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

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.
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.

Pharmacological effect

Pharmacotherapeutic group

Sedative of plant origin.

ATX code: N05CM

Pharmacological action

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

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 drink alcoholic beverages. While taking Novo-Passit®, especially patients with fair skin, 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 symptoms of the disease persist or the condition worsens while using the drug for 7 days, as well as in the event of side effects, you should inform your doctor.

Instructions 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).

Impact on the ability to drive vehicles and machinery

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

Active ingredient

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

Composition

Composition per 100 ml of the drug:
active ingredients: Novo-Passita liquid extract (1:4.5) (obtained from valerian officinalis rhizomes with roots (5 h), lemon balm herb (2 h), St. John’s wort herb (5 h), hawthorn leaves and flowers (5 h), passionflower incarnate herb (1 h), common hop fruit (5 h), black elderberry flowers (2 hours)) 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 flavor 51941A 0.05 g, sodium citrate dihydrate 0.40 g, maltodextrin 8.00 g, propylene glycol 10.00 g, purified water up to 100 ml.

Pregnancy

During pregnancy, the drug is prescribed only for absolute indications, if the expected effect for the mother exceeds the possible risk for 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, sucrase/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, 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, may occur.

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 not listed in the instructions, tell your doctor.

Interaction

When taking Novo-Passit® and other medications simultaneously, their effect may be enhanced or weakened. Before starting to take the drug simultaneously with other medications, 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 drug reduces the effectiveness of hormonal contraception, as well as drugs used primarily after transplantation to reduce the risk of rejection of a transplanted organ or tissue (immunosuppressive drugs), drugs intended for the treatment of AIDS, cardiovascular diseases, bronchial diseases and the prevention of thromboembolism.

Therefore, before starting to take Novo-Passit along with these medications, you should consult your doctor.

Overdose

An 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 overdose appear, the drug should be discontinued.

First aid: gastric lavage.

Treatment is symptomatic.

You need to see a doctor.

Storage conditions

Store at temperatures from 8 to 25 °C in the original packaging (pack).
Keep out of the reach of children!

Shelf life

4 years.

Manufacturer

Teva Czech Enterprises s.r.o., Czech Republic