Erespal

General characteristics. Structure:

Active agent: a fenspirida a hydrochloride - 80 mg.
Excipients: calcium hydrophosphate of 104,5 mg; gipromelloza of 100 mg; povidone of 12,80 mg; silicon dioxide of colloid anhydrous 0,50 mg; magnesium stearate of 2,20 mg;
Cover: titanium dioxide of 0,841 mg; глицерол 0,263 mg; gipromelloza of 4,370 mg; macrogoal of 6000 0,263 mg; magnesium stearate of 0,263 mg.
Description
Round, biconvex tablets, film coated, white color.

Pharmacological properties:

Pharmacodynamics. Antiinflammatory and antibronkhokonstriktorny activity of a fenspirid is caused by reduction of products of a number of biologically active agents (cytokines, especially a factor
necrosis of tumors α (ФНО-α), derivatives of arachidonic acid, free radicals), playing an important role in development of an inflammation and bronchospasm. The inhibition fenspiridy metabolism of arachidonic acid is exponentiated by its H1-antihistaminic action since the histamine stimulates metabolism of arachidonic acid with formation of prostaglandins and leukotrienes. Fenspirid blocks α-adrenoceptors, which stimulation is followed by increase in secretion of bronchial glands. Thus, фенспирид reduces action of a number of factors which promote hypersecretion of pro-inflammatory factors, development of an inflammation and obstruction of bronchial tubes. Fenspirid also has spasmolytic effect.

Pharmacokinetics. Cmax after intake is reached in 6 hours. T1/2 – 12 hours.
It is removed preferential by kidneys.

Indications to use:

Diseases of upper and lower respiratory tracts:
• Nasopharyngitis and laryngitis
• Tracheobronchitis
• Bronchitis (against the background of chronic respiratory insufficiency or without it)
• Bronchial asthma (as a part of complex therapy)
• The respiratory phenomena (cough, a voice osiplost, irritation in a throat) at measles, whooping cough and flu
• At infectious diseases of the respiratory tracts which are followed by cough when a standard antibioticotherapia is shown
Otitis and sinusitis of various etiology.

Route of administration and doses:

Inside.
Adult: on 1 tablet 2 - 3 times a day.
The maximum daily dose makes 240 mg.
Duration of treatment is defined by the doctor.

Features of use:

For treatment of children and teenagers up to 18 years it is necessary to use Erespal® syrup.
Researches on studying of influence of the drug Erespal® on ability to manage vehicles and work with mechanisms were not conducted. Patients have to be informed on possible development of drowsiness at administration of drug of Erespal® especially at the beginning of therapy or at a combination to alcohol intake, and have to be careful at control of vehicles and when working, the psychomotor reactions demanding high speed.

Side effects:

Frequency of side reactions which can arise during therapy is specified in a look
following gradation: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100);
seldom (> 1/10000, <1/1000); very seldom (<1/10000) and unspecified frequency (frequency not
it can be counted according to available data).
From cardiovascular system
Seldom: moderate tachycardia which expressiveness decreases at a drug dose decline.
From the alimentary system:
Often: gastrointestinal frustration, nausea, pain in epigastriums.
Unspecified frequency: diarrhea, vomiting.
From the central nervous system:
Seldom: drowsiness.
Unspecified frequency: dizziness.
General frustration and symptoms:
Unspecified frequency: an adynamy, the increased fatigue.
From integuments and a hypodermic fatty tissue:
Seldom: an erythema, rash, urticaria, a Quincke's disease, the fixed pigmental
erythema.
Unspecified frequency: skin itch.

Interaction with other medicines:

Special researches on interaction of a fenspirid with other medicines were not conducted. Because of possible strengthening of sedation at reception of blockers histamine N1-
receptors are not recommended use of the drug Erespala® in combination with the medicines possessing sedative action or together with alcohol.

Contraindications:

Hypersensitivity to active agent and/or any of drug components.
Children's age up to 18 years (for treatment of children and teenagers up to 18 years it is necessary to use Erespal® syrup).
PREGNANCY AND PERIOD OF FEEDING BY THE BREAST
Administration of drug during pregnancy is not recommended. Therapy fenspiridy is not the basis for interruption of the occurred pregnancy. Clinical data on fetotoksichesky action of a fenspirid or its ability to cause malformations at inclusion in time of pregnancy are absent. It is not necessary to apply Erespal® during breastfeeding due to the lack of data on penetration of a fenspirid into breast milk.

Overdose:

At drug overdose (overdose cases at administration of drug in a dose more than 2320 mg are noted) it is necessary to ask for medical care immediately.
Symptoms: drowsiness or excitement, nausea, vomiting, sinus tachycardia.
Treatment: gastric lavage, monitoring of the electrocardiogram (ECG). Maintenance of the vital functions of an organism.

Storage conditions:

At a temperature not above 25 °C. To store in places, unavailable to children. List B. Period of validity 3 years.
NOT TO APPLY AFTER THE TERMINATION OF THE PERIOD OF VALIDITY SPECIFIED BY NAUPAKOVKE.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated, 80 mg.
On 15 tablets in the blister (PVC / Is scarlet). On 2 blisters with the instruction on a medical use in a pack cardboard.