Pentanov^®-ICN (Tablets) Instructions for Use

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

ATC Code

N02BB72 (Metamizole sodium in combination with psycholeptics)

Dosage Form

Pentanov®-ICN

Tablets: 12 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a yellow or creamy tint, biconvex, capsule-shaped with flat side surfaces, with a score line.

Excipients: potato starch – 120 mg, povidone (low molecular weight medical polyvinylpyrrolidone) – 4 mg, stearic acid – 4 mg, calcium stearate – 4 mg.

12 pcs. – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; anilides

Pharmacological Action

A combination drug with analgesic, antipyretic, and antimigraine action.

Paracetamol is an analgesic-antipyretic. It blocks COX primarily in the CNS, affecting the centers of pain and thermoregulation; it has analgesic and antipyretic effects.

Metamizole sodium is an analgesic-antipyretic, a pyrazolone derivative. It has a pronounced analgesic effect.

Caffeine is a psychostimulant, it improves the well-being of patients and reduces headache of vascular origin (including migraine).

Phenobarbital is a barbiturate, it increases the analgesic efficacy of metamizole sodium and paracetamol.

Codeine has an analgesic effect due to the excitation of opioid receptors in various parts of the CNS, leading to stimulation of the antinociceptive system and a change in the emotional perception of pain.

Pharmacokinetics

Pharmacokinetic data for the drug Pentanov^®-ICN are not provided.

Indications

• Pain syndrome of various origins of mild to moderate intensity (including arthralgia, myalgia, sciatica, dysmenorrhea, neuralgia, headache, toothache);
• Common colds and conditions accompanied by febrile syndrome.

ICD codes

Dosage Regimen

Administer orally with a sufficient amount of water.

Prescribe 1 tablet 1 to 3 times per day, depending on the intensity of pain or fever.

Maintain an interval of at least 4 hours between individual doses.

Do not exceed the maximum daily dose of 4 tablets.

Limit use without medical supervision to a maximum of 5 days for analgesic purposes.

Limit use without medical supervision to a maximum of 3 days for antipyretic purposes.

Adjust the dosage and duration of therapy based on the patient’s clinical response and the underlying condition being treated.

Discontinue the drug immediately and consult a physician if pain persists or fever continues beyond the recommended self-treatment period.

Avoid abrupt cessation after prolonged use due to the risk of withdrawal symptoms associated with codeine and phenobarbital.

Adverse Reactions

From the nervous system: dizziness, drowsiness.

From the cardiovascular system: palpitations, tachycardia.

From the digestive system: nausea, vomiting, constipation.

From the hematopoietic system: leukopenia, granulocytopenia, agranulocytosis.

Allergic reactions: rash, itching, urticaria.

Other: with prolonged uncontrolled use in high doses – tolerance (weakening of the analgesic effect), drug dependence (codeine), hepatic and/or renal failure.

Contraindications

• Severe hepatic insufficiency;
• Severe renal failure;
• Bronchial asthma;
• Anemia, leukopenia;
• Conditions accompanied by respiratory depression;
• Intracranial hypertension;
• Acute myocardial infarction;
• Arrhythmias;
• Glaucoma;
• Alcohol intoxication;
• Glucose-6-phosphate dehydrogenase deficiency;
• Pregnancy;
• Lactation period (breastfeeding);
• Children under 12 years of age;
• Hypersensitivity to the components of the drug.

With caution, the drug should be used for gastric and duodenal ulcers in the remission phase, for arterial hypertension, in elderly patients.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindication: severe hepatic insufficiency.

Use in Renal Impairment

Contraindication: severe renal failure.

Pediatric Use

Contraindication: children under 12 years of age.

Geriatric Use

With caution, the drug should be used in elderly patients.

Special Precautions

With long-term (more than 1 week) treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

When taking the drug Pentanov^®-ICN, the results of doping control tests in athletes may change.

Taking the drug Pentanov^®-ICN complicates the diagnosis in acute abdominal pain syndrome.

Patients suffering from atopic bronchial asthma, hay fever, have an increased risk of developing hypersensitivity reactions.

Influence on the ability to drive vehicles and mechanisms

When using the drug, patients should refrain from potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Overdose

Symptoms: nausea, vomiting, gastralgia, tachycardia, arrhythmia, depression of the respiratory center.

Treatment: gastric lavage, administration of intestinal adsorbents, if necessary – symptomatic therapy.

Drug Interactions

With simultaneous use of agents that have a depressant effect on the CNS (including sedatives and tranquilizers), an increase in the severity of the sedative effect and the depressant effect on the respiratory center is likely. It enhances the effect of ethanol on the psychomotor reaction. Metamizole sodium reduces the concentration of cyclosporine.

Metamizole sodium, displacing oral hypoglycemic drugs, indirect anticoagulants, corticosteroids, and indomethacin from protein binding, increases their activity. Tricyclic antidepressants, oral contraceptives, allopurinol disrupt the metabolism of metamizole sodium in the liver and increase its toxicity.

Simultaneous use of the drug Pentanov^®-ICN with other non-opioid analgesics may lead to an increase in toxic effects.

Barbiturates, phenylbutazone and other inducers of liver microsomal enzymes weaken the effect of metamizole sodium.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place.

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by 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.