Novo - Passit oral solution, 200ml

• 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 due to nervous tension.

• Migraine.

• Functional diseases of the gastrointestinal tract (dyspeptic syndrome, irritable bowel syndrome).

• As a symptomatic remedy for neurocirculatory dystonia and climacteric syndrome.

• Itchy dermatoses (atopic and seborrheic eczema, urticaria) caused by psychological stress.

The drug is taken undiluted or diluted in a small amount of water. When using a vial, the dosage of the drug is carried out using a measuring cap. Inside, for adults and children over 12 years old.

In the absence of other doctor's recommendations, 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 severe fatigue or depression appears, it is necessary to reduce the morning and day dose by 2 times and take 2.5 ml in the morning and afternoon and 5 ml in the evening. The interval between doses should be 4-6 hours. In case of nausea, the drug should be taken with meals.

active ingredients: Novo-Passita liquid extract (obtained from rhizomes with the roots of Valerian officinalis, herb lemon balm, herb St. 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, orange flavor 0.05 g, sodium citrate dihydrate 0.40 g, malto-dextrin 8.00 g, propylene glycol 10.00 g, purified water to 100 ml.

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

Carefully

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

Trade name:

Novo-Passit

International non-proprietary or group name:

not assigned

Dosage form:

oral solution

Composition per 100 ml of the preparation:

active ingredients: Novo-Passita liquid extract (obtained from rhizomes with the roots of Valerian officinalis, herb lemon balm, herb St. 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, orange flavor 0.05 g, sodium citrate dihydrate 0.40 g, malto-dextrin 8.00 g, propylene glycol 10.00 g, purified water to 100 ml.

Description

Syrupy, transparent or slightly turbid liquid from red-brown to brown color, with a characteristic odor. During storage, a small precipitate is allowed, which dissolves when shaken.

Pharmacotherapeutic group

Herbal sedative.

ATX code : N05CM

pharmachologic effect

Combined drug, the pharmacological activity of which is due to the components of the extract based on medicinal plant materials with a predominantly sedative (sedative) effect and guaifenesin, which has anxiolytic (anti-anxiety) effect.

Indications for use

• 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 due to nervous tension.

• Migraine.

• Functional diseases of the gastrointestinal tract (dyspeptic syndrome, irritable bowel syndrome).

• As a symptomatic remedy for neurocirculatory dystonia and climacteric syndrome.

• Itchy dermatoses (atopic and seborrheic eczema, urticaria) caused by psychological stress.

Contraindications

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

Carefully

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

Application during pregnancy and during breastfeeding

During pregnancy, the drug is prescribed only for absolute indications if the expected effect for the mother outweighs the possible risk for the fetus. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Method of administration and dosage

The drug is taken undiluted or diluted in a small amount of water. When using a vial, the dosage of the drug is carried out using a measuring cap. Inside, for adults and children over 12 years old.

In the absence of other doctor's recommendations, 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 severe fatigue or depression appears, it is necessary to reduce the morning and day dose by 2 times and take 2.5 ml in the morning and afternoon and 5 ml in the evening. The interval between doses should be 4-6 hours. In case of nausea, the drug should be taken with meals.

Side effect

Patients usually tolerate the drug well. However, in rare cases, allergic reactions, exanthema, dizziness, fatigue, drowsiness, slight muscle weakness, disorders of the gastrointestinal tract (nausea, vomiting, spasms, heartburn, diarrhea, constipation), decreased concentration of attention, which quickly pass after drug withdrawal, may appear ...

If these or other side effects appear, you should consult a doctor. If any of these side effects are aggravated, or you notice any other side effects that are not listed in the instructions, inform your doctor.

Overdose

Overdose initially manifests itself as 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 an overdose appear, the drug should be discontinued. First aid: gastric lavage. Treatment is symptomatic. You need to see a doctor.

Interaction with other medicinal products

With the simultaneous administration of Novo-PassitЃ and other drugs, their effect may be enhanced or weakened. Before you start taking the drug at the same time as other drugs, you should consult your doctor.

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

Medicines 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 prevention of thromboembolism ... Therefore, before you start taking Novo-Passit against the background of these drugs, you should consult your doctor.

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, you should not consume alcoholic beverages. While taking Novo-PassitaЃ, especially for patients with fair skin, you should avoid exposure to ultraviolet radiation (prolonged exposure to direct sunlight, visiting a solarium).

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

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

Indication for patients with diabetes mellitus:

100 ml of the preparation 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 use of the drug, one should refrain from performing potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions (including driving, working with moving mechanisms).

Release form

Oral solution.

5 ml sachet sachet - 12 and 30 sachets each (three-layer: paper / AL / PE) in a cardboard box together with instructions for use.

10 ml sachet sachet - 8 and 20 sachets each (three-layer: paper / AL / PE) in a cardboard box together with instructions for use.

100 ml, 200 ml or 450 ml in a dark glass bottle, equipped with a measuring cap. Each bottle is placed in a cardboard box along with instructions for use. Storage conditions

At temperatures from 10 ? C to 25 ? C, in a dark place. Keep out of the reach of children. Shelf life

Sachets 5 ml, 10 ml - 2 years. Bottles of 100 ml, 200 ml, 450 ml - 4 years. Do not use after the expiration date.

Vacation conditions

Without recipe.