ZESTRIL®
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.
ZESTRIL contains the active ingredient lisinopril. ZESTRIL is used to lower high blood
pressure, which doctors call hypertension. It is also used to treat heart failure
and patients who have just had a heart attack. For more information, see Section 1. Why am I using ZESTRIL? in the full CMI.
Do not use if you have ever had an allergic reaction to lisinopril 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. For more information, see Section 2. What should I know before I use ZESTRIL? in the full CMI.
Some medicines may interfere with ZESTRIL 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.
Take ZESTRIL as prescribed by your doctor. This depends on your condition and whether
you are taking other medicines.
More instructions can be found in Section 4. How do I use ZESTRIL? in the full CMI.
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using ZESTRIL.
Have your blood pressure checked when your doctor says to make sure ZESTRIL is working
Call your doctor straight away if you: feel any light-headedness or dizziness, become pregnant, have excessive vomiting
and/or diarrhoea while taking ZESTRIL
Make sure you drink enough water during exercise and hot weather when you are taking
ZESTRIL
Go to your doctor regularly for a check-up.
|
|---|---|
|
Things you should not do
|
Do not take ZESTRIL to treat any other complaints unless your doctor tells you to.
Do not give ZESTRIL 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 ZESTRIL
affects you.
|
|
Drinking alcohol
|
Your doctor may advise you to limit your alcohol intake.
|
|
Looking after your medicine
|
Store below 30°C.
Store in a cool, dry place, away from young children.
|
For more information, see Section 5. What should I know while using ZESTRIL? in the full CMI.
There are a number of side effects associated with this medicine. It is important
to be aware of them so that you can identify any symptoms if they occur (see the full
CMI for more details). The most common and serious side effects are passing less urine,
chest pain, angina, swelling of the face, lips, mouth, tongue or throat, wheeziness,
difficulty breathing, collapse, numbness/weakness of arms or legs, pinkish, hives,
fainting, heart beats changes, skin problems, infections, bruising easily, severe
abdominal pain, yellowing of the skin and/or eyes, dehydration and hallucinations.
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.
ZESTRIL®
Active ingredient(s): lisinopril
Consumer Medicine Information (CMI)
This leaflet provides important information about using ZESTRIL. 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 ZESTRIL.
Where to find information in this leaflet:
ZESTRIL contains the active ingredient lisinopril. ZESTRIL belongs to a group of medicines called angiotensin converting enzyme (ACE)
inhibitors.
ZESTRIL is used to lower high blood pressure, which doctors call hypertension. It
is also used to treat heart failure and patients who have just had a heart attack.
Do not use ZESTRIL if:
you are allergic to lisinopril, 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 taken any medicines called 'ACE inhibitors' before and have had allergic
reactions with swelling of the hands, feet, or ankles, the face, lips, tongue and/or
throat with difficulty in swallowing or breathing or if you or a member of your family
have had a similar reaction.
If you or a family member has had an allergic reaction to an ACE inhibitor before,
you may be allergic to ZESTRIL.
you or a member of your family has a history of swelling of the face, lips, tongue,
throat, hands or feet, for no apparent reason.
Some of the symptoms of an allergic reaction to ZESTRIL may include skin rash, itchiness,
difficulty breathing or swallowing, or swelling of the face, lips, tongue or throat.
you are undergoing haemodialysis
you are taking a blood pressure medicine containing aliskiren and you have diabetes
mellitus.
you are taking a blood pressure medicine containing aliskiren and you have kidney
problems
Check with your doctor if you:
have any other medical conditions, including
kidney problems, or are undergoing dialysis
low blood pressure (you may notice this as faintness or dizziness, especially when
standing)
liver problems
diabetes
aortic stenosis (narrowing of the aorta), renal stenosis (narrowing of the renal artery)
or hypertrophic cardiomyopathy (an increase in the thickness of the heart muscle)
diarrhoea or vomiting
take any medicines for any other condition
if you are following a very low salt diet
if you are going to receive desensitisation treatment for an allergy, e.g. to insect
stings
The desensitisation treatment reduces the effects of the allergy (e.g. bee or wasp
stings) but sometimes it can cause a more severe allergic reaction if you are taking
an ACE inhibitor during the desensitisation treatment.
if you are taking medicines called mTOR inhibitors (such as temsirolimus, everolimus,
sirolimus) or medicines containing NEP inhibitors (such as racecadotril).
Taking these medicines with Zestril may increase the risk of angioedema. Signs of
angioedema include swelling of the face, lips, tongue and/or throat with difficulty
in swallowing or breathing.
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.
ZESTRIL is not recommended for use during pregnancy
Talk to your doctor if you are breastfeeding or intend to breastfeed.
ZESTRIL should not be used while breastfeeding or if planning to breastfeed.
Your baby may absorb this medicine in the womb or from breast milk and therefore there
is a possibility of harm to the baby.
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 ZESTRIL and affect how it works, and some medicines
may be affected by ZESTRIL
medicines used to treat high blood pressure or heart problems called angiotensin II
receptor blockers, such as candesartan, valdesartan, telmisartan, olmesartan or irbesartan.
other medicines used to treat high blood pressure, including any that contain aliskiren
(see also information under the heading "When you must not take it") .
diuretic tablets - also called fluid or water tablets
lithium, a medicine used to treat some types of mental disorders
potassium tablets, salt substitutes containing potassium or other medicines which
can increase potassium in your body.
non-steroidal anti-inflammatory medicines used to treat arthritis and muscle pain,
such as indomethacin , naproxen or ibuprofen.
heparin, a medicine used to prevent blood clots.
a medicine used to treat infection containing sulfamethoxazole and trimethoprim, also
known as co-trimoxazole.
gold injections (such as sodium aurothiomalate) usually used to treat rheumatoid arthritis
insulin or other medicines used to treat diabetes.
medicines used to break down blood clots such as alteplase or reteplase.
medicines called mTOR inhibitors (such as temsirolimus, everolimus, sirolimus) or
medicines containing NEP inhibitors (such as racecadotril). t
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ZESTRIL.
How much to take
Your doctor will tell you how many tablets you need to take each day. This depends
on your condition and whether you are taking other medicines.
Take ZESTRIL only when prescribed by your doctor.
For high blood pressure:
For most patients, the usual starting dose is 5 mg to 10 mg taken once a day.
Some patients may need a lower starting dose. The dose may need to be increased depending
on your blood pressure.
Most patients take between 10 mg to 20 mg each day, taken once a day.
For heart failure:
The usual starting dose is 2.5 mg taken once a day.
Depending on your response, this dose may need to be increased.
The usual dose is between 5 mg to 20mg each day, taken once a day.
For heart attack:
ZESTRIL may be started within 24 hours of the onset of the symptoms of heart attack.
The usual starting dose is 5 mg, which is followed 24 hours later by another 5 mg
dose.
This is then followed 48 hours later by a 10 mg dose, and then 10 mg taken once a
day thereafter. Some patients may need a lower starting and maintenance dose.
How long to take ZESTRIL
Continue taking the tablets for as long as your doctor tells you.
ZESTRIL helps control your high blood pressure and helps improve your heart failure,
but does not cure it. Therefore, you must take ZESTRIL every day.
Follow the instructions provided and use ZESTRIL until your doctor tells you to stop
When to take ZESTRIL
ZESTRIL should be used at about the same time each day. Taking your tablet(s) at the
same time each day will have the best effect. It will also help you remember when
to take the tablets.
How to take ZESTRIL
Swallow ZESTRIL with a glass of water or other liquid.
It does not matter if you take ZESTRIL before or after food.
If you forget to use ZESTRIL
ZESTRIL should be used regularly at the same time each day .
If it is almost time for your next dose, 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 use too much ZESTRIL
If you think that you have used too much ZESTRIL, you may need urgent medical attention.
If you take too many tablets you will probably feel light-headed or dizzy, or you
may faint.
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
Have your blood pressure checked when your doctor says to make sure ZESTRIL is working.
Call your doctor straight away if you:
feel any light-headedness or dizziness after you take your first dose of ZESTRIL or
if your dose is increased
This is especially important if you are taking ZESTRIL for heart failure
feel light-headed, dizzy or faint, and this problem gets worse or continues
Get up slowly when getting out of bed or standing up
You may feel light-headed or dizzy, especially if you are also taking a diuretic (fluid
tablet). This is because your blood pressure is falling 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
become pregnant while taking ZESTRIL
are about to be started on any new medicine
plan to have surgery (even at the dentist) that needs a general anaesthetic
Your blood pressure may drop suddenly during surgery
have excessive vomiting and/or diarrhoea while taking ZESTRIL
This can result in you losing too much water and may drop your blood pressure too
much
Things you must do
Make sure you drink enough water during exercise and hot weather when you are taking
ZESTRIL, especially if you sweat a lot.
If you do not drink enough water while taking ZESTRIL, you may faint or feel light-headed
or sick. This is because your blood pressure is dropping suddenly. If you continue
to feel unwell, tell your doctor.
Go to your doctor regularly for a check-up.
Your doctor may occasionally do a blood test to check your potassium level in the
blood and see how your kidneys are working.
Remind any doctor, dentist or pharmacist you visit that you are using ZESTRIL.
Things you should not do
Do not take ZESTRIL to treat any other complaints unless your doctor tells you to.
Do not give ZESTRIL 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 ZESTRIL
affects you.
ZESTRIL may cause dizziness in some people, especially after the first dose or if
the dose is increased. Make sure you know how you react to ZESTRIL before you drive
a car, operate machinery, or do anything else that could be dangerous if you are dizzy
or light-headed. If you drink alcohol, dizziness or light-headedness may be worse.
Drinking alcohol
Tell your doctor if you drink alcohol.
Your doctor may advise you to limit your alcohol intake.
Things that would be helpful for your blood pressure or heart failure
Some self help measures suggested below may help your condition. Talk to your doctor
or pharmacist about these measures and for more information.
Diet - eat a healthy diet, which includes plenty of fresh vegetables, fruit, bread,
cereals and fish. Also eat less fat and sugar.
Exercise - regular exercise helps to reduce blood pressure and helps the heart get
fitter, but it is important not to overdo it. Walking is good exercise, but try to
find a route that is fairly flat. Before starting any exercise, ask your doctor about
the best kind of programme for you.
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.
Smoking - your doctor may advise you to stop smoking or at least cut down.
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.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them.
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.
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.
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
|
Less serious side effects
|
What to do
|
|---|---|
|
Gut-related:
mild stomach upsets such as feeling sick, diarrhoea, or stomach pains
impotence
Respiratory or breathing-related:
dry cough
running nose or sinus pain
changes in the way things smell
Other:
light-headedness or dizziness
headache
fatigue
hair loss or thinning
changes in the way things taste
feeling sleepy or difficulty in going to sleep, strange dreams
|
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:
changes in the way our heart beats, for example, if you notice it beating faster
yellowing of the skin and/or eyes, also called jaundice
tingling or numbness of the hands and feet
severe abdominal pain
Skin-related:
itchy skin rash, psoriasis or other skin problems
Other:
signs of frequent or worrying infections such as fever, severe chills, sore throat
or mouth ulcers
passing less urine than is normal for you
bruising more easily than normal
signs of dehydration such as nausea, vomiting, muscle cramps, headache, drowsiness
and tiredness.
seeing, feeling or hearing things that are not there
|
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.
|
Very side effects
|
Very serious side effects
|
What to do
|
|---|---|
|
Allergic reaction-related:
chest pain, angina
swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in
swallowing or breathing.
wheeziness due to tightness in the chest, difficulty breathing
collapse, numbness or weakness of arms or legs
pinkish, itchy swellings on the skin, also called hives or nettle rash
fainting
|
Stop taking this medicine and tell your doctor immediately, or go to Accident and
Emergency at your nearest hospital.
|
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 ZESTRIL contains
|
Active ingredient
(main ingredient)
|
lisinopril
|
|---|---|
|
Other ingredients
(inactive ingredients)
|
mannitol
calcium hydrogen phosphate dihydrate
maize starch
pregelatinised maize starch
magnesium stearate (E572)
iron oxide red C177491 (E172)
|
|
Potential allergens
|
None.
|
Do not take this medicine if you are allergic to any of these ingredients.
What ZESTRIL looks like
ZESTRIL 5 mg are pink, round, biconvex tablets with a heart image and the figure 5
marked on one side and a line through the middle on the other side. AUST R 70837
ZESTRIL 10 mg are pink, round, biconvex tablets, with a heart image and the figure
10 marked on one side and are plain on the other side. AUST R 70838
ZESTRIL 20 mg are brownish-red, round, biconvex tablets with a heart image and the
figure 20 marked on one side and are plain on the other side. AUST R 70839
A box of ZESTRIL contains 30 tablets.
