Passifit^® (Syrup) Instructions for Use

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

Or

Pharmstandard JSC (Russia)

ATC Code

V30 (Not assigned)

Dosage Form

Passifit®

Syrup: 100 ml bottle with a measuring spoon

Dosage Form, Packaging, and Composition

Syrup as a viscous, brown, opaque liquid with an aromatic odor.

Excipients: sorbic acid, sorbitol (sorbitol), purified water.

100 ml – dark glass bottles (1) with a measuring spoon – cardboard packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

Herbal preparation. Has a sedative effect.

Indications

• Use in adults and children over 12 years of age for the management of conditions characterized by increased nervous excitability.
• Employ for the treatment of sleep disorders, including difficulties with sleep initiation and maintenance.

ICD codes

Dosage Regimen

Administer orally. For adults and adolescents over 12 years, take 5 ml (one measuring spoon) of syrup.

Take the dose three times a day. For sleep disorders, take the last dose 30-60 minutes before bedtime.

The duration of therapy is determined by the physician based on clinical response and tolerability.

Adverse Reactions

Adverse reactions are generally mild and infrequent. From the digestive system: rarely, nausea or vomiting may occur.

From the central nervous system: drowsiness and weakness may be observed, particularly at the beginning of treatment or with higher doses.

Allergic reactions: monitor for skin rash, itching, or other signs of hypersensitivity. Discontinue use if any adverse reactions occur.

Contraindications

• Do not use in patients with known hypersensitivity to any component of the preparation, including valerian, hops, thyme, hawthorn, peppermint, or excipients.
• Contraindicated in patients with gastritis with increased secretory activity.
• Do not use in patients with cholelithiasis due to the choleretic effects of some components.
• Use is prohibited during pregnancy and throughout the lactation period.
• This medication is not for use in children under 12 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during breastfeeding.

Use in Hepatic Impairment

Contraindicated for use in cholelithiasis.

Pediatric Use

Contraindication: children under 12 years of age.

Special Precautions

Dosage forms may contain sorbitol and ethanol.

Drug Interactions

Concurrent use with other central nervous system depressants, including sedatives, hypnotics, tranquilizers, and antipsychotics, may result in additive sedative effects.

Exercise caution with concomitant use of antispasmodics and cardiac glycosides, as the preparation may potentiate their effects. Monitor patients closely for excessive sedation or other enhanced pharmacological responses.

Overdose

Symptoms of overdose may include marked drowsiness, lethargy, dizziness, nausea, and abdominal discomfort.

In case of significant overdose, seek immediate medical attention. Treatment is symptomatic and supportive. Gastric lavage and administration of activated charcoal may be considered if ingestion was recent. Monitor vital signs and provide supportive care as required.

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.