Prospecto:information for the user

Micardis 80mg tablets

telmisartán

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

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people 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,eveniftheydo not appearin this prospect. See section 4.

1.What is Micardis and for what it is used

2.What you need to know before starting to take Micardis

3.How to take Micardis

4.Possible adverse effects

5.Storage of Micardis

6.Contents of the package and additional information

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

Micardis is used totreat essential hypertension (high blood pressure) in adults. “Essential” means that high blood pressure is not caused by any other underlying condition.

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. 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.

Micardis is also used toreduce cardiovascular events (e.g., heart attacks or strokes) in adults at risk because their blood supply to the heart or legs is reduced or blocked, or they have had a stroke or have a high risk of developing diabetes. Your doctor will inform you if you have an elevated risk of experiencing these events.

Do not take Micardis

• if you are allergic to telmisartan or any of the other ingredients in this medication (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is best to avoid taking Micardis 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 diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.

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

Warnings and precautions

Consult your doctor before starting to take Micardis if you are suffering or have ever suffered from any of the following conditions or diseases:

• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of blood vessels to one or both kidneys).
• Liver disease.
• Heart problems.
• Elevated aldosterone levels (water and salt retention in the body along with mineral imbalance in the blood).
• Low blood pressure (hypotension) that may occur if you are dehydrated (excessive loss of water from the body) or have salt deficiency due to, for example, diuretic treatment, low-salt diet, diarrhea, or vomiting.
• Elevated potassium levels in the blood.
• Diabetes.

Consult your doctor before starting to take Micardis:

• if you are taking any of the following medications used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals. See also the information under the heading “Do not take Micardis”.

• if you are taking digoxin.

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

Inform your doctor if you think you are (or may become) pregnant. Micardis is not recommended for use at the beginning of pregnancy and should not be administered if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see Pregnancy section).

Inform your doctor before surgery or anesthesia that you are taking Micardis.

Micardis may be less effective in lowering blood pressure in black patients.

Children and adolescents

Micardis is not recommended for use in children and adolescents up to 18 years old.

Other medications and Micardis

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

• Medications containing lithium for treating certain types of depression.
• Medications that can increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially if taken in high doses along with Micardis, may cause excessive loss of water from the body and low blood pressure (hypotension).
• ACE inhibitors or aliskiren (see also the information under the headings “Do not take Micardis” and “Warnings and precautions”).
• Digoxin.

The effect of Micardis may be reduced when you use NSAIDs (e.g. aspirin or ibuprofen) or corticosteroids.

Micardis may increase the hypotensive effect of other medications used to treat high blood pressure or medications that may potentially lower blood pressure (e.g. baclofen, amifostine). Additionally, the decrease in blood pressure may be exacerbated 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 other medications while taking Micardis.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are (or may become) pregnant. Your doctor will usually advise you to stop taking Micardis before becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medication instead. Micardis is not recommended for use at the beginning of pregnancy and 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 breastfeeding or are breastfeeding. Micardis is not recommended for use in mothers who are breastfeeding, and your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

Some people may experience adverse effects such as dizziness or a sensation of spinning when taking Micardis. If you experience these adverse effects, do not drive or operate machinery.

Micardis contains sorbitol

This medication contains 337.28 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you have a condition where you are intolerant 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 your doctor before taking this medication.

Micardis contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; that is, it is essentially “sodium-free”.

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 at the same time every day.

You can take Micardis with or without food. The tablets should be swallowed whole with a little water or other non-alcoholic beverage. It is essential to take Micardis every day until your doctor tells you otherwise. If you estimate that the effect of Micardis is too strong or too weak, inform your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Micardis for most patients is one 40 mg tablet once a day, to control blood pressure over 24 hours. However, your doctor may sometimes recommend a lower dose, of 20 mg, or a higher dose, of 80 mg. Micardis may also be used in association with diuretics such as hydrochlorothiazide, which has been shown to have an additional blood pressure-lowering effect with Micardis.

For the reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once a day. At the beginning of preventive treatment with Micardis 80 mg, blood pressure should be monitored frequently.

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

If you take more Micardis than you should

If you accidentally take too many tablets, consult your doctor, pharmacist, or the nearest hospital emergency service immediately.

If you forget to take Micardis

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 day, 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* (often called "blood infection", it is a severe infection that involves a systemic inflammatory reaction) and rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (they can 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 side effects are not treated, they can be fatal.

Micardis side effects

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

Low blood pressure (hypotension) in patients treated for cardiovascular events.

Uncommon side effects(they can affect up to 1 in 100 people)

Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), decreased red blood cells (anemia), elevated potassium levels, difficulty falling asleep (insomnia), feeling of sadness (depression), dizziness (syncope), feeling of loss of balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness when standing (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal cramps, vomiting, itching, increased sweating, drug-induced rash (skin reaction to medications), back pain, muscle cramps, muscle pain (myalgia), kidney insufficiency (including acute kidney failure), chest pain, feeling of weakness, and elevated creatinine levels in blood.

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

Sepsis* (often called "blood infection", it is a severe infection that involves a systemic inflammatory reaction and can cause death), increased certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), feeling of anxiety, drowsiness, vision disturbance, increased heart rate (tachycardia), dry mouth, abdominal discomfort, taste alterations (dysgeusia), abnormal liver function (Japanese patients are more prone to experience this side effect), sudden swelling of the skin and mucous membranesthat can cause death(angioedemaincluding fatal outcome), eczema (a skin alteration), skin redness, hives (urticaria), severe drug-induced rash, joint pain (arthralgia), pain in the limbs,pain in the tendons, pseudogripal disease, decreased hemoglobin levels (a blood protein), increased uric acid levels, increased liver enzymes or creatine phosphokinase levels in blood, low sodium levels.

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

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

Unknown frequency(it cannot be estimated from available data)

Intestinal angioedema: intestinal swelling has been reported, which can be 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.

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

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 prospectus.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 yourMicardis tablet from theblister just before taking it.

Medications should not be thrown down the drain 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 Micardis

The active ingredient is telmisartan. Each tablet contains 80mg of telmisartan.

The other components are povidone (K25), meglumine, sodium hydroxide, sorbitol (E420), and magnesium stearate.

Appearance of the product and contents of the package

Micardis 80mg are white, oblong tablets, with the code “52H” engraved on one side and the company logo on the other.

Micardis is available in blister packs containing 14, 28, 56, 84, or 98 tablets, in single-dose blister packs containing 28×1, 30×1, or 90×1 tablets, or in multiple packs containing 360 tablets (4 packs of 90×1).

Only some package sizes may be marketed.

For more information about this medicine, please contact the local representative of the marketing authorization holder.

Date of the last review of this leaflet:{MM/AAAA}.

Other sources of information

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