
Fosinopril Sodium (FOS-in-O-pril SOH-dee-uhm)
Consumer Medicine Information (CMI)
This leaflet provides important information about using MONOPRIL. 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 MONOPRIL.
Where to find information in this leaflet:
MONOPRIL contains the active ingredient fosinopril sodium.
MONOPRIL is used for treating high blood pressure (hypertension) or heart failure.
Both of these are long term (chronic) diseases so it is important that you continue
to take your MONOPRIL every day.
Fosinopril sodium belongs to a class of medicines known as ACE inhibitors. It works
by widening your blood vessels, reducing the pressure in the vessels (reducing 'blood
pressure') and by making it easier for your heart to pump blood around your body.
This helps your heart to work better by increasing the supply of oxygen to your heart.
High blood pressure (hypertension):
Everyone has blood pressure. This pressure helps get your blood all around your body.
Your blood pressure may be different at different times of the day, depending on how
busy or worried you are. If you have hypertension (high blood pressure), this means
that your blood pressure stays higher than is needed, even when you are relaxed.
There are usually no symptoms of hypertension. The only way of knowing that you have
hypertension is to have your blood pressure checked on a regular basis. If high blood
pressure is not treated it can lead to serious health problems, including stroke,
heart disease and kidney failure.
Heart Failure:
Heart failure means that the heart muscle cannot pump blood strongly enough to supply
all the blood needed throughout the body. Heart failure is not the same as heart
attack and does not mean that the heart stops. Heart failure may start off with no
symptoms, but as the condition progresses, patients feel short of breath or may get
tired easily after light physical activity such as walking. Some patients may wake
up short of breath at night. Fluid may collect in different parts of the body, often
first noticed as swollen ankles and feet.
Your doctor may have prescribed MONOPRIL for another reason.
Ask your doctor if you have any questions about why MONOPRIL has been prescribed for
you.
Do not use MONOPRIL if:
you are allergic to fosinopril sodium (the active ingredient in MONOPRIL), or any
of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to MONOPRIL may include skin rash, itchiness, shortness
of breath, swelling of the face, lips or tongue, muscle pain or tenderness or joint
pain.
Always check the ingredients to make sure you can use this medicine.
you have taken any other 'ACE inhibitor' medicine before, which caused your face,
lips, tongue, throat, hands or feet to swell up or made it hard for you to breathe.
If you have had an allergic reaction to an ACE inhibitor medicine before, you may
be allergic to MONOPRIL.
you have a history of angioedema or angioneurotic oedema, which is swelling of the
face, lips, tongue, throat (which may cause difficulty in swallowing or breathing),
hands or feet, for no apparent reason.
Check with your doctor if you:
have allergies to:
any other medicine
any other substances, such as foods, preservatives or dyes
you have a family history of swelling of the face, lips, tongue, throat that may cause
difficulty in swallowing or breathing.
have any medical conditions, especially the following:
diabetes
take any other medicines or drugs including any immunosuppressant medicine or trimethoprim
containing medicines
kidney problems, or have had kidney problems in the past, or are having dialysis
liver problems, or have had liver problems in the past
low blood pressure, which you may notice as dizziness or lightheadedness
are going to have surgery (including dental surgery) involving a general anaesthetic,
even if it is minor
are pregnancy or plan to become pregnant or breastfeed.
If you have not told your doctor about any of the above, tell them before you start
taking MONOPRIL.
If you are not sure whether you should start taking MONOPRIL, talk to your doctor.
MONOPRIL is not addictive.
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 MONOPRIL if you are pregnant or are trying to become pregnant.
MONOPRIL may cause serious injury to your developing baby if you take it during pregnancy.
Do not take MONOPRIL if you are breastfeeding or intend to breastfeed.
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 can affect the way MONOPRIL works. It is especially important that
you tell your doctor if you are taking any of the following:
water tablets or diuretics
lithium or lithium-containing preparations
potassium tablets
potassium-containing salt substitutes
antacids
if you are taking MONOPRIL for high blood pressure do not take any medicine (including
ones bought without prescription) for appetite control, asthma, colds, coughs, hayfever
or sinus problems unless you have discussed the medicine with your doctor or pharmacist.
aspirin
anti-inflammatory medicines (these are used to relieve pain, swelling and other symptoms
of inflammation, including arthritis) and include nonsteroidal anti-inflammatory agents
- NSAIDs and COX-2 inhibitors .Taking a combination of Monopril with a thiazide diuretic
(fluid tablet) and an anti-inflammatory medicine may damage your kidneys.
medicines that lower your immune system, such as medicines used to prevent rejection
of transplant organs.
trimethoprim containing medicines used to treat certain types of infections
Your doctor will decide whether your treatment needs to be altered or whether you
should have check ups or blood tests more frequently
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect MONOPRIL.
How much to take
MONOPRIL is usually taken at a dose of 10mg to 40mg once a day. Your doctor may have
prescribed a different dose for you.
Your doctor or pharmacist will tell you how many tablets you will need to take each
day.
Follow all directions given to you by your doctor or pharmacist carefully. They may
differ from the information in this leaflet.
When to take MONOPRIL
Take MONOPRIL at about the same time each day.
Taking your tablet at about the same time each day will help you to remember when
to take it.
MONOPRIL helps to control your condition but does not cure it. Therefore you must
take MONOPRIL every day. Continue taking it for as long as your doctor tells you.
How to take MONOPRIL
It does not matter if you take MONOPRIL before or after food.
If you need to take an antacid, take it at least 2 hours before or two hours after
your dose of MONOPRIL.
If you do not understand the instructions on the label on the box, ask your doctor
or pharmacist for help.
If you forget to use MONOPRIL
MONOPRIL should be used regularly at the same time each day.
If you forget to take one or more doses of MONOPRIL, if it is almost time for your
next dose, skip the dose you missed and take your next dose at the normal time and
in the normal amount.
Otherwise take it as soon as you remember, and then go back to taking it as you would
normally.
Do not take a double dose to make up for the dose that you missed. Do not take any
more than your doctor prescribed for you.
If you are not sure what to do, ask your doctor or pharmacist. If you have trouble
remembering when to take your medicine, ask your pharmacist for some hints.
If you use too much MONOPRIL
If you think that you have used too much MONOPRIL, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(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.
Things you should do
Tell any other doctors, dentists and pharmacists who are treating you that you are
taking MONOPRIL.
If you are about to be started on a new medicine, tell your doctor, dentist or pharmacist
that you are taking MONOPRIL.
Make sure you drink enough water during exercise and hot weather when you are taking
MONOPRIL, especially if you sweat a lot.
If you do not drink enough water while taking MONOPRIL, your blood pressure may drop
suddenly and you may dehydrate. If you experience any of the above symptoms, tell
your doctor.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking MONOPRIL.
Having a general anesthetic while taking MONOPRIL may also cause your blood pressure
to drop suddenly.
If you are about to have blood tests, tell your doctor that you are taking MONOPRIL.
MONOPRIL may interfere with the results of some tests.
Have your blood pressure checked when your doctor says, to make sure MONOPRIL is working.
Go to your doctor regularly for a check-up.
Your doctor may like to do blood tests to see how MONOPRIL is affecting you.
As with other ACE inhibitor medicines, you may feel light-headed or dizzy when you
begin to take MONOPRIL or after your dose is increased. This is because your blood
pressure is dropping suddenly.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
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. Be careful the first time
you take MONOPRIL, especially if you are elderly.
Call your doctor straight away if you:
Have excessive vomiting or diarrhoea
Experience any of the following symptoms:
light-headed or dizzy
dry mouth or thirst
weakness, tiredness or drowsiness
muscle pain or cramps
fast heart beat
passing less urine than normal
If you experience these symptoms, you may be dehydrated because you are losing too
much water.
This is more likely to occur when you begin to take MONOPRIL or if your dose is increased.
Become pregnant while taking MONOPRIL
Things you should not do
Do not give MONOPRIL to anyone else, even if they have the same condition as you.
Do not take MONOPRIL to treat any other complaints unless your doctor or pharmacist
tells you to.
Do not stop taking MONOPRIL, or lower the dosage, without checking with your doctor.
Do not take MONOPRIL after the expiry date printed on the pack.
Do not take MONOPRIL if the packaging is torn or shows signs of tampering.
Do not take MONOPRIL if the tablets change in appearance, colour or taste.
Things that would be helpful for your blood pressure
Some self help measures suggested below may help your condition. Talk to your doctor
or pharmacist about these measures and for more information.
Alcohol
Your doctor may advise you to limit your alcohol intake.
Weight
Your doctor may suggest losing some weight to help lower your blood pressure and help
lessen the amount of work your heart has to do. Some people may need a dietician's
help to lose weight.
Diet
Eat a healthy low-fat diet which includes plenty of fresh vegetables, fruit, bread,
cereals and fish. Also eat less fat and sugar.
Salt
Your doctor may advise you to watch the amount of salt in your diet. To reduce your
salt intake you should avoid using salt in cooking or at the table.
Exercise
Regular exercise helps to reduce blood pressure and helps to get the heart fitter,
but it is important not to overdo it. Walking is good exercise, but try to find a
route that is reasonably flat. Before starting any exercise, ask your doctor about
the best kind of programme for you.
Smoking
Your doctor may advise you to stop smoking or at least cut down.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how MONORPIL
affects you.
As with other ACE inhibitor medicines, MONOPRIL may cause dizziness, or light-headedness
in some people. Make sure you know how you react to MONOPRIL before you drive a car,
operate machinery, or do anything else that could be dangerous if you are dizzy or
light-headed. If this occurs do not drive.
Drinking alcohol
Tell your doctor if you drink alcohol.
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 the tablets out of the pack they will not keep well.
Keep MONOPRIL tablets in a cool dry place, in the dark, where the temperature stays
below 25°C.
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.
When to discard your medicine
If it has expired or is damaged return it to your pharmacist for disposal.
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.
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.
Serious side effects
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Serious side effects
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What to do
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Swelling
Swollen face, swollen lips, swollen mouth, swollen throat, swollen hands or feet
Liver and Kidneys
if you faint or if your skin turns yellow
not urinating (passing water) as much as usual
Infection
sore throat and fever
Stomach
stomach pain with or without nausea
Heart and Lungs:
chest pain
difficulty breathing
Skin
itchy skin and/or rash
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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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Rare serious side effects
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What to do
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Heart
changes to your heart rhythm
Genitals
impotence (inability to get or maintain an erection)
Skin
mild rash or itching
General
severe dizziness (vertigo)
gout (painful, swollen joints)
diabetes (symptoms include - excessive thirst, greatly increased amount of urine,
increase of appetite with a loss of weight, feeling tired, drowsy, weak, depressed,
irritable and generally unwell)
Infection
sore throat and fever
infections of your urinary tract or upper respiratory tract (URTI, or cold or flu
symptoms)
Liver
hepatitis (symptoms include - nausea, vomiting, loss of appetite, feeling generally
unwell, fever, itching, yellowing of the skin and eyes and dark coloured urine)
Potassium Build-up
confusion; irregular heartbeat; nervousness; numbness or tingling of the hands, feet
or lips; shortness of breath or difficulty breathing; weakness or heaviness of legs.
(You may experience these symptoms if too much potassium builds up in your body.)
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Call your doctor as soon as possible if you notice any of these rare side effects.
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Other side effects
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More Common side effects
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What to do
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Head
feeling lightheaded, dizzy or faint
headache
General
tiredness, fatigue or weakness
dry cough
muscle cramps or pains
Gut and Digestive System
feeling sick (nausea) or vomiting
upset stomach (dyspepsia) or heartburn
diarrhoea
stomach pains
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Speak to your doctor if you have any of these side effects and they worry you.
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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.
This medicine is only available with a doctor's prescription.
What MONOPRIL contains
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Active ingredient
(main ingredient)
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Fosinopril sodium
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Other ingredients
(inactive ingredients)
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Lactose
Microcrystalline cellulose
Crospovidone
Povidone
Sodium stearyl fumarate.
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Potential allergens
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Contains sugars as lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What MONOPRIL looks like
MONOPRIL 10mg tablets -
White biconvex, diamond shaped tablet and marked on one side and with a star design
and on the other side '158' (AUST R 46475). Each carton contains 30 tablets.
Who distributes MONOPRIL
Bristol-Myers Squibb Australia Pty Ltd
4 Nexus Court, Mulgrave,
Victoria 3170, Australia.
Toll free number: 1800 067 567
Email: MedInfo.Australia@bms.com
Monopril is a registered trademark of Bristol-Myers Squibb
This leaflet was prepared in April 2024.
