Package leaflet: Information for the user

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

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please 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 effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

What Cerazette is and what it is used for
What you need to know 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 main mechanism of action of most progestogen-only pills is to prevent sperm migration through the cervical canal. Unlike 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 suppresses egg cell maturation. As a result, Cerazette is a highly effective contraceptive.
Unlike combined products, it can be used by women who are intolerant to oestrogens and by 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 small.

2. Important information before using Cerazette

The medicine 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 are present, inform your doctor before starting Cerazette. Your doctor may recommend using a non-hormonal method of contraception.

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 involves the formation of blood clots blocking veins [e.g. in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism)].
Current or past occurrence of jaundice (yellowing of the skin) or severe liver disease until liver function parameters return to normal.
Current or past occurrence of hormone-dependent tumours (e.g. specific types of breast cancer).
Vaginal bleeding of unknown cause.

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

There is current or past history of breast cancer;
There is a liver tumour; as a potentially harmful effect of Cerazette cannot be excluded;
There is a past history of venous thromboembolic disease;
There is diabetes;
There is epilepsy (see section "Cerazette with other medicines");
There is tuberculosis (see section "Cerazette with other medicines");
There is high blood pressure;
There is current or past 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 the natural oestrogen, estradiol, in plasma is comparable to its concentration in the first half of a woman's natural 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 use contraceptive pills. Breast cancer occurs slightly more frequently in women using contraceptive pills than in women of the same age who do not use them. After stopping contraceptive pills, this risk gradually decreases and after 10 years, the risk is the same for women who used pills and those who never used them. 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 older women using contraceptive pills. The duration of use of contraceptive pills is not of major significance.
For every 10,000 women using contraceptive pills for no more than 5 years in the age group under 20 years, fewer than 1 additional case of breast cancer was diagnosed within 10 years after stopping the pills, compared to 4 cases usually diagnosed in this age group. Similarly, for every 10,000 women using contraceptive pills 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. For every 10,000 women using contraceptive pills 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 pills, although the evidence is not conclusive.
Breast cancer cases diagnosed in women using contraceptive pills seem to be less advanced than those in women not using them. It is not known whether this difference is related to the use of contraceptive pills. It may be due to more frequent monitoring of 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 legs (deep vein thrombosis). If the clot detaches from its site of origin, it may travel to the lungs and block the pulmonary artery, causing a pulmonary embolism. This may lead to death. Deep vein thrombosis is very rare. It may also develop in women not using contraceptive pills and may occur during pregnancy. The risk of venous thromboembolic disease is higher in women using contraceptive pills than in those not using them. It is believed that the risk of venous thromboembolic disease in women using progestogen-only pills, such as Cerazette, is lower than in women using combined pills (containing oestrogens). If symptoms of venous thromboembolic disease occur, contact a doctor immediately (see section "Regular check-ups").
Psychiatric disorders
Some women using hormonal contraceptives, including Cerazette, have reported depression or low mood. Depression may be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact a doctor as soon as possible for further medical advice.
Children and adolescents
There are no clinical data available 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 currently or recently used, as well as any medicines planned for use. Also inform any other specialist doctor, dentist or pharmacist prescribing other medicines about the use of Cerazette. They may advise on the need for additional contraceptive methods (e.g. condoms) and the duration of their use, as well as whether modification of the prescribed medicine is necessary.
Some medicines:

may affect the concentration of Cerazette in the blood,
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 disorders (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 the patient is taking medicines or herbal remedies that may reduce the effectiveness of Cerazette, mechanical contraception should also be used. 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, leading to increased (e.g. medicines containing cyclosporine) or decreased (e.g. lamotrigine) effects.
Before taking any medicine, consult a 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 treatment with Cerazette should be continued. Contact a doctor if bleeding is very heavy and prolonged.
Functional ovarian cysts
During use of all hormonal contraceptives containing low hormone doses, small fluid-filled sacs called functional ovarian cysts may develop in the ovaries. These usually resolve spontaneously. In some cases, they may cause mild abdominal pain. Rarely, surgical intervention may be required.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a 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 decrease 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 adverse effects on the child's growth and development.
If breastfeeding and wishing to use Cerazette, contact a doctor.
Driving and operating machinery
No effects of Cerazette on the ability to drive and operate machinery have been observed.
Cerazette contains monohydrate lactose
Cerazette contains monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, she should consult a doctor before taking the medicine.
When to contact a doctor
Regular check-ups
The patient using Cerazette should be informed by the doctor about the need for regular check-ups. The frequency and type of examinations usually depend on individual patient characteristics.
Contact a doctor immediately in the following cases:

If symptoms suggestive of 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);
Detection of a breast lump;
Sudden severe pain in the lower abdomen or stomach area (indicating possible ectopic pregnancy);
Immobilisation (e.g. bed rest) or planned surgical procedure; consult a doctor at least 4 weeks in advance;
If irregular, heavy vaginal bleeding occurs;
If the patient is or may be pregnant.

3. How to use Cerazette

This medicine should always be taken exactly as your doctor has advised. 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 you start a new pack of Cerazette, begin with the top row of the blister, taking one tablet daily in the direction of the arrows until the pack is finished. For example, if you start taking tablets on Wednesday, the first tablet should be the one in the top row marked 4 F. 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.

Breakthrough bleeding may occur while taking Cerazette tablets. In such a case, continue taking the tablets as usual. The next pack should be started the day after the last tablet in the previous pack has been taken, 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 period. Start taking Cerazette tablets on the first day of your period. There is no need to use additional contraceptive methods. You may also start taking the tablets between days 2 and 5 of your cycle; however, in this case, you must use an additional contraceptive method (barrier methods) for the first 7 days of tablet-taking in the first cycle.
If you were previously taking a combined oral contraceptive (combined oral contraceptive tablets, 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 inactive tablets, or from using the vaginal system or patch). If your current contraceptive also includes placebo tablets, you should start taking Cerazette the day after taking the last hormone-containing tablet (if in doubt about which tablet this is, consult your doctor or pharmacist). There is no need to use an additional contraceptive method if you follow the instructions above.

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 pill: You may stop taking the current progestogen-only pill at any time and start taking Cerazette the next day. There is no need to use additional contraceptive methods.
If you were using contraception by injection, implant, or intrauterine system releasing progestogen: 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. There is no need to use additional contraceptive methods.
After childbirth: Start taking Cerazette between days 21 and 28 after delivery. If you start later than this, use an additional contraceptive method (barrier methods) for the first 7 days of tablet-taking. Before starting Cerazette, either confirm that you are not pregnant or wait until your first period. More information regarding breastfeeding is provided in the section "Breast-feeding". Your doctor can also provide advice.
After miscarriage: As advised by your doctor.

Taking more Cerazette than you should

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 women and young girls. Consult your doctor.

If you forget to take Cerazette

If you are less than 12 hours late 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, contraceptive effectiveness may be reduced. The more tablets you miss, the greater 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 in 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)

Follow the instructions for a missed tablet (see above). If vomiting or severe diarrhoea occurs within 3 to 4 hours after taking a Cerazette tablet, absorption of the active substance may be reduced. In case of severe diarrhoea, contact your doctor.

Stopping Cerazette

You may stop taking Cerazette at any time. If you do not wish to become pregnant, ask your doctor for advice on alternative contraceptive methods.

If you are planning a pregnancy, it is usually recommended to wait until your first natural 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 about any adverse health changes,
especially if they are severe and persistent, or if they appear to be
related to 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 light spotting not requiring sanitary protection, or heavier bleeding resembling a light menstrual period, when the use of sanitary protection 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 occur in up to 1 in 10 women

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

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 1000 women

rash, urticaria, painful red-blue 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 be reported directly to the Department of Monitoring 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 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 requirements regarding storage temperature. 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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-tocopherol, monohydrate lactose, corn starch, povidone, stearic acid; coating: hypromellose, polyethylene glycol 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, with a diameter of 5 mm, marked with the code 2 below KV on one side and the word Organon and an asterisk on the other.
The PVC/Al blister pack contains 28 tablets and is packed in a laminated aluminium foil sachet. 1 or 3 blisters in a cardboard box.
A sachet is included in the packaging, in which the blister should be placed after removal from the protective foil.
For further information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Portugal, country of export:
Organon Portugal, Sociedade Unipessoal Lda.
Marquês de Pombal, 14
1250-162 Lisbon
Portugal
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
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Portugal MA number, country of export: 2798486
Parallel Import Licence Number: 318/21
Translation of the day-of-the-week symbols printed next to each tablet on the immediate packaging:
2 F - Monday
3 F - Tuesday
4 F - Wednesday
5 F - Thursday
6 F - Friday
SAB - Saturday
DOM - Sunday