Prescription Drugs

CLINICAL PHARMACOLOGY No information provided.

Athentia Next (levonorgestrel) Tablet 1.5 mg DESCRIPTION Drug Facts Active ingredient (in each tablet) Levonorgestrel 1.5 mg

INDICATIONS Purpose Emergency contraceptive Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control) DOSAGE AND ADMINISTRATION Directions take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work. if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose. Other Information read the instructions , warnings and enclosed product leaflet before use this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation). do not use if carton is open or tear s trip is removed or the blister seal is broken or missing store at 20° to 25°C (68° to 77°F) Keep out of reach of children. HOW SUPPLIED Active ingredient (in each tablet) Levonorgestrel 1.5 mg Inactive ingredients colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch and talc. Questions? Call 1-855-274-4122 Manufactured for: AUROHEALTH LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648. Manufactured by: Aurobindo Pharma Limited., Unit-VII (SEZ), Mahaboob Nagar (Dt)-509302. India. Revised: May 2016

PATIENT INFORMATION Athentia Next (levonorgestrel) Tablet, 1.5 mg Emergency Contraceptive One Tablet. One Step. What You Need to Know What is Athentia Next? Athentia Next 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 Athentia Next is not. Athentia Next will not work if you are already pregnant and will not affect an existing pregnancy. Athentia Next will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs). When should I use Athentia Next? The sooner you take emergency contraception, the better it works. You should use Athentia Next within 72 hours (3 days) after you have had unprotected sex. Athentia Next is a backup or emergency method of birth control you can use when: your regular birth control was used incorrectly or failed you did not use any birth control method When not to use Athentia Next. Athentia Next should not be used: as a regular birth control method, because it's not as effective as regular birth control. if you are already pregnant, because it will not work. if you are allergic to levonorgestrel or any other ingredients in Athentia Next. How does Athentia Next work? Athentia Next is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Athentia Next 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 Athentia Next 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 Athentia Next? You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Athentia Next, the better it works . How effective is Athentia Next? If Athentia Next 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 Athentia Next worked? You will know Athentia Next 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 ? some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant. if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention. when used as directed, Athentia Next is safe and effective. Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness. if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose. What if I still have questions about Athentia Next? If you have questions or need more information, call our toll-free number AUROHEALTH LLC at 1-855-274-4122. Other Information 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 us e if the blister seal is opened. Store at room temperature 20° to 25°C (68° to 77°F). Active ingredient: levonorgestrel 1.5 mg Inactive ingredients : colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, and talc. 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.

OVERDOSE In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. CONTRAINDICATIONS No information provided.

SIDE EFFECTS No information provided. DRUG INTERACTIONS No information provided.

WARNINGS Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs Do not use if you are already pregnant (because it will not work) for regular birth control When using this product you may have menstrual changes nausea lower stomach (abdominal) pain tiredness headache dizziness breast pain vomiting PRECAUTIONS Please see WARNINGS above.