Brand name Micardis

Form tablets

Active substance / Dosage

TELMISARTAN

Prescription type Prescription only

ATC code

C09CA07

Registration number 034328

Manufacturer BOEHRINGER INGELHEIM INTERNATIONAL GMBH

Table of Contents

Package leaflet: Information for the user
Micardis 20 mg tablets
1. What Micardis is and what it is used for
2. What you need to know before taking Micardis
3. How to take Micardis
4. Possible side effects
5. How to store Micardis
6. Package contents and other information
Package leaflet: information for the user
Micardis 40 mg tablets
1. What Micardis is and what it is used for
2. What you should know before taking Micardis
3. How to take Micardis
4. Possible side effects
5. How to store Micardis
6. Package contents and other information
Patient Information Leaflet: Information for the User
Micardis 80 mg tablets
1. What Micardis is and what it is used for
2. What you should know before taking Micardis
3. How to take Micardis
4. Possible side effects
5. How to store Micardis
6. Package contents and other information

Package leaflet: Information for the user

Micardis 20 mg tablets

telmisartan
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Micardis is and what it is used for
What you need to know before taking Micardis
How to take Micardis
Possible side effects
How to store Micardis
Contents of the pack and other information

1. What Micardis is and what it is used for

Micardis belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Micardis blocks the effect of angiotensin II, causing blood vessels to relax and thereby reducing blood pressure.
Micardis is used for the treatment of essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not caused by other conditions.
If left untreated, high blood pressure can damage blood vessels in many organs and may sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage has occurred. Therefore, it is important to have your blood pressure checked regularly to ensure it is within the normal range.
Micardis is also used for reducing cardiovascular events (e.g., heart attack or stroke) in adults at risk because of reduced or blocked blood flow to the heart or legs, or because they have had a stroke or have high-risk diabetes. Your doctor can advise you whether you are at high risk for these events.

2. What you need to know before taking Micardis

Do not take Micardis

if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
if you are more than 3 months pregnant (it is better to avoid taking Micardis even in the early stages of pregnancy – see section Pregnancy).
if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other severe liver disease.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are in any of the above conditions, inform your doctor or pharmacist before taking Micardis.

Warnings and precautions

Talk to your doctor before taking Micardis if you have or have ever had any of the following conditions or diseases:

Kidney disease or kidney transplant.
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Liver diseases.
Heart problems.
Elevated levels of aldosterone (water and salt retention in the body with imbalance of various minerals in the blood).
Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of body water) or have salt deficiency due to, for example, diuretic therapy ("diuretics"), a low-salt diet, diarrhoea or vomiting.
High levels of potassium in the blood.
Diabetes.

Talk to your doctor before taking Micardis:

if you are taking any of the following medicines used to treat high blood pressure:
- an ACE-inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
- aliskiren. Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section “Do not take Micardis”.
if you are taking digoxin.

Talk to your doctor if, after taking Micardis, you experience abdominal pain, nausea, vomiting or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Micardis on your own.

You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Micardis is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section Pregnancy).

If you are undergoing surgery or anaesthesia, you must inform your doctor that you are taking Micardis.

Micardis may be less effective in lowering blood pressure in patients of African origin.

Children and adolescents

The use of Micardis is not recommended in children and adolescents under 18 years of age.

Other medicines and Micardis

Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may decide to adjust the dose of these other medicines or take other precautions. In some cases, it may be necessary to stop taking one of these medicines. This particularly applies to the following medicines when taken concomitantly with Micardis:

Medicines containing lithium used to treat certain types of depression.
Medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (some "diuretics"), ACE-inhibitors, angiotensin II receptor blockers, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
Diuretics, especially when taken at high doses together with Micardis, may cause excessive loss of body water and low blood pressure (hypotension).
If you are taking an ACE-inhibitor or aliskiren (see also the sections: “Do not take Micardis” and “Warnings and precautions”).
Digoxin.

The effect of Micardis may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.

Micardis may enhance the effect of other medicines used to lower high blood pressure or medicines that may potentially lower blood pressure (e.g. baclofen, amifostine). In addition, low blood pressure may be worsened by alcohol, barbiturates, narcotics or antidepressants. You may experience this drop in blood pressure as dizziness when standing up. Consult your doctor if you need to adjust the dose of other medicines while taking Micardis.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Micardis before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to Micardis. Micardis is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Micardis is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines

Some patients may experience side effects such as fainting or dizziness (vertigo) when taking Micardis. If these side effects occur, do not drive or operate machinery.

Micardis contains sorbitol

This medicine contains 84.32 mg of sorbitol per tablet.

Micardis contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Micardis

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet daily. Try to take the tablet at the same time each day.
You may take Micardis with or without food. Swallow the tablets whole with a glass of water or another non-alcoholic drink. It is important to take Micardis every day unless your doctor tells you otherwise. If you feel that the effect of Micardis is too strong or too weak, consult your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Micardis for most patients is one 40 mg tablet once daily to control blood pressure over a 24-hour period. Your doctor has prescribed you a lower dose of 20 mg daily. Micardis may also be used in combination with diuretics such as hydrochlorothiazide, with which it has demonstrated an additive effect in lowering blood pressure.

For reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once daily. At the start of preventive therapy with Micardis 80 mg, blood pressure should be monitored frequently.

If your liver is not functioning properly, the usual dose of 40 mg daily must not be exceeded.

If you take more Micardis than you should
If you have accidentally taken too many tablets, contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

If you forget to take Micardis
If you forget to take your dose, do not worry. Take it as soon as you remember, then continue as before. If you miss a day’s dose, take your normal dose the next day. Do not take a double dose to make up for missed doses.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and require immediate medical attention.
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection" – a severe infection causing a systemic inflammatory response throughout the body), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (may occur in up to 1 in 1,000 people), but extremely serious, and patients must stop taking the medicine and consult a doctor immediately. If these effects are not treated, they may be fatal.

Possible side effects of Micardis

Common side effects (may occur in up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated to reduce cardiovascular events.

Uncommon side effects (may occur in up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), red blood cell deficiency (anaemia), elevated potassium levels, difficulty falling asleep, feeling of sadness (depression), dizziness, fainting (syncope), sensation of dizziness (vertigo), slowed heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness upon standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, stomach pain, bloated stomach, vomiting, itching sensation, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment (including acute renal failure), chest pain, feeling of weakness, increased levels of creatinine in the blood.

Rare side effects (may occur in up to 1 in 1,000 people):
Sepsis* (often called "blood infection" – a severe infection with systemic inflammatory response that may be life-threatening), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. skin rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), feeling of anxiety, drowsiness, visual disturbances, increased heart rate (tachycardia), dry mouth, stomach discomfort, taste disturbances (dysgeusia), abnormal liver function (Japanese patients are more predisposed to this side effect), rapid swelling of the skin and mucous membranes, which may also be fatal (angioedema, including fatal outcomes), eczema (skin disease), skin redness, urticaria, severe drug-induced skin rash, joint pain (arthralgia), limb pain, tendon pain, influenza-like illness, decreased haemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or creatine phosphokinase in the blood, low sodium levels.

Very rare side effects (may occur in up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease)**.

Frequency not known (frequency cannot be estimated from the available data):
Intestinal angioedema: following the use of similar products, swelling in the intestine has been reported, presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

* The event may have occurred by chance or could be related to a mechanism currently unknown.
** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Micardis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from moisture. Remove the Micardis tablet from the blister pack only immediately before taking it.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Micardis contains
The active substance is telmisartan. Each tablet contains 20 mg of telmisartan.
The other components are povidone (K25), meglumine, sodium hydroxide, sorbitol (E420), and magnesium stearate.

Description of the appearance of Micardis and contents of the pack
Micardis 20 mg tablets are white, round, with the code “50H” engraved on one side and the company logo on the other.
Micardis is available in blisters containing 14, 28, 56, or 98 tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorization Holder Manufacturer
Boehringer Ingelheim International GmbH Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Str. 173 Binger Strasse 173
55216 Ingelheim am Rhein 55216 Ingelheim am Rhein
Germany Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Boehringer Ingelheim SComm Boehringer Ingelheim RCV GmbH & Co KG
Tél/Tel: +32 2 773 33 11 Lietuvos filialas
Tel.: +370 5 2595942

България Luxembourg/Luxemburg
Бьорингер Ингелхайм РЦВ ГмбХ и Ко. Boehringer Ingelheim SComm
КГ - клон България Tél/Tel: +32 2 773 33 11
Тел: +359 2 958 79 98

Česká republika Magyarország
Boehringer Ingelheim spol. s r.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +420 234 655 111 Magyarországi Fióktelepe
Tel.: +36 1 299 89 00

Danmark Malta
Boehringer Ingelheim Danmark A/S Boehringer Ingelheim Ireland Ltd.
Tlf.: +45 39 15 88 88 Tel: +353 1 295 9620

Deutschland Nederland
Boehringer Ingelheim Pharma GmbH & Co. KG Boehringer Ingelheim B.V.
Tel: +49 (0) 800 77 90 900 Tel: +31 (0) 800 22 55 889

Eesti Norge
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Danmark
Eesti filiaal Norwegian branch
Tel: +372 612 8000 Tlf: +47 66 76 13 00

Ελλάδα Österreich
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε. Boehringer Ingelheim RCV GmbH & Co KG
Tηλ: +30 2 10 89 06 300 Tel: +43 1 80 105-7870

España Polska
Boehringer Ingelheim España, S.A. Boehringer Ingelheim Sp. z o.o.
Tel: +34 93 404 51 00 Tel.: +48 22 699 0 699

France Portugal
Boehringer Ingelheim France S.A.S. Boehringer Ingelheim Portugal Lda.
Tél: +33 3 26 50 45 33 Tel: +351 21 313 53 00

Hrvatska România
Boehringer Ingelheim Zagreb d.o.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +385 1 2444 600 Viena - Sucursala Bucureşti
Tel: +40 21 302 28 00

Ireland Slovenija
Boehringer Ingelheim Ireland Ltd. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +353 1 295 9620 Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland Slovenská republika
Vistor ehf. Boehringer Ingelheim RCV GmbH & Co KG
Sími: +354 535 7000 organizačná zložka
Tel: +421 2 5810 1211

Italia Suomi/Finland
Boehringer Ingelheim Italia S.p.A. Boehringer Ingelheim Finland Ky
Tel: +39 02 5355 1 Puh/Tel: +358 10 3102 800

Κύπρος Sverige
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Boehringer Ingelheim AB
Α.Ε. Tel: +46 8 721 21 00
Tηλ: +30 2 10 89 06 300

Latvija
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Tel: +371 67 240 011

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

Package leaflet: information for the user

Micardis 40 mg tablets

telmisartan
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Micardis is and what it is used for
What you need to know before taking Micardis
How to take Micardis
Possible side effects
How to store Micardis
Contents of the pack and other information

1. What Micardis is and what it is used for

Micardis belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Micardis blocks the effect of angiotensin II, causing blood vessels to relax and thereby reducing blood pressure.
Micardis is used for the treatment of essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not caused by other conditions.
If left untreated, high blood pressure can damage blood vessels in many organs and may sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage occurs. Therefore, it is important to have your blood pressure checked regularly to ensure it is within the normal range.
Micardis is also used for reducing cardiovascular events (e.g., heart attack or stroke) in adults who are at risk because their blood supply to the heart or legs is reduced or blocked, or because they have had a stroke or have high-risk diabetes. Your doctor can advise you whether you are at high risk for these events.

2. What you should know before taking Micardis

Do not take Micardis

if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6).
if you are more than 3 months pregnant (it is better to avoid taking Micardis even in early pregnancy – see section Pregnancy).
if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other severe liver disease.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are in any of the above conditions, inform your doctor or pharmacist before taking
Micardis.
Warnings and precautions
Talk to your doctor before taking Micardis if you have or have ever had any of the following
conditions or diseases:

Kidney disease or kidney transplant.
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Liver diseases.
Heart problems.
Elevated levels of aldosterone (water and salt retention in the body with imbalance of various minerals in the blood).
Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive loss of water from the body) or have a salt deficiency due to, for example, diuretic therapy (“diuretics”), a low-salt diet, diarrhoea or vomiting.
High levels of potassium in the blood.
Diabetes.

Talk to your doctor before taking Micardis:

if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
- aliskiren. Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section “Do not take Micardis”.
if you are taking digoxin.

Talk to your doctor if, after taking Micardis, you experience abdominal pain, nausea, vomiting or
diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking
Micardis on your own.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Micardis is not recommended during early pregnancy and must not be taken if you are
more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this
period (see section Pregnancy).
If you are undergoing surgery or anaesthesia, you must inform your doctor that you are taking Micardis.
Micardis may be less effective in lowering blood pressure in patients of African origin.
Children and adolescents
The use of Micardis is not recommended in children and adolescents under 18 years of age.
Other medicines and Micardis
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. Your doctor may decide to adjust the dose of these other medicines or take other precautions. In some cases, it may be necessary to stop taking one of these medicines. This particularly applies to the following medicines taken concomitantly with Micardis:

Medicines containing lithium used to treat certain types of depression.
Medicines that may increase potassium levels in the blood such as potassium-containing salt substitutes, potassium-sparing diuretics (some “diuretics”), ACE inhibitors, angiotensin II receptor blockers, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
Diuretics, especially if taken at high doses together with Micardis, may cause excessive loss of body water and low blood pressure (hypotension).
If you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take Micardis” and “Warnings and precautions”).
Digoxin.

The effect of Micardis may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.
Micardis may increase the effect of other medicines used to lower high blood pressure or of medicines that may potentially lower blood pressure (e.g. baclofen, amifostine).
In addition, the lowering of blood pressure may be worsened by alcohol, barbiturates, narcotics or antidepressants. You may experience this drop in blood pressure as dizziness when standing up. Consult your doctor if you need to adjust the dose of other medicines while taking Micardis.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Normally your doctor will advise you to stop taking Micardis before becoming pregnant or as soon as you find out you are pregnant, and will recommend another medicine instead of Micardis. Micardis is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Micardis is not recommended for women who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Some patients may experience side effects such as fainting or dizziness (vertigo) when taking Micardis. If these side effects occur, do not drive or operate machinery.
Micardis contains sorbitol
This medicine contains 168.64 mg of sorbitol per tablet.
Micardis contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Micardis

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one tablet daily. Try to take the tablet at the same time each day.
You may take Micardis with or without food. The tablets should be swallowed whole with a little water
or another non-alcoholic drink. It is important to take Micardis every day unless your doctor tells you
otherwise. If you feel that the effect of Micardis is too strong or too weak, consult your doctor or
pharmacist.
For the treatment of high blood pressure, the usual dose of Micardis for most patients is one 40 mg
tablet once daily to control blood pressure over a 24-hour period. However, sometimes your doctor may
recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Micardis may be used in
combination with diuretics such as hydrochlorothiazide, with which it has demonstrated an additive
effect in lowering blood pressure.
For the reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once daily.
At the beginning of preventive treatment with Micardis 80 mg, blood pressure should be monitored
frequently.
If your liver is not functioning properly, the usual dose of 40 mg daily should not be exceeded.
If you take more Micardis than you should
If you have taken too many tablets by mistake, contact your doctor, pharmacist, or the nearest hospital
emergency department immediately.
If you forget to take Micardis
If you forget to take your medicine, do not worry. Take it as soon as you remember, then continue as
before. If you miss a day's dose, take your usual dose the next day. Do not take a double dose to
make up for missed doses.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious and require immediate medical attention.
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection" — a severe infection causing a systemic inflammatory response throughout the body), rapid swelling of the skin and mucous membranes (angioedema). These side effects are rare (may occur in up to 1 in 1,000 people), but extremely serious, and patients must stop taking the medicine and consult a doctor immediately. If these effects are not treated, they may be fatal.

Possible side effects of Micardis
Common side effects (may occur in up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated for reduction of cardiovascular events.

Uncommon side effects (may occur in up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), low red blood cell count (anaemia), elevated potassium levels, difficulty falling asleep, feeling of sadness (depression), dizziness, fainting (syncope), sensation of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness when standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, stomach pain, bloated stomach, vomiting, itching sensation, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment (including acute kidney failure), chest pain, feeling of weakness, increased blood creatinine levels.

Rare side effects (may occur in up to 1 in 1,000 people):
Sepsis* (often called "blood infection" — a severe infection causing a systemic inflammatory response throughout the body that may lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. skin rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), feeling of anxiety, drowsiness, visual disturbances, fast heart rate (tachycardia), dry mouth, stomach discomfort, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more predisposed to this side effect), rapid swelling of the skin and mucous membranes that may also be fatal (angioedema, including fatal outcomes), eczema (skin disease), skin redness, urticaria, severe drug-induced skin rash, joint pain (arthralgia), limb pain, tendon pain, influenza-like illness, decreased haemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or creatine phosphokinase in the blood, low sodium levels.

Very rare side effects (may occur in up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease)**.

Frequency not known (frequency cannot be estimated from the available data):
Intestinal angioedema: following the use of similar products, swelling in the intestine has been reported, presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

* The event may have occurred by chance or could be related to a currently unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Micardis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from moisture. Remove the Micardis tablet from the blister pack only immediately before taking it.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Micardis contains
The active substance is telmisartan. Each tablet contains 40 mg of telmisartan.
The other components are povidone (K25), meglumine, sodium hydroxide, sorbitol (E420), and magnesium stearate.

Description of the appearance of Micardis and contents of the pack
Micardis 40 mg tablets are white, oval-shaped, with the code “51H” imprinted on one side and the company logo on the other.
Micardis is available in blisters containing 14, 28, 56, 84 or 98 tablets, in divisible blisters for single doses containing 28 × 1, 30 × 1 or 90 × 1 tablets, or in multiple packs containing 360 tablets (4 packs of 90 × 1 tablets).
Not all pack sizes may be marketed in your country.

Marketing Authorization Holder Manufacturer
Boehringer Ingelheim International GmbH Boehringer Ingelheim Hellas Single Member
Binger Str. 173 S.A.
55216 Ingelheim am Rhein 5th km Paiania – Markopoulo
Germany Koropi Attiki, 19441
Greece
Rottendorf Pharma GmbH
Ostenfelder Straße 51 - 61
59320 Ennigerloh
Germany
Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France