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Cyproterone Acetate + Ethinylestradiol

Drug Class: Commonly Known As: Category:
Contraceptive Estelle-35/35 ED Adult

Cyproterone Acetate + Ethinylestradiol - What is it for

Estelle™-35/35 ED contains two types of sex hormones, a progestogen called Cyproterone acetate and an estrogen called Ethinylestradiol. It is used in women of reproductive age who suffer from conditions due to an increased sensitivity to androgens in the body. Androgens are hormones in the body that make one display more male characteristics. Women who are more sensitive to androgen may have conditions such as acne, very oily skin or excessive hair growth in certain areas of the face or body. The medication also provides effective oral contraception in women being treated for the above conditions.
If you are taking Estelle™-35/35 ED for any of the conditions above, you must not take any other hormonal contraceptive at the same time. 

Estelle™ and Estelle™-35 ED is a 21 day and 28 day pack, respectively. The only difference between them is that Estelle™-ED contains additional 7 (white) inactive tabletss in the 28-day pack.

Cyproterone Acetate + Ethinylestradiol - Side Effects, Precautions, and Contraindications

What side effects can Cyproterone Acetate + Ethinylestradiol cause?

  • Spotting or bleeding may occur between your periods during the first 1-2 months of taking oral contraceptives. However, if this continues after the second month, check with your doctor
  • Nausea, vomiting, bloating and stomach cramps.
    • Take the medication after food to reduce these side effects.
  • Breast tenderness
  • Headache or migraine
    • You may take Paracetamol to manage headaches
  • Intolerance to contact lenses
  • Weight changes, mood swings.
    • Take medication at the same time every day to avoid huge changes in the hormone levels in your body.
  • Pigmentation (changes in colour) of the skin.
    • Apply sunblock when you are outdoors and avoid long hours of sun exposure.

Check with your doctor about any symptoms that becomes bothersome.

Using a combined hormonal medication increases a woman’s risk of developing blood clots compared with a woman not taking any combined hormonal medication. The risk of developing blood clots in a vein is highest during the first year a woman uses the medication. Other risk factors of developing blood clots include smoking and obesity. However, blood clot formation is rare and the doctor would have evaluated and weighed its benefits over risks before making the recommendation.

  • The symptoms of blood clot include one or more of the following:
    • Any unusual sudden cough, breathlessness or difficulty in breathing
    • Severe pain in the chest which may reach the left arm
    • Severe pain in legs or swelling in either of your legs
    • Weakness or numbness in any part of your body
    • Change in your speech, including slurring of words
    • Change in your senses of hearing, smell or taste
    • Vision changes such as loss of vision/ blurred vision

Other rare but serious side effects that you may or may not experience.

  • Unusual, severe or long lasting headache or worsening of migraine
  • Dizziness or fainting
  • Severe pain in your abdomen
  • Dark urine or light coloured stools, nausea, vomiting, loss of appetite, stomach pain, yellowing of your eyes or skin

The symptoms of a drug allergy include one or more of the following:

  • Swollen face/eyes/lips/tongue
  • Difficulty in breathing
  • Itchy skin rashes over your whole body

If you experience any of these side effects/ symptoms, you should stop your medication and see your healthcare professional immediately.

Before taking Cyproterone Acetate + Ethinylestradiol, what precautions must I follow?

​Inform your healthcare professional if:

  • You are allergic to this medication or any of the other ingredients of this medication
  • You are pregnant, planning to become pregnant, or breastfeeding
  • You are taking any other medications, including supplements, traditional medications and herbal remedies.
  • You have a history of or current medical conditions such as liver problems, stroke, heart disease, migraine headaches, epilepsy (fits), diabetes or cancer

If you are seeing other healthcare professionals for any other medical conditions, inform them that you are taking this medication.

What food or medicine must I avoid when I take Cyproterone Acetate + Ethinylestradiol?

Some medications including antibiotics and antifungals may affect how Estelle™-35/35ED works or be affected by Estelle™-35/35ED. Please inform other healthcare professionals about this medication you are taking if you are seeing them for other medical conditions.

Cyproterone Acetate + Ethinylestradiol - Dosage and How to Use

How should Cyproterone Acetate + Ethinylestradiol be used?

  • Do not stop taking your medication without checking with your healthcare professional.
  • You should take this medication after food.
  • You may start taking this medication on the first or second day of your menses (if this is your first time taking hormonal contraceptives).
  • If you are also using it for contraceptive purposes, a barrier method of contraception e.g. condoms, is recommended for the first 7 days of taking Estelle™-35/35 ED for the first time.
  • You should take one yellow (active) tablet daily for 21 consecutive days, preferably at the same time every day. Each subsequent pack is started after a 7-day tablet-free interval or 7-day period of white (inactive) tablets, during which a withdrawal bleeding usually occurs. This usually starts on day 2-3 after the last yellow (active) tablet is taken and may not have finished before the next pack is started.

What should I do if I miss a dose?

There is no action needed if you have missed the white (inactive tablets) ; however you must  follow the steps below if you miss any of your 21 yellow (active) tablets to ensure that contraception effect is not reduced.

Within 12 hours:
Take the missed tablet as soon as remembered, then continue taking the next one at your usual time.

More than 12 hours:
If the missed tablet is within

  • Week 1 of the pack: Take the missed tablet as soon as remembered, even if it means taking 2 tablets at the same time. Continue to take your tablets at your usual time. Use a barrier method such as a condom for the next 7 days.
  • Week 2 of the pack: Take the missed tablet as soon as remembered, even if it means taking 2 tablets at the same time. Continue to take your tablets at your usual time. If you have taken your tablets correctly in the 7 days before the first missed tablet, there is no need to use extra contraceptive precautions. However if this is not the case, or you have missed more than 1 tablet, use a barrier method such as a condom for the next 7 days.
  • Week 3 of the pack:  Depending on whether you have taken your tablets correctly in the 7 days before the first missed tablet, you would have to follow the following options:
​No missed tablets in the last 7 days

​Take the missed tablet as soon as remembered, even if it means taking 2 tablets at the same time. Continue to take your tablets at your usual time and start the next pack right away without the 7-day tablet free period or 7-day white (inactive) tablets i.e. no gap should be left between packs. Your menses may not come until the next pack is finished, but there is no need to worry. However, if your menses does not occur after the next pack is finished, you should take a pregnancy test to rule out pregnancy.

OR

Stop the current pack and have a tablet-free period of up to 7 days – during which time a withdrawal bleed (menses) usually occurs and then continue with the next pack.

​Missed tablet in the last 7 days ​Take the missed tablet as soon as remembered, even if it means taking 2 tablets at the same time. Continue to take your tablets at your usual time and start the next pack right away without the 7-day tablet free period / 7-day white (inactive) tablets i.e. no gap should be left between packs. Your menses may not come until the next pack is finished, but there is no need to worry. However, if your menses does not occur after the next pack is finished, you should take a pregnancy test to rule out pregnancy.
AND
Use a barrier method such as a condom for the next 7 days

 

**If you miss your period (especially with missed tablets), check with your doctor to determine if you are pregnant before continuing to take the next cycle of contraceptives.

If you vomit or suffer from diarrhea within 3 to 4 hours of taking this medication, the tablet may not be absorbed. This is considered a missed dose. You should then follow the instructions above.

What should I do if I overdose?

Cyproterone Acetate + Ethinylestradiol - Handling

How should I handle Cyproterone Acetate + Ethinylestradiol safely?

Cyproterone Acetate + Ethinylestradiol - Storage

How should I store Cyproterone Acetate + Ethinylestradiol?

Keep away from children;#Keep in a cool, dry place, away from direct sunlight;#

How should I dispose of Cyproterone Acetate + Ethinylestradiol safely?

​Pack this medication into a black trash bag and seal it tightly before throwing into the rubbish chute or bin.

Cyproterone Acetate + Ethinylestradiol - Additional Information

  • Updated on Monday, September 30, 2019
  • Article contributed by PSS National Medication Information Workgroup PSS National Medication Information Workgroup

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