Arphasetin (Herbal mixture) Instructions for Use

Marketing Authorization Holder

Ivan-Chai JSC (Russia)

ATC Code

V30 (Not assigned)

Dosage Form

Arphasetin

Herbal mixture – crushed raw material: filter bags 20 or 40 pcs.

Dosage Form, Packaging, and Composition

Filter bags (20) – cardboard packs.
Filter bags (40) – cardboard packs.
Laminated paper sachets (20) – cardboard packs.
Laminated paper sachets (40) – cardboard packs.
Paper bags.
Paper bags (1) – cardboard packs.
Laminated paper sachets.
Polymer bags.
Filter bags (20) – polymer bags.
Filter bags (40) – polymer bags.
Laminated paper sachets (20) – polymer bags.
Laminated paper sachets (40) – polymer bags.

Clinical-Pharmacological Group

Hypoglycemic agent of plant origin

Pharmacotherapeutic Group

Hypoglycemic agent of plant origin

Pharmacological Action

Hypoglycemic action.

Indications

• Type 2 diabetes mellitus.

Use as an adjunct to diet and other therapeutic measures for glycemic control.

Intended for the management of non-insulin-dependent diabetes.

ICD codes

Dosage Regimen

Administer orally, 2-3 times a day, 30 minutes before meals.

Continue the treatment course for 20-30 days.

Conduct 3-4 courses per year as part of a long-term management strategy.

Prepare as an infusion according to the provided instructions for the specific dosage form.

Adverse Reactions

Possible adverse reactions include allergic reactions such as skin rash or itching.

Gastrointestinal disturbances like heartburn may occur.

Central nervous system effects include insomnia and increased excitability.

Cardiovascular effects may manifest as increased blood pressure.

Drug Interactions

Exercise caution with concurrent use of other hypoglycemic agents, including insulin and oral antidiabetic drugs, due to risk of additive effects and hypoglycemia.

Potential interaction with CNS stimulants may exacerbate effects on blood pressure and insomnia.

Monitor for increased effects when used with other substances possessing stimulant properties.

Contraindications

• Hypersensitivity to any component of the herbal mixture.
• Arterial hypertension.
• Nephritis.
• Active gastric and duodenal ulcer.
• Conditions associated with increased excitability.
• Insomnia.
• Epilepsy.
• Pregnancy.
• Breastfeeding period.
• Children under 12 years of age.

Overdose

Symptoms of overdose may include a pronounced decrease in blood glucose levels (hypoglycemia), marked increase in blood pressure, severe agitation, insomnia, and tachycardia.

In case of suspected overdose, discontinue use immediately and seek medical attention.

Treatment is symptomatic and supportive; monitor blood glucose and cardiovascular parameters closely.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Use in Renal Impairment

Contraindicated in nephritis.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

It is not recommended to use in the afternoon to avoid insomnia.

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.