Package leaflet: Information for the user

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Cerazette
0.075 mg, coated tablets
Desogestrel
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Cerazette is and what it is used for
Before you take 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 egg maturation. As a result, Cerazette is a highly effective contraceptive.
Unlike combined oral contraceptives, Cerazette can be used by women who are intolerant to oestrogens and by breastfeeding women. The most common 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 HIV (AIDS)
or other sexually transmitted infections.
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 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 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 symptoms listed above occur for the first time while taking Cerazette, consult your doctor immediately.
Warnings and precautions
When using Cerazette under any of the following circumstances, close medical supervision is required. Before starting Cerazette, inform your doctor if you have:

Current or past breast cancer;
Liver tumour; as a potentially harmful effect of Cerazette cannot be excluded;
Previous history of venous thromboembolic disease;
Diabetes;
Epilepsy (see section “Cerazette with other medicines”);
Tuberculosis (see section “Cerazette with other medicines”);
High blood pressure;
Current or past chloasma (yellowish-brown 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. When using Cerazette, the concentration of the natural oestrogen, estradiol, in plasma is comparable to its concentration in the first half of the 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 take oral contraceptives. Breast cancer occurs slightly more frequently in women taking oral contraceptives than in women of the same age who do not. After stopping oral contraceptives, this risk gradually decreases, so that after 10 years, the risk is the same for women who took oral contraceptives and those who never did. Breast cancer is less common in women under 40 years of age, but the risk increases with age. Therefore, more cases of breast cancer occur in older women taking oral contraceptives. The duration of taking oral contraceptives is not as significant.
Among 10,000 women taking 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 taking 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 taking 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 pills, although evidence is not conclusive.
Breast cancer cases diagnosed in women taking 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 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 may sometimes occur 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 taking oral contraceptives and may occur during pregnancy. The risk of venous thromboembolic disease is higher in women taking 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 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 you are currently taking, have recently taken, or plan to take. Also inform any other doctor, dentist, or pharmacist prescribing other medicines about your use of Cerazette. They may advise whether additional contraceptive methods (e.g. condoms) are needed and for how long, and whether adjustment of the prescribed medicine is necessary.
Some medicines:

may affect the blood concentration of Cerazette
may reduce its contraceptive effectiveness
may cause unexpected bleeding.

This applies to medicines used in the treatment of:

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 arteries (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 products that may reduce the effectiveness of Cerazette, use mechanical contraception as well. Because the effect of another medicine on Cerazette may last up to 28 days after stopping the medicine, additional mechanical contraception is required during this time. Your doctor will advise you on the 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 effects (e.g. lamotrigine).
Before taking any medicine, consult your doctor or pharmacist.
Vaginal bleeding
While taking 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 needed, and you should continue taking Cerazette. Contact your doctor if bleeding is very heavy and 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, they require surgical intervention.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to become pregnant, 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 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 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 use machines have been observed.
Cerazette contains lactose monohydrate
Cerazette contains lactose monohydrate. 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
Women using Cerazette should be informed by their doctor about the need for regular check-ups. 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 yellowing of the skin (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 surgical procedure; 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 exactly 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 day of the week on which it should be taken, and on the reverse side arrows indicate the direction in which the tablets should be taken. Each time starting a new pack of Cerazette, tablets should be taken from the top row of the blister, following the direction of the arrows, one tablet per day, until the pack is finished. For example, if you start taking the tablets on Wednesday, the first tablet should be taken from the top row marked 4 F (a translation of the day-of-the-week symbols marked next to each tablet on the immediate packaging can be found at the end of this leaflet and on the carton).

This allows you to easily 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. Spot bleeding may occur while taking Cerazette tablets. In such a case, however, you should continue taking the tablets. After finishing all tablets in the pack, start taking tablets from a new pack the next day, 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 until your next menstrual 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, but 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 pills, vaginal contraceptive ring, contraceptive patch):

You may start taking Cerazette tablets the day after taking the last active tablet of your current contraceptive, or on the day of removal of the vaginal contraceptive ring or contraceptive patch (without taking a break from tablets, vaginal ring or patch). If your current contraceptive also includes inactive (placebo) tablets, you may 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 above instructions.

Alternatively, you may start taking Cerazette no later than the first day after the tablet-free interval of your current contraceptive, on the day you would insert the next vaginal ring or apply the next 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 tablets the next day. There is no need to use additional contraceptive methods.

If you were previously using contraception by injection, implant, or intrauterine system releasing a progestogen:

Start taking Cerazette tablets 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 tablets between day 21 and 28 after childbirth. If you start later, you must use an additional contraceptive method (barrier methods) for the first 7 days of tablet-taking. Before starting the tablets, check that you are not pregnant after any sexual intercourse that occurred prior to starting, or wait until your first menstrual period. More information regarding breastfeeding can be found in the section "Breast-feeding". Your doctor can also provide advice.

After miscarriage or abortion:

As directed by your doctor.

Taking more Cerazette than prescribed

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

Missed dose of Cerazette

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

If you are more than 12 hours late taking a tablet, contraceptive protection may be reduced. The more tablets you miss, the greater the risk of reduced contraceptive effectiveness. Take the missed tablet as soon as possible, then continue taking the remaining tablets at your usual time. For the next 7 days, use an additional contraceptive method (e.g. a condom). 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 sexual intercourse in the week before the missed dose. Consult your doctor.

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

Act as 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 ingredient 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 plan to become pregnant, ask your doctor for advice on 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.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should inform your doctor about any adverse changes in your health,
especially if they are severe and persistent, as well as any health changes that appear to be
caused by taking Cerazette tablets.
Serious adverse reactions 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 this section 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 use of sanitary protection is necessary.
Bleeding may also not occur at all. Irregular bleeding does not mean that the contraceptive efficacy 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.
The following adverse reactions have been reported by women using Cerazette:

Common: may occur in up to 1 in 10 women

mood changes, depressed mood, decreased sexual drive (libido)
headache
nausea
acne
breast pain; irregular menstrual bleeding or absence of menstruation
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 blue-red nodules (erythema nodosum) (these are skin disorders).

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

allergic reaction.

In addition to the adverse reactions listed above, breast discharge may occur.
Reporting of adverse reactions
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also 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, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions 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 storage requirements. Store the blister pack in the original sachet to protect from light and moisture. After opening the sachet, the medicine 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 in household waste. Ask your pharmacist how to dispose of medicines you no longer use. 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, RRR-α-Tocopherol, monohydrate lactose, corn 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.
PVC/Al blister pack containing 28 tablets, packed in a laminated aluminium foil sachet.
1 or 3 blisters in a cardboard box.
A cardboard sachet is included with the package, in which the blister should be placed.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Portugal, country of export:
Organon Portugal, Sociedade Unipessoal Lda.
Rua Alexandre Herculano, 50 - Piso 9
1250-011 Lisbon
Portugal
Manufacturer:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Portugal, country of export: 2798486
Parallel Import Licence Number: 40/24
Translation of the weekday symbols printed next to each tablet in the immediate packaging:
2 F - Monday
3 F - Tuesday
4 F - Wednesday
5 F - Thursday
6 F - Friday
SAB - Saturday
DOM - Sunday