Ново-Пассит®
Producer: Teva (Tev) Israel
Code of automatic telephone exchange: N05CM
Pharm group: Psikholeptiki
Release form: Liquid dosage forms. Solution for intake.
General characteristics. Structure:
Active components:
New Passitum extract liquid (received from rhizomes with roots of a valerian medicinal, herbs of a melissa medicinal, herbs of the St. John's Wort which is made a hole, leaves and flowers of a hawthorn odnopestichny or prickly, herbs of a passionflower inkarnatny (passionflower), compound fruits of hop ordinary, flowers of elder black) 7,75 g; Gvayfenezin - 4,00 g in 100 ml of solution
Excipients:
sodium cyclomate, gum xanthane, sugar syrup invert, Natrium benzoicum, sodium saccharin monohydrate, ethanol of 96%, aroma orange, sodium citrate a dihydrate, maltodextrin, propylene glycol, the water purified.
Description
Siropoobrazny, transparent or slightly muddy liquid from red-brown till brown color, with a characteristic smell. In the course of storage the small deposit which is dissolved when stirring is allowed.
Pharmacological properties:
The combined drug which pharmacological activity is caused by the extract components which are its part on the basis of medicinal vegetable raw materials with preferential sedative (calming) action and gvayfeneziny. the possessing anxiolytic (antialarming) effect.
Indications to use:
• The neurasthenia and neurotic reactions which are followed by irritability, alarm, fear, fatigue, absent-mindedness.
• "Manager's syndrome" (condition of constant mental tension).
• Sleeplessness (easy forms).
• The headaches caused by nervous tension.
• Migraine.
• Functional diseases of digestive tract (dispeptic syndrome, syndrome of "the angry intestines").
• As symptomatic cure for neurocirculatory dystonia and a menopausal syndrome.
• The pruritic dermatosis (eczema atopic and seborrheal, a small tortoiseshell) caused by psychological loading.
Route of administration and doses:
Drug is accepted undiluted or parted in a small amount of water. When using a bottle the drug dosing is carried out by means of a measured cap.
Inside, to adults and children 12 years are more senior:
In the absence of other recommendations of the doctor it is necessary to accept drug on 5 ml 3 times a day to food. After consultation with the doctor increase in a dose up to 10 ml 3 times a day is possible. At emergence of strong fatigue or depression it is necessary to reduce a morning and day dose twice and to accept 2,5 ml in the morning and in the afternoon and 5 ml in the evening. The interval between receptions has to make 4-6 hours.
In case of nausea drug should be accepted during food.
Features of use:
Drug contains 12,19% of ethanol; each single dose contains up to 0,481 g of ethanol. During treatment by drug it is not necessary to take alcoholic beverages.
During reception of New Passitum, especially to patients with light skin, it is necessary to avoid impact of ultra-violet radiation (long influence of direct sunshine, visit of a sunbed).
At administration of drug it is not necessary to manage vehicles and mechanisms. Drug is not recommended to be used to patients with disturbances of digestibility of glucose and a galactose and with inborn intolerance of fructose.
If within 7 days symptoms of a disease do not disappear, or there will be their strengthening, and also in case of side effects or other unusual reactions, it is recommended to see a doctor.
The instruction for patients with a diabetes mellitus: In 100 g of drug 12,5-14,2 of glucose and 13,6-15,3 of fructose contains. At reception each dose contains no more than 1,42 g of glucose and 1,53 g of fructose in the recommended doses.
Side effects:
Patients usually well transfer drug. However in rare instances can appear allergic reactions, a dieback, dizziness, fatigue, drowsiness, easy muscular weakness, disorders of digestive tract (nausea, vomiting, spasms, heartburn, diarrhea, a lock), decrease in concentration of attention which quickly pass after drug withdrawal. At emergence of the specified or other side effects it is necessary to see a doctor.
Interaction with other medicines:
At a concomitant use of the drug Novo-Passit® and other medicines their action can be strengthened or weakened. Before administration of drug along with other medicines it is necessary to consult with the doctor.
Drug strengthens effect of alcohol and other substances oppressing the central nervous system.
The medicines applied to relaxation of skeletal muscles (the central muscle relaxation) can increase risk of emergence of side effects of drug, first of all - muscular weakness.
The St. John's Wort extract which is contained in drug reduces efficiency of hormonal contraception, and also the medicines applied preferential after transplantation to decrease in risk of rejection of a transplanted organ or fabric (immunodepressive drugs), the medicines intended for treatment of AIDS, cardiovascular diseases, diseases of bronchial tubes and the prevention of a thromboembolism. Therefore before reception of Novo-Passita® against the background of the specified drugs it is necessary to consult with the doctor.
Contraindications:
Hypersensitivity to drug components, in particular to a gvayfenezin. a myasthenia, children's age up to 12 years.
With care: acute diseases of digestive tract, liver disease, alcoholism, diseases or brain injuries, epilepsy.
Use at pregnancy and a lactation
During pregnancy drug is appointed only according to absolute indications if the expected effect for mother exceeds possible risk for a fruit.
In need of use of drug in the period of a lactation breastfeeding should be stopped.
Overdose:
The overdose is shown by feeling of depression and drowsiness in the beginning. Later these symptoms can be followed by nausea, easy muscular weakness, joint pains, heavy feeling in a stomach. At emergence of symptoms of overdose administration of drug should be stopped. Symptomatic treatment. It is necessary to see a doctor.
Storage conditions:
At a temperature from 10 °C to 25 °C, in the place protected from light. To store in the place, unavailable to children. Period of validity
Bags sachets on 5 ml, 10 ml - 2 years. Bottles on 100 ml, 200 ml, 450 ml - 4 years. Not to apply after a period of validity.
Issue conditions:
Without recipe
Packaging:
Solution for intake.
Bag sachet on 5 ml - on 12 and 30 bags sachets (three-layered: paper/AL/PE) in a cardboard pack together with the application instruction.
Bag sachet on 10 ml - on 8 and 20 bags sachets (three-layered: paper/AL/PE) in a cardboard pack together with the application instruction.
On 100 ml, 200 ml or 450 ml in the bottle of dark glass supplied with a measured cap. The bottle contains the label representing the application instruction put inside. Each bottle is placed in a cardboard pack together with the application instruction.