Espa-Bastin, 20 mg 10 pcs

Urticaria, Skin itching, Allergic rhinitis, Allergic conjunctivitis, AllergyAllergic rhinitis, allergic conjunctivitis, urticaria.

Active ingredient

Composition

Each film-coated tablet contains:

The tablet core:

the active ingredient:

excipients:

Microcrystalline cellulose – 85.00 mg/171.00 mg,

sodium carboxymethyl starch (type A) – 3.00 mg/6.00 mg,

colloidal anhydrous silica – 1.00 mg/2.00 mg,

magnesium stearate – 0.50 mg/1.00 mg.

Film Coating

Opadray Y-1-7000 white, consisting of: Hypromellose-5cP – 4.69 mg/9.38 mg, titanium dioxide – 2.34 mg/4.68 mg, macrogol 400 – 0.47 mg/0.94 mg.

How to take, the dosage

Orally, regardless of meals.

Adults and children over 12 years of age are recommended to start therapy with a dose of 10 mg once daily using Espa-Bastin®, film-coated tablets, 10 mg.

In case of insufficient efficacy, a double dose is recommended, i.e., Espa-Bastin®, film-coated tablets, 20 mg, 1 tablet (20 mg) once daily.

The course of treatment will be determined by the disappearance of symptoms.

Elderly patients: No dose adjustment is necessary.

Patients with impaired renal function: no dose adjustment is required.

Patients with mild to moderate hepatic impairment (Child-Pugh class A, B): No dose adjustment is necessary.

In patients with severe hepatic impairment (Child-Pugh Class C), the daily dose should not exceed 10 mg, so we recommend Espa-Bastin®, film-coated tablets, 10 mg.

Interaction

It is not recommended to prescribe concomitantly with ketoconazole or itraconazole and erythromycin (increased risk of QT interval prolongation).

There are no clinically significant interactions with theophylline, indirect anticoagulants, cimetidine, diazepam, ethanol and ethanol-containing drugs.

Rifampicin decreases the plasma concentration of ebastine and has an inhibitory effect on the antihistamine effect of ebastine.

May increase the effect of other antihistamines.

Special Instructions

Ebastin may distort the results of skin allergy tests. Therefore, it is recommended that such tests not be performed earlier than 5-7 days after discontinuation of the drug.

Cautions should be taken with prolonged QT interval on electrocardiogram, hypokalemia, and concomitant use of azole antimycotic agents and antibiotics of macrolide group (see section “Interaction with other medicinal products”) during therapy.

Patients with significant hepatic impairment should be treated with caution (see section “Dosage and administration”).

In therapeutic doses, there is no effect on driving and operating ability.

In case of side effects on the central nervous system, such as drowsiness, caution should be exercised while driving vehicles and engaging in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

Synopsis

Contraindications

Hypersensitivity to the active ingredient or other ingredients of the drug;

Severe hepatic impairment (Child-Pugh class C);

Pregnancy;

lactation period;

childhood (under 12 years).

QT interval prolongation on ECG, hypokalemia, renal and/or mild to moderate hepatic impairment (Child-Pugh class A, B).

The drug should be used with caution when concomitant administration with ketoconazole or itraconazole and erythromycin – there may be increased risk of QT interval prolongation on ECG.

Side effects

According to the World Health Organization (WHO), adverse effects are classified according to their frequency of development as follows: Very common (≥ 1/10), common (≥ 1/100, < 1/10), infrequent (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000) and very rare (< 1/10000); frequency unknown (the incidence of events cannot be determined from available data).

Gastrointestinal disorders: common: dry mouth; rare: nausea, abdominal pain, dyspepsia; very rare: vomiting.

Nervous system disorders: frequently: drowsiness, headache; very rarely: nervousness, insomnia, dizziness, paresthesia, dysesthesia.

Liver and biliary tract disorders: very rarely: hepatitis, cholestasis, changes of laboratory parameters (increased activity of liver transaminases, GGT, alkaline phosphatase, bilirubin).

Immune system disorders: frequency unknown: hypersensitivity reactions (e.g., anaphylaxis, angioedema).

Cardiovascular system disorders: very rare: tachycardia, palpitation.

Skin and subcutaneous tissue disorders: very rare: urticaria, rash, dermatitis.

Reproductive system disorders: very rare: menstrual disorders.

General and local reactions: very rare: edema, asthenic syndrome.

Overdose

Taking up to 100 mg of ebastine per day, there are no clinically significant symptoms of overdose.

A specific antidote has not been identified.

Treatment: gastric lavage, control of vital body functions, including ECG monitoring, symptomatic therapy.

Pregnancy use

The safety of the drug in pregnant women has not been studied, therefore it is contraindicated to take Espa-Bastin® during pregnancy.

It is not recommended to take the drug during breastfeeding.

Similarities