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DIN (Drug Identification Number)DIN (Drug Identification Number)DIN (Drug Identification Number)DIN (Drug Identification Number)
 

How does this medication 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.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. 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 this medication?

This medication is taken in 28-day cycles consisting of one 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.

If spotting or breakthrough bleeding occurs during the three weeks during which this medication is being taken, 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 that this medication be used 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 missing 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.

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 this medication come in?

Each beige, round, 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.

Some medications may have other generic brands available. Always ask your doctor or pharmacist about the safety of switching between brands of the same medication.

Who should NOT take this medication?

Cyproterone - ethinyl estradiol should not be taken by people who:

  • is allergic to cyproterone, estradiol, or to any ingredients of the medication
  • is or may be pregnant
  • has a history of cholestatic jaundice
  • has active liver disease
  • has any eye lesion caused by blood vessel disease in the eye (such as partial or complete loss of vision or a defect in the visual fields)
  • has existing or have had blood vessel or blood clotting disorders (including thrombophlebitis, thromboembolic disorders, cerebrovascular disease, heart attack, and coronary artery disease)
  • has had otosclerosis with deterioration during pregnancy
  • has known or suspected breast cancer
  • has known or suspected tumours dependent on estrogen
  • has or have had liver tumours
  • has severe diabetes with blood vessel changes
  • has undiagnosed abnormal vaginal bleeding
  •  
 
 

What side effects are possible with this medication?

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor. Your health professional may be able to help you deal with some of the effects.

The following side effects may go away as your body becomes used to the medication; check with your doctor if they continue or become bothersome.

More common:

  • abdominal, cramping, or bloating
  • breast pain, tenderness, or swelling
  • dizziness
  • nausea
  • swelling of ankles and feet
  • unusual tiredness or weakness
  • vomiting

    Less common:

  • brown, blotchy spots on exposed skin
  • gain or loss of body or facial hair
  • increased or decreased interest in sexual intercourse
  • increased sensitivity of skin to sunlight
  • weight gain or loss

Check with your doctor as soon as possible if any of the following side effects occur:

More common (usually less common after the first 3 months of use):

  • changes in the uterine bleeding pattern during or between menstrual periods (such as decreased bleeding, breakthrough bleeding or spotting between periods, prolonged bleeding, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometimes)

    Less common:

  • headaches or migraines (although headaches may lessen for many users, for others, they may increase in number or become worse)
  • increased blood pressure
  • vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge
  • for women with diabetes: mild increase of blood sugar-faintness, nausea, pale skin, or sweating

    Rare:

  • depression
  • swelling, pain, or tenderness in upper abdominal area
  • for women who smoke tobacco: pains in stomach, side, or abdomen; yellow eyes or skin
  • for women with a history of breast disease: lumps in breast

Get emergency medical help immediately if any of the following side effects occur:

Rare:

  • abdominal or stomach pain (sudden, severe, or continuing)
  • coughing-up of blood
  • headache (severe or sudden)
  • loss of coordination (sudden)
  • loss of vision or change in vision (sudden)
  • pains in chest, groin, or leg (especially in calf of leg)
  • shortness of breath (sudden or unexplained)
  • slurring of speech (sudden)
  • weakness, numbness, or pain in arm or leg (unexplained)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Birth control: This medication should not be used only for the purpose of birth control. Women should use a non-hormonal method of birth control (such as condoms) while taking this medication.

Breast cancer: All women who take this medication should practice breast self-examination. Ask your doctor to teach you how to do this. Women with a family history of breast cancer should be closely monitored by their doctor while taking this medication.

Medical conditions: The combination of obesity, high blood pressure, and diabetes greatly increases the risk of side effects from this medication. If you have this combination of medical conditions, talk to your doctor. This medication can cause fluid retention, which may worsen conditions such as high blood pressure, heart disease, or kidney disease.

Smoking: Smoking increases the risk of serious side effects on the heart and blood vessels. This risk increases with age and heavy smoking (15 or more cigarettes per day) and is even more serious for women over 35 years of age. Women who use this medication should not smoke.

Vaginal bleeding: Report any unusual vaginal bleeding to your doctor.

Vision and contact lenses: If your contact lenses do not seem to fit as well as they used to, consult your doctor or eye care professional. You may need to stop wearing them, or be fitted for a different pair.

Pregnancy: This medication should not be taken by pregnant women. If you are or may be pregnant, stop taking the medication and talk to your doctor as soon as possible. After stopping treatment, you should wait until at least one normal menstrual cycle has occurred before trying to get pregnant.

Surgery: If you are scheduled for surgery, let all doctors involved in your care know that you are taking this medication.

Breast-feeding: Women who are using this medication should not breast-feed.

What other drugs could interact with this medication?

There may be an interaction between cyproterone - ethinyl estradiol and any of the following:

  • ampicillin
  • analgesics (painkillers; e.g., codeine)
  • antidiabetes medications (e.g., glyburide, gliclazide)
  • antihistamines (e.g., chlorpheniramine, loratidine)
  • anti-migraine medications (e.g., dihydroergotamine)
  • barbiturates (e.g., pentobarbital, secobarbital)
  • beta-blockers (e.g., metoprolol, atenolol)
  • blood pressure-lowering medications (e.g., hydrochlorothiazide)
  • caffeine
  • carbamazepine
  • certain benzodiazepines (e.g., alprazolam, clonazepam)
  • chloramphenicol
  • corticosteroids (e.g., prednisone)
  • griseofulvin
 
  • isoniazid
  • neomycin
  • nitrofurantoin
  • penicillin V
  • phenothiazines (e.g., chlorpromazine)
  • phenobarbital
  • phenylbutazone
  • phenytoin
  • primidone
  • rifampin
  • sulfonamides (e.g., sulfamethoxazole)
  • tetracycline
  • theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
  • topiramate
  • tricyclic antidepressants (e.g., amitriptyline, desipramine)
  • warfarin
  • vitamin C (ascorbic acid)

If you are taking any of these medications, speak with your doctor or pharmacist.Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
© DR. PRAVEEN RAMACHANDRA
womenhormone@gmail.com, womenhormone@rediffmail.com