MicardisPlus 80 mg/12.5 mg tablets

MicardisPlus is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both substances help to control high blood pressure.

• Telmisartan belongs to a group of medicines called 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. Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your urine output to increase leading to a lowering of your blood pressure.

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.

MicardisPlus is used to treat high blood pressure (essential hypertension) in patients whose blood pressure is not controlled enough when either telmisartan or hydrochlorothiazide is used alone.

Do not take MicardisPlus

• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in MicardisPlus tablets (see "Further Information" for a list of other ingredients).
• if you are allergic (hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medicines.
• if you are more than 3 months pregnant. (It is also better to avoid MicardisPlus 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 gall bladder) or any other severe liver disease.
• if you have severe kidney disease.
• if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.

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

Take special care with MicardisPlus

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

• 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, vomiting, or haemodialysis.
• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Liver disease.
• Heart trouble.
• Diabetes.
• Gout.
• Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
• Lupus erythematosus (also called ?lupus? or ?SLE?) a disease where the body?s immune system attacks the body.

You must tell your doctor if you think you are ( or might become) pregnant. MicardisPlus 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).

Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart rate (faster than 100 beats per minute). If you experience any of these you should tell your doctor.

You should also tell your doctor, if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal.

In case of surgery or anaesthetics, you should tell your doctor that you are taking MicardisPlus.

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

As with all other angiotensin II receptor antagonists, telmisartan 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 medications 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 MicardisPlus:

• Lithium containing medicines to treat some types of depression.
• Medicines associated with low blood potassium (hypokalaemia) such as other diuretics, ('water tablets'), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone),

amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.

• Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors that may increase blood potassium levels.
• Heart medicines (e.g. digoxin) or medicines to control the rhythm of your heart (e.g. quinidine, disopyramide).
• Medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine).
• Other medicines used to treat high blood pressure, steroids, painkillers, medicines to treat cancer, gout, or arthritis, and vitamin D supplements.

MicardisPlus may increase the blood pressure lowering effect of other medicines and you should consult with your doctor if you need to adjust the dose of your other medicine while taking MicardisPlus.

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

Taking MicardisPlus with food and drink

You can take MicardisPlus tablets 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 MicardisPlus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of MicardisPlus. MicardisPlus 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. MicardisPlus 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 MicardisPlus 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 MicardisPlus

MicardisPlus contains milk sugar (lactose) and sorbitol.
If you are intolerant to some sugars, consult your doctor before taking MicardisPlus.

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

The usual dose of MicardisPlus is one tablet a 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 with some water or other non-alcoholic drink. It is important that you take MicardisPlus every day until your doctor tells you otherwise.

If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.

If you take more MicardisPlus 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 MicardisPlus

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 further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, MicardisPlus 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:
Dizziness

Uncommon side effects may include:
Decreased blood potassium levels; anxiety; fainting (syncope); sensation of tingling, pins and needles (paraesthesia); feeling of spinning (vertigo); fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up; shortness of breath (dyspnoea); symptoms of an upset stomach such as diarrhoea; dry mouth; flatulence; back pain, muscle spasm, muscle pain; erectile dysfunction (inability to get or keep an erection); chest pain; increased blood uric acid levels.

Rare side effects may include:
Inflammation of the lung (bronchitis); feeling sad (depression); difficulty falling asleep (insomnia); impaired vision; difficulty breathing; abdominal pain, constipation, bloating (dyspepsia), feeling sick; abnormal liver function; rapid swelling of the skin and mucosa (angioedema), redness of the skin (erythema); allergic reactions such as itching or rash; increased sweating, hives (urticaria); joint pain (arthralgia) and pain in extremities, muscle cramps; flu-like-illness; pain; increased levels of uric acid, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.

Side effects of unknown frequency may include:
Sore throat, inflamed sinuses; inflammation of the stomach (gastritis)

Telmisartan

In patients taking telmisartan alone the following additional side effects have been reported:

Side effects of unknown frequency may include:
Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract infections; increase in certain white blood cells (eosinophilia), deficiency in red blood cells (anaemia), low platelet count (thrombocytopenia); serious allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash); high potassium levels; slow heart rate (bradycardia); upset stomach; eczema (a skin disorder); inflammation of the tendons; kidney impairment including acute kidney failure;

weakness; decreased haemoglobin (a blood protein), 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.

Hydrochlorothiazide

In patients taking hydrochlorothiazide alone the following additional side effects have been reported:

Side effects of unknown frequency may include:
Inflammation of the salivary gland; decreases in the number of cells in the blood, including low red and white blood cell count, low platelet count (thrombocytopenia); serious allergic reactions; (e.g. hypersensitivity, anaphylactic reaction), inflammation of blood vessels (vasculitis necrotising), decreased or loss of appetite; restlessness, weakness, light-headedness, blurred or yellowing of vision; inflamed pancreas, upset stomach; yellowing of the skin or eyes (jaundice); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis); kidney inflammation or impaired kidney function; fever; impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, glucose in the urine (glycosuria), increased levels of glucose, or fat in the blood.

If any of the side effects get 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 MicardisPlus 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.

Occasionally, the outer layer of the blister pack separates from the inner layer between the blister pockets. You do not need to take any action if this happens.

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 MicardisPlus contains

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)

What MicardisPlus looks like and contents of the pack

MicardisPlus 80 mg/12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the company logo and the code 'H8'.

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

Not all pack sizes may be available in your country.

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

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 Magyarország Boehringer Ingelheim RCV GmbH Co KG Magyarországi Fióktelepe Tel. 36 1 299 8900

eská republika Boehringer Ingelheim spol. s r.o. Tel 420 234 655 111 Malta Boehringer Ingelheim Ltd. Tel 44 1344 424 600

Danmark Boehringer Ingelheim Danmark AS Tlf 45 39 15 88 49 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 RCV GmbH Co KG 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. SímiTel 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 RCV GmbH & Co KG
Lietuvos filialas
Tel.: +370 37 473922

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