Optionelle by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc, Naari Pte. Limited, Haupt Pharma Muenster GmbH. Drug facts, warnings, and ingredients follow.
Levonorgestrel Tablet 1.5 mg
Optionelle is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and should not be used as regular birth control.
What Optionelle is not.
Optionelle will not work if you are already pregnant and will not affect an existing pregnancy. Optionelle will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).
When should I use Optionelle?
The sooner you take emergency contraception, the better it works. You should use Optionelle within 72 hours (3 days) after you have had unprotected sex.
Optionelle is a backup or emergency method of birth control you can use when:
Optionelle should not be used:
Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of Optionelle and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.
How does Optionelle work?
Optionelle is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Optionelle contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Optionelle may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).
How can I get the best results from Optionelle?
You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Optionelle, the better it works.
How effective is Optionelle?
If Optionelle is taken as directed, it can significantly decrease the chance that you will get pregnant. About 7 out of every 8 women who would have gotten pregnant will not become pregnant.
How will I know Optionelle worked?
You will know Optionelle has been effective when you get your next period, which should come at the expected time, or within a week of the expected time. If your period is delayed beyond 1 week, it is possible you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional.
Will I experience any side effects?
If you have questions or need more information, call our toll free number, 1-877-244-9825.
Keep out of reach of children:
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Do not use if the blister seal is opened.
Store at room temperature 20°-25°C (68° to 77°F).
Active ingredient: levonorgestrel 1.5 mg
Inactive ingredients: colloidal silicon dioxide, FD&C Yellow No. 6 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch
If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about and, if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have.
Strides Pharma Inc.
East Brunswick, NJ 08816
Product made in Germany.
NDC: 59556-286-01 Rev. September 2022
levonorgestrel tablet, 1.5 mg tablet
|Labeler - Strides Pharma Inc (078868278)|
|Registrant - Naari Pte. Limited (659345996)|
|Haupt Pharma Muenster GmbH||344172564||ANALYSIS(59556-286) , MANUFACTURE(59556-286)|