ZOELY® – NATURAL BALANCE 1,2

Zoely® contains Nomegestrol Acetate and 17β-estradiol1. 17β-estradiol is a natural estrogen with a structure that is identical to the estrogen produced in a woman’s body1, Nomegestrol Acetate is metabolically neutral without any androgenic, estrogenic or mineralo-glucocorticoid activities.1

What is Zoely and what it is used for?

  • Zoely® is a contraceptive pill and is used to prevent pregnancy.
  • Each tablet contains a small amount of two different female hormones, namely nomegestrol acetate and 17β-estradiol.
  • Contraceptive pills that contain two hormones are called “combined oral contraceptive” pills.

How Does it work?

  • Zoely acts in various ways to prevent pregnancy; most importantly it works to prevent egg release.
  • It also causes changes to the lining of your womb.

How to take Zoely®1

Take Zoely® every day for 28 days

  • Unlike some pills, Zoely comes in a pack of 28 pills, each pack starts with 24 white pills which contain active ingredients and 4 yellow pills which are placebo pills.
  • One tablet of Zoely should be taken at the same time every day, it does not matter if you take your pill with a meal or not. Zoely can be taken with liquid if needed.
  • Stickers marked with the 7 days of the week are provided in your pack. You should choose the sticker that starts with the day you begin taking Zoely and stick that days sticker on the blister.
  • Follow the direction of the arrows on the blister when taking your pills each day. Take one pill each day, until you have finished all 28 pills.

After you have taken all 28 pills in your pack, start your next pack the following day.

  • You may experience withdrawal bleeding on day 2-3 after intake of the last white tablet and it may not have finished before you need to start the next pack. Start your next pack the day after you finished your existing pack irrespective of whether your withdrawal bleed has stopped or not.

How to start taking Zoely®1

If you have not used a contraceptive with hormones in the previous month.

  • Begin with Zoely® on the first day of your cycle (that is the first day of your period).
  • If you start Zoely®on the first day of your period you are immediately protected against pregnancy.

Changing from a combined hormonal contraceptive, or combined contraceptive vaginal ring or patch.

  • You can start Zoely® preferably on the day after the last active tablet of your previous pill, or on the day immediately after the tablet-free days of your previous pill finish.

Changing from a progestogen-only-method (progestogen-only pill, injection, implant or a progestogen-releasing intrauterine system (IUS).

  • You may switch any day from the progestogen-only pill.
  • You may switch to Zoely® from an implant or an IUS on the day of its removal.
  • You may switch to Zoely® from an injectable when the next injection would be due.
  • In all cases use extra protective measures (for example, a condom) for the first 7 days of taking Zoely®.

Missed pill guidance

  • If you are less than 24 hours late taking a tablet, protection against pregnancy is not reduced. Take Zoely® as soon as you remember and then take the following tablets again at the usual time.
  • If you are more than 24 hours late taking your pill, protection against pregnancy may be reduced. The greater the number of tablets that you have forgotten, the greater is the risk of becoming pregnant. The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or at the end of the pack.
  • If you miss your pill in day 1 – 7 of the blister, take the last missed white pill even if it means taking two tablets together, continue to take Zoely® as before and use a barrier method such as a condom to protect against pregnancy for the next 7 days.
  • If you miss your pill on day 8 to 17, the advice is the same as for day 1 – 7. If you took your white pill correctly for the 7 days preceding the missed pill, there is no need for additional contraceptive protection such as a condom. However if you did not take the white pill correctly for the 7 days preceding the missed pill day or if you missed more than one pill, there is a need for extra contraceptive protection until you have completed 7 days of uninterrupted white pill taking.
  • If you miss your pill on day 18 – 24, the risk of pregnancy is high because of the forthcoming yellow placebo pill phase. You have three options.
  • Option 1: If you had 7 days of un-interrupted white pill taking before the missed pill, take the last missed pill as soon as you remember even if that means taking two pills together. Continue to take your white pills until they are used up. Discard your four placebo (yellow) pills and start the next day on your next pack of Zoely®. You may not experience a withdrawal bleed in this cycle but experience some spotting during white pill days. Additional contraceptive protection is not required.
  • Option 2: If you have 7 days of un-interrupted white pill taking AND have not missed more than one pill in the pack, discontinue white pill taking and take the placebo (yellow) tablets for a maximum of three days. Immediately start the next pack. Additional contraceptive protection is not required.
  • Option 3: If you do not have 7 days of uninterrupted white pill taking, take the last missed pill as soon as you remember even if that means taking two pills together. Continue to take your white pills until they are used up. Discard your four placebo (yellow) pills and start the next day on your next pack of Zoely®. You may not experience a withdrawal bleed in this cycle but experience some spotting during white pill days. Additional contraceptive protection is required for at least 7 days to protect you from pregnancy.
  • If you miss your pill from day 25 – day 28, contraceptive protection is not reduced, you can disregard taking the pill for that missed day(s) and resume on the yellow pill for the next day. However, on day 29, you must start your new pack of ®.
  • If you are unsure about the number or colours of pills taken and which advice is relevant for you, please take additional contraception protection until you have completed at least 7 days of uninterrupted white pill taking.

What if I vomit or have severe diarrhea after taking Zoely

If you vomit or you have severe diarrhoea within 3-4 hours of taking a white pill, there is a risk that the active substances in the pill will not be fully taken up by your body.

  • After vomiting or diarrhoea, take another pill as soon as possible.
  • If possible take it within 24 hours of when you normally take your pill.
  • If that is not possible or 24 hours have passed, you should follow the missed pill guidance as above to ensure you are protected against pregnancy.
  • You may need to take a pill from another pack to maintain your schedule.

Frequently asked questions about Zoely

What if I miss a dose of Zoely®?
If you miss a pill, follow the missed pill guidance or review the Patient Information Leaflet contained inside every pack of Zoely®. If you miss more than one pill ask your doctor, nurse or pharmacist for advice.

What happens if I have a stomach upset?
If you have been sick within 3-4 hours after taking your pill or you have severe diarrhoea, your body may not get its usual dose of hormones from that pill. After vomiting or diarrhoea, take another pill from a reserve strip as soon as possible. If possible take it within 24 hours of when you normally take your pill. If that is not possible or 24 hours or more have passed, you should follow the advice given for missing a pill.

What side effects may I experience?
Like all combined hormonal contraceptives Zoely® may cause side effects, although not everybody gets them. Common side effects include depressive mood, headache, migraine, nausea, breast pain, acne, bleeding between periods etc., Depressed mood and depression are undesirable effects of hormonal contraceptives. Contact your physician in the case of mood changes and depressive symptoms. If you get side effects, including any possible side effects not listed above, talk to your doctor or pharmacist.

Am I likely to develop a blood clot if I take Zoely®?
The use of any combined oral contraceptive pill increases your risk of developing a blood clot compared with women who do not take any contraceptive pill. If you notice any of the signs below, stop taking your pill and contact your doctor immediately.

  • Severe pain and/or swelling in one of your legs which may only be felt on walking / standing.
  • Sudden severe pain in the chest which may reach the left arm.
  • Sudden breathlessness.
  • Sudden cough without an obvious cause.
  • Any unusual, severe or long-lasting headache or worsening of migraine.
  • Partial or complete blindness or double vision.
  • Difficulty in speaking or inability to speak.
  • Giddiness or fainting.
  • Weakness, strange feeling or numbness in any part of the body.
  • Severe pain in your tummy (abdomen).

Are there any medicines I shouldn’t take whilst I am on oral contraceptives?
Some medicines may stop your pill from working properly and mean that you need to take extra contraceptive precautions. These include antibiotics, St John’s Wort and medicines to treat epilepsy, tuberculosis, HIV and fungal infections. Your pill may also stop other medicines from working properly such as ciclosporin, (an immunosuppressant) and lamotrigine (to treat epilepsy). Your doctor or pharmacist will advise you if you are unsure about taking other medicines in combination with Zoely®.

Am I at risk of developing breast cancer?
Breast cancer has been observed slightly more often in women using combined oral contraceptive pills, but it is not known whether this is caused by the treatment. For example, it may be that more tumours are detected in women on combined oral contraceptive pills because they are examined by their doctors more often. The risk of breast cancer gradually reduces after stopping combined oral contraceptives.

Zoely® General Information

  • If taken correctly, Zoely®is an effective, reversible form of contraception.
  • Zoely® will not protect you against sexually transmitted diseases. Only condoms can help to do this.
  • Zoely® slightly increases the risk of having a blood clot in veins and arteries, especially in the first year of use or when restarting a combined hormonal contraceptive following a break of 4 or more weeks.
  • Please be alert and see your doctor if you think you may have symptoms of a blood clot, or suffer any side effects when taking Zoely®.

References:

  1. ZOELY Summary of Product Characteristics
  2. Chabbert_Buffet N et al., Gynaecol Endocrinol 2013;29 (10) 891 – 96

Information placed on this digital platform is not intended as a substitute for consultation with your healthcare professional. Please consult your doctor or nurse for further information.

For all other queries, please contact our Irish office at Tel: +353 (0) 1 2057760, Fax: +353 (0) 1 2698919 or irishoffice@consilienthealth.com or our Malta office at Tel: +356 22588600 or on email info@viviancorp.com.

Copyright ©2021 Consilient Health Ltd. All rights reserved.

The information on this website is intended for patients who have been prescribed Zoely that reside in the Republic of Ireland or Malta only.

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