Expiration date: 03/2025

Active substance: Telmisartan

The drug forms

Tablets 40 mg: white or almost white, oblong shaped tablets, one side applied marking «51H», on the other side - the symbol of the company.

Tablets 80 mg: white or almost white, oblong shaped tablets, one side applied marking «52H», on the other side - the symbol of the company.

Pharmachologic effect

Mode of action - hypotensive.

Blocks the receptors of angiotensin II (type AT1) and eliminates its vasoconstrictor effect. It reduces systemic blood pressure, plasma aldosterone concentration.

Pharmacokinetics

If ingestion is rapidly absorbed from the gastrointestinal tract. Bioavailability - 50%. When concomitantly with food AUC reduction ranges from 6% (at 40 mg) to 19% (at a dose of 160 mg). After 3 h after administration plasma concentration aligned independently of the drug on an empty stomach or with food. AUC and Cmax in the 2 and 3 times, respectively, higher in women than men, without significant effect on the concentration. Binding to plasma proteins - 99.5%, mainly to albumin and alpha-1 glycoprotein. The mean value of the apparent volume of distribution in the equilibrium stage - 500 l. It is metabolized by conjugation with glucuronic acid. The metabolites are pharmacologically inactive. T1 / 2 -. More than 20 hours total plasma high Cl (900 ml / min) compared with hepatic blood flow (about 1500 ml / min). Displayed through the intestine unchanged to the kidneys excretion - less than 2%.

Clinical pharmacology

The maximum effect develops within 3 hours after a single dose. The antihypertensive effect persists over 24 hours, including the last 4 hours before taking the next dose. Stable clinical outcome is achieved through a course of 4-8 weeks, and long-term maintenance. In a dramatic admission BP gradually (over several days) is returned to the original values ??without causing "rebound" hypertension.

Testimony: Arterial hypertension.

Contraindications

Hypersensitivity, disorders of the biliary tract patency, expressed human liver or kidney disease, hereditary fructose intolerance, pregnancy, breastfeeding, childhood and adolescence.

Pregnancy and breast-feeding

Contraindicated during pregnancy. At the time of treatment should stop breastfeeding.

Side effects

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

The respiratory system: upper respiratory tract infection (including pharyngitis, sinusitis, bronchitis), cough.

Cardio-vascular system: marked reduction of blood pressure, bradycardia, tachycardia, chest pain.

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

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

From the urinary system: peripheral edema, urinary tract infection, hypercreatininemia.

Allergic reactions: skin rash, and others.

Laboratory findings: rarely - hyperkalemia, hyperuricemia, or anemia.

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

Interaction

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

Dosing and Administration

Inside, regardless of meals. Adults - 40 mg 1 time per day. In some patients, the therapeutic effect can be achieved using doses of 20 mg / day. In the absence of reducing blood pressure to the desired level of dose may be increased to 80 mg 1 time a day. Maximum efficiency of the hypotensive effect of the drug is usually observed after 4 -8 weeks after starting treatment.

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

Overdose

Symptoms: marked reduction of blood pressure.

Treatment: symptomatic therapy; Hemodialysis is ineffective.

Precautionary measures

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

Be wary appoint patients with bilateral renal artery stenosis or stenosis of the renal artery only functioning kidney (increased risk of severe hypotension and renal insufficiency), aortic stenosis and mitral valve, obstructive hypertrophic cardiomyopathy, renal and / or hepatic impairment, severe heart failure (possible hyperkalemia, so you need to constantly monitor the level of potassium and creatinine in serum), diseases of the digestive tract.

Do not use in primary aldosteronism and congenital fructose intolerance (see Table 1 -. 40 mg and 80 mg contain 169 mg of sorbitol and 338 mg, respectively). When planned pregnancy is recommended in advance to replace the drug other antihypertensive agents. If pregnancy is established, you should immediately stop taking Micardis. Be wary of during the drivers of vehicles and people skills relate to the high concentration of attention.

When concomitant administration with drugs lithium requires monitoring of the content of the latter in blood serum - possibly transitory increase in (and toxicity) of lithium in plasma.

Manufacturer

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

Storage conditions

In a dry place at a temperature no higher than 30 ° C. (In closed containers)

Keep out of the reach of children.

The shelf life: 4 years.

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