Details for: ELLA
Company: LABORATOIRE HRA PHARMA
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02436329 | ELLA | ULIPRISTAL ACETATE | 30 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Use ella™ within 120 hours or 5 days to help reduce your chances or prevent pregnancy after:
- known or suspected birth control failure. Examples include missed contraceptive pills or a condom breaking or slipping
- unprotected sex (you did not use any birth control)
ella™ is not for regular use as a contraceptive
What it does
ella™ is an emergency or back-up method of preventing
pregnancy.
ella™ may stop or delay the release of an egg from the ovary.
When it should not be used
- If you are allergic to ulipristal acetate,
- If you are allergic to the non-medicinal ingredients, or the container
- If you are pregnant or suspect a pregnancy.
What the medicinal ingredient is
Ulipristal acetate
What the non-medicinal ingredients are
Croscarmellose sodium, lactose monohydrate, magnesium stearate, and povidone K30.
What dosage form it comes in
Tablet, 30 mg
Warnings and precautions
It is very important that you have a reliable form of birth
control that is right for you.
ella™ is not indicated for regular birth control.
ella™ does not prevent pregnancy in every case.
ella™ is only effective for one episode of unprotected sex.
Right after using ella™, you are again able to get pregnant.
To prevent pregnancy, you should continue your regular
method of contraception as usual or you can start to use
regular birth control. However, ella™ may make your regular
hormonal birth control method less effective. This lasts for the
amount of time between taking ella™ and your next period.
For the rest of your menstrual cycle, it is important that you
use a barrier method of birth control every time you have sex.
An example is a condom.
It is not recommended to use ella™ twice in the same
menstrual cycle.
ella™ is not used to end an existing pregnancy. ella™ does
not interrupt a pregnancy.
ella™ will not protect you against:
- HIV infection (AIDS)
- other sexually transmitted diseases (STDs)
ella™ is not recommended if you have severe liver disease.
Before you take ella™, tell your doctor if your last period was not normal. You may already be pregnant.
After taking ella™, your menstrual cycle may be early or late. If you are more than 1 week late, you should get a pregnancy test.
Do not breastfeed your baby for one week after taking ella™. During this time, it is recommended to pump and discard your breast milk in order to stimulate and maintain lactation.
Interactions with this medication
Tell your healthcare provider if you are taking or have
recently taken any other medicines, including medicines taken
without a prescription.
Other medications or herbal products that you are taking
might cause ella™ to work less well such as St. John’s wort.
Drugs that may interact with ella™ include:
- phenytoin (used for treatment of epilepsy)
- rifampin, rifampicin (antibiotic treatment of tuberculosis)
- phenobarbital (used for treatment of epilepsy)
- carbamazepine (used for treatment of epilepsy)
- barbiturates (used for treatment of epilepsy)
- bosentan (used for treatment of pulmonary hypertension)
- felbamate (used for treatment of epilepsy)
- griseofulvin (antibiotic used in treatment of certain skin lesions)
- oxcarbazepine (used for treatment of epilepsy)
- topiramate (used for treatment of epilepsy)
- dabigatran etexilate (used to prevent blood clots)
- digoxin (used for treatment of various heart conditions)
ella™ may reduce how well oral contraceptives work to
prevent pregnancy. This includes combined hormonal
contraceptives and progestogen-only contraception.
ella™ should not be used together with emergency
contraceptives containing levonorgestrel.
Proper use of this medication
Usual dose
Follow your doctor’s instructions very carefully.
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.
The tablet can be taken with or without food.
If you vomit within 3 hours of taking ella™, contact your
healthcare provider immediately in order to take another
tablet.
ella™ can be taken at any time during the menstrual cycle.
The use of ella™ as an emergency contraception is only
effective for a single episode of unprotected intercourse.
Overdose
Side effects and what to do about them
Side effects may include:
- headache, fatigue, dizziness
- nausea, stomach (abdominal) pain, menstrual pain (dysmenorrhea)
- acne
This is not a complete list of side effects. For any unexpected effects while taking ella™, contact your doctor or pharmacist.
How to store
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 of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
-
Fax toll-free to 1-866-678-6789, or
Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals, can be found by contacting the Distributor, Actavis Specialty Pharmaceuticals Co., at 1-855-892-8766.
This leaflet was prepared by:
Actavis Specialty Pharmaceuticals Co.
Under License From:
Laboratoire HRA Pharma
75003 Paris, France
Imported and distributed in Canada by:
Actavis Specialty Pharmaceuticals Co.
Markham, Ontario
L6G 0B5
Last revised: May 12, 2016