Micardis 80 Mg 28 Tablets

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Excipients

Povidone, meglumine, sodium hydroxide, sorbitol, magnesium stearate.

2. What is MICARDIS and what is it used for?

• MICARDIS is produced in tablet form. Tablets are white colored, notched and long, with a company logo on one side and 52 H on the other.

• MICARDIS is available in blister packages containing 28 tablets.

• Telmisartan, the active ingredient of MICARDIS, belongs to a group of drugs called angiotensin-II receptor antagonists.

Angiotensin II is a substance present in the body; By narrowing your blood vessels, it makes it difficult for the blood to pass through these veins and it increases your blood pressure. MICARDIS (telmisartan) relaxes your blood vessels by blocking this effect of angiotensin II and thus decreases your blood pressure.

• MICARDIS is used for the treatment of high blood pressure. This condition is also known as essential hypertension.

Your doctor has measured your blood pressure and has found that you are higher than the normal range for your age. High blood pressure can lead to damage to blood vessels in various organs such as the heart, kidneys, brain, and eyes when untreated. Thus, in some cases heart attacks can result in heart or kidney failure, stroke or blindness. High blood pressure usually does not give a symptom before such damage occurs. Therefore, blood pressure measurements are required to verify whether they are within normal limits.

High blood pressure can be treated and controlled by drugs such as MICARDIS. Your doctor may also advise you to make some arrangements in your lifestyle to help lower your blood pressure; such as weight loss, avoiding smoking, reducing alcohol consumption and reducing the amount of salt in your food. Itas walking and swimming

may also encourage you to do mild (non-compelling) exercises, such.

3. How to use MICARDIS

Adults:

Proper use and instructions for dose / frequency of administration

Always take MICARDIS exactly as your doctor says. If you're not sure, you should ask your doctor or pharmacist. To keep your blood pressure under control, you should continue taking MICARDIS every day as long as your doctor prescribes it.

Since the effect of MICARDIS continues for 24 hours, it is applied once a day.

In order to control blood pressure for 24 hours, the usual dose in most patients is 40 mg once a day. However, your doctor may sometimes recommend taking 20 mg once a day or 80 mg once a day. In cases where the targeted blood pressure cannot be obtained, the dose of telmisartan can be increased to a maximum of 80 mg daily.

If you have liver problems, do not use more than 40 mg per day.

Telmisartan may alternatively be used in combination with thiazide-type diuretics (diuretics), such as hydrochlorothiazide, which is shown to exert an additional reducing effect in blood pressure when used with telmisartan.

The highest blood pressure lowering effect is usually obtained four to eight weeks after the start of treatment.

Method and method of

administration Tablets should be swallowed with some liquid. Take care to take your medicine every day at the same time of day.

Different age groups

Use in children Use in

elderly People in the

elderly

MICARDIS can be used in elderly people without dose adjustment.

Specific Use Conditions

Kidney Failure: Dose adjustment is not required in patients with renal insufficiency. No dose adjustment is necessary in patients with severe kidneys who are connected to the dialysis device to remove blood.

Liver failure: In patients with mild or moderate hepatic impairment, the daily dose should not exceed 40 mg.

If you have an impression that the effect of MICARDIS is too strong or too weak, talk to your doctor or pharmacist.

If you use more MICARDIS

than you should use, talk to a doctor or pharmacist if you have used more than you should use from MICARDIS.

It is important to follow the dose prescribed by your doctor. If you accidentally take more tablets, ask your doctor without delay or contact the nearest hospital's

immediately emergency department.

forgot to use MICARDIS, ifsoon as

If youyou forget to take your medicine, take it as you remember it. If you do not take your tablet the same day, please take your normal dose the next day. Do not take two doses on the same day.

Do not take double doses to compensate for forgotten doses.

When will the MICARDIS treatment be stopped?

Hypertension is a chronic disease.your doctor offers another treatment

You should continue to use MICARDIS every day until.

The effects that may occur when you stop treatment with MICARDIS When you stop

using MICARDIS, your blood pressure will gradually step back to the pretreatment levels within a few days without sudden increases.

If you have any further questions regarding the use of this medicine, ask your doctor.

4. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to substances found in the content of MICARDIS.

Stop using MICARDIS if any of the following and tell your doctor immediately or contact the emergency department of the hospital nearest you:

- severe allergic, anaphylactic reactions, which may be accompanied by swelling of the face, mouth and throat (angioedema), hives and shortness of breath which may accompany them;

These are all very serious side effects.

If you have one of these, you have a serious allergy to MICARDIS. You may need urgent medical attention or hospitalization. All of these very serious side effects are very rare.

If you notice any of the following, tell your doctor immediately or contact the emergency department of the hospital nearest you:

- Night urination, weakness, shortness of breath, palpitations, decrease in urine, swelling around the hands, feet and eyes (may be signs of acute renal failure);

- Faints;

- High levels of potassium in blood;

- Skin rash and toxic skin rash.

All these are serious side effects. Emergency medical intervention may be required. Serious side effects are very rare.

If you notice any of the following, tell your doctor: With

MICARDIS, you may also experience the following undesirable effects:

"Uncommon" undesirable effects (less than 1 in 100 people, more than 1 in 1,000 people):

- Insomnia,

- Inner ear and dizziness caused by the central nervous system,

- Low blood pressure,

- Shortness of breath,

- Abdominal pain, diarrhea, indigestion, gas in the stomach and intestines,

- Over sweats, itching, skin rash,

- Muscle spasms (cramps in the legs), muscle pain,

- Renal impairment,

- Chest pain, weakness

Undesirable effects in the frequency of "rare" (less than 1 in 1,000 people, more than 1 in 10,000 people):

- Upper respiratory tract infections,

- Anemia, decrease in blood platelets,

- Hypersensitivity,

- Fear and state of anxiety, collapsed mood,

- Visual impairment,

- Acceleration in pulse,

- Blood pressure when standing up or sitting up. drop,

- Dry mouth, feeling uneasiness in the stomach, vomiting,

- Liver dysfunction, liver disorder,

- Flushing in the skin,

- Pain in the back, back pain, pain in the legs,

- Disease similar to influenza,

- Uric acid in the blood, creatinine, liver enzymes and creatine phosphokinase increases.

"Unknown" level of frequency adverse events in (can not be estimated frequency data of the movement):

- Bladder infections, including urinary tract infections,

- allergic reactions,

- Kanda "eosinophilia" increase white cell type called,

- deceleration pulse,

- eczema,

- Tendon pain ( symptoms similar to tendon inflammation / tendons are special structures that allow the muscles to join with the bone),

- Reduction in hemoglobin (oxygen carrying molecule in the blood).

These are the mild side effects of MICARDIS.

2. Things to consider before using MICARDIS Do not use

MICARDIS in the following cases

;

- If you are allergic to any of the excipients in Telmisartan or MICARDIS;

- If you are pregnant;

- If you are breastfeeding your baby;

- If there is congestion in your biliary tract (a problem that prevents the bile from flowing out of the gallbladder);

- If you have severe liver disease.

It should not be used in the presence of rare hereditary tables which may not match one of the excipients in the drug.

USE MICARDIS CAREFULLY

;

- If you have kidney disease or if you have kidney transplantation;

- If your kidney artery has stenosis;

- If you are diabetic (diabetic);

- If you are receiving intensive treatment with diuretic drugs;

- If you are following a low salt diet;

- If you are vomiting or diarrhea in excessive amounts;

- If there are problems in your heart;

- If the amount of aldosterone in your blood is high (a hormone);

- If your blood potassium levels are high;

- If you are using potassium-containing drugs or potassium-containing products instead of salt;

- If you have liver disease;

- If you are taking non-steroidal anti-inflammatory drugs (medications with pain relieving and anti-inflammatory effects such as aspirin);

- if you have a hereditary fructose intolerance (a very rare, hereditary disease in which the body is intolerant of certain types of sugars);

- If you are taking another blood pressure medication known as the ACE inhibitor with MICARDIS.

MICARDIS is less effective in lowering blood pressure in the black race than in a non-black race, as is observed with other high blood pressure drugs from similar groups.

Please These warnings are valid for you, even at any time in the past

consult your doctor if.

Using MICARDIS with food and drink

MICARDIS can be taken with an open stomach or food.

pregnancy

Consult your doctor or pharmacist before using medication.

MICARDIS should not be used during pregnancy. If you plan pregnancy or get pregnant while you are using MICARDIS, contact your doctor.

Before a planned pregnancy, another suitable alternative treatment should be initiated.

If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

breastfeeding

Ask your doctor or pharmacist before using themedication. MICARDIS should not be used during breastfeeding.

Driving and using the machine

MICARDIS will not affect your ability to drive and drive machines. However, some people may experience dizziness and fatigue from time to time during high blood pressure therapy. Do Vehicles or machines dizziness and fatigue occur

not use if.

Important information about some of the ingredients in

MICARDIS contains MICARDIS sorbitol. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

In combination with other medications,

MICARDIS may increase the blood pressure lowering effects of other high blood pressure medications. Other clinically relevant interactions have not been reported.

There was no clinically significant interaction when MICARDIS was administered with the following drugs; warfarin (blood thinner), hydrochlorothiazide (diuretic), glibenclamide (blood sugar lowering), ibuprofen, paracetamol (pain killers), simvastatin (cholesterol-lowering) and amlodipine (heart drug).

In combination with MICARDIS, lithium-containing drugs, potassium promoters, potassium-containing compounds used as a substitute for potassium, potassium-sparing drugs (some diuretics), non-steroidal anti inflammatory group drugs (medications with relieving pain and anti-inflammatory drugs such as aspirin) If you are taking ACE inhibitors (for high blood pressure), heparin (blood thinner), cyclosporine (an immunosuppressive drug), tacrolimus (used after organ transplantation) or trimethoprim (for infectious diseases), take some special precautions (eg blood tests). may be appropriate.

In combination with MICARDIS, non-steroidal anti-inflammatory drugs (medications with anti-inflammatory and anti-inflammatory drugs such as aspirin) or corticosteroid drugs (cortisone) may reduce the blood-lowering effect of MICARDIS.

When using non-steroidal anti-inflammatory drugs in combination with MICARDIS, your body's fluid status and kidney function should be checked. If your body is dehydrated (dehydrated), there is a potential for renal failure.

5. Storage of Keep

MICARDIS out of the reach of children and in its packaging. 25 o Store at room temperature below, protected from moisture.

Use in accordance with expiration dates.

Do not use MICARDIS after the expiration date in the packaging.

Do not use MICARDIS if you notice defects in the product and / or its packaging.