Erispirus - instructions for use, dose, side effects, contraindications

Excipients: core: silicon dioxide colloidal anhydrous 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 hydrophosphate dihydrate - 104.5 mg;

shell: macrogol 6000 - 0.3 mg; glycerin - 0.3 mg; magnesium stearate - 0.3 mg; titanium dioxide - 0.8 mg; hypromellose E5 - 4.4 mg.

Description:

Round biconvex tablets coated with film

Sheath, white to white with a cream color shade.

Pharmacotherapeutic group:anti-inflammatory anti-bronchoconstrictive agent

ATX: & nbsp

R.03.D.X.03 Fenspiride

Pharmacodynamics:

Anti-inflammatory and anti-bronchoconstrictive activity of fenspiride is caused by a decrease in the production of a number of biologically 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 fenspiride metabolism of arachidonic acid is potentiated by its H₁antihistamine action, t. histamine stimulates the metabolism of arachidonic acid with the formation of prostaglandins and leukotrienes. Fenspiride blocks α-adrenoreceptors, stimulation of which is accompanied by an increase in the secretion of bronchial glands. In this way, fenspiride reduces the effect of a number of factors that contribute to the hypersecretion of proinflammatory factors, the development of inflammation and bronchial obstruction. Fenspiride also has an antispasmodic effect.

Pharmacokinetics:

After oral administration, the maximum concentration in the blood plasma (C_max) is achieved after 2.3 ± 2.5 hours (0.5 to 8 hours).

It is excreted mainly by the kidneys, the half-life (T_1/2) is 12 hours.

Indications:

Diseases of the upper and lower respiratory tract:

- rhinopharyngitis and laryngitis;

- tracheobronchitis;

- bronchitis;

- bronchial asthma in complex therapy;

- respiratory effects (cough, hoarseness, throat swelling) with measles, pertussis, influenza;

- with infectious diseases of the respiratory tract accompanied by a cough, when the standard therapy with antibiotics is shown;

- sinusitis and otitis of various etiologies.

Contraindications:

- Hypersensitivity to fenspiride and other components of the drug;

- pregnancy;

- lactation period;

- Children under 18 years.

Carefully:Bacterial and fungal infections, diabetes mellitus, concurrent use of sedatives.

Pregnancy and lactation:

Data on the use of Erispirus ® in pregnant women are absent or limited. Taking the drug during pregnancy is not recommended.

Therapy with fenspiride is not a reason for interrupting the pregnancy that has occurred. Clinical data on the fetotoxic effect of fenspiride or its ability to cause malformations during admission during pregnancy are absent.

It is not known whether the fenspiride in breast milk. If it is necessary to use the drug during breastfeeding, it is necessary to resolve the issue of stopping breastfeeding.

Dosing and Administration:

Inside. Before eating.

Adults over the age of 18:

1 tablet 2 times a day (160 mg fenspiride) (morning and evening).

In the case of acute conditions, it is recommended to take 1 tablet three times a day (240 mg fenspiride).

The maximum daily dose is 240 mg.

The duration of therapy is determined by the attending physician.

Side effects:

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development 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 available data, it was not possible to establish the frequency of occurrence.

From the nervous system:

rarely: drowsiness;

frequency is unknown: dizziness.

From the cardiovascular system:

rarely: sinus tachycardia, the severity of which decreases with a decrease in the dose of the drug.

frequency is unknown: a feeling of palpitation, a reduction in blood pressure, possibly associated with tachycardia.

From the gastrointestinal tract:

often: gastrointestinal disorders, nausea, pain in the epigastric region;

frequency is unknown: diarrhea, vomiting.

From the skin and subcutaneous tissues:

rarely: erythema, rash, hives, angioedema, fixed erythema pigmentosa;

frequency is unknown: pruritus, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Other:

frequency is unknown: asthenia, increased fatigue.

Overdose:

If an overdose of the drug should immediately seek medical help.

Symptoms: drowsiness or agitation, nausea, vomiting, sinus tachycardia.

Treatment: symptomatic therapy, gastric lavage, ECG monitoring. Maintaining important body functions.

Interaction:

Because of the possible increase in sedation with the administration of histamine H blockers₁-receptor is not recommended the use of the drug in combination with drugs that have a sedative effect.

It is recommended simultaneous use of the drug with alcohol.

Special instructions:

For the treatment of children and adolescents under the age of 18, it is recommended that fenspiride syrup.

In the event of infections of the respiratory system caused by bacteria or fungi, fenspiride it is recommended to prescribe only in combination with antibacterial and antifungal therapy.

Special precautions for the destruction of unused medicinal product

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

Effect on the ability to drive transp. cf. and fur:

Studies to study the effect of the drug on the ability to drive vehicles and work with mechanisms have not been 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 the intake of alcohol. Care must be taken when working with vehicles, mechanisms.

Form release / dosage:

Tablets of prolonged action, film-coated, 80 mg.

Packaging:

For 15 tablets of prolonged action, film-coated, in PVC / Al blisters.

For 1, 2, 3 or 4 blisters per pack of cardboard along with instructions for use.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002853

Date of registration:06.02.2015

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

SANDOZ ILAC SANAYI VE TICARET, A.S. Turkey

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp21.09.2015

Illustrated instructions

Instructions

Erispirus ® (ERISPIRUS®)