Ella One 30mg Film Coated Tablet UK PI (1)

Tablets

16 and over

ellaOne is for occasional use only. It should in no instance replace a regular contraceptive method. In any case, women should be advised to adopt a regular method of contraception.

Do not take ellaOne if:

You are allergic to ulipristal acetate or any of the other ingredients of this medicine.
Talk to your pharmacist, doctor or other healthcare professional before taking this medicine if:

Your period is late or you have symptoms of pregnancy (heavy breasts, morning sickness), as you may already be pregnant.
You suffer from severe asthma.
You suffer from severe liver disease.
Emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that this medicine may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, ellaOne is still recommended for all women regardless of their weight or BMI.

If you become pregnant despite taking this medicine, it is important that you see your doctor. Your doctor may want to check that the pregnancy is not outside the womb, especially if you have severe abdominal (stomach) pain or bleeding or if you have previously had a pregnancy outside the womb, tubal surgery or long term (chronic) genital infection.

Other medicines and ellaOne:

This medicine may make regular hormonal contraceptives, like pills and patches, temporarily less effective. If you are currently taking hormonal contraception, continue to use it as usual after taking the tablet, but be sure to use condoms every time you have sex until your next period.

Do not take ellaOne together with another emergency contraceptive pill that contains levonorgestrel, as this might make this medicine less effective.

Some medicines may prevent ellaOne from working effectively if used during the last 4 weeks. These include medicines used to treat epilepsy (e.g., primidone, phenobarbital, phenytoin, carbamazepine, oxcarbazepine and barbiturates), tuberculosis (e.g., rifampicin, rifabutin), HIV (ritonavir, efavirenz, nevirapine), fungal infections (griseofulvin), and herbal remedies containing St John's wort (Hypericum perforatum). Speak to your doctor or pharmacist if you use or have recently used any of these medicines.

Pregnancy, breast-feeding and fertility:

This medicine is a contraceptive used to prevent a pregnancy from starting. If you are already pregnant it will not interrupt an existing pregnancy. If you become pregnant despite taking this medicine, there is no evidence that it will affect your pregnancy. However, it is important to see your doctor. If you take this medicine while you are breast-feeding, do not breast-feed for one week after taking it. During this time, it is recommended to use a breast pump to maintain milk production but discard the milk.

This medicine will not affect your future fertility. However, if you have unprotected sex after taking this medicine, it will not stop you from becoming pregnant, so it is important to use condoms until your next period.

Driving and using machines:

Some women may experience dizziness, drowsiness, blurred vision and/or loss of concentration. If you experience these symptoms, do not drive or use machines.

ellaOne contains lactose:

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. ellaOne contains less than 1 mmol sodium (23 mg) per tablet, so it is essentially ‘sodium-free’.

Active Ingredient: Ulipristal Acetate 30mg.

Other Ingredients:

Tablet core: Lactose monohydrate, Povidone K30, Croscarmellose Sodium, Magnesium Stearate.
Film coating: Poly(vinyl alcohol) (E1203), Macrogol (E1521), Talc (E553b), Titanium dioxide (E171), Polysorbate 80 (E433), Iron oxide yellow (E172), Potassium aluminium silicate (E555).