Libeksin 100 mg (20 tablets)

The instruction for medical use


of LIBEKSIN medicine


the Trade name
of Libeksin

the International unlicensed


name Prenoxdiazinum Dosage Form
of the Tablet of 100 mg


One tablet contains Structure:
active agent - Prenoxdiazinum a hydrochloride of 100.0 mg
excipients: glycerin, magnesium stearate, talc, PVP, starch corn, lactoses monohydrate.

The description
of the Tablet of almost white color, a ploskotsilindrichesky form, with slanted edges, with crosswise risky on one party and an engraving of LIBEXIN – on another.

Pharmacotherapeutic group
Drugs for elimination of symptoms of cold and cough.
Antibechic drugs other. Prenoxdiazinum
the ATX R05DB18 Code

the Pharmacological

Pharmacokinetics Active Agent properties of Libexinum is quickly and intensively soaked up from intestines. Peak concentration of drug in blood serum is reached within 30 minutes after reception, the therapeutic level of concentration of drug can be observed within 6-8 hours. Drug contacts proteins of plasma in average degree, 55%-59% within the first hour. The period of its semi-removal is 2.6 hours. The most part of the accepted dose is exposed to metabolism in a liver, about 1/3 part of the accepted dose are brought out of an organism in not changed look, the rest - in the form of metabolites. In the course of drug metabolism the most important role in the first 12 hours is played by a zhelchevydeleniye. Within 24 hours after reception of 93% of drug it is brought out of an organism. Within 72 hours after reception from 50% to 74% and of 26% up to 50% of the accepted dose it is allocated with excrements and urine respectively.
The pharmacodynamics
Antibechic Libeksin's effect is carried out by several mechanisms:
- due to decrease in excitability of peripheral afferent receptors of a mucous membrane of airways, drug has local anesthetic effect
- by direct broncholitic action (relaxation of the reduced bronchial tubes) the stretching of receptors in a wall of bronchial tubes which play an important role in induction of a tussive reflex is prevented
- drug in insignificant degree also has the central effect due to decrease of the activity of the tussive center, without causing respiratory depression.
Libexinum facilitates breath and also slightly reduces quantity of the separated phlegm.
Antibechic the effect of drug lasts 3-4 hours.
Libexinum does not cause accustoming and medicinal dependence.

Indications
- sharp and chronic, first of all unproductive cough of any (tracheobronchial, pulmonary, pleural and cardial) origins
Libexinum effectively softens the cough accompanying diseases with disturbances of breath and oxygenation while does not affect activity of a respiratory center.
- at bronchoscopic and bronkhografichesky researches in premedication

the Route of administration and doses
Adult
the Standard dose 1 tablet 3-4 times a day (3-4 tablets on 100 mg).
In especially hard cases the dose can be increased up to 2 tablets 3-4 times a day or 3 tablets 3 times a day (3-4 times on 200 mg or 3 times on 300 mg respectively).
Children's age
to Children aged from 1 year up to 6 years or with the body weight from 10 to 20 kg: on 1/4-½ tablets 3 times a day (3 times on 50 mg).
To children aged from 6 up to 12 years or with body weight more than 20 kg: ½ tablets 3-4 times a day (3-4 times on 50 mg).
Premedication before a bronchoscopic research: 0.9-3.8 mg of Prenoxdiazinum of a hydrochloride on kilogram of body weight in combination with 0.5-1 mg of atropine, in one hour prior to intervention.
The maximum single dose makes ½ tablets for children and 3 tablets for adults.
The maximum daily dose makes 200 mg (2 tablets) for children and 900 mg (9 tablets) for adults.

Side effects
Seldom (from ³ 1/10.000 to & lt, 1/1.000)
- temporary numbness and decrease in sensitivity of a mucous membrane of an oral cavity
- dryness of an oral cavity and throat
- allergic reactions, skin rash, a Quincke's disease
Frequency is unknown
- disturbances from digestive tract (a stomach ache, tendency to constipations)
- weakness, fatigue

of the Contraindication
- hypersensitivity to active agent or to any of excipients
- the states which are followed by plentiful bronchial secretion
- postoperative states (after an inhalation anesthesia).

Medicinal interactions
Data are absent.

Special instructions
with viscous separated, with difficulties at expectoration, reception of expectorant or mucolytic means under control of the doctor is also necessary for Patients.
Tablets should be swallowed entirely as when chewing or smashing in powder they can cause short-term lack of sensitivity and numbness of a mucous membrane of an oral cavity.
Drug contains 38.0 mg of lactose of monohydrate. Patients with rare hereditary intolerance of a galactose, congenital insufficiency of Lappa lactase or a sprue of glucose should not take this drug.
Pregnancy
Limited amount of available data demonstrates absence malformatsionny or feto / neonatal toxicity of Prenoxdiazinum of a hydrochloride. So far there are no other relevant epidemiological data.
Pregnant women should appoint drug with the standard precautionary measures: if the potential advantage for mother exceeds possible risk for a fruit.
The lactation period
Clinical data on penetration of drug into breast milk are absent, therefore, it can be applied during breastfeeding according to testimonies of the doctor only after careful assessment of a ratio of advantage and risk.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
In high doses drug can reduce vigilance and speed of response, therefore, driving of the car and work with mechanisms demands individual assessment when using drug in high doses.

The overdose
When using doses is higher than therapeutic, sedation and fatigue which pass within several hours after reception can be observed.
Specific treatment is not required.

The form of release and packing
On 20 tablets place in blister strip packagings from a film of polyvinylchloride and aluminum foil.
On 1 planimetric packing together with the instruction for medical use in the state and Russian languages put in a pack cardboard.


To Store storage conditions at a temperature below 25C.
To store out of children's reach.



Not to apply a period of storage of 5 years after an expiration date.

Prescription status
Without prescription


the HINOIN Producer Plant Pharmaceutical and Chemical of Products of closed joint stock company, Hungary
the Owner of the registration certificate
Sanofi-Aventis of closed joint stock company, Hungary

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Sanofi-aventis Kazakhstan LLP 050016 Almaty, Kunayev St. 21btelefon: 8 (727) 244-50-96факс: 8 (727) 258-25-96e-mail: quality.info@sanofi.com