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

Excipients: calcium hydrophosphate dihydrate 104,50 mg, povidone-K29-32 - 12.90 mg, silicon dioxide colloid - 0.60 mg, hypromellose-2208 - 99.90 mg, magnesium stearate - 2.10 mg.

Film Sheath: fall off II white 85F18422 - 6,000 mg: polyvinyl alcohol - 2.40 mg, titanium dioxide (E171) - 1.50 mg, macrogol-3350 - 1.212 mg, talc - 0.888 mg.

Description:

Round, biconcave tablets covered with a film shell of white or almost white color, engraved "R33" on one side. Light surface roughness is allowed.

Pharmacotherapeutic group:Anti-inflammatory, anti-bronchoconstrictive agent

ATX: & nbsp

R.03.D.X.03 Fenspiride

Pharmacodynamics:

The anti-inflammatory and anti-bronchoconstrictive activity of fenspiride is due to a decrease in the production of biologically active substances (cytokines, in particular 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 the metabolism of arachidonic acid by fenspiride is enhanced by its H1-antihistamine action, since histamine stimulates the metabolism of arachidonic acid followed by the formation of prostaglandins and leukotrienes. Fenspiride blocks α-adrenergic receptors, stimulation of which is accompanied by increased secretion of the bronchial glands. In this way, fenspiride reduces the effect of a number of factors that promote increased secretion of proinflammatory factors, the development of inflammation and bronchial obstruction.

Fenspiride also has an antispasmodic effect.

Pharmacokinetics:

After oral administration, the maximum serum concentrations are reached after 6 hours, after which they gradually decrease.

The drug nc accumulates in the tissues.

The half-life (T1 / 2) is approximately 12 hours.

Fenspiride is excreted mainly by the kidneys (90%), 10% - through the intestines.

Indications:

Diseases of the upper and lower respiratory tract:

Rhinopharyngitis and laryngitis;

Tracheobronchitis;

Bronchitis (with or without chronic respiratory failure); Bronchial asthma (as part of complex therapy);

Respiratory effects (cough, hoarseness, swelling in the throat) in measles, pertussis, influenza;

Infectious respiratory diseases accompanied by cough, when standard antibiotic therapy is indicated;

Otitis and sinusitis of various etiologies.

Contraindications:

Hypersensitivity to the active substance and / or any other component of the drug;

Children under 18 years of age (for the treatment of children and adolescents under 18 years of age, Epistat® syrup should be used).

Pregnancy and lactation:

Pregnancy

It is not recommended to use this drug during pregnancy. 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 fetal malformations when used during pregnancy are absent.

Breastfeeding period

Do not use Epistat® during breastfeeding due to lack of data on the penetration of fenspiride into breast milk.

Dosing and Administration:

For oral administration.

Tablets should be swallowed whole at the beginning of food intake, washed down with a small amount of water.

Adults: 1 tablet 2 or 3 times a day.

The maximum daily dose is 240 mg.

The duration of treatment is determined by the doctor.

Side effects:

PLEASE, INFORM YOUR PHYSICIAN IF YOU HAVE ANY ADVERSE REACTIONS AND SYMPTOMS (INCLUDING THOSE WHO ARE NOT RELATED TO THIS INSTRUCTION) OR ANY CHANGES IN LABORATORY INDICATORS DURING TREATMENT.

The frequency of adverse reactions that may occur during therapy is given in the following gradation: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000), the frequency is unknown (the frequency can not be estimated from the available data).

From the nervous system:

Rarely: drowsiness;

Frequency unknown: dizziness.

From the side of the heart and blood vessels:

Rarely: mild tachycardia, the severity of which decreases with decreasing dose preparation.

From the gastrointestinal tract:

Often: gastrointestinal disorders, nausea, epigastric pain;

The frequency is unknown: diarrhea, vomiting.

From the skin and subcutaneous tissues:

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

Frequency is unknown: itchy skin.

Common disorders and disorders together:

The frequency is unknown: asthenia, fatigue.

Overdose:

In the case of an overdose (there have been cases of overdose when taking the drug at a dose of more than 2320 mg), you should immediately seek medical help.

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

Treatment: gastric lavage, electrocardiogram monitoring (ECG); maintenance of vital body functions.

Interaction:

Special studies on the interaction of fenspiride with other drugs have not been conducted.

Given that the use of H1-histamine receptor blockers can enhance the sedative effect, the use of Epistat in combination with medications with sedative effects, or with alcohol, is not recommended.

Note: treatment with Epistat® should not prevent the initiation of antibiotic therapy.

Special instructions:

For the treatment of children and adolescents under 18 years of age, Epistat® syrup should be used.

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

Studies to study the effect of fenspiride on the ability to drive vehicles and work with mechanisms have not been conducted. Patients should be advised that when taking Epistat®, drowsiness may develop, especially at the onset of therapy or when combined with alcohol intake. Patients should be careful when driving vehicles, as well as when performing work that requires a high rate of psychomotor reactions.

Form release / dosage:

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

Packaging:

For 15 tablets in a blister of PVC and aluminum foil. For 2, 4 or 6 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-003158

Date of registration:31.08.2015 / 24.02.2016

Expiration Date:31.08.2020

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER ROMANIA, S.A. Romania

GEDEON RICHTER-RUS, CJSC Russia

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp15.03.2017

Illustrated instructions

Instructions

Epistat® (Epistat®)