Ortho-Cept Tablets (28 Day): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• prevention of pregnancy

What it does:

ORTHO-CEPT^® is a birth control pill (oral contraceptive) that contains two female sex hormones (desogestrel and ethinyl estradiol). It 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.

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 per cent effective in preventing pregnancy when

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

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

The chance of becoming pregnant increases with incorrect use.

Other Ways to Prevent Pregnancy:

Other methods of birth control are available to you. They are usually less effective than birth control pills. When 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.

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 should always be supervised by your doctor.

You should not use ORTHO-CEPT^® 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 or thrombophlebitis (inflammation of the veins)
• a stroke, heart attack, or coronary artery disease (angina pectoris) or a condition that may be a first sign of a stroke (such as a transient ischemic attack or small reversible stroke)
• disease of the heart valves with complications
• persistent high blood pressure
• over age 35 and smoke
• you are scheduled for major surgery
• prolonged bed rest
• loss of vision due to blood vessel disease of the eye
• known or suspected cancer of the breast or sex organs
• liver tumour associated with the use of the pill or other estrogen-containing products
• jaundice (yellowing of skin and eyes) or liver disease if still present
• diabetes with complications of the kidneys, eyes, nerves, or blood vessels
• migraines with visual and/or sensory disturbances
• known abnormalities of blood clotting system that increase your risk for developing blood clots
• you are pregnant or if pregnancy is suspected
• pancreatitis (inflammation of the pancreas) associated with high levels of fatty substance (triglycerides) in your blood
• very high blood cholesterol or triglyceride levels and/or

• allergic reaction to ethinyl estradiol, desogestrel or to any of

  the other ingredients in ORTHO-CEPT^® (see What the nonmedicinal ingredients are).

What the medicinal ingredients are:

Desogestrel and ethinyl estradiol

What the nonmedicinal ingredients are:

FD&C Blue No. 1 or indigotin blue, colloidal silicon dioxide, hydroxypropyl methylcellulose, iron oxide (red and yellow), lactose, magnesium stearate, stearic acid, povidone, polyethylene glycol, starch, talc, titanium dioxide and vitamin E

What dosage forms it comes in:

ORTHO-CEPT^® (desogestrel and ethinyl estradiol) Tablets are available in a 28-day regimen.

28-day VERIDATE^® Package contains: 21 ORANGE tablets containing 0.15 mg desogestrel and 0.03 mg ethinyl estradiol, 7 GREEN tablets with inactive ingredients.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Cigarette smoking increases the risk of serious side effects on the heart and blood vessels. This risk increases with age and becomes significant in hormonal contraceptive users older than 35 years of age and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including ORTHO-CEPT^®, should not be used by women who are over 35 years of age and smoke.

Birth control pills DO NOT PROTECT against sexually transmitted infections (STIs), including HIV/AIDS.

For protection against STIs, it is advisable to use latex or polyurethane condoms IN COMBINATION WITH the birth control pills.

There are also conditions that your doctor will want to watch closely or that might cause your doctor to recommend a method of contraception other than birth control pills.

BEFORE you use ORTHO-CEPT^® talk to your doctor or pharmacist if the following apply to you:

• breast disease (e.g., breast lumps) or a family history of breast

  cancer

• 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

• wear contact lenses

  • pregnant or breast-feeding
  • systemic lupus erythematosus
  • inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
  • hemolytic uremic syndrome
  • sickle cell disease
  • problems with the valves in your heart and/or have an irregular heart rhythm
  • hereditary angioedema or have had episodes of swelling in body parts such as hands, feet, face, or airway passages
  • gallbladder or pancreatic disease
  • plans for forthcoming surgery
  • history of jaundice (i.e. yellowing of skin and eyes) or other liver disease.

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

If you see a different doctor, inform him or her that you are using ORTHO-CEPT^®.

Tell your doctor if you are scheduled for any laboratory tests since certain blood tests may be affected by hormonal contraceptives.

Also tell your doctor if you are scheduled for MAJOR surgery. You should consult your doctor about stopping the use of ORTHO-CEPT^® four weeks before surgery and not using ORTHO-CEPT^® for a time period after surgery or during bed rest.

ORTHO-CEPT^® should be used only under the supervision of a doctor, with regular follow-up to identify side effects associated with its use. Your visits may include a blood pressure check, a breast exam, an abdominal exam and a 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 ORTHO-CEPT^® only on the advice of your doctor and carefully follow all directions given to you. You must use the birth control pill exactly as prescribed. Otherwise, you may become pregnant. If you and your doctor decide that, for you, the benefits of ORTHO-CEPT^® outweigh the risks, you should be aware of the following risks:

THE RISKS OF USING ORTHO-CEPT^®

1. 1. 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. The risk of developing clots is high during the first year a woman uses a hormonal contraceptive. Clots may occur in many areas of the body.

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 and/or swelling in the calf. These symptoms could indicate a possible blood clot in the leg.
• crushing chest pain or heaviness. These symptoms could indicate a possible heart attack.

• sudden severe or worsening headache or vomiting, dizziness or

  fainting, disturbances 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 blood clot in the eye.

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 or in a blood vessel leading to an arm or leg, resulting in damage to or loss of a limb.

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.

1. 2. 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, 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.

1. 3. Cervical cancer

Some studies have found an increase of cancer of the cervix in women who use hormonal contraceptives, although this finding may be related to factors other than the use of oral contraceptives. However, there is insufficient evidence to rule out the possibility that oral contraceptives may cause such cancers.

Chronic infection with the Human Papilloma Virus (HPV) is believed to be the most important risk factor for cervical cancer. In women who use combination oral contraceptives (COCs) for a long time the chance of getting cervical cancer may be slightly higher. This finding may not be caused by the pill itself but may be related to sexual behaviour and other factors.

1. 4. Gallbladder disease

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

1. 5. Liver tumours

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.

Contact your doctor immediately if you experience nausea, vomiting, severe pain or a lump in the abdomen.

1. 6. 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 pill can damage a developing child. You should check with your doctor about risks to your unborn child from any medication taken during pregnancy.

1. 7. Use after pregnancy, miscarriage or an abortion

Your doctor will advise you of the appropriate time to start the use of ORTHO-CEPT^® after childbirth, miscarriage, or therapeutic abortion.

1. 8.

   Pregnancy after stopping ORTHO-CEPT^®

You will have a menstrual period when you stop taking ORTHO-CEPT^®. 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.

1. 9. Use while breast-feeding

The hormones in birth control pills are known to appear in breast milk. These hormones may decrease the flow of breast milk. Adverse effects on the child have been reported, including 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.

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 ORTHO-CEPT^® include:

• drugs used for epilepsy (e.g., primidone, phenytoin, carbamazepine, lamotrigine, oxcarbazepine, topiramate, rufinamide)
• drugs used for tuberculosis (e.g., rifampin and rifabutin)
• antibiotics (e.g., penicillins, tetracyclines) for infectious diseases
• (fos)aprepitant (drug used for nausea)
• selegiline (drug used for Parkinson’s disease)
• tizanidine (drug used for multiple sclerosis [MS])
• antiretroviral drugs used for HIV/AIDS (e.g., atazanavir, indinavir, nelfinavir, ritonavir, ritonavir-boosted protease inhibitors, etravirine, nevirapine)
• salicylic acid
• bosentan (drug used for pulmonary hypertension which is high blood pressure in the blood vessels between the heart and the lungs)
• theophylline (drug used for asthma)
• stimulants (e.g., modafinil)
• lipid-lowering drugs (e.g., atorvastatin, rosuvastatin)
• colesevelam
• cyclosporine

• antifungals (e.g., griseofulvin, voriconazole, itraconazole,

  fluconazole, ketoconazole)

• the herbal remedy St. John’s wort (primarily used for the

  treatment of depressive moods)

• antihypertensive drugs (for high blood pressure)
• antidiabetic drugs and insulin (for diabetes)
• prednisone, prednisolone

• sedatives and hypnotics (e.g., benzodiazepines, barbiturates,

  chloral hydrate, glutethimide, meprobamate)

• pain medication (e.g., meperidine)
• antidepressants (e.g., clomipramine)
• acetaminophen

• grapefruit juice

• some nutritional supplements (e.g., vitamin B₁₂,

  vitamin C, folic acid)

• antacids (use 2 hours before or after taking ORTHO-CEPT^®)

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 ORTHO-CEPT^®. 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 ORTHO-CEPT^®. Talk to your doctor for more information about drug interactions.

PROPER USE OF THIS MEDICATION

HOW TO TAKE ORTHO-CEPT^®:

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:

   • 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.

1. 3.

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

   latex or polyurethane 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.

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

      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. 6.

      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.

   4. 7.

      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.
   5. 8.

      ALWAYS BE SURE YOU HAVE READY:

      • ANOTHER KIND OF BIRTH CONTROL (such as latex or polyurethane condoms and spermicidal foam or gel) to use as a back-up in case you miss pills, and
      • AN EXTRA, FULL PACK OF PILLS.
   6. 9.

      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 method, such as latex or polyurethane condoms and spermicidal foam or gel, until you can check with your doctor or clinic.

   7. 10.

      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.

   8. 11.

      THERE IS NO NEED TO STOP TAKING BIRTH

      CONTROL PILLS FOR A REST PERIOD.

   9. 12. 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.

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.

   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 VERIDATE^® TABLET DISPENSER. FOLLOW THESE INSTRUCTIONS CAREFULLY:

1. 1.

   Open the compact. Place the blister card into the compact,

   with the tablets facing up, so that the V notch in the blister card matches up with the V shaped post at the top of the compact. Press down firmly on each edge of the blister card and make sure that the edge of the blister card is firmly seated under each of the nibs inside the compact (see diagram).

   There are 21 light orange “active” pills (with hormones) and 7 green “reminder” pills (no hormones).

2. 2.

   If you are to start pill-taking on Sunday, take your first light

   orange pill on the first Sunday after your menstrual period begins. If your period begins on Sunday, take your first pill that day. Remove the first pill at the top of the dispenser (Sunday) by pressing the pill through the hole in the bottom of the dispenser.

3. 3.

   If you are to start pill-taking on “Day 1”, choose a light

   orange pill that corresponds with the day of the week on which you are taking the first pill. Remove that light orange pill by pressing the pill through the hole in the bottom of the dispenser.

4. 4.

   Continue taking one light orange pill daily, clockwise, until no

   pills remain in the outer circle.

5. 5.

   The next day take the green pill from the inner circle that

   corresponds with the day of the week it happens to be. Take a green pill each day until all seven pills are taken. During this

   time your period should begin.

   1. 6. After you have taken all the green pills, begin a new blister card (see Step 1 above in “Instructions for using your VERIDATE^® Tablet Dispenser”) and take the first light orange “active” pill on the next day, even if your period is not yet over.

WHAT TO DO DURING THE MONTH

1. 1.

   TAKE A PILL AT APPROXIMATELY THE SAME

   TIME EVERY DAY UNTIL THE PACK IS EMPTY.

   • Try to associate taking your pill with some regular activity such as eating a meal or going to bed.
   • Do not skip pills even if you have bleeding between monthly periods or feel sick to your stomach (nausea).
   • Do not skip pills even if you do not have sex very often.
2. 2.

   WHEN YOU FINISH A PACK

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

Overdose:

Symptoms of overdose may include nausea, vomiting or vaginal bleeding. Available information from cases of accidental ingestion of oral contraceptives by children indicates no serious effects. Contact your doctor, your hospital or your local Poison Control Centre in case of accidental overdose.

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.

Always be sure you have on hand:

• a back-up method of birth control (such as latex or

  polyurethane condoms and spermicidal foam or gel) 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 ways to make pill-taking easier or about using another method of birth control.

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

  disorders also may be improved.

• Ectopic (tubal) pregnancy may occur less frequently.

  • Acute pelvic inflammatory disease may occur less frequently.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Some users of birth control pills have unpleasant side effects. These side effects are temporary and are not hazardous to health.

There may be tenderness of the breasts, nausea and vomiting. Some users will experience weight gain or loss. Many of these side effects occurred with high-dose combination birth control pills. These side effects are less common with the low-dose pills prescribed today.

Unexpected vaginal bleeding or spotting and changes in the usual menstrual period also may occur. These side effects usually disappear after the first few cycles. They are NOT an indication to stop taking birth control pills. Unless more significant complications occur, a decision to stop using the pill or to change the brand of pill should be made only after three consecutive months of use. Occasionally, users develop high blood pressure that may require stopping the use of birth control pills.

The following additional symptoms have been reported in women taking hormonal contraceptives in general:

• difficulty wearing contact lenses
• vaginal irritation or infections
• urinary tract infections or inflammation
• upper respiratory tract infections (colds, bronchitis, runny or stuffy nose, sore throat, etc.)
• severe headaches
• insomnia
• amenorrhea (lack of a period or breakthrough bleeding)
• flu-like symptoms
• allergy, fatigue, fever
• diarrhea, flatulence

A woman's menstrual period may be delayed after stopping birth control pills. There is no evidence that the use of the pill leads to a decrease in fertility. As mentioned, it is wise to delay starting a pregnancy for one menstrual period after stopping birth control pills.

HOW TO STORE IT

Store in original packaging, between 15°C - 30°C. Keep out of the reach of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions

associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be found at: http://www.janssen.ca or by contacting the sponsor, Janssen Inc. at: 1-800-567-3331 or 1-800-387-8781.

Janssen Inc.

Toronto, Ontario M3C 1L9

Last revised: June 25, 2013