Uses of Deblitane:

• It is used to prevent pregnancy.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Deblitane?

• If you are allergic to Deblitane (norethindrone (contraceptive)); any part of Deblitane (norethindrone (contraceptive)); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are pregnant or may be pregnant. Do not take Deblitane (norethindrone (contraceptive)) if you are pregnant.
• If you have had any of these health problems: Bleeding disorder; blood clots or risk of having a blood clot; breast cancer; liver disease; liver tumors; recent heart attack; or recent stroke.
• If you have had any of these health problems: Cancer of the uterus, ovary, cervix, or vagina; or vaginal bleeding where the cause is not known.

This is not a list of all drugs or health problems that interact with Deblitane (norethindrone (contraceptive)).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Deblitane (norethindrone (contraceptive)) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Deblitane?

• Tell all of your health care providers that you take Deblitane (norethindrone (contraceptive)). This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
• Some studies have shown the risk of breast cancer is raised in women taking birth control pills, especially at a younger age. The risk was also linked to how long the birth control pills were taken. One study showed the risk was also raised in women who took birth control pills within the past 10 years.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Deblitane (norethindrone (contraceptive)).
• If you have any signs of pregnancy or if you have a positive pregnancy test, call your doctor right away.
• Certain drugs, herbal products, or health problems could cause Deblitane (norethindrone (contraceptive)) to not work as well. Be sure your doctor knows about all of your drugs and health problems.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through having sex. Do not have any kind of sex without using a latex or polyurethane condom. If you have questions, talk with your doctor.
• The chance of pregnancy outside of the uterus (ectopic pregnancy) may be raised in some women. Talk with your doctor.
• Do not use in children who have not had their first menstrual period.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Deblitane) best taken?

Use Deblitane (norethindrone (contraceptive)) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take tablet with or without food. Take with food if it causes an upset stomach.
• If you throw up or have diarrhea, Deblitane (norethindrone (contraceptive)) may not work as well to prevent pregnancy. Use an extra form of birth control, like condoms, until you check with your doctor.
• Do not skip doses, even if you are spotting, bleeding, or feel sick to your stomach.
• If you miss 2 periods in a row, take a pregnancy test before starting a new cycle.

What do I do if I miss a dose?

• If a dose is missed, check the package insert or call the doctor to find out what to do. If using Deblitane (norethindrone (contraceptive)) to prevent pregnancy, another form of birth control may need to be used for some time to prevent pregnancy.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Stomach pain.
• Very bad dizziness or passing out.
• Eyesight changes or loss, bulging eyes, or change in how contact lenses feel.
• A lump in the breast, breast pain or soreness, or nipple discharge.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Depression or other mood changes.
• Swelling.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of Deblitane?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness or headache.
• Upset stomach or throwing up.
• Cramps.
• Bloating.
• Tender breasts.
• Trouble sleeping.
• Pimples (acne).
• Weight gain.
• This medicine may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Period (menstrual) changes. These include spotting or bleeding between cycles.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Deblitane?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Deblitane (norethindrone (contraceptive)), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.