This product (like all oral contraceptives) is used to prevent pregnancy.
It does not protect against HIV infection (AIDS) or other sexually transmitted
ORTHO MICRONOR® (norethindrone) 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,
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
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
||Typical Use 1(2)
| Ovulation Method
| Parous Women
| Nulliparous Women
| Parous Women
| Nulliparous Women
| Female (Reality®)
| Progestin Only
| Progesterone T
| Copper T380A
| LNg 20
| Adapted from Hatcher et al, 1998, Ref. #
Emergency Contraceptive Pills: Treatment initiated within 72 hours after
unprotected intercourse reduces the risk of pregnancy by at least 75%.9
Lactational Amenorrhea Method: LAM is highly effective, temporary method
of contraception. 10 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.
1 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.
2 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.
3Among couples attempting to avoid pregnancy, the percentage
who continue to use a method for one year.
4 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.
5Foams, creams, gels, vaginal suppositories, and vaginal film.
6 Cervical mucus (ovulation) method supplemented by calendar
in the pre-ovulatory and basal body temperature in the post-ovulatory
7With spermicidal cream or jelly.
9 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:
OvralR (1 dose is 2 white pills), AlesseR (1 dose is 5 pink pills), NordetteR
or LevlenR (1 dose is 2 light-orange pills), Lo/OvralR (1 dose is 4 white
pills), TriphasilR or Tri-LevlenR (1 dose is 4 yellow pills).
10 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.
ORTHO MICRONOR® (norethindrone) 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
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 b enign 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.
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.
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
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.
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 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
If you are concerned about any of these side effects, check with your healthcare
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:
- Phenytoin (Dilantin®)
- Carbamazepine (Tegretol)
Medicine for TB:
Before you begin taking any new medicines be sure your healthcare professional
knows you are taking a progestin-only birth control pill.
HOW TO TAKE POPs
IMPORTANT POINTS TO REMEMBER
- POPs must be taken at the same time every day, so choose a time and then
take the pill at that same time every day. Every time you take a pill late,
and especially if you miss a pill, you are more likely to get pregnant.
- Start the next pack the day after the last pack is finished. There is no
break between packs. Always have your next pack of pills ready.
- You may have some menstrual spotting between periods. Do not stop taking
your pills if this happens.
- If you vomit soon after taking a pill, use a backup method (such as a condom
and/or a spermicide) for 48 hours.
- If you want to stop taking POPs, you can do so at any time, but, if you
remain sexually active and don't wish to egnant, be certain to use another
birth control method.
- If you are not sure about how to take POPs, ask your healthcare professional.
- It's the first day of your menstrual period.best to take your first POP
- If you decide to take your first POP on another day, use a backup method
(such as a condom and/or a spermicide) every time you have sex during the
next 48 hours.
- If you have had a miscarriage or an abortion, you can start POPs the ne
IF YOU ARE LATE OR MISS TAKING YOUR POPs
- If you are more than 3 hours late or you miss one or more POPs:
- TAKE a missed pill as soon as you remember that you missed it,
- THEN go back to taking POPs at your regular time,
- BUT be sure to use a backup method (such as a condom and/or a
spermicide) every time you have sex for the next 48 hours.
- If you are not sure what to do about the pills you have missed, keep taking
POPs and use a backup method until you can talk to your healthcare professional.
IF YOU ARE BREASTFEEDING
- If you are fully breastfeeding (not giving your baby any food or formula),
you may start your pills 6 weeks after delivery.
- If you are partially breastfeeding (giving your baby some food or formula),
you should start taking pills by 3 weeks after delivery.
IF YOU ARE SWITCHING PILLS
- If you are switching from the combined pills to POPs, take the first POP
the day after you finish the last active combined pill. Do not take any of
the 7 inactive pills from the combined pill pack. You should know that many
women have irregular periods after switching to POPs, but this is normal and
to be expected.
- If you are switching from POPs to the combined pills, take the first active
combined pill on the first day of your period, even if your POPs pack is not
- If you switch to another brand of PO Ps, start the new brand anytime.
- If you are breastfeeding, you can switch to another method of birth control
at any time, except do not switch to the combined pills until you stop breastfeeding
or at least until 6 months after delivery.
PREGNANCY WHILE ON THE PILL
If you think you are pregnant, contact your healthcare professional. Even though
research has shown that POPs do not cause harm to the unborn baby, it is always
best not to take any drugs or medicines that you don't need when you are pregnant.
You should get a pregnancy test:
- If your period is late and you took one or more pills late or missed taking
them and had sex without a backup method.
- Anytime it has been more than 45 days since the beginning of your last period.
WILL POPs AFFECT YOUR ABILITY TO GET PREGNANT LATER?
If you want to become pregnant, simply stop taking POPs. POPs will not delay
your ability to get pregnant.
If you are breastfeeding, POPs should not affect the quality or amount of your
breast milk or the health of your nursing baby. However, isolated cases of decreased
milk production have been reported.
No serious problems have been reported when many pills were taken by accident,
even by a small child, so there is usually no reason to treat an overdose.
OTHER QUESTIONS OR CONCERNS
If you have any questions or concerns, check with your healthcare professional.
You can also ask for the more detailed “Professional Labeling” written
for doctors and other healthcare professionals.
HOW TO STORE YOUR POPs
Store at 25°C
Keep out of reach of children.