Ascophen-P^® (Tablets) Instructions for Use

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

ATC Code

N02BA71 (Acetylsalicylic acid in combination with psycholeptics)

Active Substances

Paracetamol (Rec.INN registered by WHO)

Acetylsalicylic acid (Ph.Eur. European Pharmacopoeia)

Caffeine (Ph.Eur. European Pharmacopoeia)

Dosage Form

Ascophen-P®

Tablets 200 mg+200 mg+40 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a creamy or pinkish tint, flat-cylindrical, with a bevel and a score, odorless or with a faint odor; marbling is allowed.

Excipients: potato starch, povidone (low molecular weight medical polyvinylpyrrolidone), stearic acid, talc, calcium stearate, silicone emulsion KE-10-12, vaseline oil VGM-30M.

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

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

Combined analgesic agent (NSAID + non-narcotic analgesic agent + psychostimulant agent)

Pharmacological Action

A combined drug, the action of which is determined by the components included in its composition.

Acetylsalicylic acid has analgesic, antipyretic, and anti-inflammatory effects associated with the suppression of COX-1 and COX-2, which regulate the synthesis of prostaglandins; it inhibits platelet aggregation.

Paracetamol has antipyretic and analgesic effects.

Caffeine increases the reflex excitability of the spinal cord, stimulates the respiratory and vasomotor centers, dilates blood vessels of skeletal muscles, brain, heart, kidneys, reduces platelet aggregation; reduces drowsiness, feeling of fatigue, increases mental and physical performance.

Pharmacokinetics

Pharmacokinetic data for the drug Ascophen-P^® are not provided.

Indications

Moderate or mild pain syndrome in adults

• Headache;
• Migraine;
• Toothache;
• Neuralgia;
• Thoracic radicular syndrome, lumbago;
• Arthralgia;
• Myalgia;
• Algodysmenorrhea.

To reduce elevated body temperature in adults and children over 15 years of age

• For acute respiratory infections;
• For infectious and inflammatory diseases.

ICD codes

Dosage Regimen

The drug is taken orally after meals, 1-2 tablets 2-3 times/day. The maximum daily dose is 6 tablets. The interval between doses of the drug should be at least 4 hours. To reduce the irritating effect on the gastrointestinal tract, the drug should be taken after meals with water, milk, or alkaline mineral water.

In case of impaired renal or liver function, the interval between doses should be at least 6 hours.

The drug should not be taken for more than 5 days when prescribed as an analgesic and for more than 3 days as an antipyretic. Other doses and regimens are determined by the doctor.

Adverse Reactions

From the digestive system anorexia, nausea, vomiting, gastralgia, diarrhea, erosive and ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding, hepatic and/or renal failure.

From the cardiovascular system increased blood pressure, tachycardia.

Allergic reactions skin rash, angioedema, bronchospasm.

With long-term use dizziness, headache, visual disturbances, tinnitus, decreased platelet aggregation, hypocoagulation, hemorrhagic syndrome (including nosebleeds, gum bleeding, purpura), kidney damage with papillary necrosis; deafness; Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), Reye’s syndrome in children (metabolic acidosis, disorders of the nervous system and psyche, vomiting, impaired liver function).

Contraindications

• Hypersensitivity to the components of the drug;
• Hypersensitivity to other NSAIDs, xanthines;
• Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase;
• Gastrointestinal bleeding;
• Severe renal impairment;
• Severe hepatic impairment;
• Asthma induced by the intake of acetylsalicylic acid, salicylates and other NSAIDs;
• Hemorrhagic diatheses (von Willebrand disease, hemophilia, telangiectasia, hypoprothrombinemia, thrombocytopenia, thrombocytopenic purpura);
• Dissecting aortic aneurysm;
• Glucose-6-phosphate dehydrogenase deficiency;
• Portal hypertension;
• Vitamin K deficiency;
• Increased excitability, sleep disorders, anxiety disorders (agoraphobia, panic disorders);
• Organic diseases of the cardiovascular system (acute myocardial infarction, severe coronary artery disease, arterial hypertension), paroxysmal tachycardia, frequent ventricular extrasystole;
• Glaucoma;
• Surgical interventions accompanied by bleeding;
• Children under 15 years of age.

With caution hyperuricemia, urate nephrolithiasis, gout, history of gastric and/or duodenal ulcer, severe heart failure.

Use in Pregnancy and Lactation

Contraindicated in the first and third trimesters of pregnancy; in the second trimester of pregnancy, a single dose of the drug in recommended doses is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Acetylsalicylic acid has a teratogenic effect: when used in the first trimester of pregnancy, it leads to a developmental defect – cleft palate; in the third trimester – it contributes to the inhibition of labor (inhibition of prostaglandin synthesis), closure of the arterial duct in the fetus, which causes hyperplasia of the pulmonary vessels and hypertension in the pulmonary circulation.

If it is necessary to use the drug during lactation, breastfeeding should be discontinued. Acetylsalicylic acid is excreted in breast milk, which increases the risk of bleeding in the child due to impaired platelet function.

Use in Hepatic Impairment

Contraindicated in severe hepatic impairment, portal hypertension.

Use in Renal Impairment

Contraindicated in severe renal impairment.

The drug should be used with caution in urate nephrolithiasis.

Pediatric Use

The drug is not prescribed as an analgesic for children and adolescents under 18 years of age, as an antipyretic – for children under 15 years of age with acute respiratory viral infections due to the danger of developing Reye’s syndrome.

Special Precautions

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

Since Acetylsalicylic acid has an antiplatelet effect, the patient, if he is to undergo surgery, should inform the doctor in advance about taking the drug.

Acetylsalicylic acid in low doses reduces the excretion of uric acid. This may in some cases provoke an attack of gout.

During treatment, the patient should refrain from drinking alcohol (increased risk of gastrointestinal bleeding).

Use in pediatrics

The drug is not prescribed as an analgesic for children and adolescents under 18 years of age, as an antipyretic – for children under 15 years of age with acute respiratory viral infections due to the danger of developing Reye’s syndrome (encephalopathy and acute fatty liver degeneration with acute development of liver failure).

Overdose

Symptoms nausea, vomiting, stomach pain, sweating, pale skin, tachycardia. In mild intoxications – ringing in the ears; severe intoxication – drowsiness, collapse, convulsions, bronchospasm, difficulty breathing, anuria, bleeding. As intoxication increases – progressive respiratory paralysis and uncoupling of oxidative phosphorylation, causing respiratory acidosis.

Treatment: gastric lavage, intake of adsorbents (activated charcoal). If poisoning is suspected, the patient should immediately seek medical help.

Drug Interactions

The drug enhances the effect of heparin, indirect anticoagulants, reserpine, steroid hormones and hypoglycemic agents.

Reduces the effectiveness of spironolactone, furosemide, antihypertensive drugs, anti-gout agents that promote the excretion of uric acid.

Enhances the side effects of glucocorticosteroids, sulfonylurea derivatives, methotrexate, non-narcotic analgesics and NSAIDs.

Combination of the drug with barbiturates, antiepileptic drugs, zidovudine, rifampicin, and beverages containing ethanol should be avoided (increases the risk of hepatotoxic effect).

Under the influence of paracetamol, the elimination time of chloramphenicol increases 5 times.

Caffeine accelerates the absorption of ergotamine.

Salicylamide and other stimulators of microsomal oxidation promote the formation of toxic metabolites of paracetamol that affect liver function.

Metoclopramide accelerates the absorption of paracetamol.

With repeated use, Paracetamol may enhance the effect of anticoagulants (dicoumarol derivatives).

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is available without a prescription.

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.