MicardisPlus 80 mg/25 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

MicardisPlus 80mg/25mg tablets

telmisartan/hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What MicardisPlus is and what it is used for

MicardisPlus is a combination of two active substances, telmisartan and hydrochlorothiazide, in one tablet. Both active substances help 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, thereby 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, resulting in a reduction of your blood pressure.

If left untreated, high blood pressure can damage blood vessels in various organs, which may lead, in some cases, to heart attacks, heart or kidney failure, strokes, or blindness. High blood pressure generally does not cause symptoms before damage occurs. Therefore, it is important to measure your blood pressure regularly to ensure it remains within the normal range.

MicardisPlus is used for the treatment of 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 on telmisartan and hydrochlorothiazide given separately.

2. What you need to know before taking 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 to other sulfonamide-derived medicines.
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking MicardisPlus also in early 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 severe kidney disease or anuria (less than 100 ml of urine per day).
• if your doctor finds that you have low potassium levels or high calcium levels in the blood, which do not improve with treatment.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor before starting to take MicardisPlus if you have or have had any of the following conditions or diseases:

• Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to treatment with diuretics, a low-salt diet, diarrhoea, 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 levels of aldosterone (water and salt retention in the body along with imbalance of several 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 may cause a rare reaction leading to vision loss and eye pain. These symptoms may indicate fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may appear from hours to weeks after taking MicardisPlus. If untreated, this may 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking MicardisPlus.

Talk to your doctor before starting to take MicardisPlus:

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

• an angiotensin-converting enzyme (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 information under the heading “Do not take MicardisPlus”.

• if you are taking digoxin.
• if you have previously experienced breathing or lung problems (including lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you experience shortness of breath or severe difficulty breathing after taking MicardisPlus, contact your doctor immediately.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea 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 might be pregnant, or plan to become pregnant, you must inform your doctor. Use of MicardisPlus is not recommended in early pregnancy and must not be given after the third month of pregnancy because it may cause serious harm to your baby if used at this stage (see Pregnancy section).

Treatment with hydrochlorothiazide may cause an electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and abnormally rapid heartbeat (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 sunlight with symptoms of sunburn (such as redness, itching, swelling, or blistering) appearing more quickly than usual.

If you are scheduled for surgery (surgical procedure) or anesthesia, you must inform your doctor that you are taking MicardisPlus.

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

Children and adolescents

The use of MicardisPlus is not recommended 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 need to take any other medicines. Your doctor may need to adjust 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 important for the following medicines when taken together with MicardisPlus:

• Medicines containing lithium used to treat certain types of depression.

• Medicines associated with low potassium levels in blood (hypokalaemia), 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), sodium benzylopencillin (an antibiotic), and acetylsalicylic acid and its derivatives.

• Iodinated contrast agents used in imaging procedures.

• Medicines that may increase potassium levels in blood, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medicines such as sodium heparin (an anticoagulant).

• Medicines affected by changes in blood potassium levels, such as heart medicines (e.g., digoxin) or medicines to control your heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines such as certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medicines used to treat allergic reactions (e.g., terfenadine).

• Medicines for the treatment of diabetes (insulins or oral agents such as metformin).

• Cholestyramine and colestipol, medicines used to reduce blood fat levels.

• Medicines to increase blood pressure, such as noradrenaline.

• Muscle relaxants, such as tubocurarine.

• Calcium and/or vitamin D supplements.

• Anticholinergic medicines (medicines used to treat various disorders such as gastrointestinal spasms, urinary bladder spasm, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anesthesia), such as atropine and biperiden.

• Amantadine (a medicine used to treat Parkinson’s disease and also to treat or prevent certain viral infections).

• Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), cancer treatments, gout, or arthritis.

• If you are taking an ACE inhibitor or aliskiren (see also information under the headings “Do not take MicardisPlus” and “Warnings and precautions”).

• Digoxin.

MicardisPlus may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or of medicines that may potentially lower blood pressure (e.g., baclofen, amifostine). In addition, the blood pressure reduction may be worsened 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 may take MicardisPlus with or without food.

Avoid alcohol until you have spoken with your doctor. Alcohol may further lower your blood pressure and/or increase the risk of feeling dizzy or weak.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking MicardisPlus before becoming pregnant or as soon as you know you are pregnant, and will recommend another antihypertensive medicine instead. MicardisPlus is not recommended during pregnancy and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby if used from that point.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as MicardisPlus is not recommended for women during this period. Your doctor may decide on an alternative treatment if you wish to breastfeed.

Driving and using machines

Some people feel dizzy, faint, or experience a sensation of spinning when taking MicardisPlus. If you experience any of these effects, do not drive or operate machinery.

MicardisPlus contains sodium

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

MicardisPlus contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

MicardisPlus contains sorbitol

This medicine contains 338 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the patient cannot break down fructose, consult your doctor before taking this medicine.

3. How to take MicardisPlus

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet daily. Try to take the tablet at the same time each day. You may 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 unless your doctor tells you otherwise.

If your liver is not functioning properly, the usual dose should not exceed 40 mg of telmisartan once daily.

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 component hydrochlorothiazide, markedly low blood pressure and low potassium levels in the blood may also occur, which can lead to nausea, drowsiness, muscle cramps and/or irregular heartbeat, particularly when used concomitantly with medicines such as digitalis or certain antiarrhythmic treatments. Contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.

If you forget to take MicardisPlus

If you forget to take a dose, do not worry. Take it as soon as you remember and then continue as before. If you miss a day, take your normal dose the next day. Do not take a double dose to make up for missed doses.

If you have any further questions about 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 everyone will experience them.

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

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

Sepsis* (commonly referred to as "blood infection", a severe infection involving a systemic inflammatory response), rapid swelling of the skin and mucous membranes (angioedema, including fatal outcomes), 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 must stop taking the medicine and see their doctor immediately. If these adverse effects are not treated, they may be fatal. An increased incidence of sepsis has been observed with telmisartan alone; however, this 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)

Low blood potassium levels, anxiety, fainting (syncope), tingling sensation, pins and needles (paraesthesia), sensation of spinning (vertigo), rapid heartbeat (tachycardia), irregular heart rhythm, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence, back pain, muscle spasms, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, and increased blood uric acid levels.

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

Inflammation of the airways to the lungs (bronchitis), sore throat, sinusitis, increased uric acid levels, low sodium levels, feeling of sadness (depression), difficulty sleeping (insomnia), sleep disorder, visual disturbance, blurred vision, difficulty breathing, abdominal pain, constipation, abdominal bloating (dyspepsia), nausea (vomiting), stomach inflammation (gastritis), liver function abnormalities (this adverse effect is more commonly observed in Japanese patients), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia), limb pain (leg pain), 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), flu-like illness, pain, increased levels of creatinine, liver enzymes, or creatine phosphokinase in blood.

Adverse reactions reported for either individual component may also 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, sinus inflammation, common cold), urinary tract infections, bladder infection, deficiency of red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), cough, kidney function impairment including acute renal failure, weakness.

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

Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), low blood sugar levels (in diabetic patients), drowsiness, stomach discomfort, eczema (a skin disorder), drug rash, toxic skin eruption, tendon pain (symptoms of pseudo-tendinitis), decreased haemoglobin (a blood protein).

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

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

Frequency not known (cannot be estimated from available data)

Intestinal angioedema: intestinal swelling has been reported with symptoms such as abdominal pain, nausea, vomiting, and diarrhoea following the use of similar products.

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

** Cases of progressive fibrosis of lung tissue 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)

Elevated blood lipid levels.

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

Nausea, low blood magnesium levels, 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 blood calcium levels, high blood sugar levels, headache, abdominal discomfort, yellowing of the skin or eyes (jaundice), excess bile substances in the blood (cholestasis), photosensitivity reaction, uncontrolled blood glucose levels in patients diagnosed with diabetes mellitus, sugar in urine (glucosuria).

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

Abnormal breakdown of red blood cells (haemolytic anaemia), inability of the bone marrow to function properly, reduction in white blood cells (leucopenia, agranulocytosis), severe allergic reactions (e.g., hypersensitivity), increased pH due to low chloride levels in the blood (acid-base imbalance, hypochloraemic alkalosis), acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion), pancreatitis, pseudolupus syndrome (a disorder resembling systemic lupus erythematosus, in which the body's immune system attacks the body itself), inflammation of blood vessels (necrotising vasculitis).

Frequency not known (cannot be estimated from available data)

Skin and lip cancer (non-melanoma skin cancer), deficiency of blood cells (aplastic anaemia), decreased vision 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 inflammation of blood vessels in the skin, increased sensitivity to sunlight, skin rash, redness of the skin, blistering of the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney function impairment.

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

Reporting of adverse effects

If you experience any adverse effect, talk to 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 listed in Appendix V. By reporting adverse effects, you can help provide 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 refers to the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect it from moisture. Remove your MicardisPlus tablet from the sealed blister pack immediately before taking it.

Occasionally, the outer layer of the blister packaging may separate from the inner layer between the blister cavities. If this is observed, no action is required on your part.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of MicardisPlus

• The active substances are telmisartan and hydrochlorothiazide.

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

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

Appearance of the product and contents of the pack

MicardisPlus 80 mg/25 mg tablets are two-layered, oblong tablets, yellow and white, with the company's logo and the code 'H9' engraved.

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

Only certain pack sizes may be marketed in your country.

Marketing Authorization Holder
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

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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