Cardiomagnyl, 30 pcs., 75 mg+15.2 mg, film-coated tablets

Cardiomagnyl tablet s/p/v 75 mg+15.2 mg 100 pcs

The drug should be used after a doctor's prescription. ASA can provoke bronchospasm, as well as cause attacks of bronchial asthma and other hypersensitivity reactions. Risk factors include a history of bronchial asthma, hay fever, nasal polyposis, chronic respiratory diseases, and allergic reactions to other drugs (for example, skin reactions, itching, urticaria).

ASA can cause bleeding of varying severity during and after surgery. Several days before planned surgery, the risk of bleeding should be assessed in comparison with the risk of ischemic complications in patients taking low doses of ASA. If the risk of bleeding is significant, ASA should be temporarily discontinued. The combination of ASA with anticoagulants, thrombolytics and antiplatelet drugs is accompanied by an increased risk of bleeding.

ASA in low doses can trigger the development of gout in predisposed patients (those with reduced excretion of uric acid).

The combination of ASA with methotrexate is accompanied by an increased incidence of side effects from the hematopoietic organs.

High doses of ASA have a hypoglycemic effect, which must be kept in mind when prescribing it to patients with diabetes mellitus receiving oral hypoglycemic agents and insulin.

When using systemic glucocorticosteroids (GCS) and salicylates in combination, it should be remembered that during treatment the concentration of salicylates in the blood is reduced, and after discontinuation of systemic glucocorticosteroids (GCS), an overdose of salicylates is possible.

The combination of ASA with ibuprofen is not recommended in patients with an increased risk of cardiovascular diseases: when used simultaneously with ibuprofen, there is a decrease in the antiplatelet effect of ASA in doses up to 300 mg, which leads to a decrease in the cardioprotective effects of ASA.

Exceeding the dose of ASA above the recommended therapeutic doses is associated with the risk of gastrointestinal bleeding.

With long-term use of low doses of ASA as aggregative therapy, caution must be exercised in elderly patients due to the risk of gastrointestinal bleeding.

When taking ASA simultaneously with alcohol, there is an increased risk of damage to the mucous membrane of the gastrointestinal tract and prolongation of bleeding time.

Effect on the ability to drive vehicles and moving machinery During treatment with ASA drugs, care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Cardiomagnyl tablets p/o 75 mg No. 100

Name

Cardiomagnyl tablet p/plen.ob. 75mg/15.2mg per bottle. No. 100

Description

White film-coated tablets in the shape of a stylized “heart”.

Main active ingredient

Acetylsalicylic acid

Release form

pills

Dosage

75 mg

Special instructions and precautions

Long-term use of the drug Cardiomagnyl in combination with other NSAIDs should be avoided due to the increased risk of adverse reactions (see section “Interaction with other drugs and other forms of interaction”). Cardiomagnyl should not be used in children under 2 years of age unless directed by a doctor. Elderly patients should not use Cardiomagnyl for a long time as an analgesic, anti-inflammatory, antipyretic, or for the treatment of rheumatic diseases due to the risk of gastrointestinal bleeding. The use of low doses of acetylsalicylic acid in elderly patients for the treatment of acute or chronic ischemic heart disease, stroke, stroke prevention or coronary heart disease should be carried out with caution due to the risk of gastrointestinal bleeding. Preparations containing acetylsalicylic acid should not be used to treat viral infections in children under 15 years of age without a doctor's prescription. In case of viral diseases such as influenza A, influenza B and chicken pox, there is a risk of developing Reye's syndrome, which is a very rare but potentially life-threatening disease that requires immediate medical attention. The risk of developing this syndrome may be increased with concomitant use of acetylsalicylic acid, but there is no evidence of a cause-and-effect relationship. The appearance of persistent vomiting against the background of these viral diseases may be a sign of the development of Reye's syndrome. It should be assessed whether it is necessary to temporarily stop taking low doses of the drug Cardiomagnyl several days before the date of planned surgical procedures if the risk of bleeding outweighs the risk of ischemia. Acetylsalicylic acid can provoke bronchospasm, as well as cause attacks of bronchial asthma and other hypersensitivity reactions. Risk factors include a history of asthma, hay fever, nasal polyps or chronic respiratory diseases, as well as allergic reactions to other drugs (for example, skin reactions, itching or urticaria). Therefore, the drug Cardiomagnyl should be used with caution in patients with hypersensitivity to other analgesics, anti-inflammatory and antirheumatic drugs and with a history of allergies. The drug should be prescribed with caution when:

• diseases of the gastrointestinal tract, tendency to dyspepsia;
• concomitant treatment with anticoagulants (vitamin K antagonists and heparin (see section “Interaction with other drugs and other forms of interaction”));
• renal failure;
• liver failure.

Fertility The use of acetylsalicylic acid may reduce fertility and the drug should not be used by women who are planning pregnancy. Women who are having difficulty conceiving or are being evaluated for infertility should consider stopping taking acetylsalicylic acid (see Pregnancy and Lactation).

Pharmacological properties

Acetylsalicylic acid is an analgesic, anti-inflammatory, antipyretic substance that also prevents platelet aggregation. This increases blood clotting time. The main pharmacological effect of acetylsalicylic acid is the inhibition of the formation of prostaglandins and thromboxanes. The analgesic effect is peripheral and is associated with inhibition of the enzyme cyclooxygenase. The anti-inflammatory effect is associated with a decrease in blood flow due to inhibition of PGE2 synthesis. Acetylsalicylic acid acetylates and irreversibly inhibits prostaglandin G/H synthase, and this effect in platelets lasts longer than the time of presence of acetylsalicylic acid in the body. The effect of acetylsalicylic acid on the biosynthesis of thromboxane in platelets and on bleeding time is maintained for several days after cessation of treatment. This effect decreases as new platelets appear in the plasma. Salicylate (the active metabolite) in addition to its anti-inflammatory effect has effects on respiration, acid-base balance and the stomach. Salicylates primarily stimulate respiration by direct action on the medulla oblongata. Salicylates have a direct irritating effect on the gastric mucosa, which creates a predisposition to ulcer formation by inhibiting vasodilatory and cytoprotective prostaglandins.

Pharmacokinetic properties

Absorption Acetylsalicylic acid is rapidly absorbed from the gastrointestinal tract. After oral administration of the drug, non-ionized acetylsalicylic acid is absorbed in the stomach and intestines. Food reduces the rate of absorption; the same is true for patients who suffer from migraines. The rate of absorption is increased in patients suffering from achlorhydria or in patients taking polysorbents or antacids. The peak concentration of acetylsalicylic acid in serum is reached within half an hour, salicylic acid - within 1-2 hours. Distribution Acetylsalicylic acid is 80-90% bound to plasma proteins. The volume of distribution in adult patients is 170 ml/kg body weight. With an increase in the concentration of the active substance in plasma, protein binding centers are saturated with acetylsalicylic acid, which helps to increase the volume of distribution. Salicylates bind well to plasma protein and are quickly distributed in the body. Salicylic acid passes into breast milk and can pass through the placenta. Biotransformation Acetylsalicylic acid is partially hydrolyzed to the active metabolite salicylate in the intestinal walls. After absorption, acetylsalicylic acid is quickly converted to salicylic acid, but in the first 20 minutes after oral administration, acetylsalicylic acid predominates in the plasma. Excretion Salicylic acid is excreted from the body primarily through hepatic metabolism. Steady-state plasma concentrations of salicylate increase disproportionately to the dose. A dose of 325 mg of acetylsalicylic acid corresponds to first-order kinetics, the half-life is 2-3 hours. High doses of acetylsalicylic acid increase its elimination time to 15-30 hours. Salicylate is also excreted unchanged in the urine. The amount excreted depends on the dose of the drug and the pH level of the urine. Approximately 30% of the drug dose will be excreted in the urine if the urine is alkaline, and only 2% of the drug dose will be excreted in the urine if the urine is acidic. Excretion through the kidneys involves the process of glomerular filtration, active tubular secretion and passive tubular reabsorption. Preclinical Safety Data Limited formal toxicity studies have been conducted with acetylsalicylic acid. The oral LD50 in rats is 1.75 g/kg. Rats that received acetylsalicylic acid had a longer gestational period and birth period, and the mortality of rats during childbirth also increased.

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 repeated transient ischemic attack (TIA) and repeated cerebral infarction.
• Prevention of thrombosis after surgery and invasive vascular interventions (for example, after coronary artery bypass grafting (CABG) or primary percutaneous coronary intervention (PCI)).
• Prevention of cardiovascular diseases in patients at high risk is possible only as prescribed by a doctor, if the benefit of therapy outweighs the risk of adverse events, in particular bleeding, and it is possible to diagnose hidden bleeding.

Note: acetylsalicylic acid in a single dose of 75-150 mg is not intended for the treatment of pain.

Directions for use and doses

It is recommended to take acetylsalicylic acid once a day, before meals, with plenty of liquid. In case of acute myocardial infarction, it is recommended to chew the first tablet and drink plenty of water. Acetylsalicylic acid 75 mg is intended for long-term use. The duration of therapy is determined by the doctor. Children under 2 years of age Do not use in children unless directed by a physician. Hepatic impairment Should not be administered to patients with severe hepatic impairment (see section "Contraindications"). When treating patients with hepatic impairment, dose adjustment may be required (see section "Special Instructions and Precautions"). Renal impairment Should not be used in patients with severe renal impairment (glomerular filtration rate (GFR)

Use during pregnancy and lactation

Pregnancy Low doses (up to 100 mg/day) Clinical studies indicate that doses up to 100 mg/day are safe for certain obstetric conditions, but require specialized patient monitoring. Doses 100-500 mg/day There is insufficient clinical experience with the use of doses 100-500 mg/day. Therefore, it is recommended to follow the directions below for dosing at 500 mg/day. Doses 500 mg/day and above Third trimester: Prostaglandin synthesis inhibitors are contraindicated during the third trimester of pregnancy, as their use may cause the fetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction, which can progress to renal failure and consequently lead to a decrease in amniotic fluid volume.

At the end of pregnancy, prostaglandin synthesis inhibitors can provoke in the mother and newborn:

• possible increase in bleeding time due to the antiplatelet effect, which can occur even when taking the drug in very low doses;
• suppression of uterine contractions, which will lead to a delay in labor.

First and second trimester: During the first and second trimester of pregnancy, prostaglandin synthesis inhibitors should not be taken unless clearly necessary, and the dose should be kept to a minimum and the duration of treatment as short as possible. Fertility: Acetylsalicylic acid should not be used by women who are planning pregnancy as prostaglandin synthesis inhibitors are thought to reduce fertility. If it is necessary to undergo treatment with acetylsalicylic acid, then treatment should be as short as possible and doses should be minimal. The effect of the drug on fertility is reversible. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Data from epidemiological studies indicate an increased risk of spontaneous abortion, congenital heart defects and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of congenital cardiovascular defects increases from less than 1% to approximately 1.5%. The risk is believed to increase with increasing drug dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to increase pre- and post-implantation embryo loss and fetal fetal lethality. In addition, the number of cases of development of various defects, including the cardiovascular system, increased, which was recorded in animals receiving prostaglandin synthesis inhibitors during the period of organogenesis. Therefore, acetylsalicylic acid in doses of 100 mg/day and above is contraindicated during the third trimester of pregnancy. Lactation Data are insufficient. Before using acetylsalicylic acid, all benefits of treatment should be assessed taking into account the potential risk to the child.

Interaction with other drugs

Combinations with the following drugs should be avoided. Methotrexate Possible mechanism: decreased clearance of methotrexate. Consequence: methotrexate toxicity (leukopenia, thrombocytopenia, anemia, nephrotoxicity, mucosal ulcers). Angiotensin-converting enzyme (ACE) inhibitors Possible mechanism: inhibition of prostaglandin synthesis. Consequence: decreased effect of ACE inhibitors. Acetazolamide Possible mechanism: Increased concentrations of acetazolamide may result in diffusion of salicylate from plasma into tissues. Consequence: acetazolamide toxicity (fatigue, lethargy, drowsiness, confusion, hyperchloremic metabolic acidosis). Salicylate toxicity (vomiting, tachycardia, hyperpnea, confusion). Probenecid, sulfinpyrazone Possible mechanism: probenecid and high doses of salicylate (>500 mg) mutually block each other's effect on uric acid secretion. Consequence: decreased excretion of uric acid. When combining with the following drugs, caution should be exercised. Clopidogrel, ticlopidine The combination of clopidogrel and acetylsalicylic acid has a synergistic effect. This is associated with an increased risk of bleeding, which requires caution when prescribing this combination. Anticoagulants: warfarin, phenprocoumon Possible mechanism: reduces thrombin formation, which indirectly leads to a decrease in platelet activity (vitamin K antagonist). Consequence: increased risk of bleeding. Abciximab, tirofiban, eptifibatide Possible mechanism: slows down the action of glycoprotein IIb/IIIa receptors in platelets. Consequence: increased risk of bleeding. Heparin Possible mechanism: Reduces the rate of thrombin formation, which indirectly reduces platelet activity. Consequence: increased risk of bleeding. If two or more of the above substances are taken simultaneously with acetylsalicylic acid, this may result in a synergistic effect with enhanced inhibition of platelet activity and an increased risk of bleeding. NSAIDs and COX-2 inhibitors (celecoxib) Possible mechanism: additional irritation of the gastrointestinal tract. Consequence: increased risk of gastrointestinal bleeding. Ibuprofen Concomitant use of ibuprofen inhibits platelet aggregation induced by acetylsalicylic acid. The cardioprotective effect of acetylsalicylic acid may be reduced in patients at increased risk of cardiovascular disease who take ibuprofen. Patients taking acetylsalicylic acid once daily for the treatment or prevention of cardiovascular disease who require ibuprofen should take acetylsalicylic acid at least 2 hours before taking ibuprofen. Furosemide Possible mechanism: inhibition of furosemide secretion in the proximal tubules of the kidneys. Consequence: decreased diuretic effect of furosemide. Quinidine Possible mechanism: additive effect on platelets. Consequence: increased bleeding time. Spironolactone Possible mechanism: modification of the renin effect. Consequence: decreased effect of spironolactone. Selective serotonin reuptake inhibitor Possible mechanism: additional irritation of the gastrointestinal tract. Consequence: increased risk of gastrointestinal bleeding. Valproate Possible mechanism: Acetylsalicylic acid alters the binding and metabolism of valproate. Consequence: valproate toxicity (CNS depression, gastrointestinal disorders). When combining drugs, the dose of valproate may need to be adjusted. Corticosteroids Possible mechanism: additive irritation of the gastrointestinal tract, as well as increased renal clearance or metabolism of salicylates. Consequence: increased risk of gastrointestinal ulcers and subtherapeutic plasma concentrations of salicylic acid. Antidiabetic drugs Possible mechanism: additive hypoglycemic effect. Consequence: hypoglycemia. Antacids Possible mechanism: increased renal clearance and decreased renal absorption (due to increased urine pH). Consequence: decreased effect of acetylsalicylic acid. Varicella vaccination Possible mechanism: unknown. Consequence: increased risk of developing Reye's syndrome. Ginkgo Biloba Possible mechanism: Ginkgo Biloba inhibits platelet aggregation. Consequence: increased risk of bleeding.

Contraindications

Cardiomagnyl is contraindicated in patients with the following conditions/diseases:

• hypersensitivity to salicylates, non-steroidal anti-inflammatory drugs (NSAIDs) and/or to any of the excipients;
• hemorrhagic diathesis (vitamin K deficiency, thrombocytopenia, hemophilia);
• acute peptic ulcer;
• severe renal failure (GFR
• severe liver failure;
• severe heart failure;
• doses >100 mg/day during the third trimester of pregnancy;
• children under 15 years of age with fever (risk of developing Reye's syndrome, see section "Special instructions and precautions").

Compound

Each tablet contains 75 mg of acetylsalicylic acid. For a complete list of excipients, see the “List of excipients” section.

Overdose

Toxicity Toxic dose Adults: 300 mg/kg. Children: Single dose of 150 mg/kg or more than 100 mg/kg/day for more than 2 days. Symptoms Chronic intoxication with salicylates in a mild form occurs, as a rule, only after prolonged use of high doses of the drug. Symptoms include fever, tachypnea, tinnitus, respiratory alkalosis, metabolic acidosis, lethargy, mild dehydration, nausea and vomiting. Symptoms of severe or acute salicylate intoxication include hypoglycemia (especially in children), encephalopathy, coma, hypotension, pulmonary edema, seizures, coagulopathy, cerebral edema, and arrhythmias. Acute salicylate intoxication (>300 mg/kg) is often insufficient, and doses above 500 mg/kg can be fatal. The severity of intoxication is usually more pronounced with chronic overdose or abuse of the drug, as well as when taken by the elderly or children. Treatment In case of acute overdose of salicylate, gastric lavage should be performed. Repeated doses of activated charcoal may be given if the patient is believed to have taken more than 120 mg/kg of the drug. Serum salicylate levels should be measured at least every two hours after dosing until salicylate levels decrease and acid-base balance improves. Prothrombin time and/or INR should be monitored, especially if bleeding is suspected. Fluid and electrolyte balance must be restored. Alkaline diuresis and hemodialysis are effective methods for removing salicylate from plasma. The need for hemodialysis should be considered in cases of severe intoxication, as it quickly removes salicylate and restores the acid-base and water-salt balance.

Side effect

The most common adverse reactions are reactions from the gastrointestinal tract. The development of adverse reactions, as a rule, depends on the dose of the drug and the duration of treatment.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 °C. Keep out of the reach of children.