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Novo-Person (Tablets, Solution) Instructions for Use

ATC Code

N05CM (Other hypnotic and sedative drugs)

Clinical-Pharmacological Group

Sedative agent

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

Sedative agent of herbal origin. It has primarily sedative and anxiolytic effects.

Indications

Neurasthenia and neurotic reactions accompanied by irritability, anxiety, fear, fatigue, absent-mindedness; “manager’s syndrome” (a state of constant mental tension); insomnia (mild forms); headaches caused by nervous tension; migraine; functional gastrointestinal disorders (dyspeptic syndrome, irritable bowel syndrome); as a symptomatic agent for neurocirculatory dystonia and climacteric syndrome; pruritic dermatoses (atopic and seborrheic eczema, urticaria) caused by psychological stress.

ICD codes

ICD-10 code Indication
F41.9 Anxiety disorder, unspecified
F45.3 Somatoform dysfunction of the autonomic nervous system
F48.0 Neurasthenia
F48.9 Unspecified neurotic disorder
F51.0 Nonorganic insomnia
G43 Migraine
G44.2 Tension-type headache
K30 Functional dyspepsia (digestive disorder)
K58 Irritable bowel syndrome
L20.8 Other atopic dermatitis (neurodermatitis, eczema)
L30.0 Nummular eczema
L50 Urticaria
N95.1 Menopausal and other perimenopausal disorders
N95.3 States associated with artificial menopause
R45.0 Nervousness
R45.1 Restlessness and agitation
Z73.3 Stress, not elsewhere classified (physical and mental strain)
ICD-11 code Indication
6A8Z Affective disorders, unspecified
6B0Z Anxiety or fear-related disorders, unspecified
6B6Z Dissociative disorders, unspecified
6C20.Z Bodily distress disorder, unspecified
7A00 Chronic insomnia
7A01 Acute insomnia
7A0Z Insomnia disorders, unspecified
8A80.Z Migraine, unspecified
8A83 Other primary headache disorders
8A8Z Headache disorders, unspecified
9A06.70 Atopic eczema of the eyelids
DD90.0 Globus sensation
DD90.1 Functional dysphagia
DD90.3 Functional dyspepsia
DD90.Z Functional disorders of esophagus or gastroduodenal system, unspecified
DD91.0Z Irritable bowel syndrome, unspecified
EA80.0 Infantile atopic eczema
EA80.1 Childhood atopic eczema
EA80.2 Adult atopic eczema
EA80.Z Atopic eczema, unspecified
EA82 Nummular dermatitis
EA85.20 Atopic hand eczema
GA30.00 Menopausal or climacteric states in women
GA30.3 States associated with artificial menopause
MB24.3 Anxiety
MB24.F Restlessness
QE01 Stress, not elsewhere classified

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.

Administer orally. Adhere strictly to the three times per day schedule for consistent therapeutic effect.

For tablets, swallow whole with a sufficient amount of water. Do not crush or chew.

For the oral solution, use the measuring device provided for accurate dosing. Do not use household spoons.

The standard adult and adolescent (12 years and older) dose is one single dose per administration.

Space doses evenly throughout waking hours, for example, in the morning, afternoon, and evening.

For insomnia, take the last dose approximately 30-60 minutes before bedtime.

Do not exceed the recommended daily frequency. The maximum daily dose is three single doses.

Duration of therapy is determined by the treating physician based on clinical response. Do not use continuously for extended periods without medical supervision.

If a dose is missed, take it as soon as remembered unless it is nearly time for the next dose. In that case, continue with the next scheduled dose. Do not double the dose to make up for a missed one.

Discontinue use and consult a physician if symptoms persist or worsen after a reasonable treatment period.

Adverse Reactions

Rarely allergic reactions, exanthema, dizziness, fatigue, drowsiness, mild muscle weakness, nausea, vomiting, cramps, heartburn, diarrhea, constipation, decreased concentration, which quickly disappear after drug withdrawal.

Contraindications

Hypersensitivity to the combination components, myasthenia gravis, children under 12 years of age.

With caution

Acute gastrointestinal diseases, liver diseases, alcoholism, traumatic brain injury, brain diseases, epilepsy, children over 12 years of age.

Use in Pregnancy and Lactation

During pregnancy, use only for absolute indications if the expected benefit for the mother outweighs the potential risk to the fetus.

If use during lactation is necessary, breastfeeding should be discontinued.

Use in Hepatic Impairment

Use with caution in liver diseases.

Pediatric Use

Contraindicated in children under 12 years of age.

Use with caution in children over 12 years of age.

Special Precautions

During drug administration, especially in patients with fair skin, avoid exposure to UV radiation (prolonged exposure to direct sunlight, visiting a solarium).

Effect on ability to drive vehicles and operate machinery

During use, refrain from potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (including driving vehicles, working with moving machinery).

Drug Interactions

It enhances the effect of alcohol and other substances that depress the central nervous system.

Central muscle relaxants may increase the risk of the drug’s adverse reactions, primarily muscle weakness.

The St. John’s wort extract contained in the drug reduces the effectiveness of hormonal contraceptives, immunosuppressants, antiviral drugs for AIDS treatment, cardiovascular diseases, bronchial diseases, anticoagulants.

Storage Conditions

Store at 8°C (46°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.

Medical Disclaimer

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

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Novo-Person Oral solution: fl. 50 ml, 100 ml or 200 ml with a measuring cup

Dosage Form, Packaging, and Composition

Oral solution in the form of a syrupy, transparent or slightly turbid liquid, from reddish-brown to brown in color, with a characteristic odor; during storage, a slight sediment is allowed, which breaks up upon shaking.

100 ml
Novo-Persona liquid extract (obtained from dry extracts of hawthorn leaves and flowers, black elder flowers, valerian officinalis rhizomes with roots, St. John’s wort herb, lemon balm herb, passionflower herb, common hop strobiles in a ratio of 5:2:5:5:2:1:5) 7.75 g
Guaifenesin 4 g

Excipients : sodium cyclamate – 0.5 g, xanthan gum – 0.1 g, invert sugar syrup – 39.73 g, sodium benzoate – 0.35 g, sodium saccharin monohydrate – 0.0926 g, ethanol (ethyl alcohol) 95% – 7.03 g, orange flavor – 0.05 g, sodium citrate dihydrate – 0.4 g, maltodextrin – 8 g, propylene glycol – 10 g, purified water – up to 100 ml.

50 ml – glass bottles (1) complete with a measuring cup – cardboard packs.
100 ml – glass bottles (1) complete with a measuring cup – cardboard packs.
200 ml – glass bottles (1) complete with a measuring cup – cardboard packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Novo-Person Film-coated tablets: 10, 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets light yellow in color, oval in shape, biconvex, with a dividing score; on the cross-section from light brown with a gray tint to brown in color.

1 tab.
Guaifenesin 200 mg
Novo-Persona dry extract (20:1) 157.5 mg
   From a mixture of medicinal plant materials 0.105 g valerian officinalis rhizomes with roots, 0.042 g lemon balm herb, 0.105 g St. John’s wort herb, 0.105 g hawthorn (single-seeded and prickly) leaves and flowers, 0.021 g passionflower herb, 0.105 g common hop strobiles, 0.042 g black elder flowers, with a content of the sum of flavonoids calculated as rutin Not less than 0.1%

Excipients : silicon dioxide – 2 mg, microcrystalline cellulose – 96 mg, glycerol – 10 mg, magnesium stearate – 10 mg, lactose monohydrate – up to 800 mg.

Shell composition: Opadry II green 85A210030* – 24 mg.
* Composition of Opadry II green 85A210030 polyvinyl alcohol – 37%, titanium dioxide – 20.5%, talc – 31%, CAPMUL MCM – 4%, quinoline yellow dye – 2.04%, yellow iron oxide – 1.64%, indigo carmine dye – 0.82%.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – glass bottles (1) – cardboard packs.
60 pcs. – glass bottles (1) – cardboard packs.
100 pcs. – glass bottles (1) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.
60 pcs. – polymer bottles (1) – cardboard packs.
100 pcs. – polymer bottles (1) – cardboard packs.

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