Cerazette

Leaflet accompanying the packaging: information for the user

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

Cerazette (Jubrele), 75 micrograms, film-coated tablets

Desogestrel
Cerazette and Jubrele are different trade names for the same drug.

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 another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects 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 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 biggest 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 has been 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 use Cerazette

Cerazette should not be used in case of any of the following conditions. If they occur, the doctor should be informed before starting treatment with Cerazette. The doctor may advise the use of a non-hormonal contraceptive method.

• If the patient is 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 jaundice (yellowing of the skin) 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 symptoms occur for the first time while taking Cerazette, the doctor should be consulted immediately.

Warnings and precautions

When using Cerazette in any of the following cases, close medical supervision is required. Before starting treatment with Cerazette, the doctor should be informed about:

• current or past breast cancer;
• liver tumor; because the potentially harmful effect of Cerazette cannot be ruled out;
• 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 the face); in these cases, sun exposure or ultraviolet radiation should be avoided.

Possible serious diseases
Decreased bone mass
Estrogens play an important role in maintaining normal bone mass. During treatment with Cerazette, the concentration of natural estrogen - estradiol - in the blood is comparable to its concentration in the first half of the natural female cycle, 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 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 be 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, but the risk increases with the woman's age. Therefore, more cases of breast cancer occur in women taking oral contraceptives at an older age. The duration of oral contraceptive use is not that important.
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 was 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 were 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 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 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 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 formed, it can reach 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 oral contraceptives are not used. 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, the doctor should be contacted 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, the doctor should be contacted 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

The doctor should be informed about the medicines or herbal products currently being taken or recently taken by the patient, as well as those that the patient plans to take. The doctor of another specialty or the dentist prescribing other medicines (or pharmacist) should also be informed about the use of Cerazette. They may inform about the possible need to use additional contraceptive methods (e.g. condoms) and the time 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 the patient is taking medicines or herbal products that may reduce the effectiveness of Cerazette, additional mechanical contraception should be used. 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. The doctor will inform the patient about the possible need to use additional contraceptive methods and the time 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 treatment with 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 Cerazette should be continued. However, if the bleeding is very heavy or prolonged, the doctor should be consulted.

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 resolve on their own. In some cases, they may cause mild abdominal pain. Rarely, they may require surgical intervention.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a 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 quality. However, decreased milk production has occasionally occurred 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 was observed.
In case of breastfeeding and the desire to use Cerazette, the doctor should be consulted.

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 the patient has previously been found to be intolerant to some sugars, the patient 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 the doctor. In case of doubts, the doctor or pharmacist should be consulted.

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 each tablet on the immediate packaging" in section 6 at the end of the leaflet), and on the other side, there are arrows showing the direction of the tablets being taken. Each time you start taking tablets from a new package of Cerazette, you should start with the top 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, 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 treatment with Cerazette, slight bleeding may occur. In this case, however, tablet intake should be continued. After the tablets in the package are used up, you should start taking the tablets from a new package 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 of stopping tablet intake.

Starting the first package of Cerazette

• If the patient is not currently taking any oral contraceptives:You should wait until the next menstrual period. You should start taking Cerazette tablets on the first day of your menstrual period. There is no need to use additional contraceptive methods. Tablet intake can also be started between the 2nd and 5th day of the cycle, but in this case, an additional contraceptive method (mechanical contraceptive methods) should be used for the first 7 days of tablet intake in the first cycle. Regular check-upsThe patient taking Cerazette should be informed by the 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 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 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 a planned surgical procedure; the doctor should be consulted at least 4 weeks in advance;
• If irregular heavy vaginal bleeding occurs;
• If the patient is or may be pregnant.
• If the patient has previously taken a combined contraceptive(combined oral contraceptives, contraceptive vaginal ring, contraceptive patch): Cerazette tablets can be started the next day after taking the last tablet of the currently used medicine or on the day of removal of the contraceptive vaginal ring or patch (without a break between tablet intake, use of the contraceptive vaginal ring or patch). There is no need to use additional contraceptive methods. If the currently used medicine also contains tablets that do not contain active substances, Cerazette can be started the next day after taking the last tablet containing hormones (if in doubt, which tablet it is, the doctor or pharmacist should be asked). There is no need to use additional contraceptive methods if the above instructions are followed.

Cerazette tablets can also be started no later than on the first day following the break in taking the currently used medicine, on the day of insertion of the next contraceptive vaginal ring or patch, or on the day following the last tablet of the currently used medicine. In these cases, an additional contraceptive method (mechanical) should be used for the first 7 days of Cerazette tablet intake.

• If the patient has previously taken another progestogen-only medicine: You can stop taking the tablets of any progestogen-only medicine on any day and start taking Cerazette tablets the next day. There is no need to use additional contraceptive methods.
• If the patient has previously used contraceptive injections, an implant, or an intrauterine system releasing progestogen: You should start taking Cerazette tablets on the day when the next injection is due or on the day of implant or intrauterine system removal. There is no need to use additional contraceptive methods.
• After childbirth: After childbirth, tablet intake should be started between the 21st and 28th day after childbirth. If tablet intake is started later, additional mechanical contraception should be used for the first 7 days of tablet intake. After intercourse before starting tablet intake, it should be checked whether the patient is pregnant or it is necessary to wait for the first menstrual period. More information on breastfeeding can be found in the "Breastfeeding" section. The doctor will also provide advice.
• After a miscarriage: As advised by the 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 slight vaginal bleeding may occur in both women and young girls. The doctor should be consulted.

Missing a Cerazette tablet

If the delay in taking the tablets is less than 12 hours, the effectiveness of the tablet is maintained. The missed tablet should be taken as soon as possible, and the remaining tablets should be taken 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. The missed tablet should be taken as soon as possible, and the remaining tablets should be taken as usual. For the next 7 days, an additional contraceptive method (e.g. condom) should be used. There is a possibility of becoming pregnant if one or more tablets are missed in the first week of starting tablet intake, if there was sexual intercourse in the week preceding the missed tablet. The doctor should be consulted.

Procedure in case of gastrointestinal disorders (e.g. vomiting, severe diarrhea)

Proceed as in the case of a missed tablet (see above). If vomiting or severe diarrhea occur 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, the doctor should be consulted.

Stopping Cerazette treatment

Taking Cerazette tablets can be stopped at any time. If you do not plan to become pregnant, you should 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.
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.
Severe 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 for additional information and, if necessary, consult 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), the doctor should be contacted immediately.
During treatment with Cerazette, vaginal bleeding may occur irregularly. This can be slight 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 at all.
Irrregular bleeding does not mean that the contraceptive effectiveness of Cerazette is reduced. Usually, no action is necessary, and Cerazette should be continued. However, if the bleeding is very heavy or prolonged, the doctor should be consulted.
Women taking Cerazette have reported the following side effects:

• Frequent: may occur in no more than 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 no more than 1 in 100 women

• vaginal infection
• intolerance to contact lenses
• vomiting
• excessive hair loss
• painful menstruation, ovarian cysts
• feeling of fatigue

Rare: may occur in no more than 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 available data)

• allergic reaction

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

Reporting side effects

If you experience any side effects, including any side effects 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 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 temperature 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 of environmental hazard 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 pack and other information

What Cerazette contains

• The active substance of Cerazette is desogestrel in a quantity of 75 micrograms.
• The other ingredients are: anhydrous colloidal silica, all-rac-α-tocopherol, lactose monohydrate, corn starch, povidone K 30, 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 pack 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 packed in a sachet made of laminated aluminum foil. 1 or 3 blisters in a cardboard box.
A sachet is provided to put the blister in after it is removed from the protective foil.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

Organon Healthcare GmbH
Neuturmstr. 5
80331 Munich
Germany

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
German permit number: 43300.00.00

Parallel import permit number: 196/19

Translation of the day of the week symbols on each tablet on the immediate packaging:

Mo

• Monday Di
• Tuesday Mi
• Wednesday Do
• Thursday Fr
• Friday Sa
• Saturday So
• Sunday

Date of leaflet approval: 06.05.2024

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