Translation of the instruction Mose

РЕСПИКС® SPRAY solution of oral 10 mg / 0.2 ml

Instruction

On medical use of medicine

Ingredients:

Active ingredient: solutio ambroxoli hydrochloridi;

1 ml of Ambroxol of a hydrochloride of 50 mg

1 stream of solution (0.2 ml) contains Ambroxol of a hydrochloride 10 mg

excipients: trometamol, a macrogoal hydroxystearate, glycerin, potassium to atsesulfa, xylitol, Natrium benzoicum (E 211), left menthol, ammonium glitsirizat, ethanol of 96%, sodium hydroxide, water purified.

Dosage form.

Solution oral.

Main physical and chemical properties: colourless or yellowish rather turbid solution. With a slight smell of menthol.

Pharmacological group.

Mucolytics. atx r05c b06 code.

Pharmacological properties.

Pharmacodynamics.

Ambroxol substituted with benzylamine is a Bromhexine metabolite.

Differs in

from Bromhexine in absence of methyl group and additional hydroxyl group in 4 (trance) - the provision of a tsiklohexilny ring. Though the exact mechanism of action is completely not installed, in various researches sekretolitichesky and sekretomotorny effects are shown.

effect is shown by

After intake on average in 30 min. and proceeds depending on a dose of 6-12 hours.

In preclinical trials Ambroxol increased the number of serous bronchial secretion. It is established that Ambroxol raises mukotsiliarny transport by stimulation of mobility of eyelashes of a bronchial epithelium and decrease in viscosity of slime.

Ambroxol causes activation of a surfaktantny system by direct impact on II pulmotsita of alveoluses and secretory cells of bronchioles (final site of airways).

Ambroxol stimulates with

education and discharge of surface active agents in alveolar and bronchial sites easy a fruit and adult patients.

Pharmacokinetics.

Ambroxol is almost completely soaked up by

After intake, reaching the maximum concentration in plasma in 1-3 hours. The bioavailability after oral administration decreases on a third at the first phase of metabolism. To the metabolites which are subject to kidney secretion compounds of dibromantranilovy and glucuronic acids belong.

Ambroxol easily contacts proteins of plasma (80 — 90%). Elimination half-life makes from 7 to 12:00. Total elimination half-life of Ambroxol and its metabolites makes about 22 hours of plasma.

Ambroxol gets into liquor of the central nervous system, it passes a placental barrier and also gets into breast milk.

About 90% of a dose of Ambroxol it is removed by kidneys in the form of the metabolites which are formed in a liver. Less than 10% of Ambroxol are removed in not changed look.

Because of high ability to linking with proteins of blood plasma, large volume of distribution and slow release from fabrics with return to blood dialysis or an artificial diuresis do not influence Ambroxol conclusion level.

Heavy abnormal liver functions metabolism of Ambroxol can reduce

by 20 — 40%. Heavy renal failures can lead to cumulation of the metabolites which are formed in a liver.

Clinical characteristics.

Indication.

Treatment of the sharp and chronic bronchopulmonary diseases which are followed by violation of education and removal of slime.

Contraindication.

Hypersensitivity to active substance or to any of excipients in structure респикс® spray.

Children's age up to 12 years — for the high content of active ingredient in solution.

Interaction with other medicines and other types of interactions.

Antibechics. simultaneous application респикс® spray with antibechics can lead to cumulation of large amounts of bronchial secretion because of decrease in a tussive reflex. such medicinal combinations should be applied with care.

Antibiotics. Simultaneous use of Ambroxol with some antibiotics, such as amoxicillin, tsefuroksy, leads erythromycin, doxycycline to increase in concentration of antibiotics in a bronchopulmonary secret and in a phlegm.

Gistamin. Ambroxol influences metabolism of a histamine therefore it is necessary to avoid prolonged use of Respiks® of Spray at patients with the established hypersensitivity to a histamine.

Alcohol. Респикс® Spray contains a small amount of ethanol (alcohol) less than 100 mg on a single dose.

Feature of application.

At use of Ambroxol. in case of changes from skin or a mucous membrane it is necessary to stop immediately use of Ambroxol and to see a doctor.

to Patients with the established oppression bronchomotor functions should avoid application of mucolytic means if only they are not under observation of the doctor, because of risk of possible accumulation of large amounts of slime.

At patients with dysfunctions of kidneys/liver from moderated to heavy degree, delay of speed of discharge can lead to cumulation of Ambroxol and/or its metabolites which are formed in a liver. In such cases of Respiks® Spray can be accepted only with extra care, extending intervals between receptions or reducing a dose.

Use during pregnancy or feeding by a breast.

Ambroxol gets through a placental barrier. researches on animals did not reveal a direct or indirect adverse effect on a pregnancy course, development of an embryo / fruit, childbirth or the post-natal period. in i a trimester of pregnancy its application is not recommended. in ii and iii pregnancy trimesters medicament can be used on condition of careful assessment of possible advantage of treatment and the risk connected with it. Ambroxol gets into breast milk therefore its application during feeding by a breast is not recommended.

Ability to influence speed of response at control of motor transport or other mechanisms.

Respiks® spray at sensitive persons can sometimes show insignificant influence on ability to control of motor transport and work with technical means. medicine contains 96% of ethanol, it should be considered to drivers of vehicles.

Route of administration and doses.

dosing Mode at adults and children is more senior than 12 years

Standard dose makes 3 streams of spray three times a day that corresponds to 90 mg of Ambroxol of a hydrochloride a day. 1 stream of spray it is equivalent to 0.2 ml of solution and 10 mg of Ambroxol of a hydrochloride.

Patients with a renal and liver failure

At dysfunctions of kidneys/liver from moderated to heavy degree should consult with the doctor concerning dose adjustment of Respiks® of Spray.

Route of administration

Spray is intended to

by

Respiks® for oral administration.

Before the first use of spray the pump should be pumped over, having three times pressed it. Before each application it is necessary to remove a protective cap.

From a bottle the recommended dose is received by means of the measured pump for spray which is added medicine directly gets into an oral cavity then to swallow.

Respiks® Spray needs to be accepted together with food or after a meal. The mucolytic activity of Respiks® of Spray is maintained by the use of a large amount of liquid.

treatment Duration

Without consultation of the doctor the treatment has to last no more than 4-5 days.

Children.

is Applied to children 12 years are more senior.

Overdose.

overdose Symptoms

has no data on heavy intoxication after overdose by Ambroxol. Manifestations about which it was reported — short-term excitement and diarrhea.

in general daily oral doses up to 25 mg/kg/days are very well transferred by

.

by

After considerable overdose, according to results of preclinical trials, observed salivation, nausea, vomiting and falling of arterial blood pressure.

overdose Treatment

in general, urgent actions, such as call of vomiting or gastric lavage, are not shown, they can be applied only at very heavy overdose. Thus, in all cases of expected overdose it is necessary to perform symptomatic and maintenance therapy.

Side reactions.

Frequency of emergence of side effects is given by

as follows: very often (≥ 1/10); often (≥ 1/100,

from a digestive tract: infrequently — heartburn, nausea, vomiting, a stomach ache, decrease in sensitivity in an oral cavity and a drink, dryness in a mouth and a throat, a dysgeusia.

Allergic reactions: infrequently — hypersensitivity reactions (rash, a Quincke's disease, short wind, a small tortoiseshell), fever, allergic contact dermatitis rare — heavy acute anaphylactic reactions, including shock, severe damages of skin, such as Stephens-Johnson's syndrome, Lyell's disease (toxic epidermal necrolysis).

In sensitive patients of hypersensitivity reaction (including an asthma) can be caused left menthol.

Expiration date.

3 years. an expiration date after the first use — 1 month.

Storage conditions.

to Store

out of children's reach at a temperature not above 25 °C. not to cool, not to freeze.

Packing.

On 13 ml in a bottle with the portioning device; on 1 bottle in a cardboard box.

Category of a holiday.

Without recipe.

Producer.

Franchia of a pharmasyyuticha of the industry pharmako biologica of neuter of l., Italy/francia farmaceutici industria farmaco biologica s.r.l., italy.

Location of the producer and address of production of its activity.

VIA Tay of a pestagalla, 7 — 20100 Milan (mi), Italy/via dei pestagalli, 7 — 20100 milano (mi), italy.