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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 Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

FPK PharmVILAR, JSC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

Dosage Form

Bottle OTC Icon 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.

Marketing Authorization Holder

FPK PharmVILAR, JSC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

Contact Information

FPK PharmVILAR, JSC (Russia)

Dosage Form

Bottle OTC Icon 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.

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