Novo-Passit^® (Tablets) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Czech Industries, s.r.o. (Czech Republic)

Contact Information

TEVA (Israel)

ATC Code

N05CX (Hypnotic and sedative drugs, excluding barbiturates, in combination with other drugs)

Dosage Forms

	Novo-Passit®	Film-coated tablets: 10, 30, 60 or 100 pcs.
		Oral solution: 100 ml or 200 ml bottle with a measuring cap

Dosage Form, Packaging, and Composition

Film-coated tablets pale green, oval, biconvex, with a score line.

Excipients: colloidal silicon dioxide, microcrystalline cellulose, glycerol, magnesium stearate, lactose monohydrate.

Shell composition Opadry “AMB 80W31115” green (polyvinyl alcohol, titanium dioxide, talc, soy lecithin, xanthan gum, quinoline yellow dye, yellow iron oxide, indigo carmine dye).

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
60 pcs. – polyethylene jars (1) – cardboard packs.

Oral solution in the form of a syrupy, transparent or slightly cloudy liquid from reddish-brown to brown in color, with a characteristic odor; over time, cloudiness may occur or an easily shaken sediment may form.

Excipients: sodium cyclamate, xanthan gum, invert sugar syrup 50%, sodium benzoate, sodium saccharin monohydrate, ethanol 96%, orange flavor 51941A, sodium citrate dihydrate, maltodextrin, propylene glycol, purified water.

100 ml – dark glass bottles (1) with a measuring cap – cardboard packs^x.
200 ml – dark glass bottles (1) with a measuring cap – cardboard packs^x.

^x protective stickers may be applied to the cardboard pack

Clinical-Pharmacological Group

Sedative agent

Pharmacotherapeutic Group

Hypnotic and sedative (calming and reducing nervous tension in the body) drugs (excluding barbiturates) in combination with other drugs

Pharmacological Action

A combined herbal preparation with a sedative effect, the pharmacological activity is due to its components of the extract based on medicinal raw materials with a predominantly sedative effect and guaifenesin, which has an anxiolytic effect. The sedative effect of the drug is complemented by the anxiolytic effect of guaifenesin.

Pharmacokinetics

The action of Novo-Passit^® is the combined action of its components, therefore conducting kinetic studies is not possible.

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 gastrointestinal diseases (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

Dosage Regimen

Orally, adults and children over 12 years are prescribed 1 tablet or 5 ml of oral solution 3 times/day before meals. If necessary, as prescribed by a doctor, the dose may be increased to 2 tablets or 10 ml of solution 3 times/day. If severe fatigue or depression occurs, it is necessary to reduce the morning and daytime dose to 1/2 tablet or 2.5 ml of solution per dose, and take 1 tablet or 5 ml of solution in the evening. The interval between doses should be 4-6 hours.

If nausea occurs, the drug should be taken with meals.

The drug in the form of a solution is taken undiluted or diluted in a small amount of water. When using the drug from a bottle, dosing is carried out using a measuring cap.

Adverse Reactions

From the digestive system rarely – nausea, vomiting, cramps, heartburn, diarrhea, constipation.

From the CNS rarely – decreased concentration, dizziness, drowsiness.

Other rarely – allergic reactions, exanthema, fatigue, mild muscle weakness. Symptoms quickly disappear after discontinuation of the drug.

The patient should be warned that if the specified or other adverse reactions occur, it is necessary to consult a doctor.

Contraindications

• Myasthenia gravis;
• Children under 12 years of age;
• Hypersensitivity to the components of the drug.

With caution, the drug should be used in patients with acute gastrointestinal diseases, with liver diseases, chronic alcoholism, brain diseases and injuries, with epilepsy.

Use in Pregnancy and Lactation

During pregnancy, the drug is prescribed only for absolute indications, if the expected benefit of therapy for the mother outweighs the possible risk to the fetus.

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

Use in Hepatic Impairment

The drug should be used with caution in liver diseases.

Pediatric Use

Contraindication: children under 12 years of age.

Special Precautions

During treatment with Novo-Passit^®, alcohol should not be consumed.

The drug should be used with caution in acute gastrointestinal diseases.

The patient should be warned that if the symptoms of the disease do not disappear within 7 days of therapy or if they intensify, it is recommended to consult a doctor.

While taking Novo-Passit^®, exposure to ultraviolet radiation (prolonged exposure to direct sunlight, visiting a solarium) should be avoided, especially in patients with fair skin.

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

Patients with diabetes should be aware that 100 g of oral solution contains 12.5-14.2 g of glucose and 13.6-15.3 g of fructose. When taken in recommended doses, each dose contains no more than 1.42 g of glucose and 1.53 g of fructose.

The oral solution contains 12.19% ethanol; each single dose contains up to 0.481 g of ethanol.

Effect on ability to drive vehicles and mechanisms

During treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Do not drive vehicles or operate machinery.

Overdose

Symptoms initially – drowsiness, feeling of depression, later – nausea, mild muscle weakness, joint pain, feeling of heaviness in the stomach.

Treatment gastric lavage, symptomatic therapy. The patient should be warned about the need to consult a doctor.

Drug Interactions

When taking Novo-Passit^® simultaneously with other drugs, their action may be enhanced or weakened. Before starting to take the drug simultaneously with other drugs, the patient should consult a doctor.

The drug enhances the effect of ethanol and other substances that have a depressant effect on the central nervous system.

Drugs used for skeletal muscle relaxation (central muscle relaxation) may increase the risk of adverse effects of the drug, primarily muscle weakness.

The extract of Hypericum perforatum contained in the drug 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 (immunosuppressants), drugs for the treatment of AIDS, cardiovascular diseases, bronchial diseases and for the prevention of thromboembolism. Therefore, before starting to take Novo-Passit^® while taking the specified drugs, the patient should consult a doctor.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature from 10°C (50°F) to 25°C (77°F).

Shelf Life

The shelf life of tablets is 3 years. The shelf life of the oral solution in bottles is 4 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.