Micardis 80 mg tablets

Micardis belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body which 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 lowered.

Micardisis used to treat essential hypertension (high blood pressure). ?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 several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.

Micardis is also used to reduce cardiovascular events (i.e. heart attack or stroke) in patients who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.

Do not take Micardis

• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Micardis tablets (see section Further information for a list of other ingredients).
• if you are more than 3 months pregnant. (It is also better to avoid Micardis in early pregnancy ? see pregnancy section.)
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.

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

Take special care with Micardis

Please tell your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:

• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Liver disease.
• Heart trouble.
• Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting.
• Elevated potassium levels in your blood.
• Diabetes.

You must tell your doctor if you think you are ( or might become) pregnant. Micardis is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

In case of surgery or anaesthesia, you should tell your doctor that you are taking Micardis.

The use of Micardis in children and adolescents up to the age of 18 years is not recommended.

As with all other angiotensin antagonists, Micardis may be less effective in lowering the blood pressure in black patients.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Micardis:

• Lithium containing medicines to treat some types of depression.
• Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
• Diuretics ('water tablets'), especially if taken in high doses together with Micardis, may lead to excessive loss of body water and low blood pressure (hypotension).

As with other blood pressure lowering medicines, the effect of Micardis may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.

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

Taking Micardis with food and drink

You can take Micardis with or without food.

Pregnancy and breast-feeding

Pregnancy
You must tell 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 of Micardis. Micardis is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Micardis is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

No information is available on the effect of Micardis on the ability to drive or operate machinery. Some people feel dizzy or tired when they are treated for high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.

Important information about some of the ingredients of Micardis

Micardis contains sorbitol.
If you are intolerant to some sugars, consult your doctor before taking Micardis.

Always take Micardis exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of Micardis is one tablet a 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 with some water or other non-alcoholic drink. It is important that you take Micardis every day until your doctor tells you otherwise. If you have the impression that the effect of Micardis is too strong or too weak, talk to your doctor or pharmacist.

For 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 the 24 hour period. However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Micardis may be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.

For reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once a day. At the beginning of the preventive therapy 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 daily.

If you take more Micardis than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or your 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 then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

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

Like all medicines, Micardis can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.

Common side effects may include:
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.

Uncommon side effects may include:
Upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), urinary tract infections, deficiency in red blood cells (anaemia), high potassium levels, feeling sad (depression), fainting (syncope), difficulty falling asleep, feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, increased sweating, itching, drug rash, muscle pain (myalgia), back pain, muscle cramps, kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.

Rare side effects may include:
Low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), feeling anxious, impaired vision, fast heart beat (tachycardia), upset stomach, dry mouth, abnormal liver function, severe drug rash, redness of skin, rapid swelling of the skin and mucosa (angioedema), eczema (a skin disorder), joint pain (arthralgia), pain in extremity, flu-like-illness, increased levels of uric acid, hepatic enzymes or creatine phosphokinase in the blood, and decreased haemoglobin (a blood protein).

Side effects of unknown frequency may include:
Increase in certain white blood cells (eosinophilia), severe allergic reaction (anaphylactic reaction), hives (urticaria), tendon pain, and sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death).

*In a long-term study involving more than 20,000 patients, more patients treated with telmisartan experienced sepsis compared with patients who received no telmisartan. The event may have happened by chance or could be related to a mechanism currently not known.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Micardis after the expiry date which is stated on the carton after ?EXP?. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions. You should store your medicine in the original package in order to protect the tablets from moisture.

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 to protect the environment.

What Micardis contains

The active substance is telmisartan. Each tablet contains 80 mg telmisartan.
The other ingredients are povidone, meglumine, sodium hydroxide, sorbitol (E420) and magnesium stearate.

What Micardis looks like and contents of the pack

Micardis 80 mg tablets are white, oblong-shaped and engraved with the code number '52H' on one side and the company logo on the other side.

Micardis is available in blister packs containing 14, 28, 30, 56, 84, 90 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Str. 173 D-55216 Ingelheim am Rhein Germany Manufacturer Boehringer Ingelheim Pharma GmbH Co. KG Binger Str. 173 D-55216 Ingelheim am Rhein Germany

and

Delpharm Reims S.A.S.
10 rue Colonel Charbonneaux
51100 Reims
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien S.C.S. Boehringer Ingelheim Comm.V. TélTel 32 2 773 33 11 LuxembourgLuxemburg S.C.S. Boehringer Ingelheim Comm.V. TélTel 32 2 773 33 11

359 2 958 79 98 eská republika Boehringer Ingelheim spol. s r.o. Tel 420 234 655 111 Magyarország Boehringer Ingelheim RCV GmbH Co KG Magyarországi Fióktelepe Tel. 36 1 299 89 00 Malta Boehringer Ingelheim Ltd. Tel 44 1344 424 600

Danmark Boehringer Ingelheim Danmark AS Tlf 45 39 15 88 88 Nederland Boehringer Ingelheim b.v. Tel 31 0 800 22 55 889

Deutschland Boehringer Ingelheim Pharma GmbH Co. KG Tel 49 0 800 77 90 900 Norge Boehringer Ingelheim Norway KS Tlf 47 66 76 13 00

Österreich MERCK Gesellschaft mbH Tel 43 1 57 6000 Eesti Boehringer Ingelheim Pharma GmbH Eesti Filiaal Tel 372 60 80 940

Boehringer Ingelheim Ellas A.E. T 30 2 10 89 06 300 Polska Boehringer Ingelheim Sp.zo.o. Tel. 48 22 699 0 699

España Boehringer Ingelheim España S.A. Tel 34 93 404 58 00 Portugal Boehringer Ingelheim, Lda. Tel 351 21 313 53 00

France Boehringer Ingelheim France S.A.S. Tél 33 3 26 50 45 33 România Boehringer Ingelheim RCV GmbH Co KG Viena - Sucursala Bucuresti Tel 40 21 330 99 63

Ireland Boehringer Ingelheim Ireland Ltd. Tel 353 1 295 9620 Slovenija Boehringer Ingelheim RCV GmbH Co KG podrunica Ljubljana Tel 386 1 586 40 00

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Boehringer Ingelheim RCV GmbH Co KG organizaná zloka Tel 421 2 5810 1211

Italia Boehringer Ingelheim Italia S.p.A. Tel 39 02 5355 1 SuomiFinland Boehringer Ingelheim Finland Ky PuhTel 358 10 3102 800

Boehringer Ingelheim Ellas A.E. T 30 2 10 89 06 300 Sverige Boehringer Ingelheim AB Tel 46 8 721 21 00

United Kingdom Boehringer Ingelheim Ltd. Tel 44 1344 424 600 Latvija Boehringer Ingelheim Pharma GmbH Prstvniecba Latvij Tel 371 67 240 068

Lietuva
Boehringer Ingelheim Pharma Ges mbH
Atstovyb- Lietuvoje
Tel.: +370 37 473922

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