Novo-passit pills 357.5mg №60

Film Coated Tablets pale green, oval, biconvex, with dividing risk.

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, iron yellow oxide, indigo carmine dye).

10 pieces. - blisters (1) - packs cardboard.
10 pieces. - blisters (3) - packs cardboard.
30 pieces - polyethylene cans (1) - cardboard packs.
60 pcs. - polyethylene cans (1) - cardboard packs.
100 pieces. - polyethylene cans (1) - cardboard packs.

◊ Oral solution in the form of a syrupy, transparent or slightly turbid liquid from red-brown to brown in color, with a characteristic odor; during storage a small precipitate is allowed to dissolve when shaken.

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

5 ml - three-layer bags (12) - cardboard packs.
5 ml - three-layer bags (30) - cardboard packs.
10 ml - bags three-layer (8) - packs cardboard.
10 ml - three-layer bags (20) - cardboard packs.
100 ml - dark glass bottles (1) complete with a measuring cap - packs cardboard.
200 ml - dark glass bottles (1) complete with a measuring cap - packs cardboard.
450 ml - bottles of dark glass (1) complete with a measured cap - packs cardboard.

Clinico-pharmacological group

Sedative drug

Mechanism of action

Combined herbal remedy with a sedative effect, pharmacological activity due to its constituent 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 supplemented by the anxiolytic effect of guaifenesin.

Pharmacokinetics

The effect of the drug Novo-Passit® is the cumulative effect of its components, so the conduct of kinetic studies is not possible.

Indications for use of the drug

- neurasthenia and neurotic reactions, accompanied by irritability, anxiety, fear, fatigue, absent-mindedness;

- "manager's syndrome" (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 menopausal syndrome;

- pruritic dermatosis (atopic and seborrheic eczema, urticaria), due to psychological stress.

Dosage and administration

Insideadults and children over 12 years old appoint 1 tab. or 5 ml of oral solution 3 times / day before meals. If necessary, the doctor may increase the dose up to 2 tab. or up to 10 ml of solution 3 times / day. In the event of severe fatigue or depression, it is necessary to reduce the morning and daily dose to 1/2 tab. or up to 2.5 ml of solution per dose, in the evening take 1 tab. or 5 ml of solution. The interval between doses should be 4-6 hours.

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

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

Side effect

Gastrointestinal: rarely - nausea, vomiting, cramps, heartburn, diarrhea, constipation.

From the side of the central nervous system: rarely - decreased concentration, dizziness, drowsiness.

Other: rarely - allergic reactions, rash, fatigue, mild muscle weakness. Symptoms quickly pass after drug withdrawal.

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

Contraindications to the use of the drug

- myasthenia gravis;

- children's age up to 12 years;

- hypersensitivity to the drug.

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

Use of the drug during pregnancy and lactation

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

If necessary, the use of the drug during lactation breastfeeding should be discontinued.

Application for violations of the liver

With caution should use the drug for liver disease.

Special notes

During treatment with Novo-Passit® should not drink alcohol.

With caution should use the drug in acute gastrointestinal diseases.

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

While taking the drug Novo-Passit® Exposure to ultraviolet radiation should be avoided (prolonged exposure to direct sunlight, visiting a tanning bed), especially for patients with fair skin.

The drug in the form of a solution is not recommended for use in patients with impaired glucose uptake and galactose and congenital fructose intolerance.

Patients with diabetes should be borne in mind that 100 g of the 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 not more than 1.42 g of glucose and 1.53 g of fructose.

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

Influence on ability to drive motor transport and control mechanisms

During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and quickness of psychomotor reactions. Do not drive vehicles and mechanisms.

Overdosage

Symptoms: in the beginning - drowsiness, feeling of depression, later - nausea, slight muscle weakness, pain in the joints, feeling of heaviness in the stomach.

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

Drug interaction

While taking the drug Novo-Passit® and other drugs their action may be enhanced or weakened.Before taking the drug at the same time as other drugs, the patient should consult a doctor.

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

Drugs used to relax skeletal muscles (central muscle relaxation) can increase the risk of side effects of the drug, first of all - muscle weakness.

The herb extract 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 prevention of thromboembolism . Therefore, before taking the drug Novo-Passit® against the background of these drugs, the patient should consult a doctor.

Pharmacy sales terms

The drug is approved for use as a means of OTC.

Terms and conditions of storage

The drug should be stored out of the reach of children, protected from light at a temperature of 10 ° to 25 ° C. Shelf life of tablets and solution for oral administration in bags - 2 years. The shelf life of the solution for oral administration in vials is 4 years.