Mastodon

Acetylsalicylic acid (Tablets) Instructions for Use

ATC Code

N02BA01 (Acetylsalicylic acid)

Active Substance

Acetylsalicylic acid (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

NSAID

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; salicylic acid and its derivatives

Pharmacological Action

NSAID. It has anti-inflammatory, analgesic, and antipyretic effects, and also inhibits platelet aggregation. The mechanism of action is associated with the inhibition of COX activity, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins that play a major role in the pathogenesis of inflammation, pain, and fever.

A decrease in the content of prostaglandins (mainly E1) in the thermoregulation center leads to a decrease in body temperature due to the dilation of skin vessels and increased sweating. The analgesic effect is due to both central and peripheral action. It reduces aggregation, platelet adhesion, and thrombus formation by suppressing the synthesis of thromboxane A2 in platelets.

At a daily dose of 6 g or more, it inhibits prothrombin synthesis in the liver and increases prothrombin time. It increases the fibrinolytic activity of plasma and reduces the concentration of vitamin K-dependent coagulation factors (II, VII, IX, X). It increases the frequency of hemorrhagic complications during surgical interventions and increases the risk of bleeding during therapy with anticoagulants. In high doses, it stimulates the excretion of uric acid (impairs its reabsorption in the renal tubules). Blockade of COX-1 in the gastric mucosa leads to inhibition of gastroprotective prostaglandins, which can cause erosive and ulcerative lesions of the mucosa and subsequent bleeding.

Pharmacokinetics

When taken orally, it is rapidly absorbed mainly from the proximal small intestine and to a lesser extent from the stomach. The presence of food in the stomach significantly alters the absorption of acetylsalicylic acid.

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 plasma proteins. Salicylates easily penetrate into many tissues and body fluids, including cerebrospinal, peritoneal, and synovial fluids. Salicylates are found in small amounts in brain tissue, and traces are found in bile, sweat, and feces. It quickly crosses the placental barrier and is excreted in small amounts in breast milk.

In newborns, salicylates can displace bilirubin from its binding with albumin and contribute to the development of bilirubin encephalopathy.

Penetration into the joint cavity is accelerated in the presence of hyperemia and edema and slowed down in the proliferative phase of inflammation.

When acidosis occurs, most of the salicylate is converted into a non-ionized acid, which penetrates well into tissues, including the brain.

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 T1/2 of acetylsalicylic acid is approximately 15 minutes. The T1/2 of salicylate when taken in low doses is 2-3 hours, and with an increase in dose it can increase to 15-30 hours.

Indications

Fever in infectious and inflammatory diseases; pain syndrome of mild to moderate intensity of various origins (including neuralgia, myalgia, headache), algodysmenorrhea.

ICD codes

ICD-10 code Indication
M79.1 Myalgia
M79.2 Neuralgia and neuritis, unspecified
N94.4 Primary dysmenorrhea
N94.5 Secondary dysmenorrhea
R50 Fever of unknown origin
R51 Headache
R52.0 Acute pain
R52.2 Other chronic pain
ICD-11 code Indication
8A8Z Headache disorders, unspecified
8E4A.1 Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
FB56 Specified soft tissue diseases, not elsewhere classified
FB56.2 Myalgia
GA34.3 Dysmenorrhea
MG26 Fever of other or unknown origin
MG30.Z Chronic pain syndrome, unspecified
MG31.Z Acute pain, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Determine the dosage individually based on the indication and patient response.

For analgesic and antipyretic indications, administer a single dose of 250 mg to 1 g.

Do not exceed a maximum daily dose of 3 grams for these indications.

Divide the total daily dose into 2 to 6 separate administrations.

Allow an interval of at least 4 hours between doses.

For short-term self-medication of pain, limit use to no more than 7 days.

For self-medication of fever, limit use to no more than 3 days.

Discontinue and consult a physician if symptoms persist or worsen.

Use the lowest effective dose for the shortest duration necessary to control symptoms.

For long-term or high-dose therapy, ensure regular medical supervision.

Swallow tablets whole with a full glass of water.

Take tablets after meals to minimize gastrointestinal irritation.

Adverse Reactions

From the digestive system: nausea, vomiting, anorexia, epigastric pain, diarrhea; rarely – the occurrence of erosive and ulcerative lesions, gastrointestinal bleeding, impaired liver function.

From the nervous system: with prolonged use, dizziness, headache, reversible visual disturbances, tinnitus, aseptic meningitis are possible.

From the hematopoietic system: rarely – thrombocytopenia, anemia.

From the blood coagulation system: rarely – hemorrhagic syndrome, prolonged bleeding time.

From the urinary system: rarely – impaired renal function; with prolonged use – acute renal failure, nephrotic syndrome.

Allergic reactions: rarely – skin rash, angioedema, bronchospasm, “aspirin triad” (a combination of bronchial asthma, recurrent nasal and sinus polyposis, and intolerance to acetylsalicylic acid and pyrazolone drugs).

Other: in some cases – Reye’s syndrome; with prolonged use – increased symptoms of chronic heart failure.

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, gastrointestinal bleeding, inflammatory bowel diseases in the acute phase (ulcerative colitis, Crohn’s disease), “aspirin triad”, a history of urticaria, rhinitis caused by taking acetylsalicylic acid and other NSAIDs, bleeding, hemophilia, hemorrhagic diathesis, hypoprothrombinemia, dissecting aortic aneurysm, severe hepatic failure, active liver disease, portal hypertension, severe renal failure (creatinine clearance <30 ml/min), vitamin K deficiency, combined use of methotrexate at a dose of ≥15 mg/week, simultaneous use of oral anticoagulants and acetylsalicylic acid at a dose of >3 g/day, Reye’s syndrome, children under 15 years of age (risk of developing Reye’s syndrome in children with hyperthermia due to viral diseases), pregnancy, breastfeeding period, hypersensitivity to acetylsalicylic acid and other salicylates.

With caution

Gout, hyperuricemia, mild to moderate hepatic failure, moderate renal failure (creatinine clearance 30-60 ml/min), in bronchial asthma, a history of erosive and ulcerative lesions and gastrointestinal bleeding, with increased bleeding or during simultaneous anticoagulant therapy, decompensated chronic heart failure, COPD, hay fever, nasal polyposis, drug allergy, simultaneous use of oral anticoagulants and acetylsalicylic acid at a dose of <3 g/day, use of methotrexate at a dose of less than 15 mg/week, acyclic uterine bleeding, hypermenorrhea.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use with caution in patients with liver diseases.

Contraindicated for use in severe hepatic failure, active liver disease, and portal hypertension.

Use in Renal Impairment

Use with caution in patients with kidney diseases.

Contraindicated for use in severe renal failure (creatinine clearance <30 ml/min).

Pediatric Use

Contraindication: children’s age (under 15 years – risk of developing Reye’s syndrome in children with hyperthermia due to viral diseases).

Geriatric Use

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

Special Precautions

Acetylsalicylic acid, even in small doses, reduces the excretion of uric acid from the body, which can cause an acute attack of gout in predisposed patients. During long-term therapy and/or the use of acetylsalicylic acid in high doses, medical supervision and regular monitoring of hemoglobin levels are required.

The use of acetylsalicylic acid as an anti-inflammatory agent in a daily dose of 5-8 g is limited due to the high probability of developing side effects from the gastrointestinal tract.

Before surgery, to reduce bleeding during the operation and in the postoperative period, salicylates should be discontinued 5-7 days before.

During long-term therapy, it is necessary to perform a complete blood count and a stool test for occult blood.

The use of acetylsalicylic acid in pediatrics is contraindicated, since in the case of a viral infection in children, the risk of developing Reye’s syndrome increases under the influence of acetylsalicylic acid. Symptoms of Reye’s syndrome are prolonged vomiting, acute encephalopathy, and liver enlargement.

The duration of treatment (without consulting a doctor) should not exceed 7 days when prescribed as an analgesic and more than 3 days as an antipyretic.

During treatment, the patient should refrain from drinking alcohol.

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 glucocorticosteroids, the risk of ulcerogenic action and the occurrence of 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 and piroxicam.

With simultaneous use with gold preparations, Acetylsalicylic acid may 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 Cmax 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 salicylates in high doses 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 Cmax of salicylate in blood plasma.

When using pentazocine against the background of long-term use of acetylsalicylic acid in high doses, there is a risk of developing 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Alliancepharma, LLC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 500 mg: 10, 20, 30, 50, 100, or 200 pcs.

Dosage Form, Packaging, and Composition

Tablets are white, flat-cylindrical, slightly marbled, with a score and a bevel, odorless or with a slight characteristic odor.

1 tab.
Acetylsalicylic acid 500 mg

Excipients: potato starch – 91 mg, talc – 9 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging (20) – cardboard packs.
10 pcs. – contour cell packaging (300) – cardboard packs (for hospitals).
10 pcs. – contour cell packaging (500) – cardboard packs (for hospitals).
20 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (30) – cardboard packs (for hospitals).
20 pcs. – polymer jars (40) – cardboard packs (for hospitals).
30 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (30) – cardboard packs (for hospitals).
30 pcs. – polymer jars (40) – cardboard packs (for hospitals).

Marketing Authorization Holder

Apteki 36,6, CJS (Russia)

Manufactured By

Veropharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 250 mg: 10, 20, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 250 mg

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Apteki 36,6, CJS (Russia)

Manufactured By

Veropharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 500 mg: 10, 20, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 500 mg

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 500 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 600, 700, 800, 900, or 1000 pcs.

Dosage Form, Packaging, and Composition

Tablets are white or almost white, round, flat-cylindrical, with a score on one side and bevels on both sides, with a slight characteristic odor; slight marbling is allowed.

1 tab.
Acetylsalicylic acid 500 mg

Excipients: microcrystalline cellulose – 42 mg, povidone K25 – 24 mg, croscarmellose sodium – 24 mg, citric acid monohydrate – 6 mg, magnesium stearate – 4 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (7) – cardboard packs.
10 pcs. – contour cell packaging (8) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging (20) – cardboard packs.
10 pcs. – contour cell packaging (30) – cardboard packs.
10 pcs. – contour cell packaging (40) – cardboard packs.
10 pcs. – contour cell packaging (50) – cardboard packs.
10 pcs. – contour cell packaging (60) – cardboard packs.
10 pcs. – contour cell packaging (70) – cardboard packs.
10 pcs. – contour cell packaging (80) – cardboard packs.
10 pcs. – contour cell packaging (90) – cardboard packs.
10 pcs. – contour cell packaging (100) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
70 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 500 mg: 10, 20, 30, 40, or 3900 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 500 mg

10 pcs. – contour non-cell packaging.
10 pcs. – contour non-cell packaging (390) – cardboard boxes.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (300) – cardboard boxes.
10 pcs. – contour cell packaging (PVC/paper) (1) – cardboard packs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 250 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 250 mg

10 pcs. – contour non-cell packaging.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 500 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 500 mg

10 pcs. – contour non-cell packaging.
10 pcs. – contour cell packaging.

Marketing Authorization Holder

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 250 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets of flat-cylindrical shape, white in color, slightly marbled, with a score and a bevel, odorless or with a weak characteristic odor.

1 tab.
Acetylsalicylic acid 250 mg

Excipients: potato starch 37.9 mg, talc 9 mg, sodium carboxymethyl starch 3 mg, citric acid 0.1 mg.

10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour non-cell packaging (550) – cardboard boxes.
10 pcs. – contour non-cell packaging (1000) – cardboard boxes.

Marketing Authorization Holder

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 500 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white in color, round, flat-cylindrical in shape, with a double-sided bevel and a score on one side, odorless or with a weak characteristic odor; marbling of the tablet surface is allowed.

1 tab.
Acetylsalicylic acid 500 mg

Excipients: potato starch – 75.8 mg, talc – 9 mg, sodium starch glycolate – 15 mg, citric acid monohydrate – 0.2 mg.

10 pcs. – contour non-cell packaging.
10 pcs. – contour cell packaging.
10 pcs. – contour cell packaging (2) – cardboard packs.

Marketing Authorization Holder

Marbiopharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 500 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 500 mg

10 pcs. – contour cell packaging.
10 pcs. – contour non-cell packaging.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 500 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 500 mg

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour non-cell packaging (1) – cardboard packs.
10 pcs. – contour non-cell packaging (2) – cardboard packs.
10 pcs. – contour non-cell packaging.

Marketing Authorization Holder

PFKO-1, LLC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 250 mg: 10, 20, 30, or 40 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 250 mg

10 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

PFKO-1, LLC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 500 mg: 10, 20, 30, or 40 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 500 mg

10 pcs. – contour cell packaging.
10 pcs. – contour non-cell packaging.
10 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

PFKO-1, LLC (Russia)

Manufactured By

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 500 mg: 10, 20, or 200 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white in color, round, flat-cylindrical, slightly marbled, with a bevel and a score, odorless or with a weak characteristic odor.

1 tab.
Acetylsalicylic acid 500 mg

Excipients: potato starch – 83.632 mg, citric acid monohydrate – 0.168 mg, talc – 16.2 mg.

10 pcs. – contour non-cell packaging (20) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (20) – cardboard packs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 250 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white in color, round, flat-cylindrical, with a bevel and a score, odorless or with a weak characteristic odor; marbling of the tablet surface is allowed.

1 tab.
Acetylsalicylic acid 250 mg

Excipients: potato starch, povidone K-17 (low molecular weight polyvinylpyrrolidone), citric acid monohydrate, talc, calcium stearate.

10 pcs. – contour non-cell packaging (1).
10 pcs. – contour non-cell packaging (1) – cardboard packs.
10 pcs. – contour non-cell packaging (2) – cardboard packs.
10 pcs. – contour non-cell packaging (3) – cardboard packs.
10 pcs. – contour non-cell packaging (4) – cardboard packs.
10 pcs. – contour non-cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (1).
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 500 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white in color, round, flat-cylindrical, with a bevel and a score, odorless or with a weak characteristic odor; marbling of the tablet surface is allowed.

1 tab.
Acetylsalicylic acid 500 mg

Excipients: potato starch, povidone K-17 (low molecular weight polyvinylpyrrolidone), citric acid monohydrate, talc, calcium stearate.

10 pcs. – contour non-cell packaging (1).
10 pcs. – contour non-cell packaging (1) – cardboard packs.
10 pcs. – contour non-cell packaging (2) – cardboard packs.
10 pcs. – contour non-cell packaging (3) – cardboard packs.
10 pcs. – contour non-cell packaging (4) – cardboard packs.
10 pcs. – contour non-cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (1).
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 500 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white in color, round, flat-cylindrical, slightly marbled.

1 tab.
Acetylsalicylic acid 500 mg

Excipients: potato starch – 72.1 mg, citric acid – 0.2 mg, stearic acid – 6 mg, talc – 12.7 mg, colloidal silicon dioxide (aerosil) – 3 mg, sodium starch glycolate – 6 mg.

10 pcs. – contour non-cell packaging.
10 pcs. – contour cell packaging.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.

Marketing Authorization Holder

Pharmstandard-Tomskkhimpharm OJSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 250 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 250 mg

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.

Marketing Authorization Holder

Pharmstandard-Tomskkhimpharm OJSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Tablets 500 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 500 mg

10 pcs. – non-cell contour packs.
10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – non-cell contour packs (2) – cardboard packs.
10 pcs. – blister contour packs.
10 pcs. – blister contour packs (1) – cardboard packs.

Marketing Authorization Holder

International Trade Association Of America (USA)

Manufactured By

Cispharma Inc. (USA)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid “York” Tablets 325 mg: 20, 30, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 325 mg

20 pcs. – plastic bottles (1) – cardboard packs.
30 pcs. – plastic bottles (1) – cardboard packs.
50 pcs. – plastic bottles (1) – cardboard packs.
100 pcs. – plastic bottles (1) – cardboard packs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Avexima Siberia LLC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Avexima Tablets 500 mg: 10, 12, 20, or 24 pcs.

Dosage Form, Packaging, and Composition

Tablets white, slightly marbled, flat-cylindrical, with a bevel and a score, odorless or with a slight characteristic odor.

1 tab.
Acetylsalicylic acid 500 mg

Excipients : stearic acid, talc, potato starch, citric acid, water-soluble methylcellulose.

10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – blister contour packs (1) – cardboard packs.
10 pcs. – blister contour packs (2) – cardboard packs.
12 pcs. – blister contour packs (1) – cardboard packs.
12 pcs. – blister contour packs (2) – cardboard packs.

Marketing Authorization Holder

Medisorb, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Medisorb Tablets 500 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 70, 100, or 140 pcs.

Dosage Form, Packaging, and Composition

Tablets white, slightly marbled, round, flat-cylindrical, with a bevel and a score.

1 tab.
Acetylsalicylic acid 500 mg

Excipients : potato starch, talc, lactose monohydrate, povidone K-30 (medium molecular weight polyvinylpyrrolidone), stearic acid.

7 pcs. – blister contour packs (1) – cardboard packs.
7 pcs. – blister contour packs (2) – cardboard packs.
7 pcs. – blister contour packs (3) – cardboard packs.
7 pcs. – blister contour packs (4) – cardboard packs.
7 pcs. – blister contour packs (5) – cardboard packs.
7 pcs. – blister contour packs (10) – cardboard packs.
10 pcs. – blister contour packs (1) – cardboard packs.
10 pcs. – blister contour packs (2) – cardboard packs.
10 pcs. – blister contour packs (3) – cardboard packs.
10 pcs. – blister contour packs (4) – cardboard packs.
10 pcs. – blister contour packs (5) – cardboard packs.
10 pcs. – blister contour packs (10) – cardboard packs.
14 pcs. – blister contour packs (1) – cardboard packs.
14 pcs. – blister contour packs (2) – cardboard packs.
14 pcs. – blister contour packs (3) – cardboard packs.
14 pcs. – blister contour packs (4) – cardboard packs.
14 pcs. – blister contour packs (5) – cardboard packs.
14 pcs. – blister contour packs (10) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Renewal Film-coated tablets 500 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; surface roughness is allowed; the core on the cross-section is white or almost white.

1 tab.
Acetylsalicylic acid 500 mg

Excipients : microcrystalline cellulose 101, corn starch, citric acid monohydrate.

Shell composition [hypromellose (HPMC 2910), macrogol 6000 (polyethylene glycol 6000)] or [dry film coating mixture consisting of: hypromellose (HPMC 2910), macrogol 6000 (polyethylene glycol 6000)]

10 pcs. – blister contour packs (1) – cardboard packs.
10 pcs. – blister contour packs (2) – cardboard packs.
10 pcs. – blister contour packs (3) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid Renewal Effervescent tablets 500 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Effervescent tablets white or almost white, round, flat-cylindrical, with a bevel, odorless or with a slight specific odor; slight roughness, marbling is allowed.

1 tab.
Acetylsalicylic acid 500 mg

Excipients : sodium bicarbonate, citric acid, sodium citrate, sodium carbonate.

10 pcs. – tube with first opening control (1) – cardboard packs.
20 pcs. – tube with first opening control (1) – cardboard packs.

Marketing Authorization Holder

AsPharma LLC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid tablets Tablets 250 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 250 mg

10 pcs. – blister contour packs (1) – cardboard packs.
10 pcs. – blister contour packs (2) – cardboard packs.

Marketing Authorization Holder

AsPharma LLC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid tablets Tablets 500 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 500 mg

10 pcs. – blister contour packs (1) – cardboard packs.
10 pcs. – blister contour packs (2) – cardboard packs.

Marketing Authorization Holder

Tyumen Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid-LekT Tablets 500 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Acetylsalicylic acid 500 mg

10 pcs. – non-cell contour packs.
10 pcs. – blister contour packs (1) – cardboard packs.
10 pcs. – blister contour packs (2) – cardboard packs.
10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – non-cell contour packs (2) – cardboard packs.

Marketing Authorization Holder

Uralbiopharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Acetylsalicylic acid-UBF Tablets 500 mg: 10, 20, 25, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white, slightly marbled, round, flat-cylindrical in shape, with a bevel and a score, odorless or with a slight characteristic odor.

1 tab.
Acetylsalicylic acid 0.5 g

Excipients : citric acid – 0.0002 g, potato starch – 0.0947 g, talc – 0.0051 g, to obtain a tablet weighing 0.6 g.

10 pcs. – blister contour packs (1) – cardboard packs.
10 pcs. – blister contour packs (2) – cardboard packs.
10 pcs. – blister contour packs (3) – cardboard packs.
10 pcs. – blister contour packs (4) – cardboard packs.
10 pcs. – blister contour packs (5) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
25 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.

Table of Contents

→ TABLE OF CONTENTS