Brevicon (Norethindrone/Ethinyl Estradiol)

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Brevicon 0.5/35 (28 days)

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Manufactured by: Pfizer Inc
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Brevicon 0.5/35 (28 days)
Product of Canada
Manufactured by Pfizer Inc
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Brevicon (Norethindrone/Ethinyl Estradiol) Dosage and Side Effects

BREVICON is a birth control pill (oral contraceptive) that contains two female sex hormones (ethinyl estradiol and norethindrone).

Warnings and Precautions

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 controls.

If you see a different doctor, inform him or her that you are taking BREVICON 0.5/35 or BREVICON 1/35.

BEFORE you use BREVICON talk to your doctor or pharmacist if the following apply to you:

  • Pregnant or breastfeeding

  • History of jaundice or other liver disease

  • High blood pressure

  • Migraines and headaches

  • Diabetes or family history of diabetes

  • Wear contact lenses

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

  • Fibroid tumours on the uterus

  • History of emotional disorders, especially depression

  • Metabolic or endocrine diseases and abnormal metabolism of calcium and phosphorus

  • Rheumatoid arthritis or synovitis

  • Hereditary or history of angioedema (episodes of swelling in body parts such as hands, feet, face, or airway passage)

  • Abnormal level of fat in the blood stream (high cholesterol or triglycerides)

  • Smoke cigarettes

  • Heart or kidney disease

  • Epilepsy/seizures

  • Gallbladder or pancreatic disease

  • Family history of blood clots, heart attacks or strokes

  • Persistent irregular vaginal bleeding

  • Overweight

  • 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

If you detect any new masses on your breasts while taking BREVICON you should advise your doctor.

If you have to undergo a major elective surgery, you should advise your surgeon that you are taking BREVICON. You should consult your doctor about stopping the use of BREVICON four weeks before surgery and not use BREVICON for a time period after surgery or during bed rest.

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

BREVICON 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 BREVICON 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.

Breakthrough bleeding/spotting may occur while you are taking an oral contraceptive, especially during the first three months of use. If this bleeding persists or recurs, you should advise your doctor. Women with history of amenorrhea (absence of menstrual periods) or oligomenorrhea (irregular or infrequent menstrual periods) may remain anovulatory or become amenorrheic following discontinuation of oral contraceptives.

The Risks of Using Birth Control Pills:

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

    Blood clots are the most common serious side effect 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. While the risk of blood clots increases with age in both pill users and non users, the increased risk from the pill appears to be present at all ages. 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.

  2. Breast Cancer

    The most significant risk factors for breast cancer are increasing age and a 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.

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

    • a history of breast cancer in the family

    • breast nodules or thickenings

    • discharge from the nipple

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

  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.

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

    Oral contraceptives should not be taken by pregnant women because they may damage the developing child. An increased risk of heart and limb and other defects has been associated with the use of sex hormones, including oral contraceptives, during pregnancy. In addition, the developing female child whose mother has received DES (diethylstilbestrol), an estrogen, during pregnancy has a risk of developing cancer of the vagina or cervix in her teens or young adulthood. Abnormalities of the urinary tract and sex organs have been reported in male offspring so exposed. It is possible, although this has not been demonstrated, that other estrogens such as those in oral contraceptives could have the same effect in the child if the mother takes them during pregnancy.

    There is also no conclusive 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, she should be aware that pregnancy may be delayed for some months. 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.

  5. 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 benign or malignant liver tumours. Such tumours are extremely rare. Benign tumours do not spread but they may rupture and produce internal bleeding which may cause death.

  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 and may interfere with the normal development of the baby.

  7. Pregnancy after stopping taking birth control pills

    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 alternate methods of contraception during this time.

  8. Use after pregnancy, miscarriage or abortion

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

  9. Use while breastfeeding

    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 hormones may decrease the flow of breast milk. The long-term effects on the developing child are not known. However, cases of breast enlargement have been reported in breast-fed infants. You should use another method of contraception and only consider starting the birth control pill once you have weaned your child completely.

  10. Increase in epileptic seizures

    Stop taking BREVICON 0.5/35 and BREVICON 1/35 and notify your doctor if you are having seizures more often.

Side Effects

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 or liquid leaking from your breasts. You can have nausea, and vomiting and tremors. Some users will experience weight gain or loss, change in appetite. 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. High blood pressure may persist after stopping the pill and may lead to serious disease of the kidney and circulatory system.

Other side effects may include:

  • Growth of pre-existing fibroid tumours of the uterus

  • Mental depression, nervousness

  • Increased blood sugar levels, tell your doctor if you are drinking or urinating more frequently

  • Liver problems with jaundice (yellowing of the skin)

  • An increase or decrease in hair growth (hirsutism, loss of scalp hair), sex drive and appetite

  • Skin pigmentation (brown spots that may not go away). Avoid exposure to the sun, especially if you have a history of brown spots.

  • Headaches, dizziness

  • Migraines

  • Changes or loss of hearing

  • Cloudy vision, sore eyes

  • Rash

  • Vaginal infections

  • Difficult or painful urination, blood in the urine

Infrequently, there is a need to change contact lens prescription or an inability to use contact lenses.

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.

Interactions with this medication

The concurrent administration of BREVICON with other drugs may result in an altered effectiveness of either drug. It is important to advise your doctor of any drug you are taking, both prescription and non-prescription, before you take BREVICON.

Drugs that may interact with BREVICON include:

  • Anticonvulsants (carbamazepine, ethosuximide, felbamate, oxcarbazepine, phenobarbital, phenytoin, primidone, topiramate, lamotrigine)

  • Antibiotics (ampicillin, cotrimoxazole, penicillin, rifampin, chloramphenicol, metronidazole, neomycin, nitrofurantoin, sulfonamides, tetracyclines, troleandomycin, rifabutin)

  • Antifungals (griseofulvin, fluconazole)

  • Cholesterol Lowering Agents (clofibrate, atorvastatin)

  • Sedatives and Hypnotics (benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate, chlordiazepoxide, lorazepam, oxazepam, diazepam)

  • Antacids

  • Alpha-II Adrenoreceptor Agents (clonidine)

  • Antidiabetic Drugs (oral hypoglycemics and insulin)

  • Antihypertensive Agents (guanethidine, methyldopa and beta blockers)

  • Antipyretics (acetaminophen, antipyrine, ASA)

  • Betamimetic Agents (isoproterenol)

  • Corticosteroids (prednisone, dexamethasone)

  • Phenothiazine Tranquilizers (all phenothiazines, reserpine and similar drugs)

  • HIV infection (ritonavir, indinavir, nevirapine)

  • Hepatitis C virus (HCV) (boceprevir, telaprevir)

  • Bronchodilator (theophylline)

  • Stimulants (modafinil)

  • Tricyclic antidepressants (clomipramine)

  • Bosentan

  • Others: phenylbutazone, antihistamines, analgesics, antimigraine preparations, anticoagulants, aminocaproic acid, vitamin E, vitamin B12, vitamin C, cyclosporine, folic acid, meperidine, St John's wort, flunarizine

Caffeine and alcohol may also affect the efficacy of Oral Contraceptives.

During concomitant use of BREVICON and substances that may affect its effectiveness, it is recommended that you use a non-hormonal back-up method of birth control in addition to the regular intake of BREVICON. In the case of prolonged use of such substances, oral contraceptive should not be considered the primary contraceptive. You should consult your doctor or pharmacist for guidance if you are taking drugs that interact with BREVICON.

This is not a complete list of possible drug interactions with BREVICON. Talk to your doctor for more information about drug interactions.

Proper Use of this medication

Usual dose:

  1. Read these directions

    • Before you start taking your pills, and

    • Any time you are not sure what to do.

  2. Look at your pill pack to see if it has 21 or 28 pills:

    • 21-PILL PACK: 21 active pills (with hormones) taken daily for three weeks, and then no pills for one week

      OR

    • 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

    Note: Diagrams apply to both BREVICON 0.5/35 and BREVICON 1/35.

    (See package insert for illustrations.)

  3. It is recommended that you 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.

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

  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.

  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.

  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.

  8. Always be sure you have ready:

    • Another kind of birth control (such as latex condoms and spermicidal foam or gel) to use as back-up in case you miss pills, and

    • An extra, full pack of pills.

  9. If you experience vomiting or diarrhea, or if you take certain medicines, such as antibiotics, you pills may not work as well. Use a back-up method, such as latex condoms and spermicidal foam or gel, until you can check with your doctor or clinic.

  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.

  11. If your questions are not answered here, call your doctor or clinic.

There is no need to stop taking birth control pills for a rest period.

When to start the first pack of BREVICON 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.

  1. 21-day combination:

    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.

    1. The first day of your menstrual period (bleeding) is day 1 of your cycle. 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. Take one pill at approximately the same time every day for 21 days. Then take no pills 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.)

  2. 28-day combination

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

    1. The first day of your menstrual period (bleeding) is day 1 of your cycle. 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. Take one pill at approximately the same time every day for 28 days. Begin a new pack the next day, not missing any days. Your period should occur during the last seven days of using the pills.

What to do during the month:

  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. When you finish a pack

    • 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:

Numerous cases of the ingestion, by children, of estrogen progestogen combinations have been reported. Although mild nausea may occur in case of overdosage, there appears to be no other reaction.

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 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. Talk 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.

  • Effects of menses: increased menstrual cycle regularity; decreased menstrual blood loss; decreased incidence of iron deficiency anemia secondary to reduced menstrual blood loss; decreased incidence of dysmenorrhea (painful periods) and premenstrual syndrome (PMS)

  • Effects related to ovulation inhibition: decreased incidence of functional ovarian cysts; decreased incidence of ectopic pregnancy

  • Effects on other organs of the reproductive tract: decreased incidence of acute uterine tube inflammation; decreased incidence of endometrial cancer (50 per cent); decreased incidence of ovarian cancer (40 per cent); potential beneficial effects on endometriosis; decreased incidence of acne, excessive hair growth and other male hormone-related disorders

  • Effects on breasts: decreased incidence of benign (non-cancerous) breast disease; decreased incidence of breast biopsies

Other related products

The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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