Akard tablets p / o enteric 75mg №30×1

Name:
Acard tab. p/intestinal.about. 75mg in bl. in pack. No. 30×1
Description:
Heart-shaped tablets, coated white, biconvex. The main active ingredient Acetylsalicylic acid Release form Tablets Dosage 75 mg Pharmacological properties The drug Akard contains acetylsalicylic acid, which inhibits platelet aggregation. The drug is intended for long-term prophylactic use in diseases that threaten the development of thrombosis and embolism of blood vessels. Indications for use Secondary prevention of myocardial infarction. Prevention of cardiovascular diseases in patients with coronary heart disease (angina pectoris). Unstable angina (with the exception of the acute phase). Prevention of graft occlusion after coronary artery bypass grafting (CABG). Coronary angioplasty (except for the acute phase). Secondary prevention of transient ischemic attacks (TIA) and ischemic cerebral infarction (MI) with the exclusion of intracerebral hemorrhages. Acetylsalicylic acid in enteric-coated tablets, 75 mg, is not recommended for acute cardiovascular diseases. Its use is limited to secondary prevention in the treatment of chronic pathology. Method of administration and doses Before using the drug Akard, you should consult your doctor. The doctor will prescribe the dose of the drug needed for this patient and determine the duration of therapy. For oral administration. Tablets should be swallowed whole with a sufficient amount of liquid (? glass of water). Tablets should not be crushed or chewed. Adults. Secondary prevention of myocardial infarction The recommended dose is 75150 mg once daily. Prevention of cardiovascular disease in patients with stable angina The recommended dose is 75150 mg once daily. Unstable angina (excluding the acute phase) The recommended dose is 75150 mg once daily. Prevention of graft occlusion after CABG The recommended dose is 75150 mg once daily. Coronary angioplasty (excluding the acute phase) The recommended dose is 75150 mg once daily. Secondary prevention of transient ischemic attacks (TIA) and ischemic cerebral infarctions (MII), provided that intracerebral hemorrhages are excluded, the recommended dose is 75300 mg once a day. Use in Elderly Patients Acard should be used with caution in elderly patients who are more prone to side effects. In the absence of severe renal or hepatic insufficiency, the drug is used in the same doses as in adults. It is recommended to periodically monitor the safety of treatment in this category of patients. Use in children Acard should not be administered to children and adolescents under 16 years of age, unless the benefit outweighs the expected risk. Use during pregnancy and lactation Before using any medicine, consult your doctor or pharmacist. Low doses (up to 100 mg/day): Clinical studies show that these doses, with limited use and special monitoring, are safe. Doses of 100500 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 planning a pregnancy or during the first and second trimester of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can lead the fetus to: cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligohydroamnios; in mother and newborn at the end of pregnancy to prolong bleeding time, anti-aggregation effect, even when taken in very low doses; in the mother to inhibition of uterine contractions and, as a result, to delayed or prolonged labor. Therefore, acetylsalicylic acid at a dose of 100 mg / day and above is contraindicated in the third trimester of pregnancy. Acetylsalicylic acid and its metabolites pass into breast milk in small amounts. With short-term use by mothers of acetylsalicylic acid in recommended doses, weaning the child from the breast is not mandatory. In cases of prolonged use and / or use of higher doses, breastfeeding should be discontinued. The ability to influence the reaction rate when driving vehicles or working with other mechanisms There have been no studies of the effect of the drug on the ability to drive vehicles. Based on the pharmacodynamic properties and side effects of acetylsalicylic acid, it can be concluded that Akard does not affect the reaction and ability to drive vehicles. Precautions Caution should be exercised and consult a doctor before using Akard. Acard is not suitable for use as an anti-inflammatory, analgesic, or antipyretic. This medicinal product is not recommended for use in adolescents (children) under 16 years of age unless the expected benefit outweighs the possible risks. Acardia 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 12 days before surgery. Akard is not recommended during menorrhagia, it can increase menstruation. Acard 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 anticoagulants. Patients should report any unusual bleeding to their doctor. If gastrointestinal bleeding or ulceration occurs, treatment should be discontinued. Acard should be used with caution in patients with moderate renal or hepatic impairment (contraindicated in severe impairment), or in patients who are dehydrated, as the use of NSAIDs may lead to deterioration of renal function. In such patients, liver function tests should be performed regularly. Acard 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, are rarely observed in connection with the use of Acard. Reception should be discontinued at the first appearance of a skin rash, mucosal lesions or any other sign of hypersensitivity. Elderly patients are particularly susceptible to the adverse effects of NSAIDs, including acetylsalicylic acid, especially gastrointestinal bleeding and perforation, which can be fatal. In the case of long-term therapy, patients should be regularly monitored by a doctor. Concomitant treatment with Acard and other drugs that alter hemostasis (i.e., anticoagulants such as warfarin, thrombolytic and antiplatelet agents, anti-inflammatory drugs, and selective serotonin reuptake inhibitors) is not recommended unless it is a life-saving therapy, as how they can increase the risk of bleeding. If the combination cannot be avoided, careful monitoring for the first manifestations of hemorrhagic complications is recommended. Particular attention should be paid to patients receiving concomitant drugs that increase the risk of ulceration, such as oral corticosteroids, selective serotonin reuptake inhibitors and deferasirox. Acard 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. Interactions with other drugs Inform your doctor or pharmacist about all medicines you are currently or recently taking, including those available without a prescription. Contraindicated combinations. Methotrexate (when used in doses> 15 mg / week): simultaneous use with acetylsalicylic acid increases the hematological toxicity of methotrexate. Combinations that are not recommended Uric acid scavengers, such as probenecid. Salicylates weaken the effect of probenecid. Combinations should be avoided. 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, such as sulfonylurea derivatives: acetylsalicylic acid may increase their hypoglycemic effect. Digoxin and lithium: acetylsalicylic acid reduces the renal excretion of digoxin and lithium, resulting in elevated plasma concentrations. Monitoring of plasma concentrations of digoxin and lithium is recommended at the beginning and after discontinuation of treatment with Acard. 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): May cause severe acidosis and increased central nervous system toxicity. Systemic corticosteroids: increased risk of gastrointestinal ulceration and bleeding. Methotrexate (when used in doses less than 15 mg / week): simultaneous use with acetylsalicylic acid may increase the hematological toxicity of methotrexate. Weekly blood monitoring is required during the first weeks of using this combination. Enhanced monitoring should be carried out even with slightly impaired renal function, as well as in elderly patients. Other NSAIDs: increased risk of ulcers and gastrointestinal bleeding due to synergistic effects. Ibuprofen: You should refrain from regular use in combination with acetylsalicylic acid. Cyclosporine, tacrolimus: Concomitant use of NSAIDs and cyclosporine or tacrolimus may increase the nephrotoxic effects of cyclosporine and tacrolimus. Renal function should be monitored in case of concomitant use of these drugs and Akard. Valproate: acetylsalicylic acid reduces the binding of valproate to serum albumin, thereby increasing its free plasma concentrations at steady state. Phenytoin: Salicylates reduce the binding of phenytoin in plasma to albumin. This may lead to a decrease in total plasma levels of phenytoin, but an increase in its free fraction. Thus, the therapeutic effect of phenytoin as a whole will not change significantly. Alcohol: the simultaneous use of alcohol and the drug Akard increases the risk of gastrointestinal bleeding. Contraindications Hypersensitivity to acetylsalicylic acid derivatives or cyclooxygenase inhibitors (eg in some patients with asthma) and to 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 and kidney failure. Doses greater than 100 mg/day during the third trimester of pregnancy. Methotrexate at doses > 15 mg/week. Composition One enteric-coated tablet contains: Active ingredient: acetylsalicylic acid 75 mg Excipients: tablet core: cellulose, powder, corn starch, carmellose sodium; shell: hypromellose, methacrylic acid copolymer C, talc, titanium dioxide, triethyl citrate, lauryl sulfate, anhydrous colloidal silicon, sodium carbonate monohydrate. Overdose In case of overdose, you should consult a doctor, and in case of severe poisoning, the patient should be immediately taken to the hospital. The toxic dose is approximately 200 mg/kg in adults and 100 mg/kg in children. The lethal dose of acetylsalicylic acid is 2530 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 elderly patients and especially for young children (overdose due to therapeutic use or frequent accidental poisoning can be fatal). 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. Hyperventilation with respiratory alkalosis and then respiratory acidosis occurs due to suppression of the respiratory center. In addition, metabolic acidosis results from the presence of salicylate itself. Young children often do not reach the last stages of acidosis when poisoned. In addition, the following symptoms may be observed: pyrexia and sweat resulting from 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, activated charcoal (adsorbent) and sodium sulfate (laxative) should be given to the patient. Activated charcoal can be given as a single dose (50 g for an adult, 1 g/kg body weight for a child under 12 years of age). Urinary alkalinization (250 mmol NaHCO3, for three hours) is necessary under the control of urine pH. In case of severe intoxication, hemodialysis is preferred. For other symptoms, symptomatic therapy is carried out. Missing a dose of a drug Do not take a double dose to make up for the missed dose, take the next dose as usual. Side effects Like all medicines, Acard can have side effects, although not everyone gets them. Stop using the medicinal product and contact your doctor immediately if the patient develops the first symptoms of an allergic reaction (e.g. swelling of the face, lips, tongue, throat, making it difficult to breathe or swallow) or if internal bleeding occurs, for example, from the digestive tract (symptoms: black stool) or bleeding. The doctor will assess the severity of the symptoms and decide on further actions. 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), infrequent (> 1/1000 to < 1/100), rare (> 1/100). 10,000 to < 1/1000), very rare (< 1/10,000) and unknown (cannot be estimated from the available data). Blood and lymphatic system disorders: often - increased bleeding; rarely thrombocytopenia, agranulocytosis, aplastic anemia; bleeding with an increase in clotting time, such as epistaxis, bleeding from the gums (symptoms may persist for up to 48 days after discontinuation of Acard), increased risk of bleeding during surgical procedures, overt (hematemesis, melena) or hidden gastrointestinal bleeding, which can lead to iron deficiency anemia (more common when taken in high doses). Immune system disorders: rarely, hypersensitivity reactions, angioedema, allergic edema, anaphylactic reactions, including shock. Metabolic and nutritional disorders: Not known hyperuricemia. Nervous system disorders: rarely intracranial hemorrhage; unknown headache, dizziness. Hearing and labyrinth disorders: unknown hearing loss, tinnitus. Vascular disorders: Rarely, hemorrhagic vasculitis. Respiratory, thoracic and mediastinal disorders: infrequently rhinitis, dyspnoea; rarely bronchospasm, asthma attacks. On the part of the genital organs and the mammary gland: rarely menorrhagia. Gastrointestinal disorders: often dyspepsia; rarely gastrointestinal bleeding, nausea, vomiting; unknown ulcer or perforation of the stomach or duodenum. Liver and biliary tract disorders: unknown - liver failure. Skin and subcutaneous tissue disorders: infrequently urticaria; rarely Stevens-Johnson syndrome, Lyell's syndrome, purpura, erythema, erythema multiforme. Renal and urinary tract disorders: unknown - impaired renal function. In the event of an increase in any of the adverse reactions or the appearance of any adverse effects not described in this leaflet, you should inform your doctor or pharmacist about them. Storage conditionsStore at a temperature not exceeding 25 °C. Store in original packaging to protect from moisture and light. Store out of the reach of children.