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

Excipients (core): calcium hydrophosphate dihydrate - 118.0 mg, hypromellose - 106.0 mg, povidone-K25 - 13.0 mg, silicon dioxide colloid - 1.0 mg, magnesium stearate - 2.0 mg.

Auxiliary substances (shell): hypromellose - 4.7 mg, macrogol-4000 - 0.9 mg, titanium dioxide -1.15 mg, magnesium stearate - 0.25 mg.

Description:

Round biconvex tablets covered with a film coat of white or almost white color. On the cross-section of the tablet: the nucleus is white or almost white in color and the film membrane.

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 (FIO-α), arachidonic acid derivatives, free radicals), which play an important role in the development of inflammation and bronchospasm.

Inhibition of fenspiride metabolism of arachidonic acid potentiates its H1-antihistamine 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 (Cmax) after oral administration is achieved after 6 hours. Half-life T1/2 - 12 hours.

It is excreted mainly by the kidneys.

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, whooping cough and flu;

- In case of infectious diseases of the respiratory tract accompanied by cough, when standard antibiotic therapy is indicated.

- Otitis and sinusitis of various etiologies.

Contraindications:

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

Children under 18 years of age (for the treatment of children and adolescents under 18 years of age, fenspiride in a dosage form syrup).

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 Fespalen during breastfeeding because of the lack of data on the penetration of fenspiride into breast milk.

Dosing and Administration:

Inside.

Adults: 1 tablet 2 - 3 times a day.

The maximum daily dose is 240 mg.

The duration of treatment is determined by the doctor.

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 unset frequency (the frequency can not be calculated from the available data).

From the cardiovascular system:

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

unknown frequency: lowering blood pressure, feeling palpitations.

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, urticaria, angioedema, fixed pigmented erythema.

Unidentified frequency: itching, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Overdose:

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

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

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

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:

For the treatment of children and adolescents under the age of 18, other dosage forms of preparations containing fenspiride.

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 to study the effect of fenspiride on the ability to drive vehicles and work with mechanisms have not been conducted.

Patients should be aware of the possible development of drowsiness when taking the drug, especially at the beginning of therapy or when combined with taking alcohol, and should be careful when driving vehicles and performing work that requires a high rate of psychomotor reactions.

Form release / dosage:

Tablets, film-coated 80 mg.

Packaging:

For 10, 20, 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

10, 20, 30, 40, 50, 60 or 100 tablets in cans of polyethylene terephthalate for medicinal products sealed with caps screwed on with first opening control or by a "push-turn" system of polypropylene or polyethylene or polypropylene cans for drugs sealed with lids stretched with the control of the first opening of polyethylene or cans of polypropylene for drugs, sealed with lids pulled with the control of the first opening of high-pressure polyethylene.

One jar or 1, 2, 3, 4, 5, 6 or 10 contour mesh packages 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 (shipping container) from 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-003313

Date of registration:17.11.2015 / 06.06.2016

Expiration Date:17.11.2020

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

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp31.10.2017

Illustrated instructions

Instructions

Fezpalen (Fespalen)