Ella (Page 4 of 4)

FDA Approved Patient Labeling

Patient Informationella (“el-uh”)(ulipristal acetate) tablet

Read this Patient Information Leaflet before you take ella. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is ella?

ella is a prescription emergency contraceptive that reduces your chance of becoming pregnant if your birth control fails or you have unprotected sex.
ella should not be used as your regular birth control. It is very important that you have a reliable form of birth control that is right for you.

ella will not protect you against HIV infection (AIDS) and other sexually transmitted diseases (STDs).

Who should not take ella?

  • Do not take ella if you know or suspect you are already pregnant. ella is not for use to end an existing pregnancy. Talk to your healthcare provider before taking ella if you think you are pregnant.

What should I tell my healthcare provider before taking ella?

See “Who should not take ella ?”
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Using some other medicines may have an effect on how ella or the other medicine works. These include St. John’s Wort, phenytoin, rifampin, phenobarbital, dabigatran etexilate, digoxin and carbamazepine. Talk to your healthcare provider if you are currently using these medications.
Talk to your healthcare provider if you use hormonal birth control. Using ella may make your regular hormonal birth control method less effective. After using ella , you should use a reliable barrier method of birth control (such as a condom with spermicide) during any other times that you have sex in that same menstrual cycle.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

When is it not appropriate to use ella?

  • Do not use ella as a regular birth control method. It does not work as well as most other forms of birth control when they are used consistently and correctly.
  • Do not use ella if you are already pregnant.
  • Do not use ella more than one time in the same menstrual cycle for different acts of unprotected sex or birth control failure.

How does ella work?
ella is thought to work for emergency contraception primarily by stopping or delaying the release of an egg from the ovary. It is possible that ella may also work by preventing attachment (implantation) to the uterus.

How should I take ella?

  • Take ella as soon as possible within 5 days (120 hours) after unprotected sex or if you had a birth control failure.
  • ella can be taken with or without food.
  • Contact your healthcare provider right away if you vomit within 3 hours of taking ella. Your healthcare provider may prescribe another dose of ella for you.
  • ella can be taken at any time during the menstrual cycle.

How effective is ella?

If ella is taken as directed, it will reduce the chance that you will get pregnant. ella is not effective in every case. ella is only to be used for a single episode of unprotected intercourse. Be sure to use a regular birth control method the next time you have sex.
ella and other emergency contraceptives may be less effective in women with a body mass index (BMI) > 30 kg/m2.

What if I am already pregnant and use ella?

ella should not be taken if you are already pregnant. There is little information on whether ella would harm a developing baby. Contact your healthcare provider if you think you may be pregnant and have taken ella.
ella is not for use to terminate an existing pregnancy.

What should I do if my menstrual period is delayed beyond 1 week or I have severe lower stomach (abdominal) pain?

After taking ella , your next menstrual period may begin a few days earlier or later than expected. If your period is more than 7 days later than expected, you may be pregnant. You should get a pregnancy test and follow up with your healthcare provider.
If you have severe lower stomach (abdominal) pain about 3 to 5 weeks after taking ella , you may have a pregnancy outside of the uterus (womb), which is called an ectopic or tubal pregnancy. An ectopic pregnancy is a serious condition that needs medical treatment right away. Call your healthcare provider or go to the nearest emergency room right away if you think you may have an ectopic pregnancy.

How often can I use ella?

ella is meant for emergency contraception only, and is not to be used frequently or as a regular birth control. If you need to use emergency contraception often, talk to your healthcare provider and learn about methods for birth control and sexually transmitted disease prevention that are right for you.

What are the possible side effects of ella?

The most common side effects of ella include:

  • headache
  • nausea
  • stomach (abdominal) pain
  • menstrual pain (dysmenorrhea)
  • tiredness
  • dizziness

Some women taking ella may have their next period earlier or later than expected. If your period is more than a week late, you should get a pregnancy test.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ella. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA 1-800-FDA-1088.

How should I store ella?

  • Store ella at 68-77°F (20-25°C).
  • Protect ella from light. Keep ella in the blister card inside the original box until you are ready to take it.

Do not use ella if the package is torn or broken.
Keep ella and all medicines out of the reach of children.

General information about the safe and effective use of ella:

Medicines are sometimes prescribed for purposes other than those in a Patient Information Leaflet. Do not use ella for a condition for which it was not prescribed. Do not give ella to other people, even if they have the same symptoms that you have. It may harm them.
In the case of an overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Overdose experience with ella is limited.

This Patient Information Leaflet summarizes the most important information about ella. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ella that is written for health professionals.

For more information, go to www.ella-rx.com or you can contact Watson Medical Communications at 1-800-272-5525.

What are the ingredients in ella?
Active ingredients: ulipristal acetate, 30 mg
Inactive ingredients: lactose monohydrate, povidone, croscarmellose sodium, and magnesium stearate

For all medical inquiries contact:
ACTAVIS
Medical Communications
Parsippany, NJ 07054
1-800-272-5525

Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Under License From:
Laboratoire HRA Pharma
75003 Paris, France

ella ® is a registered trademark
of Laboratoire HRA Pharma

Manufactured By:
Cenexi, 95520 Osny, France

or
Laboratorios León Farma S.A., 24008 León, Spain

or
Delpharm Lille SAS, 59390 Lys-Lez-Lannoy, France

Content Updated: October 2013

PRINCIPAL DISPLAY PANEL

ella® (ulipristal acetate) tablet 30 mg
NDC 52544-238-54Carton x 1 tablet

ella® (ulipristal acetate) tablet 30 mg NDC 52544-238-54 Carton x 1 tablet
(click image for full-size original)
ella® (ulipristal acetate) tablet 30 mg NDC 52544-238-54 Carton x 1 tablet
(click image for full-size original)
ELLA ulipristal acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52544-238
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULIPRISTAL ACETATE (ULIPRISTAL) ULIPRISTAL ACETATE 30 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
POVIDONE K30
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code ella
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52544-238-54 1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 1 TABLET (1 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (52544-238-54)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022474 08/13/2010
Labeler — Watson Pharma, Inc. (106931488)

Revised: 01/2014 Watson Pharma, Inc.

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