CERAZETTE

Patient Information Leaflet

Warning! Keep this leaflet. The packaging information is in a foreign language.
Cerazette, 75 micrograms, coated tablets
Desogestrel
Please read this leaflet carefully before taking 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, 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 reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

1. What Cerazette is and what it is used for
2. Important information before taking Cerazette
3. How to take Cerazette
4. Possible side effects
5. How to store Cerazette
6. Contents of the pack and other information

1. What Cerazette is and what it is used for

How 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 referred to 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 penetration 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 products, it can be used in women who do not tolerate oestrogens and in 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

Like other hormonal contraceptives, Cerazette 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 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. 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
If you have any of the following conditions, close medical supervision is required. Before starting Cerazette, inform your doctor if you:

• Currently have or have had breast cancer;
• Have liver tumours; as the potentially harmful effect of Cerazette cannot be excluded;
• 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 (yellowish-brown 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. When taking Cerazette, the concentration of 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 contraceptive pills. Breast cancer occurs slightly more frequently in women taking contraceptive pills than in women of the same age who do not take them. This risk gradually decreases after stopping contraceptive pills and after 10 years of stopping, the risk is the same for women who took the pills 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 taking contraceptive pills at an older age. The duration of taking contraceptive pills is less significant.
For every 10,000 women taking 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 10,000 women taking 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 age group. For 10,000 women taking 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 taking progestogen-only pills, such as Cerazette, appears to be similar to the risk in women taking combined pills, although evidence is not conclusive.
Breast cancer cases diagnosed in women taking contraceptive pills seem to be less advanced than those in women not taking them. It is not known whether this difference is related to taking 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 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 contraceptive pills and may occur during pregnancy. The risk of venous thromboembolic disease is higher in women taking contraceptive pills than in those not taking them. It is believed that the risk in women taking progestogen-only pills, such as Cerazette, is lower than in women taking combined contraceptive pills 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 or have recently taken, as well as any medicines you plan to take. Also inform any other specialist doctor, dentist or pharmacist prescribing other medicines that you are taking Cerazette. They may advise you on the need for additional contraceptive methods (e.g. condoms) and the duration of their use, or 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 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
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 taking 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 may be 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 milk production or quality. However, a slight 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 showed no effect on the child's growth and development.
If you are breastfeeding and wish to use Cerazette, contact your doctor.
Driving and operating machinery
No effects of Cerazette on the ability to drive and operate machinery 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 in the following cases:

• 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);
• 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 your doctor at least 4 weeks in advance;
• If irregular, heavy vaginal bleeding occurs;
• If you are or may be pregnant.

3. How to take 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 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, 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 starting on Wednesday, the first tablet taken should be the one in the top row marked "Mi" (abbreviation for Wednesday). This helps easily verify whether the tablet for a given 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 directed. After finishing a pack, start the next pack the following 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 for your next menstrual period. Begin taking Cerazette tablets on the first day of your period. There is no need to use additional contraceptive methods. You may also start 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 using a combined hormonal contraceptive (combined oral contraceptive pills, vaginal 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 between the end of the previous method and starting Cerazette). If your current contraceptive includes inactive (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 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.

• If you were previously using another progestogen-only contraceptive: You may stop taking your current progestogen-only pills on any day and start Cerazette the next day. There is no need to use additional contraceptive methods.

• If you were using a progestogen-only injectable, implant, or intrauterine system: Start taking Cerazette on the day the next injection would have been due, or on the day of removal of the implant or intrauterine system. There is no need to use additional contraceptive methods.

• After childbirth: Begin taking Cerazette between days 21 and 28 after childbirth. If you start later than this, use an additional contraceptive method (barrier methods) for the first 7 days of tablet-taking. After any sexual intercourse before starting Cerazette, you should either confirm you are not pregnant or wait until your first menstrual period. More information regarding breastfeeding is provided in the "Breast-feeding" section. Your doctor can also provide advice.

• After miscarriage or abortion: As directed 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 the same time. Nausea, vomiting, and slight vaginal bleeding may occur in women and young girls. Consult your doctor if this happens.

Missing a 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 and continue taking the following 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. condom) 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 sexual 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 (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, consult your doctor about using another contraceptive method.

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 an accurate estimated date of delivery.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
You should inform your doctor about any adverse changes in your health,
especially if they are severe and persistent, as well as about any health changes that seem to be
caused by taking Cerazette tablets.
Serious adverse effects associated with the use of Cerazette are described in the section
"Breast cancer", "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.
During treatment with Cerazette, vaginal bleeding may occur irregularly. 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 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 affect up to 1 in 10 women

• mood changes, depressive mood, decreased sexual drive (libido)
• headache
• nausea
• acne
• breast pain; irregular menstrual bleeding or absence of bleeding
• 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, you should inform your doctor, pharmacist or nurse. Adverse effects
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
tel.: +48 22 49-21-301
fax: +48 22 49-21-309
website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, more information on the safety of the medicine can be collected.

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 pack in the original packaging 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 in household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Cerazette contains

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

What Cerazette looks like and contents of the pack
The tablets are white, round, biconvex, 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 sachet made of laminated aluminium foil. 1 or 3 blisters per cardboard box.
A sachet is included with the packaging, in which the blister should be placed after removal from the protective foil.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
Organon Biosciences S.R.L.
Strada Av. Popișteanu, Nr. 54A, Expo Business Park, Clădirea 2
Office 306 and Office 307, Floor 3, Sectorul 1, Bucharest, Romania
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 Romania, country of export: 10970/2018/01
10970/2018/02
10970/2018/03
Parallel import authorisation number: 55/21
Translation of the weekday symbols printed next to each tablet on the immediate packaging:
Lu - Monday
Ma - Tuesday
Mi - Wednesday
Jo - Thursday
Vi - Friday
Sb - Saturday
Du - Sunday