IMPORTANT: PLEASE READ
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full-term pregnancy at a late age.
Some women who use birth control pills may be at increased
risk of developing breast cancer before menopause which
occurs around age 50. These women may be long-term
users of birth control pills (more than eight years) or women
who start using birth control pills at an early age. In a few
women, the use of birth control pills may accelerate the
growth of an existing but undiagnosed breast cancer. Early
diagnosis, however, can reduce the effect of breast cancer on
a woman's life expectancy. The potential risks related to
birth control pills seem to be small; however, a yearly breast
examination by a doctor is recommended for all women.
ASK YOUR DOCTOR FOR ADVICE AND
INSTRUCTIONS ON REGULAR SELF-
EXAMINATION OF YOUR BREASTS.
4. Cervical Cancer
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 progestin-only pills increases
the risk of developing cancer of the cervix.
5. Liver Tumours
In rare cases, combined oral contraceptives can cause benign
liver tumours. These benign liver tumours 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
progestin-only pills increase the risk of liver tumours.
6. Diabetic Women
Diabetic women taking progestin-only pills generally require
changes in the amount of insulin they are taking. However,
your physician may monitor you more closely under these
conditions.
7. Use During Pregnancy
Birth control pills should never be taken if you think you are
pregnant. They will not prevent the pregnancy from
continuing. There is no evidence, however, that the
progestin-only pill can damage a developing child. You
should check with your doctor about risks to your unborn
child from any medication taken during pregnancy.
8. Use After Pregnancy, Miscarriage or An Abortion
Your doctor will advise you of the appropriate time to start
the use of MICRONOR
®
after childbirth, miscarriage, or
therapeutic abortion.
9. Pregnancy After Stopping MICRONOR
®
You will have a menstrual period when you stop taking
MICRONOR
®
. You should delay pregnancy until another
menstrual period occurs within four to six weeks. Contact
your doctor for recommendations on alternative methods of
contraception during this time.
10. Use While Breast-feeding
In most women, progestin-only contraceptives, such as
MICRONOR
®
, do not affect the quantity and quality of
breast milk or length of lactation. However, isolated post-
marketing cases of decreased milk production have been
reported. Studies with various orally administered
progestin-only contraceptives have shown that small
amounts of progestins pass into the breast milk of nursing
mothers resulting in detectable steroid levels in infant
plasma.
No adverse effects have been found on the health, growth or
development of the infant.
INTERACTIONS WITH THIS MEDICATION
Certain drugs may interact with birth control pills to make
them less effective in preventing pregnancy or cause an
increase in breakthrough bleeding. You may also need to use
a nonhormonal method of contraception during any cycle in
which you take drugs that can make oral contraceptives less
effective.
Drugs that may interact with MICRONOR
®
include:
drugs used for the treatment of epilepsy (e.g., primidone,
phenytoin, carbamazepine, rufinamide);
drugs used for the treatment of tuberculosis (e.g.,
rifampin, rifabutin);
drugs used for HIV/AIDS (e.g., nelfinavir, ritonavir-
boosted protease inhibitors, darunavir, (fos)amprenavir,
lopinavir, nevirapine);
(fos)aprepitant (drug used for nausea);
bosentan (drug used for pulmonary hypertension);
antifungals (griseofulvin);
the herbal remedy St. John’s wort (primarily used for the
treatment of depressive moods); and
sedatives and hypnotics (e.g., benzodiazepines,
barbiturates, chloral hydrate, glutethimide,
meprobamate).
The pill may also interfere with the working of other drugs.
Please inform your doctor and pharmacist if you are taking
or have recently taken any other drugs or herbal products,
even those without a prescription. Also tell any other doctor
or dentist who prescribes another drug (or the dispensing
pharmacist) that you use MICRONOR
®
. They can tell you if
you need to use an additional method of contraception and if
so, for how long.
This is not a complete list of possible drug interactions with
MICRONOR
®
. Talk to your doctor for more information
about drug interactions.
PROPER USE OF THIS MEDICATION