MykardisPlus® (MicardisPlus®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHydrochlorothiazide + TelmisartanHydrochlorothiazide + Telmisartan
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    • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active ingredients:

    Hydrochlorothiazide 12.5 mg

    telmisartan 40 mg

    Excipients: sodium hydroxide 3.36 mg, rape 12.00 mg, meglumine 12.00 mg, sorbitol 168.64 mg, magnesium stearate 5.00 mg. lactose monohydrate 112.17 mg. cellulose microcrystalline 64.00 mg. dye iron oxide red (AND 172) 0.33 mg. sodium carboxymethyl starch 4.00 mg. corn starch 6.00 mg.

    active ingredients:

    hydrochlorothiazide 12.5 mg

    telmisartan 80 mg

    Excipients: sodium hydroxide 6.72 mg. Povidop 24.00 mg. meglumine 24.00 mg. sorbitol 337.28 mg. magnesium stearate 9.00 mg. lactose monohydrate 112.17 mg. cellulose microcrystalline 64.00 mg. ferric iron oxide red (E 172) 0.33 mg. sodium carboxymethyl starch 4.00 mg. corn starch 6.00 mg.

    Description:Oval-shaped, biconvex, two-layer tablets,one layer of pinkish-beige color with possible fine impregnations of white color, another layer of white with possible inclusions of pinkish-beige color. On the white surface of the tablets there is engraving "114" (for tablets 40 mg) or "118" (for tablets 80 mg) and the company logo.
    Pharmacotherapeutic group:antihypertensive drug combined (apogotenzin II receptor antagonist + diuretic).
    ATX: & nbsp

    C.09.D.A.07   Telmisartan in combination with diuretics

    Pharmacodynamics:

    MICARDI DP is a combination of telmisartan (angiotensin II receptor antagonist) and hydrochlorothiazide - a thiazide diuretic. The simultaneous use of these components leads to a more pronounced antihypertensive effect than the use of each of them separately.

    Receiving the drug MICARDIPIPLYUS once a day leads to a significant gradual

    lowering blood pressure (BP).

    Telmisartan

    Telmisartan is a specific angiotensin receptor antagonist II (subtype AT1), effective at ingestion. Has a high affinity for the subtype AT1 receptors of angiotensin II, through which the action of angiotensin is realized II. Releases angiotensin II from binding to the receptor without exhibiting the properties of an agonist for this receptor. Telmisartan binds only to the subtype AT1 receptors of angiotensin II. Communication is of a lasting nature. Has no affinity for other receptors, including AT: receptor and other, less studied receptors of angiotensin. The functional significance of these receptors, as well as the effect of their possible excessive stimulation with angiotensin II. the concentration of which increases with the appointment of telmisartan. not studied. Telmisartan reduces the concentration of aldosterone in the blood, does not inhibit renin in the blood plasma and does not block the ion channels. Telmisartan does not inhibit angiotensin-converting enzyme (kininase II) (an enzyme that also breaks down bradykinin). Therefore, the enhancement of bradykinin-induced side effects is not expected.

    In patients with hypertension telmisartan in a dose of 80 mg completely blocks the hypertensive effect of angiotensin II. The onset of antihypertensive action is noted within 3 hours after the first intake of telmisartan inside. The drug remains for 24 hours and lasts for up to 48 hours. The pronounced antihypertensive effect usually develops 4 weeks after regular intake of the drug.

    In patients with hypertension, telmisartan reduces systolic and diastolic blood pressure (BP), without affecting the heart rate (heart rate). In the case of a sharp cancellation of telmisartan, blood pressure gradually returns to the original without the development of the "withdrawal" syndrome.

    The telmisartan study evaluated cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, or hospitalization due to chronic heart failure. Cardiovascular morbidity and mortality have been shown to decrease in patients with high cardiovascular risk (coronary artery disease, stroke, peripheral arterial disease, or diabetes mellitus with concomitant lesion of target organs such as retinopathy, left ventricular hypertrophy, history of macro or microalbuminuria ) over the age of 55 years.

    Hydrochlorothiazide

    Hydrochlorothiazide is a thiazide diuretic. Thiazide diuretics affect the reabsorption of electrolytes in the renal tubules, directly increasing the excretion of sodium and chlorides (approximately in equivalent amounts).The diuretic effect of hydrochlorothiazide leads to a decrease in the volume of circulating blood (BCC). increased renin activity of blood plasma, increased secretion of aldosterone. with the subsequent increase in the content in the urine of potassium and hydrocarbonates and. as a consequence, a decrease in the potassium content in the blood plasma. With simultaneous administration with telmisartan, there is a tendency to stop the loss of potassium caused by these diuretics, presumably due to the blockade of the renin-angiotensin-aldosterone system (RADO.

    After intake, diuresis is intensified after 2 hours, and the maximum effect is observed after about 4 hours. The diuretic effect of the drug persists for approximately. 6-12 hours.

    Prolonged use of hydrochlorothiazide reduces the risk of complications of cardiovascular disease and mortality from them.

    The maximum antihypertensive effect of the preparation MIKLRDIS1IJIK) ('usually achieved 4 weeks after the start of treatment.

    Pharmacokinetics:

    The combined use of telmisartan and hydrochlorothiazide does not affect the pharmacokinetics of each component of the drug.

    Telmisartan: when ingested quickly absorbed from the gastrointestinal tract. Bioavailability is approximately 50%. 11pc concentration occurs approximately in 0.5-1.5 hours. At reception simultaneously with food decrease AUC (the area under the concentration-time curve) ranges from 6% (when taking a dose of 40 mg) to 19% (with a dose of 160 mi ). After 3 hours after ingestion, the concentration in the blood plasma levels up, regardless of food intake. There is a difference in the concentrations of telmisartan in the blood plasma in men and women. FROMwax (maximum concentration in the blood plasma) and AUC, approximately 3 and 2 times, respectively, higher in women than in men without significant effect on efficacy. Nevertheless, there is no increase in the hypotensive effect in women.

    The association with plasma proteins is significant (more than 99.5%), mainly with albumin and alpha 1-acid glycoprotein. The distribution volume is approximately 500 liters.

    Metabolized telmisartan by conjugation with glucuronic acid. Metabolites are pharmacologically inactive. Half-life (T'1/2) - more than 20 hours. Output through the intestine in an unchanged form, excretion by the kidneys - less than 2%. The community plasma clearance is high (about 900 mL / min).

    Elderly patients

    The pharmacokinetics of telmisartan in elderly patients does not differ from young patients.

    Dose correction is not required.

    Patients with renal insufficiency

    A change in the dose of telmisartan in patients with renal insufficiency is not required, including patients on hemodialysis. Telmisartan not removed by hemodialysis.

    Patients with hepatic insufficiency

    Studies of pharmacokinetics in patients with hepatic insufficiency showed an increase in the absolute bioavailability of telmisartan to almost 100%. With hepatic insufficiency, T1 / 2 does not change (see the section "Method of administration and dose"),

    Hydrochlorothiazide: after ingestion of the drug MICARDIUMPLUS, the maximum concentrations of hydrochlorothiazide in the plasma are reached within 1-3 hours. Absolute bioavailability, based on total excretion by the kidneys, is about 60%. It binds with blood plasma proteins 64% hydrochlorothiazide, and the volume of distribution is 0.810.3 l / kg. Hydrochlorothiazide It is not metabolized in the body and is excreted by the kidneys practically unchanged. About 60% of the dose taken internally is eliminated within 48 hours.Kidney clearance is about 250-300 ml / min. T'1 / 2 hydrochlorothiazide - 10 - 15 hours. There is a difference in plasma concentrations in men and women. In women, the concentration of telmisartan in blood plasma in 2-3 times higher than in men, also in women there is a tendency to increase in blood plasma concentrations of hydrochlorothiazide is clinically insignificant. Patients with renal insufficiency

    In patients with impaired renal function, the rate of excretion of hydrochlorothiazide is reduced.

    Studies conducted with the participation of patients with creatinine clearance (CK) of 90 ml / min, showed that T'1 / 2 hydrochlorothiazide is increased. In patients with decreased renal function T1 / 2 about 34 hours.

    Indications:Arterial hypertension (in case of ineffectiveness of telmisartan or hydrochlorothiazide in monotherapy).
    Contraindications:
    - Hypersensitivity to the active substances or auxiliary components of the drug or other derivatives of sulfonamides;

    - Pregnancy;

    - Breastfeeding period;

    - Obstructive diseases of the biliary tract;

    - Severe liver dysfunction (class C but Child-Pugh classification);

    - Severe renal dysfunction (CC less than 30 mL / min);

    - Refractory hypokalemia, hypercalcemia:

    - Simultaneous therapy with aliskiren in patients with diabetes mellitus and renal insufficiency (Glomerular filtration rate (GFR) <60 ml / min / 1.73 m2);

    - Hereditary intolerance to fructose (contains sorbitol);

    - Deficiency of lactase. lactose intolerance, glucose-galactose malabsorption syndrome;

    - Age to 18 years (effectiveness and safety not established).
    Carefully:
    - Two-sided stenosis of the renal arteries or stenosis of the artery of a single kidney (see section "Special instructions"):

    - Dysfunction of the liver or progressive liver disease (class A and B according to the Child-Pugh classification) (see section "Special instructions");

    - Reduction of BCC due to previous therapy with diuretics, restriction of salt intake, diarrhea or vomiting;

    - Hyperkalemia;

    - Condition after kidney transplantation (no experience is available):

    - Chronic heart failure III-IV functional class (FC) according to the classification of the New York Heart Association;

    - Hypercalcemia;

    - Hypercholesterolemia;

    - Hypertriglyceridemia;

    - Cardiac ischemia;

    - Progressive liver disease (risk of hepatic coma);

    - Stenosis of the aortic and mitral valve;

    - Idiopathic hypertrophic subaortic stenosis;

    - Hypertrophic obstructive cardiomyopathy:

    - Diabetes;

    - Primary aldosteroism;

    - Gout, hyperuricemia;

    - Systemic lupus erythematosus:

    - Secondary closed-angle glaucoma (due to the presence of hydrochlorothiazide in the composition);

    - The use of Negroid race in patients;

    - The experience of using in patients with renal insufficiency (QC more than 30 ml / min) is limited, but does not confirm the development of side effects on the part of the kidneys and correction of the dose is not required.
    Pregnancy and lactation:

    The use of the drug MICARDI DP is contraindicated during pregnancy. Telmisartan

    The use of angiotensin II receptor antagonists during the first trimester of pregnancy is not recommended, these drugs should not be administered during pregnancy. When diagnosing pregnancy, the drug should be stopped immediately. If necessary, alternative therapy should be prescribed (other classes of antihypertensive drugs permitted for use during pregnancy).

    The use of angiotensin II receptor antagonists during the second and third trimesters of pregnancy is contraindicated.

    In pre-clinical studies of telmisartan, there was no teratogenic effect, but fetotoxicity was established. It is known that the effect of angiotensin II receptor antagonists during the second and third trimesters of pregnancy causes a person to have fetotoxicity (decreased function of the nights, oligohydramnios, slowing ossification of the bones of the skull), and neonatal toxicity (kidney failure, arterial hypotension, hyperkalemia). Patients planning a pregnancy should be prescribed an alternative therapy with a proven safety profile in pregnant women. If treatment with antagonists of angiotensin II receptors occurred during the second trimester of pregnancy, it is recommended that ultrasound be checked for kidney function and skull bones in the fetus.

    Newborns whose mothers received angiotensin II receptor antagonists. must

    carefully observed for arterial hypotension.

    Hydrochlorothiazide

    The experience with hydrochlorothiazide during pregnancy, especially during the first trimester, is limited.

    Hydrochlorothiazide penetrates the placental barrier.Given the pharmacological mechanism of action of hydrochlorothiazide. it is assumed that its use during the second and third trimester of pregnancy can disrupt fetoplacental perfusion and cause changes in the embryo and fetus, like jaundice, disturbances in water-electrolysis balance and thrombocytopenia. Gidrochlorothiazide ne should be used for edema of pregnant women, for hypertension in pregnant women or during preeclampsia, since there is a risk of reducing plasma volume and reducing placental perfusion, and there is no favorable effect in these clinical situations.

    Hydrochlorothiazide should not be used to treat essential hypertension in pregnant women, except in those rare situations. When other types of treatment can not be used. Therapy with the drug MICARDI DP is contraindicated in the period of breastfeeding. In animal studies, the effects of telmisartan and hydrochlorothiazide on fertility were not observed. Studies of the impact on human fertility have not been conducted.

    Dosing and Administration:
    Inside, regardless of the time of reception.

    The drug MICRADISPLUS must be taken 1 time per day.

    - MICRADISPLUS 40 / 12.5 mg may be given to patients in whom the use of the drug MICARIDIS in a dose of 40 mg or hydrochlorothiazide does not lead to adequate control of blood pressure.

    - MICIRDISPLUS 80 / 12.5 mg may be given to patients in whom the use of the drug MICARDIIS and a dose of 80 mg or of the drug MICARDIUMPLUS 40 / 12.5 mg does not lead to adequate control of blood pressure.

    In patients with severe arterial hypertension, the maximum daily dose of telmisartan is 160 mg / day. This dose was well tolerated and effective.

    Violations of the function of the nights

    The limited experience of using MICARDIUMPLUS in patients with small or moderate disturbances of the function of the nights does not require a change in the dose of the drug in these cases. In such patients, kidney function should be monitored (with a QC of less than 30 ml / min, see "Contraindications").

    Dysfunction of the liver

    In patients with mild and moderate impairment of liver function (class A and B according to the Child-Pugh classification), the daily dose of MICARDIPIPLYUS should not exceed 40 / 12.5 mg per day (see section "Pharmacokinetics").

    Elderly patients

    Dosage regimen does not require changes.

    Side effects:

    1)expected on the basis of experience with telmisartan

    2) Expected on the basis of the experience of using hydrochlorothiazide

    3) side effects that were not observed in clinical studies with concomitant use of telmisartan and hydrochlorothiazide, but are expected during the application of the drug MICRADISPLUS

    From the respiratory system:

    Respiratory distress syndrome (including pneumonia and non-cardiogenic otek lung)3), dyspnea3).

    From the cardiovascular system:

    arrhythmias3), tachycardia3), bradycardia1). a marked decrease in blood pressure (including orthostatic hypotension)3).

    From the central nervous system:

    syncope / fainting3), paresthesia3), sleep disorders3), insomnia3), dizziness3), anxiety3), depression3), increased excitability2), headache2).

    From the digestive system:

    diarrhea3), dryness of the oral mucosa3), flatulence3), abdominal pain3), constipation3), vomiting3), gastritis3), decreased appetite2), anorexia2). hyperglycemia2), giehercholesterpinspie2). pancreatitis2), impaired liver function3), jaundice (hepatocellular or cholestatic)2). dyspepsia1)2)3)

    From the skin: increased sweating3).

    From the musculoskeletal system:

    backache3), muscle spasms3), myalgia3). arthralgia3). cramps calf muscles3), arthrosis1), tendonitis-like symptoms1), pain in the chest 3).

    From the hemopoietic system and lymphatic system:

    Iron-deficiency anemia1), aplastic anemia2), hemolytic anemia2), thrombocytopenia1), eosinophilia1), leukopenia2), neutropenia / agranuloptosis2). thrombocytopaedy2).

    From the urinary system:

    renal insufficiency1)2), including acute renal failure1), interstitial nephritis2), glucosuria2).

    From the sense organs:

    blurred vision3), transient blurred vision3), xanthopsy2). acute closed angle glaucoma2) , acute myopia2).

    On the part of the reproductive system:

    impotence3).

    Infections:

    sepsis, including cases with a legal outcome1), upper respiratory tract infection (bronchitis, pharyngitis, sinusitis)1)3). urinary tract infections (including cystitis)1), inflammation of the salivary glands2).

    Metabolic disorders:

    increase in the concentration of creatinine in the blood plasma3), increased activity of "hepatic" enzymes3), increased activity of creatine phosphoconnazine3). increase in the concentration of uric acid in the blood3), hypertriglycerpidemia2). hypokalemia2)3). hypomagnesemia2), hyperkalemia1), hyponatraemia2)3). hyperuricemia3). decrease in BCC2). hypoglycemia (in patients with diabetes mellitus)1), impaired glucose tolerance2), a decrease in hemoglobin in the blood1).

    Allergic reactions:

    angioedema (including fatal cases)3). erythema3). itchy skin3). rash3). anaphylactic reactions1)2), eczema1), drug rash1)2), toxic epidermal necrosis1)2), lupus-like reactions2), exacerbation or exacerbation of symptoms of systemic lupus erythematosus3). necrotic veculitis2). systemic vasculature2). photosensitization reaction2). relapse systemic lupus erythematosus2), vasculitis2).

    Other:

    influenza-like syndrome3), fever2), weakness1)2)

    Overdose:
    Cases of overdose have not been identified. Possible symptoms of an overdose consist of symptoms from the individual components of the drug. Telmisartan - marked decrease in blood pressure. tachycardia, bradycardia.

    Hydrochlorothiazide - violations of water-electrolyte balance of blood (hypokalemia, hypochloraemia). decrease in BCC.which can lead to muscle spasms and / or increase cardiovascular disorders: arrhythmias caused by the simultaneous use of cardiac glycosides or some antiarrhythmic drugs.

    Treatment: symptomatic therapy, hemodialysis is ineffective. The degree of removal of hydrochlorothiazide during hemodialysis is not established. It is necessary to regularly monitor the content of electrolytes and creatinine in the blood serum.
    Interaction:

    TELMISARTAN

    With the simultaneous use of telmisartan with:

    - other antihypertensive agents: possibly increased antihypertensive effect. In one study, combined use of telmisartan and ramipril showed an increase AUC0-24 and FROMmax ramipril and ramiprilate in 2.5 times. The clinical significance of this interaction is not established.

    When analyzing the adverse events that led to discontinuation of treatment and analysis of serious adverse events in a clinical trial, it was found that cough and angioedema were more likely to occur with ramipril therapy, while arterial hypotension was more common with telmisartan therapy . Cases of hyperkalemia, renal insufficiency, arterial hypotension and syncope, were significantly more frequent when combined use of telmisartan and ramipril:

    with lithium preparations: There was a reversible increase in the concentration of lithium in the blood, accompanied by toxic effects when taking AIF inhibitors. In rare cases, such changes were registered with the appointment of antagonists of the angiotensin receptor II, at

    in particular, telmisartan. When concomitant administration of lithium preparations and angiotensin II receptor antagonists, it is recommended to determine the content of lithium in the blood;

    - non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid in doses used as an anti-inflammatory drug. inhibitors of cyclooxygenase-2 (COX-2) and non-selective NSAIDs, can cause the development of acute renal failure in patients with reduced BCC. Drugs affecting the RAAS. may have a synergistic effect. In patients receiving NSAIDs and telmisartan, at the beginning of treatment should be compensated for BCC and kidney function monitoring performed.

    Reduction of the effect of antihypertensive drugs, such as telmisartan, by inhibiting the vasodilating effect of prostaglandins was observed in co-treatment with NSAIDs. With the simultaneous administration of telmisartan with ibuprofen or paracetamol, there was no clinically significant effect:

    - digoxin, warfarin, hydrochlorothiazide, glibenclamide, simvastatin and amlodipine: no clinically significant interaction was found. An increase in the average concentration of digoxin in the blood plasma was observed on average by 20% (in one case by 39%). With the simultaneous administration of telmisartan and digoxin, it is advisable to periodically determine the concentration of digoxin in the blood:

    - aliskiren, aliskiren containing preparations: Clinical evidence has shown that the double blockade of RAAS by co-administration with ACE inhibitors. blockers of the receptors of angiogenesin II or aliskiren is associated with a high incidence of side effects such as hypotension, hierkalemia, decreased renal function (including octriple renal failure) compared with the use of one active blocker of RAAS.

    - HYDROCHLOROTHYASIDE

    When used simultaneously with:

    - ethanol, barbiturates or narcotic analgesics: risk of orthostatic hypotension:

    - hypoglycemic agents for ingestion and insulin: may be required to correct a dose of hypoglycemic agents for oral and insulin intake;

    - metformin: risk of lactic acidosis:

    - kolestiraminom and kolestipolom: in the presence of anion exchange resins hydrochlorothiazide absorption is impaired:

    - cardiac glycosides: risk of hypokalemia or hypomagnesemia. caused by thiazide diuretics, the development of arrhythmias caused by the intake of cardiac glycosides:

    - pressor amines (for example, norepinephrine): possible weakening of the effect of pressor amines:

    - nondepolarizing mioreclactants (for example, tubocurarine chloride): hydrochlorothiazide can enhance the effect of nondepolarizing myorex-clavants;

    - anti-gouty agents: the concentration of uric acid in the blood serum may increase and, therefore, changes in the dose of uricosuric agents may be required.

    The use of thiazide diuretics increases the frequency of development of hypersensitivity reactions to allopurinol:

    - preparations of calcium and vitamin D: Thiazide diuretics can increase the calcium content in the blood serum due to the decrease in its excretion by the kidneys. If you want to use calcium preparations, you should regularly monitor the calcium content in the blood and. if necessary, change the dose of calcium preparations:

    - beta adrenoblockers and diazoxide: Thiazide diuretics can increase hyperglycemia caused by beta-blockers and diazoxide:

    - m-cholinic blockers (for example, atropine, biperidin): a decrease in the motility of the gastrointestinal tract, an increase in the bioavailability of thiazide diuretics:

    - amantadine: the clearance of amantadine can be reduced by hydrochlorothiazide. which leads to an increase in the concentration of amantadine in blood plasma and possible toxicity;

    - cytotoxic agents (for example, cyclophosphamide, methotrexate): decrease in renal excretion of cytotoxic agents and enhancement of their myelosuspirative action;

    - NSAIDs: joint use with thiazide diuretics can lead to a decrease in diuretic and antihypertensive effect;

    - means that lead to the excretion of potassium and hypokalemia (for example, diuretics that excrete potassium, laxatives, glucocorticosteroids, calcitonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (found in the licorice root), amphotericin B: carbenoxolone: ​​benzylpenicillin: derivatives of acetylsalicylic acid): increased hypokalemic effect. Hypokalemia. caused by hydrochlorothiazide. is compensated by the potassium-sparing effect of telmisartan;

    - theophylline: increased risk of hypokalemia;

    - amiodarone: simultaneous use with thiazide diuretics can lead to an increased risk of arrhythmias associated with hypokalemia:

    - potassium-sparing diuretics, katia preparations, other agents capable of increasing the serum potassium content (eg, heparin) or the replacement of sodium in table salt with potassium salts can lead to hyperkalemia.

    Periodic monitoring of potassium and blood plasma levels is recommended in cases when the drug MICARDI DP is assigned together with drugs that can cause hypokalemia, as well as with drugs that can increase the potassium content in the blood serum.

    Special instructions:

    States contributing to increased activity of RAAS

    In some patients, due to the suppression of the activity of RAAS, especially with the simultaneous administration of drugs acting on this system, renal function (including acute renal failure) is impaired. Therefore, therapy followed by such a double blockade of RAAS (for example, with the addition of an angiotensin-converting enzyme (ACE inhibitor) inhibitor or direct renin inhibitor-aliskiren to angiotensin II receptor antagonists) should be carried out strictly individually and with regular monitoring of renal function, including periodic monitoring of the content potassium and creatinine in the blood serum (see section "Contraindications").

    The use of thiazide diuretics in patients with impaired renal function can lead to azotemia. Periodic monitoring of renal function is recommended.

    Renovascular hypertension

    In patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single functioning night with the use of drugs that affect RAAS, the risk of development of severe arterial hypotension and renal failure increases. Dysfunction of the liver

    In patients with impaired liver function or progressive liver disease, the drug MIKARDISPLEC should be applied with caution, because the even small changes in the water and electrolyte balance may contribute to the development of "hepatic" coma.

    Effect on the metabolism and function of the endocrine glands

    Patients with diabetes may require a change in the dose of insulin or hypoglycemic agents for oral administration. According to the time of therapy, thiazide diuretics may manifest latent flowing diabetes. In some cases, with the use of thiazide diuretics, it is possible to develop hyperuricemia and exacerbation of gout.

    P.14

    Diabetes

    Patients with diabetes mellitus and additional cardiovascular risk, such as patients with diabetes mellitus and coronary heart disease (CHD) in the case of drugs that lower blood pressure, such as angiotensin II receptor antagonists (ARAII) or ACE inhibitors, may increase the risk of fatal myocardial infarction and sudden cardiovascular death.In patients with diabetes, IHD can be asymptomatic and therefore can be undiagnosed. In patients with diabetes mellitus, before starting the use of the drug MIKARDIDPLUS for the identification and treatment of coronary artery disease should be conducted, appropriate diagnostic tests, including a sample with physical activity.

    Acute myopia and secondary closed angle glaucoma

    Hydrochlorothiazy, being a sulfonamide derivative, can be induced, an idiosyncratic reaction in the form of acute transient myopia and closed-angle glaucoma. Symptoms of these disorders are an unexpected reduction in visual acuity or eye pain, which typically occurs within a few hours to several weeks after starting the drug. Meli is not treated, acute angle-closure glaucoma can lead to loss of vision. The main treatment consists in the fastest possible removal of hydrochlorothiazide. It is necessary to bear in mind. what. if intraocular pressure remains uncontrolled, immediate surgical or surgical treatment may be required. The risk factors for the development of acute closed-angle glaucoma include information on allergiesto sulphonamides or penicillin in the anamnesis. Violations of the water-electrolyte balance

    When using the drug MICRADISPLUS, 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 violations of the water-electrolyte balance and acid-base state (hypokalemia, hyponatremia and hypochloraemic alkalosis). Signs, alarming for these disorders, are the dryness of the oral mucosa. feeling of thirst, general weakness, drowsiness, anxiety, myalgia or convulsive twitching of calf muscles, muscle weakness, marked decrease in blood pressure. oliguria, tachycardia and such gastrointestinal disorders as nausea or vomiting.

    With the use of thiazide diuretics, hypokalemia may develop,­But simultaneously used gelmisartan can increase the content of potassium in the blood. The risk of hypokalemia is greatest in patients with cirrhosis of the liver, with increased diuresis, while observing a salt-free diet, as well as in the case of simultaneous use of glucocorticosteroids.

    P. 15

    calcitonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (found in licorice root). Telmisartan, which is part of the drug MICARDI DP on the contrary, can lead to hyperkalemia due to antagonism to angiotensin II receptors (subtype AT1). Although with the use of the drug MICRADISPLUS, clinically significant hyperkalemia has not been documented, we should take into account that chlamydia and / or heart failure and diabetes mellitus are among the risk factors for its development.

    Data that the drug MICRADISPLEC can reduce or prevent hyponatraemia caused by the use of diuretics, no. 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 small increase in the serum calcium level. More pronounced hypercalcemia may be a sign of latent hperperathyroidism. Before performing an evaluation of parathyroid function, thiazide diuretics should be discontinued.

    It is shown that thiazide diuretics increase the excretion of magnesium by the kidneys, which can lead to hypomagnesemia.

    In patients with coronary heart disease, the use of any antihypertensive agent, in the case of excessive blood pressure lowering. can lead to myocardial infarction or stroke. Enhanced monitoring of patients with impaired uric acid metabolism is required: thiazides can reduce the amount of iodine that binds to serum proteins without showing signs of thyroid dysfunction: there is information about cases of developing a photosensitivity reaction when taking thiazide diuretics. If the photosensitivity reaction occurs during treatment, it is recommended to suspend treatment. If a decision is made about the need to resume a diuretic. it is necessary to protect areas of the body that can be exposed to sunlight or ultraviolet radiation 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 in the conduct of doping control.

    There are reports of the development of the system crane oil lupus with the use of thiazide diuretics. MIKARDIDPLUS can, if necessary, be used in conjunction with other antihypertensive agents.

    Dysfunction of the liver with the appointment of telmisartan in most cases were observed in residents of Myopia.

    Mycardisplus is less effective in patients of the Negroid race.

    Effect on the ability to drive transp. cf. and fur:Special clinical studies to assess the effect of the drug MICARDI-PLUS on the ability to drive vehicles and work with mechanisms that require increased attention, was not conducted. However, when driving and dealing with potentially hazardous activities, one should take into account the possibility of developing dizziness and drowsiness, which requires caution.
    Form release / dosage:
    Tablets 12.5 / 40 mg and 12.5 / 80 mg.
    Packaging:
    For 7 tablets in a blister of polyamide / aluminum / PVX.

    For 2.4 or 8 blisters and a cardboard box with instructions for use.
    Storage conditions:At a temperature of no higher than 25 ° C. in a dry place. Keep out of the reach of children.
    Shelf life:3 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N015915 / 01
    Date of registration:22.07.2009/24.07.2015
    The owner of the registration certificate:Boehringer Ingelheim International GmbHBoehringer Ingelheim International GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspBERINGER INGELCHAIM INTERNATIONAL GmbH BERINGER INGELCHAIM INTERNATIONAL GmbH Germany
    Information update date: & nbsp08.05.2016
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