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Description
The instruction for medical use
of INSPIRON medicine
the Trade name
Inspiron
Mezhdunarodnoye the unlicensed
name Fenspirid Lekarstvennaya
the Tablet form, film coated, with the prolonged release, 80 mg
1 tablet contains Structure:
active agent: fenspirida a hydrochloride, in terms of 100% substance of 80 mg,
excipients: calcium hydrophosphate dihydrate, gipromeloz (hydroksipropilmetiltsellyuloz), povidone, silicon dioxide colloidal anhydrous, magnesium stearate,
structure of a cover: mix for a covering of Opadry II WHITE 33G28707 (a gipromeloz (hydroksipropilmetiltsellyuloz), the titan dioxide (E 171), lactoses monohydrate, polyethyleneglycol (macrogoal) 3000, triacetin).
The description
of the Tablet, film coated white color, round shape, with a biconvex surface. On a break the kernel of white or almost white color is visible.
Pharmacotherapeutic group
Drugs for treatment of respiratory diseases. Other drugs for treatment of obstructive respiratory diseases for system use. Fenspirid.
ATX R03D X03 code.
Pharmacological
Pharmacokinetics properties.
The maximum concentration in blood plasma is reached on average in 6 hours after oral administration. Elimination half-life of 12 hours. Fenspirid is brought from an organism mainly with urine.
Pharmacodynamics.
Inspiron possesses broncholitic and the anti-inflammatory properties caused by interaction of several interconnected mechanisms:
blocks H1-histamine receptors and has spasmolytic effect on smooth muscles of bronchial tubes,
has anti-inflammatory effect which leads to reduction of producing pro-inflammatory factors (cytokines, TNF-a, derivative arachidonic acid, prostaglandins, leukotrienes, thromboxane, free radicals), some of which also have bronkhokonstriktorny effect.
Indications
Cough in diseases of upper and lower airways:
– nasopharyngites and laryngitis
– otitises and sinusitis
– rinotrakheobronkhita
– bronchitis
– measles
– flu
as maintenance therapy in asthma and its complications.
It is recommended to adult to apply a route of administration and doses.
For oral administration.
To accept before food.
Daily dose. The usual recommended therapeutic dose for treatment of chronic inflammatory processes makes 2 tablets a day (in the morning and in the evening).
For strengthening of effect and/or in case of acute diseases 3 tablets a day (in the morning, in the afternoon and in the evening).
Course of treatment. Duration of treatment depends on a course of the disease and is defined by the doctor individually.
To children drug is used only in the form of syrup.
Side effects
On emergence frequency side reactions are divided into such categories: very often (& gt, 1/10), it is frequent (& gt, 1/100, & lt, 1/10), infrequently (& gt, 1/1000, & lt, 1/100), is rare (& gt, 1/10000, & lt, 1/1000), is very rare (& lt, 1/10000).
From a cardiovascular system: seldom moderate sinus tachycardia which decreases after a dose decline.
From digestive tract: often digestive disturbances, nausea, a stomach ache, frequency diarrhea, vomiting is unknown.
From nervous system: seldom drowsiness.
From skin and hypodermic cellulose: seldom the erythema, the fixed pigmentary erythema, rash, a small tortoiseshell, a Quincke’s edema, frequency is unknown – an itching.
General disturbances: asthenia (weakness), fatigue.
Contraindications
Hypersensitivity to a fenspirid or any of drug components.
Medicinal interactions
As fenspirid are increased by sedation of H1-antihistaminic drugs, it is not recommended to combine it with sedative drugs and alcohol.
The special
instructions Drug treatment does not replace antibiotic treatment.
Inspiron patients should apply with care with hereditary intolerance of a galactose, deficiency of lactase or a sprue of a glucose/galactose.
Pregnancy and the period of feeding by a breast
is not recommended to use drug during pregnancy or feeding by a breast.
Use in pediatrics
This dosage form is not applied in pediatric practice.
Drowsiness can cause features of influence of medicine on ability to run the vehicle or potentially dangerous Inspiron mechanisms, it is necessary to show care at control of motor transport or other mechanisms, especially at the beginning of therapy.
Overdose
At reception of a large amount of drug the drowsiness or excitement, nausea, vomiting, sinus tachycardia can be observed.
Treatment. It is necessary to wash out a stomach, to carry out monitoring of the electrocardiogram. To perform symptomatic therapy.
A form of release and packing
On 10 tablets in blister strip packaging of their film of polyvinylchloride and aluminum foil with the press varnished.
On the 3rd blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in original packing at
a temperature not higher than 25 S. Hranit out of children’s reach.
Period of storage 2 years.
Prescription status
According to the prescription.
JSC Kiyevmedpreparat producer, Ukraine, 01032, Kiev, Saksagansky St., 139.
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Representative office of Arterium corporation in
Republic of Kazakhstan 050060, Almaty, Al-Farabi Avenue 97, 3 entrance, office 54
Ph. / fax: 8 (727) 315-82-09, 8 (727) 315-82-10,
E-mail: office@arterium.kz
Additional information
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