Errin

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, breast cancer, abnormal vaginal bleeding, liver disease, or if you have recently had an incomplete miscarriage or abortion.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

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

Norethindrone does not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to help protect yourself from these diseases.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using norethindrone.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication at room temperature away from moisture and heat.

Do not smoke while using norethindrone, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by norethindrone.

Norethindrone will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

In the U.S.

• Aygestin
• Camila
• Errin
• Jolivette
• Lyza
• Nora-BE
• Nor-QD
• Ortho Micronor

Available Dosage Forms:

• Tablet

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Progestin

Norethindrone is used to prevent pregnancy. It is a birth control pill that contains a hormone, norethindrone, and when taken properly, prevents pregnancy.

Norethindrone is also used to treat secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period who are not pregnant), endometriosis, and irregular menstrual periods caused by hormonal imbalance.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not protect against HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of Ortho Micronor® have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medicine in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Use of norethindrone acetate tablets is not recommended in children.

Geriatric

Appropriate studies on the relationship of age to the effects of norethindrone have not been performed in the geriatric population. This medicine should not be used in elderly women.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aprepitant
• Bosentan
• Carbamazepine
• Dabrafenib
• Darunavir
• Dexamethasone
• Eliglustat
• Enzalutamide
• Fosphenytoin
• Griseofulvin
• Isotretinoin
• Lesinurad
• Lixisenatide
• Lumacaftor
• Mitotane
• Modafinil
• Oxcarbazepine
• Phenytoin
• Pitolisant
• Prednisone
• Rifabutin
• Rifampin
• St John's Wort
• Sugammadex
• Theophylline
• Tizanidine
• Topiramate
• Ulipristal

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam
• Amprenavir
• Atazanavir
• Bacampicillin
• Betamethasone
• Bexarotene
• Colesevelam
• Cyclosporine
• Delavirdine
• Fosamprenavir
• Fosaprepitant
• Lamotrigine
• Licorice
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nelfinavir
• Parecoxib
• Prednisolone
• Rifapentine
• Ritonavir
• Rosuvastatin
• Rufinamide
• Selegiline
• Telaprevir
• Troglitazone
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Breast cancer, active or history of or
• Liver disease, including tumors or cancer—Should not be used in patients with these conditions.

• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Heart attack, history of or
• Stroke, history of—Norethindrone acetate tablets should not be used in patients with these conditions.

• Diabetes or
• Hypercholesterolemia (high cholesterol or fats in the blood) or
• Hypertension (high blood pressure) or
• Obesity, or history of or
• Systemic lupus erythematosus (SLE, autoimmune disorder)—These conditions may increase risk for more serious side effects.

• Depression, history of or
• Epilepsy or
• Heart disease or
• Kidney disease or
• Migraine headaches—Use with caution. Norethindrone acetate may make these conditions worse.

• Diabetes or
• Ovarian cyst—Use with caution. Ortho Micronor® may make these conditions worse.

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

1. General

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

2. Physical Examination and Follow-up

It is considered good medical practice for sexually active women using oral contraceptives to have annual history and physical examinations. The physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the healthcare professional.

3. Carbohydrate and Lipid Metabolism

Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.

Lipid metabolism is occasionally affected in that HDL, HDL2, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is usually no effect on total cholesterol, HDL3, LDL, or VLDL.

4. Drug Interactions

The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and the antituberculosis drug rifampin. No significant interaction has been found with broad-spectrum antibiotics.

Herbal products containing St. John’s Wort (Hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.

Concurrent use of bosentan and norethindrone containing products may result in decreased concentrations of these contraceptive hormones thereby increasing the risk of unintended pregnancy and unscheduled bleeding.

5. Interactions with Laboratory Tests

The following endocrine tests may be affected by progestin-only oral contraceptive use:

6. Carcinogenesis

See WARNINGS.

7. Pregnancy

Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.

8. Nursing Mothers

In general, no adverse effects have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant plasma.

9. Pediatric Use

Safety and efficacy of norethindrone tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.

10. Fertility Following Discontinuation

The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.

11. Headache

The onset or exacerbation of migraine or development of severe headache with focal neurological symptoms which is recurrent or persistent requires discontinuation of progestin-only contraceptives and evaluation of the cause.

Errin (norethindrone tablets USP 0.35 mg) are packaged in cartons of six blister cards each containing 28 tablets (NDC: 0555-0344-58). Each yellow, round, flat-faced, beveled-edge, unscored tablet is debossed with stylized b on one side and 344 on the other side.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Errin® (norethindrone tablets USP) 0.35 mg, 6 Blister Cards; 28 Tablets Each, Carton Text

NDC 0555-0344-58

28

DAY

REGIMEN

6 Blister Cards, 28 Tablets Each

Errin®

(norethindrone tablets USP)

0.35 mg

Each yellow tablet contains 0.35 mg norethindrone, USP.

Rx only

SHAPING

WOMEN’S HEALTH®

TEVA