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Instructions

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Instructions / Instruction for use: Micardis

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Dosage form: tablets

Active substance: Telmisartanum

ATX

C09CA07 Telmisartan

Pharmacological group

Angiotensin II receptor antagonists (AT1 subtype)

Nosological classification (ICD-10)

I10 Essential (primary) hypertension: hypertension; Arterial hypertension; Arterial hypertension crisis course; Essential Hypertension; Essential hypertension; Essential hypertension; Essential hypertension; Essential hypertension; Primary hypertension; Arterial hypertension, complications of diabetes; The sudden increase in blood pressure; Hypertensive disorders of blood circulation; hypertensive condition; hypertensive crises; arterial Hypertension; malignant Hypertension; Hypertonic disease; hypertensive crises; accelerated hypertension; malignant hypertension; The aggravation of hypertensive disease; Transient hypertension; Isolated systolic hypertension

I15 Secondary hypertension: Arterial hypertension, complications of diabetes; hypertension; The sudden increase in blood pressure; Hypertensive disorders of blood circulation; hypertensive condition; hypertensive crises; hypertension; arterial Hypertension; malignant Hypertension; hypertensive crises; accelerated hypertension; malignant hypertension; The aggravation of hypertensive disease; Transient hypertension; hypertension; Arterial hypertension; Arterial hypertension crisis course; renovascular hypertension; Hypertension symptomatic; Renal hypertension; Renovascular hypertension; renovascular hypertension; Symptomatic hypertension

I15.0 Renovascular Hypertension: Hypertensive Crisis; Renovascular diseases; Malignant hypertension; Isolated systolic hypertension

Composition and release form

Tablets - 1 table.

Telmisartan 40 mg

Excipients: polyvidon; Meglumine; Sodium hydroxide; sorbitol; Magnesium stearate

In the blistere 7 pcs .; In a box of cardboard 2 or 4 blisters.

Tablets - 1 table.

Telmisartan 80 mg

Excipients: polyvidon; Meglumine; Sodium hydroxide; sorbitol; Magnesium stearate

In the blistere 7 pcs .; In a box of cardboard 2 or 4 blisters.

Description of dosage form

Tablets of 40 mg: white or almost white, oblong tablet, on one side marked "51H", on the other side - the symbol of the company.

Tablets of 80 mg: white or almost white, oblong pill form, on one side marked "52H", on the other side - the symbol of the company.

Pharmachologic effect

Mode of action - hypotensive.

It blocks the receptors of angiotensin II (type └Ď1) and eliminates its vasoconstrictive effect. Reduces systemic blood pressure, the concentration of aldosterone in the plasma.

Pharmacokinetics

When ingested quickly absorbed from the digestive tract. Bioavailability - 50%. At simultaneous admission with food, the decrease in AUC ranges from 6% (at a dose of 40 mg) to 19% (at a dose of 160 mg). After 3 hours after taking the concentration in the plasma is equalized regardless of the administration of the drug on an empty stomach or with food. Cmax and AUC are 3 and 2 times higher in women than in men, without significant effect on concentration. Binding to plasma proteins - 99.5%, mainly with albumin and alpha1 glycoprotein. The average value of the apparent volume of distribution in the equilibrium stage is 500 liters. Metabolized by conjugation with glucuronic acid. Metabolites are pharmacologically inactive. T1 / 2 - more than 20 hours. The total plasma Cl high (900 ml / min) compared with the hepatic blood flow (about 1500 ml / min). Output through the intestine in an unchanged form, excretion by the kidneys - less than 2%.

Clinical Pharmacology

The maximum effect develops 3 hours after a single dose. The hypotensive effect persists for more than 24 hours, including the last 4 hours before the next dose. A stable clinical result is achieved after 4-8 weeks of course use and is maintained for a long time. With a sharp discontinuation of blood pressure gradually (within a few days) returns to the initial values without manifestation of "ricochet" hypertension.

Indications of the drug Micardis

arterial hypertension.

Contraindications

Hypersensitivity, bile duct obstruction, marked violations of the liver or kidney function, hereditary intolerance to fructose, pregnancy, breastfeeding, child and adolescence.

Application of pregnancy and breastfeeding

Contraindicated in pregnancy. For the duration of treatment, breastfeeding should be stopped.

Side effects

From the nervous system: headache, dizziness, fatigue, insomnia, anxiety, depression, convulsions.

On the part of the respiratory system: infections of the upper respiratory tract (including pharyngitis, sinusitis, bronchitis), cough.

From the cardiovascular system: a pronounced lowering of blood pressure, bradycardia, tachycardia, chest pain.

On the part of the digestive system: nausea, dyspepsia, diarrhea, abdominal pain, increased activity of "liver" transaminases.

From the musculoskeletal system: myalgia, arthralgia, back pain, symptoms like tendonitis.

On the part of the urinary system: peripheral edema, urinary tract infection, hypercreatininaemia.

Allergic reactions: skin rash, etc.

Laboratory indicators: rarely - hyperkalemia, anemia or hyperuricemia.

Other: flu-like syndrome, rarely - erythema, pruritus, syncope, dyspnoea, eosinophilia, thrombocytopenia, angioedema, urticaria.

Interaction

Thiazide diuretics (eg hydrochlorothiazide) increase the hypotensive effect of telmisartan. Telmisartan enhances the antihypertensive effect of other antihypertensive drugs, increases the concentration of digoxin in the blood.

Dosing and Administration

Inside, regardless of food intake. Adults - 40 mg once a day. In some patients, a therapeutic effect can be achieved with a dose of 20 mg / day. In the absence of a decrease in blood pressure to the desired level, the dose can be increased to 80 mg once a day. The maximum effectiveness of the antihypertensive effect of the drug is usually noted in 4-8 weeks after the start of treatment.

Patients with severe arterial hypertension - up to 160 mg / day or in combination with hydrochlorothiazide 12.5-25 mg / day.

Overdose

Symptoms: marked decrease in blood pressure.

Treatment: symptomatic therapy; Hemodialysis is ineffective.

Precautionary measures

For dehydrated patients with hyponatremia (treatment with diuretics, salt intake restriction, diarrhea, vomiting), a dose reduction is recommended.

With caution appoint patients with bilateral renal artery stenosis or stenosis of the renal artery of a single functioning kidney (increased risk of severe hypotension and renal failure), stenosis of the aorta and mitral valve, obstructive hypertrophic cardiomyopathy, renal and / or hepatic, severe heart failure (possible hyperkalemia, Therefore, it is necessary to constantly monitor the level of potassium and creatinine in the blood serum), diseases of the digestive tract.

It cannot be used for primary aldosteronism and congenital intolerance to fructose (Table 1-40 mg and 80 mg contain 169 mg and 338 mg sorbitol, respectively). When a planned pregnancy is recommended in advance to replace the drug with another antihypertensive drug. If pregnancy is established, you should immediately stop taking Mikardis. With caution apply during work drivers of vehicles and people whose profession is associated with increased concentration of attention.

With concomitant administration with lithium preparations, monitoring of the latter's serum levels is necessary, possibly a transient increase in the level (and toxicity) of lithium in plasma.

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG. KG, Germany.

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Micardis

In a place protected from moisture, at a temperature not exceeding 30 ░ C. (In the closed packing)

Keep out of the reach of children.

The shelf life of the drug Micardis

4 years.

Do not use beyond the expiration date printed on the package.

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