Cerazette

Package Leaflet: Information for the User

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

Cerazette

75 micrograms (0.075 mg), film-coated tablets

Desogestrel

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a 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, you should 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 hormonal 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 hormonal 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 by women who are intolerant to estrogens and by 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 any of these conditions occur, you should inform your doctor before starting to take 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, you should immediately consult a doctor.

Warnings and precautions

If you are taking Cerazette in any of the situations listed below, close medical supervision is required. Before starting to take Cerazette, you should 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 on the face); in these cases, you should avoid sun exposure 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 the natural cycle of a woman, 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 the risk of breast cancer, regardless of whether she is taking contraceptive pills or not. In women taking contraceptive pills, breast cancer occurs slightly more often than in women of the same age who do not take them. After stopping the use of contraceptive pills, this risk gradually decreases to become the same as that of women who have never taken contraceptive pills after 10 years of stopping the use of contraceptive pills. 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 contraceptive pills at an older age. The duration of taking contraceptive pills does not seem to be of great importance.
Out of every 10,000 women taking contraceptive pills for no more than 5 years, up to the age of 20, fewer than 1 additional case of breast cancer was diagnosed within 10 years of stopping the use of contraceptive pills, compared to 4 cases of breast cancer usually diagnosed in this age group. Similarly, out of every 10,000 women taking contraceptive pills for up to 5 years, up to the age of 30, 5 additional cases of breast cancer were diagnosed, compared to 44 cases usually diagnosed in this age group. Out of every 10,000 women taking contraceptive pills for up to 5 years, over the age of 40, 20 additional cases of breast cancer were 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 contraceptive pills 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 contraceptive pills. It may be related to more frequent medical check-ups and thus earlier diagnosis 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 contraceptive pills. It can also occur during pregnancy. The risk of venous thromboembolic disease is higher in women taking contraceptive pills than in those who do not take them.
It is assumed that the risk of venous thromboembolic disease in women taking progestogen-only pills, such as Cerazette, is lower than in women taking combined contraceptive pills that also contain estrogen (combined pills). If symptoms of venous thromboembolic disease occur, you should immediately contact a doctor (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, you should contact a doctor as soon as possible to receive 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

You should 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 (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 mechanical contraception. Due to the fact that the effect of another medicine on Cerazette may persist for up to 28 days after stopping the use of the medicine, it is necessary to use additional mechanical contraception during this time. The 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, causing an increase (e.g., medicines containing cyclosporin) or decrease (e.g., lamotrigine) in their action.
Before taking any medicine, you should consult a 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 should continue taking Cerazette. However, if the bleeding is very heavy or prolonged, you should contact a doctor.

Functional ovarian cysts

During the use of all contraceptive methods 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, you should consult a doctor or pharmacist before taking this medicine.
Pregnancy
The use of Cerazette is contraindicated in pregnancy or if pregnancy is suspected.
Breastfeeding
Cerazette may be used during breastfeeding. It does not seem to affect milk production or quality. However, breast milk production has occasionally decreased 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 take Cerazette, you should consult a 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, you should consult a doctor before taking the medicine.

When to contact a doctor

3. How to take Cerazette

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

When and how to take the tablets

The Cerazette blister pack 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 taking tablets from a new pack of Cerazette, you should start with the tablet marked with the corresponding day of the week from the top row of the blister. Take the tablets in the direction of the arrows, one tablet at a time, until the pack is empty, e.g., if you start taking the tablets on Wednesday, take the tablet from the top row marked with "WED" (meaning Wednesday; see "Translation of day symbols on the packaging" at the end of the leaflet). This will help you 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, you should continue taking the tablets. After finishing the tablets in the pack, start taking the tablets from a new pack the next day, without a break 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 contraceptive pills:Regular check-upsIf you are taking Cerazette, you should be informed by your doctor about the need for regular check-ups. Usually, the frequency and type of check-ups depend on your individual characteristics.

You should immediately contact a doctor 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 jaundice (indicating possible liver disease);
• A breast lump is detected;
• 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 a doctor at least 4 weeks in advance;
• If irregular heavy vaginal bleeding occurs;
• If you are or may be pregnant.

Wait until your next period. You should start taking Cerazette tablets on the first day of your period. You do not need to use additional contraceptive methods.
You can also start taking Cerazette between the 2nd and 5th day of your cycle, but in this case, you should use an additional contraceptive method (mechanical) for the first 7 days of taking Cerazette tablets.

• If you have been taking a combined contraceptive pill (combined oral contraceptive, contraceptive vaginal ring, contraceptive patch):You can start taking Cerazette the next day after taking the last tablet of your current pill or on the day you remove the vaginal ring or patch (without a break between pills, use of the vaginal ring or patch). If your current pill 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, which tablet this is, 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 pill, 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 pill. 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 contraceptive injections, 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 Cerazette between the 21st and 28th day after giving birth. If you start taking Cerazette later, you should use an additional contraceptive method (mechanical) for the first 7 days of taking the tablets. After having sex before starting to take Cerazette, you should check if you are pregnant or wait for your first 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. You should consult a doctor.

Missed dose of Cerazette

If the delay in taking a tablet is less than 12 hours, the effectiveness of the tablet is maintained. You should 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 missed tablets, the higher the risk of reduced contraceptive effectiveness. You should take the missed tablet as soon as possible and continue taking the rest of the tablets as usual. For the next 7 days, you should 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 Cerazette, if you had sex in the week before missing the tablet. You should consult a doctor.

What to do in case of gastrointestinal disorders (e.g., vomiting, severe diarrhea)

You should proceed as in the case of a missed 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 the case of severe diarrhea, you should contact a doctor.

Stopping Cerazette

You can stop taking Cerazette at any time. If you do not plan to become pregnant, you should ask your doctor for another contraceptive method.
If you plan to become pregnant, it is usually recommended to wait until your first natural 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.
You should 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". You should read this section to obtain additional information and, if necessary, immediately consult a doctor.
If allergic reactions occur (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 a doctor.
During the use of Cerazette, vaginal bleeding may occur irregularly. This can be slight spotting that does not require the use of sanitary pads or more intense bleeding that looks like a scanty menstrual period, when sanitary pads are 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, you should contact a 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 its absence
• 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 bumps (erythema nodosum) (these are skin diseases).

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

• allergic reaction

Breast discharge may also occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should 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, 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 provide 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.
There are no special storage instructions.
Store the blister pack in the original sachet to protect it from light and moisture.
After opening the sachet, the medicine 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. You should 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. Each film-coated tablet contains 75 micrograms (0.075 mg) of desogestrel.
• The other ingredients are: colloidal anhydrous silica, all-rac-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, and biconvex, with a diameter of 5 mm, marked with the code 2 below KV on one side and ORGANON and a star on the other.
A blister pack (PVC/Aluminum) containing 28 tablets is packaged in a sachet made of laminated aluminum foil.
1 or 3 blister packs in a cardboard box.
A cardboard sachet is attached to the packaging, in which you should place the blister pack after removing it from the protective foil.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Ireland, the country of export:

Organon Pharma (Ireland) Limited
2 Dublin Landings
North Wall Quay - North Dock
D01 V4A3
Dublin 1
Ireland

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Ireland, the country of export:PA23198/016/001

Parallel import authorization number: 158/24

Translation of day symbols on the packaging:
MON– Monday
TUE– Tuesday
WED– Wednesday
THU– Thursday
FRI– Friday
SAT– Saturday
SUN– Sunday.

Date of revision of the leaflet: 18.04.2024

[Information about the trademark]