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

Excipients: sodium saccharinate 0.45 mg, sucrose 600.00 mg, methyl parahydroxybenzoate 0.90 mg, propyl parahydroxybenzoate 0.35 mg, glycerol 225.00 mg, potassium sorbate 1.90 mg, licorice extract 2.00 mg, honey flavoring 5.00 mg, vanilla flavoring 4.00 mg, dye sunset yellow ( E110) 0.10 mg, citric acid solution 10% q.s. (to adjust the pH), water up to 1 ml.

Description:

Transparent liquid of orange color with a characteristic smell.

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, particularly 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-antigistamine 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 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:

Fenspiride is well absorbed from the gastrointestinal tract.

The maximum concentration in the blood plasma after ingestion is achieved after 2.3 ± 2.5 hours (0.5-8 hours).

The drug does not accumulate 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 ingredient and / or any other component of the drug.

Pregnancy, the period of breastfeeding.

Children under 2 years.

Patients with fructose intolerance, glucose-galactose malabsorption, sugarase / isomaltase deficiency (due to the presence of sucrose in the composition of Epistat® syrup).

Carefully:

Patients with diabetes mellitus (due to the presence of sucrose in the composition Epistat® syrup).

Pregnancy and lactation:

Pregnancy

Data on the use of fenspiride in pregnant women are absent or limited. It is not recommended to use this drug during pregnancy. Therapy with fenspiride is not a reason for interrupting the pregnancy that has occurred.

Breastfeeding period

Should not be used Epistat® syrup during breastfeeding due to a lack of penetration fenspirid data into breast milk.

Dosing and Administration:

STRICTLY following recommendations of the attending physician.

Inside.

Children between the ages of 2 and 16

The recommended dose is 4 mg / kg / day.

Body weight less than 10 kgFrom 2 to 4 teaspoons of the syrup in the day (or 10-20 ml), the syrup can be added in a small bottle with meals.

Body weight more than 10 kgFrom 2 to 4 tablespoons per day syrup (or 30-60 ml), taken before meals.

1 tablespoon (15 ml of syrup) contains 30 mg of fenspiride hydrochloride and 9 g of sucrose.

1 teaspoon (5 ml of syrup) contains 10 mg of fenspiride hydrochloride and 3 g of sucrose. The duration of treatment is determined by the doctor.

Children over 16 years and adults

From 3 to 6 tablespoons of syrup (45 - 90 ml) per day, take before meals.

Epistat® syrup is supplied with a measuring cup, with which 2.5 ml, 3 ml, 5 ml, 7.5 ml, 10 ml, 12.5 ml, 15 ml or 20 ml can be measured.

Use this measuring cup to get the required dose of the drug. The duration of treatment is determined by the doctor.

Side effects:

The most frequent adverse reactions with fenspiride were observed from the gastrointestinal tract.

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).

Disorders from the central nervous system:

Rarely: drowsiness;

Frequency unknown *: dizziness.

Violations from the heart and blood vessels:

Rarely: mild tachycardia, the severity of which decreases with a decrease in the dose of the drug;

Frequency unknown *: palpitations, decreased blood pressure, possibly associated with tachycardia.

Disorders from the gastrointestinal tract:

Often: gastrointestinal disorders, nausea, epigastric pain;

Frequency unknown *: diarrhea, vomiting.

Disturbances from the skin and subcutaneous tissues:

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

Frequency unknown *: pruritus, toxic epidermal necrolysis, Stevens-Johnson syndrome.

General disorders and disorders at the site of administration:

Frequency unknown *: asthenia, increased fatigue.

* Data on the registration of fenspiride.

The risk of developing reactions of hypersensitivity to the dye is the sunset yellow, which is part of the preparation.

If any of the side effects indicated in the manual are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.

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 blockers H1-gistaminovyh receptors can enhance the sedative effect, it is not recommended the use of the drug Epistat® in combination with drugs that have a sedative effect, or in conjunction with alcohol.

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

Special instructions:

When prescribing the drug to patients with diabetes it is necessary to take into account that Epistat® syrup contains sucrose (1 teaspoon - 3 g sucrose = 0.3 XE, 1 tablespoon - 9 g sucrose = 0.9 XE).

Patients with rare hereditary diseases of fructose intolerance, with a violation of absorption of glucose-galactose or with sugar-isomaltase deficiency should not take this drug.

The preparation includes parabeys (megylparahydroxybenzoate and propyl parahydroxybenzoate), so that the use of this drug can provoke the development of allergic reactions, including deferred.

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 carried out. 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:Syrup, 2 mg / ml.

Packaging:

Syrup, 2 mg / ml, 150 ml of syrup in light-protective bottles made of polyethylene terephthalate with a capacity of 150 ml. Each vial is sealed with a plastic screw cap (polypropylene PP-28 white), which has a child-proofing device. A plastic dispensing cup (polypropylene PP 28), graduated from 2.5 ml to 20 ml, is placed on top of the screw cap. 1 bottle with instructions for use in a cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

2 years.

Shelf life after opening the bottle is 28 days.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-003281

Date of registration:30.10.2015

Expiration Date:30.10.2020

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

Manufacturer: & nbsp

GEDEON RICHTER ROMANIA, S.A. Romania

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp15.03.2017

Illustrated instructions

Instructions

Epistat® (Epistat®)