Minzoya: Uses, Side Effects and Dosage

What is the most important information I should know about Minzoya?

Do not use Minzoya if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from 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 Minzoya?

Minzoya is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

Minzoya does not protect against HIV infections (AIDS) and other sexually transmitted infections.

How does Minzoya 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 one clinical study of a 28-day regimen of levonorgestrel 0.1 mg/ethinyl estradiol 0.02 mg tablets, about 1 out of 100 women may get pregnant within the first year they use Minzoya.

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.

Do not take Minzoya if you:

• smoke and are over 35 years of age
• have or have had blood clots in your arms, legs, lungs, or eyes
• have 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 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 have had breast cancer or any cancer that is sensitive to female hormones
• are allergic to levonorgestrel, ethinyl estradiol, ferrous bisglycinate or any of the ingredients in Minzoya. See the end of this Patient Information leaflet for a complete list of ingredients in Minzoya.
• 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 Minzoya; stop taking Minzoya right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Minzoya.

Before you take Minzoya tell your healthcare provider about all of your medical conditions, including if you:

• are scheduled for surgery. Minzoya may increase your risk of blood clots after surgery. You should stop using your Minzoya at least 4 weeks before you have surgery and not restart it until at least 2 weeks after your surgery.
• 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)
• are breastfeeding or plan to breastfeed. Minzoya may decrease the amount of breast milk you make. A small amount of the hormones in Minzoya 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.

Minzoya may affect the way other medicines work, and other medicines may affect how well Minzoya 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 Minzoya?

• Read the detailed Instructions for Use at the end of this Patient Information leaflet about the right way to take your Minzoya.

What are the possible serious side effects of Minzoya?

• Like pregnancy, Minzoya 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. You should see your healthcare provider to check your blood pressure regularly.
• 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 if you have a history of angioedema.

• dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma).

Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking Minzoya. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of Minzoya?

The most common side effects of Minzoya include:

• headache (including migraine)
• irregular vaginal bleeding (including absence of period)
• nausea
• breast tenderness, pain and discomfort
• stomach (abdominal) pain
• pain with your periods (menstrual cycle)
• mood changes, including depression
• acne
• vaginal infections

These are not all the possible side effects of Minzoya.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What else should I know about taking Minzoya?

• If you are scheduled for any lab tests, tell your healthcare provider you are taking Minzoya. Certain blood tests may be affected by Minzoya.

How should I store Minzoya?

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

General information about the safe and effective use of Minzoya.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use Minzoya for a condition for which it was not prescribed. Do not give Minzoya to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Minzoya that is written for health professionals.

Do birth control pills cause cancer?

It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.

If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones.

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 Minzoya?

Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking Minzoya, especially during the first few months of use. This usually is not a serious problem. If the irregular vaginal bleeding or spotting continues or happens again after you have had regular menstrual cycles call your healthcare provider. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.

What if I miss my scheduled period when using Minzoya?

Some women miss periods on hormonal birth control, even when they are not pregnant. However, if you go 2 or more months in a row without a period, or you miss your period after a month where you did not use all of your Minzoya correctly, call your healthcare provider because you may be pregnant. Also call your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. Stop taking Minzoya if you are pregnant.

What are the ingredients in Minzoya?

Active ingredients: White to off-white tablets: levonorgestrel and ethinyl estradiol.

Inactive ingredients: White to off-white tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone.

Inactive ingredients: Blue tablets: ferrous bisglycinate (containing citric acid, glycine and iron), colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C BLUE #2, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide.

For more information, call Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or visit our website at www.lupinpharmaceuticals.com