Novo-Passit, 100 ml

Pharmacotherapeutic group

Pharmacological sedative of herbal origin.

The ATX code: N05CM

Pharmacological action

A combined product which pharmacological activity is due to its constituent herbal extract components with predominantly sedative (sedative) action and guaifenesin which has anxiolytic (anti-anxiety) effect.

Indications

Irritability, Psycho-emotional tension, Migraine, Stress, Eczema, Anxiety, Dermatosis, Insomnia, Vascular disorders, Headache, Dermatitis, Irritable bowel syndrome, Premenstrual syndrome, Climax

• Nevrosthenia and neurotic reactions, accompanied by irritability, anxiety, fear, fatigue, distraction.
• “Manager’s Syndrome” (state of constant mental tension).
• Insomnia (mild forms).
• Headaches caused by nervous tension.
• Migraine.
• Functional diseases of the gastrointestinal tract (dyspeptic syndrome, irritable bowel syndrome).
• As a symptomatic agent in neurocirculatory dystonia and menopausal syndrome.
• Itchy dermatoses (eczema atopic and seborrheic, urticaria) caused by psychological stress.
  

Active ingredient

Hawthorn flowers and leaves, Hawthorn fruits, Guaifenesin, St. John’s wort herb, Hops, Melissa, Passiflora,

Composition

Composition per 100 ml of the drug: Active ingredients: Novo-Passita liquid extract (1:4,5) (obtained from valerian herbal rhizomes with roots (5 parts), melissa herb (2 parts), St. John’s Wort herb (5 parts), hawthorn leaves and flowers (5 parts), Passiflora incarnata herb (1 part), common hops (5 parts), black elderflower (2 parts)) 7.75 g; guaifenesin 4.00 g; excipients: sodium cyclamate 0.50 g, xanthan gum 0.10 g, invert sugar syrup 50% 39.73 g, sodium benzoate 0.35 g, sodium saccharinate monohydrate 0.0926 g, ethanol 96% 7.03 g, orange flavoring 51941A 0.05 g, sodium citrate dihydrate 0.40 g, maltodextrin 8.00 g, propylene glycol 10.00 g, water purified to 100 ml.

How to take, the dosage

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

When using the bottle the drug is dosed using the measuring cup.

Ingestion, adults and children over 12 years of age.

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

In consultation with a physician it is possible to increase the dose to 10 ml 3 times a day.

In case of severe fatigue or depression, reduce the morning and daily dosage by half 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 food.

Interaction

When taking Novo-Passit® and other drugs at the same time, their effect can be enhanced or weakened. Before starting taking the drug simultaneously with other medicinal products, it is necessary to consult a doctor.

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

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

The Hypericum extract contained in the drug reduces the effectiveness of hormonal contraception, as well as medications used primarily after transplantation to reduce the risk of rejection of the transplanted organ or tissue (immunosuppressive drugs), medications designed to treat AIDS, cardiovascular disease, bronchial disease and prevention of thromboembolism.

Therefore, before starting Novo-Passit against the background of these drugs, it is necessary to consult a 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 ethanol. Contents of absolute ethyl alcohol in maximum single dose (10 ml) is up to 1,040 g, in maximum daily dose (30 ml) – up to 3,120 g.

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

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

If symptoms persist or worsen after 7 days of use, or if there are any side effects, the physician should be told.

Hint for patients with diabetes mellitus:

The drug contains 39.73 g of invert sugar syrup in 100 ml. 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 BE (bread units).

Impact on driving and operating machinery

When using the drug, one should refrain from performing potentially hazardous activities requiring increased concentration and quick psychomotor reactions (including driving vehicles and operating moving machinery).

Synopsis

Syrup-like, transparent or slightly turbid liquid of red-brown to brown color, with a characteristic odor.

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

Side effects

Patients usually tolerate the drug well.

In rare cases, however, allergic reactions, exanthema, dizziness, fatigue, drowsiness, mild muscle weakness, gastrointestinal disorders (nausea, vomiting, cramps, heartburn, diarrhea, constipation), reduced concentration may occur, which quickly pass after discontinuation of the drug.

If any of these or other side effects occur, a physician should be consulted.

If any of these side effects worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Overdose at first is manifested by a feeling of depression and drowsiness.

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

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

Pre-hospital care: gastric lavage.

The treatment is symptomatic.

Physician should be consulted.

Pregnancy use

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

Breastfeeding should be discontinued if the drug has to be used during lactation.