MICARDIS 80 mg TABLETS

Introduction

Package Leaflet:Information for the User

Micardis 80mg tablets

telmisartan

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 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 get 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 Micardis and what is it used for
2. What you need to know before you take Micardis
3. How to take Micardis
4. Possible side effects
5. Storage of Micardis
6. Contents of the pack and other information

1. What is Micardis and what is it used for

Micardis belongs to a class 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. Micardis blocks the effect of angiotensin II, so that the blood vessels relax and your blood pressure is reduced.

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

High blood pressure, if not treated, can damage blood vessels in various organs, which could lead to heart attack, heart or kidney failure, stroke, or blindness. Usually, high blood pressure does not produce symptoms before damage occurs. Therefore, it is important to regularly measure your blood pressure to check if it is within the normal range.

Micardis is also used toreduce cardiovascular events (e.g., heart attack or stroke) in adults at risk because their blood supply to the heart or legs is reduced or blocked, or who have had a stroke or have a high risk of diabetes. Your doctor will tell you if you are at high risk of having these events.

2. What you need to know before you take Micardis

Do not take Micardis

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is recommended not to take Micardis during the first few months of 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 diabetes or kidney impairment and you are treated with an ACE inhibitor or aliskiren.

If any of these apply to you, tell your doctor or pharmacist before taking Micardis.

Warnings and precautions

Consult your doctor before taking 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 the blood vessels to one or both kidneys).
• Liver disease.
• Heart problems.
• High levels of aldosterone (water and salt retention in the body along with an imbalance of various minerals in the blood).
• Low blood pressure (hypotension) that may occur if you are dehydrated (excessive loss of water from the body) or have low salt levels due to, for example, treatment with diuretics, low-salt diet, diarrhea, or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Consult your doctor before taking Micardis:

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

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

Your doctor may check 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 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.

You should inform your doctor if you think you are (or might become) pregnant. Micardis is not recommended during the first few months of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see section Pregnancy).

In case of surgery or anesthesia, inform your doctor 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 children and adolescents up to 18 years.

Other medicines and Micardis

Tell 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 Micardis:

• Medicines containing lithium for treating certain types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, non-steroidal anti-inflammatory drugs (e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses with Micardis, may cause excessive water loss from the body and low blood pressure (hypotension).
• if you are taking an ACE inhibitor 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 non-steroidal anti-inflammatory drugs (e.g., aspirin or ibuprofen) or corticosteroids.

Micardis may increase the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may 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 Micardis.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Micardis before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead. Micardis is not recommended during the first few months of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Micardis is not recommended for women who are breast-feeding, and your doctor may choose another treatment for you if you want to breast-feed, especially if your baby is a newborn or premature.

Driving and using machines

Some people may experience side effects such as fainting or a feeling that everything is spinning (vertigo) when taking Micardis. If you experience these side effects, do not drive or use machines.

Micardis contains sorbitol

This medicine contains 337.28 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 you cannot break down fructose, consult your doctor before taking this medicine.

Micardis contains sodium

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

3. How to take Micardis

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 Micardis 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 Micardis every day until your doctor tells you to stop. If you think that the effect of Micardis is too strong or too weak, talk to 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 can also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to have an additive 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 start of preventive treatment with Micardis 80 mg, blood pressure should be frequently monitored.

If your liver is not working properly, 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 department 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 then 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and require immediate medical attention

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

Sepsis* (often called “blood infection”, a serious infection that involves an inflammatory reaction of the whole body) and rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Micardis

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

Low blood pressure (hypotension) in users treated for cardiovascular event reduction.

Uncommon side effects (may 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), high potassium levels, difficulty falling asleep (insomnia), feeling sad (depression), fainting (syncope), feeling of losing balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness when standing up (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, stomach pain, abdominal distension, vomiting, itching, increased sweating, drug rash (skin reaction to medicines), back pain, muscle cramps, muscle pain (myalgia), kidney failure (including acute kidney failure), chest pain, feeling weak, and high creatinine levels in the blood.

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

Sepsis* (often called “blood infection”, a serious infection that involves an inflammatory reaction of the whole body and can cause death), increased white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, drowsiness, vision disturbance, increased heart rate (tachycardia), dry mouth, abdominal discomfort, taste disturbance (dysgeusia), abnormal liver function (Japanese patients show a higher tendency to experience this side effect), rapid swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), eczema (a skin disorder), skin redness, hives (urticaria), severe drug rash, joint pain (arthralgia), limb pain, tendon pain, pseudogrip syndrome, decrease in hemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or creatine phosphokinase in the blood, low sodium levels.

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

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

Frequency not known (cannot be estimated from the available data)

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

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

** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Micardis

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 carton after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions. Store in the original package to protect from moisture. Remove your Micardis tablet from the blister pack just before taking it.

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

6. Package Contents and Additional Information

Micardis Composition

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

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

Product Appearance and Package Contents

Micardis 80 mg 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 blisters containing 28 × 1, 30 × 1, or 90 × 1 tablets, or in multiple packs containing 360 tablets (4 packs of 90 × 1).

Only some pack sizes may be marketed.

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

Date of Last Revision of this Leaflet:{MM/AAAA}.

Other Sources of Information

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