Cerazette

Leaflet accompanying the packaging: information for the user

Cerazette, 75 micrograms, film-coated tablets

Desogestrel

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What Cerazette is and what it is used for
• 2. Important information before taking Cerazette
• 3. How to take Cerazette
• 4. Possible side effects
• 5. How to store Cerazette
• 6. Contents of the pack and other information

1. What Cerazette is and what it is used for

How Cerazette works?

Cerazette is used to prevent pregnancy. The tablets contain a small amount of the female sex hormone, progestogen, called desogestrel. For this reason, Cerazette is called a progestogen-only pill. Unlike combined oral contraceptives, progestogen-only pills do not contain estrogen, the other female sex hormone.
The mechanism of action of most progestogen-only pills is mainly based on preventing sperm migration through the cervix. Unlike combined oral contraceptives, they do not always inhibit ovulation. Cerazette differs from other progestogen-only pills in that, like combined pills, it usually inhibits ovulation. As a result, Cerazette is a very effective contraceptive.
Unlike combined products, it can be used in women who are intolerant to estrogens and in breastfeeding women. The biggest inconvenience when using Cerazette may be irregular bleeding. Bleeding can also not occur at all.
The possibility of becoming pregnant while taking Cerazette (provided that no tablet is missed) is very low.

2. Important information before taking Cerazette

Cerazette, like other hormonal contraceptives, does not protect against HIV (AIDS) and other sexually transmitted diseases.

When not to take Cerazette

Do not take Cerazette if you have any of the conditions listed below. If any of these conditions occur, tell your doctor before starting Cerazette. Your doctor may advise you to use a non-hormonal method of contraception.

• If you are allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).
• Current venous thromboembolic disease. Venous thromboembolic disease is a condition where blood clots form in the veins, e.g. in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• Current or history of jaundice (yellowing of the skin) or severe liver disease until liver function tests have returned to normal.
• Current or history of hormone-dependent tumors (e.g. certain types of breast cancer).
• Vaginal bleeding of unknown cause.

If any of the above conditions occur for the first time while taking Cerazette, you should immediately consult your doctor.

Warnings and precautions

When taking Cerazette in any of the following situations, close medical supervision is required. Before starting Cerazette, tell your doctor if you have:

• current or history of breast cancer;
• liver tumor; as the potential harmful effect of Cerazette cannot be excluded;
• history of venous thromboembolic disease;
• diabetes;
• epilepsy (see section "Cerazette and other medicines");
• tuberculosis (see section "Cerazette and other medicines");
• high blood pressure;
• current or history of chloasma (brown patches on the skin, especially on the face); in these cases, you should avoid exposure to the sun or ultraviolet radiation.

Possible serious diseases
Reduced bone mass
Estrogens play an important role in maintaining normal bone mass. During treatment with Cerazette, the level of natural estrogen - estradiol in the blood is comparable to its level in the first half of the natural female cycle, but reduced compared to its level in the second half of the natural female cycle. It is not known whether this has an effect on bone mass.
Breast cancer
Every woman is exposed to the risk of breast cancer, regardless of whether she is taking oral contraceptives or not. In women taking oral contraceptives, breast cancer occurs slightly more often than in women of the same age who do not take them. After stopping oral contraceptives, the risk gradually decreases to become the same as for women who have never taken oral contraceptives after 10 years of stopping oral contraceptives. Breast cancer occurs less frequently in women under 40 years of age, but the risk increases with the age of the woman. Therefore, more cases of breast cancer occur in women taking oral contraceptives at an older age. The duration of oral contraceptive use does not have such great significance.
Out of every 10,000 women taking oral contraceptives for no more than 5 years, up to the age of 20, fewer than 1 additional case of breast cancer is diagnosed within 10 years of stopping oral contraceptives, compared to 4 cases of breast cancer usually diagnosed in this age group. Similarly, out of every 10,000 women taking oral contraceptives for up to 5 years, up to the age of 30, 5 additional cases of breast cancer are diagnosed, compared to 44 cases usually diagnosed in this age group. Out of every 10,000 women taking oral contraceptives for up to 5 years, over the age of 40, 20 more cases of breast cancer are diagnosed, compared to 160 cases usually diagnosed.
The risk of breast cancer in women taking progestogen-only pills, such as Cerazette, is similar to the risk of breast cancer in women taking combined pills, but the evidence is not yet final.
Cases of breast cancer diagnosed in patients taking oral contraceptives seem to be less advanced than those found in women who do not take them. It is not known whether this difference is related to the use of oral contraceptives. It may be related to more frequent medical check-ups and thus earlier diagnosis of breast cancer.
Venous thromboembolic disease
Venous thromboembolic disease is a condition where a blood clot forms that can block a blood vessel. Sometimes it can occur in the deep veins of the legs (deep vein thrombosis). If the clot breaks loose from where it formed, it can travel to the lungs and block a pulmonary artery, forming a pulmonary embolism. This can lead to death. Deep vein thrombosis is very rare. It can also develop if you are not taking oral contraceptives. It can also occur during pregnancy. The risk of venous thromboembolic disease is higher in women taking oral contraceptives than in those not taking them.
It is assumed that the risk of venous thromboembolic disease in women taking oral contraceptives containing only progestogen, such as Cerazette, is lower than in women taking oral contraceptives that also contain estrogen in their composition (combined pills). If symptoms of venous thromboembolic disease occur, you should immediately contact your doctor (see section "Regular check-ups").
Psychiatric disorders
Some women taking hormonal contraceptives, including Cerazette, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.

Children and adolescents

There are no clinical data available on the efficacy and safety of Cerazette in adolescents under 18 years of age.

Cerazette and other medicines

Tell your doctor about any medicines or herbal products you are currently taking, or have recently taken, and about any medicines you plan to take. Also, tell any other doctor or dentist prescribing other medicines (or pharmacist) that you are taking Cerazette. They may tell you if you need to use additional contraceptive methods (e.g. condoms) and for how long, and whether you need to adjust the dose of the prescribed medicine.
Some medicines:

• may affect the level of Cerazette in the blood
• may reduce its contraceptive effectiveness
• may cause unexpected bleeding. This applies to medicines used to treat:
• epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate, and phenobarbital),
• tuberculosis (e.g. rifampicin, rifabutin),
• HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz),
• hepatitis C virus (HCV) infection (e.g. boceprevir, telaprevir),
• other infectious diseases (e.g. griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• depressive moods (St. John's wort (Hypericum perforatum)),
• certain bacterial infections (e.g. clarithromycin, erythromycin),
• fungal infections (e.g. ketoconazole, itraconazole, fluconazole),
• high blood pressure (hypertension), angina pectoris, or certain heart rhythm disorders (e.g. diltiazem).

If you are taking medicines or herbal products that may reduce the effectiveness of Cerazette, you should also use a mechanical contraceptive method. Since the effect of another medicine on Cerazette may persist for up to 28 days after stopping the medicine, it is necessary to use additional mechanical contraception during this time. Your doctor will inform you about the possible need to use additional contraceptive methods and the duration of their use.
Cerazette may also affect the action of other medicines, resulting in increased (e.g. medicines containing cyclosporin) or decreased activity (e.g. lamotrigine).
Before taking any medicine, consult your doctor or pharmacist.

Vaginal bleeding

During treatment with Cerazette, vaginal bleeding may occur irregularly. This can be slight spotting or heavy bleeding. Bleeding may also not occur.
Irrregular bleeding does not mean that the contraceptive effectiveness of Cerazette is reduced. Usually, no action is required and you should continue taking Cerazette. However, if the bleeding is very heavy or prolonged, you should contact your doctor.

Functional ovarian cysts

During treatment with all hormonal contraceptives that contain small amounts of hormones, small fluid-filled blisters called functional ovarian cysts may develop in the ovaries. They usually disappear on their own. In some cases, they may cause mild abdominal pain. Rarely, they may require surgical intervention.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Cerazette if you are pregnant or think you may be pregnant.
Breastfeeding
Cerazette can be used during breastfeeding. It does not appear to affect milk production or quality. However, a decrease in milk production has been reported in some cases during treatment with Cerazette. Small amounts of the active substance of Cerazette pass into breast milk.
There are observations of the health of children up to 2.5 years of age whose mothers used Cerazette for 7 months. No effect on the growth and development of the child has been observed.
If you are breastfeeding and wish to use Cerazette, consult your doctor.

Driving and using machines

No effects of Cerazette on the ability to drive or use machines have been observed.

Cerazette contains lactose

Cerazette contains lactose. If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking Cerazette.

When to contact your doctor Regular check-ups

A woman taking Cerazette should be informed by her doctor about the need for regular check-ups. Usually, the frequency and type of check-ups depend on the individual characteristics of the woman.
You should contact your doctor immediately in the following situations:

• If symptoms suggesting venous thromboembolic disease occur (e.g. severe pain or swelling of the legs, unusual chest pain, shortness of breath, unusual cough, coughing up blood);
• Sudden severe abdominal pain with yellowing of the skin (indicating possible liver disease);
• A breast lump is felt;
• Sudden severe pain in the lower abdomen or stomach area (indicating possible ectopic pregnancy);
• Immobility (e.g. bed rest) or planned surgery; you should consult your doctor at least 4 weeks in advance;
• If irregular heavy vaginal bleeding occurs;
• If you are or think you may be pregnant.

3. How to take Cerazette

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

When and how to take the tablets

The pack of Cerazette contains 28 tablets. On one side of the blister, each tablet has a symbol of the day of the week on which it should be taken, and on the other side, there are arrows indicating the direction of the tablets to be taken. Each time you start a new pack of Cerazette, take the tablet from the top row of the blister, taking the tablets in the direction of the arrows, one each day, until the pack is empty, e.g. if you start taking the tablets on a Wednesday, take the first tablet from the top row marked with the day "Wednesday". This will help you check that you have taken a tablet on the corresponding day of the week. Take the tablets at the same time every day. Swallow the tablet whole with water. During treatment with Cerazette, spotting may occur. In this case, continue taking the tablets. After finishing the tablets in the pack, start taking the tablets from a new pack the next day, without interruption and without waiting for bleeding to occur. You can stop taking Cerazette at any time. Contraceptive effectiveness ends on the day you stop taking the tablets.

Starting the first pack of Cerazette

• If you are not currently taking any oral contraceptives:Wait until your next menstrual period. You should start taking Cerazette tablets on the first day of your menstrual period. You do not need to use additional contraceptive methods.

You can also start taking the tablets between days 2 and 5 of your cycle, but in this case, you should use an additional contraceptive method (mechanical contraceptive methods) for the first 7 days of taking the tablets in the first cycle.

• If you have been taking a combined oral contraceptive (combined oral contraceptive, contraceptive vaginal ring, contraceptive patch):You can start taking Cerazette the day after you take the last tablet of your current contraceptive, or the day you remove the vaginal ring or patch (without taking a break, i.e. without taking tablets that do not contain hormones, without using a vaginal ring or patch). If your current contraceptive contains tablets that do not contain hormones, you can start taking Cerazette the day after you take the last tablet that contains hormones (if in doubt, ask your doctor or pharmacist). There is no need to use additional contraceptive methods if you follow the above instructions.

You can also start taking Cerazette no later than the first day after the break in taking your current contraceptive, the day you insert a new vaginal ring or apply a new patch, or the day after you take the last inactive tablet of your current contraceptive. In these cases, you should use an additional contraceptive method (mechanical) for the first 7 days of taking Cerazette tablets.

• If you have been taking another progestogen-only pill:You can stop taking the other pill at any time and start taking Cerazette the next day. You do not need to use additional contraceptive methods.
• If you have been using an injectable contraceptive, an implant, or an intrauterine system releasing progestogen:You should start taking Cerazette on the day you would have your next injection or on the day the implant or intrauterine system is removed. You do not need to use additional contraceptive methods.
• After childbirth:After childbirth, you should start taking the tablets between the 21st and 28th day after giving birth. If you start taking the tablets later, you should use an additional contraceptive method (mechanical contraceptive methods) for the first 7 days of taking the tablets. After having sex before starting to take the tablets, you should check if you are pregnant or wait for your first menstrual period. More information on breastfeeding can be found in the section "Breastfeeding". Your doctor will also advise you.
• After a miscarriage:Follow your doctor's advice.

What to do if you take more Cerazette than you should

No serious harmful effects have been observed after taking more than one Cerazette tablet at the same time. Nausea, vomiting, and slight vaginal bleeding may occur in both women and young girls. Consult your doctor.

What to do if you forget to take Cerazette

If the delay in taking the tablet is less than 12 hours, the effectiveness of the tablet is maintained. Take the missed tablet as soon as possible, and continue taking the rest of the tablets as usual.
If the delay in taking the tablet is more than 12 hours, the effectiveness of the tablet may be reduced. The more missed tablets, the higher the risk of reduced contraceptive effectiveness. Take the missed tablet as soon as possible, and continue taking the rest of the tablets as usual. For the next 7 days, use an additional contraceptive method (e.g. condoms). There is a possibility of becoming pregnant if you miss one or more tablets in the first week of taking the tablets, if you had sex in the week before missing the tablets. Consult your doctor.

What to do if you have gastrointestinal disorders (e.g. vomiting, severe diarrhea)

Follow the same procedure as when you miss a tablet (see above). If vomiting or severe diarrhea occur within 3 to 4 hours of taking a Cerazette tablet, the absorption of the active substance may be reduced. In the case of severe diarrhea, you should contact your doctor.

Stopping Cerazette

You can stop taking Cerazette at any time. If you do not plan to become pregnant, ask your doctor for another contraceptive method.
If you plan to become pregnant, your doctor usually advises you to wait until your first natural menstrual period before becoming pregnant. This will make it easier to determine the expected date of delivery.

4. Possible side effects

Like all medicines, Cerazette can cause side effects, although not everybody gets them.
Tell your doctor if you experience any unwanted changes in your health, especially if they are severe and prolonged, and about any changes in your health that you think may be due to taking Cerazette.
Serious side effects related to the use of Cerazette are described in the sections "Breast cancer" and "Venous thromboembolic disease" in section 2 "Important information before taking Cerazette". Read this section for more information, and if necessary, consult your doctor immediately.
If you experience an allergic reaction (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, causing difficulty breathing or swallowing (angioedema and/or anaphylactic reaction), you should immediately contact your doctor.

During treatment with Cerazette, vaginal bleeding may occur irregularly. This can be slight spotting or more heavy bleeding, which looks more like a scanty menstrual bleeding, when a pad is needed. Bleeding may also not occur.
Irrregular bleeding does not mean that the contraceptive effectiveness of Cerazette is reduced. Usually, no action is required, and you should continue taking Cerazette. However, if the bleeding is very heavy or prolonged, you should contact your doctor.
Women taking Cerazette have reported the following side effects:

• Frequent: may occur in up to 1 in 10 women
• mood changes, depressive mood, decreased libido
• headache
• nausea
• acne
• breast pain; irregular menstrual bleeding or absence of bleeding
• weight gain
• Uncommon: may occur in up to 1 in 100 women
• vaginal infection
• intolerance to contact lenses
• vomiting
• excessive hair loss
• painful menstruation, ovarian cysts
• feeling tired

Rare: may occur in up to 1 in 1,000 women

• rash, hives, painful red-purple patches (erythema multiforme) (these are skin diseases)

Frequency not known (frequency cannot be estimated from the available data)

• allergic reaction

Besides the above-mentioned side effects, breast discharge may also occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cerazette

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special storage instructions for the medicine. After opening the blister, store it in the original sachet to protect it from light and moisture. After opening the sachet, the product should be used within 1 month.
The active substance has been shown to pose a risk to the environment with regard to fish.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cerazette contains

• The active substance of Cerazette is desogestrel, 75 micrograms.
• The other ingredients are: colloidal anhydrous silica, alpha-tocopherol, lactose monohydrate, maize starch, povidone, stearic acid, hypromellose, macrogol 400, talc, titanium dioxide (E171). See also section 2 "Cerazette contains lactose".

What Cerazette looks like and contents of the pack

The tablets are white, round, biconvex, 5 mm in diameter, marked with the code 2 below KV on one side and the words Organon and a star on the other.
A blister pack (PVC/Al) containing 28 tablets is packed in a sachet made of laminated aluminum foil.
1 or 3 blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o.
Marszałkowska Street 126/134
00-008 Warsaw
Phone: +48 22 105 50 01
organonpolska@organon.com

Manufacturer

N.V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands

Date of last revision of the leaflet: 07/2021