Telpres Plus pills 80mg+12.5mg, 28pcs

Composition

1 tab. hydrochlorothiazide 12.5 mg telmisartan 80 mgcomegative substances: mannitol – 327.7 mg, povidone K 25 – 21.6 mg crospovidone 12 mg, magnesium stearate – 8.5 mg, meglumin – 24 mg, sodium hydroxide – 6.7 mg, lactose monohydrate – 49.84 mg, microcrystalline cellulose – 32 mg, hypromellose 3 mg, carboximetilkrahmal sodium (type A) 2 mg, iron oxide yellow (E 172) – 0.17 mg.

Pharmacological action

Combined antihypertensive agent (angiotensin II receptor antagonist + diuretic) Telpres Plus is a combination of telmisartan (an angiotensin II receptor antagonist) and a hydrochlorothiazide-thiazide diuretic. The simultaneous use of these components leads to a more pronounced antihypertensive effect than the use of each of them separately. Taking Telpres Plus once a day leads to a significant gradual decrease in blood pressure (BP).

Indications

Arterial hypertension (in case of ineffectiveness of telmisartan or hydrochlorothiazide in monotherapy)

Recommendations for use

Inside, regardless of the meal time. The drug Telpres Plus should be taken 1 time a day. Telpres Plus 12.5 / 40 mg can be prescribed to patients who do not have adequate blood pressure control due to the use of telmisartan 40 mg or hydrochlorothiazide. Telpres Plus 12.5 / 80 mg can be prescribed to patients in whom the use of telmisartan at a dosage of 80 mg or Telpres Plus 12.5 / 40 mg does not lead to adequate blood pressure control. Telpres Plus 25/80 mg may be prescribed to patients whose use of telmisartan at a dosage of 80 mg or Telpres Plus 12.5 / 80 mg does not lead to adequate blood pressure control, or to patients whose condition was previously stabilized by telmisartan or hydrochlorothiazide with separate use. In patients with severe hypertension, the maximum daily dose of telmisartan is 160 mg in combination with hydrochlorothiazide in a daily dose of 12.5-25 mg.

Contraindications

Hypersensitivity to active substances or auxiliary components of the drug or other sulfonamide derivatives;Pregnancy;Breast-feeding;Obstructive biliary tract diseases;Severe liver function disorders (Child-Pugh class C);Severe renal function disorders (creatinine clearance less than 30 ml/min);Refractory hypokalemia, hypercalcemia;Concomitant use with aliskiren in patients with diabetes mellitus and/or impaired renal function (glomerular filtration rate less than 60 ml/min/1.73 m 2);Concomitant use of ACE inhibitors in patients with diabetic nephropathy;Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;Age up to 18 years (efficacy and safety have not been established).

Side effects

1) expected based on experience with telmisartan 2) expected based on experience with hydrochlorothiazide 3) Side effects that have not been observed in clinical studies with the simultaneous use of telmisartan and hydrochlorothiazide, but are expected during the use of Telpres Metatarsal Respiratory system disorders: respiratory distress syndrome (including pneumonia and non-cardiogenic pulmonary edema)3), shortness of breath 3). Cardiac disorders: arrhythmias 3), tachycardia 3), bradycardia 1). Vascular disorders: marked decrease in blood pressure (including orthostatic hypotension)3). Nervous system disorders: syncope / syncope 3), paresthesia 3), sleep disorders 3), insomnia 3), dizziness 3), increased excitability 2), headache 2). Mental disorders: anxiety 3), depression 3). Gastrointestinal disorders: diarrhea 3), dry oral mucosa 3), flatulence 3), abdominal pain 3), constipation 3), vomiting 3), gastritis 3), decreased appetite 2), anorexia 2), hyperglycemia 2), hypercholesterolemia 2), pancreatitis 2), dyspepsia 1),2),3). Liver and biliary tract disorders: impaired liver function 3), jaundice (hepatocellular or cholestatic)2)Skin and subcutaneous tissue disorders: eczema 1), drug rash 1),2), toxic epidermal necrosis 1),2), erythema 3), pruritus 3), rash 3), increased sweating 3), photosensitization reaction 2). Musculoskeletal and connective tissue disorders: back pain 3), muscle spasms 3), myalgia 3), arthralgia 3), calf muscle cramps 3), osteoarthritis 1), tendinitis-like symptoms 1), chest pain 3). Blood and lymphatic system disorders: iron deficiency anemia 1), aplastic anemia 2), hemolytic anemia 2), thrombocytopenia 1), eosinophilia 1), leukopenia 2), neutropenia/agranulocytosis 2), thrombocytopenia 2). Renal and urinary tract disorders: renal failure 1).2), including acute renal failure 1), interstitial nephritis 2), glucosuria 2). Visual disorders: visual impairment 3), transient blurred vision 3), xanthopsia 2), acute angle-closure glaucoma 2), acute myopia 2). Disorders of the genitals and breast: impotence 3). Infectious and parasitic diseases: sepsis, including fatal cases 1), upper respiratory tract infections (bronchitis, pharyngitis, sinusitis)1),3), urinary tract infections (including cystitis )1), inflammation of the salivary glands 2). Effects on the results of laboratory and instrumental studies: increased plasma creatinine concentration 3), increased activity of “liver” enzymes 3), increased creatine phosphokinase activity 3), increased blood uric acid concentration 3), hypertriglyceridemia 2), hypokalemia 2),3), hypomagnesemia 2), hyperkalemia 1), hyponatremia 2),3), hyperuricemia 3), BCC decrease 2), hypoglycemia (in patients with diabetes mellitus)1), impaired glucose tolerance 2), decreased hemoglobin in the blood 1). Immune system disorders: angioedema (including fatal cases)3), anaphylactic reactions 1),2), lupus-like reactions 2), exacerbation or worsening of symptoms of systemic lupus erythematosus 3), necrotic vasculitis 2), systemic vasculitis 2), relapse of systemic lupus erythematosus 2), vasculitis 2). General disorders and disorders at the injection site: flu-like syndrome 3), fever 2), weakness 1),2).

How to take, course of use and dosage

Inside, regardless of the meal time.

The drug Telpres Plus should be taken 1 time a day.

• Telpres Plus 12.5 / 40 mg can be prescribed to patients who do not have adequate blood pressure control due to the use of telmisartan 40 mg or hydrochlorothiazide.
• Telpres Plus 12.5 / 80 mg can be prescribed to patients in whom the use of telmisartan at a dosage of 80 mg or Telpres Plus 12.5 / 40 mg does not lead to adequate blood pressure control.
• Telpres Plus 25/80 mg may be prescribed to patients whose use of telmisartan at a dosage of 80 mg or Telpres Plus 12.5 / 80 mg does not lead to adequate blood pressure control, or to patients whose condition was previously stabilized by telmisartan or hydrochlorothiazide with separate use.

In patients with severe hypertension, the maximum daily dose of telmisartan is 160 mg in combination with hydrochlorothiazide in a daily dose of 12.5-25 mg.

Impaired renal function

Limited experience with the use of Telpres Plus in patients with mild or moderate renal impairment does not require changing the dose of the drug in these cases. In such patients, renal function should be monitored (if creatinine clearance is less than 30 ml / min, see section “Contraindications”).

Liver function disorders

In patients with mild to moderate hepatic impairment (Child-Pugh class A and B), the daily dose of Telpres Plus should not exceed 12.5 / 40 mg per day (see section “Pharmacokinetics”).

Elderly patients

The dosage regimen does not require any changes.

Overdose

Information regarding overdose is limited. Possible symptoms of overdose consist of symptoms from the individual components of the drug. Telmisartan – the most significant – a pronounced decrease in blood pressure and tachycardia, bradycardia, dizziness, increased serum creatinine concentration and acute renal failure may also occur. Hydrochlorothiazide – disorders of the water-electrolyte balance of the blood (hypokalemia, hypochloremia), a decrease in BCC, which can lead to muscle spasms and / or increase disorders of the cardiovascular system: arrhythmias caused by the simultaneous use of cardiac glycosides or certain antiarrhythmic agents. Treatment: symptomatic therapy, hemodialysis is ineffective. The degree of removal of hydrochlorothiazide during hemodialysis has not been established. It is necessary to regularly monitor the content of electrolytes and creatinine in the blood serum. Hemodialysis is not effective.

Special instructions

Hepatic impairment The use of Telpres Plus is contraindicated in patients with cholestasis, biliary tract obstruction, or severe hepatic impairment (Child-Pugh Class C) (see section “Contraindications”), since telmisartan is mainly excreted in the bile. It is assumed that the hepatic clearance of telmisartan is reduced in such patients. In patients with mild or moderate hepatic impairment (Child-Pugh Class A and B), Telpres Plus should be used with caution (see section “With caution”). Renovascular hypertension: When treated with drugs acting on the RAAS, patients with bilateral arterial stenosis or stenosis of the artery of a single functioning kidney have an increased risk of severe hypotension and renal failure.Impaired renal function and kidney transplantationwith the use of Telpres Plus in patients with impaired renal function, periodic monitoring of the content of potassium and creatinine in blood plasma is recommended. There is no experience of clinical use of Telpres Plus in patients who have recently undergone kidney transplantation. The use of thiazide diuretics in patients with impaired renal function may lead to azotemia. Periodic monitoring of renal function is recommended. Decreased blood circulationsymptomatic hypotension, especially after the first use of Telpres Plus, may occur in patients with reduced BCC and / or plasma sodium levels during previous diuretic treatment, restriction of salt intake, diarrhea or vomiting. Such conditions (fluid and/or sodium deficiency) should be corrected before taking Telpres Plus. Dual blockade of the renin-angiotensin-aldosterone systemthe non-concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal insufficiency (glomerular filtration rate less than 60 ml / min/1.73 m2) (see section “Contraindications”). Concomitant use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy (see section “Contraindications”). As a result of RAAS suppression, hypotension, syncope, hyperkalemia, and impaired renal function (including acute renal failure) were noted in predisposed patients, especially with the combined use of several medications that also affect this system. Therefore, double blockade of RAAS (for example, while taking telmisartan with other RAAS antagonists) is not recommended. In cases where vascular tone and renal function depend primarily on the activity of the RAAS (for example, in patients with chronic heart failure or kidney disease, including renal artery stenosis, or stenosis of the artery of a single kidney), the appointment of drugs that affect this system may be accompanied by the development of acute arterial hypotension, hyperazotemia, oliguria, and in rare cases acute renal failure. Primary aldosteronism in patients with primary aldosteronism, treatment with antihypertensive drugs, the effect of which is carried out by inhibiting the RAAS, is usually ineffective. Aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathies Caution should be exercised when using Telpres Plus (as well as other vasodilators) in patients with aortic or mitral stenosis, as well as hypertrophic obstructive cardiomyopathy. Acute myopia and secondary angle-closure glaucomahydrochlorothiazide, being a sulfonamide derivative, can cause an idiosyncratic reaction in the form of acute transient myopia and acute angle-closure glaucoma. Symptoms of these disorders include an unexpected decrease in visual acuity or pain in the eyes, which typically occur within a few hours to several weeks after starting the drug. If left untreated, acute angle-closure glaucoma can lead to vision loss. The main treatment is to eliminate hydrochlorothiazide as quickly as possible. It should be borne in mind that if intraocular pressure remains uncontrolled, urgent conservative or surgical treatment may be required. Risk factors for acute angle-closure glaucoma include a history of allergy to sulfonamides or penicillin. Effects on metabolism and endocrine function patients with diabetes mellitus may need to change the dose of insulin or hypoglycemic agents for oral use. Latent diabetes mellitus may occur during therapy with thiazide diuretics. In some cases, the use of thiazide diuretics may lead to hyperuricemia and exacerbation of the course of gout. Violations of the water-electrolyte balance When using the drug Telpres Plus, as in the case of diuretic therapy, periodic monitoring of the content of electrolytes in the blood serum is necessary. Thiazide diuretics, including hydrochlorothiazide, can cause disturbances in the water-electrolyte balance and acid-base state (hypokalemia, hyponatremia, and hypochloremic alkalosis). Warning signs for these disorders are dryness of the oral mucosa, thirst, general weakness, drowsiness, anxiety, myalgia or convulsive twitching of the calf muscles (crampi), muscle weakness, marked decrease in blood pressure, oliguria, tachycardia, and gastrointestinal disorders such as nausea or vomiting. Hypokalaemia may occur with thiazide diuretics, but concomitant use of telmisartan may increase blood potassium levels. The risk of hypokalemia is most increased in patients with cirrhosis of the liver, with increased diuresis, with a salt-free diet, as well as in the case of simultaneous use of glucocorticosteroids, calcitonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (found in licorice root), Telmisartan, which is part of the drug Telpres Plus, on the contrary, can lead to hyperkalemia due to antagonism to angiotensin II receptors (subtype AT 1 ). Although no clinically significant hyperkalemia has been reported with Telpres Plus, it should be taken into account that the risk factors for its development include renal and/or heart failure and diabetes mellitus. There is no evidence that Telpres Plus can reduce or prevent hyponatremia caused by diuretics. Hypochloremia is usually minor and does not require treatment. Thiazide diuretics can reduce the excretion of calcium by the kidneys and cause (in the absence of obvious violations of calcium metabolism) a transient and slight increase in the content of calcium in the blood serum. More severe hypercalcemia may be a sign of latent hyperparathyroidism. Thiazide diuretics should be discontinued before evaluating parathyroid function. Thiazide diuretics have been shown to increase the excretion of magnesium by the kidneys, which can lead to hypomagnesemia. In patients with ischemic heart disease, the use of any antihypertensive agent, in case of excessive lowering of blood pressure, can lead to myocardial infarction or stroke. Increased monitoring of patients with impaired uric acid metabolism is required; thiazides can reduce the amount of iodine binding to serum proteins, without showing signs of thyroid dysfunction; there is information about cases of photosensitivity reactions when taking thiazide diuretics. If a photosensitivity reaction occurs during treatment, it is recommended to suspend treatment. If a decision is made to resume taking a diuretic, it is necessary to protect areas of the body that may be exposed to sunlight or ultraviolet rays of type A and avoid exposure to the sun; hydrochlorothiazide can increase the concentration of cholesterol and triglycerides in the blood; hydrochlorothiazide can give a positive result during doping control. Systemic lupus erythematosus has been reported with thiazide diuretics. Ethnic differencein ACE inhibitors, telmisartan, and other ARA II drugs appear to be less effective in lowering blood pressure in black patients than in other races, possibly due to a greater predisposition to a decrease in renin activity in the population of these patients, but as with other antihypertensive agents, excessive lowering of blood pressure in patients suffering from ischemic cardiomyopathy or coronary heart disease may lead to the development of myocardial infarction or stroke. Effects on the ability to drive vehicles or mechanismspecial clinical studies to assess the effect of Telpres Plus on the ability to drive vehicles and work with mechanisms that require increased attention have not been conducted. However, when driving vehicles and engaging in potentially dangerous activities, the possibility of dizziness and drowsiness should be taken into account, which requires caution.

Storage conditions

At a temperature not exceeding 25°C, in the original packaging. Keep out of reach of children!

Shelf

life is 2 years.

Active ingredient

Hydrochlorothiazide, Telmisartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension