Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Cerazette, 75 micrograms, coated tablets
Desogestrel
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

What Cerazette is and what it is used for
Important information before taking Cerazette
How to take Cerazette
Possible side effects
How to store Cerazette
Contents of the pack and other information

1. What Cerazette is and what it is used for

How does Cerazette work?
Cerazette is used to prevent pregnancy. Cerazette tablets contain a small amount of a female sex hormone, a progestogen called desogestrel. For this reason, Cerazette is known as a progestogen-only pill. Unlike combined oral contraceptives, progestogen-only pills do not contain oestrogen, the second female sex hormone.
The mechanism of action of most progestogen-only pills is primarily based on preventing sperm from passing through the cervical canal. In contrast to combined oral contraceptives, they do not always inhibit the maturation of the egg cell. Cerazette differs from other progestogen-only pills in that, like combined pills, it usually inhibits the maturation of the egg cell. As a result, Cerazette is a highly effective contraceptive.
Unlike combined products, it can be used in women who are intolerant to oestrogens and in breastfeeding women. The main inconvenience during treatment with Cerazette may be irregular bleeding. Bleeding may also not occur at all.
The possibility of becoming pregnant while correctly using Cerazette (provided no tablet has been missed) is very low.

2. Important information before using Cerazette

Cerazette, like other hormonal contraceptives, does not protect against infection with the HIV virus (AIDS) or other sexually transmitted diseases.
When not to use Cerazette
Do not use Cerazette if any of the conditions listed below apply. If any of these conditions occur, inform your doctor before starting treatment with Cerazette. Your doctor may recommend using a non-hormonal method of contraception.

If you are allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).
If you currently have venous thromboembolic disease. Venous thromboembolic disease involves the formation of blood clots blocking veins [e.g. in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism)].
If you currently have or have previously had jaundice (yellowing of the skin) or severe liver disease until liver function parameters have returned to normal.
If you currently have or have previously had hormone-dependent tumours (e.g. certain types of breast cancer).
Unexplained vaginal bleeding.

If any of the symptoms listed above occur for the first time during treatment with Cerazette, consult your doctor immediately.
Warnings and precautions
Strict medical supervision is required if you are using Cerazette and any of the following conditions apply. Before starting treatment with Cerazette, inform your doctor if you:

Currently have or have previously had breast cancer;
Have a liver tumour; as a potentially harmful effect of Cerazette cannot be excluded;
Have previously had venous thromboembolic disease;
Have diabetes;
Have epilepsy (see section "Cerazette with other medicines");
Have tuberculosis (see section "Cerazette with other medicines");
Have high blood pressure;
Currently have or have previously had chloasma (brownish pigmentation patches on the skin, especially on the face); in such cases, avoid exposure to sunlight or ultraviolet radiation.

Possible serious conditions
Reduced bone mass
Oestrogens play an important role in maintaining normal bone mass. During treatment with Cerazette, the concentration of natural oestrogen – estradiol – in plasma is comparable to its concentration in the first half of the natural menstrual cycle, but reduced compared to its concentration in the second half of the natural cycle. It is not known whether this affects bone mass.
Breast cancer
All women are at risk of developing breast cancer, regardless of whether they take contraceptive pills. Breast cancer occurs slightly more frequently in women using oral contraceptives than in women of the same age who do not use them. This risk gradually decreases after stopping oral contraceptives and after 10 years is the same for women who used them and those who never did. Breast cancer is less common in women under 40 years of age, but the risk increases with age. Therefore, a higher number of breast cancer cases occurs in women using oral contraceptives at an older age. The duration of oral contraceptive use is not highly significant.
For every 10,000 women using oral contraceptives for no more than 5 years in the age group under 20 years, fewer than 1 additional case of breast cancer was diagnosed per 10 years after stopping the pill compared to 4 cases usually diagnosed in this age group. Similarly, among 10,000 women using oral contraceptives for up to 5 years in the age group under 30 years, 5 additional cases of breast cancer were diagnosed compared to 44 cases usually diagnosed in this group. Among 10,000 women using oral contraceptives for up to 5 years in the age group over 40 years, 20 more cases of breast cancer were diagnosed compared to 160 cases usually diagnosed.
The occurrence of breast cancer in women using progestogen-only pills, such as Cerazette, appears similar to the risk in women using combined oral contraceptives, although evidence is not conclusive.
Breast cancer cases diagnosed in women using oral contraceptives seem to be less advanced than those in women not using them. It is not known whether this difference is related to oral contraceptive use. It may be due to more frequent medical check-ups in women using contraception, leading to earlier detection of breast cancer.
Venous thromboembolic disease
Venous thromboembolic disease is the formation of a blood clot that may block a blood vessel. It sometimes occurs in the deep veins of the lower limbs (deep vein thrombosis). If the clot detaches from its site of origin, it may travel to the lungs and block the pulmonary artery, causing pulmonary embolism, which may be fatal. Deep vein thrombosis is very rare. It may also develop in women not using oral contraceptives and may occur during pregnancy. The risk of venous thromboembolic disease is higher in women using oral contraceptives than in those who do not. It is believed that the risk of venous thromboembolic disease in women using progestogen-only oral contraceptives such as Cerazette is lower than in women using combined oral contraceptives containing oestrogens. If symptoms of venous thromboembolic disease occur, contact your doctor immediately (see section "Regular check-ups").
Psychiatric disorders
Some women using hormonal contraceptives, including Cerazette, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice.
Children and adolescents
There are no available clinical data on the efficacy and safety of use in adolescents under 18 years of age.
Cerazette with other medicines
Inform your doctor about any medicines or herbal products you are currently taking, have recently taken, or plan to take. Also inform any other specialist doctor or dentist prescribing other medicines (or a pharmacist) that you are taking Cerazette. They may advise you on the need for additional contraceptive methods (e.g. condoms) and how long to use them, and whether modification of the prescribed medicine is necessary.
Some medicines:

May affect the blood concentration of Cerazette,
May reduce its contraceptive effectiveness,
May cause unexpected bleeding. These include 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 infections (e.g. griseofulvin),
High blood pressure in the pulmonary blood vessels (bosentan),
Depressive mood (St John's wort (Hypericum perforatum)),
Certain bacterial infections (e.g. clarithromycin, erythromycin),
Fungal infections (e.g. ketoconazole, itraconazole, fluconazole),
High blood pressure (hypertension), angina, or certain heart rhythm disorders (e.g. diltiazem).

If you are taking medicines or herbal remedies that may reduce the effectiveness of Cerazette, you should also use mechanical contraception. Because the effect of another medicine on Cerazette may persist for up to 28 days after stopping the medicine, additional mechanical contraception is necessary during this period. Your doctor will advise you on the possible need for additional contraceptive methods and the duration of their use.
Cerazette may also interfere with the action of other medicines, increasing (e.g. medicines containing cyclosporine) or decreasing (e.g. lamotrigine) their effect.
Before taking any medicine, consult your doctor or pharmacist.
Vaginal bleeding
During treatment with Cerazette, vaginal bleeding may occur irregularly. This may be light spotting or heavy bleeding. Bleeding may also not occur at all. Irregular bleeding does not mean that the contraceptive effectiveness of Cerazette is reduced. Usually, no action is required, and you should continue taking Cerazette. Contact your doctor if bleeding is very heavy or prolonged.
Functional ovarian cysts
While using all hormonal contraceptives containing low hormone doses, small fluid-filled sacs called functional ovarian cysts may develop in the ovaries. These usually disappear spontaneously. In some cases, they may cause mild abdominal pain. Rarely, surgical intervention is required.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Cerazette must not be used during pregnancy or if pregnancy is suspected.
Breastfeeding
Cerazette may be used during breastfeeding. It does not appear to affect the production or quality of breast milk. However, a reduction in milk production has occasionally been reported during use of Cerazette. Small amounts of the active substance pass into breast milk.
Observations on the health of children up to 2.5 years of age whose mothers used Cerazette for 7 months have shown no effect on the child's growth and development.
If you are breastfeeding and wish to use Cerazette, consult your doctor.
Driving and using machines
No effects of Cerazette on the ability to drive and operate machinery have been observed.
Cerazette contains monohydrate lactose
Cerazette contains monohydrate lactose. If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
When to contact your doctor
Regular check-ups
You should be informed by your doctor about the need for regular check-ups while using Cerazette. The frequency and type of examinations usually depend on individual patient characteristics.
Contact your doctor immediately if:

Symptoms suggesting venous thromboembolic disease occur (e.g. severe pain or swelling in 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);
Immobilisation (e.g. bed rest) or planned surgery; consult your doctor at least 4 weeks in advance;
Irregular, heavy vaginal bleeding occurs;
You are or may be pregnant.

3. How to use Cerazette

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.

When and how to take the tablets

The Cerazette pack contains 28 tablets. On one side of the blister, each tablet is marked with the symbol of the day of the week on which it should be taken (see "Translation of the day-of-the-week symbols next to each tablet on the immediate packaging" in section 6 at the end of this leaflet). On the other side, arrows indicate the direction in which the tablets should be taken. Each time starting a new pack of Cerazette, always begin with the top row of the blister, taking the tablets in the direction of the arrows, one tablet per day, until the pack is finished. For example, if you start taking the tablets on Wednesday, take the first tablet from the top row marked WED. This makes it easy to check whether the tablet marked for a particular day of the week has been taken on that day. The tablets should be taken at the same time each day. Swallow the tablet whole with water. Spotting or breakthrough bleeding may occur while taking Cerazette tablets. In such cases, continue taking the tablets as usual. The next pack should be started the following day after finishing the previous one, without interruption and without waiting for bleeding to occur.

You may stop taking Cerazette tablets at any time. Contraceptive effectiveness ends on the day you stop taking the tablets.

Starting the first pack of Cerazette

If you are currently not taking any contraceptive tablets: Wait for your next menstrual period. Start taking Cerazette tablets on the first day of your period. No additional contraceptive methods are needed. You may also start taking the tablets between day 2 and day 5 of your cycle; however, in this case, you must use an additional contraceptive method (barrier methods) for the first 7 days of tablet intake in the first cycle.
If you were previously taking a combined hormonal contraceptive (combined oral contraceptive pills, vaginal contraceptive system, contraceptive patch): You may start taking Cerazette the day after taking the last active tablet of your current contraceptive, or on the day of removal of the vaginal contraceptive system or contraceptive patch (without taking a break from tablets, vaginal system, or patch). If your current contraceptive includes placebo tablets, start Cerazette the day after taking the last hormone-containing tablet (if in doubt about which tablet this is, consult your doctor or pharmacist). No additional contraceptive method is required if you follow this instruction.

Alternatively, you may start taking Cerazette no later than the first day after the tablet-free interval of your current contraceptive, on the day of insertion of the next vaginal contraceptive system or contraceptive patch, or the day after taking the last placebo tablet of your current contraceptive. In these cases, you must use an additional contraceptive method (barrier method) for the first 7 days of taking Cerazette tablets.

If you were previously taking another progestogen-only medicine: You may stop taking the tablets on any day and start taking Cerazette the following day. No additional contraceptive methods are required.
If you were previously using a progestogen-releasing injectable, implant, or intrauterine system: Start taking Cerazette on the day when the next injection would have been due, or on the day of removal of the implant or system. No additional contraceptive methods are required.
After childbirth: Start taking Cerazette between day 21 and day 28 after delivery. If you start later than this, use an additional contraceptive method (barrier methods) for the first 7 days of tablet intake. Before starting Cerazette, check that you are not pregnant or wait until your first menstrual period after delivery. More information regarding breastfeeding is provided in the "Breastfeeding" section. Your doctor can also provide advice.
After miscarriage or abortion: As advised by your doctor.

Taking more than the recommended dose of Cerazette

No serious harmful effects have been observed after taking more than one Cerazette tablet at a time. Nausea, vomiting, and slight vaginal bleeding may occur in women and young girls. Consult your doctor if you take more than the recommended dose.

Missed dose of Cerazette

If you are less than 12 hours late in taking a tablet, contraceptive protection is maintained. Take the missed tablet as soon as possible and continue taking the remaining tablets at your usual time.

If you are more than 12 hours late in taking a tablet, contraceptive effectiveness may be reduced. The more tablets you miss, the higher the risk of reduced contraceptive effectiveness. Take the missed tablet as soon as possible and continue taking the remaining tablets at your usual time. Use an additional contraceptive method (e.g. condoms) for the next 7 days. There is a risk of pregnancy if you miss one or more tablets during the first week of starting the tablets, especially if you had unprotected intercourse in the week before the missed dose. Consult your doctor.

Gastrointestinal disturbances (e.g. vomiting, severe diarrhoea)

In case of gastrointestinal disturbances, follow the instructions for a missed tablet as described above. If vomiting or severe diarrhoea occurs within 3 to 4 hours after taking a Cerazette tablet, absorption of the active ingredient may be reduced. In case of severe diarrhoea, contact your doctor.

Stopping treatment with Cerazette

You may stop taking Cerazette at any time. If you do not plan to become pregnant, consult your doctor about alternative contraceptive methods.

If you are planning pregnancy, it is usually recommended to wait until your first natural menstrual period before trying to conceive. This helps to establish the expected date of delivery more accurately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should inform your doctor of any adverse health changes,
especially if they are severe and persistent, as well as any health changes that appear to be
caused by taking Cerazette tablets.
Serious adverse effects associated with the use of Cerazette are described in the sections
"Breast cancer" and "Venous thromboembolic disease" in section 2 "Important information before
using Cerazette". Please read these sections for additional information and seek immediate medical advice if necessary.
If allergic reactions (hypersensitivity) occur, including swelling of the face, lips, tongue and (or) throat causing difficulty in breathing or swallowing (angioedema and (or) anaphylactic reaction), you should contact your doctor immediately.
Vaginal bleeding may occur irregularly during treatment with Cerazette. This may be slight spotting not requiring the use of sanitary pads, or heavier bleeding resembling a light menstrual period, when the use of sanitary pads is necessary.
Bleeding may also not occur at all. Irregular bleeding does not mean that the contraceptive effectiveness of Cerazette is reduced. Usually, no action is required and you should continue taking Cerazette as directed. However, if bleeding is very heavy or prolonged, you should contact your doctor.
Women using Cerazette have reported the following adverse effects:
Common: may affect up to 1 in 10 women

mood changes, depressed mood, decreased sex drive (libido)
headache
nausea
acne
breast pain; irregular menstrual bleeding or absence of periods
increased body weight

Uncommon: may affect up to 1 in 100 women

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

Rare: may affect up to 1 in 1000 women

rash, urticaria, painful blue-red nodules (erythema nodosum) (these are skin disorders)

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

allergic reaction

In addition to the adverse effects listed above, breast discharge may occur.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Cerazette

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
There are no special temperature requirements for storage. 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 poses an environmental risk to fish.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Cerazette contains

The active substance is desogestrel 75 micrograms.
The other ingredients are: colloidal anhydrous silica, all-rac-α-tocoferol, monohydrate lactose, maize starch, povidone, stearic acid; coating: hypromellose, macrogol 400, talc, titanium dioxide (E 171). See also section 2 "Cerazette contains monohydrate lactose".

What Cerazette looks like and contents of the pack
The tablets are white, round, biconvex, 5 mm in diameter, marked with the code 2 below KV on one side and the word Organon and a star on the other.
The PVC/Al blister pack contains 28 tablets and is packed in a pouch made of laminated aluminium foil. 1 or 3 blisters are supplied in a cardboard box.
A pouch is included in the packaging, intended for storing the blister after removal from the protective foil.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Ireland, 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, The Netherlands
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Marketing Authorisation number in Ireland, country of export: PA23198/016/001
Parallel Import Licence number: 446/24
Translation of the day-of-the-week symbols printed next to each tablet in the immediate packaging:
MON - Monday
TUE - Tuesday
WED - Wednesday
THU - Thursday
FRI - Friday
SAT - Saturday
SUN - Sunday