BMA Concise Guide to Medicine & Drugs

Ulipristal

Brand name EllaOne

Used in the following combined preparations None

QUICK REFERENCE

Drug group Oral contraceptive

Overdose danger rating Low

Dependence rating Low

Prescription needed Yes

Available as generic No

GENERAL INFORMATION

Ulipristal is a synthetic progesterone that is used as an emergency contraceptive after unprotected intercourse. It works by blocking the action of naturally produced progesterone, thereby inhibiting or delaying ovulation. Ulipristal is only effective if taken within 120 hours (5 days) of intercourse and is solely for occasional use; it should not be used instead of regular contraception, although you can use it while taking other oral contraceptives but this may reduce their effectiveness. Ulipristal does not prevent pregnancy in every case: up to 2 per cent of women still become pregnant after using it. If after using ulipristal your next period is more than 7 days late or you have abnormal bleeding at the expected date of your period, the drug may have failed and you should have a pregnancy test. If the test is positive, you should see your doctor to check for the possibility of an ectopic pregnancy.

INFORMATION FOR USERS

Your drug prescription is tailored for you. Do not alter dosage without checking with your doctor.

How taken/used Tablets.

Frequency and timing of doses One tablet as soon as possible but within 120 hours (5 days) of unprotected intercourse. If vomiting occurs within 3 hours, take another tablet immediately.

Adult dosage range 30mg per tablet.

Onset of effect 2 hours.

Duration of action Up to 120 hours.

Diet advice None.

Storage Keep at room temperature in original packaging to protect from light. Keep out of reach of children.

Missed dose Not applicable as treatment is one dose.

Stopping the drug Not applicable as treatment is one dose.

Exceeding the dose An occasional unintentional extra dose is unlikely to be a cause for concern. However, if you notice any unusual symptoms, notify your doctor.

POSSIBLE ADVERSE EFFECTS

Ulipristal generally causes few serious adverse effects. The most common are nausea, vomiting, and dizziness, although upper abdominal discomfort or pain, headache, tiredness, mood swings, muscle aches, and breast tenderness are also fairly common. Discuss with your doctor if these are severe. If you have lower abdominal or back pain or any other signs of pregnancy, you should consult your doctor immediately to check for the possibility of an ectopic pregnancy.

INTERACTIONS

General note Numerous drugs can interact with ulipristal to reduce its effectiveness, including phenytoin, phenobarbital, carbamazepine, rifampicin, ritonavir, antacids, H2 blockers (e.g. cimetidine), proton pump inhibitors (e.g. omeprazole), and St John’s wort. If you have used any of these drugs with ulipristal, you should use a barrier contraceptive until your next period.

Oral contraceptives Ulipristal may reduce the effectiveness of oral contraceptives so you should use a reliable barrier method of contraception until your next period.

Antifungals and antibiotics Certain antifungals (e.g. ketoconazole and traconazole) and antibiotics (e.g. telithromycin and clarithromycin) may increase the activity of ulipristal and concomitant use should be avoided.

SPECIAL PRECAUTIONS

Be sure to tell your doctor if:

· You are definitely already pregnant.

· You have severe asthma.

· You have liver disease.

· You have lactose intolerance.

· You are taking or have recently taken any other medicines, including over-the-counter medicines and herbal remedies.

Pregnancy Should not to be taken if you are definitely already pregnant.

Breast-feeding Breast-feeding is not recommended in the 36 hours after use of ulipristal.

Infants and children Not recommended under age 16 years.

Over 60 Not needed for postmenopausal women.

Driving and hazardous work Avoid until you know how the drug has affected you. It may sometimes cause dizziness, drowsiness, blurred vision, and difficulty concentrating.

Alcohol No known problems.

PROLONGED USE

Ulipristal is intended for one-off use only for emergency postcoital contraception. Repeated use in the same menstrual cycle is not recommended as its safety and effectiveness are unknown.