HEATHER (Page 3 of 5)

8. Nursing mothers

Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma of 1-6% of the levels of maternal plasma. However, isolated post-market cases of decreased milk production have been reported in POPs. Very rarely, adverse effects in the infant/child have been reported, including jaundice.

9. Fertility following discontinuation

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

10. Headache/Migraine

If you have a headache or a worsening migraine headache with a new pattern that is recurrent, persistent, or severe, this requires discontinuation of oral contraceptives and evaluation of the cause.

11. Gastrointestinal

Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations.

12. Pediatric use

Safety and efficacy of HEATHER has 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.

Information for the Patient

See PATIENT LABELING for detailed information.
Counseling issues.

The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives

The necessity of taking pills at the same time every day, including throughout all bleeding episodes.
The need to use a backup method such as condoms and spermicides for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late
The potential side effects of progestin-only oral contraceptives, particularly menstrual irregularities
The need to inform the clinician of prolonged episodes of bleeding, amenorrhea or severe abdominal pain
The importance of using a barrier method in addition to progestin-only oral contraceptives if a woman is at risk of contracting or transmitting STDs/HIV

ADVERSE REACTIONS

Menstrual irregularity is the most frequently reported side effect
Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely.
Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies
Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.

OVERDOSAGE

There have been no reports of serious ill effects from overdosage, including ingestion by children.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, HEATHER must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See PATIENT LABELING for detailed instructions.

HOW SUPPLIED

HEATHER (Norethindrone tablets, USP 0.35 mg) are available in 28-tablet dispensers as pale yellow round, flat faced beveled edged, uncoated tablets with ‘303’ debossed on one side and ‘G’ on the other side (NDC 68462-303-29).

STORAGE

Store at controlled room temperature 20 o C to 25o C (68 to 77o F).

Manufactured by:

Glenmark Pharmaceuticals Limited
Colvale-Bardez, Goa 403513, India

Manufactured for:

Glenmark logo

Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com

August 2021

DETAILED INFORMATION FOR THE PATIENT

Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

INTRODUCTION

This leaflet is about birth control pills that contain one hormone, a progestin. Please read this leaflet before you begin to take your pills. It is meant to be used along with talking with your doctor or clinic.

Progestin-only pills are often called “POPs” or “the minipill”. POPs have less progestin than the combined birth control pill (or “the pill”) which contains both an estrogen and a progestin.

HOW EFFECTIVE ARE POPS?

About 1 in 200 (0.5%) POPs users will get pregnant in the first year if they all take POPs perfectly (that is, on time, every day). About 1 in 20 (5%) “typical” POPs users (including women who are late taking pills or miss pills) gets pregnant in the first year of use. The following table will help you compare the efficacy of different methods.

IUD: 1-2%

Depo-Provera® (injectable progesterone): 0.3%

Norplant® System (levonorgestrel implants): 0.1%

Diaphragm with spermicides: 18%

Spermicides alone: 21%

Male condom alone: 12%

Female condom alone: 21%

Cervical cap:

Women who have never given birth : 18%

Women who have given birth : 36%

Periodic abstinence: 20%

No methods: 85%

HOW DO POPS WORK?

They make the cervical mucus at the entrance to the womb (the uterus) too thick for the sperm to get through to the egg.
They prevent ovulation (release of the egg from the ovary) in about half the time
They also affect other hormones, the fallopian tubes and the lining of the uterus.

YOU SHOULD NOT TAKE POPS

If there is any chance you may be pregnant.
If you have breast cancer.
If you have bleeding between your periods which has not been diagnosed.
If you are taking certain drugs for epilepsy (seizures) or for TB. (See USING POPS WITH OTHER MEDICINES below).
If you are hypersensitive or allergic to any component of this product.
If you have liver tumors, either benign or cancerous.
If you have acute liver disease.

RISKS OF TAKING POPS

WARNING: If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your doctor or clinic immediately.

Ectopic pregnancy. An ectopic pregnancy is a pregnancy outside the womb. Because POPs protect against pregnancy, the chance of having a pregnancy outside the womb is very low. If you do get pregnant while taking POPs, you have slightly higher chance that the pregnancy will be ectopic than do users of some other birth control methods.
Ovarian cysts. These cysts are small sacs of fluid in the ovary. They are more common among POP users than among users of most other birth control methods. They usually disappear without treatment and rarely cause problems.
Cancer of the reproductive organs and breasts. Some studies in women who use combined oral contraceptives that contain both estrogen and a progestin have reported an increase in the risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. There is insufficient data to determine whether the use of POPs similarly increases this risk.
Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives and there is insufficient data to determine whether the use of POPs increases the risk of developing cancer of the cervix.
Liver tumors. In rare cases, combined oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with combined oral contraceptives and liver cancers in studies in which a few women who developed these very rare cancers were found to have used combined oral contraceptives for long periods of time. There is insufficient data to determine whether POPs increase the risk of liver tumors.

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