Novo-Passit, oral solution 100ml vial

Composition

Composition per 100 ml of the drug:

active ingredients:

Novo-Passit liquid extract (obtained from rhizomes with roots of valerian officinalis, herb melissa officinalis, herb St. John’s wort holed, leaves and flowers of hawthorn odnopestichny or prickly, grass passionflower incarnate (passion flower), coplods of ordinary hops, black elderberry flowers) 7.75 g;

guaifenesin 4.00 g;

excipients:

sodium cyclamate 0.50 g,

xanthan gum 0,10 g,

invert sugar syrup 39,73 g,

sodium benzoate 0.35 g,

sodium saccharin mono-hydrate 0,0926 g

ethanol 96% 7.03 g,

the scent of orange 0.05 g

of sodium citrate dihydrate and 0.40 g,

malto-dextrin of 8.00 g,

propylene glycol 10,00 g,

purified water to 100 ml.

Pharmacological properties

Pharmacotherapeutic group

Sedative of plant origin.

ATX code: N05CM

Pharmacological action

A combined drug whose pharmacological activity is determined by the components of an extract based on medicinal plant raw materials that are included in its composition with a predominantly sedative (calming) effect and guaifenesin, which has an anxiolytic (anti-anxiety) effect.

Indications

• Neurasthenia and neurotic reactions accompanied by irritability, anxiety, fear, fatigue, absent-mindedness.
• “Manager’s syndrome ” (a state of constant mental stress).
• Insomnia (mild forms).
• Headaches caused by nervous tension.
• A migraine.
• Functional diseases of the gastrointestinal tract (dyspeptic syndrome, irritable bowel syndrome).
• As a symptomatic treatment for neurocirculatory dystonia and menopausal syndrome.
• Itchy dermatoses (eczema atopic and seborrheic, urticaria) caused by psychological stress.

Use during pregnancy and lactation

During pregnancy, the drug is prescribed only for absolute indications, if the expected effect for the mother exceeds the possible risk to the fetus.

If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Contraindications

Hypersensitivity to the components of the drug, especially to guaifenesin, myasthenia gravis, children under 12 years of age, sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

With caution

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

Side effects

Patients usually tolerate the drug well.

However, in rare cases, there may be allergic reactions, exanthema, dizziness, fatigue, drowsiness, mild muscle weakness, gastrointestinal disorders (nausea, vomiting, cramps, heartburn, diarrhea, constipation), decreased concentration, which quickly disappear after discontinuation of the drug.

If these or other side effects occur, you should consult a doctor.

If any of these side effects get worse, or you notice any other side effects that are not listed in the instructions, tell your doctor.

Interaction

When taking Novo-Passit® and other medications at the same time, their effect may be enhanced or weakened. Before starting taking the drug simultaneously with other medications, you should consult your doctor.

The drug increases the effect of alcohol and other substances that depress the central nervous system.

Medications used to relax skeletal muscles (central muscle relaxation) may increase the risk of side effects of the drug, primarily muscle weakness.

St. John’s wort extract contained in the preparation reduces the effectiveness of hormonal contraception, as well as drugs used mainly after transplantation to reduce the risk of rejection of the transplanted organ or tissue (immunosuppressive drugs), drugs intended for the treatment of AIDS, cardiovascular diseases, bronchial diseases and the prevention of thromboembolism.

Therefore, before taking Novo-Passit on the background of these drugs, it is necessary to consult a doctor.

How to take, course of use and dosage

The drug is taken undiluted or diluted in a small amount of water.

When using a bottle, the dosage of the drug is carried out using a measuring cap.

Inside, adults and children over 12 years of age.

In the absence of other recommendations of the doctor, the drug should be taken 5 ml 3 times a day before meals.

After consulting a doctor, it is possible to increase the dose to 10 ml 3 times a day.

If you feel very tired or depressed, you should reduce the morning and afternoon dose by 2 times and take 2.5 ml in the morning and afternoon and 5 ml in the evening.

The interval between meals should be 4-6 hours.

In case of nausea, the drug should be taken with a meal.

Overdose

Overdose is initially manifested by a feeling of depression and drowsiness.

Later, these symptoms may be accompanied by nausea, mild muscle weakness, joint pain, and a feeling of heaviness in the stomach.

If symptoms of overdose occur, the drug should be discontinued.

First aid: gastric lavage.

Treatment is symptomatic.

You should consult a doctor.

Description

Syrupy, clear or slightly cloudy liquid from red-brown to brown in color, with a characteristic smell. During storage, a small precipitate is allowed, which dissolves when shaken.

Special instructions

The drug contains ethanol (from 8.9 to 10.4 g per 100 ml).5 ml of the drug (single dose) contains up to 0.520 g of absolute ethyl alcohol. The content of absolute ethyl alcohol in the maximum single dose of the drug (10 ml) is up to 1,040 g, in the maximum daily dose (30 ml) – up to 3,120 g.

During treatment with the drug, do not drink alcoholic beverages. When taking Novo-Passit®, especially patients with fair skin, avoid exposure to ultraviolet radiation (prolonged exposure to direct sunlight, visiting a tanning salon).

The drug is not recommended for use in patients with impaired glucose and galactose absorption and congenital fructose intolerance.

If the symptoms of the disease persist or the condition worsens during the use of the drug for 7 days, as well as in case of side effects, you should inform your doctor about this.

Note for patients with diabetes mellitus:

100 ml of the drug contains 39.73 g of invert sugar syrup. One dose of the drug (5 ml) contains 1.99 g of invert sugar syrup containing 1.4 g of a mixture of glucose and fructose, which corresponds to 0.12 XE (bread units).

Influence on the ability to drive vehicles and mechanisms

During the period of using the drug, you should refrain from performing potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).

Form of production

Solution for oral use.

Storage conditions

In a dark place, at a temperature not exceeding 25°C.

Shelf

life is 4 years.

Active ingredient

Hawthorn flowers and leaves, Hawthorn fruits, Guaifenesin, St. John’s wort grass, Hops, Lemon balm, Passionflower,

Dosage form

solution for oral use

Description

Children over 12 years old, For adults

Indications

Insomnia, Vegetative-vascular disorders, Dermatitis, Irritable Bowel Syndrome, Premenstrual Syndrome, Menopause, Stress, Migraines, Eczema, Dermatosis