Ramilong plus tablets 10mg/12.5mg №10×3

NameRamilong Plus tabl. The main active ingredient Ramipril + hydrochlorothiazide Release form Tablets Dosage 10 mg / 12.5 mg Indications for use Arterial hypertension in patients who are indicated for combination therapy. Method of administration and doses For oral administration. Take the tablets once a day, every day in the morning, regardless of the meal, with a sufficient amount of liquid. It is usually recommended to take the entire daily dose in the morning at one time. Ramilong plus is not intended for initial therapy. It is recommended to prescribe the combined preparation Ramilong plus only after individual selection of the dose of each of the components. Special attention should be paid to patients on dialysis. After completion of the titration of the individual components, Ramilong Plus can be administered in the appropriate form of release, if the titrated dose and dosing regimen allow the use of a permanent combination. Titration is carried out by the physician according to the severity of hypertension and the presence of other concomitant factors. Usual dose: 2.5 mg ramipril and 12.5 mg hydrochlorothiazide per day. Maximum daily dose: 10 mg ramipril and 25 mg hydrochlorothiazide. If a dose of a drug is missed, it should be taken as soon as possible. If a dose is missed close to the time of the next dose, then the missed dose should not be taken and a regular dosing schedule should be followed. Do not double the dose! Special groups of patients Patients undergoing treatment with diuretics. Patients taking diuretics at the same time, after the start of treatment, it is recommended to exercise special care, as there is a risk of hypotension. For patients on diuretic therapy, it is recommended to stop treatment or reduce the dose of diuretics before starting treatment with Ramilong Plus. Doses for patients with impaired renal function. Ramilong plus is contraindicated in severe renal failure due to the presence of hydrochlorothiazide in the formulation (creatinine clearance < 30 ml/min). Patients with impaired renal function may need to reduce the dose of ramipril and hydrochlorothiazide. Patients with creatinine clearance between 30 and 60 mL/min should be given the lowest fixed dose combination of ramipril and hydrochlorothiazide after treatment with ramipril alone. The maximum allowable dose is 5 mg of ramipril and 25 mg of hydrochlorothiazide per day. Patients with liver failure. In patients with mild to moderate hepatic insufficiency, treatment with Ramilong Plus should be under strict medical supervision with a maximum daily dose of 2.5 mg ramipril and 12.5 mg hydrochlorothiazide. The drug is contraindicated in severe liver failure. Elderly patients. Initial doses for elderly patients should be lower, and subsequent dose titration should be gradual, since there is a greater likelihood of adverse effects, especially in elderly patients and in immunocompromised patients. Use during pregnancy and lactationRamilong plus is not recommended during the first trimester of pregnancy and is contraindicated in the second and third trimesters of pregnancy. Epidemiological data suggesting a risk of teratogenicity following the use of ACE inhibitors during the first trimester of pregnancy were inconclusive, but a slight increase in risk cannot be ruled out. If the patient is planning pregnancy, it is necessary to replace therapy with ACE inhibitors for treatment with alternative antihypertensive drugs, the safety profile of which has been established for use during pregnancy. If pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately and, if necessary, alternative therapy initiated. Therapy with ACE inhibitors / angiotensin II receptor antagonists during the second and third trimesters has a fetotoxic effect (decreased renal function, oligohydramnios, delayed ossification of the skull) and neonatal toxicity (renal failure, arterial hypotension, hyperkalemia). If ACE inhibitors were used in the second trimester of pregnancy, an ultrasound examination of the function of the kidneys and skull is recommended. Newborns whose mothers used ACE inhibitors should be monitored for the timely detection of hypotension, oliguria and hyperkalemia. Hydrochlorothiazide, with prolonged exposure during the third trimester of pregnancy, can cause fetoplacental ischemia and fetal growth retardation. Rare cases of hypoglycemia and thrombocytopenia have been reported in newborns in the case of the use of the drug during pregnancy. Hydrochlorothiazide can reduce plasma volume, and, accordingly, uteroplacental blood flow. Ramipril and hydrochlorothiazide are excreted in breast milk in sufficient quantities to have an effect on the child when using therapeutic doses of drugs during breastfeeding. Due to the lack of information regarding the use of ramipril during breastfeeding, it is preferable to prescribe alternative therapies with an established safety profile during breastfeeding, especially in neonates or premature infants. Hydrochlorothiazide is excreted in breast milk. The use of thiazides during lactation has been associated with a decrease or even suppression of lactation. Hypersensitivity to sulfonamide derivatives, hypokalemia and kernicterus may develop. Due to the possibility of serious reactions associated with exposure to both active substances, a decision should be made to discontinue breastfeeding or discontinue therapy, taking into account the need for this therapy for the mother. Use in children It is not recommended to prescribe the drug to children under 18 years of age due to the lack of data on the efficacy and safety of use in children. Influence on the ability to drive vehicles and control mechanisms If it is necessary to drive vehicles and work with mechanisms during the use of the drug, the possibility of individual reactions should be taken into account, in some patients the ability to drive a car, work with mechanisms, and also perform other types of work that require increased attention may be impaired . This is especially pronounced at the beginning of treatment and / or after increasing the dosage. Precautions and special instructions Patients with a highly activated renin-angiotensin-aldosterone system (RAAS) Patients with a highly activated renin-angiotensin-aldosterone system are at risk of a pronounced decrease in blood pressure and deterioration of kidney function in connection with the use of ACE inhibitors, especially when taking an ACE inhibitor or an additional diuretic for the first time or if the first dose is increased. Significant activation of the renin-angiotensin-aldosterone system requires careful medical supervision, including blood pressure monitoring, which is necessary for: patients with severe forms of hypertension; patients with decompensated congestive heart failure; patients with hemodynamically significant impairment of blood inflow or outflow from the left ventricle (for example , stenosis of the aortic or mitral valve); patients with unilateral stenosis of the renal artery of the second functional kidney; patients with a deficiency of fluid or salt in the body (including patients taking diuretics); patients with cirrhosis of the liver and / or ascites; patients who have undergone significant surgical interventions or to which anesthesia with drugs that cause hypotension was used. As a rule, it is recommended to eliminate dehydration, hypovolemia or salt deficiency before starting treatment (for patients with heart failure, these actions should be carefully evaluated, as there is a risk volume overload). Double blockade of the renin-angiotensin-aldosterone system Double blockade of the renin-angiotensin-aldosterone system is associated with an increased risk of hypotension, hyperkalemia and renal dysfunction (including acute renal failure) compared with monotherapy. Dual RAAS blockade with ACE inhibitors, AT II receptor blockers (ARB II), or Aliskiren cannot be recommended for any patient, especially those with diabetic nephropathy. In some cases, when the combined use of ACE inhibitors and ARB II is absolutely indicated, careful observation of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. This refers to the use of candesartan or valsartan as add-on therapy to ACE inhibitors in patients with chronic heart failure. Conducting a double blockade of the RAAS under the close supervision of a specialist and mandatory monitoring of kidney function, water and electrolyte balance and blood pressure is possible in patients with chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistent symptoms of chronic heart failure, despite other adequate therapy. Surgery Treatment with ACE inhibitors such as ramipril should, if possible, be stopped the day before the planned surgery. Patients at risk of developing coronary heart disease or cerebral ischemia in case of severe hypotension Careful medical supervision is required at the initial stage of treatment. Primary hyperaldosteronism Combinations of ramipril and hydrochlorothiazide are not indicated for the treatment of primary hyperaldosteronism. If the combination of ramipril with hydrochlorothiazide is used in patients with primary hyperaldosteronism, monitoring of plasma potassium levels is required. Patients with liver disease Electrolyte disturbances due to diuretic therapy, including treatment with hydrochlorothiazide, may lead to hepatic encephalopathy in patients with liver disease. Monitoring of renal function Renal function should be monitored before and during treatment and when adjusting dosage - especially in the first weeks of treatment. Patients with renal insufficiency should be under close medical supervision. There is a risk of developing renal dysfunction, especially in patients with chronic heart failure or in patients who have undergone kidney transplantation. Renal insufficiency In patients with renal insufficiency, thiazides may accelerate the development of uremia. Cumulative effects of the active substance may occur in patients with impaired renal function. With the development of progressive renal failure, as evidenced by an increase in the level of non-protein nitrogen, it is necessary to adjust the method of treatment, up to the termination of treatment with diuretics. Electrolyte imbalance Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalemia, hyponatremia, and hypochloremic alkalosis). Although hypokalemia may develop with thiazide diuretics, concomitant use of ramipril may attenuate diuretic-induced hypokalemia. The risk of developing hypokalemia is greatest in patients with cirrhosis of the liver, in patients with rapid diuresis, in patients receiving insufficient electrolytes, and in patients who were simultaneously treated with corticosteroids or ACTH. The first measurement of plasma potassium levels should be carried out within the first week after the start of treatment. If the potassium level is low, it needs to be corrected. There is a risk of developing dilutional hyponatremia. Low sodium levels may initially be asymptomatic, so regular testing is essential. Most often, it is worth taking tests in elderly patients and patients suffering from cirrhosis of the liver. Thiazides increase the excretion of magnesium in the urine, which can lead to hypomagnesemia. Hyperkalemia Hyperkalemia has been observed in some patients taking ACE inhibitors, including Ramilong plus. Patients at risk of developing hyperkalemia include patients with renal insufficiency, elderly patients (> 70 years), patients with uncontrolled diabetes mellitus, or patients taking potassium salts, potassium-sparing diuretics and other potassium-sparing substances, or patients suffering from dehydration, acute heart failure, metabolic acidosis. With the simultaneous use of the above substances, it is advisable to regularly monitor the level of potassium in the blood serum. Hepatic encephalopathy Electrolyte disturbances that occur with diuretic therapy, including hydrochlorothiazide, in patients with liver disease can lead to hepatic encephalopathy. In case of hepatic encephalopathy, treatment should be stopped immediately. Hypercalcemia Hydrochlorothiazide stimulates renal calcium reabsorption and may lead to hypercalcemia, which may adversely affect the analysis of parathyroid function. Angioedema Angioedema has been reported in patients treated with ACE inhibitors; including ramipril. If angioedema occurs, the use of Ramilong Plus should be discontinued. Emergency assistance must be provided immediately. The patient should be under medical supervision for at least 12 to 24 hours and discharged after complete resolution of symptoms. Angioedema of the intestine may occur in patients taking ACE inhibitors, including Ramilong plus. These patients experience abdominal pain (with or without nausea or vomiting). Anaphylactic reactions during desensitization The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens increase with the use of ACE inhibitors. It is necessary to temporarily stop treatment with Ramilong Plus until desensitization. Neutropenia/Agranulocytosis Cases of neutropenia/agranulocytosis and bone marrow suppression have been reported. In order to detect leukopenia, it is recommended to monitor the number of leukocytes in the blood. More frequent monitoring is recommended in the initial phase of treatment and for patients with impaired renal function, with associated collagen diseases (eg, lupus erythematosus or scleroderma), and for patients taking other drugs that cause changes in the blood count. Ethnic Differences ACE inhibitors may cause more severe angioedema in patients of black race than in patients of other races. Like other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black patients compared to patients of other races, presumably due to the higher prevalence of renin-depleted hypertension in black patients. Athletes The hydrochlorothiazide contained in the medicinal product may give a positive, analytical result during a doping test. Metabolic and endocrine disorders Diuretic therapy may lead to impaired glucose tolerance. Patients with diabetes may need to adjust the dosage of insulin or oral hypoglycemic agents. In the treatment of thiazide drugs, latent diabetes mellitus may occur. An increase in the level of cholesterol and triglycerides may be associated with the use of thiazide diuretics. Taking thiazide drugs can cause hyperuricemia or gout. Cough During treatment with ACE inhibitors, an unproductive, persistent cough has been observed, which resolves after discontinuation of therapy. Cough induced by ACE inhibitors should be considered in the differential diagnosis of cough. Miscellaneous Hypersensitivity reactions may occur in patients with or without a history of allergies or asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. The drug Ramilong plus contains lactose monohydrate. It should not be given to patients with rare hereditary disorders of galactose tolerance, hereditary lactase deficiency or glucose-galactose malabsorption syndrome. Interactions with other drugs Contraindicated combinations Extracorporeal treatments that result in contact of blood with a negatively charged surface, such as dialysis or hemofiltration using certain membranes with high hydraulic permeability (for example, polyacrylonitrile membranes) and low density lipoprotein apheresis with dextran sulfate increase the risk of acute anaphylactoid reactions . If this treatment is necessary, consideration should be given to using a different type of dialysis membrane or another class of antihypertensive drugs. Combination with drugs containing Aliskiren in patients with diabetes mellitus (type I or II) or with moderate to severe renal insufficiency (glomerular filtration rate less than 60 ml / min / 1.73 m2). Use with caution Potassium salts, heparin, potassium-sparing diuretics and other substances that increase plasma potassium levels (including angiotensin II receptor antagonists, trimethoprim, tacrolimus, cyclosporine). Careful monitoring of blood potassium levels is recommended to prevent hyperkalemia. Antihypertensive drugs (eg, diuretics) and other substances that lower blood pressure (eg, nitrates, tricyclic antidepressants, anesthetics, acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin). Possible risk of hypotension. Double blockade of the renin-angiotensin-aldosterone system (RAAS). Based on the available data, dual blockade of the RAAS with ACE inhibitors, AT II receptor blockers (ARB II) or Aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy. In patients with diabetes mellitus or moderate/severe renal insufficiency (GFR < 60 ml/min/1.73 m2), concomitant use of Aliskiren with ACE inhibitors or ARBs II is contraindicated. In some cases, when the combined use of ACE inhibitors and ARB II is absolutely indicated, careful observation of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. Vasopressor sympathomimetics and other substances (eg, isoproterenol, dobutamine, dopamine, adrenaline) that reduce the antihypertensive effect. Blood pressure monitoring is recommended. Allopurinol, immunosuppressants, corticosteroids, procainamide, cytotoxic drugs, and other substances that can change the number of blood cells. Increased likelihood of hematological reactions. Lithium salts. ACE inhibitors can reduce the excretion of lithium, as a result of which its toxicity increases. Lithium levels need to be monitored. Antidiabetic drugs, including insulin. Hypoglycemic reactions may occur. It is necessary to control the level of glucose in the blood. Non-steroidal anti-inflammatory drugs and acetylsalicylic acid. There may be a decrease in the antihypertensive effect. The simultaneous use of ACE inhibitors and NSAIDs may increase the risk of impaired renal function and increase potassium. Oral anticoagulants. The anticoagulant effect may decrease with the simultaneous use of hydrochlorothiazide. Corticosteroids, ACTH, amphotericin B, carbenoxolone, drugs containing large amounts of licorice root, laxatives (in case of long-term use), and other kaliuretic or plasma potassium-lowering drugs. Increased risk of developing hypokalemia. Digitalis preparations, active substances that prolong the QT interval, antiarrhythmic drugs. The proarrhythmic toxicity of these drugs may be increased and the antiarrhythmic effect reduced in electrolyte imbalances (eg, hypokalemia, hypomagnesemia). Methyldopa. There is a risk of hemolysis. Colestyramine or other enterally administered ion exchangers. Reduce the absorption of hydrochlorothiazide. Sulfanilamide diuretics should be taken at least one hour before or four to six hours after taking these drugs. Curariform muscle relaxants. It is possible to enhance and prolong the effect of muscle relaxation. Calcium salts and drugs that increase plasma calcium levels. An increase in serum calcium concentration should be expected in the case of simultaneous use of hydrochlorothiazide, therefore, monitoring of serum calcium levels is required. Carbamazepine. There may be a risk of developing hyponatremia due to the additive effect of hydrochlorothiazide. Iodine-containing contrast agents. With dehydration caused by diuretics, including hydrochlorothiazide, there is an increased risk of developing acute renal failure, in particular when using large doses of iodine containing contrast agents. Penicillin. Hydrochlorothiazide is excreted into the distal tubules and reduces the excretion of penicillin. Quinine. Hydrochlorothiazide reduces the excretion of quinine. Contraindications Hypersensitivity to the active components of the drug or to ACE inhibitors, hydrochlorothiazide or other thiazide diuretics, sulfonamides or to individual components of the drug; history of angioedema associated with the use of ACE inhibitors, as well as hereditary or idiopathic angioedema; extracorporeal treatment, which leads to blood contact with negatively charged surfaces; bilateral renal artery stenosis or stenosis of the arteries of a single kidney; second or third trimester of pregnancy; breastfeeding; severe renal impairment (creatinine clearance less than 30 ml / min) in patients on dialysis; in combination with drugs containing Aliskiren in patients with diabetes mellitus (type I or II) or with moderate to severe renal insufficiency (glomerular filtration rate less than 60 ml / min / 1.73 m2). Clinically significant electrolyte imbalances that may be aggravated by treatment and Ramilong plus; severe liver dysfunction, hepatic encephalopathy. Composition 1 tablet Ramilong plus 10 mg / 12.5 mg contains: Active substances: ramipril - 10 mg, hydrochlorothiazide - 12.5 mg. Excipients: sodium starch glycolate, hydroxypropyl methylcellulose, lactose monohydrate, sodium stearyl fumarate, microcrystalline cellulose. Overdose Symptoms: persistent diuresis, excessive peripheral vasodilation (with severe hypotension, electrolyte imbalance, bradycardia, cardiac arrhythmias, impaired consciousness up to coma and seizures), renal failure, paresis, paralytic ileus. In patients with risk factors (for example, prostatic hyperplasia), an overdose of hydrochlorothiazide can provoke acute urinary retention. Treatment is symptomatic and supportive. Gastric lavage and intake of absorbents. In case of hypotension, alpha1-adrenergic agonists (eg, norepinephrine, dopamine) or angiotensin II (angiotensinamide) may be required in addition to volume and salt replenishment. When carrying out dialysis or hemofiltration (removal of ramipril), the risk of developing anaphylactoid reactions should be taken into account when using high-flow membranes. Removal of thiazides from the body by dialysis is negligible. Side effect The frequency of adverse reactions indicated below was determined using the following note: very often (> 1/10), often (> 1/100 – < 1/10), infrequently (> 1/1.000 – < 1/100), rarely (> 1/10.000 – < 1/1.000), very rare (< 1/10.000), not known (cannot be determined from the available data). Cardiovascular disorders: infrequently - myocardial ischemia, including angina pectoris, tachycardia, arrhythmia, palpitations, peripheral edema; unknown - myocardial infarction. Blood and lymphatic system disorders: infrequently - a decrease in the number of leukocytes, erythrocytes, platelets, a decrease in hemoglobin, hemolytic anemia; unknown - bone marrow failure, neutropenia, including agranulocytosis, pancytopenia, eosinophilia, hemoconcentration on the background of dehydration. Central nervous system disorders: often - headache, dizziness; infrequently - vertigo, paresthesia, tremor, balance disorders, burning sensation, ageusia, dysgeusia; unknown - cerebral ischemia, including ischemic stroke, transient ischemic attack, psychomotor skills disorders, parosmia. On the part of the organ of vision: infrequently - visual disturbances, including blurred vision, conjunctivitis; unknown - xanthopsia, decreased lacrimation in connection with the intake of hydrochlorothiazide. Hearing disorders and labyrinth disorders: infrequently - tinnitus; unknown - hearing impairment. Respiratory, thoracic and mediastinal disorders: often - dry tickling cough, bronchitis; infrequently - sinusitis, shortness of breath, nasal congestion; unknown - bronchospasm, including asthma, allergic alveolitis, non-cardiogenic pulmonary edema, in connection with the use of hydrochlorothiazide. Gastrointestinal disorders: infrequently - gastrointestinal inflammation, digestive disorders, abdominal discomfort, dyspepsia, gastritis, nausea, constipation, gingivitis in connection with hydrochlorothiazide; very rarely - vomiting, aphthous stomatitis, glossitis, diarrhea, pain in the upper abdomen, dry mouth; unknown - pancreatitis (cases of death were reported exclusively in connection with the use of ACE inhibitors), an increase in the number of pancreatic enzymes, angioedema of the small intestine, sialadenitis in connection with the use of hydrochlorothiazide. Renal and genitourinary disorders: infrequently - impaired renal function, including acute renal failure, increased diuresis, increased levels of urea and creatinine in the blood; unknown - worsening of previous proteinuria, interstitial nephritis due to hydrochlorothiazide. Skin and subcutaneous tissue disorders: infrequently - angioedema: in exceptional cases, airway obstruction due to angioedema can be fatal, psoriasis-like dermatitis, hyperhidrosis, rash, in particular maculopapular, pruritus, alopecia; unknown - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, exacerbation of psoriasis, exfoliative dermatitis, photosensitivity reactions, onycholysis, pemphoid or lichenoid exanthema or enanthema, urticaria, systemic lupus erythematosus in connection with hydrochlorothiazide. Musculoskeletal and connective tissue disorders: infrequently - myalgia; unknown - arthralgia, muscle spasms, muscle weakness, musculoskeletal stiffness, tetany in connection with the use of hydrochlorothiazide. Metabolic and nutritional disorders: often - uncontrolled diabetes mellitus, decreased glucose tolerance, increased blood glucose levels, increased blood uric acid levels, complication of gout, increased blood cholesterol and / or triglycerides in connection with hydrochlorothiazide; infrequently - anorexia, loss of appetite, decrease in the level of potassium in the blood, thirst in connection with the intake of hydrochlorothiazide; very rarely - an increase in the level of potassium in the blood due to the use of ramipril; unknown - a decrease in the level of sodium in the blood, glucosuria, metabolic alkalosis, hypochloremia, hypomagnesemia, hypercalcemia, dehydration in connection with the use of hydrochlorothiazide. Vascular disorders: infrequently - hypotension, decrease in orthostatic blood pressure, fainting, hyperemia; unknown - thrombosis due to severe dehydration, vascular stenosis, hypoperfusion, Raynaud's phenomenon, vasculitis. General disorders and injection site: often - fatigue, asthenia; infrequently - chest pain, fever. Immune system disorders: unknown - anaphylactic or anaphylactoid reactions to ramipril or hydrochlorothiazide, an increase in the number of antinuclear antibodies. On the part of the hepatobiliary system: infrequently - cholestatic or cytolytic hepatitis (death was observed in exceptional cases), an increase in the number of hepatic and / or bilirubin conjugated enzymes, calculous cholecystitis in connection with hydrochlorothiazide; unknown - acute liver failure, cholestatic jaundice, hepatocellular damage. Reproductive system and mammary gland disorders: infrequently - transient erectile impotence; unknown - decreased libido, gynecomastia. Mental disorders: infrequently - depressed mood, apathy, anxiety, nervousness, sleep disturbances, drowsiness; unknown - confusion, agitation, impaired concentration. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25C. Keep out of the reach of children. Buy Ramilong plus tablets 10mg/12.5mg No. 10x3