Erispirus pills prolonged 80mg №20

Trade name of the drug: Erispirus.
International Nonproprietary Name: Fenspirid
Dosage form: pills of the prolonged action, film coated.

Composition:

1 pill contains: active ingredient: fenspiride hydrochloride - 80.0 mg; excipients: core: anhydrous colloidal silicon dioxide 0.5 mg; Magnesium stearate - 2.2 mg; Hypromellose K100 M - 10.0 mg; Povidone K-30 - 12.8 mg; hypromellose E15 - 30.0 mg; Hypromellose K15 M - 60.0 mg; Calcium phosphate dihydrate - 104.5 mg; sheath: macrogol 6000 - 0.3 mg; glycerin - 0.3 mg; magnesium stearate - 0.3 mg; titanium dioxide - 0.8 mg; Hypromellose E5 - 4.4 mg.

anti-inflammatory anti-bronchoconstrictor agent.

Pharmacological properties

Pharmacodynamics
Anti-inflammatory and anti-bronchoconstrictor activity of fenspiride is due to a decrease in the production of a number of biological active substances (cytokines, especially tumor necrosis factor α (TNF-α), arachidonic acid derivatives, free radicals) that play an important role in the development of inflammation and bronchospasm.
Inhibition of arachidonic acid metabolism with fenspiride is potentiated by its H1-antihistamine effect, sinceHistamine stimulates the metabolism of arachidonic acid to form prostaglandins and leukotrienes. Fenspiride blocks α-ad-receptors, stimulation of which is accompanied by an increase in the secretion of bronchial glands. Thus, fenspirid reduces the effect of a number of factors that contribute to the hypersecretion of pro-inflammatory factors, the development of inflammation and bronchial obstruction. Fenspirid also has a spasmolytic effect.
Pharmacokinetics
After oral administration, the maximum plasma concentration (Cmax) is reached after 2.3 ± 2.5 hours (from 0.5 to 8 hours).
Excreted mainly by the kidneys, the half-life (T1 / 2) is 12 hours.

Indications for use

Diseases of the upper and lower respiratory tract:

• rhinopharyngitis and laryngitis;
• tracheobronchitis;
• bronchitis;
• bronchial asthma as part of complex therapy;

• respiratory symptoms (cough, hoarseness, sore throat) for measles, whooping cough, flu;
• in infectious diseases of the respiratory tract, accompanied by cough, when shown standard antibiotic therapy;
• sinusitis and otitis media of various etiologies.

Contraindications

• hypersensitivity to fenspiride and other components of the drug;
• pregnancy;
• lactation period;

• children's age up to 18 years.

With caution bacterial and fungal infections, diabetes mellitus, the simultaneous use of sedatives.

Use during pregnancy and during breastfeeding

Data on the use of Erispirus® in pregnant women are not available or are limited. Taking the drug during pregnancy is not recommended.
Therapy with fenspiride is not a basis for abortion of the onset of pregnancy. There are no clinical data on the fetotoxic effect of fenspiride or its ability to cause malformations when taken during pregnancy.
It is not known whether fenspiride passes into breast milk. If necessary, the use of the drug during breastfeeding, it is necessary to solve the issue of stopping breastfeeding.

Dosage and administration

Inside Before taking write.
Adults over 18 years old:
On 1 pill 2 times a day (160 mg of fenspirid) (in the morning and in the evening).
In case of acute conditions, it is recommended to take 1 pill three times a day (240 mg of fenspiride).
The maximum daily dose is 240 mg.
The duration of therapy is determined by the attending physician.

Side effect

According to the World Health Organization (WHO), adverse reactions are classified according to their development frequency as follows: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, < 1/100), rarely (> 1/10000, <1/1000) and very rarely (<1/10000); frequency is unknown - according to the available data it was not possible to establish the frequency of occurrence.
From the nervous system:
rarely: drowsiness;
frequency unknown: dizziness.
Since the cardiovascular system:
rarely: sinus tachycardia, the severity of which decreases with a decrease in the dose of the drug;
frequency is unknown: feeling of heartbeat, lowering blood pressure, possibly associated with tachycardia.
From the gastrointestinal tract:
often: gastrointestinal disorders, nausea, epigastric pain;
frequency is unknown: diarrhea, vomiting.
Skin and Subcutaneous Tissues:
rarely: erythema, rash, urticaria, angioedema, fixed erythema pigmentosa;
frequency is unknown: pruritus, toxic epidermal necrolysis, Stevens-Johnson syndrome.
Other:
frequency is unknown: asthenia, fatigue.

Overdosage

In case of overdose of the drug should immediately seek medical attention.
Symptoms: drowsiness or agitation, nausea, vomiting, sinus tachycardia.
Treatment: symptomatic therapy, gastric lavage, ECG monitoring.
Maintain important body functions.

Drug interactions

Due to the possible increase in the sedative effect when taking histamine H1 receptor blockers, the use of the drug in combination with drugs that have a sedative effect is not recommended.
Not recommended simultaneous use of the drug with alcohol.

For the treatment of children and adolescents under 18 years old it is recommended to use fenspirid syrup.
In the case of infections of the respiratory system caused by bacteria or fungi, it is recommended to administer fenspiride only in combination with antibacterial and antifungal therapy.

There is no need for special precautions when destroying unused Erispirus®.

Studies on the effect of the drug on the ability to drive and work with the mechanisms was not carried out. Patients should be aware of the possible development of drowsiness when taking the drug, especially at the beginning of therapy or in combination with alcohol. Care must be taken when working with vehicles, machinery.

Storage conditions
Store at a temperature not higher than 25 ° С.
Keep out of the reach of children.

Shelf life
Do not use the drug after the expiration date printed on the package.