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
| 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