Cerazette

Leaflet accompanying the packaging: information for the user

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

Cerazette, 75 micrograms, coated tablets

Desogestrel

You should carefully read the contents of the leaflet before using 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, 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 using Cerazette
• 3. How to use Cerazette
• 4. Possible side effects
• 5. How to store Cerazette
• 6. Contents of the packaging 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 from migrating 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 by women who are intolerant to estrogens and by breastfeeding women. The biggest inconvenience when using Cerazette may be irregular bleeding. Bleeding may also not occur at all.
The possibility of becoming pregnant while using Cerazette (provided that no tablet has been missed) is very low.

2. Important information before using Cerazette

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

When not to use Cerazette

Do not use Cerazette if you have any of the conditions listed below. If any of these conditions occur, you should inform your doctor before starting to use 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 (e.g. jaundice) or severe 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 using Cerazette, you should consult your doctor immediately.

Warnings and precautions

When using Cerazette in any of the following situations, close medical supervision is required. Before starting to use 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 spots 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 concentration of natural estrogen - estradiol in the blood is comparable to its concentration in the first half of the natural cycle of a woman, but decreased compared to its concentration 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 uses oral contraceptives or not. In women using oral contraceptives, breast cancer occurs slightly more often than in women of the same age who do not use them. After stopping the use of oral contraceptives, this risk gradually decreases to be the same as for women who have never used oral contraceptives after 10 years of stopping the use of 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, a larger number of breast cancer cases occur in women using oral contraceptives at an older age. The duration of oral contraceptive use is not that important.
Out of every 10,000 women using oral contraceptives 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 oral contraceptives, compared to 4 cases of breast cancer usually diagnosed in this age group. Similarly, out of every 10,000 women using oral contraceptives 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 using oral contraceptives for up to 5 years, over the age of 40, 20 more cases of breast cancer were diagnosed, compared to 160 cases usually diagnosed.
The risk of breast cancer in women using progestogen-only pills, such as Cerazette, is similar to the risk of breast cancer in women using combined pills, but the evidence is not final.
Breast cancer cases diagnosed in patients using oral contraceptives seem to be less advanced than those found in women who do not use 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 for women using contraception 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 was formed, it can reach the lungs and block the pulmonary artery, forming a pulmonary embolism. This can lead to death. Deep vein thrombosis is very rare. It can also develop if oral contraceptives are not used. It can also occur during pregnancy. The risk of venous thromboembolic disease is higher in women using oral contraceptives than in those not using them.
It is assumed that the risk of venous thromboembolic disease in women using oral contraceptives containing only progestogen, such as Cerazette, is lower than in women using oral contraceptives that also contain estrogen in their composition (combined pills). If symptoms of venous thromboembolic disease occur, you should contact your doctor immediately (see "Regular check-ups").
Psychiatric disorders
Some women using 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

You should inform your doctor about the medicines or herbal products you are currently using or have recently used, as well as the medicines you plan to use. You should also inform your doctor of another specialty or dentist prescribing other medicines (or pharmacist) that you are using 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 concentration 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 a mechanical contraceptive. 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. 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, which can increase (e.g. medicines containing cyclosporin) or decrease their action (e.g. lamotrigine).
Before taking any medicine, you should consult your doctor or pharmacist.

Vaginal bleeding

During the use of Cerazette, vaginal bleeding may occur irregularly. This can be minor spotting or intense 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 to take Cerazette. However, if the bleeding is very heavy or prolonged, you should contact 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 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 have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Using Cerazette is contraindicated in pregnancy or if pregnancy is suspected.
Breastfeeding
Cerazette may be used during breastfeeding. It does not appear to affect milk production or the quality of the milk produced. 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 use Cerazette, you should contact 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 previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

When to contact your doctor

3. How to use Cerazette

This medicine should always be used as directed by your doctor. If you are in doubt, you should 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, there is a symbol of the day of the week when you should take it (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 showing the direction of taking the tablets. Each time you start taking tablets from a new packaging of Cerazette, you should start from the top row of the blister, taking the tablets in the direction of the arrows, one per day, until the packaging is empty, e.g. if you start taking the tablets on Wednesday, you should take the first tablet from the top row marked with the abbreviation for Wednesday. This allows you to easily check if the tablet marked with a given day of the week has been taken on that day. The tablets should be taken at the same time every day. The tablet should be swallowed whole with water. During the use of Cerazette, minor bleeding may occur. In this case, however, you should continue to take the tablets. After finishing the tablets from the packaging, you should start taking the tablets from a new packaging the next day, without a break 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 packaging of Cerazette

• If you are not currently taking any oral contraceptives:You should 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 the 2nd and 5th day 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. Regular check-upsWomen using 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 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 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 a planned surgical procedure; you should consult your doctor at least 4 weeks in advance;
• If irregular heavy vaginal bleeding occurs;
• 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 medicine or on the day of removal of the vaginal ring or patch (without a break between the two methods). You do not need to use additional contraceptive methods. If your current medicine also 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, you should 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 the first day after the break in taking your current medicine, the day of insertion of the next vaginal ring or patch, or the day after taking the last placebo tablet of your current medicine. In these cases, you should use an additional contraceptive method (mechanical) for the first 7 days of taking Cerazette tablets.

• If you were previously taking another progestogen-only medicine:You can stop taking the tablets of the other medicine 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 contraceptive, implant, or intrauterine system releasing progestogen:You should start taking Cerazette tablets on the day you would have your next injection or on the day of removal of the implant or intrauterine system. 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 childbirth. 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 about breastfeeding can be found in the "Breastfeeding" section. Your doctor will also advise you.
• After a miscarriage:As directed by your doctor.

Using more Cerazette than prescribed

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

Missing a Cerazette tablet

If the delay in taking the tablets is less than 12 hours, the effectiveness of the tablet is maintained. You should take the missed tablet as soon as possible, and take the remaining tablets 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 of the tablet. You should take the missed tablet as soon as possible, and take the remaining tablets as usual. For the next 7 days, you should 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 the tablets, if you had sex in the week before missing the tablet. You should consult your 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 occur within 3 to 4 hours of taking a Cerazette tablet, the absorption of the active substance may have been 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, you should ask your doctor for another contraceptive method.
In the 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.
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 using Cerazette". You should read this section to get more information, and if necessary, you should contact your doctor immediately.
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 contact your doctor immediately.
During the use of Cerazette, vaginal bleeding may occur irregularly. This can be minor spotting or more intense bleeding, which looks more like a scarce menstrual bleeding, when it is necessary to use sanitary pads. Bleeding may also not occur. Irregular bleeding does not mean that the contraceptive effectiveness of Cerazette is reduced. Usually, no action is required, and you should continue to take Cerazette. However, if the bleeding is very heavy or prolonged, you should contact your doctor.
Women using 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, urticaria, painful blue-red nodules (erythema nodosum) (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, you should 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

The medicine should be stored 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. The blister should be stored in its original packaging 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. 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 packaging and other information

What Cerazette contains

• The active substance of Cerazette is desogestrel, 75 micrograms.
• The other ingredients are: anhydrous colloidal 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 what the packaging contains

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 it has been removed from the protective foil.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Organon Biosciences S.R.L.
Strada Av. Popișteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 și Birou 307, Etaj 3, Sectorul 1, Bucharest, Romania

Manufacturer:

N.V. Organon
Kloosterstraat 6, 5349 AB Oss, Netherlands
Organon (Ireland) Limited
Drynam Road, Swords, Co. Dublin, Ireland

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
Marketing authorization number in Romania, the country of export:
10970/2018/01
10970/2018/02
10970/2018/03

Parallel import authorization number: 55/21

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

Lu

• Monday Ma
• Tuesday Mi
• Wednesday Jo
• Thursday Vi
• Friday Sb
• Saturday Du
• Sunday

Date of leaflet approval: 19.04.2023
[Information about the trademark]