Sanovasc^® (Tablets) Instructions for Use

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Or

Avexima Siberia LLC (Russia)

ATC Code

B01AC06 (Acetylsalicylic acid)

Active Substance

Acetylsalicylic acid (Ph.Eur. European Pharmacopoeia)

Dosage Forms

	Sanovasc®	Enteric-coated tablets, film-coated, 50 mg: 20, 30, 40, 60, 80 or 100 pcs.
		Enteric-coated tablets, film-coated, 75 mg: 20, 30, 40, 60, 80 or 100 pcs.
		Enteric-coated tablets, film-coated, 100 mg: 20, 30, 40, 60, 80 or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets, film-coated white or almost white, round, biconvex; on cross-section – a core of white or almost white color and a thin shell strip.

Excipients: lactose monohydrate – 31.5 mg, microcrystalline cellulose 102 – 16.3 mg, colloidal silicon dioxide – 1.7 mg, sodium carboxymethyl starch – 0.5 mg.

Shell composition methacrylic acid and ethyl acrylate copolymer 1:1 – 3.35 mg, povidone K17 – 0.56 mg, talc – 0.75 mg, macrogol 4000 – 0.34 mg.

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.

Enteric-coated tablets, film-coated white or almost white, round, biconvex; on cross-section – a core of white or almost white color and a thin shell strip.

Excipients: lactose monohydrate – 47.25 mg, microcrystalline cellulose 102 – 24.4 mg, colloidal silicon dioxide – 2.6 mg, sodium carboxymethyl starch – 0.75 mg.

Shell composition methacrylic acid and ethyl acrylate copolymer 1:1 – 6.7 mg, povidone K17 – 1.12 mg, talc – 1.5 mg, macrogol 4000 – 0.68 mg.

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.

Enteric-coated tablets, film-coated white or almost white, round, biconvex; on cross-section – a core of white or almost white color and a thin shell strip.

Excipients: lactose monohydrate – 63 mg, microcrystalline cellulose 102 – 32.6 mg, colloidal silicon dioxide – 3.4 mg, sodium carboxymethyl starch – 1 mg.

Shell composition methacrylic acid and ethyl acrylate copolymer 1:1 – 10.05 mg, povidone K17 – 1.68 mg, talc – 2.25 mg, macrogol 4000 – 1.02 mg.

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

NSAID. Antiplatelet agent

Pharmacotherapeutic Group

Antithrombotic agents; antiplatelet agents, other than heparin

Pharmacological Action

NSAID, antiplatelet agent. The mechanism of action of acetylsalicylic acid is based on the irreversible inhibition of the COX-1 enzyme, resulting in the blockade of thromboxane A₂ synthesis and suppression of platelet aggregation.

It is believed that acetylsalicylic acid has other mechanisms of suppressing platelet aggregation, which expands its scope of application in various vascular diseases.

Acetylsalicylic acid in higher doses also has anti-inflammatory, analgesic, and antipyretic effects.

Pharmacokinetics

When taken orally, it is rapidly absorbed mainly from the proximal part of the small intestine and to a lesser extent from the stomach.

The presence of food in the stomach significantly alters the absorption of acetylsalicylic acid.

The bioavailability of acetylsalicylic acid is about 70%, but this value is characterized by significant individual variability due to presystemic hydrolysis in the mucous membranes of the gastrointestinal tract and in the liver with the formation of salicylic acid under the action of enzymes.

The bioavailability of salicylic acid is 80-100%.

It is metabolized in the liver by hydrolysis to form salicylic acid followed by conjugation with glycine or glucuronide.

The concentration of salicylates in blood plasma is variable.

About 80% of salicylic acid binds to blood plasma proteins.

Salicylates easily penetrate into many tissues and body fluids, including cerebrospinal, peritoneal, and synovial fluids.

Small amounts of salicylates are found in brain tissue, traces – in bile, sweat, and feces.

It quickly crosses the placental barrier and is excreted in small amounts in breast milk.

It is excreted mainly by active secretion in the renal tubules unchanged (60%) and in the form of metabolites.

The excretion of unchanged salicylate depends on the pH of the urine (when the urine is alkalized, the ionization of salicylates increases, their reabsorption deteriorates, and excretion increases significantly).

The T_1/2 of acetylsalicylic acid is approximately 15 minutes.

The T_1/2 of salicylate when taken in low doses is 2-3 hours; with an increase in dose (>3 g) it can increase to 15-30 hours due to saturation of enzyme systems.

Indications

Unstable angina and stable angina; prevention of recurrent myocardial infarction; prevention of recurrent transient ischemic attack and recurrent ischemic stroke in patients who have previously suffered a cerebrovascular accident; prevention of thrombotic complications after operations and invasive interventions on blood vessels (such as coronary artery bypass grafting, carotid endarterectomy, arteriovenous shunting, coronary artery angioplasty and stenting, carotid artery angioplasty).

ICD codes

Dosage Regimen

Administer the dosage individually based on the specific clinical indication and patient risk factors.

For secondary prevention of myocardial infarction, use a daily dose of 75-150 mg.

For secondary prevention of ischemic stroke and transient ischemic attacks, use a daily dose of 75-150 mg.

For the management of unstable angina, use an initial single dose of 150-300 mg, followed by a daily maintenance dose of 75-150 mg.

For the prevention of thrombotic complications after vascular procedures, use a daily dose of 75-150 mg.

Take tablets orally, swallowed whole with a sufficient amount of liquid.

Take the dose once daily or as divided doses, depending on the total daily amount and tolerability.

Administer enteric-coated tablets before meals to facilitate passage through the stomach.

Do not crush or chew the tablets, as this will compromise the enteric coating.

The maximum daily dose for antiplatelet therapy is typically 150 mg; higher doses are not associated with increased efficacy but elevate the risk of adverse events.

Continue therapy long-term unless a significant bleeding event or other contraindication occurs.

Re-evaluate the treatment regimen periodically, especially in elderly patients or those with an increased risk of gastrointestinal bleeding.

Adverse Reactions

Allergic reactions often – urticaria, angioedema; sometimes – anaphylactic reactions.

From the digestive system very often – heartburn; often – nausea, vomiting; sometimes – abdominal pain, ulcers of the gastric and duodenal mucosa, gastrointestinal bleeding; rarely – perforation of gastric or duodenal ulcer, increased activity of liver enzymes; very rarely – stomatitis, esophagitis, erosive lesions of the upper gastrointestinal tract, strictures, colitis, irritable bowel syndrome.

From the respiratory system often – bronchospasm.

From the hematopoietic system very often – increased bleeding; rarely – anemia; very rarely – hypoprothrombinemia, thrombocytopenia, neutropenia, aplastic anemia, eosinophilia, agranulocytosis.

From the nervous system sometimes – dizziness, drowsiness; often – headache, insomnia; rarely – tinnitus, cerebral hemorrhage.

Contraindications

Cerebral hemorrhage; tendency to bleeding (vitamin K deficiency, thrombocytopenia, hemorrhagic diathesis); bronchial asthma induced by salicylates and NSAIDs; erosive-ulcerative lesions of the gastrointestinal tract (in the acute phase); gastrointestinal bleeding; severe renal failure (creatinine clearance <10 ml/min); glucose-6-phosphate dehydrogenase deficiency; simultaneous use with methotrexate (>15 mg per week); I and III trimesters of pregnancy; lactation period (breastfeeding); children and adolescents under 18 years of age; hypersensitivity to acetylsalicylic acid and other NSAIDs.

With caution

Gout, hyperuricemia, history of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding, renal and/or hepatic insufficiency, bronchial asthma, hay fever, nasal polyposis, allergic conditions, II trimester of pregnancy.

Use in Pregnancy and Lactation

Contraindicated for use in the I and III trimesters of pregnancy. In the II trimester of pregnancy, a single dose is possible for strict indications.

It has a teratogenic effect: when used in the I trimester, it leads to the development of cleft palate; in the III trimester – it causes inhibition of labor (inhibition of prostaglandin synthesis), premature closure of the arterial duct in the fetus, hyperplasia of the pulmonary vessels and hypertension in the pulmonary circulation.

Acetylsalicylic acid is excreted in breast milk, which increases the risk of bleeding in the child due to impaired platelet function, therefore acetylsalicylic acid should not be used by the mother during lactation.

Use in Hepatic Impairment

Contraindication: hepatic insufficiency.

Use with caution in patients with liver diseases.

Use in Renal Impairment

Contraindication: renal failure.

Use with caution in patients with kidney diseases.

Pediatric Use

Contraindication: children and adolescents under 18 years of age.

Geriatric Use

Use with caution to avoid the risk of exacerbation of chronic diseases.

Special Precautions

Acetylsalicylic acid can provoke bronchospasm, as well as cause attacks of bronchial asthma and other hypersensitivity reactions.

Risk factors are a history of bronchial asthma, hay fever, nasal polyposis, chronic respiratory diseases, as well as allergic reactions (for example, skin reactions, itching, urticaria) to other drugs.

Acetylsalicylic acid can cause bleeding of varying severity during and after surgical interventions.

A few days before a planned surgical intervention, the risk of bleeding should be assessed compared to the risk of ischemic complications in patients taking low doses of acetylsalicylic acid.

If the risk of bleeding is significant, the use of acetylsalicylic acid should be temporarily discontinued.

The combination of acetylsalicylic acid with anticoagulants, thrombolytics and antiplatelet drugs is accompanied by an increased risk of bleeding.

Taking acetylsalicylic acid in low doses can provoke the development of gout in predisposed individuals (with reduced excretion of uric acid).

The combination of acetylsalicylic acid with methotrexate is accompanied by an increased frequency of side effects from the hematopoietic organs.

Taking acetylsalicylic acid in high doses has a hypoglycemic effect, which should be taken into account when prescribing it to patients with diabetes mellitus receiving oral hypoglycemic agents and insulin.

When using systemic corticosteroids and salicylates together, it should be remembered that during treatment the concentration of salicylates in the blood is reduced, and after discontinuation of systemic corticosteroids, an overdose of salicylates is possible.

The combination of acetylsalicylic acid with ibuprofen is not recommended in patients with an increased risk of cardiovascular diseases: with simultaneous use with ibuprofen, a decrease in the antiplatelet effect of acetylsalicylic acid in doses up to 300 mg is noted, which leads to a decrease in the cardioprotective effects of acetylsalicylic acid.

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

With long-term use of acetylsalicylic acid in low doses as antiplatelet therapy, caution is required in elderly patients due to the risk of gastrointestinal bleeding.

When taking acetylsalicylic acid simultaneously with ethanol, the risk of damage to the gastrointestinal mucosa and prolongation of bleeding time increases.

Effect on the ability to drive vehicles and mechanisms

During treatment with acetylsalicylic acid preparations, patients should exercise caution when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use, antacids containing magnesium and/or aluminum hydroxide slow down and reduce the absorption of acetylsalicylic acid.

With simultaneous use of calcium channel blockers, agents that limit calcium intake or increase calcium excretion from the body, the risk of bleeding increases.

With simultaneous use with acetylsalicylic acid, the effect of heparin and indirect anticoagulants, hypoglycemic agents of sulfonylurea derivatives, insulins, methotrexate, phenytoin, valproic acid is enhanced.

With simultaneous use with corticosteroids, the risk of ulcerogenic action and gastrointestinal bleeding increases.

With simultaneous use, the effectiveness of diuretics (spironolactone, furosemide) is reduced.

With simultaneous use of other NSAIDs, the risk of side effects increases. Acetylsalicylic acid may reduce plasma concentrations of indomethacin, piroxicam.

With simultaneous use with gold preparations, acetylsalicylic acid can induce liver damage.

With simultaneous use, the effectiveness of uricosuric agents (including probenecid, sulfinpyrazone, benzbromarone) is reduced.

With simultaneous use of acetylsalicylic acid and alendronate sodium, severe esophagitis may develop.

With simultaneous use of griseofulvin, impaired absorption of acetylsalicylic acid is possible.

A case of spontaneous hemorrhage in the iris when taking ginkgo biloba extract against the background of long-term use of acetylsalicylic acid at a dose of 325 mg/day has been described. It is believed that this may be due to an additive inhibitory effect on platelet aggregation.

With simultaneous use of dipyridamole, an increase in C_max of salicylate in blood plasma and AUC is possible.

With simultaneous use with acetylsalicylic acid, the concentrations of digoxin, barbiturates and lithium salts in blood plasma increase.

With simultaneous use of high doses of salicylates with carbonic anhydrase inhibitors, salicylate intoxication is possible.

Acetylsalicylic acid in doses of less than 300 mg/day has little effect on the effectiveness of captopril and enalapril. When using acetylsalicylic acid in high doses, a decrease in the effectiveness of captopril and enalapril is possible.

With simultaneous use, caffeine increases the rate of absorption, concentration in blood plasma and bioavailability of acetylsalicylic acid.

With simultaneous use, metoprolol may increase the C_max of salicylate in blood plasma.

When using pentazocine against the background of long-term use of high doses of acetylsalicylic acid, there is a risk of severe adverse reactions from the kidneys.

With simultaneous use, phenylbutazone reduces uricosuria caused by acetylsalicylic acid.

With simultaneous use, ethanol may enhance the effect of acetylsalicylic acid on the gastrointestinal tract.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.