Label:information for the user

MicardisPlus 80mg/25mg tablets

telmisartán/hidroclorotiazida

Read this label carefully before starting to take this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

MicardisPlus is a combination of two active ingredients, telmisartán and hydrochlorothiazide, in a tablet. Both active ingredients help control high blood pressure.

-Telmisartán belongs to a group of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, increasing blood pressure. Telmisartán blocks the effect of angiotensin II, causing blood vessels to relax and reducing blood pressure.

• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase urine production, resulting in a decrease in blood pressure..

Untreated high blood pressure can damage blood vessels in various organs, which can lead, in some cases, to heart attacks, heart failure, or renal failure, or strokes or blindness. Generally, there are no symptoms of high blood pressure before damage occurs. Therefore, it is essential to regularly measure blood pressure to verify if it is within the normal range.

MicardisPlus is used forthe treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled with MicardisPlus 80mg/12.5mg or in patients who have previously been stabilized with telmisartán and hydrochlorothiazide separately.

Do not take MicardisPlus

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to hydrochlorothiazide or other sulfonamide-derived medicines.
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking MicardisPlus also at the beginning of your 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 severe liver disease.
• if you have a severe kidney disease or anuria (less than 100 ml of urine per day).
• if your doctor determines that you have low potassium levels or high calcium levels in your blood, which do not improve with treatment.
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If your case is any of the above, inform your doctor or pharmacist before starting to take MicardisPlus.

Warnings and precautions

Consult your doctor before starting to take MicardisPlus if you have or have had any of the following conditions or diseases:

• Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have a salt deficiency due to diuretic treatment, low-salt diet, diarrhea, 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 (retention of water and salts in the body along with imbalance of several minerals in the blood).
• SLE (systemic lupus erythematosus), a disease in which the body's immune system attacks the body itself.
• The active ingredient hydrochlorothiazide may cause a rare reaction, leading to a decrease in vision and eye pain. These symptoms may be indicative of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in your eye and may appear between hours and weeks after taking MicardisPlus. If not treated, it may lead to permanent vision loss.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanocytic skin cancer). Protect your skin from sun exposure and UV rays while taking MicardisPlus.

Consult your doctor before starting to take MicardisPlus:

• if you are taking any of the following medicines used to treat high blood pressure:

• a renin-angiotensin-aldosterone system (RAAS) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in your blood (e.g., potassium) at regular intervals. See also the information under the heading "Do not take MicardisPlus".

• if you are taking digoxin.
• ifyou have had respiratory or pulmonary problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after takingMicardisPlus, see your doctor immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking MicardisPlus. Your doctor will decide whether to continue treatment. Do not stop taking MicardisPlus on your own.

If you are pregnant, if you suspect you may beor if you plan to becomepregnant, you must inform your doctor. MicardisPlus is not recommended for use at the beginning of pregnancy and should not be administered if you are more than 3 months pregnant because it may cause serious harm to your baby if used at this stage (see Pregnancy section).

Treatment with hydrochlorothiazide may cause an electrolyte imbalance in your body. Typical symptoms of an electrolyte imbalance include dry mouth, weakness, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and an abnormally fast heart rate (more than 100 beats per minute).If you experience any of these symptoms, inform your doctor.

You must also inform your doctor if you experience increased skin sensitivity to the sun with sunburn symptoms (such as redness, itching, swelling, and blistering) that appear more quickly than usual.

If you are to undergo surgery (surgery) or anesthesia, inform your doctor that you are taking MicardisPlus.

MicardisPlus may be less effectivein reducing blood pressurein black patients.

Children and adolescents

MicardisPlus is not recommended for use in children and adolescents up to 18 years of age.

Other medicines and MicardisPlus

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases, you may need to stop taking one of the medicines.This applies especially to the following medicines when taken with MicardisPlus:

• Medicines containing lithium for treating certain types of depression.
• Medicines associated with low potassium levels in the blood (hypokalemia) such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used in the treatment of mouth ulcers), sodium benzoate (a type of antibiotic), and aspirin and its derivatives.
• Contrast agent containing iodine used in the context of an imaging examination.

• Medicines that may increase potassium levels in the blood such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, RAAS inhibitors, ciclosporin (an immunosuppressant), and other medicines such as heparin sodium (an anticoagulant).
• Medicines affected by changes in potassium levels in the blood such as heart medicines (e.g., digoxin) or medicines used to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used to treat mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines such as certain antibiotics (e.g., ciprofloxacin, pentamidine) or certain medicines used to treat allergic reactions (e.g., terfenadine).
• Medicines used to treat diabetes (insulins or oral agents such as metformin).
• Colestiramine and colestipol, medicines used to reduce cholesterol levels in the blood.
• Medicines used to increase blood pressure, such as noradrenaline.
• Relaxants, such as tubocurarine.
• Calcium and/or vitamin D supplements.
• Anticholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal spasms, urinary tract spasms, asthma, dizziness, muscle spasms, Parkinson's disease, and as an aid to anesthesia) such as atropine and biperiden.
• Amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses).

• Other medicines used to treat high blood pressure, corticosteroids, analgesics (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines used to treat cancer, gout, or arthritis.
• RAAS inhibitors or aliskiren (see also the information under the headings "Do not take MicardisPlus" and "Warnings and precautions").
• Digoxin.

MicardisPlus may increase the hypotensive effect of other medicines used to treat high blood pressure or of medicines that may potentially lower blood pressure (e.g., baclofen, amifostine). Additionally,the decrease in blood pressure may be exacerbatedby alcohol, barbiturates, narcotics, or antidepressants.You may notice this effect as dizziness when standing up. You should consult your doctor if you need to adjust the dose of your other medicines while taking MicardisPlus.

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

Taking MicardisPlus with food and alcohol

You can take MicardisPlus with or without food.

Avoid drinking alcohol until you have spoken with your doctor. Alcohol may further lower your blood pressure and/or increase the risk of feeling dizzy or weak.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may beor if you plan to becomepregnant. 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 taking another antihypertensive medicine instead. MicardisPlus is not recommended for use during pregnancy, and it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby if used at this stage.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding, as MicardisPlus is not recommended for use during this period. Your doctor may decide to administer another treatment if you want to breastfeed.

Driving and operating machinery

Some people may feel dizzy, faint, or feel like everything is spinning when taking MicardisPlus. If you experience any of these effects, do not drive or operate machinery.

MicardisPlus contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

MicardisPlus contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

MicardisPlus contains sorbitol

This medicine contains 338 mg of sorbitol in each 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 (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult with your doctor before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. Try to take the tablet every day at the same time. You can take MicardisPlus with or without food. The tablets should be swallowed whole with a little water or other non-alcoholic beverage. It is essential to take MicardisPlus every day until your doctor tells you otherwise.

If your liver does not function correctly, the usual dose should not exceed 40 mg of telmisartan once a day.

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 heartbeats. Slow heartbeats, dizziness, vomiting, and reduced kidney function, including kidney failure, have also been reported. Due to the hydrochlorothiazide component, you may also experience notably low blood pressure and low potassium levels in the blood, which can cause nausea, drowsiness, and muscle cramps and/or irregular heartbeats associated with the simultaneous use of medications such as digitalis or certain antiarrhythmic treatments. Contact your doctor or pharmacist immediately or the nearest hospital emergency service.

If you forgot to take MicardisPlus

If you forget to take a dose, do not worry. Take it as soon as you remember and continue as before. If you miss a tablet, take your normal dose the next day.Do nottake a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious and require immediate medical attention:

If you experience any of the following symptoms, you should visit your doctor immediately:

Sepsis* (also known as "blood infection", a serious infection that involves a systemic inflammatory reaction), rapid swelling of the skin and mucous membranes (including angioedema with fatal outcome), formation of blisters and peeling of the skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 10,000 people) or very rare (toxic epidermal necrolysis; may affect up to 1 in 100,000 people), but are extremely serious and patients should stop taking the medicine and visit their doctor immediately. If these side effects are not treated, they can be fatal. An increased incidence of sepsis with telmisartan alone has been observed; however, it cannot be ruled out for MicardisPlus.

Possible side effects of MicardisPlus:

Frequent side effects (may affect up to 1 in 10 people)

Dizziness.

Less frequent side effects (may affect up to 1 in 100 people)

Decreased potassium levels in the blood, anxiety, fainting (syncope), sensation of tingling, numbness (paresthesia), sensation of spinning (vertigo), rapid heart rate (tachycardia), heart rhythm disturbances, low blood pressure, sudden drop in blood pressure when standing, shortness of breath (dyspnea), diarrhea, dry mouth, flatulence, back pain, muscle spasms, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, and increased uric acid levels in the blood.

Rare side effects (may affect up to 1 in 10,000 people)

Respiratory tract infections (e.g., sore throat, sinusitis, common cold), urinary tract infections, urinary tract infection, anemia, high potassium levels, slow heart rate (bradycardia), cough, kidney function impairment including acute renal failure, weakness.

Very rare side effects (may affect up to 1 in 10,000 people)

Low platelet count (thrombocytopenia), increased levels of certain white blood cells (eosinophilia), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), low blood sugar levels (in diabetic patients), drowsiness, stomach discomfort, eczema (a skin disorder), drug-induced rash, toxic skin eruption, tendon pain (pseudotendinitis), decreased hemoglobin (a protein in the blood).

Unknown frequency (cannot be estimated from available data)

Progressive fibrosis of lung tissue (interstitial lung disease)**

Telmisartan

Additionally, the following side effects have been reported in patients taking telmisartan alone:

Less frequent side effects (may affect up to 1 in 100 people)

Upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), urinary tract infections, urinary tract infection, anemia, high potassium levels, slow heart rate (bradycardia), cough, kidney function impairment including acute renal failure, weakness.

Rare side effects (may affect up to 1 in 10,000 people)

Low platelet count (thrombocytopenia), increased levels of certain white blood cells (eosinophilia), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), low blood sugar levels (in diabetic patients), drowsiness, stomach discomfort, eczema (a skin disorder), drug-induced rash, toxic skin eruption, tendon pain (pseudotendinitis), decreased hemoglobin (a protein in the blood).

Very rare side effects (may affect up to 1 in 10,000 people)

Fibrosis of lung tissue (interstitial lung disease)**

Hidroclorotiazida

Additionally, the following side effects have been reported in patients taking hidroclorotiazida alone:

Very frequent side effects (may affect up to 1 in 10 people)

High levels of fats in the blood.

Frequent side effects (may affect up to 1 in 10 people)

Nausea, low magnesium levels in the blood, decreased appetite.

Less frequent side effects (may affect up to 1 in 100 people)

Acute kidney failure.

Rare side effects (may affect up to 1 in 10,000 people)

Low platelet count (thrombocytopenia), which increases the risk of bleeding and hematoma formation (small purple-red marks on the skin or other tissues caused by bleeding), high calcium levels in the blood, high blood sugar levels, headache, abdominal discomfort, yellowing of the skin or eyes (jaundice), bile duct obstruction (cholestasis), photosensitivity reaction, uncontrolled blood sugar levels in patients with diabetes mellitus, glucose in the urine.

Very rare side effects (may affect up to 1 in 10,000 people)

Abnormal breakdown of red blood cells (hemolytic anemia), failure of the bone marrow to function correctly, reduction of white blood cells (leukopenia, agranulocytosis), severe allergic reactions (e.g., hypersensitivity), low pH due to low chloride levels in the blood (acid-base imbalance, alkalosis hypochloremic), acute respiratory distress (symptoms include severe shortness of breath, fever, weakness, and confusion), pancreatitis, pseudolupus syndrome (a disorder that resembles a disease called systemic lupus erythematosus in which the body's immune system attacks the body, causing joint pain, skin rashes, and fever), necrotizing vasculitis.

Unknown frequency (cannot be estimated from available data)

Skin cancer and lip cancer (non-melanoma skin cancer), aplastic anemia (a blood disorder), vision loss and eye pain (possible signs of corneal edema or acute angle-closure glaucoma), skin disorders such as vasculitis of the skin, increased sensitivity to sunlight, skin rash, redness of the skin, formation of blisters on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney function impairment.

In isolated cases, low sodium levels are accompanied by symptoms related to the brain or nerves (nausea, progressive disorientation, lack of interest or energy).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from moisture. Remove your MicardisPlus tablet from the sealed blister pack just before taking it.

Occasionally, the outer layer of the blister pack may separate from the inner layer between the blister cells. If this is detected, no action is required on your part.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of MicardisPlus

• The active ingredients are telmisartan and hydrochlorothiazide.

Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.

• The other components are lactose monohydrate, magnesium stearate, cornstarch, meglumine, microcrystalline cellulose, povidone K25, yellow iron oxide (E172), sodium hydroxide, carboxymethylstarch sodium (type A), and sorbitol (E420).

Appearance of the product and contents of the package

MicardisPlus 80 mg/25 mg tablets are oblong, two-layered, yellow and white tablets with the company's logo and the code 'H9' engraved.

MicardisPlus is available in blister packs containing 14, 28, 56, or 98 tablets, or in single-dose blister packs containing 28 × 1, 30 × 1, or 90 × 1 tablets.

Only some package sizes may be marketed in your country.

Marketing Authorization HolderManufacturer

Boehringer Ingelheim International GmbHBoehringer Ingelheim Hellas Single

Binger Str. 173Member S.A.

55216 Ingelheim am Rhein5th km Paiania‑Markopoulo

GermanyKoropi 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

You can obtain more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

Detailed information about this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu.