DETAILED PATIENT LABELING
This product (like all oral contraceptives ) is used
to prevent pregnancy. It does not protect against HIV infection (AIDS) and
other sexually trans mitted diseases .
Norethindrone Tablet 28 Day Regimen
Each yellow tablet contains 0.35 mg norethindrone. Inactive
ingredients include anhydrous lactose, corn starch, D&C yellow no. 10
aluminum lake, ethylcellulose aqueous dispersion, lactose monohydrate, magnesium
stearate, microcrystalline cellulose and povidone.
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 within the First
||an Unintended Pregnancy Year of Use
||% of Women Continuing Use at One Year*(4)
|Typical Use† (2)
||Perfect Use‡ (3)
|Norplant® and Norplant-2®
|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%.a
Lactational Amenorrhea Method: LAM is highly effective, temporary method of
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.
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 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
- If you are taking certain drugs for epilepsy (seizures)
or for TB, or medicine for pulmonary
- hypertension or certain herbal products. (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.
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 methods.
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 .
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, vomiting, dizziness, and fatigue. Depression, nervousness, leg
pain, vaginal discharge, fluid retention, allergic reactions, jaundice or a yellowing
of the skin or eyeballs, loss of scalp hair, rash/itchy rash, 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.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1- 800-FDA-1088.
USING POPS WITH OTHER MEDICINES
Before taking a POP, inform your healthcare professional
of any other medication, including over-thecounter medicine, that you may be
These medicines can make POPs less effective:
Medicines for seizures such as:
- Phenytoin (Dilantin®)
- Carbamazepine (Tegretol®)
Medicine for TB:
Medicine for pulmonary hypertension such as:
Herbal products such as:
Before you begin taking any new medicines be sure your
healthcare professional knows you are taking a progestin-only birth control
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
- 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
- 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
anytime, but, if you remain sexually active and don't wish to become pregnant,
be certain to use another birth control method.
- If you are not sure about how to take POPs, ask your
- It's best to take your first POP on the first day of your
- 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 next day.
IF YOU ARE LATE OR MISS TAKING YOUR POPS
- If you are more than 3 hours late or you miss one or more
1) TAKE a missed pill as soon as you remember that
you missed it,
2) THEN go back to taking POPs at your regular
3) 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
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 finished.
- If you switch to another brand of POPs, start the new
- If you are breastfeeding, you can switch to another
method of birth control at anytime, 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 will 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 20° to 25°C (68° to 77°F).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF
INSTRUCTIONS TO PATIENTS
How to Use the Errin® Tablets Blister Card
1. The first time you use these pills, take your first
pill on the first day of your menstrual period. Pick the Days of the Week
Sticker that starts the first day of your period. When you have picked the
right sticker, throw away the others and place the sticker on the blister card
over the pre-printed days of the week and make sure it lines up with the pills.
2. Your blister package consists of three parts, the foil
pouch, wallet, and a blister card containing 28 individually sealed pills. Note
that the pills are arranged in four numbered rows of 7 pills, with the
preprinted days of the week printed above them. All 28 pills are “active” birth
control pills. Refer to the sample of the blister card below:
3. To remove a pill, push down on the pill with your thumb
and forefinger so that the pill releases through the back of the blister card.
Each day, take one pill. Always go from left to right along the row. Each new
row will begin on the same day of the week.
4. Take one pill every day for 28 days, whether bleeding
or not, until you have taken all the pills. It is important that you take your
pill at the same time every day.
5. After you have taken all 28 pills, begin taking your
pills again the next day. Be sure that the calendar day on your new package
corresponds with the actual day.