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Telzap® AM

The incidence of adverse reactions was determined according to the World Health Organization (WHO) classification: very common (≥1/10); often (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥ 1/10000 and < 1/1000); very rare (< 1/10000), frequency unknown (cannot be calculated based on available data).

Potential adverse reactions during treatment with Telzap® AM include all adverse reactions that were previously reported during the use of individual components of the drug.

Adverse reactions expected based on experience with telmisartan

Serious adverse reactions include anaphylactic reactions and angioedema (incidence "rare"), and acute renal failure.

In controlled clinical trials in patients with arterial hypertension, the overall incidence of adverse reactions in the telmisartan group was generally similar to that in the placebo group (41.4% and 43.9%, respectively). The incidence of adverse reactions did not depend on the dose of the drug, nor on the gender, age or race of the patients.

The safety profile of telmisartan in patients receiving the drug to reduce cardiovascular morbidity was similar to that in patients with arterial hypertension.

The adverse reactions listed below were reported in controlled clinical trials in patients with arterial hypertension or were identified in the analysis of reports received in the post-marketing period. This list also includes serious and non-serious adverse reactions that caused treatment discontinuation in three long-term clinical studies involving 21,642 patients receiving telmisartan to reduce cardiovascular morbidity over a period of up to 6 years.

Infectious and parasitic diseases:

uncommon - urinary tract infections (including cystitis), upper respiratory tract infections (including pharyngitis and sinusitis); rarely - sepsis (including death).

Blood and lymphatic system disorders:

infrequently - anemia; rarely - eosinophilia, thrombocytopenia.

Immune system disorders:

rarely - anaphylactic reactions, hypersensitivity reactions.

Metabolic and nutritional disorders:

uncommon - hyperkalemia; rarely - hypoglycemia (in patients with diabetes mellitus).

Mental disorders

: infrequently - insomnia, depression; rarely - anxiety.

Nervous system disorders: infrequently - fainting; rarely - drowsiness. Visual disorders: rarely - visual disturbances.

Hearing and labyrinth disorders:

infrequently - vertigo.

Cardiac disorders:

infrequently - bradycardia; rarely - tachycardia.

Vascular disorders:

uncommon - decreased blood pressure, orthostatic hypotension.

Disorders of the respiratory system, chest and mediastinal organs:

infrequently - shortness of breath, cough; very rarely - interstitial lung disease.

Gastrointestinal disorders:

uncommon - abdominal pain, diarrhea, dyspepsia, bloating, vomiting; rarely - dry mouth, discomfort in the stomach.

Disorders of the liver and biliary tract:

rarely - liver dysfunction/liver damage.

Disorders of the skin and subcutaneous tissues:

uncommon - skin itching, increased sweating, skin rash; rarely - angioedema (including fatal), eczema, erythema, urticaria, drug rash, toxicoderma.

Musculoskeletal and connective tissue disorders

: uncommon - back pain (eg, sciatica), muscle spasms, myalgia; rarely - arthralgia, pain in the limbs, pain in the tendons (symptoms resembling tendonitis).

Renal and urinary tract disorders:

uncommon - renal dysfunction, including acute renal failure.

General disorders and disorders at the injection site:

uncommon - chest pain, asthenic syndrome (general weakness); rarely - influenza-like syndrome.

Laboratory and instrumental data:

infrequently - increased concentration of creatinine in blood plasma; rarely - a decrease in the concentration of hemoglobin in the blood plasma, an increase in the concentration of uric acid in the blood plasma, an increase in the activity of liver enzymes, an increase in the concentration of creatine phosphokinase in the blood plasma.

Description of selected adverse reactions

Sepsis

In a clinical study, the incidence of sepsis in the telmisartan group was higher than in the placebo group. This may be regarded as an incidental finding or as a development of a phenomenon associated with a currently unknown mechanism.

Decreased blood pressure

This adverse reaction has often been reported in patients with controlled blood pressure while using telmisartan in combination with standard therapy to reduce cardiovascular morbidity.

Liver dysfunction/liver damage

The largest number of cases of liver dysfunction or liver damage was identified in the analysis of post-marketing case reports in patients of the Japanese ethnic group. Patients of this ethnic group are susceptible to the development of adverse reactions of this type.

Interstitial lung disease

During the post-marketing period, there have been reports of cases of interstitial lung disease that were temporarily associated with telmisartan. However, a cause-and-effect relationship between the use of telmisartan and the development of this disease has not been established.

Adverse reactions expected based on experience with amlodipine

The most common adverse reactions associated with the use of amlodipine include drowsiness, dizziness, headache, palpitations, a feeling of a “rush” of blood to the skin, abdominal pain, nausea, swelling of the ankles and other localizations, fatigue.

Blood and lymphatic system disorders:

very rarely - leukopenia, thrombocytopenia.

Immune system disorders

: very rarely - allergic reactions.

Metabolic and nutritional disorders

: infrequently - weight loss, weight gain; very rarely - hyperglycemia.

Mental disorders:

uncommon - insomnia, mood changes (including anxiety), depression; rarely - confusion.

Nervous system disorders

: often - drowsiness, dizziness, headache (especially at the beginning of treatment); infrequently - tremor, dysgeusia, syncope, hypoesthesia, paresthesia; very rarely - hypertonicity, peripheral neuropathy; frequency unknown - extrapyramidal disorders.

Visual disorders:

often - visual disturbances (including diplopia).

Hearing and labyrinth disorders:

infrequently - tinnitus.

Cardiac disorders:

often - a feeling of palpitations; uncommon - arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation); very rarely - myocardial infarction.

Vascular disorders:

often - a feeling of a “rush” of blood to the skin; infrequently - decreased blood pressure; very rarely - vasculitis.

Disorders of the respiratory system, chest and mediastinal organs:

often - shortness of breath; infrequently - cough, rhinitis.

Gastrointestinal disorders:

often - abdominal pain, nausea, disturbances in the rhythm of bowel movements (including diarrhea and constipation); infrequently - vomiting, dry oral mucosa; very rarely - pancreatitis, gastritis, gum hyperplasia.

Disorders of the liver and biliary tract:

very rarely - hepatitis, jaundice, increased activity of liver enzymes (in most cases in combination with cholestasis).

Disorders of the skin and subcutaneous tissues:

often - swelling of the ankles and feet; uncommon - alopecia, purpura, changes in skin pigmentation (appearance of discolored areas of the skin), increased sweating, itching, skin rash, exanthema, urticaria; very rarely - angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity; frequency unknown - toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders:

often - muscle spasms; infrequently - arthralgia, myalgia, back pain.

Renal and urinary tract disorders:

infrequently - frequent urination, dysuria, nocturia.

Disorders of the genital organs and breast:

infrequently - erectile dysfunction, gynecomastia.

General disorders and disorders at the injection site:

very often - swelling; often - increased fatigue, asthenic syndrome; Uncommon: chest pain, pain, general malaise.

Adverse reactions expected based on experience with amlodipine and telmisartan

Infectious and parasitic diseases:

rarely - cystitis.

Mental disorders:

rarely - anxiety, insomnia, depression.

Nervous system disorders:

often - dizziness, infrequently - drowsiness, migraine, headache, paresthesia; rarely - fainting, peripheral neuropathy, hypesthesia, dysgeusia, tremor.

Hearing and labyrinth disorders:

infrequently - vertigo.

Cardiac disorders:

infrequently - bradycardia, palpitations.

Vascular disorders

: uncommon - hypotension, orthostatic hypotension, hot flashes.

Disorders of the respiratory system, chest and mediastinal organs:

infrequently - cough; very rarely - interstitial lung disease.

Gastrointestinal disorders

: uncommon - abdominal pain, diarrhea, nausea; rarely - vomiting, gum hypertrophy, shortness of breath, dry mouth.

Disorders of the skin and subcutaneous tissues:

infrequently - skin itching; rarely - eczema, erythema.

Musculoskeletal and connective tissue disorders

: uncommon - arthralgia, muscle spasms (calf muscle cramps), myalgia; rarely - back pain, pain in the lower extremities (legs).

Urinary tract disorders

: rarely - nocturia.

Genital and breast disorders:

infrequently - erectile dysfunction.

General disorders and disorders at the injection site:

often - peripheral edema; uncommon - asthenia, chest pain, fatigue, swelling.

Laboratory and instrumental data:

infrequently - increased contransaminases; rarely - increased concentration of uric acid in the blood.

Additional information regarding the combination of amlodipine and telmisartan:

Peripheral edema, a dose-related side effect of amlodipine, was observed in patients receiving the combination of amlodipine and telmisartan less frequently than in patients receiving amlodipine alone.