ellaOne - Morning After Pill

ellaOne is an emergency contraceptive.

ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive
method has failed. For example:

• if you had sex without protection;
• if your or your partner’s condom tore, slipped or came off, or if you forgot to use one;
• if you did not take your contraceptive pill as recommended

You should take the tablet as soon as possible after sex, and within a maximum of 5 days (120 hours).

This is because it is more effective if you take it as soon as possible after unprotected sex.

This medicine is suitable for any woman of childbearing age, including adolescents.

You can take the tablet at any time in the menstrual cycle.

ellaOne does not work if you are already pregnant

If your menstrual period is late, there is a possibility that you may be pregnant. When your period is late or when you have symptoms of pregnancy (heavy breasts, morning sickness) you should consult a doctor or other healthcare professional before taking the tablet.

If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant. Unprotected sex at any time during your cycle can lead to pregnancy.

ellaOne is not to be used for regular contraception

If you do not have a regular method of contraception, talk to your doctor or healthcare professional to choose one that is suitable for you.

How ellaOne works

ellaOne contains the substance ulipristal acetate which acts by modifying the activity of the natural hormone progesterone which is necessary for ovulation to occur. As a result, this medicine works by postponing ovulation. Emergency contraception is not effective in every case. Of 100 women who take this medicine approximately 2 will become pregnant.

This medicine is a contraceptive used to prevent a pregnancy from starting. If you are already pregnant, it will not interrupt an existing pregnancy.

Emergency contraception does not protect against sexually transmitted infections Only condoms can protect you from sexually transmitted infections. This medicine will not protect you against HIV infection or any other sexually transmitted diseases (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B and syphilis). Ask a healthcare professional for advice if you are worried about this.

• How effective is the morning after pill?

  If EllaOne is taken when you are not ovulating and within the 120 hour timeframe after unprotected sex, there is a 98-99% chance of the pregnancy being terminated. 

  If Levonelle is taken when you are not ovulating and within the 72 hour timeframe after unprotected sex, there is a 97-99% chance of the pregnancy being terminated. 

  If you are close to ovulation, EllaOne is the better choice to Levonelle. During ovulation neither pill will work. 

  Levonelle does not hinder the ability of contraceptive pills, so contraceptive pills are still able to be used as normal.

  EllaOne can hinder the ability of contraceptive pills by your body building tolerance to them. Due to this, you must use a different type of contraception 7 days after using EllaOne for full protection against pregnancy. 

• How long after sex can you take the morning after pill?

  There are two different morning after pills, Levonelle and Ellaone. When you can take it depends on which brand you take.

  Levonelle needs to be taken within 72 hours of unprotected sex, whereas EllaOne can be taken until up to 120 hours after unprotected sex. The sooner after sex you take the morning after pill, the better - this goes for both Levonelle and Ellaone.

• How Does the Morning After Pill Work?

  Levonelle and EllaOne contain chemicals that mimic the female sex hormone progesterone. They are thought to prevent ovulation, fertilisation and change the lining of the womb. 

  Levonelle and EllaOne trick the body into thinking that it has already ovulated, which prevents eggs being released from the ovaries. They also thickens the mucus in the cervix (the neck of the womb) which makes it harder for sperm to cross from the vagina into the womb to fertilise any eggs that might be there. Finally, Levonelle and EllaOne change the lining of the womb so that any fertilised eggs cannot implant into it.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms such as breast tenderness and abdominal (stomach) pain, throwing up (vomiting),
feeling sick (nausea) are also possible signs of pregnancy. If you miss your period and experience such
symptoms after taking ellaOne, you should do a pregnancy test (see section 2 “Pregnancy, breastfeeding and fertility”).

Common side effects (may affect up to 1 in 10 people)

• nausea, abdominal (stomach) pain or discomfort, vomiting
• painful periods, pelvic pain, breast tenderness
• headache, dizziness, mood swings
• muscle pain, back pain, tiredness

Uncommon side effects (may affect up to 1 in 100 people)

• diarrhoea, heartburn, wind, dry mouth
• unusual or irregular vaginal bleeding, heavy/prolonged periods premenstrual syndrome, vaginal
• irritation or discharge, lesser or greater sex drive
• hot flushes
• appetite changes, emotional disorders, anxiety, agitation, trouble sleeping, sleepiness, migraine
• visual disturbances
• influenza
• acne, skin lesions, itching
• fever, chills, malaise

Rare side effects (may affect up to 1 in 1,000 people)

• genital pain or itching, pain during sex, rupture of an ovarian cyst, unusually light period
• loss of concentration, vertigo, shaking, disorientation, fainting
• unusual sensation in eye, red eye, sensitivity to light
• dry throat, disturbance in taste
• allergic reactions such as rash, hives or swelling of the face
• feeling thirsty

Reporting of side effects

If you get any side effects, talk to your pharmacist, doctor or other healthcare professional. This
includes any possible side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can provide more information on the safety of this medicine.

Before using any medication, it is important to read the Patient Information Leaflet. You can find information leaflets for your medicines by typing them into the search bar at medicines.org, or by contacting us.

Patient Information Leaflet: Click Here for ellaOne Information Leaflet

Pregnancy, breast-feeding and fertility

Pregnancy

Before taking this medicine, if your period is late, tell your pharmacist, doctor or other healthcare professional, or do a pregnancy test in order to make sure you are not already pregnant (see section
“Warning and precautions”).

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 that you see your doctor.

As for any pregnancy, your doctor may want to check that the pregnancy is not outside the womb. This is especially important 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.

If you become pregnant despite taking ellaOne, you are encouraged to ask your doctor to register your pregnancy in an official registry. You can also report this information on your own at www.hra-pregnancy-registry.com.Your information will remain anonymous – nobody will know it is information about you.

Sharing your information may help women in the future understand the safety or risks of ellaOne during a pregnancy.

Breast-feeding

If you take this medicine while you are breast-feeding a baby, do not breast-feed for one week after taking this medicine. During this time, it is recommended to use a breast pump in order to maintain milk production, but throw away your breast milk. The effect of breast-feeding your baby in the week after taking this medicine is not known.

Fertility

This medicine will not affect your future fertility. If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant. Therefore it is important you use condoms until your next period.

If you wish to start or continue with a regular method of contraception after using this medicine, you
can do so but you should also use condoms until your next period.

Driving and using machines

After taking this medicine, some women experience dizziness, drowsiness, blurred vision and/or loss
of concentration (see section 4). 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, that is to say essentially ‘sodium-free’.

Do not take ellaOne if: you are allergic to ulipristal acetate or any of the other ingredients of this medicine.

Warning and precautions
Talk to your pharmacist, doctor or other healthcare professional before taking this medicine

• if you suffer from severe asthma;
• if your period is late or you have symptoms of pregnancy (heavy breasts, morning sickness), as
  you may already be pregnant (see section “Pregnancy, breast-feeding and fertility”);
• if you suffer from severe liver disease.

In all women, 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.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

If you become pregnant despite taking the tablet, it is important that you see your doctor. See section “Pregnancy, breast-feeding and fertility” for more information.

Other contraceptives 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 this medicine, but be sure to use condoms every time you have sex until your next period.

Do not take this medicine together with another emergency contraceptive pill that contains levonorgestrel. By taking them both together, you might make this medicine less effective.

Other medicines and ellaOne
Tell your pharmacist, doctor or other healthcare professional if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent ellaOne from working effectively. If you have used any of the medicines
listed below during the last 4 weeks, ellaOne may be less suitable for you. Your doctor may prescribe
another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD):

• medicines used to treat epilepsy (for example, primidone, phenobarbital, phenytoin,
• fosphenytoine, carbamazepine, oxcarbazepine and barbiturates)
• medicines used to treat tuberculosis (for example, rifampicin, rifabutin)
• a treatment for HIV (ritonavir, efavirenz, nevirapine)
• a medicine used to treat fungal infections (griseofulvin)
• herbal remedies containing St John's wort (Hypericum perforatum).

Speak to your doctor or pharmacist before using ellaOne when you use (or have recently used) any of
the medicines stated above.

The active substance is ulipristal acetate. Each tablet contains 30 milligrams of ulipristal acetate.

The other ingredients are lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate.