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

Source: http://www.seasonale.ca/_media/pdf/ConsumerInformation_EN.pdf