Jolivette

• Actavis Pharma, Inc.

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Do not use this medication if you are allergic to norethindrone, or if you have:

• a history of a stroke, blood clot, or circulation problems;

• breast cancer;

• abnormal vaginal bleeding; or

• if you have recently had an incomplete miscarriage or abortion.

Before using norethindrone, tell your doctor if you have any of the following conditions. You may need a dose adjustment or special tests to safely take norethindrone.

• high blood pressure or a history of heart disease;

• migraines;

• kidney disease;

• liver disease or liver cancer;

• a history of depression or mental illness;

• high cholesterol or triglycide (fatty acid) levels in your blood;

• asthma; or

• seizures or epilepsy.

Norethindrone can pass into breast milk. Make sure your doctor knows if you are breast-feeding a baby while taking this medication.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

This section provides information on the proper use of a number of products that contain norethindrone. It may not be specific to Jolivette. Please read with care.

To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If you are using Ortho Micronor®:

• This medicine is available in a blister card with a tablet dispenser. Each blister card contains 28 tablets.
• Take this medicine at the same time each day. You may take this medicine with or without food.
• Start the next pack the day after the last pack is finished. There is no break between packs.
• Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 Start). When you begin on another day, you need to use another form of birth control (eg, condom, spermicide) for the first 48 hours. If you have a miscarriage or an abortion, you may start the taking the pill on the next day.
• You may have light bleeding or spotting when you first take the pill.
• If you are switching from the a combination hormonal method to Ortho Micronor®, take the medicine the day after you finish the last active combined pill.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For contraception (to prevent pregnancy):
    • Adults and teenagers—One tablet taken at the same time each day for 28 days.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of secondary amenorrhea or abnormal vaginal bleeding:
    • Adults—2.5 to 10 milligrams (mg) once a day for 5 to 10 days.
    • Children—Use is not recommended.
  • For treatment of endometriosis:
    • Adults—At first, 5 milligrams (mg) once a day for 2 weeks. Your doctor may increase your dose by 2.5 mg per day every 2 weeks up to 15 mg per day for 6 to 9 months.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you take a pill more than 3 hours late, use another form of birth control for the next 48 hours.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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 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.
• Chest pain or pressure.
• Shortness of breath.
• Coughing up blood.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Very bad headache.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Very bad dizziness or passing out.
• Bulging eyes.
• Change in eyesight.
• Loss of eyesight.
• A lump in the breast, breast soreness, or nipple discharge.
• Breast pain.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Low mood (depression).
• Mood changes.
• Swelling in the feet or hands.

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:

• Headache.
• Upset stomach or throwing up.
• Cramps.
• Bloating.
• Dizziness.
• Breast soreness.
• Not able to sleep.
• 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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Jolivette® Tablets

Each tablet contains 0.35 mg norethindrone. Inactive ingredients include D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, modified corn starch, and povidone.

norethindrone

Meets USP Dissolution Test 2

Actavis

NDC 52544-892-28

Rx Only

Jolivette®
TABLETS
(norethindrone 0.35 mg)

28-DAY REGIMEN

Each lime green tablet contains 0.35 mg norethindrone.

This product (like all oral contraceptives) is intended to prevent pregnancy.
It does not protect against HIV infection (AIDS) and other sexually
transmitted diseases.

6 Tablet Dispensers, 28 Tablets Each

Applies to norethindrone: compounding powder, oral tablet

General

The most commonly reported side effects included cycle irregularity, spotting/breakthrough bleeding, and temporary amenorrhea.[Ref]

Genitourinary

Common (1% to 10%): Uterine/vaginal bleeding and spotting/breakthrough bleeding, short-lasting amenorrhea
Uncommon (0.1% to 1%): Breast discomfort
Frequency not reported: Irregular/increased/decreased bleeding/delayed menstruation, change in menstrual flow, menorrhagia, vaginal hemorrhage, cervical secretion alteration, cervical erosions, prolonged anovulation, suppressed lactation, galactorrhea, mastodynia, breast tenderness/enlargement, genital discharge, withdrawal bleeding (on treatment discontinuation), premenstrual-type depression, changes in cervical squamocolumnar junction and secretions[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache
Frequency not reported: Drowsiness, somnolence, concentration loss, migraine, tremor, cerebral thrombosis and embolism[Ref]

Local

Common (1% to 10%): Injection site reaction, local skin reaction[Ref]

Gastrointestinal

Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Bloating
Frequency not reported: Vomiting, abdominal pain, gastrointestinal disturbance[Ref]

Dermatologic

Common (1% to 10%): Skin disorder
Frequency not reported: Angioedema, acne, hirsutism, alopecia, rash, pruritus, pruritic rash, melasma, chloasma, urticaria, exacerbation of existing skin conditions, sweating, allergic rash with and without pruritus[Ref]

Metabolic

Common (1% to 10%): Increased weight
Frequency not reported: Increased fasting insulin levels, Cushing's syndrome, decreased glucose tolerance, exacerbation of diabetes mellitus, glycosuria, weight gain/change, change in appetite, fluid retention, increased serum calcium and potassium levels, altered serum lipid and lipoprotein levels (e.g., decreased HDL, increased LDL/HDL ratio)[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reaction
Frequency not reported: Anaphylaxis/anaphylactoid reactions[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depressed mood/depression/clinical depression/metal depression
Frequency not reported: Insomnia, nervousness, libido change, mood swings[Ref]

Respiratory

Frequency not reported: Urge to cough, paroxysmal cough, respiratory distress, dyspnea, pulmonary embolism, voice deepening[Ref]

Ocular

Frequency not reported: Retinal thrombosis, diabetic cataract, vision disorders, visual disturbance, contact lens intolerance, optic neuritis (may lead to partial or complete vision loss)[Ref]

Cardiovascular

Frequency not reported: Circulatory irregularity, thromboembolic disorders, thrombophlebitis, increased blood pressure/hypertension, edema[Ref]

Hepatic

Frequency not reported: Cholestatic liver changes/cholestatic jaundice, hepatitis, disturbed liver function, transient liver test abnormalities (e.g., AST, ALT, bilirubin)[Ref]

Other

Frequency not reported: Fever, hyperpyrexia, fatigue, extremity pain[Ref]

Hematologic

Frequency not reported: Increased white cell and platelet counts[Ref]

Endocrine

Frequency not reported: Masculinization of the female fetus[Ref]

Some side effects of Jolivette may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.