Ella: Uses, Side Effects and Dosage

What is ella used for?

You must use ella within 5 days (120 hours) to prevent pregnancy after:

• you had unprotected sex

• your method of birth control has failed. For example:

  • you or your partner’s condom tore, slipped or came off
  • you did not take your birth control pill the right way

You should not use ella in place of a regular birth control method.

How does ella work?

Ulipristal acetate (the active ingredient in ella) is in a class of medications called progestins. It works by modifying the activity of the natural hormone progesterone. Progesterone is necessary for the release of an egg during the monthly cycle (ovulation). As a result, this medicine works by preventing or delaying ovulation.

ella is an emergency contraceptive. It is a way to prevent pregnancy if you had sex without using birth control or your birth control method failed.

ella is not effective in every case. Of 100 women who take this medicine approximately 2 will become pregnant.

ella prevents pregnancy from starting. It does not end a pregnancy that has already started (this means that ella will not work if you are already pregnant).

What are the ingredients in ella?

Medicinal ingredient: Ulipristal acetate

Non-medicinal ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate, and povidone K30.

ella comes in the following dosage forms:

Tablet, 30 mg

Do not use ella if:

• you are allergic to:

  • ulipristal acetate

  • any of the other ingredients of this medicine, or the component of the container

    See “What are the ingredients in ella?”

• you are pregnant or suspect a pregnancy

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ella. Talk about any health conditions or problems you may have, including if :

• your period is late or you have symptoms of pregnancy (heavy breasts, morning sickness), as you may already be pregnant
• you have severe liver disease
• you are lactose intolerant. ella contains lactose.
• you are breast feeding. Do not breastfeed your baby for one week after taking ella. During this time, pump and discard your breast milk in order to stimulate and maintain milk supply.

Other warnings you should know about:

• The sooner you take ella, the better it works, so take it as soon as possible after unprotected sex, and within a maximum of 5 days (120 hours).
• It is very important that you have a reliable form of birth control that is right for you. If you do not have a regular birth control method, talk to your healthcare professional to choose one that is suitable for you.
• ella does not prevent pregnancy in every case. If you become pregnant despite taking the tablet, it is important that you see your healthcare professional
• ella is only effective for one episode of unprotected sex. Right after using ella, you are again able to get pregnant. To prevent pregnancy after taking ella, you should use a reliable barrier birth control method (such as condoms) every time you have sex for the rest of your menstrual cycle (e.g. time between taking ella and your next period).

• after taking ella, you may wish to resume the hormonal birth control (such as birth control pill, patch, ring) that you usually take or start a new hormonal birth control. In any case, be sure to:

  • wait 5 days before doing so

    and

  • use condoms every time you have sex until your next period
• If you used ella because you had a problem with your hormonal birth control (e.g. birth control failure), follow the instructions provided in the patient medication information leaflet for that specific hormonal birth control product or contact your healthcare professional for further information. Be sure to use condoms each time you have sex until your next menstrual period.
• Do not use ella twice in the same menstrual cycle.
• ella is not for frequent or regular use to prevent pregnancy. If you need to use emergency birth control often, talk with your healthcare professional.
• ella does not end a pregnancy that has already started. Talk to your healthcare professional if you think you may already be pregnant.
• ella will not protect you against sexually transmitted diseases (STDs):
• HIV infection (AIDS)
• other sexually transmitted diseases (STDs) (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B and syphilis).

Only condoms can protect you from sexually transmitted infections.

• Before you take ella, tell your doctor if your last period was not normal. You may already be pregnant.

• Next period after use of ella: After taking ella, it is normal for your next period to be a few days late. However, you may be pregnant if:

  • your period is more than 7 days late; if it is unusually light or unusually heavy;
  • you experience symptoms such as abdominal (stomach) pain, breast tenderness, vomiting or nausea.

You should do a pregnancy test right away in the case of either of the above scenarios. If you are pregnant, it is important that you see your healthcare professional.

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

• Driving and using machines: After taking ella, you may have dizziness, drowsiness, blurred vision and/or loss of concentration. If you experience these symptoms, do not drive or use machines

• ella contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ella:

• medicines used to treat epilepsy (e.g., phenytoin, phenobarbital, carbamazepine, barbiturates, felbamate, oxcarbazepine, topiramate)
• rifampin, rifampicin (antibiotic used to treat tuberculosis)
• bosentan (used to treat a condition known as pulmonary hypertension)
• griseofulvin (an antibiotic used to treat certain skin infections)
• dabigatran etexilate (used to prevent blood clots)
• digoxin (used to treat various heart conditions)
• esomeprazole (used to treat gastric acidity (heartburn)
• St John’s wort/Hypericum perforatum
• ritonavir (used to treat HIV)
• itraconazole, ketoconazole (used to treat mycosis (fungal infections))

• Other birth control methods. These include

  • hormonal birth controls like birth control pill, patch, or ring. ella may make your hormonal birth control less effective. Be sure to:

    • wait 5 days before starting a new birth hormonal control or resuming the hormonal birth control that you usually take

      and

    • always use reliable barrier birth control method (such as condoms) every time you have sex from the time between taking ella and until your next period.
  • emergency birth control pills that contain levonorgestrel. Do not take ella together with another birth control pill that contains levonorgestrel. By taking them both together, you might make ella less effective.

How to take ella:

• You should take ella as soon as possible and within a maximum of 5 days (120 hours)
• Follow your healthcare professional’s instructions very carefully.

• you can take ella tablet

  • at any time during the menstrual cycle.

  • by mouth with or without food.

• If you vomit within 3 hours of taking ella, contact your healthcare professional immediately in order to take another tablet.

Usual dose:

Take one tablet by mouth as soon as possible within 5 days (120 hours) after unprotected sex or if you had a birth control failure.

Overdose:

If you have taken too much ella,

• you may have a shortened menstrual cycle (this mean you may have your period 2-3 days earlier than expected)
• your period may last longer than usual with spotting.

What are possible side effects from using ella?

These are not all the possible side effects you may have when taking ella. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• acne
• back pain
• breast tenderness
• dizziness
• fatigue
• headache
• menstrual pain (dysmenorrhea)
• mood disorders
• muscle pain
• nausea
• pelvic pain
• stomach (abdominal) pain
• stomach (abdominal) discomfort
• vomiting

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

This package is sealed for your protection. Do not use if torn or broken.

Store at 15-25°C. Store in the original packaging to protect from moisture.

Keep the blister in the outer carton in order to protect from light.

Keep out of reach and sight of children.

If you want more information about ella:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.abbvie.ca, or by calling 1-888-704-8271.

ella® is a registered trademark of: Laboratoire HRA Pharma 92320 CHATILLON, France

Used under licence by Allergan Inc., an AbbVie company.

© 2023 AbbVie. All rights reserved.

Last Revised FEB 16, 2023