Hartil D 5/25mg 28 tablets

Form

tableti

Dosage mg

5მგ+25

Pack

28

International Name - ramipril, hydrochlorothiazide Clinical - pharmacological group - Angiotensin-converting enzyme inhibitors Composition and dosage form 2.5mg/12.5mg tablet #28 5mg/25mg tablet #28 Composition: Each tablet contains 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide or 5 mg of ramipril and 25 mg of hydrochlorothiazide. Excipients: Lactose monohydrate, crospovidone, microcrystalline cellulose, sodium stearyl fumarate. Pharmacological properties The preparation contains a combination of two active substances that reduce blood pressure. Ramipril is a long-acting ACE (angiotensin-converting enzyme) inhibitor that reduces blood pressure and cardiac load. It is used to treat arterial hypertension, certain heart and kidney diseases, and to prevent their complications such as myocardial infarction and stroke. Hydrochlorothiazide is a diuretic. It stimulates the kidneys to excrete salts and water, and also reduces blood pressure. The hypotensive effect becomes more pronounced from the 3rd-4th day of daily use. The combination of ramipril and hydrochlorothiazide has a more pronounced antihypertensive effect than either component alone, while reducing the risk of side effects. Indications Hartil-D is used to treat arterial hypertension when combination therapy is indicated. Dosage and administration Hartil-D is used once daily in the morning. Tablets should be swallowed whole without chewing, with sufficient liquid – at least half a glass of water. Hartil-D tablets can be taken independently of meals: they can be taken on an empty stomach, during or after a meal. Tablets can be divided in half by breaking on the score line. The preparation should only be taken as prescribed by a doctor. The usual starting dose for adults is 2.5 mg ramipril and 12.5 mg hydrochlorothiazide. The dose can be increased at intervals of at least 3 weeks. The usual maintenance dose is 2.5 mg ramipril and 12.5 mg hydrochlorothiazide or 5 mg ramipril and 25 mg hydrochlorothiazide. The maximum daily dose is 10 mg ramipril and 50 mg hydrochlorothiazide. The duration of treatment is determined by the doctor. For elderly patients and patients with impaired liver or kidney function, doses are usually lower than usual and are selected individually by the doctor, taking into account the functional state of the kidneys and liver. Side effects At recommended doses, the preparation is usually well tolerated. In isolated cases, side effects may occur, which usually do not require discontinuation of the preparation. In case of severe side effects or effects not mentioned in these instructions, consult a doctor. At the beginning of treatment and after dose increase, a significant drop in blood pressure may occur – hypotension, which manifests with symptoms such as dizziness, general weakness, blurred vision, sometimes with seizures and confusion. The risk of developing hypotension is higher in patients with water-electrolyte imbalance, chronic heart failure, and renal insufficiency. In case of hypotension, the patient should be placed in a horizontal position, and if necessary, an intravenous infusion should be administered to increase the circulating blood volume. Transient hypotensive reaction is not a contraindication for continuing the use of the preparation. In case of pronounced and prolonged hypotension, it may be necessary to reduce the dose or discontinue the preparation. It is known that the use of ACE inhibitors can be accompanied by a dry cough, which intensifies at night and when lying down, and is more common in women and non-smokers. This cough always resolves on its own after discontinuation of the preparation. Sometimes the cough may resolve when the patient is switched to another ACE inhibitor. The following are other more common side effects observed during registered clinical trials and therapeutic use of ramipril in combination with hydrochlorothiazide and ACE inhibitors. Metabolic disorders: Significant decrease in blood potassium, in severe cases with convulsions or muscle weakness, increase in blood creatinine and urea, gout, increase in blood glucose, infrequently increase in blood potassium. Nervous system disorders: Dizziness, fatigue, headache, weakness, drowsiness. Cardiovascular system disorders: Arterial hypotension, palmar edema. Digestive organ disorders: Vomiting, abdominal pain, indigestion, abdominal cramps, thirst, constipation, diarrhea, loss of appetite. Respiratory organ disorders: Cough, bronchitis, rhinitis, sinusitis. Kidney and urinary organ disorders: Worsening of kidney function, increase in blood urea and serum creatinine, dehydration. Sensory organ function disorders: Conjunctivitis, phlebitis, visual disturbances, tinnitus. General body disorders, allergic reactions, skin lesions: Allergic reactions, often in the form of skin rash, rarely – urticaria, skin rash accompanied by itching, blistering or peeling, swelling of the skin and mucous membranes, photosensitivity, increased sweating, joint pain, exacerbation of psoriasis, systemic lupus erythematosus, vasculitis. Contraindications • Allergy (hypersensitivity reaction, including skin itching and rash) to ramipril, other ACE inhibitors, thiazides, sulfonamides, or any other ingredient of Hartil-D. • Swelling of the skin or mucous membranes and difficulty breathing (angioneurotic edema) when using ACE inhibitors. Angioneurotic edema of any origin in the anamnesis. • Severe bilateral (or unilateral in case of one kidney) stenosis of the renal arteries. Hemodynamically significant aortic stenosis and/or mitral stenosis. • Arterial hypotension (systolic pressure less than 95 mmHg), hemodynamic instability. • Severe liver dysfunction and/or bile stasis. • Severe renal insufficiency with creatinine clearance less than 30 ml/min per 1.73 m2 of body surface area. • Simultaneous desensitization therapy for allergies to insect bites. Simultaneous hemodialysis using high-flux membranes (e.g., polyacrylonitrile membranes). • Pregnancy. • Lactation period. • Children under 18 years of age. Special instructions Regular medical supervision is necessary during treatment with the preparation. In addition to blood pressure, kidney function, blood counts, and biochemical parameters should be periodically monitored. Water-electrolyte imbalances must be corrected before starting the preparation. Hartil-D intake can cause a significant drop in blood pressure, especially after the first dose or after the first increased dose. The likelihood of developing hypotension is higher with reduced circulating blood volume due to fluid and salt loss, and in patients with chronic heart failure with normal or low blood pressure. In case of hypotension, the patient should be placed in a horizontal position, and if necessary, an intravenous infusion should be administered to increase the circulating blood volume. Transient hypotensive reaction is not a contraindication for continuing the use of the preparation. In case of pronounced and prolonged hypotension, it may be necessary to reduce the dose or discontinue the preparation. Special caution is required when using Hartil-D in the following cases: - In patients with dehydration, diarrhea, and nausea; - In patients taking diuretics; - In patients with hypersecretion of adrenal cortex hormones (Conn's syndrome); - In individuals on a low-salt diet, taking potassium-rich supplements or potassium-sparing drugs; - In patients with renal hypertension, severe heart failure, hypertrophic cardiomyopathy; - In patients with diabetes mellitus, for whom regular monitoring of blood glucose levels is necessary. It may be necessary to individually adjust the dose of hypoglycemic drugs or switch from oral medications to insulin; - In patients with systemic lupus erythematosus or psoriasis, the disease may worsen. Hemodialysis is not recommended during treatment with Hartil-D. If dialysis is necessary, it is necessary to switch to an antihypertensive agent that is not an ACE inhibitor. The doctor must be informed about the use of Hartil-D before surgical interventions and anesthesia, including dental procedures. Treatment with the preparation can cause a dry cough, which always disappears after the end of treatment. Hartil-D contains lactose monohydrate. This should be considered when treating patients with lactose deficiency and other rare metabolic disorders (galactosemia or glucose/galactose malabsorption syndrome). If a dose of Hartil-D is missed, the missed dose should be taken as soon as possible, and then the preparation should be continued as prescribed by the doctor. However, if there is little time left before the next dose, the dose should not be doubled to compensate. In this case, it is better to skip the missed dose altogether and continue taking the preparation according to the usual schedule. Do not stop taking the preparation on your own! Discontinuation or dose adjustment of the preparation should be done under medical supervision. Effect on ability to drive and operate machinery Depending on the individual reaction, Hartil-D can negatively affect the ability to perform tasks requiring high concentration. At the beginning of treatment and when increasing the dose, it is recommended to refrain from driving and operating machinery. Subsequently, the continuation of activities and the determination of a safe dose will be carried out individually by the doctor. Overdose Symptoms of overdose: Pronounced hypotension, pale skin, anxiety, sweating, confusion (up to coma), urinary retention, water-electrolyte imbalance (hypokalemia, hyponatremia, and hypochloremic alkalosis), convulsions, paresis, cardiac rhythm disturbances (bradycardia, arrhythmias), circulatory shock, renal failure, paralytic intestinal obstruction. Treatment of overdose: Depends on the dose and time of administration of the preparation, the main symptoms and their severity. To remove unabsorbed preparation, gastric lavage, administration of adsorbents and sodium sulfate should be performed to accelerate the passage of the preparation through the intestines, which is most effective within the first hour. Monitoring and maintenance of vital functions are necessary in an intensive care unit. The cardiovascular system, circulating blood volume, electrolyte levels, acid-base balance, blood glucose levels, and diuresis should be monitored. In case of hypotension, the patient should be placed on their back with their legs elevated, and circulating blood volume should be restored by infusing physiological solution. If these measures are insufficient, catecholamines and angiotensinamide should be administered intravenously. In case of hypokalemia, it is necessary to restore potassium levels. In case of persistent bradycardia, an artificial pacemaker may be necessary. Ramipril can be removed from the body by dialysis, but hemodialysis using high-flux membranes (polyacrylonitrile membranes) is contraindicated with Hartil-D due to the risk of life-threatening hypotension and anaphylactic reaction. Drug interactions Hartil-D should be used with caution with the following preparations. Lithium preparations – may increase blood lithium levels and lead to toxic effects. Concurrent use of Hartil-D and lithium salts is not recommended. Salicylates – at high doses (3 g per day or more), their toxic effect on the central nervous system may be enhanced. This effect is not observed with low-dose acetylsalicylic acid. Cardiac glycosides and antiarrhythmics (e.g., amiodarone and diltiazem) – their effects and side effects may be enhanced. Antidiabetic drugs – their efficacy may change, including enhancement of their hypoglycemic effect. Non-depolarizing neuromuscular blockers used during surgery – their effect may be enhanced. Calcium preparations and vitamin D – risk of significant increase in blood calcium due to reduced excretion. Cyclosporine – high risk of renal insufficiency and increased blood potassium. The following medicinal preparations can increase the hypotensive effect of Hartil-D: other hypotensive drugs and diuretics, vasodilators, tricyclic antidepressants, analgesics, hypnotics. In case of a significant drop in blood pressure, kidney function may be impaired. The following medicinal preparations can reduce the hypotensive effect of Hartil-D: sodium chloride, including in infusion solutions, salicylates in high doses and non-steroidal anti-inflammatory drugs, cholestyramine and colestipol, sympathomimetics, including those used to treat bronchial asthma. The following medicinal preparations can increase blood potassium: potassium preparations, potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene), heparin-sodium, trimethoprim, lovastatin. The following medicinal preparations can decrease blood potassium: potassium-lowering diuretics (e.g., furosemide), glucocorticoids (e.g., prednisolone), corticotropin, carbenoxolone, amphotericin B, penicillin, laxatives with prolonged use. Changes in the number of blood cells may occur when Hartil-D is used with the following agents: cytostatic agents, cytostatics, immunosuppressants, systemic corticosteroids, procainamide, allopurinol. Use during pregnancy and lactation The use of Hartil-D during pregnancy and lactation is contraindicated. Hartil-D is contraindicated during pregnancy, so pregnancy must be ruled out before starting its use. If the patient plans to have a child, she should stop using ACE inhibitors and hydrochlorothiazide and switch to other antihypertensive drugs. If pregnancy occurs during the use of Hartil-D, it should be quickly replaced (before the end of the first trimester) with a preparation that does not contain an ACE inhibitor to prevent the risk of fetal damage. Since ramipril and hydrochlorothiazide are excreted in breast milk, the preparation cannot be used during lactation. Storage conditions and shelf life Store at a temperature not exceeding 25°C, out of reach of children. The shelf life is indicated on the packaging. The preparation must not be used after the expiry date indicated on the packaging. Dispensing from pharmacy By prescription.