20 mg telmisartan tablets
What Micardis is and what it is used for
Micardis belongs to a group of medicines called angiotensin -II inhibitors. Angiotensin II is a body-specific substance that causes the blood vessels to constrict, leading to a rise in blood pressure. Micardis inhibits this effect of angiotensin II, which causes the blood vessels to dilate and the blood pressure to drop.
Micardis is used to treat high blood pressure, so-called essential hypertension in adults. Essential means that high blood pressure is not caused by any other disease. Untreated high blood pressure can cause damage to the blood vessels in several organs. This can lead to heart attacks, heart or kidney failure, stroke, or blindness. Usually, high blood pressure does not cause any symptoms before the injuries occur. It is therefore important to regularly measure blood pressure to check if it is within normal values.
Micardis is also used to reduce the number of cardiovascular events (such as heart attack or stroke / cerebral hemorrhage) in adults who are at risk due to reduced or blocked blood supply to the heart or bones, or who have had a stroke or have high-risk diabetes. Your doctor can tell you if you are at high risk for such events.
What you need to know before using Micardis
Do not use Micardis
- if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
- Pregnant women should not use Micardis during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Micardis, see Pregnancy and breast-feeding).if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile outflow from the liver and gallbladder) or any other severe liver disease.
- if you have diabetes or renal impairment and you are being treated with a blood pressure lowering medicine containing aliskiren.
If any of the above apply to you, tell your doctor or pharmacist before using Micardis.
Warnings and cautions
Talk to your doctor before taking Micardis if you have or have had any of the following diseases or conditions:
- Kidney disease or kidney transplantation.
- Renal artery stenosis (contraction of the blood vessels in one or both kidneys).
- Liver disease.
- Heart problems.
- Elevated aldosterone levels (accumulation of water or salt in the body and altered mineral balance in the blood).
- Low blood pressure ( hypotension ), which can occur if you are dehydrated (have lost a lot of body fluid) or have a lack of salt due to diuretic treatment (diuretic treatment), diet with low salt intake, diarrhea or vomiting.
- High potassium in the blood.
- Diabetes .
Talk to your doctor before taking Micardis:
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (eg enalapril , lisinopril, ramipril), especially if you have diabetes-related kidney problems.
- aliskiren.
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals. See also information under the heading “Do not use Micardis”.
- if you are taking digoxin .
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Micardis is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, see Pregnancy and breastfeeding.
During surgery or anesthesia, tell your doctor that you are using Micardis.
Micardis may be less effective in treating low blood pressure in colored patients.
Children and young people
Micardis is not recommended for the treatment of children or adolescents up to 18 years of age.
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 one of the other medicines or take other precautions. In some cases, you may need to stop treatment with a medicine. This is especially true if the medicines below are taken at the same time as Micardis.
- Drugs containing lithium for the treatment of certain types of depression.
- Drugs that increase the level of potassium in the blood, such as potassium -containing salt substitutes, potassium-sparing diuretics (certain diuretics), ACE inhibitors , angiotensin II inhibitors, non-steroidal anti-inflammatory drugs ( NSAIDs , eg acetylsalicylic acid , ibuproic acid , ibupro ) , immunosuppressive drugs (eg cyclosporine or tacrolimus) and trimethoprim ( antibiotics ).
- Diuretics (diuretic tablets) can, especially if taken in high doses with Micardis, lead to excessive fluid loss and low blood pressure ( hypotension ).
- If you are taking an ACE inhibitor or aliskiren (see also information under the headings “Do not use Micardis” and “Warnings and precautions”).
- Digoxin .
The effect of Micardis may be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid or ibuprofen ) or corticosteroids.
Micardis can increase the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that can lower blood pressure (eg baclofen, amifostine).
In addition, low blood pressure can be aggravated by alcohol, barbiturates, drugs, and antidepressants. You may feel dizzy when you get up. You should consult your doctor if you need to adjust the dose of one of your other medicines while taking Micardis.
Pregnancy and breastfeeding
Pregnancy
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Usually, your doctor will suggest that you stop taking Micardis before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Micardis should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects.
Breast-feeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Micardis is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breastfeed your baby, especially if your baby is newborn or premature.
Ability to drive vehicles and use machinery
Some people feel dizzy and tired when taking Micardis. If you feel dizzy or tired, do not drive or operate machinery.
Micardis contains sorbitol and sodium
Micardis contains sorbitol
This medicine contains 84.32 mg sorbitol per tablet.
Micardis contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Micardis
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one tablet a day. Try to take the tablet at the same time each day.
You can take Micardis with or without food. You should swallow the tablets with a glass of water or some other non-alcoholic beverage. It is important to 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 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 for 24 hours. Your doctor has recommended a lower dose, a 20 mg tablet. Alternatively, Micardis can be used with a diuretic (diuretic) such as hydrochlorothiazide, which has been shown to have an additional antihypertensive effect together with Micardis.
To reduce the number of cardiovascular events, the usual dose is one Micardis 80 mg tablet once a day. At the beginning of the preventive treatment with Micardis 80 mg, blood pressure should be checked frequently.
If you have impaired liver function, the normal dose should not exceed 40 mg once daily.
If you use more Micardis than you should
If you take more doses than you should, contact your doctor, pharmacist, or nearest emergency department immediately.
If you forget to take Micardis
If you forget to take your medicine, do not worry. Take a dose as soon as you remember and continue as before. If you miss the medicine one day, take the usual dose the next day. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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.
Contact a doctor immediately if you experience any of the following symptoms:
Sepsis * (often called “blood poisoning” is a severe infection with inflammatory reactions throughout the body), 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 a doctor immediately. The conditions can be fatal if left untreated.
Possible side effects of Micardis:
Common side effects ( may affect up to 1 in 10 people):
Low blood pressure ( hypotension ) in users treated to reduce the number of cardiovascular events.
Uncommon side effects ( may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infection (eg sore throat, inflamed sinuses, common cold), lack of red blood cells ( anemia ), high potassium levels, difficulty falling asleep, depression, syncope, a feeling of dizziness ( vertigo ), slow heart rhythm ( bradycardia ), low blood pressure ( hypotension ) in users treated for high blood pressure, dizziness when getting up ( orthostatic hypotension ), shortness of breath, cough, abdominal pain, diarrhea, stomach discomfort, swelling, vomiting, itching, sweating, skin rash due to medication, back pain, muscle cramps, muscle pain ( myalgia ), impaired kidney function including acute kidney failure, chest pain, weakness and increased creatinine levels in the blood.
Rare side effects ( may affect up to 1 in 1,000 people):
Sepsis * (often called “blood poisoning”, is a severe infection with inflammatory reactions throughout the body, which can lead to death), increased number of certain white blood cells (eosinophilia), low platelet count ( thrombocytopenia ), severe allergic reactions ( anaphylactic reaction ), allergic reactions (eg rash, itching , difficulty breathing, wheezing, swelling of the face or low blood pressure ), low blood sugar (in patients with diabetes ), anxiety, somnolence , visual disturbances, rapid heart rhythm ( tachycardia ), dry mouth, upset stomach, altered taste sensation ( dysgeusia ), abnormal liver function (Japanese patients are at greater risk of getting this side effect), rapid swelling of skin and mucous membranes that can lead to death ( angioedema even with fatal outcome), eczema (a skin disease), skin redness , hives , severe skin rash due to medication, joint pain ( arthralgia ), pain in the extremities , pain in tendons, flu-like illness, decreased levels of hemoglobin (a blood protein), increased levels of uric acid , increased levels of liver enzymes or creatine phosphokinase in the blood.
Very rare side effects (may affect up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease) **
* These side effects may be incidental or may be related to a mechanism that is not currently known.
** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known if telmisartan is the cause.
How to store 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 expiration date is the last day of the specified month.
No special temperature instructions. Store in the original package. Moisture sensitive. Take the Micardist tablet out of the blister pack just before you take 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 to protect the environment.
Contents of the package and other information
Content declaration
The active substance is telmisartan. Each tablet contains 20 mg of telmisartan.
The other ingredients are povidone (K25), meglumine, sodium hydroxide, sorbitol (E420), and magnesium stearate.
What the medicine looks like and contents of the pack
Micardis 20 mg tablets are white, round, and embossed with the code “50H” on one side and the company logo on the other side.
Micardis is available in blister packs of 14, 28, 56, or 98 tablets.
Not all pack sizes may be marketed in your country.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Boehringer Ingelheim International GmbH
Binger Page 173
55216 Ingelheim am Rhein
Germany
Manufacturer:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Page 173
55216 Ingelheim am Rhein
Germany
Delpharm Reims SAS
10 Rue Colonel Charbonneaux
51100 Reims
France
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