Pages 50 to 57 of sea-15-u10 seasonale pm en jun-10-2010
IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION
• the pill is TAKEN AS DIRECTED, and Seasonale®
• the amount of estrogen is 20 micrograms or more.
(levonorgestrel and ethinyl estradiol USP)
A 99 percent effectiveness rate means that if 100
This leaflet is Part III of a three-part "Product
women used birth control pills for one year, one woman
Monograph" published when Seasonale® was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell
The chance of becoming pregnant increases with
you everything about Seasonale®. Contact your doctor or pharmacist if you have any questions about the drug.
Other Ways to Prevent Pregnancy ABOUT THIS MEDICATION
Other methods of birth control are available to you.
What the medication is used for:
They are usually less effective than birth control pills.
Seasonale® is indicated for the prevention of pregnancy.
When used properly, however, other methods of birth
control are effective enough for many women.
SeasonaleTM is a birth control pill (oral contraceptive) that
The following table gives reported pregnancy rates for
contains two female sex hormones (levonorgestrel and
various forms of birth control, including no birth
ethinyl estradiol). It has been shown to be highly effective
control. The reported rates represent the number of
in preventing pregnancy when taken as prescribed by your
women out of 100 who would become pregnant in one
doctor. Pregnancy is always more risky than taking birth
control pills, except in smokers older than age 35.
Reported Pregnancies per 100 Women per Year:
1. They inhibit the monthly release of an egg by the
2. They change the mucus produced by the cervix. This
slows the movement of the sperm through the mucus and
What You Should Know About Your Menstrual Cycle When Taking SeasonaleTM
When you take SeasonaleTM, which has a 91-day treatment
Pregnancy rates vary widely because people differ in
cycle, you should expect to have 4 menstrual periods per
how carefully and regularly they use each method.
year (bleeding when you are taking the 7 white pills).
(This does not apply to IUDs since they are implanted
However, you should expect to have more bleeding or
in the uterus). Regular users may achieve pregnancy
spotting between your menstrual periods than if you were
rates in the lower ranges. Others may expect pregnancy
taking an oral contraceptive with a 28-day treatment cycle.
During the first SeasonaleTM treatment cycle, about 1 in 3 women may have 20 or more days of unplanned bleeding
The effective use of birth control methods other than
or spotting (bleeding when you are taking pink pills). This
birth control pills and IUDs requires more effort than
bleeding or spotting tends to decrease during later cycles.
taking a single pill every day. It is an effort that many
Do not stop SeasonaleTM because of the bleeding. If the
spotting continues for more than 7 consecutive days or if the bleeding is heavy, call your healthcare professional.
When it should not be used:
The birth control pill is not suitable for every woman. In a small number of women, serious side effects may
Effectiveness of Birth Control Pills
occur. Your doctor can advise you if you have any conditions that would pose a risk to you. The use of the
Combination birth control pills are more than 99 percent
birth control pill should always be supervised by your
IMPORTANT: PLEASE READ
days of pink tablets followed by 7 days of white
You should not use SeasonaleTM if you have or have had
• blood clots in the legs, lungs, eyes, or elsewhere,
WARNINGS AND PRECAUTIONS
or thrombophlebitis (inflammation of the veins)
• stroke, heart attack, or coronary artery disease
(e.g. angina pectoris), or a condition that may be a
Serious Warnings and Precautions
first sign of a stroke (such as a transient ischemic attack or small reversible stroke)
Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. This
disease of the heart valves with complications
risk increases with age and becomes significant in hormonal contraceptive users older than 35 years of age. Women should not smoke.
known abnormalities of the blood clotting system that increases your risk for developing blood clots
Birth control pills DO NOT PROTECT against
very high blood cholesterol or triglyceride levels
sexually transmitted diseases (STDs), including
• heavy smoking (>15 cigarettes per day) and over
HIV/AIDS. For protection against STDs, it is advisable to use latex condoms IN COMBINATION WITH birth control pills.
• jaundice (yellowing of the eyes or skin), liver
Use of SeasonaleTM provides women with more
• known or suspected cancer of the breast or uterus
hormonal exposure on a yearly basis than
(womb) or other estrogen-dependent cancer
conventional monthly oral contraceptives containing
• unusual vaginal bleeding without a known reason
similar strength synthetic estrogens and progestins
• loss of vision due to blood vessel disease of the
(9 additional weeks of hormonal exposure per year). While this added exposure may pose an additional risk of thrombotic and thromboembolic diseases,
you are pregnant or suspect you may be pregnant
studies to date with SeasonaleTM have not suggested,
pancreatitis (inflammation of the pancreas) associated with high levels of fatty substances in
nor can exclude, this additional risk. SeasonaleTM Oral Contraceptive
allergy (hypersensitivity) to ethinyl estradiol, levonorgestrel or to any of the other ingredients in
SeasonaleTM (see What the medicinal
SeasonaleTM is a 91-day cyclic dosing regimen (84 days
ingredients are and What the non medicinal
with active oral tablets of 0.15 mg levonorgestrel and
ingredients are)
0.03 mg ethinyl estradiol, followed by 7 days with
placebo tablets). Pregnancy should be ruled out in cases
of unanticipated bleeding/spotting, missed withdrawal
What the medicinal ingredients are:
bleeding/amenorrhea or signs and symptoms of
What the important non medicinal ingredients are: BEFORE you use SeasonaleTM talk to your doctor
Each active pink tablet contains the following non
or pharmacist if you:
medicinal ingredients: anhydrous lactose, FD&C Blue No.
1, FD&C Red No. 40, hydroxypropyl methylcellulose,
• have a history of breast disease (e.g. breast
magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate 80 and titanium dioxide.
Each inert white tablet contains the following non
medicinal ingredients: anhydrous lactose, hydroxypropyl
methylcellulose, magnesium stearate and microcrystalline
• have a history of liver disease or jaundice
What dosage forms it comes in:
• have uterine fibroids (benign tumours of the
Tablets. SeasonaleTM is used with a 91-day schedule (84
IMPORTANT: PLEASE READ
• may be pregnant or are breast feeding
• sharp pain in the chest, coughing blood, or
sudden shortness of breath. These symptoms
• have inflammatory bowel disease such as Crohn’s
could indicate a possible blood clot in the
• pain and/or swelling in the calf. These
symptoms could indicate a possible blood clot
• have any problems with the valves in your heart
• crushing chest pain or heaviness. These
symptoms could indicate a possible heart
You should also inform your doctor about a family history
• sudden severe or worsening headache or
of blood clots, heart attacks, or strokes.
vomiting, dizziness or fainting, disturbances of
If you see a different doctor, inform him or her that you are
vision or speech, or weakness or numbness in
an arm or leg. These symptoms could indicate a possible stroke.
Tell your doctor if you are scheduled for any laboratory
• sudden partial or complete loss of vision. This
tests since certain blood tests may be affected by hormonal
symptom could indicate a blood clot in the
Also tell your doctor if you are scheduled for MAJOR
Any of these conditions can cause death or disability.
surgery. You should consult your doctor about stopping
Clots also occur rarely in the blood vessels of the eye,
the use of SeasonaleTM four weeks before surgery and not
resulting in blindness or impaired vision or in a blood
using SeasonaleTM for a time period after surgery or during
vessel leading to an arm or leg, resulting in damage to
SeasonaleTM should be used only under the supervision of a
Women who use hormonal contraceptives have a
doctor, with regular follow-up to identify side effects
higher incidence of blood clots. The risk of clotting
associated with its use. Your visits may include a blood
seems to increase with higher estrogen doses. It is
pressure check, a breast exam, an abdominal exam and a
important, therefore, to use as low a dosage of estrogen
pelvic exam, including a Pap smear. Visit your doctor
three months or sooner after the initial examination. Afterward, visit your doctor at least once a year. Use
SeasonaleTM only on the advice of your doctor and
Breast cancer
carefully follow all directions given to you. You must use
The most significant risk factors for breast cancer are
the birth control pill exactly as prescribed. Otherwise, you
increasing age and a strong history of breast cancer in
the family (mother or sister). Other established risk factors include obesity, never having children, and
If you and your doctor decide that, for you, the benefits of
having your first full-term pregnancy at a late age.
SeasonaleTM outweigh the risks, you should be aware of the following:
Some women who use hormonal contraceptives may be at increased risk of developing breast cancer before
THE RISKS OF USING SEASONALETM
menopause, which occurs around age 50. These women may be long-term users of birth control pills
1. Circulatory disorders (including blood clot in legs,
(more than eight years) or women who start using birth
lungs, heart, eyes or brain)
control pills at an early age. In a few women, the use of birth control pills may accelerate the growth of an
Blood clots are the most common serious side effects of
existing, but undiagnosed, breast cancer. Early
birth control pills. The risk of developing blood clots is
diagnosis, however, can reduce the effect of breast
especially high during the first year a woman ever uses a
cancer on a woman’s life expectancy. The potential
hormonal contraceptive. Clots can occur in many parts of
risks related to birth control pills seem to be small,
however. A yearly breast examination by a health care professional is recommended for all women.
Be alert for the following symptoms and signs of serious adverse effects. Call your doctor immediately if they
ASK YOUR DOCTOR FOR ADVICE AND INSTRUCTIONS ON REGULAR SELF- EXAMINATION OF YOUR BREASTS. IMPORTANT: PLEASE READ 3. Cervical cancer INTERACTIONS WITH THIS MEDICATION
Some studies have found an increase of cancer of the
cervix in women who use hormonal contraceptives,
Certain drugs may interact with birth-control pills to
although this finding may be related to factors other than
make them less effective in preventing pregnancy or
the use of oral contraceptives. However, there is
cause an increase in breakthrough bleeding. Please
insufficient evidence to rule out the possibility that oral
inform your doctor or pharmacist if you are taking or
have recently taken any other drugs or herbal products, even those without a prescription. Also tell any other
4. Liver tumours
doctor or dentist who prescribes another drug (or the
The short and long-term uses of birth control pills have
dispensing pharmacist) that you use SeasonaleTM. They
also been linked with the growth of liver tumors. Such
can tell you if you need to use an additional method of
tumors are extremely rare.
Contact your doctor immediately if you experience severe
Drugs that may interact with SeasonaleTM include: 5. Gallbladder disease
• drugs used for the treatment of epilepsy (e.g.
primidone, phenytoin, barbiturates, carbamazepine,
Users of birth control pills have a greater risk of
developing gallbladder disease requiring surgery within the
felbamate); tuberculosis (e.g. rifampin, rifabutin)
first year of use. The risk may double after four or five
• antibiotics (e.g. penicillins, tetracyclines) for
infectious diseases; you may be at higher risk of a
6. Use in pregnancy
specific type of liver dysfunction if you take troleandomycin and oral contraceptives at the same
Birth control pills should not be taken by pregnant women.
There is no evidence, however, that the birth control pill
can damage a developing child. You should check with
your doctor about risks to your unborn child from any medication taken during pregnancy.
• the herbal remedy St. John’s Wort (primarily used
7. Use after pregnancy, miscarriage or an abortion
• cholesterol-lowering drugs (e.g. clofibrate)
• antihypertensive drugs (for high blood pressure)
Your doctor will advise you of the appropriate time to start
• antidiabetic drugs and insulin (for diabetes)
the use of SeasonaleTM after childbirth, miscarriage, or
• sedatives and hypnotics (e.g. benzodiazepines,
8. Pregnancy after stopping SeasonaleTM
barbiturates, chloral hydrate, glutethimide, meprobamate)
You will have a menstrual period when you stop using
SeasonaleTM.You should delay pregnancy until another
menstrual period occurs within four to six weeks. In this
• some nutritional supplements (e.g. Vit. B12, folic
way, the pregnancy can be more accurately dated. Contact
your doctor for recommendations on alternate methods of
antacids (use 2 hours before of after taking
9. Use while breast feeding
The pill may also interfere with the working of other
If you are breast-feeding, consult your doctor before
starting the birth control pill. The hormones in birth control pills are known to appear in breast milk. These
This is not a complete list of possible drug interactions
hormones may decrease the flow of breast milk. Adverse
with SeasonaleTM. Talk to your doctor for more
effects on the child have been reported, including
information about drug interactions.
yellowing of the skin (jaundice) and breast enlargement. You should use another method of contraception and only
consider starting the birth control pill once you have weaned your child completely.
IMPORTANT: PLEASE READ PROPER USE OF THIS MEDICATION
DISPENSER. Your Tablet Dispenser consists of 3
trays with cards that hold 91 individually sealed pills (a
● Before you start taking your pills.
13-week or 91-day cycle). The 91 pills consist of 84
● Anytime you are not sure what to do.
pink pills (active pills with hormones) and 7 white pills (inactive pills without hormone). Trays 1 and 2 each
contain 28 pink pills (4 rows of 7 pills). Tray 3
contains 35 pills consisting of 28 pink pills (4 rows of 7
pills) and 7 white pills (1 row of 7 pills).
If you miss pills you could get pregnant. This
includes starting the pack late. The more pills you
miss, the more likely you are to get pregnant.
• Where on the first tray in the pack to
start taking pills (upper left corner at the
OF TAKING PILLS. If you feel sick to your stomach, do not stop
• In what order to take the pills (follow
taking the pill. The problem will usually go away.
If it doesn't go away, check with your healthcare professional.
CONTROL (such as condoms or spermicide),
to use as a back-up in case you miss pills.
MONTHS OF TAKING SEASONALETM. Do not stop taking your pills even if you are WHEN TO START SEASONALETM having irregular bleeding. If the bleeding lasts for more than a few days, talk to your healthcare
1. Take the first “active” pink pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday,
start the first pink pill that same day.
SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills. On the days you
2. Use another method of birth control (such as
take 2 pills to make up for missed pills, you could
condom or spermicide) as a back-up method if
also feel a little sick to your stomach.
you have sex anytime from the Sunday you start your first pink pill until the next Sunday
IF YOU TAKE SOME MEDICINES, including some antibiotics and the herbal supplement St.
HOW TO TAKE SEASONALETM
John’s Wort, SeasonaleTM may not work as well. Use a back-up method (such as condoms or
1. Take one pill at the same time every day
spermicide) until you check with your healthcare
until you have taken the last pill in the tablet dispenser. Do not skip pills even if you are spotting or bleeding or feel sick to
Do not skip pills even if you do not have sex
healthcare provider about how to make pill-taking
easier or about using another method of birth control.
2. WHEN YOU FINISH A TABLET DISPENSER.
After taking the last white pill, start taking the
first pink pill from a new Extended-Cycle
Tablet Dispenser the very next day regardless of when your period started. This should be on BEFORE YOU START TAKING SEASONALETM
3. If you miss your period when you are taking
TO TAKE YOUR PILL. It is important to take it
the white pills, call your healthcare provider because you may be pregnant. IMPORTANT: PLEASE READ Usual dose:
2. KEEP TAKING ONE PILL EACH DAY
One pink tablet should be taken daily for 84 consecutive
days, followed by 7 days of white tablets.
Overdose: IF YOU FORGET MORE THAN ONE PILL TWO
Symptoms of overdose may include nausea, vomiting or
MONTHS IN A ROW, TALK TO YOUR DOCTOR
vaginal bleeding. Available information from cases of
OR CLINIC about ways to make pill-taking easier or
accidental ingestion of oral contraceptives by children
about using another method of birth control.
indicates no serious effects. In case of an overdose, contact your healthcare professional or pharmacist.
Non-contraceptive Benefits of Birth Control Pills Missed Dose:
Several health advantages have been linked to the use
If you MISS one pink “active” pill:
1. Take it as soon as you remember. Take the next
• Combination estrogen and progestin birth control
pill at your regular time. This means you take 2
pills reduce the incidence of cancer of the uterus and
2. You do not need to use a back-up birth-control
• Birth control pills reduce the likelihood of
developing benign (non-cancerous) breast disease
If you MISS two pink “active” pills in a row:
1. Take 2 pills on the day you remember and 2 pills
• Users of birth control pills lose less menstrual blood
and have more regular cycles. The risk of
2. Then take 1 pill a day until you finish the pack.
developing iron-deficiency anemia is thus reduced.
3. You COULD BECOME PREGNANT if you have
• There may be a decrease in painful menstruation
sex in the 7 days after you restart your pills. You
MUST use another birth control method (such as
condoms or spermicide) as a back-up on the 7
Acne, excessive hair growth and male-hormone-
If you MISS 3 OR MORE pink “active” pills in a row:
Ectopic (tubal) pregnancy may occur less
1. Do not remove the missed pills from the pack as
they will not be taken. Keep taking 1 pill every
• Acute pelvic inflammatory disease may occur less
day as indicated on the pack until you have
completed all of the pills in the pack. For
example: if you resume taking the pill on
Thursday, take the pill under “Thursday” and do
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
not take the previous missed pills. You may
experience bleeding during the week following
The following side effects have been observed in
2. You COULD BECOME PREGNANT if you have
sex during the days of missed pills or during the
Most side effects when using the birth control pill are
first 7 days after you restart your pills.
not serious. The most common side effects are nausea,
3. You must use a non-hormonal birth control
vomiting, bleeding or spotting between menstrual
method (such as condoms or spermicide) as a
periods, weight gain, breast tenderness and difficulty
back-up when you miss pills and for the first 7
wearing contact lens. Some of these side effects,
days after you restart your pills. If you miss your
especially nausea and vomiting may subside within the
period when you are taking the white pills, call your healthcare professional because you may be pregnant.
Other side effects can occur such as fluid retention,
If you MISS ANY of the 7 white inactive pills.
darkening of the skin (particularly on the face),
headache, nervousness, depression, dizziness, loss of
2. Keep taking the scheduled pills until the pack is
scalp hair, vaginal infections and allergic reactions. If
any of these side effects occur, consult your healthcare
3. You do not need a back-up method of birth
FINALLY, IF YOU ARE STILL NOT SURE WHAT
Two subjects had pulmonary embolism and one subject
TO DO ABOUT THE PILLS YOU HAVE MISSED
had myocardial infarction while on SeasonaleTM in
1. Use a BACK-UP METHOD anytime you have IMPORTANT: PLEASE READ
You will have more bleeding or spotting between your
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
menstrual periods than if you were taking an oral
HAPPEN AND WHAT TO DO ABOUT THEM
contraceptive with a 28-day treatment cycle. During the first SeasonaleTM treatment cycle, about 1 in 3 women may
Symptom / effect Talk with your Stop
have 20 or more days of unplanned bleeding or spotting
doctor or
(bleeding when you are taking pink pills)
pharmacist call your doctor or
Irregular bleeding may vary from slight staining between
Only if In pharmaci
menstrual periods to breakthrough bleeding which is a flow
all cases st
much like a regular period. Irregular bleeding occurs most often during the first few 91-day cycles of SeasonaleTM
Uncommon
use, tends to decrease during later cycles, but may also
occur after you have been taking SeasonaleTM for some
time. Such bleeding usually does not indicate any serious
problems. It is important to continue taking your pills on schedule even if you are having irregular bleeding.
If the bleeding lasts for more than 7 consecutive days, talk
Unscheduled bleeding and/or spotting as a reason for
discontinuation for women using SeasonaleTM was reported
more often during the first seven months of treatment as
opposed to the last five months of treatment. The pattern
of unscheduled bleeding and/or spotting continued to
The following additional symptoms have been reported in
women taking hormonal contraceptives in general:
urinary tract infections or inflammation
upper respiratory tract infections (colds, bronchitis,
runny or stuffy nose, sore throat, etc.)
• amenorrhea (lack of a period or breakthrough
In the post-market period, there have been cases of This is not a complete list of side effects. For any
myocardial infarction, stroke, deep vein thrombosis and
unexpected effects while taking SeasonaleTM contact
pulmonary embolism reported with the use of SeasonaleTM.
your doctor or pharmacist.
These adverse events have been reported and their relationship to Seasonale
HOW TO STORE IT
Store at room temperature (15°C to 30°C).
IMPORTANT: PLEASE READ REPORTING SUSPECTED SIDE EFFECTS To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by: Toll-free telephone: 866-234-2345 Toll-free fax 866-678-6789 By email: cadrmp@hc-sc.gc.ca By regular mail: National AR Centre Marketed Health Products Safety and Effectiveness Information Division Marketed Health Products Directorate Tunney’s Pasture, AL 0701C Ottawa ON K1A 0K9 NOTE: Before contacting Health Canada, you should contact your physician or pharmacist. MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.paladinlabs.com or by contacting the sponsor, Paladin Labs Inc. at: 1-866-940-3687 This leaflet was prepared by Paladin Labs Inc. Last revised: June 10, 2010
St. John’s Wort: NIH study failed On 10th April, 2002, the American medical journal JAMA (287: 1840 – 47) published a controlled clinical study with St. John’s Wort extract. In the following, the members of the “St. John’s Wort” International Consensus Conference comment on the published data. The authors treated 340 patients with moderately severe depression for eight weekswith
LES ADOLESCENTS ET LES ASSUÉTUDES Préfet des Etudes, A.R. Fragnée-LiègeMaître de Conférences-Université de Liègel’évidence. Par contre, entre la négation pure et simple du problème à coup de répression, d’exclusion et de refusd’inscription et un laxisme aveugle tendant à ne gommerL’importance croissante que connaissent le commerce que la partie la plus visible de l’ic