Epistat

Release form Tablets. Composition 1 tab. fenspiride hydrochloride 80 mg Excipients: calcium hydrogen phosphate dihydrate - 104.5 mg, povidone K29-32 - 12.9 mg, colloidal silicon dioxide - 0.6 mg, hypromellose 2208 - 99.9 mg, magnesium stearate - 2.1 mg. Film shell composition: opadry II white 85F18422 - 6 mg: polyvinyl alcohol - 2.4 mg, titanium dioxide (E171) - 1.5 mg, macrogol 3350 - 1.212 mg, talc - 0.888 mg.

Pharmacological action Drug with anti-inflammatory and antibronchoconstrictor activity Pharmacotherapeutic group: Anti-inflammatory antibronchoconstrictor agent.

Epistat, indications for use Diseases of the upper and lower respiratory tract: - nasopharyngitis and laryngitis; - tracheobronchitis; - bronchitis (with or without chronic respiratory failure); — bronchial asthma (as part of complex therapy); - respiratory phenomena (cough, hoarseness, sore throat) with measles, whooping cough, influenza; - infectious diseases of the respiratory tract, accompanied by cough, when standard antibiotic therapy is indicated.

Contraindications : children and adolescents under 18 years of age (Epistat® syrup should be used to treat children and adolescents under 18 years of age); - hypersensitivity to the active substance and/or any other component of the drug.

Method of administration and dosage The drug is taken orally. The tablets should be swallowed whole, preferably at the beginning of a meal, with a small amount of water. For adults, the drug is prescribed 1 tablet. 2-3 times/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, From the nervous system: rarely - drowsiness; frequency unknown - dizziness. From the cardiovascular system: rarely - moderate tachycardia, the severity of which decreases with decreasing dose of the drug. From the digestive system: often - gastrointestinal intestinal disorders, nausea, epigastric pain; frequency unknown - diarrhea, vomiting. From the skin and subcutaneous tissues: rarely - erythema, rash, urticaria, angioedema, fixed erythema pigmentosa; frequency unknown - itching. General disorders and local disorders administration: frequency unknown - asthenia, fatigue.The patient should be informed of the need to inform the doctor about any adverse reactions and symptoms (including those not mentioned in this instruction) or changes in laboratory parameters during therapy.

Special instructions Use in pediatrics Epistat® syrup should be used to treat children and adolescents under the age of 18 years.

Effect on the ability to drive vehicles and operate machinery. No studies have been conducted to study the effect of fenspiride on the ability to drive vehicles and operate machinery. Patients should be advised that drowsiness may occur while taking Epistat®, especially at the beginning 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 speed of psychomotor reactions.

Drug interactions No special studies have been conducted on the interaction of fenspiride with other drugs. Considering that the use of H1-histamine receptor blockers may enhance the sedative effect, the use of Epistat® in combination with drugs that have a sedative effect or with ethanol is not recommended. Treatment with Epistat should not interfere with the initiation of antibiotic therapy.

Overdose In case of overdose (cases of overdose have been reported when taking the drug at a dose of more than 2320 mg), the patient should immediately seek medical help. Symptoms: drowsiness or agitation, nausea, vomiting, sinus tachycardia. Treatment: gastric lavage, ECG monitoring, maintaining vital body functions.