ORTHO MICRONOR
® (norethindrone) Tablets
This product (like all oral contraceptives) is
used to prevent pregnancy. It does not protect against HIV infection (AIDS) or
other sexually transmitted diseases.
DESCRIPTION
ORTHO MICRONOR®
Tablets
Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn
starch, D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate
and povidone .
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 healthcare professional.
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 POP users will get pregnant in the first year if they all take
POPs perfectly (that is, on time, every day). About 1 in 20 "typical" POP users
(including women who are late taking pills or miss pills) gets pregnant in the
first year of use. Table 2 will help you compare the efficacy of different
methods.
Table 2: Percentage of Women Experiencing an Unintended Pregnancy
During the First Year of Typical Use and the First Year of Perfect Use of
Contraception and the Percentage Continuing Use at the End of the First Year.
United States.
| % of Women Experiencing an Unintended Pregnancy
within the First Year of Use | % of Women Continuing Use at One Year* |
|---|
Method
(1) | Typical Use †
(2) | Perfect Use‡
(3) |
(4) |
|---|
| Chance# | 85 | 85 |
|
| SpermicidesÞ | 26 | 6 | 40 |
| Periodic abstinence | 25 |
| 63 |
| Calendar |
| 9 |
|
| Ovulation Method |
| 3 |
|
| Sympto-Thermalß |
| 2 |
|
| Post-Ovulation |
| 1 |
|
| Capà |
|
|
|
| Parous Women | 40 | 26 | 42 |
| Nulliparous Women | 20 | 9 | 56 |
| Sponge |
|
|
|
| Parous Women | 40 | 20 | 42 |
| Nulliparous Women | 20 | 9 | 56 |
| Diaphragmà | 20 | 6 | 56 |
| Withdrawal | 19 | 4 |
|
| Condomè |
|
|
|
| Female (Reality®) | 21 | 5 | 56 |
| Male | 14 | 3 | 61 |
| Pill | 5 |
| 71 |
| Progestin Only |
| 0.5 |
|
| Combined |
| 0.1 |
|
| IUD |
|
|
|
| Progesterone T | 2.0 | 1.5 | 81 |
| Copper T380A | 0.8 | 0.6 | 78 |
| LNg 20 | 0.1 | 0.1 | 81 |
| Depo-Provera® | 0.3 | 0.3 | 70 |
| Norplant® and Norplant-2® | 0.05 | 0.05 | 88 |
| Female Sterilization | 0.5 | 0.5 | 100 |
| Male Sterilization | 0.15 | 0.10 | 100 |
Adapted from Hatcher et al, 1998, Ref. # 1.
Emergency Contraceptive Pills: Treatment initiated within 72 hours after
unprotected intercourse reduces the risk of pregnancy by at least 75%.§Lactational Amenorrhea Method: LAM is highly effective, temporary method of
contraception.¶
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart
F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth
Revised Edition. New York NY: Irvington Publishers, 1998.
*Among couples attempting to avoid pregnancy, the percentage who continue to
use a method for one year.
†Among
typical couples who initiate use of a
method (not necessarily for the first time), the percentage who experience an
accidental pregnancy during the first year if they do not stop use for any other
reason.
‡Among couples who initiate use of a method (not necessarily for the first
time) and who use it
perfectly (both consistently and
correctly), the percentage who experience an accidental pregnancy during the
first year if they do not stop use for any other reason.
§The treatment schedule is one dose within 72 hours after unprotected
intercourse, and a second dose 12 hours after the first dose. The Food and Drug
Administration has declared the following brands of oral contraceptives to be
safe and effective for emergency contraception: Ovral® (1 dose is 2 white
pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2
light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or
Tri-Levlen® (1 dose is 4 yellow pills).
¶However, to maintain effective protection against pregnancy, another method
of contraception must be used as soon as menstruation resumes, the frequency or
duration of breastfeeds is reduced, bottle feeds are introduced, or the baby
reaches six months of age.
#The percents becoming pregnant in columns (2) and (3) are based on data from
populations where contraception is not used and from women who cease using
contraception in order to become pregnant. Among such populations, about 89%
become pregnant within one year. This estimate was lowered slightly (to 85%) to
represent the percent who would become pregnant within one year among women now
relying on reversible methods of contraception if they abandoned contraception
altogether.
ÞFoams, creams, gels, vaginal suppositories, and vaginal film.
ßCervical mucus (ovulation) method supplemented by calendar in the
pre-ovulatory and basal body temperature in the post-ovulatory phases.
àWith spermicidal cream or jelly.
èWithout spermicides.
ORTHO MICRONOR® Tablets have
not been studied for and are not indicated for use in emergency
contraception.
HOW DO POPs WORK?
POPs can prevent pregnancy in different ways including:
- 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 of
the cycles.
- 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 that 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
Cigarette smoking greatly increases the possibility of suffering heart
attacks and strokes. Women who use oral contraceptives are strongly advised not
to smoke.
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 healthcare professional 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 a 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.
A meta-analysis of 54 studies found a small increase in the frequency of
having breast cancer diagnosed for women who were currently using combined oral
contraceptives or had used them within the past ten years. This increase in the
frequency of breast cancer diagnosis, within ten years of stopping use, was
generally accounted for by cancers localized to the breast. There was no
increase in the frequency of having breast cancer diagnosed ten or more years
after cessation of use.
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, some studies report an increased risk of developing liver
cancer among women who use combined oral contraceptives. However, liver cancers
are rare. There is insufficient data to determine whether POPs increase the risk
of liver tumors.
Diabetic Women
Diabetic women taking POPs do not generally require changes in the amount of
insulin they are taking. However, your healthcare professional may monitor you
more closely under these conditions.
SEXUALLY TRANSMITTED DISEASES (STDs)
WARNING: POPs do not protect against getting or giving
someone HIV (AIDS) or any other STD, such as chlamydia, gonorrhea, genital warts
or herpes.
SIDE EFFECTS
Irregular Bleeding:
The most common side effect of POPs is a change in menstrual bleeding. Your
periods may be either early or late, and you may have some spotting between
periods. Taking pills late or missing pills can result in some spotting or
bleeding.
Other Side Effects:
Less common side effects include headaches, tender breasts, nausea and
dizziness. Weight gain, acne and extra hair on your face and body have been
reported, but are rare.
If you are concerned about any of these side effects, check with your
healthcare professional.
USING POPs WITH OTHER
MEDICINES
Before taking a POP, inform your healthcare professional of any other
medication, including over-the-counter medicine, that you may be taking.
These medicines can make POPs less effective:
Medicines for seizures such as:
