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Medication Information Leaflet
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™-35 and Estelle™-35 ED is a 21 day and 28 day pack, respectively. The only difference between them is that Estelle™-35 ED contains additional 7 (white) inactive tablets in the 28-day pack.
- 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 or restarting this medication after a break).
- 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 days in a row, 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 (menses). This usually starts within day 2-3 after the last yellow (active) tablet is taken.
- Start taking your next pack of medication after the 7-day tablet-free days or 7-day period of white (inactive) tablets, even if you are still having menstrual bleeding.
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. Take the next tablet 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 on the next day.
- Use a barrier method such as a condom for the next 7 days.
If sexual intercourse happened in the previous 7 days, you may be pregnant. See your doctor for advice as soon as possible.
- 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 on the next day.
- 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 do not occur after the next pack is finished, you should take a pregnancy test to make sure you are not pregnant. OR Stop taking medication from the current pack for 7 days (7-day tablet-free period). A withdrawal bleed (menses) usually occurs and then start a next pack after 7 days. |
| 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 make sure you are not pregnant. 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
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
- You are a smoker
- 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 painkillers such as Paracetamol to manage headaches
- Unable to tolerate 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.
Inform your doctor if these side effects become severe and bothersome.
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
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
If you experience any of these side effects/ symptoms, you should stop your medication and see your healthcare professional immediately.
- Some medications might interact with this medication. These include antibiotics and antifungals. Check with your healthcare professional if you are taking any other medicines, supplements or herbal products.
- If you see another healthcare professional, inform him that you are taking this medication before he prescribes any other medications.
Store in a cool and dry place, away from direct sunlight. Keep this medication away from children.
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