Hypertension. Treatment of essential hypertension in adults. Prevention of cardiovascular diseases. Reducing the incidence of cardiovascular disease in patients with: manifest atherothrombotic cardiovascular disease (ischemic heart disease, stroke or peripheral artery lesions in history); type II diabetes with documented target organ damage.
active substance: telmisartan;
1 tablet contains 40 mg of telmisartan;
Excipients: povidone, meglumine, sodium hydroxide, lactose monohydrate, sorbitol (E 420), magnesium stearate.
Dosage form. Tablets.
Basic physical and chemical properties:
40 mg tablets: oval biconvex tablets from white to almost white.
This drug belongs to the group of selective angiotensin antagonists used in the treatment of arterial hypertension, which mainly have an effect on the blood vessels.
The main active ingredients are telmisartan, hydrochlorothiazide.
Telmisartan is a potent non-peptide type II angiotensin receptor antagonist.
Able to actively influence the pathogenesis of increased pressure in the arteries. Capable of blocking the ability of angiotensins to block blood vessels. Strengthens the conduction of nerve impulses, which reduces the activity of the central nervous system, improves renal blood flow.
The effect of the substance lasts for 24 hours, and its abrupt withdrawal does not cause side effects.
- Treatment of essential hypertension in adults.
- Prevention of cardiovascular diseases.
Reducing the incidence of cardiovascular disease in patients with:
- manifest atherothrombotic cardiovascular disease (ischemic heart disease, stroke or history of peripheral artery disease);
- type II diabetes mellitus with documented lesions of target organs.
- Hypersensitivity to the components of the drug;
- pregnant women or women planning to become pregnant;
- obstructive biliary disorders;
- severe liver dysfunction.
Concomitant use of telmisartan and aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 ml / min / 1.73 m2) is contraindicated.
Telmist is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Only limited information on human overdose is available.
The most significant manifestations of telmisartan overdose were hypotension and tachycardia; there have also been cases of bradycardia, dizziness, increased serum creatinine and acute renal failure.
Telmisartan is not removed by hemodialysis. In the event of an overdose, the patient should be closely monitored and symptomatic and supportive therapy instituted. The choice of treatment depends on the time elapsed after administration and the severity of symptoms. Measures such as stimulation of vomiting and / or gastric lavage should be considered. Activated charcoal may be useful in the treatment of overdose. Serum electrolytes and creatinine should be checked frequently. If hypotension occurs, the patient should be placed in a supine position and rapidly replaced with salt substitutes and fluid volume restored.
The overall incidence of adverse events in patients with hypertension in controlled clinical trials with telmisartan was usually compared with placebo (41.4% vs. 43.9%). The incidence of adverse events is not dose-dependent and does not relate to the sex, age or race of patients. Data on the safety of Telmist in the prevention of cardiovascular disease were consistent with data in the treatment of hypertension.
In each group, side effects are listed in order of decreasing severity:
- Infections and invasions: urinary tract infections, including cystitis, upper respiratory tract infections, including pharyngitis and sinusitis;
sepsis, in particular fatal.
- From the blood and lymphatic system: anemia; eosinophilia, thrombocytopenia.
- From the immune system: anaphylactic reaction, hypersensitivity.
- Metabolic disorders: hyperkalemia; hypoglycemia (in patients with diabetes).
- Mental disorders: insomnia, depression; concern.
- From the nervous system: syncope; drowsiness.
- From the eyes: visual impairment.
- From the organs of hearing, vestibular apparatus: vertigo.
- From the heart: bradycardia; tachycardia.
- From vessels: arterial hypotension2, orthostatic hypotension.
- From the respiratory system, chest and mediastinum: dyspnea, cough; interstitial lung disease4.
- From the digestive tract: abdominal pain, diarrhea, dyspepsia, flatulence, vomiting; dry mouth, stomach discomfort.
- Hepatobiliary disorders: liver dysfunction / hepatic disorders3.
- From the skin and subcutaneous tissue: itching, sweating, rash; angioneurotic edema (including fatal), eczema, erythema, urticaria, drug dermatitis, toxic dermatitis.
- From the musculoskeletal system and connective tissue: back pain (eg sciatica), muscle cramps, myalgia; arthralgia, pain in the extremities, tendon pain (symptoms similar to tendinitis).
- From the urinary system: renal dysfunction, including acute renal failure.
- General disorders: chest pain, asthenia (weakness); flu-like symptoms.
- Laboratory data: increase in blood creatinine; decrease in hemoglobin, increase in uric acid in the blood, increase in liver enzymes, increase in the level of creatine phosphokinase in the blood.
Store at a temperature not exceeding 30 oC.
Store in the original package in order to protect from light.
Keep out of reach of children.