Tablets
telmisartan
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Micardis.
It does not contain all available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking
this medicine against the benefits it is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
This leaflet was last updated on the date at the end of this leaflet. More recent
information may be available. The latest Consumer Medicine Information is available
from your pharmacist, doctor, or from www.medicines.org.au and may contain important
information about the medicine and its use of which you should be aware.
Keep this leaflet with the medicine.
You may need to read it again.
What Micardis is used for
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.
How Micardis works
Micardis contains 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.
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.
Before you take Micardis
When you must not take it
Do not take Micardis if you have an allergy to:
any medicine containing telmisartan (the active ingredient in Micardis)
any other ingredients listed at the end of this leaflet.
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 take 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 take Micardis if you are 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.
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.
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.
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.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell your doctor before you
start taking Micardis.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
shop.
Some medicines and Micardis may interfere with each other. These include:
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.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking Micardis.
How to take 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 take it
Swallow the tablet whole with a full glass of water.
When to take it
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 take it
Continue taking Micardis for as long as your doctor tells you.
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 it
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 that 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 take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26)
for advice or go to Emergency at your nearest hospital, if you think that you or anyone
else may have taken too much Micardis.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
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.
While you are taking Micardis
Things you must 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.
If you become pregnant while taking Micardis, tell your doctor immediately.
If you feel that Micardis is not helping your condition, tell your doctor or pharmacist.
Tell your doctor if, for any reason, you have not used Micardis exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment
unnecessarily.
Things you must not do
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.
Do not stop taking Micardis or lower the dosage without checking with your doctor.
Things to be careful of
Be careful driving or operating machinery until you know how Micardis affects you.
Like other medicines used to treat high blood pressure, Micardis may cause sleepiness,
dizziness or lightheadedness in some people. If you have any of these symptoms, do
not drive, operate machinery or do anything else that could be dangerous.
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. If this problem continues
or gets worse, talk to your doctor.
If you exercise, or if you sweat, or if the weather is hot, you should drink plenty
of water.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Micardis.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by the following list of possible side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
dizziness or lightheadedness when you stand up especially when getting up from a sitting
or lying position
dizziness or spinning sensation, fainting
tiredness or weakness
'flu-like' symptoms
pain in the chest
diarrhoea
indigestion
stomach pain or discomfort
wind or excessive gas in the stomach or bowel (flatulence)
upper respiratory tract infections
shortness of breath
back pain
aching muscles, not caused by exercise (myalgia)
muscle spasms or leg cramps or leg pain
painful joints (arthralgia)
tendon pain or tendonitis-like symptoms
symptoms of urinary tract infections (including cystitis) such as burning sensation
when passing urine, pain in the pelvis or mid-back, urine that appears cloudy, straining
or pain when passing urine
trouble sleeping (insomnia)
feeling anxious
depression
fast or slow heart beats
abnormal or blurred vision
increased sweating
dry mouth
allergic skin reactions including skin rash (eczema); itchiness (pruritus); redness
of the skin (erythema)
symptoms that may indicate low blood sugar levels in the blood, such as sweating,
weakness, hunger, dizziness, trembling, headache or numbness (especially in diabetic
patients)
abnormal liver functions
symptoms that may indicate a worsening of the kidney function, such as passing little
or no urine, drowsiness, nausea, vomiting, breathlessness, loss of appetite and weakness
symptoms that may indicate high potassium levels in the blood, such as nausea, diarrhoea,
muscle weakness and changes in heart rhythm
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 (thrombocytopenia)
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 may occur (such changes are usually
detected by a blood test).
If any of the following happen, tell your doctor immediately or go to Emergency at
your nearest hospital:
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing
severe and sudden onset of itchy or raised skin rash, hives or nettle rash.
These are serious side effects. You may need urgent medical attention or hospitalisation.
These side effects are rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After taking Micardis
Storage
Keep the tablets in the blister strip until it is time to take them.
The blister pack protects the tablets from light and moisture.
Keep Micardis in a cool dry place where the temperature stays below 30°C.
Do not store Micardis or any other medicine in the bathroom or near a sink. Do not
leave it in the car or on a window sill.
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.
Disposal
If your doctor tells you to stop taking Micardis or the expiry date has passed, ask
your pharmacist what to do with any that is left over.
Product description
What it looks like
Micardis is the brand name of your medicine.
Micardis tablets are available in two strengths: 40 mg and 80 mg tablets.
Micardis 40 mg 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 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.
Ingredients
Each Micardis 40 mg tablet contains 40 mg telmisartan.
Each Micardis 80 mg tablet contains 80 mg telmisartan.
The other ingredients found in both strengths are:
povidone
meglumine
sodium hydroxide
sorbitol
magnesium stearate.
Supplier
Micardis tablets are supplied in Australia by:
Boehringer Ingelheim Pty Limited
ABN 52 000 452 308
Sydney, Australia
www.boehringer-ingelheim.com.au
® Micardis is a registered trademark of Boehringer Ingelheim
© Boehringer Ingelheim Pty Limited 2022
This Consumer Medicine Information was updated in July 2022.
Australian Registration Numbers
Micardis 40 mg tablets:
AUST R 68052
Micardis 80 mg tablets:
AUST R 68053