Aspicard enteric tablets p/o 75mg №10×3

Name:
Aspicard. Forms of release Tablets. MNNA acetylsalicylic acid FTHS Non-steroidal anti-inflammatory drugs.
Description:
Pills are film-coated, pink, round, with a biconvex surface. Composition One tablet contains: active ingredient – acetylsalicylic acid – 75 mg or 150 mg; excipients – starch 1500 (corn starch partially pregelatinized), microcrystalline cellulose, stearic acid, opadry (contains: hypromellose, triacetin, talc), acrylic-from (contains: methacrylic acid and ethyl acrylate copolymer (1: 1), talc, triethyl citrate, anhydrous colloidal silicon dioxide, sodium carbonate, sodium lauryl sulfate, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172)). Pharmacotherapeutic group Inhibitors of platelet aggregation, excluding heparin. ATX code: B01AC06. Indications for use – Unstable angina – as part of standard therapy. – Acute myocardial infarction – as part of standard therapy. – Prevention of recurrent myocardial infarction. – Prevention of recurrent transient ischemic attack (TIA) and recurrent cerebral infarction. – Prevention of thrombosis after surgery and invasive interventions on the vessels (for example, after coronary artery bypass grafting (CABG) or primary percutaneous coronary intervention (PCI). – Prevention of cardiovascular diseases in high-risk patients is possible only on prescription if the benefit of therapy exceeds the risk of adverse events, in particular bleeding, and the possibility of diagnosing occult bleeding.Note: acetylsalicylic acid in a single dose of 75-150 mg is not intended for the treatment of pain.Contraindications – hypersensitivity to salicylic acid derivatives or cyclooxygenase inhibitors (for example, in some patients with asthma) and any of the excipients; – exacerbation or recurrent gastric ulcer and/or intestinal bleeding or other types of bleeding such as cerebrovascular bleeding; – hemorrhagic diathesis, bleeding disorders such as hemophilia and thrombocytopenia; – severe liver or kidney failure; – doses greater than 100 mg/day during the third trimester of pregnancy; – taking methotrexate at doses >15 mg/week. Dosage and administration – Unstable angina pectoris: 75-150 mg 1 time per day. – Acute myocardial infarction: 75-150 mg 1 time per day. – Prevention of recurrent myocardial infarction: 300 mg 1 time per day. – Prevention of recurrent transient ischemic attack (TIA) and recurrent cerebral infarction: 75-150 mg 1 time per day. – Prevention of thrombosis after surgery and invasive interventions on the vessels (for example, after coronary artery bypass grafting (CABG) or primary percutaneous coronary intervention (PCI)): 75-150 mg 1 time per day. Antiplatelet therapy with acetylsalicylic acid is recommended to start 24 hours after CABG or PPCI. – Prevention of cardiovascular diseases in patients at high risk (possible only on prescription, if the benefit of therapy outweighs the risk of adverse events): 75 mg 1 time per day. Acetylsalicylic acid is recommended to be taken once a day, before meals, with plenty of liquid. In acute myocardial infarction, it is recommended to chew the first tablet and drink plenty of water. Acetylsalicylic acid 75 mg (150 mg) is intended for long-term use. The duration of therapy is determined by the doctor. Side effect Side effects are grouped based on organ system classes. Within each class, frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/100). 10000 to <1/1000), very rare (<1/10000) and unknown (cannot be estimated from the available data). On the part of the hematopoietic organs: often - increased bleeding; rarely - thrombocytopenia, agranulocytosis, aplastic anemia; unknown - bleeding with prolonged clotting time, such as nosebleeds, bleeding from the gums (symptoms may persist for 4-8 days after stopping Aspicard), increased risk of bleeding during surgical procedures, overt (hematemesis, melena) or hidden gastric - intestinal bleeding, which can lead to iron deficiency anemia (more frequent when taken in high doses). From the immune system: rarely - hypersensitivity reactions, angioedema, allergic edema, anaphylactic reactions, including shock. From the side of digestion metabolism: unknown - hyperuricemia. From the nervous system: rarely - intracranial hemorrhage; unknown - headache, dizziness. From the senses: unknown - hearing loss, tinnitus. From the vascular system: rarely - hemorrhagic vasculitis. On the part of the respiratory system and mediastinum: infrequently - rhinitis, shortness of breath; rarely - bronchospasm, asthma attacks. From the reproductive system: rarely - menorrhagia. From the gastrointestinal tract: often - dyspepsia; rarely - gastrointestinal bleeding, nausea, vomiting; unknown - ulcer or perforation of the stomach or duodenum. From the hepatobiliary system: unknown - liver failure. From the side of the skin and subcutaneous tissue: infrequently - urticaria; rarely - Stevens-Johnson syndrome, Lyell's syndrome, purpura, erythema, erythema multiforme. From the side of the kidneys and urinary tract: unknown - impaired renal function. Precautions Aspicard is not suitable for use as an anti-inflammatory, analgesic or antipyretic agent. This medicinal product is not recommended for use in adolescents (children) under 16 years of age unless the expected benefit outweighs the possible risks. Aspicardium may be an etiological factor in Reye's syndrome in some children. There is an increased risk of bleeding, especially during or after surgery (even in cases of minor procedures such as tooth extraction). In this case, it may be necessary to temporarily stop treatment 1-2 days before surgery. Aspicard is not recommended during menorrhagia as it may increase menses. Aspicard should be used with caution in hypertension and a history of gastric or duodenal ulcer or hemorrhagic episodes, or if the patient is being treated with drugs that alter hemostasis (ie, anticoagulants such as warfarin, thrombolytic and antiplatelet agents, anti-inflammatory drugs and selective serotonin reuptake inhibitors). Patients should report any unusual bleeding to their doctor. If gastrointestinal bleeding or ulceration occurs, treatment should be discontinued. Aspicard should be used with caution in patients with moderate renal or hepatic impairment (contraindicated in severe impairment), or in patients who are dehydrated. Aspicardium can provoke bronchospasm and asthma attacks or other hypersensitivity reactions. Risk factors: existing asthma, hay fever, nasal polyposis or exacerbation of chronic respiratory diseases, allergic reaction to other substances (skin reactions, itching or urticaria). Serious skin reactions, including Stevens-Johnson syndrome, have rarely been observed in association with the use of Aspicard. Reception should be discontinued at the first appearance of a skin rash, mucosal lesions, or any other sign of hypersensitivity. Elderly patients are particularly sensitive to the adverse effects of NSAIDs, including acetylsalicylic acid. In the case of long-term therapy, patients should be regularly monitored by a doctor. Particular attention should be paid to patients receiving concomitant medications that increase the risk of ulceration, such as oral corticosteroids, selective serotonin reuptake inhibitors and deferasirox. Aspicard in low doses reduces the excretion of uric acid, in patients with a predisposition to gout, this can provoke an attack. With an overdose of acetylsalicylic acid, it is possible to increase the hypoglycemic effect of sulfonylurea and insulin. Pregnancy and lactation Low doses (up to 100 mg/day): these doses, with limited use and special monitoring, are safe. Doses of 100-500 mg/day and above: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. During the first and second trimesters of pregnancy, acetylsalicylic acid should not be taken unless absolutely necessary. If acetylsalicylic acid is used by a woman during the first and second trimester of pregnancy, or just planning a pregnancy, then the dose should be as low as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can lead the fetus to: - cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligohydroamnios. In the mother and fetus - to the prolongation of bleeding time, anti-aggregation effect at the end of pregnancy, even when taken in very low doses. In the mother - to the suppression of uterine contractions and, as a result, delayed or prolonged labor. Therefore, acetylsalicylic acid at a dose of 100 mg / day and above is contraindicated in the third trimester of pregnancy. Lactation Short-term use of the recommended dose does not require weaning the child from the breast. In cases of prolonged use and / or the introduction of higher doses, breastfeeding should be discontinued. Influence on the ability to drive vehicles and work with mechanisms Aspicard does not affect the reaction and ability to drive. Interaction with other medicinal products Contraindicated combinations Methotrexate (used at doses >15 mg/week): methotrexate and acetylsalicylic acid increase the haematological toxicity of methotrexate. Combinations not recommended Uric acid scavengers such as probenecid. Combinations that require precautions for use or should be taken into account Anticoagulants, eg coumarins, heparin, warfarin. Increased risk of bleeding. Bleeding time should be controlled. Antiplatelet agents (clopidogrel and dipyridamole) and selective serotonin reuptake inhibitors (SSRIs such as sertraline or paroxetine): increased risk of gastrointestinal bleeding. Antidiabetic, for example, sulfonylurea derivatives: acetylsalicylic acid may increase their hypoglycemic effect. Digoxin and lithium: Monitoring of plasma concentrations of digoxin and lithium is recommended when starting and stopping treatment with Aspicard. Dosing regimen may need to be adjusted. Diuretics and Antihypertensives: NSAIDs may reduce the antihypertensive effect of diuretics and other antihypertensive drugs. With the joint appointment of NSAIDs with ACE inhibitors, the risk of acute renal failure increases. Diuretic: risk of acute renal failure. It is recommended to monitor the fluid intake and kidney function of the patient at the beginning of treatment. Carbonic anhydrase inhibitors (acetazolamide): severe acidosis and increased central nervous system toxicity. Systemic corticosteroids: increased risk of gastrointestinal ulceration and bleeding. Methotrexate (when used at doses less than 15 mg/week): May increase the haematological toxicity of methotrexate. Weekly blood control is required during the first weeks of use. Enhanced control even with mildly impaired renal function and in the elderly. Other NSAIDs: increased risk of ulcers and gastrointestinal bleeding due to synergistic effects. Ibuprofen: Regular combination of this combination of drugs should be avoided. Cyclosporine, tacrolimus: May increase the nephrotoxic effects of cyclosporine and tacrolimus. Renal function should be monitored in the case of concomitant use of these drugs and Aspicard. Valproate: Acetylsalicylic acid increases plasma concentrations of valproate at steady state. Phenytoin: The therapeutic effect of phenytoin, in general, will not change significantly. Alcohol: The simultaneous use of alcohol and Aspicard increases the risk of gastrointestinal bleeding. Overdose and relief measures The toxic dose is approximately 200 mg/kg in adults and 100 mg/kg in children. The lethal dose of acetylsalicylic acid is 25-30 grams. Plasma concentrations of salicylates above 300 mg/l indicate intoxication. Plasma concentrations above 500 mg/l in adults and 300 mg/l in children usually cause severe intoxication. Overdose can be dangerous for older patients and especially for young children. Symptoms of moderate intoxication: ringing in the ears, hearing loss, headache, dizziness, confusion and gastrointestinal symptoms (nausea, vomiting and abdominal pain). Symptoms of severe intoxication: severe violation of the acid-base balance. In addition, the following symptoms may be observed: pyrexia and sweat, as a result of dehydration: feelings of restlessness, convulsions, hallucinations and hypoglycemia. Depression of the nervous system can lead to coma, heart failure, or respiratory arrest. Treatment of overdose: if the toxic dose is ingested, hospitalization is not required. In case of moderate intoxication, it is necessary to try to induce vomiting. If this does not help, gastric lavage may be attempted within the first hour after taking a significant amount of the drug. Subsequently, the patient should be given activated charcoal (adsorbent) and sodium sulfate (laxative). Activated charcoal once (50 g for an adult, 1 g/kg of body weight for a child under 12 years of age). Urinary alkalinization (250 mmol NaHCO3, for three hours) is required, while monitoring the pH of the urine. For other symptoms, symptomatic therapy is carried out. Packing: 10 tablets in a blister pack made of PVC film and aluminum foil. 3, 5 or 10 blister packs, together with the leaflet, are placed in a pack of cardboard (No. 10×3, No. 10×5, No. 10×10). Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiration date. Conditions for dispensing from pharmaciesWithout a prescription. Buy Aspicard enteric tablets p/o 75mg No. 10×3