Phyto Novo-Sed® (Extract, Powder) Instructions for Use
ATC Code
N05CM (Other hypnotic and sedative drugs)
Clinical-Pharmacological Group
Sedative agent
Pharmacotherapeutic Group
Herbal sedative
Pharmacological Action
A sedative herbal preparation. It also possesses anxiolytic properties, contributes to the improvement of cerebral circulation; exerts an activating effect on the liver’s detoxification system (on cytochrome P450 and glutathione transferase), and increases the body’s resistance to physical exertion.
Pharmacokinetics
The action of Phyto Novo-Sed® is the cumulative action of its components, therefore conducting kinetic observations is not feasible.
Indications
- Neurotic reactions accompanied by irritability, insomnia, anxiety, fear, headache.
ICD codes
| ICD-10 code | Indication |
| F41.9 | Anxiety disorder, unspecified |
| F48.0 | Neurasthenia |
| F48.9 | Unspecified neurotic disorder |
| F51.2 | Nonorganic disorders of the sleep-wake schedule |
| ICD-11 code | Indication |
| 6A8Z | Affective disorders, unspecified |
| 6B0Z | Anxiety or fear-related disorders, unspecified |
| 6B6Z | Dissociative disorders, unspecified |
| 7B2Z | Sleep-wake cycle disorders, unspecified |
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. |
Powder
Orally for adults, 3 times/day. The duration of the treatment course is up to 2 weeks. If necessary, it is possible to increase the duration of administration and conduct repeated courses of treatment.
Extract
The drug is prescribed orally for adults, 2.5 ml of extract (0.5 teaspoon), diluted in 50 ml (1/4 cup) of water, 3 times/day 30 minutes before or 40 minutes after a meal. The duration of the treatment course is up to 2 weeks. If necessary, it is possible to increase the duration of administration and conduct repeated courses of treatment.
Adverse Reactions
Possible allergic reactions.
Contraindications
- Progressive systemic diseases (tuberculosis, leukemia, multiple sclerosis, autoimmune diseases);
- Diffuse connective tissue diseases (collagenoses);
- AIDS and HIV infection;
- Pregnancy;
- Lactation (breastfeeding);
- Age under 18 years;
- Hypersensitivity to the components of the drug and plants of the Asteraceae family.
With caution, the drug should be used in epilepsy, diseases and injuries of the brain, in severe liver function disorders and chronic alcoholism (due to the ethanol content).
Use in Pregnancy and Lactation
The use of Phyto Novo-Sed® during pregnancy and lactation is contraindicated.
Use in Hepatic Impairment
Due to the presence of ethanol in the drug, it should be used with caution in severe forms of liver function impairment.
Pediatric Use
Contraindication: age under 18 years.
Special Precautions
In the recommended doses, Phyto Novo-Sed® does not cause drowsiness and impaired attention, which allows it to be taken during the daytime.
The ethanol content in the drug is not less than 33%. A single dose of the drug contains 0.83 ml of ethanol (calculated as absolute alcohol).
Overdose
Data on drug overdose have not been provided.
Drug Interactions
No clinically significant interaction of Phyto Novo-Sed® with other medicinal products has been established (the drug can be used in combination with NSAIDs, analgesics, antibiotics).
Storage Conditions
The drug should be stored in a light-protected place, out of the reach of children, at a temperature not exceeding 20°C (68°F).
Shelf Life
The shelf life is 3 years.
Dispensing Status
The drug 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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Powder for oral solution: sachet 5 g 3, 6, 9, 12, 15, 21, 24, 30, or 42 pcs.
Marketing Authorization Holder
FPK PharmVILAR, JSC (Russia)
Manufactured By
PharmVILAR NPO, LLC (Russia)
Dosage Form
 |
Phyto Novo-Sed® | Powder for oral solution: sachet 5 g 3, 6, 9, 12, 15, 21, 24, 30, or 42 pcs. |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral solution in the form of a mixture of powder and granules of light brown color, with a characteristic odor; the presence of lighter and darker inclusions is allowed.
| 1 sachet | |
| Phyto Novo-Sed® liquid extract* (calculated as dry substance) | 250 mg |
* Phyto Novo-Sed®, liquid extract is obtained from a mixture of medicinal plant materials: Lemon balm herb — Melissa officinalis L., fam. Lamiaceae; Motherwort herb (Leonurus cardiaca L. (L. Cardiac L. subsp. Villosus (Desf.) Jav.) and Five-lobed motherwort herb — Leonurus quinquelobatus Gilib., fam. Lamiaceae; Rose hips — Rosa L., fam. Rosaceae; Hawthorn fruit — Crataegus L., fam. Rosaceae; Purple coneflower herb — Echinacea purpurea (L.) Moench, fam. Asteraceae in a ratio (1:1:1:0.5:0.5) by extraction with 40% ethyl alcohol (ethanol).
Excipients: lactose monohydrate, povidone K-30, colloidal silicon dioxide.
5 g – sachets (3) – cardboard packs.
5 g – sachets (6) – cardboard packs.
5 g – sachets (9) – cardboard packs.
5 g – sachets (12) – cardboard packs.
5 g – sachets (15) – cardboard packs.
5 g – sachets (21) – cardboard packs.
5 g – sachets (24) – cardboard packs.
5 g – sachets (30) – cardboard packs.
5 g – sachets (42) – cardboard packs.
Liquid extract for oral administration: 50 ml or 100 ml bottle
Marketing Authorization Holder
FPK PharmVILAR, JSC (Russia)
Manufactured By
PharmVILAR NPO, LLC (Russia)
Contact Information
FPK PharmVILAR, JSC (Russia)
Dosage Form
|
Phyto Novo-Sed® | Liquid extract for oral administration: 50 ml or 100 ml bottle |
Dosage Form, Packaging, and Composition
Extract for oral administration (liquid) dark brown with a reddish tint, with an aromatic odor and taste; sediment may appear during storage.
| 100 ml | |
| Purple coneflower herb | 6.25 g |
| Melissa officinalis | 12.5 g |
| Rose hips | 12.5 g |
| Hawthorn fruit | 6.25 g |
| Motherwort herb | 12.5 g |
Excipients: ethanol 40%.
50 ml – dark glass bottles (1) with or without a measuring cup – cardboard packs.
100 ml – dark glass bottles (1) with or without a measuring cup – cardboard packs.
50 ml – dropper bottles (1) – cardboard packs.
100 ml – dropper bottles (1) – cardboard packs.
![Phyto Novo-Sed® [Extract, Powder] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Phyto Novo-Sed® [Extract, Powder] 2")