Composition, form of production and packaging
Tablets of prolonged action, covered with a film coat of white or almost white color, round, biconcave; on the cross section - the core is white or almost white.
1 tab.
fenspiride hydrochloride 80 mg
Auxiliary substances: collidine SR (polyvinyl acetate 80%, povidone 19%, sodium lauryl sulfate 0.8%, silicon dioxide 0.2%) 120 mg, calcium hydrophosphate dihydrate 95.5 mg, silicon colloidal dioxide 1.5 mg, magnesium stearate 3 mg.
Composition of the film coat: hypromellose 4.5 mg, talc 1.764 mg, giprolose hydroxypropyl cellulose 1.746 mg, titanium dioxide 0.99 mg or dry film-coating mixture containing hypromellose (50%), giprolose (hydroxypropylcellulose) (19.4%), talc (19.6%), titanium dioxide (11%) - 0.99 mg.
15 pcs. - packings cellular planimetric (2) - packs cardboard.
15 pcs. - packings cellular planimetric (4) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
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 TNFО±, arachidonic acid derivatives, free radicals) that play an important role in the development of inflammation and bronchospasm.
Inhibition by fenspiride of the metabolism of arachidonic acid is potentiated by its H 1 antigistamine action, t. histamine stimulates the metabolism of arachidonic acid with the formation of prostaglandins and leukotrienes. Fenspiride blocks? -adrenoceptors, stimulation of which is accompanied by an increase in the secretion of the bronchial glands. Thus, fenspiride reduces the effect of a number of factors that contribute to the hypersecretion of pro-inflammatory factors, the development of inflammation and bronchial obstruction. Fenspiride also has an antispasmodic effect.
PHARMACOKINETICS
After ingestion C max in blood plasma is achieved after 6 hours.
T 1/2 is 12 hours. It is excreted mainly by the kidneys.
INDICATIONS
Diseases of the upper and lower respiratory tract:
- Rhinopharyngitis and laryngitis;
- tracheobronchitis;
- bronchitis (on the background of chronic respiratory failure or without it);
- bronchial asthma (as part of complex therapy);
- respiratory effects (cough, hoarseness, swelling in the throat) in measles, whooping cough and flu;
- for infectious diseases of the respiratory tract accompanied by coughing, when standard antibiotic therapy is indicated.
Otitis and sinusitis of various etiologies.
DOSING MODE
Assign inside. Adults - 1 tab. 2-3 times / day. The maximum daily dose is 240 mg.
The duration of treatment is determined by the doctor.
SIDE EFFECT
The incidence of side effects that may occur during therapy is given in the following gradation: very often -? 1/10 (> 10%); often - from? 1/100 to <1/10 (> 1% and <10%); infrequently - from? 1/1000 to <1/100 (> 0.1% and <1%); rarely - from? 1/10 000 to <1/1000 (> 0.01% and <0.1%); very rarely - <1/10 000 (<0.01%); an unknown frequency - the frequency can not be calculated from the available data.
From the cardiovascular system: rarely - a moderate tachycardia, the severity of which decreases with a decrease in the dose of the drug.
On the part of the digestive system: often - gastrointestinal disorders, nausea, epigastric pain; an unknown frequency - diarrhea, vomiting.
From the side of the central nervous system: rarely - drowsiness; an unknown frequency - dizziness.
From the skin: rarely - erythema, rash, hives, angioedema, fixed erythema pigmentosa; Unidentified frequency - itchy skin.
Other: unknown frequency - asthenia, increased fatigue.
CONTRAINDICATIONS
- age up to 18 years;
- Hypersensitivity to the active substance and / or any of the components of the drug.
PREGNANCY AND LACTATION
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.
Do not use Eladon В® during breastfeeding because of the lack of data on the penetration of fenspiride into breast milk.
APPLICATION FOR CHILDREN
Contraindicated in children under 18 years.
SPECIAL INSTRUCTIONS
Impact on the ability to manage vehicles and mechanisms
Studies to study the effect of Eladon В® 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 Eladon В® , especially at the beginning of therapy or when combined with alcohol intake, and should exercise caution when driving vehicles and performing work that requires a high rate of psychomotor reactions.
OVERDOSE
If the drug is overdosed (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, ECG monitoring. Maintaining vital body functions.
DRUG INTERACTION
Special studies on the interaction of fenspiride with other drugs have not been conducted.
Because of the possible increase in sedation with the administration of histamine H 1 -receptor blockers, the use of the Eladon В® preparation in combination with drugs with sedative action or with alcohol is not recommended.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light, inaccessible to children, at a temperature of no higher than 25 В° C. Shelf life - 2 years.
