Phytosedan Sedativae species №2 (Herbal mixture) Instructions for Use

ATC Code

N05CM (Other hypnotic and sedative drugs)

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

A sedative agent of herbal origin.

The infusion of the collection has a sedative and moderate antispasmodic effect.

Indications

Use as part of a comprehensive treatment plan for the following conditions.

• Increased nervous excitability and associated restlessness.
• Sleep disorders, including difficulties with sleep initiation.
• Initial stage of arterial hypertension for its calming effect.

Administer only after a thorough evaluation by a healthcare professional.

ICD codes

Dosage Regimen

Prepare and take the herbal mixture as an infusion for oral administration.

Administer the prepared infusion twice daily for a treatment duration of two to four weeks.

Do not exceed the recommended dosage or duration. A repeat course of treatment is permissible only upon the explicit recommendation of a physician.

Adverse Reactions

Monitor for potential allergic reactions, including skin rash or itching.

Observe the digestive system for dyspeptic symptoms such as belching, nausea, diarrhea, and abdominal pain. Be aware of possible exacerbation of chronic gastrointestinal diseases.

With prolonged use at high doses, expect muscle weakness, significant drowsiness, and a marked decrease in work capacity.

Drug Interactions

Concomitant use with other central nervous system depressants requires extreme caution.

This preparation potentiates the effects of hypnotics, sedatives, and anxiolytics.

It also enhances the depressive action of other medications on the central nervous system, which may lead to excessive sedation.

Contraindications

Do not administer under any circumstances in the following patient populations.

• Patients with a known hypersensitivity or allergy to any of the herbal components within the mixture.
• Women during pregnancy and throughout the lactation period.
• Children under the age of 12 years due to a lack of safety data.

Strictly avoid use in these groups to prevent adverse outcomes.

Overdose

Symptoms of overdose are an extension of the drug’s pharmacological effects and adverse reactions.

Expect pronounced sedation, profound drowsiness, and severe muscle weakness.

In case of suspected overdose, immediately discontinue the medication and initiate symptomatic and supportive care. There is no specific antidote.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during lactation (breastfeeding).

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Due to the bitter taste of the infusion, some patients may have intolerance to this collection.

Influence on the ability to drive vehicles and mechanisms

With long-term use in high doses, a decrease in the speed of psychomotor reactions is possible. This should be taken into account when used in patients who drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

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.