2. What should I know before I use Micardis?
Do not use if you have ever had an allergic reaction to telmisartan or any of the
ingredients listed at the end of the CMI.
Do not take Micardis if you have a rare hereditary condition of fructose intolerance.
Micardis is not prescribed for children below 18 years of age. 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 Micardis and affect how it works.
4. How do I use Micardis?
The usual dose of Micardis for adults to treat high blood pressure is one 40 mg tablet
once a day. If your blood pressure is still too high after 4-8 weeks of starting treatment,
your doctor may increase your dose to 80 mg.
The usual dose of Micardis for the prevention of cardiovascular complications is one
80 mg tablet once a day. Depending on how you respond to the treatment, your doctor
may suggest a higher or a lower dose.
5. What should I know while using Micardis?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking Micardis.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
Micardis.
Tell your doctor or pharmacist if you feel that Micardis is not helping in your condition.
|
|
Things you should not do
|
Do not stop taking Micardis or lower the dosage without checking with your doctor.
Do not take Micardis to treat any other complaints unless your doctor tells you to.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how Micardis affects you.
|
|
Looking after your medicine
|
Keep the tablets in the blister strip until it is time to take them.
Keep Micardis in a cool dry place where the temperature stays below 30°C; protect
from heat, light and moisture.
|
6. Are there any side effects?
Potential side effects include headaches, upper respiratory tract infections, dizziness,
‘flu-like’ symptoms, fatigue and back pain. Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if any of the following happen: swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing or severe and sudden onset of itchy or raised skin rash, hives
or nettle rash.
Active ingredient:
telmisartan
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Micardis. 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 Micardis.
Where to find information in this leaflet:
1. Why am I using Micardis?
Micardis contains the active ingredient telmisartan. Telmisartan belongs to a group of medicines called angiotensin II receptor blockers.
Angiotensin II is a substance in the body which causes blood vessels to narrow, thus
increasing blood pressure. Telmisartan works by blocking the effect of angiotensin
II. When the effect of angiotensin II is blocked, your blood vessels relax and your
blood pressure goes down.
Micardis may be used either alone or in combination with other medicines used to treat
high blood pressure.
Micardis is used to:
treat high blood pressure (also called hypertension)
prevent cardiovascular complications, including death due to cardiovascular causes,
in patients older than 55 years of age with coronary artery disease, peripheral vascular
disease, previous stroke, previous transient ischaemic attack (TIA) or high risk diabetes
with evidence of end organ damage.
Treatment of Hypertension
Micardis is used to lower high blood pressure (hypertension).
Everyone has blood pressure. This pressure helps your blood move around your body.
Your blood pressure may be different at different times of the day, depending on how
busy or worried you are. You have hypertension (high blood pressure) when your blood
pressure stays higher than normal, even when you are calm or relaxed.
There are usually no signs 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.
Prevention of Cardiovascular Complications, including Death due to Cardiovascular
Causes
Micardis is also used to prevent cardiovascular complications, including death due
to cardiovascular causes that may arise in high risk patients older than 55 years
of age. Examples include heart attack, stroke, death caused by heart diseases or hospitalisation
due to heart failure (a condition which can cause shortness of breath or ankle swelling).
Patients who may be considered at high risk of developing cardiovascular complications
or at high risk of death due to cardiovascular causes are those aged 55 or more who
have problems such as coronary artery disease (a heart disease caused by poor blood
flow in the blood vessels of the heart), peripheral vascular disease (poor circulation
in the hands or feet), previous stroke, previous transient ischaemic attack (TIA)
or diabetes with additional high risk factors and evidence of end organ damage (e.g.
damage occurring in the kidneys, heart, brain or eyes).
Your doctor can tell you if you are at high risk of developing cardiovascular complications
or if you are at high risk of death due to cardiovascular causes.
Your doctor may have prescribed Micardis for another reason.
Ask your doctor if you have any questions about why Micardis has been prescribed for
you.
Micardis is not addictive.
This medicine is available only with a doctor's prescription.
2. What should I know before I use Micardis?
Warnings
Do not use Micardis if:
you have an allergy to any medicine containing telmisartan (the active ingredient
in Micardis) or any other ingredients listed at the end of this leaflet. Always check
the ingredients to make sure you can use this medicine.
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.
Do not use Micardis if you have a rare hereditary condition of fructose intolerance.
The maximum recommended daily dose of Micardis contains approximately 338 mg of sorbitol.
Do not give Micardis to a child under the age of 18 years.
Safety and effectiveness in children and teenagers up to 18 years of age have not
been established.
Do not take Micardis if you suffer from:
severe liver disease
biliary obstructive disorders (problem with the flow of bile from the gall bladder)
diabetes or kidney problems and you are taking aliskiren (a medicine used to treat
high blood pressure).
Do not take Micardis after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Do not take Micardis if the tablets are discoloured.
If you are not sure whether you should start taking Micardis, talk to your doctor.
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 Micardis if you are pregnant.
Check with your doctor if you are pregnant or intend to become pregnant.
Like other similar medicines, it may affect your developing baby if you take it during
pregnancy.
Do not breastfeed if you are taking Micardis.
Talk to your doctor if you breastfeeding or intend to breastfeed.
It is not known if telmisartan, the active ingredient in Micardis, passes into breast
milk and there is a possibility that your baby may be affected.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
kidney problems
liver problems
heart problems
diabetes
a condition known as primary hyperaldosteronism (raised aldosterone levels, also known
as Conn's syndrome)
fructose intolerance
recent severe diarrhoea or vomiting.
Tell your doctor if you are following a very low salt diet.
If you have not told your doctor about any of the above, tell your doctor before you
start using Micardis.
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 Micardis and affect how it works.
ramipril or any other medicines used to treat high blood pressure or heart problems
potassium supplements or potassium- containing salt substitutes
medicines or salt substitutes which may increase your potassium levels
diuretics or fluid tablets, medicines used to help the kidneys get rid of salt and
water by increasing the amount of urine produced
nonsteroidal anti-inflammatory agents such as aspirin or ibuprofen (medicines used
to relieve pain, swelling and other symptoms of inflammation including arthritis)
lithium, a medicine used to treat certain mental illnesses
digoxin, a medicine used to treat heart failure
trimethoprim, a medicine used to treat bacterial infections
heparin, a medicine used to thin your blood
corticosteroids, medicines used to treat inflammatory conditions
immunosuppressants, such as ciclosporin or tacrolimus (medicines used to prevent organ
rejection after transplantation).
These medicines may be affected by Micardis or may affect how well it works. Other
medicines used to treat high blood pressure or medicines with blood pressure lowering
potential may have an additive effect with Micardis in lowering your blood pressure.
You may need different amounts of your medicines, or you may need to take different
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 Micardis.
4. How do I use Micardis?
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
Your doctor or pharmacist will tell you how many tablets you will need to take each
day. This depends on your condition and whether or not you are taking any other medicines.
If you do not understand the instructions on the label, ask your doctor or pharmacist
for help.
How much to take
For the Treatment of Hypertension
The usual dose of Micardis for adults is one 40 mg tablet once a day.
If your blood pressure is still too high after 4-8 weeks of starting treatment, your
doctor may increase your dose to 80 mg.
For the prevention of cardiovascular complications, including death due to cardiovascular
causes
The usual dose of Micardis is one 80 mg tablet once a day.
Depending on how you respond to the treatment, your doctor may suggest a higher or
lower dose.
It is important to take Micardis exactly as your doctor or pharmacist has told you.
How to use Micardis
Swallow the tablet whole with a full glass of water.
When to use Micardis
Take Micardis at about the same time each day, either morning or evening.
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 Micardis before or after food.
How long to use it
Continue taking Micardis for as long as your doctor tells you.
Follow the instructions provided and use Micardis until your doctor tells you to stop.
Micardis helps to control your high blood pressure, and/or prevents you from developing
cardiovascular complications, but does not cure it. It is important to keep taking
Micardis every day even if you feel well.
People who have high blood pressure often feel well and do not notice any signs of
this problem.
If you forget to take Micardis
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 the dose 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 you missed.
This may increase the chance of you getting unwanted side effects.
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 Micardis
If you think that you have used too much Micardis, 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 much Micardis you may feel dizzy, light-headed or faint. Your heartbeat
may be faster or slower than usual. You may experience rapid, shallow breathing or
cold, clammy skin. This is because your blood pressure is too low.
5. What should I know while using Micardis?
Things you should do
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking Micardis.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
Micardis.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
Micardis.
Micardis may affect other medicines used during surgery.
Tell your doctor immediately if you become pregnant while taking Micardis.
Tell your doctor if you feel that Micardis is not helping in your condition.
Tell your doctor if, for any reason, you have not taken Micardis exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment
unnecessarily.
Things you should not do
Do not stop taking Micardis or lower the dosage without checking with your doctor.
Do not take Micardis to treat any other complaints unless your doctor tells you to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Things to be careful of
You may feel dizzy or light-headed when you begin to take Micardis, especially if
you are also taking a diuretic (or fluid tablet) or if you are dehydrated.
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 a bed or chair, will help your
body get used to the change in position and blood pressure. Talk to your doctor if
this problem continues or gets worse.
Drink plenty of water if you exercise, or if you sweat, or if the weather is hot.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Micardis
affects you.
Like other medicines used to treat high blood pressure, Micardis may cause sleepiness,
dizziness or light-headedness in some people. If you have any of these symptoms, do
not drive, operate machinery or do anything else that could be dangerous.
Looking after your medicine
Keep the tablets in the blister strip until it is time to take them.
The blister pack protects the tablets from light and moisture.
Store it in a cool dry place away from moisture, heat or sunlight; and where temperature
stays below 30°C. 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 Micardis where 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
If your doctor tells you to stop taking Micardis or the expiry date has passed, take
it to any pharmacy for safe disposal.
Do not take 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.
Side effects
|
Side effects
|
What to do
|
|
Side effects related to an allergic skin reaction:
skin rash
itchiness
redness of the skin
Side effects related to the nervous system:
dizziness or light-headedness when you stand up especially when getting up from a
sitting or lying position
dizziness or spinning sensation, fainting
feeling anxious
depression
Gastrointestinal related side effects:
diarrhoea
indigestion
stomach pain or discomfort
wind or excessive gas in the stomach or bowel (flatulence)
Blood related side effects:
symptoms that may indicate low sodium levels in the blood, such as headache, dizziness,
confusion, forgetfulness, weakness, unsteadiness or difficulty concentrating
signs of anaemia such as tiredness, being short of breath when exercising, dizziness
and looking pale
bleeding or bruising more easily than normal
symptoms that may indicate an infection of the blood, such as high fever, chills,
headache, confusion and rapid breathing
changes in your red or white blood cell levels (such changes are usually detected
by a blood test).
Symptoms of urinary tract infections (including cystitis):
burning sensation when passing urine
pain in the pelvis or mid-back
urine that appears cloudy
straining or pain when passing urine
Symptoms that indicate low blood sugar levels in the blood:
sweating
weakness
hunger
dizziness
trembling
headache
numbness (especially in diabetic patients)
Symptoms that may indicate worsening kidney function:
passing little or no urine
drowsiness
nausea
vomiting
breathlessness
loss of appetite
weakness
Symptoms that may indicate high potassium levels in the blood:
nausea
diarrhoea
muscle weakness
changes in heart rhythm
Other side effects
tiredness or weakness
‘flu-like’ symptoms
pain in the chest
upper respiratory tract infections
shortness of breath
back pain
aching muscles not caused by exercise
muscle spasms or leg cramps or leg pain
painful joints
tendon pain or tendonitis-like symptoms
trouble sleeping
fast or slow heart beats
abnormal or blurred vision
increased sweating
dry mouth
abnormal liver functions
|
Speak to your doctor if you have any of these side effects and they worry you.
|
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
Micardis is the brand name of your medicine.
This medicine is only available with a doctor's prescription.
What Micardis contains
|
Active ingredient
(main ingredient)
|
Each Micardis 40 mg tablet contains 40 mg telmisartan.
Each Micardis 80 mg tablet contains 80 mg telmisartan.
|
|
Other ingredients
(inactive ingredients)
|
povidone
Meglumine
sodium hydroxide
sorbitol
magnesium stearate.
|
Do not take this medicine if you are allergic to any of these ingredients.
What Micardis looks like
Micardis tablets are available in two strengths: 40 mg and 80 mg tablets.
Micardis 40 mg (AUST R 68052) tablets are white to off-white oblong tablets, marked
with the Boehringer Ingelheim logo on one face and '51H' on the other.
Micardis 80 mg (AUST R 68053) tablets are white to off-white oblong tablets, marked
with the Boehringer Ingelheim logo on one face and '52H' on the other.
Micardis tablets are available in blister packs of 7 (sample), 28, 56* and 98* tablets.
* Not currently distributed in Australia.
Who distributes Micardis
Micardis tablets are supplied in Australia by:
Boehringer Ingelheim Pty Limited
ABN 52 000 452 308
Sydney, Australia
® Micardis is a registered trademark of Boehringer Ingelheim
© Boehringer Ingelheim Pty Limited 2025.
This leaflet was prepared in May 2025.