December 19, 2014
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Synphasic

(norethindrone - ethinyl estradiol)

DIN (Drug Identification Number)

02187108 SYNPHASIC 21 TABLETS
02187116 SYNPHASIC 28 TABLETS

How does Synphasic work? What will it do for me?

Norethindrone - ethinyl estradiol belongs to the class of medications called oral contraceptives (birth control pills). It is an estrogen (ethinyl estradiol) and progestin (norethindrone) combination pill used for the prevention of pregnancy.

Norethindrone - ethinyl estradiol works by preventing ovulation (the release of an egg from an ovary) and by causing changes in the mucus of the cervix which make it difficult for sperm to penetrate the egg and for an egg to implant in the wall of the uterus.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

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How should I use Synphasic?

21-day pack: Take 1 tablet daily for 21 days, then take no pills for 7 days.

28-day pack: Take 1 tablet daily for 21 days, then 1 "reminder" pill daily for 7 days.

See the package insert for information on when to start and what to do if you forget to take a pill.

Talk with your doctor about the best time to start your pills. The first day of your menstrual period (bleeding) is known as "Day 1." Your doctor may have you start your pills on the first Sunday after your period starts or on Day 1 of your period. The pills should be taken at approximately the same time every day.

It may be advisable to use a second method of birth control (e.g., latex condoms and spermicidal foam or gel) for the first 7 days of the first cycle of pill use.

Many women have spotting or light bleeding or may feel nauseous during the first 3 months of taking 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.

If you experience vomiting or diarrhea, or if you take certain medications (such as antibiotics), your pills may not work as well. Use a backup method, such as latex condoms and spermicidal foam or gel, until you can check with your doctor or clinic.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is very important to take this medication exactly as prescribed by your doctor. If you miss pills at any time, the risk of becoming pregnant increases.

If you miss one pill, take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day.

If you miss 2 pills in a row during the first 2 weeks of your cycle, take 2 pills the day you remember and 2 pills the next day, then take one pill a day until you finish the pack. Use a second method of birth control if you have sex in the 7 days after you miss the pills.

If you miss 2 pills in a row during the third week of your cycle or 3 or more pills in a row anytime in your cycle and you start your pills on Sunday, keep taking one pill a day until Sunday. On Sunday, safely discard the rest of the pack and start a new pack that day. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.

If you miss 2 pills in a row during the third week of your cycle or 3 or more pills at anytime during your cycle and you start your pills on Day 1, safely dispose of the rest of the pill pack and start a new pack that same day. Use another method of birth control if you have sex in the 7 days after you miss the pills. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.

If you are not sure what to do after missing pills, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.





What form(s) does Synphasic come in?

0.5 mg/35 µg
Each blue circular tablet, impressed "SEARLE" on one side and "BX" on the other side, contains norethindrone 0.5 mg and ethinyl estradiol 0.035 mg (35 µg). Nonmedicinal ingredients: cornstarch, FD&C Blue No. 2, lactose hydrous, magnesium stearate, and polyvidone.

1 mg/35 µg
Each white circular tablet, impressed "SEARLE" on one side and "BX" on the other side, contains norethindrone 1 mg and ethinyl estradiol 0.035 mg (35 µg). Nonmedicinal ingredients: cornstarch, FD&C Blue No. 2, lactose hydrous, magnesium stearate, and polyvidone.

In the 28-day pack there are 7 orange tablets, impressed "SEARLE" on one side and "P" on the other, which contain no active ingredients. Nonmedicinal ingredients: FD&C Yellow No. 6 Lake, lactose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

Who should NOT take Synphasic?

Do not take norethindrone - ethinyl estradiol if you:

  • are allergic to norethindrone, to ethinyl estradiol, or any ingredients of the medication
  • are or may be pregnant
  • have eye damage resulting from blood vessel disease of the eye, such as a partial or complete loss of vision
  • have had a heart attack or coronary artery disease
  • have, have had, or may have breast cancer
  • have too much or too little lipoprotein in the blood
  • have migraine headaches
  • have or have had pancreatitis (inflammation of the pancreas) as a result of high levels of triglycerides
  • have heart valve disease with complications
  • have an irregular heart rhythm
  • have liver disease
  • have multiple risk factors for a blood clot, such as:
    • diabetes with blood vessel damage
    • heavy smoking (more than 15 cigarettes per day) and age over 35
    • inherited blood clotting problems
    • major surgery
    • prolonged bed rest
    • severe high blood pressure (blood pressure of 160/100 or higher)
  • have or have had cancerous or non-cancerous liver tumours
  • have or have had cerebrovascular disorders (e.g, stroke)
  • have or have had thrombophlebitis or thromboembolic disorders (blood clotting problems)
  • have or may have a tumour dependent on estrogen
  • have undiagnosed abnormal vaginal bleeding

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