Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Cerazette
75 micrograms (0.075 mg), coated tablets
Desogestrel
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet to be able to read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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 primarily involves preventing sperm migration 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 do not tolerate oestrogens and in women who are breastfeeding. The most common inconvenience during Cerazette use 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

Like other hormonal contraceptives, Cerazette 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 occur, 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).
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 had jaundice (yellowing of the skin) or severe liver disease until liver function parameters return to normal.
If you currently have or have had hormone-dependent cancers (e.g. certain types of breast cancer).
Unexplained vaginal bleeding.

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, strict medical supervision is required. Before starting Cerazette, inform your doctor if you:

currently have or have had breast cancer;
have a liver tumour; as the potentially harmful effect of Cerazette cannot be ruled out;
have had venous thromboembolic disease in the past;
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 had chloasma (brownish pigmented 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. While taking Cerazette, the concentration of the natural oestrogen, estradiol, in plasma is comparable to its concentration in the first half of the natural menstrual cycle, but reduced compared to 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. This risk gradually decreases after stopping the contraceptive pills and after 10 years is the same for women who used them and those who never did. Breast cancer is rare in women under 40 years of age, but the risk increases with age. Therefore, more cases of breast cancer occur in older women using contraceptive pills. The duration of use is less significant.
For every 10,000 women under 20 years of age who used combined oral contraceptives for no more than 5 years, fewer than 1 additional case of breast cancer was diagnosed per 10 years after stopping, compared to 4 cases usually diagnosed in this age group. Similarly, among 10,000 women under 30 years of age who used combined oral contraceptives for up to 5 years, 5 additional cases were diagnosed compared to 44 cases usually diagnosed in this group. Among 10,000 women over 40 years of age who used combined oral contraceptives for up to 5 years, 20 more cases were diagnosed compared to 160 cases usually diagnosed.
The risk of breast cancer in women using progestogen-only pills such as Cerazette appears similar to that in women using combined oral contraceptives, although evidence is not conclusive.
Breast cancers diagnosed in women using contraceptive pills seem to be less advanced than those in women not using them. It is unclear whether this difference is related to contraceptive use or to more frequent medical check-ups in contraceptive users, leading to earlier detection.
Venous thromboembolic disease
Venous thromboembolic disease involves 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, which may be fatal. 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 users of combined oral contraceptives than in non-users.
It is believed that the risk of venous thromboembolic disease in users of progestogen-only pills such as Cerazette is lower than in users of 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 Cerazette in adolescents under 18 years of age.
Cerazette with other medicines
Inform your doctor about any medicines or herbal products you are currently taking or have recently taken, as well as any medicines you plan to take. Also inform any other doctor, dentist or pharmacist prescribing other medicines that you are taking Cerazette. They may advise whether additional contraceptive methods (e.g. condoms) are needed and for how long, or whether the prescribed medicine requires dosage adjustment.
Some medicines:

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

This includes 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),
pulmonary arterial hypertension (bosentan),
depression (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, use additional 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 required during this period. 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, increasing (e.g. medicines containing cyclosporine) or decreasing (e.g. lamotrigine) their effect.
Before taking any medicine, consult your doctor or pharmacist.
Vaginal bleeding
Irregular vaginal bleeding may occur while taking Cerazette. 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 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 are planning a pregnancy, 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 amount or quality of breast milk. However, a slight decrease in milk production has occasionally been reported with Cerazette. Small amounts of the active ingredient 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 you are breastfeeding and wish to use Cerazette, consult your doctor.
Driving and using machines
Cerazette has not been shown to affect the ability to drive or operate machinery.
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
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 (suggesting 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 taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
When and how to take the tablets
The Cerazette blister 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 other side arrows indicate the direction in which the tablets should be taken. Each time starting a new pack of Cerazette, 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 (indicating Wednesday; see "Translation of the symbols for days of the week located next to each tablet on the immediate packaging" at the end of this leaflet). 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 every day. Swallow the tablet whole with water.
During treatment with Cerazette, light bleeding may occur. In such a case, however, continue taking the tablets as directed. After finishing 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 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 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 taking the tablets in the first cycle.
If you were previously taking a combined hormonal contraceptive (combined oral contraceptive pills, vaginal contraceptive ring, 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 ring or contraceptive patch (without a break for hormone-free days, removal of the vaginal ring, or removal of the patch). If your current contraceptive also 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). There is no need to use additional contraceptive methods if you follow the above instructions.

Alternatively, you may start taking Cerazette no later than the first day after the break from your current contraceptive pills, on the day of insertion of the next vaginal ring or application of 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 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 day 28 after childbirth. If you start later than this, use an additional contraceptive method (barrier methods) for the first 7 days of taking the tablets. If you had intercourse before starting the tablets, check whether you are pregnant or wait until your first menstrual period. More information regarding breastfeeding is provided in the section "Breastfeeding". Your doctor can also provide advice.
After miscarriage:
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 the delay in taking a tablet is less than 12 hours, the contraceptive effectiveness remains unchanged. Take the missed tablet as soon as possible and continue taking 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 tablets missed, the greater the risk of reduced contraceptive effectiveness. Take the missed tablet as soon as possible and continue taking the remaining tablets as usual. For the next 7 days, use an additional contraceptive method (e.g. condom). There is a risk of pregnancy if one or more tablets are missed during the first week of starting the tablets, especially if you had intercourse in the week before the missed dose. Consult your doctor.

Gastrointestinal disturbances (e.g. vomiting, severe diarrhoea)
Act as in the case of 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 treatment with Cerazette
You may stop taking Cerazette at any time. If you do not plan to become pregnant, consult your doctor about using another contraceptive method.
If you plan to become pregnant, it is usually recommended to wait until your first natural menstrual period before trying to conceive. This will help determine the expected date of delivery.

4. Possible adverse effects

Like any medicine, this medicine may 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, as well as about any health changes that appear to be
related to taking Cerazette tablets.
Serious adverse effects associated with the use of Cerazette are described in the section
"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
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 efficacy of Cerazette is reduced.
Usually, no action is required and it is sufficient to continue taking Cerazette. 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, depressed mood, decreased sexual 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, you should inform your doctor or pharmacist. 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 the medicine.

5. How to store Cerazette

Keep the 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 requirements regarding storage temperature.
Store the blister pack in the original sachet to protect it from light and moisture.
After opening the sachet, the medicine should be used within 1 month.
The active substance 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 no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Cerazette contains

The active substance is desogestrel. Each coated tablet contains 75 micrograms (0.075 mg) of desogestrel.
Other ingredients are: colloidal anhydrous silica, all-rac-α-tocopherol, 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 code 2 below KV on one side and with the word ORGANON and an asterisk on the other.
The blister (PVC/aluminium) contains 28 tablets and is packed in a laminated aluminium foil sachet.
1 or 3 blisters in a cardboard box.
A cardboard pouch is included in the package, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation number in Ireland, country of export: PA23198/016/001
Parallel Import Licence number: 158/24
Translation of symbols for days of the week printed next to each tablet on the immediate packaging:
MON – Monday
TUE – Tuesday
WED – Wednesday
THU – Thursday
FRI – Friday
SAT – Saturday
SUN – Sunday