Cerazette

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet – information on the immediate packaging in a foreign language!
Cerazette
75 micrograms (0.075 mg), film-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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• 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:

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 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 migrating through the cervical canal. In contrast to combined oral contraceptives, they do not always suppress the maturation of the egg cell. Cerazette differs from other progestogen-only pills in that, like combined pills, it usually suppresses ovulation (the release of an egg). As a result, Cerazette is a highly effective contraceptive.

Unlike combined products, Cerazette can be used by women who cannot tolerate 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 chance of becoming pregnant while correctly taking Cerazette (provided no tablet has been missed) is extremely low.

2. Important information before using Cerazette

Cerazette, like other hormonal contraceptives, does not protect against HIV (AIDS)
and 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).
• 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 cancers (e.g. certain types of breast cancer).
• Vaginal bleeding of unknown cause.

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

• Current or past history of breast cancer;
• Liver tumour, as a potentially harmful effect of Cerazette cannot be excluded;
• Past history of venous thromboembolic disease;
• Diabetes;
• Epilepsy (see section “Cerazette with other medicines”);
• Tuberculosis (see section “Cerazette with other medicines”);
• Hypertension;
• Current or past chloasma (yellowish-brown pigmentation spots on the skin, especially on the face); in such cases, avoid exposure to sunlight or ultraviolet radiation. Possible serious diseases

Reduced bone mass
Oestrogens play an important role in maintaining normal bone mass. During treatment with Cerazette, the concentration of the natural oestrogen, oestradiol, 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 use oral contraceptives. Breast cancer occurs slightly more frequently in women using oral contraceptives than in women of the same age who do not use them. This risk gradually decreases after stopping oral contraceptives and after 10 years of discontinuation, the risk is the same for women who used oral contraceptives 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 oral contraceptives. The duration of oral contraceptive use is less significant.
Among 10,000 women using oral contraceptives for no longer than 5 years, under the age of 20, fewer than 1 additional case of breast cancer was diagnosed within 10 years after stopping, compared to 4 cases usually diagnosed in this age group. Similarly, among 10,000 women using oral contraceptives for up to 5 years under the age of 30, 5 additional cases of breast cancer were diagnosed compared to 44 cases usually diagnosed in this group. Among 10,000 women using oral contraceptives for up to 5 years over the age of 40, 20 additional cases of breast cancer were diagnosed compared to 160 cases usually diagnosed.
The occurrence of breast cancer in women using progestogen-only pills, such as Cerazette, appears similar to the risk in women using combined oral contraceptives, although evidence is not conclusive.
Breast cancers diagnosed in women using oral contraceptives seem to be less advanced than those in women not using them. It is not known whether this difference is related to oral contraceptive use. It may be due to more frequent monitoring of women using contraception, leading to earlier detection of breast cancer.

Venous thromboembolic disease
Venous thromboembolic disease involves 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 pulmonary embolism, which may be fatal. Deep vein thrombosis is very rare. It may also develop in women not using oral contraceptives and may occur during pregnancy. The risk of venous thromboembolic disease is higher in women using oral contraceptives than in those not using them. The risk of venous thromboembolic disease in women using progestogen-only pills, such as Cerazette, is believed to be lower than in women using combined oral contraceptives (containing oestrogens). If symptoms of venous thromboembolic disease occur, contact your doctor immediately (see section “Regular check-ups”).

Psychiatric disorders
Some women using hormonal contraceptives, including Cerazette, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice.

Children and adolescents
There are no available clinical data on the efficacy and safety of use in adolescents under 18 years of age.

Cerazette with other medicines
Inform your doctor about any medicines or herbal products you are currently using, have recently used, or plan to use. Also inform any other doctor or dentist prescribing medicines (or a pharmacist) 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, as well as whether any 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.

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),
• depressive 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 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 required during this period. Your doctor will inform you about the possible need for additional contraceptive methods and the duration of their use.
Cerazette may also interfere with the action of other medicines, increasing (e.g. medicines containing cyclosporine) or decreasing (e.g. lamotrigine) their effect.
Before taking any medicine, consult your doctor or pharmacist.

Vaginal bleeding
During treatment with Cerazette, vaginal bleeding may occur irregularly. This may be light spotting or heavy bleeding. Bleeding may also not occur at all. Irregular bleeding does not mean that the contraceptive effectiveness of Cerazette is reduced. Usually, no action is required, and you should continue taking Cerazette. Contact your doctor if bleeding is very heavy 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 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 amount or quality of breast milk produced. However, a reduction in milk production has occasionally been reported during use of Cerazette. Small amounts of the active substance pass into breast milk.
Observations on the health of children up to 2.5 years of age whose mothers used Cerazette for 7 months have shown no effect on the child’s growth and development. If you are breastfeeding and wish to use Cerazette, consult your doctor.

Driving and operating machinery
No effects of Cerazette on the ability to drive or operate machinery have been observed.

Cerazette contains monohydrate lactose
Cerazette contains lactose. If you have been previously diagnosed with an 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 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 your doctor at least 4 weeks in advance;
• If irregular, heavy vaginal bleeding occurs;
• If you are or may be pregnant.

3. How to use Cerazette

This medicine should always be used exactly as your doctor has told you. If you are not sure, 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 symbol of the day of the week on which it should be taken. Arrows on the other side of the blister indicate the direction in which the tablets should be taken. Each time you start a new Cerazette blister pack, begin with the top row of the blister, taking the tablets in the direction of the arrows, one per day, until all tablets are used. For example, if you start taking the tablets on Wednesday, take the first tablet from the top row marked with "Mi" (indicating Wednesday; see "Translation of the day-of-the-week symbols next to each tablet on the immediate packaging and the blister pouch" at the end of the leaflet and on the blister pouch). This helps you easily check whether the tablet marked with a particular day-of-the-week symbol was taken on that day. The tablets should be taken at the same time each day. Swallow the tablet whole with water.
During treatment with Cerazette, light bleeding may occur. In such a case, continue taking the tablets as usual. After finishing all tablets in the blister, start taking tablets from a new blister the next day, without a break 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 using 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 tablets in the first cycle.
• If you were previously using a combined hormonal contraceptive (combined oral contraceptive pills, vaginal contraceptive system, contraceptive patch): You may start taking Cerazette the day after taking the last active tablet of your current contraceptive, or on the day of removal of the vaginal contraceptive system or contraceptive patch (without a break for hormone-free days, removal of the vaginal system, or patch). If your current contraceptive also includes inactive (placebo) tablets, start Cerazette the day after taking the last hormone-containing tablet (if you are unsure which tablet this is, consult your doctor or pharmacist). No additional contraceptive method is required if you follow this instruction. Alternatively, you may start Cerazette no later than the first day after the hormone-free interval of your current contraceptive, on the day of insertion of the next vaginal contraceptive system or 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 using another progestogen-only contraceptive: You may stop taking the 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 previously using a progestogen-releasing injection, implant, or intrauterine system: Start taking Cerazette on the day when the next injection would have been due, or on the day of removal of the implant or intrauterine system. There is no need to use additional contraceptive methods.
• After childbirth: Start taking Cerazette 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. Before starting Cerazette, check that you are not pregnant, either by a pregnancy test or by waiting for your first menstrual period. More information regarding breastfeeding is provided in the section "Breastfeeding". Your doctor can also advise you.
• After miscarriage or abortion: As advised by your doctor.

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

Missed dose of Cerazette
If you are less than 12 hours late in taking a tablet, contraceptive protection is maintained. Take the missed tablet as soon as possible and continue taking the remaining tablets at your usual time.
If you are more than 12 hours late in taking a tablet, contraceptive effectiveness may be reduced. The more tablets you miss, the 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. For the next 7 days, use an additional contraceptive method (e.g., condom). 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)
In case of gastrointestinal disturbances, follow the instructions for a missed tablet as described above. If vomiting or severe diarrhoea occurs within 3 to 4 hours after taking a Cerazette tablet, absorption of the active ingredient may be reduced. In case of severe diarrhoea, contact your doctor.

Stopping treatment with Cerazette
You may stop taking Cerazette at any time. If you do not plan to become pregnant, ask your doctor for advice on alternative contraception.
If you are planning a pregnancy, it is usually recommended to wait until your first natural menstrual period before trying to conceive. This helps in accurately determining the expected date of delivery.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
You should inform your doctor of any adverse health changes,
especially if they are severe and prolonged, as well as any health changes that appear to be
caused by taking Cerazette tablets.
Serious adverse effects associated with the use of Cerazette are described in section
"Breast cancer", "Venous thromboembolic disease" in section 2 "Important information before
using Cerazette". Please read this section for additional
information and, if necessary, seek immediate medical advice.
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 slight spotting not requiring the use of sanitary pads, or heavier bleeding resembling
light menstrual bleeding, when 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 affect 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 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 unknown (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 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 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 temperature requirements for storing this medicine. Keep the blister in the original sachet to protect it from light and moisture. After opening the sachet, the product should be used within 1 month.
The active substance poses an environmental risk to fish.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Cerazette contains

• The active substance is desogestrel in an amount of 75 micrograms (0.075 mg).
• The other ingredients are:
  Tablet core: maize starch, povidone, all-rac-α-tocopherol, stearic acid, colloidal anhydrous silica, lactose monohydrate.
  Coating: hypromellose, macrogol 400, titanium dioxide (E 171), talc.
  See also section "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.
The PVC/aluminum blister contains 28 tablets and is packed in an individual sachet made of laminated aluminium foil.
1 or 3 blisters are packed in a cardboard box.
A cardboard pocket is included with the package, in which the blister should be placed after removal from the protective foil.
For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in Romania, country of export:
Organon Biosciences S.R.L.
Strada Av. Popișteanu, Nr. 54A
Expo Business Park
Clădirea 2, Birou 306 și Birou 307
Etaj 3, Sectorul 1, Bucharest
Romania

Manufacturer:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation numbers in Romania, country of export:
10970/2018/01
10970/2018/02
10970/2018/03

Parallel import licence number: 77/20

Translation of the day-of-the-week symbols printed next to each tablet on the immediate packaging:
Lu – Monday
Ma – Tuesday
Mi – Wednesday
Jo – Thursday
Vi – Friday
Sb – Saturday
Du – Sunday