ellaOne 30mg, 1 tablet, Hra Pharma

Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or failure of the contraceptive method used.

Composition:

• Each tablet contains ulipristal acetate 30 mg
• Each tablet contains lactose 237 mg.

How to use:

• This treatment consists of an oral tablet, which will be administered as soon as possible, but no later than 120 hours (5 days) after unprotected sexual intercourse or failure of the contraceptive method used
• The tablet can be administered at any time during the menstrual cycle
• If within 3 hours of taking the tablet the patient vomits, a new tablet will be administered
• If the patient's menstruation is late or in case of pregnancy symptoms, the presence of pregnancy must be excluded before administering the tablet.

Contraindications:

Do not use ellaOne if you have hypersensitivity to the active substance or to any of the excipients of this medicine.

Precautions:

Talk to your doctor or pharmacist before using ellaOne.

Pregnancy and breast-feeding:

Pregnancy

• ellaOne is not intended for use during pregnancy and should not be taken by any woman with suspected or confirmed pregnancy
• Ulipristal acetate does not terminate an existing pregnancy
• Pregnancy may occasionally occur after taking ulipristal acetate. Although no teratogenic potential was observed, animal data are insufficient with regard to reproductive toxicity (see section 5.3). Limited human data on exposure of pregnancy to ellaOne do not suggest any safety concerns. However, it is important that any pregnancy in a patient who has taken ellaOne is reported to www.hra-pregnancy-registry.com. The aim of this web-based registry is to collect safety information from women who have taken ellaOne during pregnancy or who become pregnant after taking ellaOne. All data collected from patients will remain anonymous.

Breastfeeding

• Ulipristal acetate is excreted in human breast milk. The effect on newborns/infants has not been studied
• A risk to the breast-fed child cannot be excluded
• After taking ulipristal acetate for emergency contraception, breast-feeding is not recommended for one week. During this period, it is recommended to pump and discard breast milk to stimulate lactation.

Fertility

• A rapid return of fertility is likely following treatment with ulipristal acetate for emergency contraception
• Women should be advised to use a reliable barrier method for all subsequent sexual intercourse until their next menstrual period.

Driving and using machines

• Ulipristal acetate has minor or moderate influence on the ability to drive and use machines: after administration of ellaOne mild to moderate dizziness is common, somnolence and blurred vision are uncommon reactions and impaired attention has been reported rarely
• The patient should be advised not to drive or use machines if they experience such symptoms.

Presentation: 1 tablet