About Zelleta®
Your healthcare provider has prescribed Zelleta® as your oral contraceptive.
If you are starting Zelleta® for the first time, please carefully read the Patient Information Leaflet (PIL) provided inside the pack.
Understanding how to take Zelleta® correctly and what might make it less effective is essential to prevent an unwanted pregnancy.
If you received Cerazette® previously
Changing to Zelleta® is as simple as getting used to the new packaging – you’ll take the same number of tablets each month, and request repeat prescriptions in the same way as when you took Cerazette®.1,2 When taken correctly, Zelleta® is just as effective at preventing pregnancy as Cerazette®.
Zelleta® contains the same active ingredients in the same amounts as Cerazette®, and is therefore considered to work in the same way.1,2
If you still have any concerns about your change of brand, please talk to the healthcare provider who prescribed you this product.
Other Concerns?
Only your healthcare provider knows your full medical history, so if there is any information in the Patient Information Leaflet that you want to know more about or worries you, please talk to your doctor or healthcare provider for advice and guidance.
Zelleta® are used to prevent pregnancy. Zelleta® contain a small amount of one type of female sex hormone, the progestogen desogestrel. For this reason Zelleta® are called a progestogen-only-pill (POP), or a mini-pill. Contrary to the combined pill, the POP or mini-pill does not contain an oestrogen hormone next to the progestogen.
Most POPs or minipills work primarily by preventing the sperm cells from entering the womb but they do not always prevent the egg cell from ripening, which is the main way that combined pills. Zelleta® is distinct from other mini-pills in having a dose that in most cases is high enough to prevent the egg cell from ripening. As a result, Zelleta® provide high contraceptive efficacy.
In contrast to the combined pill, Zelleta® 75 micrograms Tablets can be used by women who do not tolerate oestrogens and by women who are breast feeding. A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Zelleta®. You also may not have any bleeding at all.
Please take the time to read the Patient Information Leaflet carefully and in full.
Do not take Zelleta®
- If you are allergic to any of the ingredients of Zelleta® 75 micrograms Tablets.
- If you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel (e.g. of the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
- If you have or have had jaundice (yellowing of the skin) or severe liver disease and your liver is still not working normally.
- If you have or if you are suspected of to have a cancer that is sensitive to sex-steroids, such as certain types of breast cancer.
- If you have any unexplained vaginal bleeding.
Tell your doctor before you start to use Zelleta® if any of these conditions apply to you.
Consult your doctor immediately if any of these conditions appear for the first time while using Zelleta®.
Contact your doctor as soon as possible if:
- you have severe pain or swelling in either of your legs, unexplained pains in the chest, breathlessness, an unusual cough, especially when you cough up blood (possible signs of a blood clot); possibly indicating a thrombosis
- you have a sudden, severe stomach ache or jaundice (possibly indicating liver problems);
- you feel a lump in your breast; (possibly indicating breast cancer)
- you have a sudden or severe pain in the lower abdomen or stomach area (possibly indicating an ectopic pregnancy, this is a pregnancy outside the womb);
- you are to be immobilised or are to have surgery (consult your doctor at least four weeks in advance);
- you have unusual, heavy vaginal bleeding
- you suspect that you are pregnant.
Zelleta®, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Wait for your period to begin. On the first day of your period take the first Zelleta®. Additional contraceptive precautions are not necessary. If you take your first tablet on days 2 to 5 of your period use an additional barrier method of contraception for the first 7 days of tablet-taking.When changing from a combined pill, vaginal ring, or transdermal patch.
You can start taking Zelleta® on the day after you take the last tablet from the present Pill pack, or on the day of removal of your vaginal ring or patch (this means no tablet-, ring- or patch-free break). If your present Pill pack also contains inactive tablets you can start Zelleta® on the day after taking the last active tablet (if you are not sure which this is, ask your doctor or pharmacist). If you follow these instructions, you need not take extra contraceptive precautions.You can also start at the latest the day following the tablet-, ring-, patch-free break, or placebo tablet interval, of your present contraceptive. If you follow these instructions, make sure you use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking.When you change from another progestogen-only pill (mini-pill)
Switch on any day from another mini pill. Additional contraceptive precautions are not necessary.
When you change from an injection, implant or a hormonal Intrauterine device (IUS)
Start using Zelleta® when your next injection is due or on the day that your implant or you IUS is removed. Additional contraceptive precautions are not necessary.
After you have a baby
You can start Zelleta® between 21 to 28 days after the birth of your baby.
If you start later, make sure that during the first cycle you use an additional barrier method of contraception for the first 7 days of tablet-taking. However, if you have already had sex, check that you are not pregnant before starting Zelleta®.
Information for breast-feeding women can be found in section 2 “Before you take Zelleta®” in the paragraph “Pregnancy and breast-feeding”. Your doctor can also advise you.
After a miscarriage or an abortion
Your doctor will advise you.
If you vomit or have diarrhoea
Follow the advice for forgotten tablets in the section above. If you vomit within 3-4 hours after taking your Zelleta 75 micrograms Tablets or have severe diarrhoea, the active ingredient may not have been completely absorbed.
Before you have any blood tests
Tell your doctor or the laboratory staff that you are taking the pill, because oral contraceptives can affect the results of some tests.
Other medicines and Zelleta 75 micrograms Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may stop Zelleta 75 micrograms Tablets from working properly. These include medicines used for the treatment of
- epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate and phenobarbital)
- tuberculosis (e.g. rifampicin)
- HIV infections (e.g. ritonavir), or other infectious diseases (e.g. griseofulvin)
- stomach upset (medical charcoal)
- depressive moods (the herbal remedy St. John’s Wort).
Your doctor can tell you if you need to take additional contraceptive precautions and if so, for how long. Zelleta 75 micrograms Tablets may also interfere with how certain medicines work, causing either an increase in effect (e.g. medicines containing cyclosporine) or a decrease in effect.
Take the missed tablet as soon as you remember and take the next one at the usual time. Zelleta® will still protect you from pregnancy.If you are more than 12 hours late:
If you are more than 12 hours late in taking any tablet, you may not be completely protected against pregnancy. The more consecutive tablets you have missed, the higher the risk that you might fall pregnant. Take a tablet as soon as you remember and take the next one at the usual time. This may mean taking two in one day. Continue to take your tablets as usual but you must also use an extra method, such as a condom, for the next 7 days. If you missed one or more tablets in the very first week of tablet-intake and had intercourse in the week before missing the tablets, you may fall pregnant. Ask your doctor for advice.If you vomit or have diarrhoea
Follow the advice for forgotten tablets in the section above. If you vomit within 3-4 hours after taking your Zelleta® or have severe diarrhoea, the active ingredient may not have been completely absorbed.
If you take more Zelleta® than you should
There have been no reports of serious harmful effects from taking too many Zelleta® at one time. Symptoms that may occur are nausea, vomiting and in young girls, slight vaginal bleeding.For more information ask your doctor for advice.
If you stop taking Zelleta®
You can stop taking Zelleta® whenever you want. From the day you stop you are no longer protected against pregnancy.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
- mood changes,
- depressed mood,
- decreased sexual drive (libido),
- headache,
- nausea,
- acne,
- breast pain,
- irregular or no periods,
- weight increase.
Uncommon (affecting less than 1 in 100 women):
- infection of the vagina,
- difficulties in wearing contact lenses,
- vomiting,
- hair loss,
- painful periods,
- ovarian cysts,
- tiredness.
Rare (affecting less than 1 in 1000 women):
- skin conditions such as: rash, hives, painful blue-red skin lumps (erythema nodosum).
Apart from these side effects, breast secretion or leakage may occur.
You should see your doctor immediately if you experience symptoms of angioedema, such as (i) swollen face, tongue or pharynx; (ii) difficulty to swallow; or (iii) hives and difficulties to breathe.
If you get any side effects talk to your doctor or pharmacist.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Zelleta® look like and contents of the pack
Each tablet is round, uncoated, biconvex, debossed with ‘152’ on one side and other side plain. Each box of Zelleta® contains 1, 3, 6 or 13 strips of 28 tablets each.
Each carton contains blisters packed separately in an aluminium laminated sachet.
Packs may be marketed with or without a desiccant. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester, LE3 0PA
United Kingdom
References
- Morningside Healthcare Ltd. Zelleta 75 micrograms Tablets. Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/9572 (accessed January 2024);
- Organon Pharma (UK) Ltd. Cerazette 75 microgram film-coated tablet. Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/1698 (accessed January 2024);
