Iralgesic (Tablets) Instructions for Use

Marketing Authorization Holder

Daru Pahsh Pharmaceutical Mfg. The Company (Iran)

ATC Code

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

Active Substances

Caffeine (Ph.Eur.)

Paracetamol (Rec.INN)

Acetylsalicylic acid (Ph.Eur.)

Dosage Form

Iralgesic

Tablets 325 mg+162.5 mg+32.5 mg: 30 or 100 pcs.

Dosage Form, Packaging, and Composition

Excipients: colloidal silicon dioxide, gelatin, talc, magnesium stearate, lactose monohydrate, plasdone, corn starch, red No.3.

10 pcs. – strips (3) – cardboard packs.
10 pcs. – strips (10) – cardboard packs.

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

NSAID

Pharmacological Action

A combined drug that has analgesic, antipyretic, and anti-inflammatory effects.

Acetylsalicylic acid is an NSAID with analgesic, antipyretic, and anti-inflammatory effects.

Paracetamol is an analgesic-antipyretic that reduces pain associated with colds (sore throat, headache, muscle and joint pain) and has an antipyretic effect.

Caffeine has a stimulating effect on the central nervous system, reduces feelings of fatigue and drowsiness, increases heart rate, and increases blood pressure in arterial hypotension.

Pharmacokinetics

Pharmacokinetic data for Iralgesic are not provided.

Indications

• Moderate or mild pain (including headache, toothache, joint pain, neuralgia, myalgia, dysmenorrhea);
• Fever in colds and other infectious-inflammatory diseases.

ICD codes

Dosage Regimen

It is prescribed orally after meals, 1-2 tablets 2-3 times/day.

The maximum dose is 6 tablets/day. The interval between doses is at least 6 hours.

In case of impaired renal or hepatic function, the interval between doses of the drug should be at least 8 hours.

The drug should not be taken for more than 5 days as an analgesic and for more than 3 days as an antipyretic.

The need to use the drug in other doses and according to other regimens is decided by the doctor individually.

Adverse Reactions

From the digestive system: nausea, stomach pain; with long-term use in high doses – impaired liver function.

Allergic reactions: skin rash, itching, urticaria.

Other: tachycardia, dizziness; with long-term use in high doses – impaired renal function.

Contraindications

• Gastric and duodenal ulcer;
• Gastrointestinal bleeding;
• Severe liver dysfunction;
• Severe renal dysfunction;
• Genetic absence of glucose-6-phosphate dehydrogenase;
• Blood diseases with a tendency to hemorrhage and bleeding;
• Glaucoma;
• Bronchial asthma;
• Pregnancy;
• Lactation;
• Hypersensitivity to the components of the drug.

The drug is not prescribed to children under 15 years of age with ARVI and influenza due to the risk of Reye’s syndrome.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

In case of impaired liver function, the interval between doses of the drug should be at least 8 hours.

Use in Renal Impairment

In case of impaired renal function, the interval between doses of the drug should be at least 8 hours.

Pediatric Use

The drug is not prescribed to children under 15 years of age with ARVI and influenza due to the risk of Reye’s syndrome.

Special Precautions

Use with caution in elderly patients, in patients with impaired liver or kidney function.

Iralgesic should not be prescribed in combination with barbiturates, anticonvulsants, rifampicin.

Do not take the drug simultaneously with alcohol.

If it is necessary to use other drugs simultaneously, the patient should consult a doctor.

Use in pediatrics

The drug is not prescribed to children under 15 years of age with ARVI and influenza due to the risk of Reye’s syndrome.

Overdose

Symptoms: nausea, vomiting, stomach pain, increased sweating, pale skin, tachycardia.

Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy.

Drug Interactions

The drug enhances the effect of anticoagulants and antiplatelet agents, as well as the side effects of glucocorticosteroids, sulfonylurea derivatives, methotrexate, non-opioid analgesics, NSAIDs.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature below 30°C (86°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.