Composition: Each tablet contains:
Mifepristone . . . . . . . . . . . . . . . . . . . . . . 10 mg
Box of 1 blister x 1 tablet.
Mifrednor 10 is an emergency contraceptive pill, which is used within 120 hours after unprotected sexual intercourse.
|Dosage and administration||
|Warnings and precautions for use||
MIFREDNOR 10 cannot replace regular contraceptive methods.
|Recommendation for pregnancy and breastfeeding||
Pregnancy: Mifrednor 10 should not be used in pregnant women. Women who use this method to induce abortion should be warned in advance that if this method fails, in other words, pregnancy is still present, there is a risk of having a baby with fetal malformations. Therefore, if this method fails, it is necessary to seek medical advice to terminate the pregnancy.
|Effects on ability to drive and use machines||
No studies on the effect of mifepristone on the ability to drive and use machines have been performed.
|Interactions, incompatibilities of medicine||
Ketoconazole, itraconazole, erythromycin, and grapefruit juice may inhibit mifepristone metabolism (increasing serum levels of mifepristone).
|Undesirable effects (ADRs)||
Besides late period, side effects are mild and rarely occur. Common side effects include hemorrhage (19%), nausea (14%), vomiting (1%), diarrhea (5%), lower abdominal pain (14%), fatigue (15%), headache (10%), dizziness (9%), breast tenderness (8%).
|Overdose and management||
Clinical trials have shown that no side effects occur with a single dose of up to 2 g of mifepristone. If acute poisoning occurs, patients should be hospitalized for monitoring and special treatment.
The bioavailability of mifepristone is about 70% after oral administration. Peak plasma concentrations occur within 1 to 2 hours after a single dose. Half time is about 20 to 30 hours. The unbound mifepristone is rapidly metabolized in the liver by demethylation and the metabolites are found in plasma about 1 hour after ingestion. Mifepristone and its metabolites are mainly excreted in feces through the biliary tract and small amount by the kidneys.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.