Cerazette

Package Leaflet: Information for the User

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Cerazette

0.075 mg, 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 them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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 cervical canal. 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 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 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 you have any of these conditions, 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 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

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

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

Possible serious diseases
Decreased 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 a woman's natural cycle, but decreased 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 exposed to 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 decreases gradually and becomes the same as for women who have never taken oral contraceptives after 10 years of stopping the pill.
Breast cancer is less common in women under 40, but the risk increases with age. 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 a significant impact.
For 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 the pill, 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, 5 additional 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, 20 additional 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 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 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 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 who do not take 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

Tell your doctor about any medicines or herbal products you are currently taking, or have recently taken, and any that you plan to take. Also, inform your doctor or other healthcare professional prescribing other medicines (or pharmacist) that you are taking Cerazette. They may inform you about the 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 (hypertension), 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 a mechanical contraceptive. Because 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 need to use additional contraceptive methods and the duration of their use.
Cerazette may also interfere with the action of other medicines, causing an increase (e.g., medicines containing cyclosporin) or decrease (e.g., lamotrigine) in their effect.
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.
Irrregular 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 pregnancy is suspected.
Breastfeeding
Cerazette can be used during breastfeeding. It does not appear to affect milk production or quality. However, a decrease in milk production has occasionally been reported 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

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

Cerazette contains lactose monohydrate

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

When to consult a 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.
Consult your doctor immediately in the following cases:

• 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 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.

3. How to take Cerazette

Always take this medicine exactly as your doctor has told you. If you are not sure, consult 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, and on the other side, there are arrows indicating the direction of the tablets. Each time you start a new pack of Cerazette, take the tablet that corresponds to the day of the week. Take one tablet every day, following the direction of the arrows, until the pack is empty, e.g., if you start taking the tablets on a Wednesday, take the tablet marked "4 F" from the top row. 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 the use of Cerazette, slight bleeding may occur. In this case, continue taking the tablets. After finishing the tablets in the pack, start a new pack the next day, without interruption and without waiting for bleeding to occur. You can stop taking Cerazette at any time. The 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 for your next menstrual period. Start taking Cerazette on the first day of your menstrual period. You do not need to use additional contraceptive methods.
You can also start taking Cerazette between days 2 and 5 of your cycle, but in this case, use an additional contraceptive method (e.g., a condom) for the first 7 days of taking Cerazette.

• If you have been taking a combined oral contraceptive (combined oral contraceptive pills, contraceptive vaginal ring, contraceptive patch):You can start taking Cerazette the day after you take the last active tablet or remove the vaginal ring or patch. You do not need to use additional contraceptive methods.

You can also start taking Cerazette on the day you would normally start your next contraceptive method (e.g., the day you would insert a new vaginal ring or apply a new patch). In these cases, use an additional contraceptive method (e.g., a condom) for the first 7 days of taking Cerazette.

• If you have been taking a progestogen-only contraceptive:You can stop taking the progestogen-only contraceptive and start taking Cerazette the next day. You do not need to use additional contraceptive methods.
• If you have been using an injectable, implant, or intrauterine system that releases progestogen:Start taking Cerazette on the day you would normally 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 Cerazette between 21 and 28 days after giving birth. If you start later, use an additional contraceptive method (e.g., a condom) for the first 7 days of taking Cerazette. 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. You may experience nausea, vomiting, and slight vaginal bleeding, both in women and young girls. Consult your doctor.

What to do if you forget to take Cerazette

If the delay in taking a 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 a tablet is more than 12 hours, the effectiveness of the tablet may be reduced. The more tablets you miss, 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., a condom). There is a possibility of becoming pregnant if you miss one or more tablets in the first week of taking Cerazette, especially if you had sexual intercourse in the week before missing the tablet. Consult your doctor.

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

Follow the same instructions as when you miss a tablet (see above). If you vomit or have severe diarrhea 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, 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.
If you plan to become pregnant, your doctor usually advises you to wait until you have had 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 about any unwanted changes in your health, especially if they are severe and prolonged, and 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 additional information, and consult your doctor if necessary.
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), consult your doctor immediately.
During the use of Cerazette, vaginal bleeding may occur irregularly. This can be slight spotting or more intense bleeding, which looks more like a scarce menstrual bleeding, when you need to use sanitary pads. Bleeding may also not occur at all.
Irrregular 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 those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects 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, 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 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.
There are no special storage instructions. Store the blister in the original sachet to protect it from light and moisture. After opening the sachet, use the medicine 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cerazette contains

• The active substance is desogestrel, 75 micrograms.
• The other ingredients are colloidal anhydrous silica, RRR-α-tocopherol, lactose monohydrate, maize starch, 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 "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 cardboard sachet is provided to store the blister.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Portugal, the country of export:

Organon Portugal, Sociedade Unipessoal Lda.
Alexandre Herculano Street, 50 - 9th floor
1250-011 Lisbon
Portugal

Manufacturer:

N.V. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Marketing authorization number in Portugal, the country of export: 2798486
2798585
2798684
Parallel import authorization number: 40/24

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

2 F

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

Date of approval of the leaflet: 25.01.2024

[Information about the trademark]