Package Insert:Information for the User

MicardisPlus 40mg/12,5mg Tablets

telmisartán/hidroclorotiazida

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

• Keep this package insert, 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 package insert. See section4.

6.Contents of the package andadditional information

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.

High blood pressure, if left untreated, can damage blood vessels in various organs, which can lead, in some cases, to heart attacks, heart failure, or kidney failure, strokes, or blindness. Generally, there are no symptoms of high blood pressure before damage occurs. Therefore, it is essential to measure blood pressure regularly 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 controlled sufficiently when using telmisartán alone.

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 diseaseor anuria (less than 100ml 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.

Inform your doctor or pharmacist before starting to take MicardisPlus if your case is any of the above.

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 (water and salt retention 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 increased pressure in your eye and may appear between hours and weeks after taking MicardisPlus. If not treated, it may lead to permanent vision deterioration.
• 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 blood pressure-lowering medicines:

• 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 (e.g., potassium) at regular intervals. See also the information under the heading “Do not take MicardisPlus”.

• if you are taking digoxin.
• if you have had respiratory or pulmonary problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking MicardisPlus, 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 3months 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 a fluid or 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 effective in lowering blood pressure in 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 treating mouth ulcers), sodium benzoate (a penicillin 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 for controlling 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., ciprofloxacin, pentamidine) or certain medicines for treating allergic reactions (e.g., terfenadine).
• Diabetes medicines (insulins or oral agents such as metformin).
• Colestiramine and colestipol, medicines for reducing blood cholesterol levels.
• Medicines for increasing blood pressure, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Calcium and/or vitamin D supplements.
• Anticholinergic medicines (medicines used for treating a variety of disorders such as gastrointestinal spasms, urinary bladder spasms, asthma, dizziness, muscle spasms, Parkinson's disease, and as an aid to anesthesia) such as atropine and biperiden.
• Amantadine (a medicine used for treating Parkinson's disease and also for treating or preventing certain diseases caused by viruses).
• Other medicines used for treating high blood pressure, corticosteroids, analgesics (such as non-steroidal anti-inflammatory drugs [NSAIDs]), cancer medicines, gout, or arthritis.
• 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 for treating high blood pressure or 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 lactation

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 blood pressure-lowering 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 when administered from that point onwards.

Lactation

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 1mmol of sodium (23mg) per tablet; it is essentially “sodium-free”.

MicardisPlus contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

MicardisPlus contains sorbitol

This medicine contains 169mg of sorbitol per tablet.

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 make up 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 severe infection that involves a systemic inflammatory reaction), rapid swelling of the skin and mucous membranes (angioedemaincluding fatal outcome), formation of blisters and peeling on the superficial layer of the skin (toxic epidermal necrolysis); these side effects are rare (can affect up to 1 in 10,000 people) or very rare (toxic epidermal necrolysis; can 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 (can affect up to 1 in 10 people)

Dizziness.

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

Decreased potassium levels in the blood, anxiety, fainting (syncope), sensationof tingling, numbness (paresthesia), sensation that everything is spinning (vertigo), rapid heart rate (tachycardia), heart rhythm disturbances, low blood pressure,rapid decrease 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 (can affect up to 1 in 10,000 people)

Respiratory tract inflammation leading to the lungs (bronchitis),throat pain, sinus inflammation, increased uric acid levels, low sodium levels, feeling of sadness (depression), difficulty falling asleep (insomnia), sleep disorder, vision disturbance, blurred vision, difficulty breathing, abdominal pain, constipation, abdominal distension (dyspepsia), nausea (vomiting), stomach inflammation (gastritis), liver function alteration (Japanese patients are more prone to experiencing this side effect), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and limb pain, muscle cramps, activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks the body, causing joint pain, skin rashes, and fever), pseudogrippe, pain,increased creatinine levels, liver enzymes or creatine phosphokinase in the blood.

The adverse reactions reported for one of the individual components may be potential adverse reactions of MicardisPlus, although they have not been observed in clinical trials with this product.

Telmisartán

The following additional side effects have been reported in patients taking telmisartán alone:

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

Upper respiratory tract infection (e.g., throat pain, sinus inflammation, common cold), urinary tract infections,urinary tract infection,anemia, high potassium levels, slow heart rate (bradycardia),cough,kidney function alteration including acute kidney failure, weakness.

Rare side effects (can 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 rash, tendon pain (pseudotendinitis symptoms),decreased hemoglobin (a protein in the blood).

Very rare side effects (can affect up to 1 in 100,000 people)

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

Frequency unknown (cannot be estimated from available data)

Intestinal angioedema: intestinal swelling has been reported, which is accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhea after use of similar products.

* This may have been a chance finding or related to an unknown mechanism.

**Progressive fibrosis of lung tissue has been reported during telmisartán use. However, it is unknown whether telmisartán was the cause.

Hidroclorotiazida

The following additional side effects have been reported in patients taking hydrochlorothiazide alone:

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

High levels of fats in the blood.

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

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

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

Acute kidney failure.

Rare side effects (can 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 in 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 glucose levels in patients with a diagnosis of diabetes mellitus, glucose in the urine (glucosuria).

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

Abnormal degradation of red blood cells (hemolytic anemia), bone marrow failure, reduced white blood cells (leukopenia, agranulocytosis), severe allergic reactions (e.g., hypersensitivity),low pH due to low chloride levels in the blood(acid-base balance alteration, hypochloremic alkalosis), 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), necrotizing vasculitis..

Frequency unknown (cannot be estimated from available data)

Skin and lip cancer (non-melanoma skin cancer),aplastic anemia,vision loss and eye pain (possible signs of fluid accumulation in the vascular layer of the eye [choroidal hemorrhage] or acute angle-closure glaucoma), skin disorders such as inflammation of the skin blood vessels, increased sensitivity to sunlight, skin rash, skin redness, blister formation on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness,kidney function alteration.

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 experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through thenational 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 packaging and medications that you no longer need. This will help protect the environment.

Composition of MicardisPlus

-Telmisartan and hydrochlorothiazide are the active ingredients. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.

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

Appearance of the product and contents of the package

MicardisPlus 40 mg/12.5 mg tablets are oblong, two-layered tablets, red and white, with the company's logo and the code 'H4' engraved.

MicardisPlus is available in blister packs containing 14, 28, 56, 84, 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 request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

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