Previfem (21Day): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• To prevent pregnancy

What it does:

PREVIFEM is a birth control pill which contains two female sex hormones (norgestimate and ethinyl estradiol) and has been shown to be highly effective in preventing pregnancy when taken as prescribed by your doctor. Pregnancy is always more risky than taking birth control pills, except in smokers older than age 35.

How Birth Control Pills Work

The birth control pills work in two ways:

1. 1. They inhibit the monthly release of an egg by the ovaries.
2. 2. They change the mucus produced by the cervix. This slows the movement of the sperm through the mucus and through the uterus (womb).

Effectiveness of Birth Control Pills

Combination birth control pills are more than 99 percent effective in preventing pregnancy when

• the pill is TAKEN AS DIRECTED, and
• the amount of estrogen is 20 micrograms or more.

A 99 percent effectiveness rate means that if 100 women used birth control pills for one year, one woman in the group would get pregnant.

The mini-pill (progestin only) is slightly less effective than combination birth control pills.

Other ways to prevent pregnancy

Other methods of birth control are available to you. They are usually less effective than birth control pills. Used properly, however, other methods of birth control are effective enough for many women.

The following table gives reported pregnancy rates for various forms of birth control, including no birth control. The reported rates represent the number of women out of 100 who would become pregnant in one year.

Reported Pregnancies Per 100 Women Per Year

Combination Pill less than 1 to 2 Intrauterine Device (IUD) less than 1 to 6 Condom with spermicidal foam or gel 1 to 6 Mini-pill 3 to 6 Condom 2 to 12 Diaphragm with spermicidal foam or gel 3 to 18 Spermicide 3 to 21 Sponge with spermicide 3 to 28 Cervical cap with spermicide 5 to 18 Periodic abstinence (rhythm), all types 2 to 20 No birth control 60 to 85

Pregnancy rates vary widely because people differ in how carefully and regularly they use each method (This does not apply to IUDs since they are implanted in the uterus.) Regular users may achieve pregnancy rates in the lower ranges. Others may expect pregnancy rates more in the middle ranges.

The effective use of birth control methods other than birth control pills and IUDs requires more effort than taking a single pill every day. It is an effort that many couples undertake successfully.

Non-Contraceptive Benefits Of Birth Control Pills

Several health advantages have been linked to the use of birth control pills.

• Combination estrogen and progestin birth control pills reduce the incidence of cancer of the uterus and ovaries.

• Birth control pills reduce the likelihood of developing benign

  (non-cancerous) breast disease and ovarian cysts.

• Users of birth control pills lose less menstrual blood and have more regular cycles. The risk of developing iron-deficiency anemia is thus reduced.
• There may be a decrease in painful menstruation and premenstrual syndrome (PMS).
• Acne, excessive hair growth and male hormone-related disorder also may be improved.

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 occur. Your doctor can advise you if you have any conditions that would pose a risk to you. The use of the birth control pill always should be supervised by your doctor.

You should not use PREVIFEM if you have or have had any of the following conditions:

• unusual vaginal bleeding that has not yet been diagnosed;
• blood clots in the legs, lungs, eyes, or elsewhere;
• a stroke, heart attack, or chest pain (angina pectoris);
• known or suspected cancer of the breast or sex organs;
• liver tumour associated with the use of the pill or other estrogen-containing products: and/or
• jaundice or liver disease if still present

The pill should not be taken if you are pregnant or if pregnancy is suspected.

Tell your doctor if you have ever had any of the above conditions (your doctor can recommend another method of birth control).

What the medicinal ingredients are:

norgestimate and ethinyl estradiol

What the nonmedicinal ingredients are:

FD & C Blue #1 HT, FD & C Blue #2, hydroxypropyl methylcellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, pregelatinized starch and polyethylene glycol.

What dosage forms it comes in:

PREVIFEM (norgestimate and ethinyl estradiol) tablets are available in a 21-day regimen (PREVIFEM 21) and a 28-day regimen (PREVIFEM 28).

PREVIFEM 21

21-Day Package contains:

• 21 BLUE tablets each containing 0.250 mg norgestimate

  and 0.035 mg ethinyl estradiol.

PREVIFEM 28

28-day Package contains:

• 21 BLUE tablets each containing 0.250 mg norgestimate

  and 0.035 mg ethinyl estradiol.

• 7 GREEN tablets with inert ingredients.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

$ Cigarette smoking increases the risk of serious adverse

effects on the heart and blood vessels. This risk increases with age and becomes significant in birth control pill users over 35 years of age. Women should not smoke. $ Oral contraceptives do not protect against sexually

transmitted diseases (STD’s) including HIV/AIDS. For protection against STDs, it is advisable to use latex condoms in combination with oral contraceptives.

BEFORE you use PREVIFEM talk to your doctor or pharmacist if you have:

•breast conditions

•a strong family history of breast cancer

•breast disorders including pain, discharge from the nipples, thickenings, or lumps. In some circumstances, benefit may be derived from taking the pill; in other cases, adverse effects may follow.

•diabetes

•high blood pressure

•abnormal levels of fats in the bloodstream (high cholesterol or triglycerides)

•cigarette smoking

•migraine headaches

•heart or kidney disease

•epilepsy

•depression

•fibroid tumours of the uterus

•gallbladder or pancreatic disease

•plans for forthcoming surgery

•history of jaundice or other liver disease.

You should also inform your doctor about a family history of blood clots, heart attacks or strokes.

Inform your doctor if you are taking or if you start to take other medications. This applies to both prescription and non-prescription drugs, including herbal or “natural” preparations or remedies. These medications may change the effectiveness and/or cycle control of your birth control pills. You may need to use a back-up (barrier) method of birth control.

If You Decide To Take Birth Control Pills

If you and your doctor decide that, for you, the benefits of birth control pills outweigh the risks, you should be aware of the following:

1. 1. Take the pills only on the advice of your doctor and carefully follow all directions given to you. You must take the pills exactly as prescribed. Otherwise, you may become pregnant.
2. 2. Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year.
3. 3.

   Be alert for the following symptoms and signs of serious adverse effects. Call your doctor immediately if they occur: •sharp pain in the chest, coughing blood, or sudden shortness of breath. These symptoms could indicate a possible blood clot in the lung;

   •pain in the calf. This symptom could indicate a possible blood clot in the leg;

   •crushing chest pain or heaviness. This symptom could indicate a possible heart attack;

   •sudden severe or worsening headache or vomiting, dizziness or fainting, disturbance of vision or speech, or weakness or numbness in an arm or leg. These symptoms could indicate a possible stroke;

   •sudden partial or complete loss of vision. This symptom could indicate a possible blood clot in the eye; •severe pain or lump in the abdomen. These symptoms could indicate a possible tumor of the liver;

   •severe depression;

   •yellowing of the skin (jaundice);

   •unusual swelling of the extremities; and/or

   •breast lumps. ASK YOUR DOCTOR FOR ADVICE AND INSTRUCTIONS ON REGULAR SELF-EXAMINATION OF YOUR BREASTS.

4. 4. Birth control pills should never be taken if you think you are pregnant. They will not prevent the pregnancy from continuing.
5. 5. You will have a menstrual period when you stop taking birth control pills. 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.
6. 6.

   The hormones in birth control pills are known to appear in

   breast milk. These hormones may decrease the flow of breast milk. If birth control pills are not resumed until nursing is established, however, the quantity and quality of breast milk does not seem to be affected. There is no evidence that birth control pills are harmful to the nursing infant.

7. 7.

   Should you require MAJOR surgery, inform your surgeon

   that you are using birth control pills.

8. 8.

   If you see a different doctor, inform him or her that you

   are taking birth control pills. Tell the doctor that your birth control pills are PREVIFEM Tablets.

   Birth control pills DO NOT PROTECT against sexually transmitted diseases (STDs) including HIV/AIDS. For protection against STDs it is advisable to use latex condoms IN COMBINATION WITH birth control pills.

The Risks Of Birth Control Pills

Circulatory disorders (including blood clots in legs, lungs, heart, eyes or brain)

Blood clots are the most common serious side effects of birth control pills. Clots can occur in many areas of the body. •In the brain, a clot can result in a stroke.

•In a blood vessel of the heart, a clot can result in a heart attack. •In the legs and pelvis, a clot can break off and travel to the lung resulting in a pulmonary embolus.

•In a blood vessel leading to an arm or leg, a clot can result in damage to or loss of a limb.

Any of these conditions can cause death or disability. Clots also occur rarely in the blood vessels of the eye, resulting in blindness or impaired vision.

Women who use birth control pills have a higher incidence of blood clots. The risk of clotting seems to increase with higher estrogen doses. It is important, therefore, to use as low a dosage of estrogen as possible.

Breast cancer

The most significant risk factors for breast cancer are 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 having your first 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.

Women with the following conditions should be examined yearly by their doctors no matter what method of contraception they use:

•a strong history of breast cancer in the family;

•breast nodules or thickenings; and/or

•discharge from the nipple.

Dangers to developing child if birth control pills are used during pregnancy.

Birth control pills should not be taken by pregnant women. There is no evidence, however, that the pill can damage a developing child.

There is also no evidence that the use of birth control pills immediately before a pregnancy will adversely affect a baby's development. When a woman stops taking birth control pills to become pregnant, however, her doctor may recommend a different method of contraception until she has a period on her own. In this way, the pregnancy can be more accurately dated.

Gallbladder disease and liver tumours

Users of birth control pills have a greater risk of developing gallbladder disease requiring surgery within the first year of use. The risk may double after four or five years of use.

The short and long-term use of birth control pills also has been linked with the growth of liver tumours. Such tumours are EXTREMELY rare.

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. Drugs that may interact with PREVIFEM include:

-drugs used for the treatment of epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate); tuberculosis (e.g., rifampicin) -antibiotics (e.g., penicillins, tetracyclines) for infectious diseases -antifungals (griseofulvin)

-the herbal remedy St. John’s Wort (primarily used for the treatment of depressive moods)

-cholesterol-lowering drugs (e.g. clofibrate)

-antihypertensive drugs (for high blood pressure) -antidiabetic drugs and insulin (for diabetes)

-prednisone

-sedatives (e.g. meperidine) and hypnotics (e.g. benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate) -antidepressants (e.g. clomipramine)

-some nutritional supplements (e.g. Vit. B12, folic acid) -antacids (use 2 hours before of after taking PREVIFEM)

Some drugs (e.g., cyclosporine) may inhibit the metabolism of PREVIFEM. The pill may also interfere with the working of other drugs (See bolded text under WARNINGS AND

PRECAUTIONS).

Please 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 doctor or dentist who prescripbes another drug (or the dispensing pharmacist) that you use PREVIFEM. They can tell you if you need to use an additional method of contraception and if so, for how long.

PROPER USE OF THIS MEDICATION

Usual dose:

HOW TO TAKE PREVIFEM

1. 1. Read these directions before you start taking your pills, and any time you are not sure what to do.
2. 2.

   LOOK AT YOUR PILL PACK to see if it has 21 or 28

   pills:

3. • 21-PILL PACK: 21 active pills (with hormones) taken daily for three weeks, and then no pills taken for one week or
4. • 28-PILL PACK: 21 active pills (with hormones) taken daily for three weeks, and then seven "reminder" pills (no hormones) taken daily for one week.

ALSO CHECK: the pill pack for instructions on 1) where to start and 2) direction to take pills.

21-Day Package

28-Day Package

1. 3.

   You may wish to use a second method of birth control (e.g.

   latex condoms and spermicidal foam or gel) for the first seven days of the first cycle of pill use. This will provide a back- up in case pills are forgotten while you are getting used to taking them.

2. 4. When receiving any medical treatment, be sure to tell your doctor that you are using birth control pills.
3. 5.

   IF YOU EXPERIENCE VOMITING OR DIARRHEA,

   OR IF YOU TAKE CERTAIN MEDICINES, such as antibiotics, your pills may not work as well. Use a back-up (barrier) method, such as latex condoms and spermicidal foam or gel, until you can check with your doctor or clinic.

   1. 6.

      Periodic Examination

      A complete medical and family history is necessary before birth control pills are prescribed. A physical examination should include measuring blood pressure, and examining the breasts, abdomen, pelvic organs, and limbs.

      A second visit to your doctor should take place three months or sooner after starting birth control pills. During this visit, any side effects should be evaluated and your blood pressure checked again. Afterward, an annual examination similar to the first visit is recommended. A Pap smear is usually taken before starting birth control pills and then at intervals recommended by your doctor.

   2. 7.

      MANY WOMEN HAVE SPOTTING OR LIGHT

      BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST THREE MONTHS ON THE PILL. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic.

   3. 8. Your doctor will advise you of the appropriate time to start the use of birth control pills after childbirth, miscarriage, or therapeutic abortion.
   4. 9.

      THERE IS NO NEED TO STOP TAKING BIRTH

      CONTROL PILLS FOR A REST PERIOD.

   5. 10. IF YOUR QUESTIONS ARE NOT ANSWERED HERE, CALL YOUR DOCTOR OR CLINIC.

WHEN TO START THE FIRST PACK OF PILLS BE SURE TO READ THESE INSTRUCTIONS:

• before you start taking your pills, and
• any time you are not sure what to do.

Decide with your doctor or clinic what is the best day for you to start taking your first pack of pills. Your pills may be either a 21-day or a 28-day type.

DIRECTIONS FOR 21-DAY AND 28-DAY PILL PACKS

1. 1. THE FIRST DAY OF YOUR MENSTRUAL PERIOD (BLEEDING) IS DAY 1 OF YOUR CYCLE. The pills may be started up to Day 6 of your cycle. Your starting day will be chosen in discussion with your doctor. You will always begin taking your pill on this day of the week. Your doctor may advise you to start taking the pills on Day 1, on Day 5, or on the first Sunday after your period begins. If your period starts on Sunday, start that same day.
2. 2.

   IF YOU ARE USING A:

   21-DAY Pill Pack

   With this type of birth control pill, you are on pills for 21 days and off pills for seven days. You must not be off the pills for more than seven days in a row.

   Take one pill at approximately the same time every day for 21 days. THEN DO NOT TAKE A PILL FOR SEVEN DAYS. Start a new pack on the eighth day. You will probably have a period during the seven days off the pill. (This bleeding may be lighter and shorter than your usual period.)

   28-DAY Pill Pack

   With this type of birth control pill, you take 21 pills that contain hormones and seven pills that contain no hormones.

   Take one pill at approximately the same time every day for 28 days. Begin a new pack the next day, NOT MISSING ANY DAYS ON THE PILLS. Your period should occur during the last seven days of using that pill pack.

   INSTRUCTIONS FOR USING YOUR PACKAGE FOR BOTH 21-DAY AND 28-DAY PACKS.

   FOLLOW THESE INSTRUCTIONS CAREFULLY:

   For Day 1 start: Start with Day 1 of your menstrual period (the first day of menstruation is Day 1). For example, if your first day of menstruation is Tuesday, take the pill on Tuesday. Peel label strip from the front of the day labels with TUE beginning first and press firmly on blister pack. OR

   For Day 5 start: Start with the day that is 5 days after your period begins. (Count 5 days including the first day of menstruation.) For example, if your first day of menstruation is Saturday, then take the pill on Wednesday. Peel label strip from the front of the day labels with WED beginning first and press firmly on blister pack.

   OR

   For Sunday start: The Package is printed for a Sunday start. (The first Sunday after your period begins, or, if your period starts on Sunday, start that same day.) Discard day labels.

   To begin taking your pills, start with the pill on the top left

   corner of the blister pack. This pill should correspond to the day of the week that you are taking your first pill. To remove the pill, push through the back of the package.

   On the following day, take the next pill in the same row, always proceeding from left to right (→). Each row will always begin on the same day of the week.

   WHAT TO DO DURING THE MONTH

3. 1.

   TAKE A PILL AT APPROXIMATELY THE SAME

   TIME EVERY DAY UNTIL THE PACK IS EMPTY.

4. • Try to associate taking your pill with some regular activity such as eating a meal or going to bed.
5. • Do not skip pills even if you have bleeding between monthly periods or feel sick to your stomach (nausea).
6. • Do not skip pills even if you do not have sex very often.
7. 2. WHEN YOU FINISH A PACK
8. • 21 PILLS

WAIT SEVEN DAYS to start the next pack. You will have your period during that week.

• 28 PILLS

Start the next pack ON THE NEXT DAY. Take one pill every day. Do not wait any days between packs.

Overdose:

In case of overdose please contact your doctor. Overdosage may cause nausea and withdrawal bleeding may occur in females. PREVIFEM 28: If you have taken the last 7 tablets from row 4 of the blister this is harmless because they do not contain active ingredients.

In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre.

Missed Dose:

MISSING PILLS ALSO CAN CAUSE SOME SPOTTING OR LIGHT BLEEDING, even if you make up the missed pills. You also could feel a little sick to your stomach on the days you take two pills to make up for missed pills.

IF YOU MISS PILLS AT ANY TIME, YOU COULD GET PREGNANT. THE GREATEST RISKS FOR PREGNANCY ARE:

• when you start a pack late, or
• when you miss pills at the beginning or at the very end of the pack.

ALWAYS BE SURE YOU HAVE READY:

• ANOTHER KIND OF BIRTH CONTROL (such as latex condoms and spermicidal foam or gel) to use as a back-up in case you miss pills, and
• AN EXTRA, FULL PACK OF PILLS.

IF YOU FORGET MORE THAN ONE PILL TWO MONTHS IN A ROW, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control.

IF YOUR QUESTIONS ARE NOT ANSWERED HERE, CALL YOUR DOCTOR OR CLINIC.

WHAT TO DO IF YOU MISS PILLS

The following chart outlines the actions you should take if you miss one or more of your birth control pills. Match the number of pills missed with the appropriate starting time for your type of pill pack.

NOTE: 28-DAY PACK - If you forget any of the seven "reminder" pills (without hormones) in Week 4, just safely dispose of the pills you missed. Then keep taking one pill each day until the pack is empty. You do not need to use a back-up method.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING , OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST THREE MONTHS ON THE PILL. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic.

Most side effects of the pill are not serious. The most common such effects are:

• nausea
• vomiting
• bleeding between menstrual periods
• weight gain
• breast tenderness
• difficulty wearing contact lenses
• acne
• vaginal irritation or infections
• urinary tract infections or inflammations (cystitis)
• upper respiratory tract infections (colds, bronchitis, etc.)
• migraine, severe headaches
• depression
• amenorrhea (lack of a period or breakthrough bleeding)
• back pain
• abdominal pain

These side effects, especially nausea and vomiting may subside within the first three months of use. If symptoms persist or worsen, please consult your doctor.

As the use of birth control pills may be associated with the occurrence of blood clots in the lungs or in the legs, be alert for the following symptoms and signs of these and other serious adverse effects. Call your doctor immediately if they occur:

• sharp pain in the chest, coughing blood, or sudden

  shortness of breath. These symptoms could indicate a possible blood clot in the lung;

• pain in the calf. This symptom could indicate a possible

  blood clot in the leg;

• crushing chest pain or heaviness. This symptom could

  indicate a possible heart attack;

• sudden severe or worsening headache or vomiting,

  dizziness or fainting, disturbance of vision or speech, or weakness or numbness in an arm or leg. These symptoms could indicate a possible stroke;

  • sudden partial or complete loss of vision. This symptom could indicate a possible blood clot in the eye;
  • severe pain or lump in the abdomen. These symptoms could indicate a possible tumour of the liver;
  • severe depression;
  • yellowing of the skin (jaundice);
  • high blood pressure; although blood pressure usually returns to normal when the pill is stopped;
  • unusual swelling of the extremities; and/or

  • breast lumps. ASK YOUR DOCTOR FOR ADVICE

    AND INSTRUCTION ON REGULAR SELF-EXAMINATION OF YOUR BREASTS.

This is not a complete list of side effects. For any unexpected effects while taking PREVIFEM, contact your doctor or pharmacist.

HOW TO STORE IT

Store between 15^oC - 30^oC. Leave contents in protective packaging until time of use. Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:

By toll-free telephone: 866-234-2345

By toll-free fax: 866-678-6789

Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca

By regular mail:

Canada Vigilance National Office

Marketed Health Products Safety and

Effectiveness Information Bureau

Marketed Health Products Directorate

Health Products and Food Branch

Health Canada

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 by contacting, Novopharm Limited:

at: 1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French)

or druginfo@novopharm.com

Novopharm Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Date of Preparation: August 20, 2007 Date of Revision: December 2, 2008