Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking Micardis Plus?
Micardis Plus contains the active ingredients telmisartan and hydrochlorothiazide,
in one single tablet. Micardis Plus is used to lower high blood pressure. For more information, see Section
1. Why am I taking Micardis Plus? in the full CMI.
2. What should I know before I take Micardis Plus?
Do not take if you have ever had an allergic reaction to telmisartan or hydrochlorothiazide
(the two active ingredients in Micardis
Plus), or any of the ingredients listed at the end of this leaflet.
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.
Do not take Micardis Plus if you have a rare hereditary condition of fructose intolerance
and/ or galactose intolerance.
Micardis Plus is not prescribed for children under the age of 18 years.
For more information, see Section
2. What should I know before I take Micardis Plus? in the full CMI.
3. What if I am taking other medicines?
4. How do I take Micardis Plus?
The usual dose for adults is one Micardis Plus 40/12.5 tablet once a day. More instructions
can be found in Section
4. How do I take Micardis Plus? in the full CMI.
5. What should I know while taking Micardis Plus?
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Things you should do
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Remind any doctor, dentist or pharmacists you visit that you are taking Micardis Plus.
Stop taking Micardis Plus and call your doctor straight away if you develop an unexpected
abnormal lump, bump, ulcer, sore or coloured area on the skin (skin lesion) during
the treatment or if you develop any shortness of breath or difficulty breathing after
taking Micardis Plus.
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Things you should not do
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Do not take any other medicines for your hypertension (high blood pressure) without
checking with your doctor.
Do not stop taking Micardis Plus or lower the dosage, without checking with your doctor
or pharmacist.
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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 Micardis
Plus affects you.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Keep your Micardis Plus in a cool, dry place where the temperature stays below 25°C
and protect from light and moisture
Do not store your medication in bathroom or in car or on windowsills.
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6. Are there any side effects?
Do not be alarmed, and speak to your doctor if you feel nausea, ‘flu-like’ symptoms,
increased heart rate, chest pain, dizziness, stomach pain or discomfort, sleeping
disturbances or pain in muscles or joints.
Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you develop any severe shortness of breath or difficulty breathing
after taking Micardis Plus or if you develop an unexpected abnormal lump, bump, ulcer,
sore or coloured area on the skin (skin lesion) during the treatment. 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.
Active ingredients:
Telmisartan and Hydrochlorothiazide
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking Micardis Plus. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking Micardis Plus.
Where to find information in this leaflet:
1. Why am I taking Micardis Plus?
Micardis Plus contains the active ingredients telmisartan and hydrochlorothiazide.
Micardis Plus is used to lower high blood pressure.
Everyone has blood pressure. This pressure helps get your blood 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 is needed, even when you are calm and relaxed. If high
blood pressure is not treated, it can lead to serious health problems, including stroke,
heart disease and kidney failure.
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.
How Micardis Plus works?
Micardis Plus contains telmisartan and hydrochlorothiazide in one single tablet. These
two active ingredients help to reduce blood pressure in different ways:
Telmisartan belongs to a group of medicines called angiotensin II receptor blockers.
Telmisartan works by blocking the effect of angiotensin II (a substance which causes
blood vessels to narrow, thus increasing blood pressure). When the effect of angiotensin
II is blocked, your blood vessels relax, and your blood pressure goes down.
Hydrochlorothiazide belongs to the group of medicines called diuretics. Diuretics
help to reduce the amount of excess fluid in the body by increasing the amount of
urine produced. They help with lowering blood pressure particularly when used with
other blood pressure lowering medicines.
2. What should I know before I take Micardis Plus?
Warnings
Do not take Micardis Plus if you have:
an allergic reaction to telmisartan or hydrochlorothiazide (the two active ingredients
in Micardis Plus), or any of the ingredients listed at the end of this leaflet. Signs
of an allergic reaction may include shortness of breath; wheezing or difficulty breathing;
swelling of the face, lips, tongue or other parts of body; rash, itching or hives
on the skin.
hypersensitivity to sulfonamide containing medicines
severe liver disease
severe kidney disease
problem with the flow of bile from the gall bladder (cholestasis or biliary obstructive
disorders)
low potassium levels in the blood
high calcium levels in the blood
low sodium levels that is treatment resistant
low blood volume causing very low blood pressure
a disease with painful, swollen joints caused by uric acid crystals (gout)
diabetes or kidney disease and you are taking medicine used to treat high blood pressure
(aliskiren)
Check with your doctor if you:
have any of the following medical conditions, especially:
liver problems
kidney problems
heart problems
diabetes
high cholesterol levels
a condition with raised aldosterone levels (primary hyperaldosteronism or Conn’s syndrome)
fructose intolerance
galactose intolerance
recent severe diarrhoea or vomiting
asthma
a disease affecting the skin, joints and kidney (systemic lupus erythematosus)
eye problems
skin cancer.
Tell your doctor if you experienced breathing or lung problems (including inflammation
or fluid in the lungs) following hydrochlorothiazide intake in the past.
Tell your doctor if you are following a very low salt diet.
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 Plus 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.
Tell your doctor immediately if you become pregnant while taking Micardis Plus.
Do not take Micardis Plus if you are breastfeeding or intend to breastfeed.
It is not known if telmisartan or hydrochlorothiazide, the active ingredients in Micardis
Plus, pass into breast milk and there is a possibility that your baby may be affected.
Do not take Micardis Plus if you have a rare hereditary condition of fructose intolerance.
The maximum recommended daily dose of Micardis Plus contains 169 mg of sorbitol (in
the 40/12.5 tablets) and approximately 338 mg of sorbitol (in the 80/12.5 and 80/25
tablets).
Do not take Micardis Plus if you have a rare hereditary condition of galactose intolerance.
The maximum recommended daily dose of Micardis Plus contains 112 mg of lactose monohydrate
(in the 40/12.5 and 80/12.5 tablets) and 99 mg of lactose monohydrate (in the 80/25
tablets).
Do not give Micardis Plus 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.
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 and Micardis Plus may interfere with each other. These include:
any other medicines used to treat high blood pressure such as beta-blockers
heart medicines such as digoxin, a medicine used to treat heart failure or antiarrhythmic
medicines
other diuretics or fluid tablets, medicines used to help the kidneys get rid of salt
and water by increasing the amount of urine produced
laxatives
potassium supplements or potassium-containing salt substitutes
medicines or salt substitutes which may increase your potassium levels
amphotericin B, a medicine used to treat fungal infections
penicillin antibiotics used to treat bacterial infections
alcohol
sleeping tablets
lithium, a medicine used to treat certain mental illnesses
medicines used to treat depression
antipsychotics, medicines used to treat certain mental and emotional conditions
antiepileptic’s, medicines used to treat epilepsy or fits
strong pain killing medicines
medicines for diabetes (oral tablets or capsules or insulin)
powder or granules used to help reduce cholesterol
corticosteroid medicines such as prednisolone, cortisone or ACTH (a hormone)
aspirin
nonsteroidal anti-inflammatory agents (medicines used to relieve pain, swelling and
other symptoms of inflammation including arthritis)
medicines used to treat gout
medicines used to increase blood pressure, such as noradrenaline
ciclosporin, a medicine used to help prevent organ transplant rejection or to treat
certain problems with the immune system
calcium supplements or medicines containing calcium
vitamin D supplements
anticholinergic medicines, which can be used to treat Parkinson’s disease, relieve
stomach cramps or prevent travel sickness
amantadine, a medicine used to treat Parkinson’s disease or to prevent influenza
medicines used to treat cancer (cytotoxic medicines).
These medicines may be affected by Micardis Plus, or may affect how well it works.
Other medicines used to treat high blood pressure may have an additive effect with
Micardis Plus 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 Plus.
4. How do I take Micardis Plus?
How much to take
The usual dose for adults is one Micardis Plus 40/12.5 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 one Micardis Plus 80/12.5 tablet once a day.
If your blood pressure is still not satisfactorily controlled with Micardis Plus 80/12.5,
your doctor may increase your dose to one Micardis Plus 80/25 tablet once a day.
It is important to take Micardis Plus exactly as your doctor or pharmacist has told
you.
When to take Micardis Plus
Take Micardis Plus around the same time each day, either morning or evening, with
or without food.
How to take Micardis Plus
Swallow the tablet whole with a full glass of water.
If you forget to take Micardis Plus
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 it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed.
If you take too much Micardis Plus
If you think that you have taken too much Micardis Plus - you may feel dizzy, light-headed,
or faint; your heartbeat may be faster or slower than usual; you may experience dehydration,
nausea, drowsiness and muscle spasm - 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.
5. What should I know while taking Micardis Plus?
Things you should do
Stop taking Micardis Plus and Call your doctor straight away if you:
develop an unexpected abnormal lump, bump, ulcer, sore or coloured area on the skin
(skin lesion) during the treatment - treatment with hydrochlorothiazide, particularly
long-term use with high doses, may increase the risk of some types of skin and lip
cancer (non-melanoma skin cancer)
develop any severe shortness of breath or difficulty breathing after taking Micardis
Plus
become pregnant while taking Micardis Plus
You should make sure that you:
protect your skin from sun exposure and UV rays while taking Micardis Plus
keep all of your doctor’s appointments so that your progress can be checked
tell your doctor that you are taking Micardis Plus, if you are about to be started
on any new medicine
tell your doctor if, for any reason, have not taken Micardis Plus exactly as prescribed
tell your doctor if you feel that Micardis Plus is not helping your condition
Things you should not do
Do not take Micardis Plus 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 Plus or lower the dosage without checking with your doctor.
Tell your surgeon or anesthetists that you are taking Micardis Plus if you plan to
have surgery. It may affect other medicines during surgery.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Micardis
Plus affects you.
Like other medicines used to treat high blood pressure, Micardis Plus may cause sleepiness,
dizziness or light-headedness in some people.
Do not drive, operate machinery, or perform hazardous physical activity if you experience
any of these side effects.
You may feel dizzy or light-headed when you begin to take Micardis Plus, especially
if you are also taking a diuretic (or fluid tablet) or if you are dehydrated.
If you feel dizzy or light-headed, and you wish to stand up, you should do so slowly.
If you exercise, or if you sweat, or if the weather is hot, you should drink plenty
of water.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your Micardis Plus in a cool, dry place where the temperature stays below 25°C
and protect from light and moisture.
Keep the tablets in the blister strip until it is time to take a dose
Do not store it:
in the bathroom or near a sink, or
in the car or on windowsills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
Take it to any pharmacy for safe disposal if you no longer need to take this medicine
or it is out of date.
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.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you experience symptoms like - feeling very thirsty, sleepy, sick or vomiting, a dry mouth, general weakness, restlessness,
seizures (fits), confusion, muscle pain or cramps, passing less urine than normal
and a very fast heart rate. It may mean that the hydrochlorothiazide part of Micardis
Plus is having an excessive effect.
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 that 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
This medicine is only available with a doctor's prescription.
What Micardis Plus contains
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Active ingredient
(main ingredient)
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Micardis Plus 40/12.5 - 40 mg telmisartan and 12.5 mg hydrochlorothiazide per tablet.
Micardis Plus 80/12.5 - 80 mg telmisartan and 12.5 mg hydrochlorothiazide per tablet.
Micardis Plus 80/25 - 80 mg telmisartan and 25 mg hydrochlorothiazide per tablet.
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Other ingredients
(inactive ingredients)
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maize starch
iron oxide red CI77491 (in Micardis Plus 40/12.5 tablet and Micardis Plus 80/12.5
tablets)
or
iron oxide yellow CI77492 (in Micardis Plus 80/25 tablets)
magnesium stearate
meglumine
microcrystalline cellulose
povidone
lactose monohydrate
sodium hydroxide
sodium starch glycollate type A
sorbitol
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Potential allergens
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lactose monohydrate, sorbitol
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Do not take this medicine if you are allergic to any of these ingredients.
What Micardis Plus looks like
Micardis Plus is the brand name of your medicine.
Micardis Plus tablets are available in three strengths: 40/12.5, 80/12.5 and 80/25
tablets.
Micardis Plus 40/12.5 tablets are oblong, white-red, biconvex, two-layer tablets,
possibly with red specks in the white layer. The white face is marked with H4 and
the Boehringer Ingelheim company symbol. (AUST R 82416)
Micardis Plus 80/12.5 tablets are oblong, white-red, biconvex, two-layer tablets,
possibly with red specks in the white layer. The white face is marked with H8 and
the Boehringer Ingelheim company symbol. (AUST R 82418)
Micardis Plus 80/25 tablets are oblong, white-yellow, biconvex, two-layer tablets,
possibly with yellow specks in the white layer. The white face is marked with H9 and
the Boehringer Ingelheim company symbol. (AUST R 143761)
Micardis Plus tablets are available in blister packs of 7* (sample), 14*, 28, 56*
and 98* tablets.
* Not currently distributed in Australia.
Who distributes Micardis Plus
Micardis Plus 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 2024
This leaflet was prepared in November 2024.