FDA-Approved Patient Labeling Low-Ogestrel [Lo-Ogest-rell]
(norgestrel and ethinyl estradiol tablets)

What is the most important information I should know about Low-Ogestrel?

Do not use Low-Ogestrel if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

What is Low-Ogestrel?
Low-Ogestrel is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

How does Low-Ogestrel work for contraception?
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.

Based on the results of clinical studies, about 1 out of 100 women may get pregnant during the first year they use Low-Ogestrel.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

Who should not take Low-Ogestrel?

Do not take Low-Ogestrel if you:

• smoke and are over 35 years old
• had blood clots in the legs, arms, lungs, or eyes
• had a problem with your blood that makes it clot more than normal
• have certain heart valve problems or irregular heart beat that increases your risk of having blood clots
• had a stroke
• had a heart attack
• have high blood pressure that cannot be controlled by medicine
• have diabetes with kidney, eye, nerve or blood vessel damage
• have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or have any migraine headaches if you are over 35 years of age
• have liver problems, including liver tumors
• have any unexplained vaginal bleeding
• are pregnant
• have or had breast cancer or any cancer that is sensitive to female hormones
• have a known allergy or hypersensitivity to any of the components of Low-Ogestrel (norgestrel and ethinyl estradiol tablets)

You should not take the pill if you take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme "alanine aminotransferase" (ALT) in the blood.

If any of these conditions happen while you are taking Low-Ogestrel, stop taking Low-Ogestrel right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Low-Ogestrel.

What should I tell my healthcare provider before taking Low-Ogestrel?
Tell your healthcare provider if you:

• are pregnant or think you may be pregnant
• are depressed now or have been depressed in the past
• had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy)
• have a condition called hereditary angioedema
• are breastfeeding or plan to breastfeed. Low-Ogestrel may decrease the amount of breast milk you make. A small amount of the hormones in Low-Ogestrel may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Low-Ogestrel may affect the way other medicines work, and other medicines may affect how well Low-Ogestrel works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Low-Ogestrel?

Read the Instructions for Use at the end of this Patient Information.

What are the possible serious side effects of Low-Ogestrel?

• Like pregnancy, Low-Ogestrel may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death.
• Some other examples of serious blood clots include blood clots in the legs or eyes.

Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age.
Serious blood clots are more likely to happen when you:

• first start taking birth control pills
• restart the same or different birth control pills after not using them for a month or more

Call your healthcare provider or go to a hospital emergency room right away if you have:

• leg pain that will not go away
• sudden severe shortness of breath
• sudden change in vision or blindness
• chest pain
• a sudden, severe headache unlike your usual headaches
• weakness or numbness in your arm or leg
• trouble speaking

Other serious side effects include:

• liver problems, including:
  • rare liver tumors
  • jaundice (cholestasis), especially if you previously had cholestasis of pregnancy.
    Call your healthcare provider if you have yellowing of your skin or eyes.
• high blood pressure
• gallbladder problems
• changes in the sugar and fat (cholesterol and triglycerides ) levels in your blood
• new or worsening headaches including migraine headaches
• depression
• possible cancer in your breast and cervix
• swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher is you have a history of angioedema.

What are the most common side effects of Low-Ogestrel?

• menstrual complaints, including unscheduled bleeding and spotting
• nausea
• headache (including migraine)
• weight increase or decrease
• cervical erosion
• acne
• menstrual cramps
• vaginal discharge
• stomach pain, discomfort, and gas
• increase in appetite
• depression
• nervousness
• dark areas on your face
• fatigue
• worsening of varicose veins

These are not all the possible side effects of Low-Ogestrel. For more information, ask your healthcare provider or pharmacist.

You may report side effects to the FDA at 1-800-FDA-1088.

What else should I know about taking Low-Ogestrel?

• If you are scheduled for any lab tests, tell your healthcare provider you are taking Low-Ogestrel. Certain blood tests may be affected by Low-Ogestrel.
• Low-Ogestrel does not protect against HIV infection (AIDS) and other sexually transmitted infections.

How should I store Low-Ogestrel?

• Store Low-Ogestrel at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Low-Ogestrel and all medicines out of the reach of children.
• Store away from light.

General information about the safe and effective use of Low-Ogestrel:

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Low-Ogestrel for a condition for which it was not prescribed. Do not give Low-Ogestrel to other people, even if they have the same symptoms that you have.

This Patient Information summarizes the most important information about Low-Ogestrel. You can ask your pharmacist or healthcare provider for information about Low-Ogestrel that is written for health professionals.

For more information, call 1-844-825-8500.

Do birth control pills cause cancer?
There may be slight increases in the risk of breast cancer among current users of hormonal birth control pills with longer duration of use of 8 years or more.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What if I want to become pregnant?
You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.

What should I know about my period when taking Low-Ogestrel?
Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking Low-Ogestrel, especially during the first few months of use. This usually is not a serious problem. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.

What are the ingredients in Low-Ogestrel?

Active ingredients:
Each white pill contains norgestrel and ethinyl estradiol.

Inactive ingredients:
White pills: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone.

Peach pills: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.