Toras Denk 10mg 30 tablets

Form

tableti

Dosage mg

10

Pack

30

Tora-Denk 10 Tablets for Oral Administration Loop Diuretics Active Ingredient: Torasemide 10 mg Medication Annotation: Information for the User Read the instructions completely before taking the medication. Keep the instructions, as you may need to read them again. If you have any further questions, consult your doctor or pharmacist. This medication is intended for you only and should not be given to others. It may be harmful to others, even if they have similar symptoms. If any side effect becomes serious, or if you notice any side effects not listed in these instructions, consult your doctor or pharmacist. Active Substance: 1 tablet contains 10 mg of torasemide. Excipients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate, colloidal anhydrous silica. Pharmacology: Pharmacotherapeutic Group: Loop diuretic/saluretic ATC Code: C03CA04 Torasemide has a saluretic effect by inhibiting the reabsorption of sodium and chloride from the ascending limb of the loop of Henle. In humans, the diuretic effect is rapidly apparent after intravenous administration or oral intake of the preparation. The maximum effect is observed within 1 hour or 2-3 hours and can last up to 12 hours. In healthy individuals, a dose-dependent increase in diuretic effect was observed after administration of approximately 5-100 mg (maximum activity). Enhanced diuresis may also occur when other diuretics (e.g., distally acting thiazides) are ineffective, for example, in cases of impaired kidney function. Due to this property, torasemide reduces edema. By reducing pre- and afterload, torasemide improves symptoms and the condition of the heart muscle during the treatment of heart failure. After oral administration of torasemide, the antihypertensive effect appears within the first week of treatment, and the maximum effect is usually observed no later than 12 weeks. Torasemide lowers blood pressure by reducing peripheral resistance. This effect is due to the regulation of electrolyte imbalance, and particularly to the reduction of a large amount of free Ca2+ ions in arterial muscle cells, which is very typical for hypertension. This likely reduces contractility or vascular sensitivity to vasoconstrictive substances, such as catecholamines. Pharmacokinetics: Absorption and Distribution: After oral administration, torasemide is rapidly and almost completely absorbed. Peak plasma concentration is observed 1-2 hours later. Bioavailability is approximately 80-90%, and the first-pass effect is 10-20%, meaning absorption is complete. Two studies have shown that the rate of torasemide absorption (time-dependent) is reduced after food intake (lower Cmax and increased tmax values), but the total absorption of torasemide remains unchanged even after food intake. 99% of torasemide binds to plasma proteins, while its metabolites M1, M3, and M5 bind to plasma proteins at 86%, 95%, and 97% respectively. The volume of distribution is 16 L. Metabolism: In humans, torasemide is metabolized into 3 metabolites: M1, M3, and M5. There is no data on the existence of other metabolites. M1 and M5 metabolites are formed when the methyl group in the phenyl ring is sequentially oxidized to a carboxylic acid, and the M3 metabolite is formed by hydroxylation of the ring. M2 and M4 metabolites were observed in experimental animals but not in humans. Torasemide and its metabolites exhibit dose-proportional kinetics, as peak plasma concentration and area under the plasma curve increase proportionally with dose. Elimination: In healthy individuals, the terminal half-life (t1/2) of torasemide and its metabolites is 3-4 hours. The total clearance of torasemide is 40 ml/min, and renal clearance is 10 ml/min. Approximately 80% of the administered dose in healthy individuals is excreted in the urine as torasemide and its metabolites with the following average percentages: torasemide – approximately 24%, metabolite M1 – approximately 12%, metabolite M3 – approximately 3%, metabolite M5 – approximately 41%. The main metabolite, M5, is inactive as a diuretic, while the active metabolites M1 and M3 account for approximately 10% of the pharmacodynamic action. In cases of kidney failure, total clearance and the half-life of torasemide remain unchanged, but the half-life of metabolites M3 and M5 is prolonged. However, the pharmacodynamic action remains unchanged, and the duration of the preparation's effect is not affected by the severity of kidney failure. Significant elimination of torasemide and its metabolites does not occur through hemodialysis and hemofiltration. In patients with liver and heart failure, the half-life of torasemide and its metabolite M5 is slightly prolonged. However, the amount of substances excreted in the urine corresponds to that of healthy individuals. Therefore, accumulation of torasemide and its metabolites is not expected. Indication Tora-Denk 10 is a diuretic and antihypertensive agent. It belongs to the group of preparations known as loop diuretics. Tora-Denk 10 is used for the prevention and treatment of fluid accumulation in tissues and body cavities (exudate) due to heart dysfunction (heart failure). Contraindications: Tora-Denk 10 should not be used in cases of: - Hypersensitivity to the active substance - torasemide, substances of similar structure (sulfonylureas), or any of the ingredients of Tora-Denk 10; - Kidney failure with no urine output (anuria); - Severe liver dysfunction with impaired consciousness (coma or hepatic pre-coma); - Low blood pressure (hypotension); - Low body fluid volume (hypovolemia); - Deficiency of sodium or potassium in the blood (hyponatremia, hypokalemia); - Obstruction of urine flow (e.g., due to enlarged prostate); - Lactation period; Use with Special Caution: As there is insufficient data on Tora-Denk 10, it should be used with caution in the following cases: - Gout; - Heart arrhythmias (sinoatrial block, AV block of II or III degree); - Acid-base balance disorders; - Combined administration with lithium, aminoglycosides, cephalosporins; - Blood count disorders (e.g., thrombocytopenia or anemia, patients with kidney dysfunction); - Kidney failure caused by nephrotoxic substances; Children under 12 years of age: As there is no data on the use of Tora-Denk 10 in children under 12 years of age, it is not recommended to prescribe Tora-Denk 10. Pregnancy and Lactation: Pregnancy: There is insufficient data on the effect of Tora-Denk 10 on the fetus. In animal studies, the active ingredient of Tora-Denk 10 did not have an embryotoxic effect. However, at high doses of the active ingredient, an embryotoxic effect was observed in both animal fetuses and their mothers. Until more information is available on Tora-Denk 10, it should not be prescribed during pregnancy unless there is a necessary medical indication. The lowest effective dose may be prescribed. Therefore, if the patient is pregnant or plans to become pregnant, she should consult her doctor. Lactation: There is no data on whether the active ingredient of Tora-Denk 10 - torasemide - is excreted in human or animal milk. Therefore, the use of Tora-Denk 10 is contraindicated during lactation. If the treating physician decides to prescribe Tora-Denk 10 during lactation, breastfeeding should be discontinued. Driving and Operating Machinery: Even when taken as prescribed, Tora-Denk 10 may alter the ability to react, impairing the ability to drive, operate machinery, or perform work. This is particularly true at the beginning of treatment, with dose increases, changes in medication, the initial phase of combination therapy, and when taking the preparation with alcohol. Special Precautions Regarding Certain Ingredients of the Preparation: This preparation contains lactose monohydrate, so if the patient has an intolerance to sugar, they should consult their doctor before taking Tora-Denk 10. Taking the Preparation with Other Medications: If the patient is taking or has recently taken any other medication, including over-the-counter drugs, they should consult their doctor or pharmacist. Please note that this information also applies to medications taken in the recent past. Tora-Denk 10 enhances the effect of other antihypertensive drugs, especially ACE inhibitors. If an ACE inhibitor is taken with or after Tora-Denk 10, severe hypotension may develop. Potassium deficiency caused by Tora-Denk 10 may enhance the side effects of digitalis if taken in combination. Tora-Denk 10 may reduce the effect of antidiabetic drugs. Probenecid (a gout medication) and some anti-inflammatory drugs (indomethacin, acetylsalicylic acid) may reduce the diuretic and antihypertensive effect of Tora-Denk 10. Tora-Denk 10 may enhance the effect of high doses of salicylates (analgesic and antirheumatic drug) on the central nervous system. Especially at high doses, Tora-Denk 10 may enhance the following side effects: ototoxic and nephrotoxic effects caused by antibiotics of the aminoglycoside group (e.g., kanamycin, gentamicin, tobramycin) or cisplatin preparations (anticancer drug), as well as nephrotoxic effects of cephalosporins (anti-infective drug). Tora-Denk 10 may enhance the effect of both theophylline (asthma medication) and curare-type muscle relaxants. Both laxatives and adrenocortical hormones (mineralocorticoids and glucocorticoids, e.g., cortisone) may enhance hypokalemia caused by Tora-Denk 10. Serum lithium levels and the cardiotoxic and nephrotoxic effects of lithium may be enhanced when Tora-Denk 10 is taken in combination. Tora-Denk 10 may make arteries less sensitive to vasoconstrictive drugs such as adrenaline and noradrenaline. When taken in combination with cholestyramine (lipid-lowering drug), the absorption of Tora-Denk 10 from the gastrointestinal tract may sometimes be reduced, and consequently its effect may be reduced. Dosage and Administration: Tora-Denk 10 should always be taken according to your doctor's instructions. If in doubt, consult your doctor or pharmacist. Tora-Denk 10 is taken orally. The antihypertensive effect of torasemide begins within 1 week of administration, and its maximum antihypertensive effect is usually observed approximately 12 weeks later. Unless otherwise prescribed by your doctor, the usual dosage is as follows: Treatment is initiated with 5 mg torasemide/day, and corresponding dosage tablets are available. The dose is usually maintenance. 1 tablet of Tora-Denk 10 (equivalent to 10 mg torasemide) per day is prescribed when the usual dose of 5 mg torasemide/day no longer provides an adequate response. In such cases, 1 tablet of Tora-Denk 10 (equivalent to 10 mg torasemide) per day may be taken. Depending on the severity of the disease, the dose may be increased to 2 tablets of Tora-Denk 10 per day (equivalent to 20 mg torasemide). Patients with Impaired Liver Function: Caution is required in patients with impaired liver function, as torasemide levels in serum may increase. Elderly Patients: Dose adjustment is not necessary in elderly patients. Children under 12 years of age: As there is no data on the use of Tora-Denk 10 in children under 12 years of age, it is not recommended to prescribe Tora-Denk 10. Method of Administration: The tablet should be swallowed whole with a small amount of water in the morning. Tora-Denk 10 does not need to be taken with food. Duration of Treatment: Tora-Denk 10 is usually taken for long-term treatment or until fluid retention (edema) is reduced. The doctor will determine the duration of treatment. The patient should consult their doctor if they feel that Tora-Denk 10 is acting too strongly or too weakly. Overdose: Intentional or accidental intake of a large amount of Tora-Denk 10 may lead to excessive and potentially dangerous elimination of water and salts, which may ultimately result in impaired consciousness, confusion, hypotension, circulatory collapse, and gastrointestinal complaints. In such cases, immediate medical attention is required for appropriate treatment. Missed Dose: If a very small dose of Tora-Denk 10 is taken or a dose is missed, the preparation will be less effective. This will manifest as a worsening of the clinical picture, e.g., weight gain or increased fluid retention. Take the missed dose as soon as you remember. Do not take the missed dose if it is close to the time for your next dose. In this case, do not take an extra tablet next time. Instead, continue taking Tora-Denk 10 as recommended by your doctor. Discontinuation of Treatment: If the course of treatment is discontinued or shortened, symptoms may worsen. Therefore, under no circumstances should the course of treatment with Tora-Denk 10 be discontinued or shortened without consulting your doctor. If you have any further questions about the use of this preparation, consult your doctor or pharmacist. Side Effects: Like all medicines, Tora-Denk 10 may cause side effects, although not everyone gets them. The following are known side effects of Tora-Denk 10 or other loop diuretics. The frequency of side effects is categorized as follows: Very common: in more than 1 in 10 patients Common: more than 1 in 100, but less than 1 in 10 patients Uncommon: more than 1 in 1,000, but less than 1 in 100 patients Rare: more than 1 in 10,000, but less than 1 in 1,000 patients Very rare: less than 1 in 10,000, including individual cases Important Side Effects/Symptoms and Treatment Methods: If the patient experiences any of the following reactions, discontinue Tora-Denk 10 and start treatment as soon as possible. Metabolism/Electrolytes: Common: Disorder of the body's acid-base balance (metabolic alkalosis). Muscle spasms (especially at the beginning of treatment). Increased levels of uric acid, glucose, and fats (triglycerides, cholesterol) in the blood. Potassium deficiency (hypokalemia), if the diet is low in potassium, as well as in cases of vomiting, diarrhea, excessive use of laxatives, and chronic liver failure. Depending on the dose and duration of treatment, water-salt balance disorders may develop, especially a reduction in fluid volume (hypovolemia), and potassium and/or sodium deficiency (hypokalemia and/or hyponatremia). Cardiovascular System: Very rare: Thromboembolic complications, impaired consciousness, decreased blood pressure (hypotension). Also, due to hemoconcentration, circulatory disturbances and hypo-perfusion of the heart and brain may develop. This in turn can lead to arrhythmias, chest pain (angina pectoris), heart attack, or loss of consciousness (syncope). Gastrointestinal Tract: Common: Gastrointestinal complaints (e.g., loss of appetite, stomach pain, nausea, vomiting, diarrhea, constipation), which are particularly pronounced at the beginning of treatment. Very rare: Pancreatitis. Kidneys and Urinary System: Uncommon: Increased levels of serum creatinine and urea. In cases of urinary tract obstruction, urine retention may develop. Liver: Common: Increased levels of certain liver enzymes (gamma-GT). Skin and Allergic Reactions: Very rare: Allergic reactions such as itching, skin inflammation (exanthema), increased sensitivity to light (photosensitivity), severe skin reactions. Blood and Hematopoietic System: Very rare: Reduction in the levels of red and white blood cells (erythrocytes, leukocytes) and platelets. General: Common: Headache, dizziness, fatigue, weakness (especially at the beginning of treatment). Uncommon: Dry mouth, sensation of numbness and cold in the extremities (paresthesia). Very rare: Visual disturbances, ringing in the ears, hearing impairment. Preventive Measures: In case of any of the above side effects, consult your doctor or pharmacist, as they can assess the severity of the condition and prescribe appropriate treatment if necessary. If any side effect occurs suddenly or worsens, notify your doctor immediately, as some side effects can be life-threatening. Your doctor will decide what measures are necessary and whether to continue treatment. Treatment with Tora-Denk 10 should be discontinued at the first sign of an allergic reaction. If any side effect occurs that is not described above, consult your doctor or pharmacist. Storage: Store in a dry place at a temperature below 25°C. The expiry date is indicated on the blister and the box. Do not use after the expiry date. Keep out of reach of children.