Ella

Ella

ulipristal

Manufacturer:

Hyphens

Distributor:

Pan-Malayan
Concise Prescribing Info
Contents
Ulipristal acetate
Indications/Uses
Emergency contraception w/in 120 hr (5 days) of unprotected sexual intercourse or contraceptive failure.
Dosage/Direction for Use
1 tab taken not later than 120 hr (5 days) after unprotected intercourse or contraceptive failure. May be taken at any moment during the menstrual cycle. Another tab should be taken if vomiting occurs w/in 3 hr of intake.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Not recommended in concomitant use w/ a levonorgestrel-containing emergency contraceptive. Not recommended in women w/ severe asthma insufficiently controlled by oral glucocorticoid. Not a replacement for regular contraceptive method. Repeated administration w/in the same menstrual cycle is not advisable; subsequent acts of intercourse after using Ella should be protected by a reliable barrier method until the next menstrual period starts. Does not prevent pregnancy in every case; exclude pregnancy by a pregnancy test in case of doubt, >7 days delay in next menstrual period, abnormal bleeding at the expected menses date, or pregnancy symptoms. Consider possible ectopic pregnancy if pregnancy still occurs after treatment. Menstrual periods may occur earlier or later than expected by a few days after intake. Not recommended in severe hepatic impairment. Not recommended in concomitant use w/ CYP3A4 inducers (eg, rifampicin, phenytoin, phenobarb, carbamazepine, efavirenz, fosphenytoin, nevirapine, oxcarbazepine, primidone, rifabutine, St. John's wort); ritonavir (long-term use). Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or use machines. Not recommended during lactation for 1 wk.
Adverse Reactions
Mood disorders; headache, dizziness; nausea, abdominal pain/discomfort, vomiting; myalgia, back pain; dysmenorrhea, pelvic pain, breast tenderness; fatigue.
Drug Interactions
Increased Cmax & AUC w/ potent & a moderate CYP3A4 inhibitor. Reduced plasma conc w/ ritonavir. Lower mean Cmax, delayed Tmax & higher AUC w/ PPIs. Reduced plasma conc w/ CYP3A4 inducers (eg, rifampicin, phenytoin, phenobarb, carbamazepine, efavirenz, fosphenytoin, nevirapine, oxcarbazepine, primidone, rifabutine, St. John's wort). Reduced contraceptive action of combined hormonal contraceptives & progestogen-only contraception.
MIMS Class
Oral Contraceptives
ATC Classification
G03AD02 - ulipristal ; Belongs to the class of emergency contraceptives. Used as systemic contraceptives.
Presentation/Packing
Form
Ella tab 30 mg
Packing/Price
1's
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