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YASMIN
YASMIN ONLINE
Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine
must be weighed against the good it will do. This is a decision
you and your doctor will make. For drospirenone and ethinyl
estradiol, the following should be considered:
Allergies—Tell your doctor if you have ever
had any unusual or allergic reaction to estrogens or progestins.
Also tell your health care professional if you are allergic to any
other substances, such as foods, preservatives, or dyes.
Diet—Make certain your health care
professional knows if you are on any special diet, such as a
low-sodium or low-sugar diet.
Pregnancy—Drospirenone and ethinyl estradiol
is not recommended for use during pregnancy and should be
discontinued if you become pregnant or think you are pregnant.
Women who are not breast-feeding may begin to take oral
contraceptives four weeks after having a baby.
Breast-feeding—Drospirenone and ethinyl
estradiol pass into the breast milk and can change the content or
lower the amount of breast milk. Also, they may shorten a woman's
ability to breast-feed. It may be necessary for you to use another
method of birth control or to stop breast-feeding while taking
drospirenone and ethinyl estradiol.
Children—This medicine is not designed for
girls that have not reached menarche.
Teenagers—This medicine is frequently used for
birth control in teenage females and has not been shown to cause
different side effects or problems than it does in adults. Some
teenagers may need extra information on the importance of taking
this medication exactly as prescribed.
Other medicines—Although certain medicines
should not be used together at all, in other cases two different
medicines may be used together even if an interaction might occur.
In these cases, your doctor may want to change the dose, or other
precautions may be necessary. When you are taking drospirenone and
ethinyl estradiol, it is especially important that your doctor and
pharmacist know if you are taking any of the following:
 | Angiotensin-converting enzyme (ACE) inhibitors (e.g.,
Accupril, Aceon, Altace, Capoten, Lotensin, Mavik, Monopril,
Prinivil, Univasc, Vasotec, and Zestril)—Potassium in the
blood may be increased by drospirenone
| Carbamazepine (e.g., Tegretol) or
| Phenobarbital (e.g., Barbita) or
| Phenytoin (e.g., Dilantin) or
| Rifampin (e.g., Rifadin)—These medicines may cause reduced
birth control effect of drospirenone and ethinyl estradiol and
increased irregular menstrual bleeding |
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| Cyclosporine (e.g., Neoral) or
| Theophylline (e.g., Elixophyllin)—Oral contraceptives may
increase the effects of these medicines and increase the
chance of problems occurring
| Griseofulvin (e.g., Fulvicin)—May cause unplanned
pregnancy; using additional birth control methods while taking
griseofulvin |
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| Smoking tobacco— Smoking may decrease the effect of oral
contraceptives and increase the chance of causing serious
blood clot, vein, or heart problems |
Although certain medicines should not be used together at all,
in other cases two different medicines may be used together even
if an interaction might occur. In these cases, your doctor may
want to change the dose, or other precautions may be necessary.
Tell your health care professional if you are taking any other
prescription or nonprescription (over-the-counter [OTC]) medicine.
Other medical problems—The presence of other
medical problems may affect the use of drospirenone and ethinyl
estradiol. Make sure you tell your doctor if you have any other
medical problems, especially:
| Abnormal changes in menstrual or uterine bleeding or
| Fibroid tumors of the uterus—Oral contraceptives usually
improve these female conditions but sometimes they can make
them worse or make the diagnosis of these problems more
difficult |
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| Adrenal insufficiency or
| Liver problems or
| Kidney problems—these conditions may increase the risk of
retaining too much potassium in the blood |
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| Blood clots (or history of) or
| Heart or circulation disease or
| Stroke (or history of)—If these conditions are already
present, oral contraceptives may have a greater chance of
causing blood clots or circulation problems, especially in
women who smoke tobacco. Otherwise, oral contraceptives may
help prevent circulation and heart disease if you are healthy
and do not smoke |
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| Cancer, including breast cancer (or history of or family
history of)—Oral contraceptives may worsen some cancers,
especially when breast, cervical, or uterine cancers already
exist. Use of oral contraceptives is not recommended if you
have any of these conditions. If you have a family history of
breast disease, oral contraceptives may still be a good choice
but you may need to be tested more often |
| Gallbladder disease or gallstones (or history of) or
| High blood cholesterol or
| High blood potassium or
| Liver disease (or history of, including jaundice during
pregnancy) or
| Mental depression (or history of)—Oral contraceptives may
make these conditions worse or, rarely, cause them to occur
again. Oral contraceptives may still be a good choice but you
may need to be tested more often |
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| High blood pressure (hypertension) or
| Migraine headaches—Oral contraceptives may cause fluid
build-up and may cause these conditions to become worse;
however, some people have fewer migraine headaches when they
use oral contraceptives |
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Proper Use of This Medicine
To make using oral contraceptives as safe and reliable as
possible, you should understand how and when to take them and what
effects may be expected.
A paper with information for the patient will be given to
you with your filled prescription, and will provide many details
concerning the use of oral contraceptives. Read this paper
carefully and ask your health care professional if you need
additional information or explanation.
When you begin to use oral contraceptives, your body
will require at least 7 days to adjust before a pregnancy will be
prevented. You will need to use an additional birth control method
for at least 7 days. Some doctors recommend using an additional
method of birth control for the first cycle (or 3 weeks) to ensure
full protection. Follow the advice of your doctor or other health
care professional.
Try to take the doses no more than 24 hours apart to reduce
the possibility of side effects and to prevent pregnancy.
Since one of the most important factors in the proper use of oral
contraceptives is taking every dose exactly on schedule, you
should never let your tablet supply run out. When possible, try to
keep an extra month's supply of tablets on hand and replace it
monthly.
It is very important that you keep the tablets in their
original container and take the tablets in the same order that
they appear in the container. The containers help you keep track
of which tablets to take next. Different colored tablets in the
same package contain different amounts of hormones or are placebos
(tablets that do not contain hormones). The effectiveness of
the medicine is reduced if the tablets are taken out of order
Dosing—
The dosing schedule is monophasic. You will be taking tablets
of one strength (color) for 21 days. You will also take an
additional 7 inactive tablets, which are another color. Taking the
last 7 tablets is not required for full protection against
pregnancy but they do help to replace estrogen.
Your health care professional may begin your dose on the first
day of your menstrual period (called Day 1 start) or on Sunday
after your period starts (called Sunday start). When you begin
on a certain day it is important that you follow that schedule,
even when you miss a dose. Do not change your schedule on your
own. If the schedule that you have been put on is not
convenient, check with your health care professional about
changing schedules. For Sunday start you need to use another form
of birth control for the first 7 days.
| For oral dosage form (tablets):
| For contraception:
| Adults and teenagers:
| Take 1 tablet a day for twenty-eight days. Then
repeat the cycle. |
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Missed dose—
Follow your doctor's orders or the directions on the label
if you miss a dose of this medicine.
| If you miss 1 tablet during the cycle—Take it as soon as
you remember and then take the next tablet at the normal time.
You may take 2 tablets in one day. Then continue your regular
dosing schedule.
| If you miss 2 tablets in a row in the first or second
week—Take 2 tablets on the day you remember and 2 tablets
the next day. Then continue taking 1 tablet a day and use
another form of birth control for seven days after the last
missed dose.
| If you miss 2 tablets in a row in the third week or
| If you miss 3 or more tablets in a row (during the first
three weeks)—
| Using Day 1 start: Throw out your current cycle and
begin a new cycle on the same day. Also, use another birth
control method for the next seven days after the last
missed dose. You may not have a menstrual period this
month. But if you miss two menstrual periods in a row,
call your health care professional.
| Using Sunday start: Keep taking 1 tablet a day from your
current pack until Sunday. Then, on Sunday, throw out your
old pack and begin a new pack. Also use another birth
control method for the next seven days after the last
missed dose. You may not have a menstrual period this
month. But if you miss two menstrual periods in a row,
call your health care professional. |
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If you miss any of the last 7 (inactive) tablets, there is no
danger of pregnancy. However, the first tablet (active) of the
next month's cycle must be taken on the regularly scheduled day,
in spite of any missed doses, if pregnancy is to be avoided. The
active and inactive tablets are colored differently for your
convenience.
Storage—
To store this medicine:
| Keep out of the reach of children.
| Store away from heat and direct light.
| Do not store in the bathroom, near the kitchen sink, or in
other damp places. Heat and moisture may cause the medicine to
break down.
| Do not keep outdated medicine or medicine no longer needed.
Be sure that any discarded medicine is out of the reach of
children. |
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Precautions While Using This Medicine
It is very important that your doctor check your progress
at regular visits to make sure this medicine does not cause
unwanted effects. These visits will usually be every 6 to 12
months, but some doctors require them more often.
Vaginal bleeding of various amounts may occur between your
regular menstrual periods during the first 3 months of use. This
is sometimes called spotting when slight, or breakthrough bleeding
when heavier. If this should occur:
| Continue on your regular dosing schedule.
| The bleeding usually stops within 1 week.
| Check with your doctor if the bleeding continues for more
than 1 week.
| After you have been taking oral contraceptives on schedule
and for more than 3 months and bleeding continues, check with
your doctor. |
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Missed menstrual periods may occur:
| If you have not taken the medicine exactly as scheduled.
Pregnancy must be considered as a possibility.
| If the medicine is not the right strength or type for your
needs.
| If you stop taking oral contraceptives, especially if you
have taken oral contraceptives for 2 or more years. |
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Check with your doctor if you miss any menstrual periods so
that the cause may be determined.
If you suspect that you may have become pregnant, stop
taking this medicine immediately and check with your doctor.
If you are scheduled for any laboratory tests, tell your doctor
that you are taking birth control pills.
Check with your doctor before refilling an old prescription,
especially after a pregnancy. You will need another physical
examination and your doctor may change your prescription.
Side Effects of This Medicine
Healthy women who do not smoke cigarettes have almost no chance
of having a severe side effect from taking oral contraceptives.
For most women, more problems occur because of pregnancy than will
occur from taking oral contraceptives. But for some women who have
special health problems, oral contraceptives can cause some
unwanted effects. Some of these unwanted effects include benign
(not cancerous) liver tumors, liver cancer, or blood clots or
related problems, such as a stroke. Although these effects are
very rare, they can be serious enough to cause death. You may want
to discuss these effects with your doctor.
Smoking cigarettes during the use of oral contraceptives
has been found to greatly increase the chances of these serious
side effects occurring. To reduce the risk of serious side
effects, do not smoke cigarettes while you are taking oral
contraceptives.
The following side effects may be caused by blood clots. Get
emergency help immediately if any of the following side
effects occur:
| Rare
| Abdominal or stomach pain (sudden, severe, or
continuing); anxiety; burning pain in lower
abdomen ; changes in skin color; chill;
coughing up blood; convulsions; fever;
feeling of heat; feeling of warmth in lips and
tongue; headache (severe or sudden); loss of
coordination (sudden); loss of vision or change in
vision (sudden); nervousness; numbness of the
fingertips; pain in lower back, pelvis, or stomach;
pains in chest, groin, or leg (especially in calf of leg);
ringing in th ears; shortness of breath (sudden or
unexplained); slurring of speech (sudden);
sudden loss of consciousness ; swelling of foot or
leg; weakness, numbness, or pain in arm or leg
(unexplained) |
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Check with your doctor as soon as possible if any of the
following side effects occur:
| More common—usually less common after the first 3
months of oral contraceptive use
| Changes in the uterine bleeding pattern at menses or
between menses, such as decreased bleeding at menses,
breakthrough bleeding or spotting between periods,
prolonged bleeding at menses, complete stopping of
menstrual bleeding that occurs over several months in a
row, or stopping of menstrual bleeding that only occurs
sometimes |
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| Less common
| Headaches or migraines (although headaches may lessen in
many users, in others, they may increase in number or
become worse); increased blood pressure;
vaginal infection with vaginal itching or irritation, or
thick, white, or curd-like discharge |
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| Rare
| Mental depression; swelling, pain, or tenderness
in upper abdominal area |
| For women who smoke tobacco
| Pains in stomach, side, or abdomen; yellow
eyes or skin |
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| For women with a history of breast disease
| Lumps in breast |
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Other side effects may occur that usually do not need medical
attention. These side effects may go away during treatment as your
body adjusts to the medicine. However, check with your doctor if
any of the following side effects continue or are bothersome:
| More common
| Abdominal cramping or bloating; acne (usually less
common after first 3 months and may improve if acne
already exists); breast pain, tenderness, or
swelling; dizziness; nausea; swelling of
ankles and feet; unusual tiredness or weakness;
vomiting |
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| Less common
| Brown, blotchy spots on exposed skin; gain or loss
of body or facial hair; increased or decreased
interest in sexual intercourse; weight gain or loss |
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Other side effects not listed above may also occur in some
patients. If you notice any other effects, check with your doctor.
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