NEW-PASSIT
Active material: New Pass dry extract, Guaifenesin
When ATH: N05CM
CCF: Anxiolytic
ICD-10 codes (testimony): F40, F43, F45.3, F48.0, F51.2, G43, K30, K58, L20.8, L21, L29, L50, N95.1, N95.3, R51
When CSF: 02.08.03.01
Manufacturer: IVAX Pharmaceuticals s.r.o. (Czech Republic)
Pharmaceutical form, composition and packaging
◊ Pills, Film-coated pale green, Oval, lenticular, a break line.
| 1 tab. | |
| New Pass dry extract (obtained from the rhizomes and roots of Valeriana officinalis, Grass Melissa officinalis, herb St. John's wort, leaves and flowers of Crataegus monogyna or spiny, herbs passionflower inkarnatnoy (passionflower), stems of hops ordinary, black elderberry flowers) | 157.5 mg |
| guaifenesin | 200 mg |
Excipients: colloidal silicon dioxide, microcrystalline cellulose, glycerol, magnesium stearate, lactose monohydrate.
The composition of the shell: opadraj “WITH 80W31115” green (polyvinyl alcohol, Titanium dioxide, talc, soy lecithin, xanthan gum, quinoline yellow dye, iron oxide yellow, dye indigo carmine).
10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.
30 PC. – Polyethylene cans (1) – packs cardboard.
60 PC. – Polyethylene cans (1) – packs cardboard.
100 PC. – Polyethylene cans (1) – packs cardboard.
◊ Oral solution a syrupy, transparent or slightly turbid liquid from red-brown to brown in color, with a characteristic odor; during storage may be a small loss precipitate, dissolved by shaking.
| 5 ml | |
| New Pass extract liquid (obtained from the rhizomes and roots of Valeriana officinalis, Grass Melissa officinalis, herb St. John's wort, leaves and flowers of Crataegus monogyna or spiny, herbs passionflower inkarnatnoy (passionflower), stems of hops ordinary, black elderberry flowers) | 387.5 mg |
| guaifenesin | 200 mg |
Excipients: sodium cyclamate, xanthan gum, invert sugar syrup, Sodium benzoate, sodium saccharin monohydrate, ethanol 96%, orange flavor, sodium citrate dihydrate, maltodextrin, propylene glycol, Purified water.
5 ml – sandwich bags (12) – packs cardboard.
5 ml – sandwich bags (30) – packs cardboard.
10 ml – sandwich bags (8) – packs cardboard.
10 ml – sandwich bags (20) – packs cardboard.
100 ml – vials of dark glass (1) complete with a measured cap – packs cardboard.
200 ml – vials of dark glass (1) complete with a measured cap – packs cardboard.
450 ml – vials of dark glass (1) complete with a measured cap – packs cardboard.
Pharmacological action
Combined with sedation phytopreparation, pharmacological activity due to its constituent components of the extract, based on medicinal plants with predominantly sedative effect and guaifenesin, having anxiolytic effect. The sedative effect of the drug supplemented anxiolytic effect of guaifenesin.
Pharmacokinetics
New action of the drug passes® It is a combination of its components, is a kinetic studies is not possible.
Testimony
- Neurosis and neurotic reactions, accompanied by irritability, anxiously, fear, fatigue, distraction;
- “syndrome manager” (state of constant mental stress);
- Insomnia (mild forms);
- Headache, caused by nervous tension;
- Migraine;
- Functional gastrointestinal diseases (dyspeptic syndrome, Irritable Bowel Syndrome);
- As a symptomatic treatment for neurocirculatory dystonia and menopausal syndrome;
- Pruritic dermatoses (atopic and seborrheic dermatitis, hives), due to psychological stress.
Dosage regimen
Inside adults and children over 12 years appoint 1 tab. or 5 ml oral solution 3 times / day before meals. If necessary, prescribed by a doctor may increase the dose to 2 tab. or to 10 ml 3 times / day. In case of extreme fatigue or depression is necessary to reduce the dose of morning and afternoon to 1/2 tab. or to 2.5 ml on reception, evening taking 1 tab. or 5 ml. The interval between doses should be 4-6 no.
In case of nausea medication should be taken with food.
A preparation in the form of a solution or undiluted take diluted in a small amount of water. When using the drug in the vial by means of dosing cap dimensional.
Side effect
From the digestive system: rarely – nausea, vomiting, spasms, heartburn, diarrhea, constipation.
CNS: rarely – poor concentration, dizziness, drowsiness.
Other: rarely – allergic reactions, rash, fatigue.
Patients should be warned, that the appearance of these or other side effects, seek medical advice.
Contraindications
- Myasthenia;
- Children up to age 12 years;
- Hypersensitivity to the drug.
FROM caution should use the drug in patients with acute gastrointestinal diseases, liver diseases, alcoholism, diseases and injuries of the brain, epilepsy.
Pregnancy and lactation
In pregnancy, the drug is prescribed only if absolutely indicated, if the expected benefit of therapy to the mother outweighs the potential risk to the fetus.
If necessary, use during lactation should stop breastfeeding.
Cautions
During treatment with the Novo-Pass® should not drink alcohol.
With care use in patients with acute gastrointestinal diseases.
Patients should be warned, in that case, if during 7 days of treatment the symptoms disappear or happen to be strengthened, it is recommended to consult a doctor.
During the reception, Passito New® Avoid exposure to ultraviolet radiation (prolonged exposure to direct sunlight, solarium), especially in 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, what in 100 g oral solution contains 12.5-14.2 g glucose 13.6-15.3 g fructose. When taken in recommended doses, each dose contains no more 1.42 g glucose 1.53 g fructose.
Oral solution contains 12.19% ethanol; Each single dose contains up 0.481 g ethanol.
Effects on ability to drive vehicles and management mechanisms
In the period of treatment should refrain from activities potentially hazardous activities, require high concentration and speed of psychomotor reactions. Do not drive vehicles and machinery.
Overdose
Symptoms: initially – drowsiness, feeling depressed, after – nausea, mild muscle weakness, joint pain, a feeling of heaviness in the stomach.
Treatment: gastric lavage, symptomatic therapy. Patients should be warned of the need to see a doctor.
Drug Interactions
At the same time taking the drug Novo-Pass® and other drugs of their action can be increased or decreased. Before you start taking the medication simultaneously with other drugs the patient should consult a doctor.
The preparation enhances the effects of ethanol and other substances, providing a depressing effect on the central nervous system.
Drugs, used for relaxation of skeletal muscles (Central muscle relaxation) may increase the risk of side effects of the drug, Firstly – muscle weakness.
Extract herb St. John's wort, contained in the product, reduces the effectiveness of hormonal contraception, and drugs, advantageously used after transplantation to reduce the risk of rejection of the transplanted organ or tissue (immunosuppressants), drugs to treat AIDS, CVD, diseases of the bronchi and the prevention of thromboembolism. Therefore, before taking the New Passito® against the background of these drugs the patient should consult a doctor.
Conditions of supply of pharmacies
The drug is resolved to application as an agent Valium holidays.
Conditions and terms
The drug should be stored out of reach of children, dark place at a temperature of 10 ° to 25 ° C. Shelf life of tablets and oral solution in sachets – 2 year. Shelf-life of oral solution in bottles – 4 year.
