MICARDISPLUS 80 mg/25 mg TABLETS

Introduction

Package Leaflet:information for the user

MicardisPlus 80mg/25mg tablets

telmisartan/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is MicardisPlus and what is it used for
2. What you need to know before you take MicardisPlus
3. How to take MicardisPlus
4. Possible side effects
5. Storage of MicardisPlus
6. 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 one tablet. Both active substances help to control high blood pressure.

• Telmisartan belongs to a group of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, so that your blood vessels relax and your blood pressure is reduced.

• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase your urine output, producing a fall in your 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 renal failure, strokes, or blindness. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly measure your blood pressure to verify if it is 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 mg/12.5 mg or in patients who have previously been stabilized with telmisartan and hydrochlorothiazide separately.

2. What you need to know before you take MicardisPlus

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 section Pregnancy).
• if you have severe liver problems, such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other severe liver disease.
• if you have severe kidney disease or anuria (less than 100 ml of urine per day).
• if your doctor determines that you have low potassium or high calcium levels in your blood that do not improve with treatment.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If any of the above applies to you, inform your doctor or pharmacist before taking MicardisPlus.

Warnings and precautions

Consult your doctor before taking MicardisPlus if you have or have had any of the following disorders or diseases:

• Low blood pressure (hypotension), which can occur if you are dehydrated (excessive loss of body water) or have a deficiency of salts due to treatment with diuretics, 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.
• High aldosterone levels (water and salt retention in the body along with an imbalance of various minerals 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 can cause a rare reaction, leading to decreased vision and eye pain. These symptoms can 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 left untreated, it can lead to permanent vision loss.
• If you have had skin cancer or if you develop 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 exposure and UV rays while taking MicardisPlus.

Consult your doctor before taking MicardisPlus:

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

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), 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 information under the heading "Do not take MicardisPlus".

• if you are taking digoxin.
• if you have had respiratory or lung 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 taking MicardisPlus, seek medical attention 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, think you may be pregnant, or plan to become pregnant, inform your doctor. MicardisPlus is not recommended during pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby if used at this stage (see section Pregnancy).

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

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

If you are going to undergo 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 recently taken, or might take any other medicines. 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 is especially applicable 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), benzylpenicillin sodium (an antibiotic), and acetylsalicylic acid and derivatives.
• Iodinated contrast product used in the context of an imaging examination.

• Medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporin (an immunosuppressive medicine), and other medicines like heparin sodium (an anticoagulant).
• Medicines affected by changes in potassium levels in the blood, such as heart medicines (e.g., digoxin) or medicines to control your heart rate (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines like certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medicines for treating allergic reactions (e.g., terfenadine).
• Medicines for the treatment of diabetes (insulins or oral agents like metformin).
• Colestyramine and colestipol, medicines for reducing blood fat levels.
• Medicines for increasing blood pressure, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Calcium and/or vitamin D supplements.
• Anticholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal spasms, bladder spasms, asthma, dizziness, muscle spasms, Parkinson's disease, and as an aid to anesthesia) like atropine and biperiden.
• Amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases).

• Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines for treating cancer, gout, or arthritis.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take MicardisPlus" and "Warnings and precautions").
• Digoxin.

MicardisPlus may increase the blood-pressure-lowering effect of other medicines used to treat high blood pressure or medicines that can potentially lower blood pressure (e.g., baclofen, amifostine). Additionally, the decrease in blood pressure may be enhanced by 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 talked to your doctor. Alcohol can further lower your blood pressure and/or increase the risk of feeling dizzy or weak.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking MicardisPlus before you become pregnant or as soon as you know you are pregnant, and will recommend that you take another blood pressure-lowering medicine instead. MicardisPlus is not recommended during pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after this point.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as MicardisPlus is not recommended for use in women during this period. Your doctor may decide to prescribe you a different treatment if you want to breastfeed.

Driving and using machines

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

MicardisPlus contains sodium

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

MicardisPlus contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult 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 some sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.

3. How to take MicardisPlus

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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

If your liver is not working properly, 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 heartbeat. Slow heartbeat, dizziness, vomiting, and reduced kidney function, including kidney failure, have also been reported. Due to the hydrochlorothiazide component, you may also experience very low blood pressure and low potassium levels in the blood, which can lead to nausea, somnolence, and muscle cramps and/or irregular heartbeat associated with the simultaneous use of medicines like digitalis or certain antiarrhythmic treatments. Contact your doctor or pharmacist or the nearest hospital emergency department immediately.

If you forget 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 do not take your tablet one day, take your normal dose the next day. Donottake a double dose to make up for forgotten doses.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

Sepsis* (frequently called "blood infection", a serious infection that involves an inflammatory reaction of the entire body), rapid swelling of the skin and mucous membranes (angioedema including fatal outcome), blistering and peeling 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 are extremely serious and patients should stop taking the medicine and visit their doctor immediately. If these adverse effects are not treated, they can be fatal. An increase in the incidence of sepsis has been observed with telmisartan alone; however, it cannot be ruled out for MicardisPlus.

Possible Adverse Effects of MicardisPlus:

Common Adverse Effects (may affect up to 1 in 10 people)

Dizziness.

Uncommon Adverse Effects (may affect up to 1 in 100 people)

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

Rare Adverse Effects (may affect up to 1 in 1,000 people)

Inflammation of the airways leading to the lungs (bronchitis), sore throat, inflammation of the paranasal sinuses, increased levels of uric acid, low sodium levels, feeling of sadness (depression), difficulty falling asleep (insomnia), sleep disorder, vision disturbance, blurred vision, breathing difficulties, abdominal pain, constipation, abdominal distension (dyspepsia), nausea (vomiting), stomach inflammation (gastritis), liver function disturbance (Japanese patients show a greater tendency to experience this adverse effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia), and pain in the limbs (pain in the legs), muscle cramps, activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks the body itself, causing joint pain, skin rashes, and fever), pseudo-flu syndrome, pain, increased levels of creatinine, liver enzymes, or creatine phosphokinase in the blood.

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

Telmisartan

The following additional adverse effects have been reported in patients taking telmisartan alone:

Uncommon Adverse Effects (may affect up to 1 in 100 people)

Upper respiratory tract infection (e.g., sore throat, paranasal sinus inflammation, common cold), urinary tract infections, bladder infection, low red blood cell count (anemia), high potassium levels, slow heart rate (bradycardia), cough, kidney function disturbance including acute renal failure, weakness.

Rare Adverse Effects (may affect up to 1 in 1,000 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 upset, eczema (a skin disorder), drug rash, toxic skin rash, tendon pain (symptoms of pseudo-tendinitis), decrease in hemoglobin (a blood protein).

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

Progressive lung tissue fibrosis (interstitial lung disease)**

Frequency Not Known (cannot be estimated from the available data)

Intestinal angioedema: swelling in the intestine has been reported, which occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea after using similar products.

• This may have been a casual finding or be related to a currently unknown mechanism.

** Cases of progressive lung tissue fibrosis have been reported during telmisartan treatment. However, it is unknown whether telmisartan was the cause.

Hydrochlorothiazide

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

Very Common Adverse Effects (may affect up to 1 in 10 people)

High levels of fats in the blood.

Common Adverse Effects (may affect up to 1 in 10 people)

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

Uncommon Adverse Effects (may affect up to 1 in 100 people)

Acute renal failure.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

Low platelet count (thrombocytopenia), which increases the risk of bleeding and bruising (small purple-red spots 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), excess bile salts in the blood (cholestasis), photosensitivity reaction, uncontrolled blood sugar levels in patients with a diagnosis of diabetes mellitus, sugar in the urine (glucosuria).

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

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

Frequency Not Known (cannot be estimated from the available data)

Skin and lip cancer (non-melanoma skin cancer), blood cell deficiency (aplastic anemia), vision loss 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 blood vessel inflammation of the skin, increased sensitivity to sunlight, skin rash, skin redness, blistering of the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney function disturbance.

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

Reporting Adverse Effects

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

5. Storage of 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 is the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect 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 pack cavities. If this is detected, no action is required on your part.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

MicardisPlus Composition

• The active ingredients are telmisartan and hydrochlorothiazide.

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

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

Product Appearance and Package Contents

MicardisPlus 80 mg/25 mg tablets are oblong, two-layer tablets, yellow and white, with the company anagram 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 x 1, 30 x 1, or 90 x 1 tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorization Holder and Manufacturer

Boehringer Ingelheim International GmbH Boehringer Ingelheim Hellas Single

Binger Str. 173 Member S.A.

55216 Ingelheim am Rhein 5th km Paiania-Markopoulo

Germany 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

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

Date of Last Revision of this Leaflet:

Other Sources of Information

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