ULIPRISTAL oral


Therapeutic action

– Hormonal contraceptive, progesterone receptor modulator with agonist/antagonist effects

Indications

– Emergency contraception after unprotected or inadequately protected intercourse (e.g. forgotten pill or condom breaking)

Forms and strengths

– 30 mg tablet

Dosage and duration

– One 30 mg tablet, whatever the day of the cycle, as soon as possible after unprotected or inadequately protected intercourse and preferably within the first 120 hours (5 days)

Contra-indications, adverse effects, precautions

– May cause: headache, nausea, vomiting, abdominal pain, dysmenorrhea, disturbance of next menstrual cycle.
– Re-administer treatment immediately if vomiting occurs within 3 hours of taking treatment.
– Avoid combination with:
• omeprazole and antacids containing aluminium or magnesium hydroxide (decreased effectiveness of the contraceptive);
• enzyme-inducing drugs: rifampicin, rifabutine, efavirenz, nevirapine, lopinavir, ritonavir, phenobarbital, phenytoin, carbamazepine, griseofulvin, etc. (decreased effectiveness of the contraceptive).
In both cases, use levonorgestrel (doble the dose with enzyme-inducing drugs) or a copper intrauterine device as emergency contraception.
– Avoid combination with hormonal contraceptives: decreased effectiveness of ulipristal and of the hormonal contraceptive if taken immediately after the administration of ulipristal.
Pregnancy: in the event of treatment failure (i.e. pregnancy develops) or if used during an undiagnosed pregnancy, there is no known harm for the foetus.
Breast-feeding: no contra-indication

Remarks

– Emergency contraception is intended to prevent pregnancy; it cannot terminate an ongoing pregnancy.
– If an oral contraceptive pill is missed, use preferably levonorgestrel or a copper intrauterine device as emergency contraception (fewer drug interactions).
– Start or resume hormonal contraception the 6th day after the administration of ulipristal. Use condoms for:
• the first 7 days of taking an oral oestroprogestogen pill or an injection of medroxyprogesterone or the insertion of an implant;
• the first 2 days of taking an oral progestogen only pill.
– There is a risk of treatment failure; carry out a pregnancy test if signs or symptoms of pregnancy (no menstruation, etc.) appear one month after taking ulipristal.
Storage: below 25 °C