Opill® Norgestrel tablets 0.075 mg - Drug Facts

Active ingredient (in each tablet)

Norgestrel 0.075 mg

Purpose

Daily Oral Contraceptive

Use

To prevent pregnancy

Warnings

Allergy alert: Do not use if you are allergic to this product or any of its ingredients, such as FD&C yellow No. 5 (tartrazine). People allergic to aspirin often have a tartrazine allergy too. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, blisters. If an allergic reaction occurs, stop use and seek medical help right away.

Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs.

Do not use

• •if you have or ever had breast cancer
• •if you are already pregnant or think you may be pregnant
• •together with another birth control pill, vaginal ring, patch, implant, injection or an IUD (intra-uterine device)
• •as an emergency contraceptive (morning after pill). This product does not prevent pregnancy when used after unprotected sex
• •if you are male

Ask a doctor before use if

• •you currently have vaginal bleeding between your periods and you have not already talked to a doctor
• •you have liver problems
• •you have or ever had any cancer

Ask doctor or pharmacist before use if

See the enclosed leaflet for a detailed list of medicines that may interact with this product.

• •you are taking a prescription drug for seizures, tuberculosis, HIV/AIDS, pulmonary hypertension
• •you are taking a supplement containing St John’s Wort (an herbal ingredient)
• •if you have taken ulipristal acetate (an emergency contraceptive, or morning after pill) in the past 5 days

When using this product

• •you are likely to experience changes in your menstrual periods, such as irregular periods, spotting or bleeding between your periods, or you may stop having periods. To prevent pregnancy, keep taking the product.
• •you may experience headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating
• •talk to a doctor (but continue taking every day) if
• •you have repeated vaginal bleeding brought on by sex
• •you start having periods that last more than 8 days or are unusually heavy
• •you start having migraines with aura (headaches that start with changes in vision) or your migraine headaches get worse
• •take a pregnancy test or talk to a doctor if
• •your period is late after missing any tablets in the last month
• •you have not had a period for 2 months or think you may be pregnant

Seek medical help right away if

• •you have sudden or severe persistent pain in your lower belly mostly on one side (you could have an ectopic pregnancy)
• •you develop yellowing of your skin or whites of your eyes especially with fever, tiredness, loss of appetite or dark colored urine

Stop use and ask a doctor if

• •you become pregnant

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

See the enclosed leaflet for more information on how to switch from another contraceptive method.

When to use a condom (or another barrier method)

• •take 1 tablet at the same time every day
• •this product will work best to prevent pregnancy when taken exactly as directed
• •you can start on any day of the month
• •use a condom (or another barrier method) every time you have sex during the first 2 days of use (48 hours) after you start your first pack of this product, because it takes 2 days for this product to start working

Other information

• •contains FD&C yellow No. 5 (tartrazine) as a color additive
• •read the instructions, warnings and enclosed product leaflet before use
• •as with any birth control method, this product does not prevent pregnancy all the time
• •this product will work best if you take it exactly as directed
• •store between 20°-25°C (68°-77°F)
• •do not flush tablets. Dispose via a take-back option or see www.fda.gov/drugdisposal

Inactive Ingredients

cellulose, FD&C Yellow No. 5, lactose, magnesium stearate, polacrilin potassium

Consumer information leaflet

Opill® Norgestrel tablets 0.075mg

Daily Oral Contraceptive

FDA APPROVED

What you need to know

Before you use Opill®, read this information carefully and take Opill® exactly as directed.

Keep this leaflet as it contains important information.

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What this leaflet covers

Before you start…

Two things you need to know.

It’s very important to take Opill® every single day at the same time:

same time every day

It takes 2 days for Opill® to start working so use a condom (or other barrier method) every time you have sex for the next 2 days (48 hours):

OPILL® WILL WORK BEST IF YOU TAKE IT EXACTLY AS DIRECTED

Opill® is a daily oral contraceptive (also called a birth control pill) used by women to prevent pregnancy.

Opill® is NOT an emergency contraceptive (morning after pill). You should not take Opill® to try to prevent pregnancy after unprotected sex because it will not work.

Opill® does NOT protect against HIV/AIDS or other sexually transmitted diseases (STDs). You should use condoms to protect against HIV/AIDS or other STDs.

Most women can use Opill®. However, do not use Opill®:

Talk to a doctor before staring Opill® if:

To start using Opill®:

What if I am late taking my tablet?

Less than 3 hours late:

Don’t worry. Take 1 tablet immediately and go back to taking your tablet at your usual time the following day.

More than 3 hours late OR you missed one or more tablets:

What if I vomit or have severe diarrhea within 4 hours of taking my tablet?

Choose a convenient time of day. It is best to link this to something you already do at the same time every day. For example, when you wake up or when you brush your teeth.

Set reminders. Consider using your smartphone to set a daily alarm, and put reminders in visible places such as bathroom mirror, phone or coffee machine.

Buy a new pack of Opill®before finishing the pack so you can start the next pack on time.

What if I am taking other medicines or herbal products?

Talk to a doctor or pharmacist if you are taking or start to take any of the following medications, as these may make Opill® less effective:

Your doctor or pharmacist may advise you to use another form of contraception.

What if I have taken an emergency contraceptive (morning after pill) before starting Opill®?

What if I have sudden or severe persistent pain in my lower belly mostly on one side?

Seek medical help right away.

You may have an ectopic pregnancy (a fertilized egg implanted in the wrong place).

While ectopic pregnancy is unlikely if you are taking Opill® as directed, it is a serious risk if it occurs. Severe persistent belly pain may occur for a few reasons and should be assessed right away.

What if I become pregnant while taking Opill®?

What if I get migraines while using Opill®?

If you start having migraines with aura (headaches that start with changes in vision) or your migraine headaches get worse, talk to a doctor but continue taking every day. Some women with migraine may be at increased risk of stroke.

What if I develop yellowing of skin or eyes while using Opill®?

Seek medical help right away if you develop the following rare symptoms: yellowing of the whites of your eyes or skin (especially with fever, tiredness, loss of appetite or dark colored urine). These may be a sign of liver problems which can be a serious medical condition.

What changes in my menstrual period are normal while using Opill®?

Most changes to periods are to be expected.

Continue taking Opill®exactly as directed, even if you have the following changes in your periods:

What changes to my period are NOT expected when using Opill®?

Talk to a doctor AND continue taking this product every day if you experience any of the following:

What type of oral contraceptive is Opill®?

How effective is Opill® at preventing pregnancy?

What if I decide I want to get pregnant?

Is it okay to use Opill® if I’m breastfeeding?

What types of side effects may I expect while using Opill®?

Routine healthcare

You should continue to see your healthcare provider(s) for routine healthcare visits.

You should tell your healthcare provider(s) that you are taking Opill®.

Regular contraception

There are many different types of contraception available, and you should be able to find the right method for you. The different contraceptive options are listed below from the most effective to the least effective. You can ask your healthcare provider(s) for advice.

Trussell J, Aiken ARA, Micks E, Guthrie KA. Efficacy, safety, and personal considerations. In: Hatcher RA, Nelson AL, Trussell J, Cwiak C, Cason P, Policar MS, Edelman A, Aiken ARA, Marrazzo J, Kowal D, eds. Contraceptive technology. 21st ed. New York, NY: Ayer Company Publishers, Inc., 2018

More about routine healthcare and contraception

For further information on all methods of contraception or screening, go to

What if I still have questions about Opill®?

If you have questions or need more information, call our toll-free number: 1-877-414-6859

Reminder card Front –

Remember to take 1 tablet at the same time every single day*

Take it without breaks

Take is even if you have changes in your menstrual period*

If a tablet is late or missed, use back up contraception for 2 days*

*refer to Drug Facts and consumer information leaflet for more details

Reminder card Back –

Opill®

Norgestrel tablets 0.075mg

I will take my pill every day at: _________AM/PM

A few tips…

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• 1.What is Opill®?
• 2.Is Opill® right for you?
• 3.How to take Opill®?
• 4.Tips to help you remember to take Opill® on-time
• 5.When to talk to a doctor or pharmacist?
• 6.What could happen to your periods while taking Opill®?
• 7.Other questions you may have