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 any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What Cerazette is and what it is 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 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 migration 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 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 in the lungs (pulmonary embolism)].
• Current or history of jaundice (yellowing of the skin) or severe liver disease until liver function tests have returned to normal.
• Current or history of 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 history of breast cancer;
• liver tumor; because the potentially harmful effect of Cerazette cannot be excluded;
• history of venous thromboembolic disease;
• diabetes;
• epilepsy (see "Cerazette and other medicines");
• tuberculosis (see "Cerazette and other medicines");
• high blood pressure;
• current or history of 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 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 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 age of the woman. Therefore, more cases of breast cancer 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 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.
Cases of breast cancer 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 monitoring of patients 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 users of oral contraceptives than in non-users.
It is assumed that the risk of venous thromboembolic disease in users of oral contraceptives containing only progestogen, such as Cerazette, is lower than in users of oral contraceptives containing 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 to receive 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

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) about the use of Cerazette. They may inform you 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 vaginal 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 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 time of their use.
Cerazette may also interfere with the action of other medicines, resulting in increased (e.g. medicines containing cyclosporine) or decreased activity (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 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 you should continue to take Cerazette. You should contact your doctor if the bleeding is very heavy and prolonged.

Functional ovarian cysts

During the use of all contraceptives containing small amounts of hormones, small fluid-filled blisters called functional ovarian cysts may develop in the ovaries. They usually disappear on their own. In some cases, they may cause slight abdominal pain. Rarely, they may require surgical intervention.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, 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 can be used during breastfeeding. It does not appear 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 use Cerazette, you should consult 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 been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

When to contact a doctor

3. How to use Cerazette

This medicine should always be used as directed by your doctor. If you are unsure, 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, each tablet has a symbol of the day of the week on which it should be taken (see "Translation of day symbols on the packaging" in section 6 at the end of the leaflet), and on the other side, there are arrows showing the direction of the tablets to be taken. Each time you start taking tablets from a new packaging 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 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 inscription WED. 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, you should continue to take the tablets. After the tablets in the packaging are used up, 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 of stopping 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-ups

A woman using Cerazette should be informed by her doctor about the need for regular check-ups. Usually, the frequency and type of check-ups depend on the individual characteristics of the woman.

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; 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 have previously taken 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 contraceptive or on the day of removal of the vaginal ring or patch (without a break). You do not need to use additional contraceptive methods. If your current contraceptive 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 it is, you should ask your doctor or pharmacist).

You can also start taking Cerazette on the first day after the break in taking your current contraceptive, on the day of insertion of the next vaginal ring or patch, or on the day after taking the last placebo tablet of your current contraceptive. In these cases, you should use an additional contraceptive method (mechanical) for the first 7 days of taking Cerazette tablets.

• If you have previously taken another progestogen-only medicine:You can stop taking the tablets at any time and start taking Cerazette tablets the next day. You do not need to use additional contraceptive methods.
• If you have previously used contraception in the form of 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 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 intercourse before starting to take the tablets, you should check if you are not pregnant or wait for your first menstrual 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.

Using more Cerazette than recommended

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 your doctor.

Missing a Cerazette tablet

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 take the remaining 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 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 starting to take the tablets, if you had sexual intercourse in the week before missing the tablet. You should consult your doctor.

Procedure 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 after taking a Cerazette tablet, the absorption of the active substance may have been reduced. In the case of severe diarrhea, you should consult 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.
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 using Cerazette". You should read this section to obtain 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), you should contact your doctor immediately.
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.
Irrregular bleeding does not mean that the contraceptive effectiveness of Cerazette is reduced. Usually, no action is required, and you can 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:
Common: may occur in up to 1 in 10 women

• mood changes, depressive mood, decreased libido
• headache
• nausea
• acne
• breast pain; irregular menstrual bleeding or absence of bleeding
• 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 1000 women

• rash, urticaria, painful blue-red 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 apart from the above-mentioned side effects.

Reporting side effects

If you experience any side effects, including any 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 provide 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. Store the blister in the original sachet 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 pack and other information

What Cerazette contains

• The active substance of Cerazette is desogestrel in a dose of 75 micrograms.
• 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, biconvex with a diameter of 5 mm, 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 with the packaging, in which the blister should be placed after being removed from the protective foil.
For more detailed information, you should contact the marketing authorization holder or the 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:

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
Ireland export license number: PA23198/016/001

Parallel import license number: 446/24

Translation of day symbols on the packaging:

MON -
Monday
TUE

• Tuesday WED - Wednesday THU
• Thursday FRI
• Friday SAT
• Saturday SUN
• Sunday

Date of leaflet approval: 20.12.2024

[Information about the trademark]