Exista hard capsules 150 mg No. 28

Exist capsules are indicated for the following diseases:

Composition

active ingredient: pregabalin;

1 capsule contains 150 mg of pregabalin;

excipients: lactose monohydrate, corn starch; talc;

capsule shell: red iron oxide (E 172), titanium dioxide (E 171), gelatin (for 75 mg capsules); titanium dioxide (E 171), gelatin (for 150 mg capsules).

Contraindication

Hypersensitivity to the active substance or to any of the excipients listed in the "Composition" section.

Method of application

Take Exista regardless of meals.

This medicine is for oral use only.

Application features

Pregnant women

Exista should not be used during pregnancy unless clearly necessary (when the benefit to the mother clearly outweighs the potential risk to the fetus).

Children

The safety and efficacy of Exista in children under 18 years of age have not been established. Currently available information is provided in the Adverse Reactions section, as well as in the Pharmacodynamics and Pharmacokinetics sections, but no dosage recommendations can be made for this patient population.

Drivers

Exista may have minor or moderate influence on the ability to drive and use machines. Exista may cause dizziness and drowsiness and thus affect the ability to drive and use machines. Therefore, patients should be advised to refrain from driving, operating complex machinery or other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform such activities.

Overdose

After the drug was marketed, the most common adverse reactions reported in pregabalin overdose were drowsiness, confusion, agitation, and restlessness. Seizures have also been reported.

Rare cases of coma have been reported.

Adverse reactions

The most frequently reported adverse reactions were dizziness and somnolence. Adverse reactions were generally mild to moderate in severity. In all controlled trials, the discontinuation rate due to adverse reactions was 12% in patients receiving pregabalin and 5% in patients receiving placebo. The most frequently reported adverse reactions leading to discontinuation of study drug in the pregabalin group were dizziness and somnolence.

Interaction

Pregabalin may potentiate the effects of ethanol and lorazepam. In controlled clinical studies, multiple oral doses of pregabalin with oxycodone, lorazepam, or ethanol did not result in clinically significant effects on respiratory function. During post-marketing surveillance, cases of respiratory failure and coma have been reported in patients taking pregabalin with other CNS depressants. Pregabalin is likely to potentiate the cognitive and gross motor impairments caused by oxycodone.

Storage conditions

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