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 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 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 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, 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 during proper use of Cerazette (provided that no tablet is forgotten) is very low.

2. Important information before taking Cerazette

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

When not to use Cerazette

Cerazette should not be used in the presence of any of the following conditions. If they occur, the doctor should be informed before starting 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 return 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 during the use of Cerazette, the doctor should be consulted immediately.

Warnings and precautions

In the event of the use of Cerazette in any of the following cases, close medical supervision is required. Before starting Cerazette, the doctor should be informed about:

• current or past breast cancer;
• liver tumor; as 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 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 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 oral contraceptives, the risk gradually decreases to be the same as for women who have never used 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, 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 as important.
For 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 is diagnosed within 10 years of stopping oral contraceptives, compared to 4 cases of breast cancer usually diagnosed in this age group.
Similarly, for every 10,000 women using 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 using 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 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 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 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, 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, the doctor should be contacted 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, 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 or recently used by the patient, as well as the medicines that the patient plans to use. 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 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 (hypertension), angina pectoris, or certain heart rhythm disorders (e.g. diltiazem).

If the patient is taking medicines or herbal products that may reduce the effectiveness of Cerazette, a mechanical contraceptive method should also 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 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 required, and the use of Cerazette should be continued. However, if the bleeding is very intense and 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 slight abdominal pain. Rarely, they may require surgical intervention.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
The use of Cerazette is contraindicated in pregnancy or if pregnancy is suspected.
Breastfeeding
Cerazette can be used during breastfeeding. It does not seem 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.
In the case of breastfeeding and the desire to use Cerazette, the doctor should be consulted.

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 the patient has previously been diagnosed with intolerance 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 Cerazette blister 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 a new package of Cerazette is started, the tablets should be taken from 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 the tablets are started on a Wednesday, the first tablet should be taken from the top row, marked with the inscription 4 F (indicating Wednesday; see "Translation of day symbols on the packaging" at the end of the leaflet). 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, slight bleeding may occur. In this case, however, the use of tablets should be continued. After the tablets in the package are used up, a new package should be started the next day, without a break and without waiting for bleeding to occur.
The use of Cerazette tablets can be stopped at any time. The contraceptive effectiveness ends on the day the tablets are stopped.

Starting the first package of Cerazette

• If the patient is not currently taking any oral contraceptives:Regular check-upsThe patient using 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.

The doctor should be contacted 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 planned surgery; the doctor should be consulted at least 4 weeks in advance;
• If irregular, intense vaginal bleeding occurs;
• If the patient is or may be pregnant.

One should wait for the next menstrual period. The tablets should be started on the first day of the menstrual period. No additional contraceptive methods are needed.
The tablets can also be started between the 2nd and 5th day of the cycle, but in this case, an additional contraceptive method (mechanical) should be used for the first 7 days of taking the tablets in the first cycle.

• If the patient has previously taken a combined oral contraceptive (combined oral contraceptives, contraceptive vaginal ring, contraceptive patch):The tablets can be started the day after taking the last tablet of the currently used medicine or on the day the contraceptive vaginal ring or patch is removed (without a break, without waiting for bleeding to occur). No additional contraceptive methods are needed. If the currently used medicine also contains tablets that do not contain active substances, the use of Cerazette can be started the day after taking the last tablet containing hormones (if in doubt, which tablet it is, the doctor or pharmacist should be asked).

The use of Cerazette can also be started on the first day after the break in taking the tablets of the currently used medicine, on the day of inserting a new contraceptive vaginal ring or applying a new contraceptive patch, or on the day after taking the last placebo tablet of the currently used medicine. In these cases, an additional contraceptive method (mechanical) should be used for the first 7 days of taking the tablets.

• If the patient has previously taken another progestogen-only medicine:The use of Cerazette can be started on any day, and the next day, the tablets of the previous medicine can be stopped. No additional contraceptive methods are needed.
• If the patient has previously used injectable contraception, an implant, or an intrauterine system releasing progestogen:The use of Cerazette should be started on the day the next injection is due or on the day the implant or intrauterine system is removed. No additional contraceptive methods are needed.
• After childbirth:After childbirth, the tablets should be started between the 21st and 28th day after childbirth. If the tablets are started later, an additional contraceptive method (mechanical) should be used for the first 7 days of taking the tablets. After intercourse before starting the tablets, it should be checked whether the patient is pregnant or one should 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.

Use of more than the recommended dose 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. The doctor should be consulted.

Missed dose of Cerazette

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. a condom) should be used. There is a possibility of becoming pregnant if one or more tablets are missed in the first week of starting Cerazette, 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)

One 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, the doctor should be consulted.

Stopping the use of Cerazette

The use of Cerazette can be stopped at any time. If pregnancy is not planned, the doctor should be asked 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.
The patient should inform the doctor about any undesirable changes in their health, especially if they are severe and prolonged, and about changes in their 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". The patient should read this section to obtain additional information and, if necessary, consult a 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 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 pads need to be used. Bleeding may also not occur at all.
Irrregular bleeding does not mean that the contraceptive effectiveness of Cerazette is reduced. Usually, no action is required, and the use of Cerazette should be continued. However, if the bleeding is very intense or prolonged, the doctor should be consulted.
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 of fatigue

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

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

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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, more information can be collected on the safety of the use of Cerazette.

5. How to store Cerazette

The medicine should be stored out of the sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special storage instructions. The blister should be stored 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 shows a risk to the environment in relation to fish.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cerazette contains

• The active substance of Cerazette is desogestrel, 75 micrograms.
• The other ingredients are: colloidal anhydrous silica, all-rac-α-tocopherol, lactose monohydrate, maize starch, povidone, stearic acid, 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, marked with the code 2 below KV on one side and the inscription 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 blisters in a cardboard box.
A cardboard sachet is attached to the packaging, in which the blister should be placed after being removed from the protective foil.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Portugal, the country of export:

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

Manufacturer:

Organon Ireland Ltd.
Drynam Road, Swords
P.O. Box 2857
County Dublin
Ireland
N.V. Organon
Kloosterstraat 6
NL-5349 AB Oss
Netherlands

Parallel importer:

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

Repackaged by:

Prodlekpol Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Portugal, the country of export:2798486
2798585
2798684
Parallel import authorization number:728/15
Translation of day 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 leaflet approval: 01.03.2022
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