Acetylsalicylic acid (Tablets) Instructions for Use

ATC Code

N02BA51 (Acetylsalicylic acid in combination with other drugs, excluding psycholeptics)

Active Substances

Ascorbic acid (Rec.INN WHO registered)

Acetylsalicylic acid (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

NSAIDs of combined composition

Pharmacotherapeutic Group

Nonsteroidal anti-inflammatory drug (NSAID) + vitamin

Pharmacological Action

A combined medicinal product with antipyretic and analgesic effects.

Acetylsalicylic acid is an NSAID that inhibits the enzymes COX-1 and COX-2, disrupting the metabolism of arachidonic acid, which leads to impaired prostaglandin synthesis. It has a strong analgesic, antipyretic, and anti-inflammatory effect; reduces thromboxane synthesis and inhibits platelet aggregation, lowering the coagulation status of the blood.

Ascorbic acid (vitamin C) is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, and in the synthesis of steroid hormones; increases the body’s resistance to infections, reduces vascular permeability, and reduces the need for vitamins B₁, B², A, E, folic acid, and pantothenic acid. It satisfies the body’s increased need for vitamin C in diseases accompanied by fever.

Indications

Febrile syndrome in infectious and inflammatory diseases; pain syndrome (of various origins) in adults: headache (including that associated with alcohol withdrawal syndrome), migraine, toothache, neuralgia, myalgia, arthralgia, dysmenorrhea.

ICD codes

Dosage Regimen

Administer orally with a full glass of water. Take with food or milk to minimize gastrointestinal irritation.

The average single dose for adults and children over 15 years of age is 330-800 mg of acetylsalicylic acid. Do not exceed a maximum single dose of 1000 mg.

The maximum daily dose must not exceed 4000 mg (4 grams). In severe pain or febrile conditions, under medical supervision, the maximum daily dose may be increased to 8000 mg (8 grams).

Administer 2-4 times per day. Maintain an interval of at least 4 hours between doses. Do not use for more than 5 days as an analgesic or for more than 3 days as an antipyretic unless directed by a physician.

For dysmenorrhea, initiate treatment at the first sign of pain or bleeding. Continue dosing as needed for 2-3 days.

Crush or chew the tablet if swallowing is difficult. Use the lowest effective dose for the shortest duration necessary to control symptoms.

Discontinue use and consult a physician if symptoms persist, worsen, or new symptoms appear. Avoid in children and adolescents under 15 years of age due to the risk of Reye’s syndrome.

Adverse Reactions

From the digestive system: abdominal pain, nausea, vomiting, overt (black stools, bloody vomit) or covert signs of gastrointestinal bleeding, which can lead to iron deficiency anemia, erosive and ulcerative lesions (including with perforation) of the gastrointestinal tract; rarely – impaired liver function (increased liver transaminases).

From the nervous system: dizziness, tinnitus (usually signs of overdose).

From the hematopoietic system: hemorrhagic syndrome, thrombocytopenia.

From the urinary system: when used in high doses – hyperoxaluria and the formation of urinary stones from calcium oxalate, damage to the glomerular apparatus of the kidneys.

Allergic reactions: skin rash, anaphylactic reactions, bronchospasm, angioedema.

Contraindications

Hypersensitivity to the components of the drug; erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase); gastrointestinal bleeding; bronchial asthma, urticaria or acute rhinitis induced by the intake of acetylsalicylic acid or other NSAIDs; hemophilia; hemorrhagic diathesis; hypoprothrombinemia; portal hypertension; vitamin K deficiency; renal failure; the first and third trimesters of pregnancy; the period of lactation (breastfeeding); glucose-6-phosphate dehydrogenase deficiency; childhood (under 15 years of age – risk of Reye’s syndrome in children with hyperthermia due to viral diseases).

With caution

Gout, liver diseases.

Use in Pregnancy and Lactation

Contraindicated for use in the first and third trimesters of pregnancy and during the lactation period (breastfeeding).

Use in Hepatic Impairment

With caution: liver diseases.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

Contraindicated for use in children under 15 years of age (risk of Reye’s syndrome in children with hyperthermia due to viral diseases).

Special Precautions

Children should not be prescribed medicines containing acetylsalicylic acid, as in the case of a viral infection they can increase the risk of Reye’s syndrome. Symptoms of Reye’s syndrome are prolonged vomiting, acute encephalopathy, and liver enlargement.

With prolonged use of the drug, monitoring of peripheral blood and the functional state of the liver is necessary.

Since Acetylsalicylic acid slows down blood clotting, a patient who is to undergo surgery should inform the doctor in advance about taking the drug.

Patients with hypersensitivity or asthmoid reactions to salicylates or their derivatives acetylsalicylic acid can be prescribed only with special precautions (in an emergency care setting).

Acetylsalicylic acid in low doses reduces the excretion of uric acid. In patients with a corresponding predisposition, this can in some cases provoke a gout attack.

During treatment, one should refrain from consuming ethanol (increased risk of gastrointestinal bleeding).

Drug Interactions

It enhances the effect of heparin, oral anticoagulants, reserpine, steroid hormones, and hypoglycemic drugs.

Concomitant use of NSAIDs and methotrexate increases the risk of side effects.

It reduces the effectiveness of spironolactone, furosemide, antihypertensive drugs, as well as anti-gout drugs that promote the excretion of uric acid.

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.