Pemozar gastro-resistant tablets 40 mg blister No. 14

Ezonex enteric-coated tablets are used for the indications listed below.

adults:

Children aged 12 and over.

Composition

Active ingredient: esomeprazole;

1 tablet contains esomeprazole magnesium (amorphous) equivalent to esomeprazole 20 mg or 40 mg;

Excipients: spherical sugar, hydroxypropyl cellulose, crospovidone, povidone, macrogol 400, talc, hypromellose phthalate, diethyl phthalate, macrogol 6000, microcrystalline cellulose, sodium stearyl fumarate, macrogol 4000, Opadry 03B86651 brown (hydroxypropyl methylcellulose, titanium dioxide (E 171), macrogol 4000, talc, iron oxide red (E172)).

Contraindication

Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients.

Esomeprazole should not be used concomitantly with nelfinavir.

Method of application

Pemozar tablets should be swallowed whole with sufficient liquid. The tablets should not be chewed or crushed.

Patients who have difficulty swallowing may be advised to dissolve the tablet in 100 ml of still water, stir until the tablet disintegrates, and then drink the suspension of microgranules immediately or within 30 minutes. Then fill the glass halfway with water, stir the remainder and drink. No other liquids should be used as they may damage the enteric coating. The microgranules should not be chewed or crushed.

Application features

Pregnant women

The drug should be prescribed with caution to pregnant women.

Children

The drug should not be used in children under 12 years of age, as there is no data on the application of the provisions of the Agreement.

Drivers

Esomeprazole has minimal influence on the ability to drive and use machines. Adverse reactions such as dizziness (uncommon) and blurred vision (rare) have been reported (see section 4.8). If these disorders occur, patients should not drive or use machines.

Overdose

Data on overdose are limited. Gastrointestinal symptoms and weakness have been described after taking 280 mg of esomeprazole. A single dose of 80 mg of esomeprazole is unlikely to cause serious adverse effects. No specific antidote is known.

Esomeprazole is highly bound to plasma proteins, so hemodialysis is ineffective. Treatment is symptomatic.

Side effects

General disorders: Rare: malaise, increased sweating.

Interaction

Drugs that can induce CYP2C19 or CYP3A4 or both of these enzymes (such as rifampicin and St. John's wort) may reduce the plasma concentration of esomeprazole by increasing its metabolism.

Esomeprazole should not be used concomitantly with nelfinavir.

Storage conditions

Store in the original packaging at a temperature not exceeding 30ºС.

Keep out of reach of children.

Shelf life - 2 years.