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Valerianae rhizomata cum radicibus (Herbal raw material) Instructions for Use

Marketing Authorization Holder

Fitofarm PKF, LLC (Russia)

ATC Code

N05CM09 (Valerian roots)

Active Substance

Valerian (BP British Pharmacopoeia)

Dosage Form

Bottle OTC Icon Valerianae rhizomata cum radicibus Herbal raw material – powder 1.5 g: filter bags 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Herbal raw material – powder 1 filter bag
Valerian officinalis rhizomes with roots 1.5 g

Filter bags (20) – carton packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

The infusion of valerian rhizomes with roots exhibits a moderately pronounced sedative effect.

The sedative effect develops slowly but is sufficiently stable.

In addition, the preparation possesses antispasmodic properties.

Indications

Increased nervous excitability, insomnia; as part of complex therapy – functional disorders of the cardiovascular system, spasms of the gastrointestinal tract organs.

ICD codes

ICD-10 code Indication
F45.3 Somatoform dysfunction of the autonomic nervous system
F48.0 Neurasthenia
F51.2 Nonorganic disorders of the sleep-wake schedule
R10.4 Other and unspecified abdominal pain (colic)
ICD-11 code Indication
6A8Z Affective disorders, unspecified
6C20.Z Bodily distress disorder, unspecified
7B2Z Sleep-wake cycle disorders, unspecified
DD93.1 Infantile colic
MD81.4 Other and unspecified abdominal pain

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Place 3 filter bags in a glass or enamelware, pour 100 ml (1/2 cup) of boiling water, cover with a lid, and infuse for 15 minutes.

Squeeze the contents of the filter bags.

Bring the volume of the obtained infusion up to 100 ml with boiled water.

The infusion is administered orally, 30 minutes after meals.

Adults: 1 tablespoon 3-4 times a day;

Children over 12 years: 1 tablespoon 2-3 times a day;

Children from 7 to 12 years: 1 dessert spoon 2-3 times a day;

Children from 3 to 6 years: 1 teaspoon 2-3 times a day;

Children from 1 to 3 years: 1/2 teaspoon 2 times a day.

Shake the infusion before use.

Adverse Reactions

Drowsiness, weakness, decreased performance; with prolonged use – constipation.

In some cases, the development of allergic reactions is possible.

Contraindications

Hypersensitivity to valerian preparations, children’s age (under 1 year).

Use in Pregnancy and Lactation

Use during pregnancy and lactation is possible. It is necessary to consult a doctor.

Pediatric Use

Contraindicated in children under 1 year.

Special Precautions

During the treatment period, caution must be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

It enhances the effect of hypnotics and sedative medicines, as well as antispasmodics.

Storage Conditions

In a dry place, protected from light.

The ready infusion – in a cool place for no more than 2 days.

Keep out of reach of children.

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The preparation 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.

Medical Disclaimer

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