Micardis®
Tablets
Telmisartan
Consumer Medicine Information
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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Micardis®. It does not contain all the information that is known about Micardis®. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, 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 (also called 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 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. You may feel fine and have no symptoms, but if high blood pressure is not treated, it can lead to serious health problems (such as heart disease).
Micardis helps to lower your blood pressure but does not cure hypertension. Micardis contains telmisartan. Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. It works by widening the blood vessels of the body, and therefore helping to lower your blood pressure.
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.
Micardis may have been prescribed for you for another reason.
Ask your doctor if you have any questions about why Micardis has been prescribed for you.
Before you take Micardis
When not to take Micardis
Only take Micardis if it has been prescribed for you by a doctor.
Never give it to someone else even if their symptoms seem to be the same as yours.
Do not take Micardis if you are allergic to telmisartan or to any of the other ingredients in Micardis.
These ingredients are listed in full at the end of this leaflet.
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.
If you are uncertain as to whether you have these allergies or conditions you should raise these concerns with your doctor.
Do not take Micardis if you suffer from:
severe liver disease
biliary obstructive disorders (problem with the flow of bile from the gall bladder)
Do not take Micardis if you are pregnant or breastfeeding.
Do not take Micardis after the EXPIRY DATE on the carton or blister strips has passed.
Do not take Micardis if the packaging is torn or shows signs of tampering.
Do not take Micardis if the tablets are discoloured.
Before you start to take Micardis
It is essential that your doctor knows your medical history before prescribing Micardis.
Before taking Micardis, tell your doctor if you have, or have had, any of the following conditions:
allergies to any medicines or substances (such as food, preservatives or dyes)
a kidney transplant
heart, kidney or liver problems
primary aldosteronism, also known as Conn's syndrome
fructose intolerance
a low salt diet
recent severe diarrhoea or vomiting
If you are uncertain as to whether you have, or have had, any of these conditions you should raise those concerns with your doctor.
Before taking Micardis it is advisable to tell your doctor if you are taking any other medicines, obtained with or without a doctor's prescription.
In particular, tell your doctor if you are taking:
ramipril or any other medicines used to treat high blood pressure or heart problems
potassium tablets (potassium supplements)
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
aspirin
nonsteroidal anti-inflammatory agents (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
These medicines may be affected by Micardis, or may affect the way it works. Also, other medicines used to treat high blood pressure may have an additive effect with Micardis in lowering your blood pressure. Therefore, you may need different amounts of your medicines.
Your doctor or pharmacist will be able to tell you what to do if you are taking Micardis with other medicines.
Pregnancy
Ask for your doctor's advice if you are pregnant, or likely to become pregnant during your course of medication.
Micardis should not be taken if you are pregnant.
Breastfeeding
Ask for your doctor's advice if you are breastfeeding or likely to breastfeed during the course of your medication.
Micardis should not be taken if you are breastfeeding.
Children
Micardis is not recommended for use in children and teenagers up to 18 years of age.
Taking Micardis
How much Micardis to take
The usual dose of Micardis is one tablet a day.
For the Treatment of Hypertension
The usual recommended dose of Micardis for adults is one 40 mg tablet once a day to control your blood pressure over the 24 hour period. 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 recommended dose of Micardis is one 80 mg tablet once a day.
Follow all directions given to you by your doctor or pharmacist.
They may differ from the information contained in this leaflet. The amount of Micardis you have to take will depend on your condition and whether or not you are taking any other medicines.
How to take Micardis
Take Micardis at about the same time each day.
Micardis should be swallowed whole with a glass of water.
Micardis can be taken with or without food.
Do not take extra doses of Micardis without consulting your doctor.
If you forget to take a dose
It is important to take Micardis as directed.
If you miss a dose, take it as soon as you remember. However, if you remember when it is almost time for your next dose, take only your usual dose at that time.
Do not take a double dose of Micardis to make up for a dose that you missed.
How long to take Micardis
Micardis helps control your high blood pressure and/or prevents you from developing cardiovascular complications, including death due to cardiovascular causes, but does not cure the condition. Therefore Micardis must be taken every day.
Continue taking Micardis for as long as your doctor prescribes it.
If you have taken too much Micardis (overdose)
Seek medical advice if you have taken more than the recommended or prescribed dose of Micardis.
Advice can be provided by a doctor, pharmacist or Poisons Information Centre (telephone 13 11 26).
Signs of overdose may include increased heart rate and low blood pressure (dizziness, lightheadedness). A slow heart beat may also occur.
While taking Micardis
Things you must do
Tell your doctor immediately if you become pregnant while taking Micardis.
Tell your doctor or pharmacist if you begin using any other medicine while you are taking Micardis.
If you feel dizzy or lightheaded, and you wish to stand up, you should do so slowly.
You may feel dizzy or lightheaded when you begin to take Micardis, especially if you are also taking a diuretic or fluid tablet. If this problem occurs, talk to your doctor.
If you exercise, or if you sweat, or if the weather is hot, you should drink plenty of water.
Ability to drive or operate machinery
It is advisable to be careful when driving or operating machinery until you know how Micardis affects you.
It is always possible that Micardis, like other medicines used to treat high blood pressure, may cause dizziness or drowsiness in some people.
When taken as recommended, and when there are no side effects, Micardis is not known to have any effect on the ability to drive or operate machinery.
Side effects
You should be aware that all prescription medicines carry some risks and that all possible risks may not be known at this stage despite thorough testing. Your doctor has weighed the risks of you taking Micardis against the benefits they expect it will have for you.
Ask for the advice of your doctor or pharmacist if you have any concerns about the effects of using this medicine.
Most side effects of Micardis are mild and temporary.
The overall frequency of side effects reported by patients taking Micardis is similar to patients taking a placebo (sugar tablet) in clinical studies.
The following side effects have been reported by patients taking Micardis. It is not known if these side effects are caused by Micardis.
dizziness or lightheadedness when you stand up (postural hypotension)
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 tendinitis-like symptoms
urinary tract infections (including cystitis)
trouble sleeping (insomnia)
feeling anxious
depression
fast or slow heart beats
visual disturbance
increased sweating
dry mouth
allergic skin reactions including skin rash (eczema); itchiness (pruritus); redness of the skin (erythema)
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
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)
Tell your doctor as soon as possible if you experience any side effects during or after taking Micardis, so that these may be properly treated.
If any of the following happens, stop taking Micardis and either tell your doctor immediately or go to Accident and 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 rare but serious side effects and may indicate a severe allergic reaction. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything unusual, during or after taking Micardis.
After taking Micardis
Storage
Leave the tablets in the blister strip until it is time to take a dose.
The blister pack protects the tablets.
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 store in direct sunlight or heat.
For example, do not leave Micardis in the car on hot days.
Heat and dampness can destroy some medicines.
Keep Micardis where young children cannot reach it.
Disposal
If you have been told by your doctor that you will not be needing Micardis anymore, or the tablets have passed their expiry date, the unused medicine should be returned to your pharmacist so that it can be disposed of safely.
Product Description
What Micardis is
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 28 tablets.
The following Australian Registration Numbers appear on the carton:
AUST R 68052 for Micardis 40 mg tablets
AUST R 68053 for Micardis 80 mg tablets
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 K25
meglumine
sodium hydroxide
sorbitol
magnesium stearate
Manufacturer
Micardis tablets are made in Germany and supplied in Australia by:
BOEHRINGER INGELHEIM PTY LIMITED
(ABN 52 000 452 308)
78 Waterloo Road
NORTH RYDE NSW 2113
Micardis is a registered trademark of Boehringer Ingelheim
This leaflet was updated on 18 February 2010.
© Boehringer Ingelheim Pty Limited 2010
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