ELLA Tablet Ref.[10802] Active ingredients: Ulipristal

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Ella is not intended for routine use as a contraceptive.

2. Dosage and Administration

Instruct patients to take one tablet orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.

The tablet can be taken with or without food.

If vomiting occurs within 3 hours of ella intake, consideration should be given to repeating the dose.

Ellacan be taken at any time during the menstrual cycle.

10. Overdosage

Experience with ulipristal acetate overdose is limited. In a clinical study, single doses equivalent to up to 4 times ella were administered to a limited number of subjects without any adverse reactions.

16.2. Storage and Handling

Store at 20-25°C (68-77°F).
[See USP controlled room temperature.]

Keep the blister in the outer carton in order to protect from light. Keep out of reach of children.

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