Fespalen Soluxhn Tablets - instructions for use, dose, side effects, contraindications

Excipients: calcium hydrophosphate dihydrate - 133,50 mg, microcrystalline cellulose - 38,50 mg, crospovidone type A - 13.50 mg, aspartame - 7.00 mg, sodium saccharinate - 1.25 mg, citric acid monohydrate - 4.50 mg, sodium stearyl fumarate - 2.25 mg, silicon dioxide colloid - 2.25 mg, raspberry flavor - 2.25 mg.

Composition per one tablet 40 mg:

Active substance: fenspiride hydrochloride-40.00 mg.

Excipients: calcium hydrophosphate dihydrate - 113,50 mg, microcrystalline cellulose - 38,50 mg, crospovidone type A - 13.50 mg, aspartame - 7.00 mg, sodium saccharinate - 1.25 mg, citric acid monohydrate - 4.50 mg, sodium stearyl fumarate - 2.25 mg, silicon dioxide colloid - 2.25 mg, lemon flavor - 2.25 mg.

Composition per tablet 80 mg:

Active substance: fenspiride hydrochloride - 80.00 mg.

Excipients: calcium hydrophosphate dihydrate 227.00 mg, microcrystalline cellulose 77.00 mg, crospovidone type A 27.00 mg, aspartame 14.00 mg, sodium saccharinate 2.50 mg, citric acid monohydrate 9.00 mg , sodium stearyl fumarate - 4.50 mg, silicon colloidal dioxide - 4.50 mg, lemon flavor - 4.50 mg.

Description:

Round, flat-cylindrical tablets white or white with a yellowish tint of color, with a risk on one side, with a weak characteristic odor. Allowed a slight marbling and surface roughness.

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 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.

Has a myotropic antispasmodic effect.

Pharmacokinetics:

Absorbed in the gastrointestinal tract is relatively slow. The maximum concentration (C_mOh) after oral administration is achieved after 2-2.3 hours. The half-life (T_1/2) - 13 hours.

It is excreted mainly by the kidneys.

Indications:

Diseases of the upper and lower respiratory tract:

- Rinopharyngitis and laryngitis;

- tracheobronchitis;

- bronhit (with or without chronic respiratory failure);

- brohnhialnaya asthma (as part of complex therapy);

- Respiratory phenomena (cough, hoarseness, swelling in the throat) in measles, whooping cough and flu;

- Pinfectious diseases of the respiratory tract accompanied by cough, when standard antibiotic therapy is indicated;

- abouttit and sinusitis of various etiologies.

Contraindications:

- Hypersensitivity to the active substance and / or any of the components of the drug;

- pregnancy, the period of breastfeeding;

- Children under 2 years;

- phenylketonuria.

Pregnancy and lactation:

It is not recommended to take the drug during pregnancy.

Therapy with fenspiride is not a reason for interrupting the pregnancy that has occurred.

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

Dosing and Administration:

Inside.

Children from 2 to 18 years old: the recommended dose is 4 mg / kg / day.

- body weight up to 10 kg: from 20 mg to 40 mg per day, can be added from a bottle with food, previously dissolved in 30 ml of water.

- body weight more than 10 kg: from 60 mg to 120 mg per day.

Adults over the age of 18 the recommended single dose is 80 mg.

The maximum daily dose is 240 mg.

For children and teenagers under 18 years of age should use tablets dispersible to 20 mg and 40 mg, for the treatment of adults - tablets are 80 mg dispersible.

Duration of treatment is determined by the doctor.

Dispersible tablets can be taken in various ways: The tablet can be swallowed whole, washed down with water or beforehand, before taking it, dissolved in water. Tablets should be dissolved in at least 50 ml of water. Before taking, carefully mix the resulting suspension.

Side effects:

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) and an unknown frequency (the frequency can not be calculated from the available data).

From the side of the cardiovascular system:

rarely: moderate tachycardia, the severity of which decreases with a decrease in the dose of the drug;

unknown frequency: a palpitation, a decrease in blood pressure, possibly associated with tachycardia.

From the central nervous system:

rarely: drowsiness;

unknown frequency: dizziness.

From the digestive system:

often: gastrointestinal disorders, nausea, epigastric pain;

unknown frequency: diarrhea, vomiting.

General disorders and symptoms:

unknown frequency: asthenia, increased fatigue.

From the skin and subcutaneous fat:

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

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

Overdose:

When an overdose of the drug (noted cases of overdose with fenspiride intake in a dose of more than 2320 mg) should immediately seek medical help.

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

Treatment: gastric lavage, monitoring of the electrocardiogram (ECG). Maintaining vital functions of the body.

Interaction:

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

Because of the possible increase in sedation with the reception of histamine blockers H₁-receptor is not recommended use of the drug in combination with drugs that have a sedative effect, or in conjunction with alcohol.

Special instructions:

Treatment with fenspiride does not replace antibacterial therapy and can not serve as a reason for postponing the proper use of antibacterial drugs.

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

Studies on the study of the influence of fenspiride 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 when combined with drinking alcohol, and should be careful when driving vehicles and performing work that requires a high rate of psychomotor reactions.

Form release / dosage:

Tablets are dispersible, 20 mg, 40 mg and 80 mg.

Packaging:

By 7, 10, 14, 20, 25, 30 tablets into a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 10, 20, 30, 40, 50 or 100 tablets in cans of polyethylene terephthalate for medicines,sealed with caps screwed on with a first opening control or by a "push-turn" system of polypropylene or polyethylene or polypropylene jars for drugs sealed with lids pulled with the control of the first opening from polyethylene or cans of polypropylene for drugs sealed with lids pulled with the control of the first opening from polyethylene high pressure.

One jar or 1, 2, 3, 4, 5, 6 or 10 contour squares, together with the instructions for use, are placed in a cardboard package (bundle).

It is allowed to bundle 2 or 3 cardboard packages (packs) into a group package (transport packaging) of cardboard for consumer packaging.

Storage conditions:

In the dark place 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 expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003915

Date of registration:20.10.2016

Expiration Date:20.10.2021

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Representation: & nbspOZONE LLC OZONE LLC Russia

Information update date: & nbsp11.11.2016

Illustrated instructions

Instructions

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