Cerazette

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Cerazette and what is it 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 is Cerazette and what is it used for

How does Cerazette work?

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 it usually inhibits ovulation, just like combined pills. 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 greatest inconvenience during the use of Cerazette may be irregular bleeding. Bleeding may also not occur at all.
The possibility of becoming pregnant while taking Cerazette (provided that no tablets have been missed) is very low.

2. Important information before taking Cerazette

Cerazette, like other hormonal contraceptives, does not protect against HIV infection (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, inform your doctor before starting Cerazette. The doctor may advise the use of a non-hormonal contraceptive method.

• 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 the formation of blood clots that block veins [e.g., in the legs (deep vein thrombosis) or lungs (pulmonary embolism)].
• Current or past liver disease, until liver function tests have returned to normal.
• Current or past 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, consult your doctor immediately.

Warnings and precautions

When taking Cerazette in any of the following situations, close medical supervision is required. Before starting Cerazette, inform your doctor about:

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

Possible serious diseases

Reduced bone mass
Estrogens play an important role in maintaining normal bone mass. During the use of Cerazette, the level of natural estrogen - estradiol - in the blood is comparable to its level in the first half of the natural cycle of a woman, but reduced compared to its level in the second half of the natural cycle. It is not known whether this has an effect on bone mass.
Breast cancer
Every woman is at risk of breast cancer, regardless of whether she is taking oral contraceptives. 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 is less common in women under 40, 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 seem to be important.
For every 10,000 women taking oral contraceptives for no more than 5 years, up to the age of 20, an additional less than 1 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, for every 10,000 women taking oral contraceptives for up to 5 years, up to the age of 30, an additional 5 cases of breast cancer are diagnosed, compared to 44 cases usually diagnosed in this age group.
For every 10,000 women taking oral contraceptives for up to 5 years, over the age of 40, an additional 20 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 conclusive.
Cases of breast cancer diagnosed in patients taking oral contraceptives seem to be less advanced than those found in women not taking 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 detection of breast cancer.
Venous thromboembolic disease
Venous thromboembolic disease is the formation of a blood clot 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 the place where it formed, it can reach the lungs and block a pulmonary artery, creating a pulmonary embolism. This can lead to death. Deep vein thrombosis is very rare. It can also develop if oral contraceptives are not taken. 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 (combined pills). If symptoms of venous thromboembolic disease occur, consult your doctor immediately (see "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, consult your doctor as soon as possible for further medical advice.

Children and adolescents

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

Cerazette and other medicines

Inform your doctor about the medicines or herbal products you are currently taking or have recently taken, as well as the medicines you plan to take. You should also inform your doctor of another specialty or dentist prescribing other medicines (or pharmacist) that you are taking Cerazette. They may inform you about the possible need to use additional contraceptive methods (e.g., condoms) and the duration of their use, as well as whether it is necessary to modify the use 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, angina, 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 mechanical contraception. Due to the fact that 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 interfere with the action of other medicines, leading to increased (e.g., medicines containing cyclosporin) or decreased activity (e.g., lamotrigine).
Before taking any medicine, consult your doctor or pharmacist.

Vaginal bleeding

During the use of Cerazette, vaginal bleeding may occur irregularly. This can be slight spotting or intense bleeding. Bleeding may also not occur at all.
Irregular bleeding does not mean that the contraceptive effectiveness of Cerazette is reduced. Usually, no action is necessary, and you can continue taking Cerazette. However, if the bleeding is very heavy or prolonged, consult your doctor.

Functional ovarian cysts

During the use of all contraceptives containing 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 slight 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 have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Using Cerazette is contraindicated in pregnancy or if there is a suspicion of pregnancy.
Breastfeeding
Cerazette can be used during breastfeeding. It does not seem to affect milk production or quality. However, decreased milk production has occasionally occurred during the use of 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 want to use Cerazette, consult your doctor.

Driving and using machines

It has not been found that Cerazette affects the ability to drive and use machines.

Cerazette contains lactose monohydrate

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

When to consult a doctor

3. How to take Cerazette

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

When and how to take the tablets

The packaging 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 (see "Translation of the day of the week symbols on the blister" in section 6 at the end of the leaflet), and on the other side, there are arrows indicating the direction of the tablets to be taken. Each time you start taking tablets from a new package of Cerazette, start with the first row of the blister, taking the tablets in the direction of the arrows, one per day, until the package is empty, e.g., if you start taking the tablets on Wednesday, take the first tablet from the top row marked with the number 4 F. This allows you to easily check if the tablet marked with a given day of the week has been taken on that day. Take the tablets at the same time every day. Swallow the tablet whole with water. During the use of Cerazette, slight bleeding may occur. In this case, however, continue taking the tablets. After finishing the tablets in the package, start taking the tablets from a new package the next day, without interruption and without waiting for bleeding to occur.
Taking Cerazette tablets can be stopped at any time. Contraceptive effectiveness ends on the day you stop taking the tablets.

Starting the first package of Cerazette

• If you are not currently taking any oral contraceptives:Wait until your next menstrual period. 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 the 2nd and 5th day of your cycle, but in this case, use an additional contraceptive method (mechanical contraceptive methods) for the first 7 days of taking the tablets in the first cycle. Regular check-upsWomen taking Cerazette should be informed by their doctor about the need for regular check-ups. Usually, the frequency and type of check-ups depend on the individual characteristics of the patient.

You should consult your doctor immediately in the following situations:

• If symptoms occur that suggest venous thromboembolic disease (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 jaundice (indicating possible liver disease);
• Feeling a breast lump;
• Sudden severe pain in the lower abdomen or stomach area (indicating possible ectopic pregnancy);
• Immobility (e.g., bed rest) or planned surgery; consult your doctor at least 4 weeks in advance;
• If you experience irregular, heavy vaginal bleeding;
• If you are or may be pregnant.
• If you were previously taking a combined contraceptive (combined oral contraceptives, contraceptive vaginal ring, contraceptive patch):You can start taking Cerazette tablets the next day after taking the last tablet of your current contraceptive or the day you remove the vaginal ring or patch (without taking a break or waiting for bleeding to occur). You do not need to use additional contraceptive methods. If your current contraceptive contains tablets that do not contain active substances, you can start taking Cerazette the next day after taking the last tablet containing hormones (if in doubt, ask your doctor or pharmacist).

You can also start taking Cerazette on the first day after the break in taking your current contraceptive, on the day you insert a new vaginal ring or apply a new patch, or the day after taking the last placebo tablet of your current contraceptive. In these cases, use an additional contraceptive method (mechanical) for the first 7 days of taking Cerazette tablets.

• If you were previously taking another progestogen-only contraceptive:You can stop taking the other contraceptive at any time and start taking Cerazette tablets the next day. You do not need to use additional contraceptive methods.
• If you were previously using an injectable, implant, or intrauterine system releasing progestogen for contraception:Start taking Cerazette tablets 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:Start taking the tablets between 21 and 28 days after childbirth. If you start taking the tablets later, use an additional contraceptive method (mechanical contraceptive methods) for the first 7 days of taking the tablets. After having sex before starting the tablets, check if you are pregnant or wait for your first menstrual period. More information on breastfeeding can be found in the "Breastfeeding" section. Your doctor will also advise you.
• After a miscarriage:As advised by your doctor.

Overdose of Cerazette

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.

Missed dose of Cerazette

If the delay in taking the tablets 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 as usual.
If the delay in taking the tablets 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 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 in case of gastrointestinal disorders (e.g., vomiting, severe diarrhea)

Follow the same procedure as when missing a tablet (see above). If vomiting or severe diarrhea occurs within 3 to 4 hours after taking a Cerazette tablet, the absorption of the active substance may have been reduced. In case of severe diarrhea, consult 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.
In case of planned pregnancy, it is usually recommended to wait until the 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.
Inform your doctor about any unwanted changes in your health, especially if they are severe and prolonged, and about changes in your health that seem to be caused by taking Cerazette tablets.
Serious side effects related to the use of Cerazette are described in the "Breast cancer" and "Venous thromboembolic disease" sections in point 2 "Important information before taking Cerazette". Read this section for additional information, and if necessary, consult your doctor immediately.
If you experience allergic reactions (hypersensitivity), including facial swelling, lip swelling, tongue swelling, and/or throat swelling causing difficulty breathing or swallowing (angioedema and/or anaphylactic reaction), consult your doctor immediately.

Vaginal bleeding

During the use of Cerazette, vaginal bleeding may occur irregularly. This can be slight spotting or more intense bleeding, which looks like a scanty menstrual bleeding, when a pad is needed. Bleeding may also not occur at all.
Irregular bleeding does not mean that the contraceptive effectiveness of Cerazette is reduced. Usually, no action is necessary, and you can continue taking Cerazette. However, if the bleeding is very heavy or prolonged, consult your doctor.

Reporting side effects

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

5. How to store Cerazette

Keep the 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. Store the blister 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 shows a risk to the environment in relation 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 silicon dioxide, all-rac-α-tocopherol, lactose monohydrate, cornstarch, povidone, stearic acid; coating: hypromellose, macrogol 400, talc, titanium dioxide (E 171). See also section 2 "Cerazette contains lactose monohydrate".

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 inscription Organon and a star on the other.
A PVC/Al blister containing 28 tablets is packaged in a sachet made of laminated aluminum foil. 1 or 3 blisters in a cardboard box.
A sachet is provided to store the blister after removing it from the protective foil.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Organon Portugal, Sociedade Unipessoal Lda.
Marquês de Pombal, 14
1250-162 Lisbon
Portugal

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Portuguese marketing authorization number, country of export:
2798486
2798585
2798684

Parallel import authorization number: 318/21

Translation of the day of the week symbols on the blister:

2 F

• Monday 3 F
• Tuesday 4 F
• Wednesday 5 F
• Thursday 6 F
• Friday SAB
• Saturday DOM
• Sunday

Date of leaflet approval: 31.03.2023
[Information about the trademark]