Package leaflet: Information for the user

MicardisPlus 40 mg/12.5 mg tablets

telmisartan/hydrochlorothiazide
Please read all of this leaflet carefully before you start 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 they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What MicardisPlus is and what it is used for

MicardisPlus is a combination of two active substances, telmisartan and hydrochlorothiazide, in a single tablet. Each of these components helps control high blood pressure.

Telmisartan 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. Telmisartan blocks this effect of angiotensin II, causing blood vessels to relax and thus reducing blood pressure.
Hydrochlorothiazide belongs to a class of medicines known as thiazide diuretics, which increase urine flow, thereby contributing to lowering blood pressure.

If left untreated, high blood pressure can damage blood vessels in various organs and may eventually 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 regularly monitor blood pressure to ensure it remains within normal limits.
MicardisPlus is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by telmisartan alone.

2. What you need to know before taking MicardisPlus

Do not take MicardisPlus

if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicine.
if you are more than 3 months pregnant (it is better to avoid taking MicardisPlus even in early pregnancy – see pregnancy section).
if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other serious liver disease.
if you have severe kidney disease or anuria (less than 100 ml of urine per day).
if your doctor finds that your blood potassium levels are low or your calcium levels are high and do not improve with treatment.
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 these conditions, inform your doctor or pharmacist before taking MicardisPlus.
Warnings and precautions
Talk to your doctor before taking MicardisPlus if you have or have had any of the following
conditions or diseases:

Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive fluid loss) or have salt deficiency due to diuretic therapy (diuretics), a low-salt diet, diarrhoea, vomiting, or haemofiltration.
Kidney disease or kidney transplant.
Renal artery stenosis (narrowing of blood vessels to one or both kidneys).
Liver disease.
Heart problems.
Diabetes.
Gout.
Elevated aldosterone levels (fluid and salt retention in the body with imbalance of various electrolytes in the blood).
Systemic lupus erythematosus (also called “lupus” or “SLE”), a disease in which the body's immune system attacks the body itself.
The active ingredient hydrochlorothiazide may cause an uncommon reaction, resulting in vision loss and eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and may occur from hours to weeks after taking MicardisPlus. This condition may lead to permanent vision impairment if not treated.
If you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun and UV exposure while taking MicardisPlus.

Talk to your doctor before taking MicardisPlus:

if you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (e.g., enalapril, lisinopril, ramipril, angiotensin-converting enzyme inhibitors), especially 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 MicardisPlus”.
if you are taking digoxin.
if you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking MicardisPlus, consult a doctor immediately.

You must inform your doctor if you think you are pregnant (or if there is a chance of becoming pregnant). MicardisPlus 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 pregnancy section).
Treatment with hydrochlorothiazide may cause an electrolyte imbalance in the body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling unwell), vomiting, muscle fatigue, and abnormally fast heartbeat (more than 100 beats per minute). If you experience any of these symptoms, inform your doctor.
You should also inform your doctor if you have noticed increased skin sensitivity to sunlight, manifesting as faster-than-normal onset of sunburn symptoms (such as redness, itching, swelling, or blistering).
If undergoing surgery or administration of anaesthetics, you must inform the doctor that you are taking MicardisPlus.
MicardisPlus may be less effective in lowering blood pressure in patients of African origin.
Children and adolescents
The use of MicardisPlus is not recommended in children and adolescents under 18 years of age.
Other medicines and MicardisPlus
Inform 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 when taken concurrently with MicardisPlus:

Medicines containing lithium used to treat certain types of depression.
Medicines associated with low blood potassium levels (hypokalaemia), such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), adrenocorticotropic hormone (ACTH), amphotericin (antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (antibiotic), salicylic acid and its derivatives.
Iodinated contrast media used during imaging diagnostic procedures.
Medicines that may increase blood potassium levels, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (immunosuppressant medicine), and other medicines such as sodium heparin (anticoagulant).
Medicines that are affected by changes in blood potassium levels, such as heart medicines (e.g., digoxin) or medicines to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines such as certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medicines for treating allergic reactions (e.g., terfenadine).
Medicines for treating diabetes (insulin or oral agents such as metformin).
Cholestyramine and colestipol, medicines used to lower blood fat levels.
Medicines to increase blood pressure, such as noradrenaline.
Muscle relaxants, such as tubocurarine.
Calcium and/or vitamin D supplements.
Anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anaesthesia), such as atropine and biperiden.
Amantadine (a medicine used to treat Parkinson’s disease and also used to treat or prevent viral infections).
Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), cancer treatments, gout, or arthritis.
If you are taking an ACE inhibitor or aliskiren (see also sections: “Do not take MicardisPlus” and “Warnings and precautions”).
Digoxin.

MicardisPlus may enhance the effect of other medicines used to lower high blood pressure or of medicines that may potentially reduce blood pressure (e.g., baclofen, amifostine). Additionally, blood pressure lowering may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may experience this drop in blood pressure as dizziness upon standing. Consult your doctor if you need to adjust the dose of other medicines while taking MicardisPlus.
The effect of MicardisPlus may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin and ibuprofen).
MicardisPlus with food and alcohol
You may take MicardisPlus with or without food.
Avoid alcohol unless you have discussed it with your doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are pregnant (or if there is a chance of becoming pregnant). Your doctor will usually advise you to stop taking MicardisPlus before becoming pregnant or as soon as you know you are pregnant and will recommend another medicine instead of MicardisPlus. MicardisPlus is not recommended during 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. MicardisPlus is not recommended for women who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed.
Driving and using machines
Some patients may experience dizziness, fainting, or a sensation of movement in their surroundings when taking MicardisPlus. If you experience these effects, do not drive or operate machinery.
MicardisPlus contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.
MicardisPlus contains lactose (milk sugar)
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
MicardisPlus contains sorbitol
This medicine contains 169 mg of sorbitol per tablet.

3. How to take MicardisPlus

Take this medicine exactly as directed 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 MicardisPlus with or without food. The tablets should be swallowed whole with a glass of water or other non-alcoholic drink. It is important to take MicardisPlus every day unless your doctor tells you otherwise.
If your liver is not functioning properly, the usual dose of 40 mg of telmisartan once daily should not be exceeded.

If you take more MicardisPlus than you should
If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, and reduced kidney function including kidney failure have also been reported. Due to the presence of hydrochlorothiazide, markedly low blood pressure and low blood potassium levels may also occur, which can cause nausea, drowsiness, and muscle cramps and/or irregular heartbeat, particularly when used concomitantly with medicines such as digitalis or certain antiarrhythmic treatments. Contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

If you forget to take MicardisPlus
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 normal dose the next day. Do not take a double dose to make up for missed doses.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Some side effects can be serious and require immediate medical treatment:
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection") is a severe infection with an inflammatory response affecting the entire organism, rapid swelling of the skin and mucous membranes (angioedema, which may be fatal), development of blisters and shedding of the outer layer of the skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or very rare (toxic epidermal necrolysis; may affect up to 1 in 10,000 people), but extremely serious, and patients must stop taking the medicine and consult their doctor immediately. If these effects are not treated, they may be fatal. An increased incidence of sepsis has been observed with telmisartan alone; however, this cannot be excluded for MicardisPlus.
Possible side effects of MicardisPlus:
Common side effects (may affect up to 1 in 10 people)
Dizziness.
Uncommon side effects (may affect up to 1 in 100 people)
Reduced potassium levels in the blood, anxiety, fainting (syncope), numbness sensation, tingling sensation (paraesthesia), vertigo, rapid heartbeat (tachycardia), heart rhythm disorders, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence (intestinal gas), back pain, muscle spasm, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased uric acid levels in the blood.
Rare side effects (may affect up to 1 in 1,000 people)
Lung inflammation (bronchitis), sore throat, sinusitis, increased uric acid levels in the blood, low sodium levels, feeling of sadness (depression), difficulty falling asleep (insomnia), sleep disturbances, visual disturbances, blurred vision, difficulty breathing, abdominal pain, constipation, abdominal swelling (dyspepsia), feeling of discomfort (vomiting), stomach inflammation (gastritis), abnormal liver function (Japanese patients are more likely to experience this side effect), skin redness (erythema), allergic reactions such as itching or skin rash, increased sweating, urticaria, joint pain (arthralgia) and extremity pain (leg pain), muscle cramps, activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body itself, causing joint pain, skin rash and fever), flu-like illness, pain, increased blood levels of creatinine, liver enzymes or creatine phosphokinase.
Adverse reactions reported with either of the individual components may also be potential adverse reactions with MicardisPlus, even if not observed in clinical studies with this product.
Telmisartan
In patients treated with telmisartan alone, the following additional side effects have been observed:
Uncommon side effects (may affect up to 1 in 100 people)
Upper respiratory tract infection (e.g. sore throat, sinusitis, common cold), urinary tract infections, bladder infection, deficiency of red blood cells (anaemia), elevated potassium levels, slowed heartbeat (bradycardia), cough, kidney impairment including acute renal failure, feeling of weakness.
Rare side effects (may affect up to 1 in 1,000 people)
Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction), low blood sugar levels (in diabetic patients), drowsiness, stomach upset, eczema (skin disease), drug rash, toxic rash, tendon pain (symptoms similar to tendinitis), decrease in haemoglobin (a blood protein).
Very rare side effects (may affect up to 1 in 10,000 people)
Progressive scarring of lung tissue (interstitial lung disease)**.
*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 telmisartan treatment. However, it is not known whether telmisartan was the cause.
Hydrochlorothiazide
In patients treated with hydrochlorothiazide alone, the following additional side effects have been observed:
Very common side effects (may affect more than 1 in 10 people)
Elevated blood lipid levels.
Common side effects (may affect up to 1 in 10 people)
Malaise (nausea), low magnesium levels in the blood, reduced appetite.
Uncommon side effects (may affect up to 1 in 100 people)
Acute renal failure.
Rare side effects (may affect up to 1 in 1,000 people)
Low platelet count (thrombocytopenia), which increases the risk of bleeding or bruising (small purple-red spots on the skin or other tissues caused by bleeding), high calcium levels in the blood, elevated blood glucose levels, headache, abdominal discomfort, yellowing of the skin or eyes (jaundice), excess bile substances in the blood (cholestasis), photosensitivity reaction, uncontrolled blood glucose levels in patients diagnosed with diabetes mellitus, sugar in the urine (glucosuria).
Very rare side effects (may affect up to 1 in 10,000 people)
Abnormal destruction of red blood cells (haemolytic anaemia), inability of the bone marrow to function properly, decrease in white blood cells (leucopenia, agranulocytosis), severe allergic reactions (e.g. hypersensitivity), increased pH due to low chloride levels in the blood (altered acid-base balance, hypochloraemic alkalosis), acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion), inflammation of the pancreas, lupus-like syndrome (a condition similar to a disease called systemic lupus erythematosus, in which the immune system attacks the body itself), inflammation of blood vessels (necrotizing vasculitis).
Not known (frequency cannot be estimated from the available data)
Inflammation of the salivary glands, skin and lip cancer (non-melanoma skin cancer), deficiency of blood cells (aplastic anaemia), decreased vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), skin disorders such as inflammation of blood vessels in the skin, increased sensitivity to sunlight, skin rash, skin redness, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), feeling of weakness, kidney impairment.
Low sodium levels accompanied by symptoms related to the brain or nerves (malaise, progressive disorientation, lack of interest or energy) occur in isolated cases.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via 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 MicardisPlus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 MicardisPlus tablet from the sealed blister pack only immediately before taking it.
Occasionally, the outer layer of the blister may separate from the inner layer between the blisters. If this occurs, no special precautions are necessary.
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 MicardisPlus contains

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
The other components are monohydrate lactose, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, red iron oxide (E172), sodium hydroxide, sodium carboxymethylstarch (Type A), sorbitol (E420).

Description of the appearance of MicardisPlus and contents of the pack
MicardisPlus 40 mg/12.5 mg tablets are red and white, two-layered, oblong tablets, with the company logo and the code 'H4' imprinted on them.
MicardisPlus is available in blisters, in pack sizes of 14, 28, 56, 84 or 98 tablets, or in unit-dose divisible blisters containing 28 x 1, 30 x 1 or 90 x 1 tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation 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
and
Boehringer Ingelheim Hellas Single Member S.A.
5th km Paiania – Markopoulo
Koropi Attiki, 19441
Greece
and
Rottendorf Pharma GmbH
Ostenfelder Strasse 51 - 61
59320 Ennigerloh
Germany
and
Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation 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. КГ - Boehringer Ingelheim SComm
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 Norway KS
Eesti filiaal Tlf: +47 66 76 13 00
Tel: +372 612 8000

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

Latvija United Kingdom (Northern Ireland)
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Ireland Ltd.
Latvijas filiāle Tel: +353 1 295 9620
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: http://www.ema.europa.eu.

Package leaflet: information for the user

MicardisPlus 80 mg/12.5 mg tablets

telmisartan/hydrochlorothiazide
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, consult 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 could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What MicardisPlus is and what it is used for

MicardisPlus is a combination of two active substances, telmisartan and hydrochlorothiazide, in a single tablet. Each of these substances helps control high blood pressure.

Telmisartan 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 constrict, thereby increasing blood pressure. Telmisartan blocks this effect of angiotensin II, causing blood vessels to relax and thus reducing blood pressure.
Hydrochlorothiazide belongs to a class of medicines known as thiazide diuretics, which increase urine flow, thereby contributing to the reduction of blood pressure.

If left untreated, hypertension can damage blood vessels in many organs and may sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. Hypertension usually does not cause symptoms until such damage occurs. Therefore, it is important to regularly check your blood pressure to ensure it is within the normal range.
MicardisPlus is used to treat high blood pressure (essential hypertension) in adults when blood pressure is not adequately controlled by telmisartan alone.

2. What you should know before taking MicardisPlus

Do not take MicardisPlus

if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicine.
if you are more than 3 months pregnant (it is better to avoid taking MicardisPlus even in the early stages of pregnancy – see section on 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 serious liver disease.
if you have severe kidney disease or anuria (less than 100 ml of urine per day).
if your doctor finds that your blood potassium levels are low or your calcium levels are high and do not improve with treatment.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive fluid loss) or have salt deficiency due to diuretic therapy (diuretics), a low-salt diet, diarrhoea, vomiting, or hemofiltration.
Kidney disease or kidney transplant.
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Liver disease.
Heart problems.
Diabetes.
Gout.
Elevated aldosterone levels (fluid and salt retention in the body with imbalance of various electrolytes in the blood).
Systemic lupus erythematosus (also called “lupus” or “SLE”), a disease in which the body’s immune system attacks the body itself.
The active ingredient hydrochlorothiazide may cause an uncommon reaction, resulting in vision loss and eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye, and may occur from hours to weeks after taking MicardisPlus. This condition can lead to permanent vision impairment if not treated.
If you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun and UV exposure while taking MicardisPlus.

Talk to your doctor before taking MicardisPlus:

if you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (e.g. enalapril, lisinopril, ramipril, angiotensin-converting enzyme inhibitors), especially 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 MicardisPlus”.
if you are taking digoxin.
if you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If shortness of breath or severe breathing difficulty occurs after taking MicardisPlus, consult a doctor immediately.

You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). MicardisPlus is not recommended in 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 on pregnancy).
Treatment with hydrochlorothiazide may cause an electrolyte imbalance in the body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling unwell), vomiting, muscle fatigue, and abnormally rapid heartbeat (more than 100 beats per minute). If you experience any of these symptoms, inform your doctor.
You should also inform your doctor if you have developed increased skin sensitivity to sunlight, manifesting as faster-than-normal onset of sunburn symptoms (such as redness, itching, swelling, or blistering).
If undergoing surgery or receiving anaesthetics, inform your doctor that you are taking MicardisPlus.
MicardisPlus may be less effective in lowering blood pressure in patients of African origin.
Children and adolescents
The use of MicardisPlus is not recommended in children and adolescents under 18 years of age.
Other medicines and MicardisPlus
Inform 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 discontinue one of these medicines. This particularly applies to the following medicines when taken concurrently with MicardisPlus:

Medicines containing lithium, used to treat certain types of depression.
Medicines associated with low blood potassium levels (hypokalaemia), such as other diuretics, laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), adrenocorticotropic hormone (ACTH), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), salicylic acid and its derivatives.
Iodinated contrast media used during imaging diagnostic procedures.
Medicines that may increase blood potassium levels, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant medicine), and other medicines such as sodium heparin (an anticoagulant).
Medicines that are affected by changes in blood potassium levels, such as heart medicines (e.g. digoxin) or medicines to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine), and other medicines such as certain antibiotics (e.g. sparfloxacin, pentamidine) or certain medicines for treating allergic reactions (e.g. terfenadine).
Medicines for treating diabetes (insulin or oral agents such as metformin).
Cholestyramine and colestipol, medicines used to lower blood fat levels.
Medicines to increase blood pressure, such as noradrenaline.
Muscle relaxants, such as tubocurarine.
Calcium and/or vitamin D supplements.
Anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anaesthesia), such as atropine and biperiden.
Amantadine (a medicine used to treat Parkinson’s disease and also used to treat or prevent viral illnesses).
Other substances used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), and medicines used to treat cancer, gout, or arthritis.
If you are taking an ACE inhibitor or aliskiren (see also sections: “Do not take MicardisPlus” and “Warnings and precautions”).
Digoxin.

MicardisPlus may enhance the effect of other medicines used to lower high blood pressure or of medicines that may potentially lower blood pressure (e.g. baclofen, amifostine). Additionally, blood pressure lowering 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 MicardisPlus.
The effect of MicardisPlus may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin and ibuprofen).
MicardisPlus with food and alcohol
You may take MicardisPlus with or without food.
Avoid alcohol unless you have discussed it with your doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Pregnancy
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 MicardisPlus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. MicardisPlus is not recommended during 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. MicardisPlus is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed.
Driving and using machines
Some patients may experience dizziness, fainting, or a sensation of spinning surroundings when taking MicardisPlus. If these effects occur, do not drive or operate machinery.
MicardisPlus contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
MicardisPlus contains lactose (milk sugar)
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
MicardisPlus contains sorbitol
This medicine contains 338 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.

3. How to take MicardisPlus

Take this medicine exactly as prescribed 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 MicardisPlus with or without food. The tablets should be swallowed whole with a glass of water or another non-alcoholic drink. It is important to take MicardisPlus every day unless your doctor tells you otherwise.
If your liver is not functioning properly, the usual dose of 40 mg telmisartan once daily should not be exceeded.

If you take more MicardisPlus than you should
If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, and reduced kidney function including renal failure have also been reported. Due to the presence of hydrochlorothiazide, markedly low blood pressure and low blood potassium levels may also occur, which can cause nausea, drowsiness, muscle cramps, and/or irregular heartbeat, particularly when used concomitantly with medicines such as digitalis or certain antiarrhythmic treatments. Contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

If you forget to take MicardisPlus
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 forgotten individual doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Some side effects can be serious and require immediate medical treatment:
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection") is a severe infection with a systemic inflammatory response, rapid swelling of the skin and mucous membranes (angioedema, including fatal outcomes), appearance of blisters and shedding of the outer layer of the skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or very rare (toxic epidermal necrolysis; may affect up to 1 in 10,000 people), but are extremely serious, and patients must stop taking the medicine and consult their doctor immediately. If these effects are not treated, they may be fatal. An increased incidence of sepsis has been observed with telmisartan alone; however, this cannot be excluded for MicardisPlus.
Possible side effects of MicardisPlus:
Common side effects (may affect up to 1 in 10 people)
Dizziness.
Uncommon side effects (may affect up to 1 in 100 people)
Low blood potassium levels, anxiety, fainting (syncope), numbness, tingling sensation (paraesthesia), vertigo, rapid heartbeat (tachycardia), heart rhythm disorders, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence (intestinal gas), back pain, muscle spasm, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased blood uric acid levels.
Rare side effects (may affect up to 1 in 1,000 people)
Lung inflammation (bronchitis), sore throat, sinusitis, increased blood uric acid levels, low sodium levels, feeling of sadness (depression), difficulty falling asleep (insomnia), sleep disturbances, visual disturbances, blurred vision, difficulty breathing, abdominal pain, constipation, abdominal swelling (dyspepsia), feeling unwell (nausea), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients have a higher likelihood of experiencing this side effect), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, urticaria, joint pain (arthralgia) and limb pain (leg pain), muscle cramps, activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body itself, causing joint pain, skin rash and fever), influenza-like illness, pain, increased blood levels of creatinine, liver enzymes or creatine phosphokinase.
Adverse reactions reported with either of the individual components may also be potential adverse reactions with MicardisPlus, even if not observed in clinical studies with this product.
Telmisartan
In patients treated with telmisartan alone, the following additional side effects have been observed:
Uncommon side effects (may affect up to 1 in 100 people)
Upper respiratory tract infection (e.g. sore throat, sinusitis, common cold), urinary tract infections, bladder infection, deficiency of red blood cells (anaemia), elevated potassium levels, slow heart rate (bradycardia), cough, impaired kidney function including acute renal failure, feeling of weakness.
Rare side effects (may affect up to 1 in 1,000 people)
Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction), low blood sugar levels (in diabetic patients), drowsiness, stomach discomfort, eczema (skin disease), drug rash, toxic rash, tendon pain (symptoms similar to tendinitis), decreased haemoglobin (a blood protein).
Very rare side effects (may affect up to 1 in 10,000 people)
Progressive scarring of lung tissue (interstitial lung disease)**.
*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 telmisartan treatment. However, it is not known whether telmisartan was the cause.
Hydrochlorothiazide
In patients treated with hydrochlorothiazide alone, the following additional side effects have been observed:
Very common side effects (may affect more than 1 in 10 people)
Elevated blood lipid levels.
Common side effects (may affect up to 1 in 10 people)
Malaise (nausea), low blood magnesium levels, reduced appetite.
Uncommon side effects (may affect up to 1 in 100 people)
Acute renal failure.
Rare side effects (may affect up to 1 in 1,000 people)
Low platelet count (thrombocytopenia), which increases the risk of bleeding or bruising (small purple-red spots on the skin or other tissues due to bleeding), high blood calcium levels, elevated blood glucose levels, headache, abdominal discomfort, yellowing of the skin or eyes (jaundice), excess bile substances in the blood (cholestasis), photosensitivity reaction, uncontrolled blood glucose levels in patients diagnosed with diabetes mellitus, sugar in the urine (glucosuria).
Very rare side effects (may affect up to 1 in 10,000 people)
Abnormal destruction of red blood cells (haemolytic anaemia), inability of the bone marrow to function properly, decrease in white blood cells (leucopenia, agranulocytosis), severe allergic reactions (e.g. hypersensitivity), increased pH due to low blood chloride levels (altered acid-base balance, hypochloraemic alkalosis), acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion), inflammation of the pancreas, lupus-like syndrome (a condition similar to systemic lupus erythematosus, in which the immune system attacks the body itself), inflammation of blood vessels (necrotizing vasculitis).
Not known (frequency cannot be estimated from the available data)
Inflammation of the salivary glands, skin and lip cancer (non-melanoma skin cancer), deficiency of blood cells (aplastic anaemia), decreased vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), skin disorders such as inflammation of skin blood vessels, increased sensitivity to sunlight, rash, skin redness, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), feeling of weakness, kidney impairment.
Low sodium levels accompanied by symptoms related to the brain or nerves (malaise, progressive disorientation, lack of interest or energy) occur in isolated cases.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via 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 MicardisPlus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging 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 MicardisPlus tablet from the blister pack only
immediately before taking it.
Occasionally, the outer layer of the blister may separate from the inner layer between the blisters. If
this occurs, no special precautions need to be taken.
Do not dispose of medicines 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 MicardisPlus contains

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
The other components are monohydrate lactose, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, red iron oxide (E172), sodium hydroxide, sodium carboxymethylstarch (Type A), sorbitol (E420).

Description of the appearance of MicardisPlus and contents of the pack
MicardisPlus 80 mg/12.5 mg tablets are red and white, elongated, two-layered tablets, with the company logo and the code 'H8' printed on them.
MicardisPlus is available in blisters in packs of 14, 28, 56, 84 or 98 tablets, or in unit-dose divisible blisters containing 28 x 1, 30 x 1 or 90 x 1 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

and
Boehringer Ingelheim Hellas Single Member S.A.
5th km Paiania – Markopoulo
Koropi Attiki, 19441
Greece

and
Rottendorf Pharma GmbH
Ostenfelder Strasse 51 - 61
59320 Ennigerloh
Germany

and
Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France

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

België/Belgique/Belgien
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

България
Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ - клон България
Тел: +359 2 958 79 98

Česká republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111

Danmark
Boehringer Ingelheim Danmark A/S
Tlf: +45 39 15 88 88

Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG
Tel: +49 (0) 800 77 90 900

Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti filiaal
Tel: +372 612 8000

Ελλάδα
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300

España
Boehringer Ingelheim España, S.A.
Tel: +34 93 404 51 00

France
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33

Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600

Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Ísland
Vistor hf.
Sími: +354 535 7000

Italia
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1

Κύπρος
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300

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

Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel.: +370 5 2595942

Luxembourg/Luxemburg
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Magyarország
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe
Tel.: +36 1 299 89 00

Malta
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Nederland
Boehringer Ingelheim B.V.
Tel: +31 (0) 800 22 55 889

Norge
Boehringer Ingelheim Norway KS
Tlf: +47 66 76 13 00

Österreich
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870

Polska
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699

Portugal
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00

România
Boehringer Ingelheim RCV GmbH & Co KG
Viena – Sucursala Bucureşti
Tel: +40 21 302 28 00

Slovenija
Boehringer Ingelheim RCV GmbH & Co KG
Podružnica Ljubljana
Tel: +386 1 586 40 00

Slovenská republika
Boehringer Ingelheim RCV GmbH & Co KG
organizačná zložka
Tel: +421 2 5810 1211

Suomi/Finland
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800

Sverige
Boehringer Ingelheim AB
Tel: +46 8 721 21 00

United Kingdom (Northern Ireland)
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

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

Patient Information Leaflet: Information for the User

MicardisPlus 80 mg/25 mg tablets

telmisartan/hydrochlorothiazide
Please read all of 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 pass it on to others, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is MicardisPlus and what is it used for?

MicardisPlus is a combination of two active substances, telmisartan and hydrochlorothiazide, in a single tablet. Each of these substances helps control high blood pressure.

Telmisartan 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. Telmisartan blocks this effect of angiotensin II, causing blood vessels to relax and thus reducing blood pressure.
Hydrochlorothiazide belongs to a class of medicines known as thiazide diuretics, which increase urine flow, thereby helping to reduce blood pressure.

If left untreated, high blood pressure can damage blood vessels in many organs and may eventually lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage has occurred. It is therefore important to have regular blood pressure checks to ensure it remains within the normal range.
MicardisPlus is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled with MicardisPlus 80/12.5 mg, or in patients whose blood pressure has previously been stabilized with telmisartan and hydrochlorothiazide given separately.

2. What you need to know before taking MicardisPlus

Do not take MicardisPlus

if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicine.
if you are more than 3 months pregnant (it is best to avoid taking MicardisPlus even in the early stages of pregnancy – see the pregnancy section).
if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other serious liver disease.
if you have severe kidney disease or anuria (less than 100 ml of urine per day).
if your doctor determines that your blood potassium levels are low or your calcium levels are high and do not improve with treatment.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive fluid loss) or have salt deficiency due to diuretic therapy (diuretics), a low-salt diet, diarrhoea, vomiting, or haemofiltration.
Kidney disease or kidney transplant.
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Liver disease.
Heart problems.
Diabetes.
Gout.
Increased levels of aldosterone (fluid and salt retention in the body with imbalance of various electrolytes in the blood).
Systemic lupus erythematosus (also called “lupus” or “SLE”), a disease in which the body’s immune system attacks the body itself.
The active ingredient hydrochlorothiazide may cause an uncommon reaction, resulting in vision loss and eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and may occur from hours to weeks after taking MicardisPlus. This condition can lead to permanent vision impairment if not treated.
If you have previously had skin cancer or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking MicardisPlus.

Talk to your doctor before taking MicardisPlus:

if you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (e.g., enalapril, lisinopril, ramipril, angiotensin-converting enzyme inhibitors), especially 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 MicardisPlus”.
if you are taking digoxin.
if you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulty after taking MicardisPlus, consult a doctor immediately.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). MicardisPlus is not recommended in 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 the pregnancy section).
Treatment with hydrochlorothiazide may cause an electrolyte imbalance in the body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling unwell), vomiting, muscle fatigue, and abnormally fast heartbeat (more than 100 beats per minute). If you experience any of these symptoms, inform your doctor.
You should also inform your doctor if you have noticed increased skin sensitivity to sunlight, manifesting as faster-than-normal onset of sunburn symptoms (such as redness, itching, swelling, or blistering).
If you are undergoing surgery or receiving anaesthetics, you must inform your doctor that you are taking MicardisPlus.
MicardisPlus may be less effective in lowering blood pressure in patients of African origin.
Children and adolescents
The use of MicardisPlus is not recommended in children and adolescents under 18 years of age.
Other medicines and MicardisPlus
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 concurrently with MicardisPlus:

Medicines containing lithium used to treat certain types of depression.
Medicines associated with low blood potassium levels (hypokalaemia) such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), adrenocorticotropic hormone (ACTH), amphotericin (antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (antibiotic), salicylic acid and its derivatives.
Iodinated contrast media used during imaging diagnostic procedures.
Medicines that may increase blood potassium levels such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (immunosuppressant medicine), and other medicines such as sodium heparin (anticoagulant).
Medicines that are affected by changes in blood potassium levels such as heart medicines (e.g., digoxin) or medicines to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines such as certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medicines for treating allergic reactions (e.g., terfenadine).
Medicines for the treatment of diabetes (insulin or oral agents such as metformin).
Cholestyramine and colestipol, medicines used to lower blood fat levels.
Medicines to increase blood pressure, such as noradrenaline.
Medicines that relax muscles, such as tubocurarine.
Calcium and/or vitamin D supplements.
Anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anaesthesia), such as atropine and biperidone.
Amantadine (a medicine used to treat Parkinson’s disease and also used to treat or prevent viral illnesses).
Other substances used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines for cancer, gout, or arthritis.
If you are taking an ACE inhibitor or aliskiren (see also the sections: “Do not take MicardisPlus” and “Warnings and precautions”).
Digoxin.

MicardisPlus 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). Additionally, blood pressure lowering 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 MicardisPlus.
The effect of MicardisPlus may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin and ibuprofen).
MicardisPlus with food and alcohol
You may take MicardisPlus with or without food.
Avoid alcohol unless you have discussed it with your doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking MicardisPlus before becoming pregnant or as soon as you know you are pregnant and will recommend an alternative medicine instead of MicardisPlus. MicardisPlus is not recommended during 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.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. MicardisPlus is not recommended for women who are breast-feeding, and your doctor may choose another treatment if you wish to breast-feed.
Driving and using machines
Some patients may experience dizziness, fainting, or a sensation of movement in their surroundings when taking MicardisPlus. If you experience these effects, do not drive or operate machinery.
MicardisPlus contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.
MicardisPlus contains lactose (milk sugar)
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
MicardisPlus contains sorbitol
This medicine contains 338 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, talk to your doctor before taking this medicine.

3. How to take MicardisPlus

Take this medicine exactly as your doctor has told you. If you are unsure, 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 MicardisPlus with or without food. Swallow the tablets whole with a glass of water or another non-alcoholic drink. It is important to take MicardisPlus every day unless your doctor tells you otherwise.
If your liver is not functioning properly, the usual dose of 40 mg telmisartan once daily should not be exceeded.

If you take more MicardisPlus than you should
If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, and reduced kidney function including renal failure have also been reported. Due to the presence of hydrochlorothiazide, markedly low blood pressure and low potassium levels in the blood may also occur, which can cause nausea, drowsiness, muscle cramps, and/or irregular heartbeat, particularly when used concomitantly with medicines such as digitalis or certain antiarrhythmic treatments. Contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some side effects may be serious and require immediate medical treatment:
You must immediately contact your doctor if you experience any of the following symptoms:
Sepsis* (often called “blood infection”) is a severe infection with a systemic inflammatory response, rapid swelling of the skin and mucous membranes (angioedema, including fatal outcomes), appearance of blisters and shedding of the outer layer of the skin (toxic epidermal necrolysis); these adverse effects are rare (may affect up to 1 in 1,000 people) or very rare (toxic epidermal necrolysis; may affect up to 1 in 10,000 people), but extremely serious, and patients must stop taking the medicine and consult their doctor immediately. If these effects are not treated, they may be fatal. An increased incidence of sepsis has been observed with telmisartan alone; however, this cannot be excluded for MicardisPlus.
Possible side effects of MicardisPlus:
Common side effects (may affect up to 1 in 10 people)
Dizziness.
Uncommon side effects (may affect up to 1 in 100 people)
Low blood potassium levels, anxiety, fainting (syncope), numbness, tingling sensation (paraesthesia), dizziness, rapid heartbeat (tachycardia), heart rhythm disorders, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence (intestinal gas), back pain, muscle spasms, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased blood uric acid levels.
Rare side effects (may affect up to 1 in 1,000 people)
Lung inflammation (bronchitis), sore throat, sinusitis, increased blood uric acid levels, low sodium levels, feeling of sadness (depression), difficulty falling asleep (insomnia), sleep disturbances, visual disturbances, blurred vision, difficulty breathing, abdominal pain, constipation, abdominal swelling (dyspepsia), feeling unwell (nausea), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are more likely to experience this side effect), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, urticaria, joint pain (arthralgia) and limb pain (leg pain), muscle cramps, activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body itself, causing joint pain, rash and fever), flu-like illness, pain, increased blood levels of creatinine, liver enzymes or creatine phosphokinase.
Adverse reactions reported with either of the individual components may also be potential adverse reactions with MicardisPlus, even if not observed in clinical studies with this product.
Telmisartan
In patients treated with telmisartan alone, the following additional adverse effects have been observed:
Uncommon side effects (may affect up to 1 in 100 people)
Upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), urinary tract infections, bladder infection, red blood cell deficiency (anaemia), elevated potassium levels, slow heartbeat (bradycardia), cough, kidney impairment including acute renal failure, feeling of weakness.
Rare side effects (may affect up to 1 in 1,000 people)
Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction), low blood sugar levels (in diabetic patients), drowsiness, stomach discomfort, eczema (skin disease), drug rash, toxic rash, tendon pain (symptoms similar to tendinitis), decreased haemoglobin (a blood protein).
Very rare side effects (may affect up to 1 in 10,000 people)
Progressive scarring of lung tissue (interstitial lung disease)**.
*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 telmisartan treatment. However, it is not known whether telmisartan was the cause.
Hydrochlorothiazide
In patients treated with hydrochlorothiazide alone, the following additional adverse effects have been observed:
Very common side effects (may affect more than 1 in 10 people)
Elevated blood lipid levels.
Common side effects (may affect up to 1 in 10 people)
Malaise (nausea), low blood magnesium levels, reduced appetite.
Uncommon side effects (may affect up to 1 in 100 people)
Acute renal failure.
Rare side effects (may affect up to 1 in 1,000 people)
Low platelet count (thrombocytopenia), which increases the risk of bleeding or bruising (small purple-red spots on the skin or other tissues caused by bleeding), high blood calcium levels, elevated blood glucose levels, headache, abdominal discomfort, yellowing of the skin or eyes (jaundice), excess bile substances in the blood (cholestasis), photosensitivity reaction, uncontrolled blood glucose levels in patients diagnosed with diabetes mellitus, sugar in the urine (glycosuria).
Very rare side effects (may affect up to 1 in 10,000 people)
Abnormal destruction of red blood cells (haemolytic anaemia), inability of the bone marrow to function properly, decreased white blood cells (leucopenia, agranulocytosis), severe allergic reactions (e.g. hypersensitivity), increased pH due to low blood chloride levels (altered acid-base balance, hypochloremic alkalosis), acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion), inflammation of the pancreas, lupus-like syndrome (a condition similar to systemic lupus erythematosus, in which the immune system attacks the body itself), inflammation of blood vessels (necrotizing vasculitis).
Not known (frequency cannot be estimated from available data)
Inflammation of the salivary glands, skin and lip cancer (non-melanoma skin cancer), deficiency of blood cells (aplastic anaemia), decreased vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), skin disorders such as inflammation of blood vessels in the skin, increased sensitivity to sunlight, rash, skin redness, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), feeling of weakness, kidney impairment.
Low sodium levels accompanied by symptoms related to the brain or nerves (malaise, progressive disorientation, lack of interest or energy) occur in isolated cases.
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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MicardisPlus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 MicardisPlus tablet from the sealed blister pack only immediately before taking it.
Occasionally, the outer layer of the blister may separate from the inner layer between the pockets. If this occurs, no special precautions are necessary.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What MicardisPlus contains

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
The other components are monohydrate lactose, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, yellow iron oxide (E172), sodium hydroxide, sodium carboxymethylstarch (Type A), sorbitol (E420).

Description of the appearance of MicardisPlus and contents of the pack
MicardisPlus 80 mg/25 mg tablets are yellow and white, elongated, two-layered tablets, with the company logo and the code 'H9' printed on them.
MicardisPlus is available in blisters, in pack sizes of 14, 28, 56 or 98 tablets, or in unit-dose divisible blisters containing 28 x 1, 30 x 1 or 90 x 1 tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorization Holder
Manufacturer
Boehringer Ingelheim International GmbH
Binger Str. 173
55216 Ingelheim am Rhein
Germany

Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany