April 18, 2014
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Drug Factsheets

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Diane-35

(cyproterone - ethinyl estradiol)

DIN (Drug Identification Number)

02233542 DIANE-35 TABLET

How does Diane-35 work? What will it do for me?

This medication contains a combination of two ingredients: cyproterone and ethinyl estradiol. Cyproterone belongs to a group of medications known as antiandrogens. Ethinyl estradiol belongs to a group of medications known as estrogens. Together, they are used to treat certain types of acne in women. This medication works by regulating hormones that affect the skin.

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.

How should I use Diane-35?

This medication is taken in 28-day cycles consisting of 1 tablet daily for 21 days, followed by a 7-day interval without medication (i.e., 3 weeks on, 1 week off). Tablets should be taken at the same time each day. Treatment is usually started on the first day of menstrual bleeding. Usually, several months of treatment are needed before improvement is seen. Once the acne has completely resolved, this medication is usually continued for another 3 or 4 cycles and then stopped. This medication may be restarted if your acne returns.

If spotting or breakthrough bleeding occurs during the 3 weeks during which this medication is being taken, continue taking this medication as the spotting or breakthrough bleeding is usually temporary. If bleeding is persistent or lasts a long time, contact your doctor

If your menstrual period fails to occur during the 7-day tablet-free interval, do not start the next medication cycle and contact your doctor.

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 using the medication without consulting your doctor.

It is very important to take this medication on a regular schedule as prescribed by the doctor. The medication will be less effective if you miss doses. If you miss a dose of this medication, and you remember within 12 hours, take the missed dose. If more than 12 hours have passed, discard the missed tablet and continue to take the remaining tablets in the pack at the usual time. Do not take a double dose to make up for a missed one.

Store this medication at room temperature 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 Diane-35 come in?

Each beige, round, biconvex, sugar-coated tablet contains cyproterone acetate 2 mg and ethinyl estradiol 0.035 mg. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate, povidone, and talc; tablet coating: calcium carbonate, ferric oxide yellow, glycerol, polyethylene glycol, povidone, sucrose, talc, titanium dioxide, and wax.

Who should NOT take Diane-35?

Do not take this medication if you:

  • are allergic to cyproterone, estradiol, or any ingredients of the medication
  • are or may be pregnant
  • have a history of cholestatic jaundice (yellowing of the skin, whites of the eyes caused by problems with bile flow)
  • have active liver disease
  • have any eye problems caused by blood vessel disease in the eye (such as partial or complete loss of vision or other vision changes)
  • have existing or have had blood vessel or blood clotting disorders (including thrombophlebitis, cerebrovascular disease such as stroke, heart attack, and coronary artery disease)
  • have had otosclerosis (abnormal bone growth in the ear) that worsened during pregnancy
  • have known or suspected breast cancer
  • have known or suspected tumours dependent on estrogen
  • have or have had liver tumours
  • have severe diabetes with blood vessel changes
  • have undiagnosed abnormal vaginal bleeding

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