Cerazette

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Cerazette (Jubrele), 75 micrograms, coated tablets
Desogestrel
Cerazette and Jubrele are different brand names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet so that you can 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any 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. What you should know 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 estrogen, the other female sex hormone.
The mechanism of action of most progestogen-only pills primarily involves preventing sperm from passing through the cervical canal. Unlike combined oral contraceptives, they do not always inhibit the maturation of the egg cell. Cerazette differs from other progestogen-only pills in that, like combined pills, it usually inhibits the maturation of the egg cell. As a result, Cerazette is a highly effective contraceptive.
Unlike combined products, Cerazette can be used in women who are intolerant to estrogens and in women who are breastfeeding. The most common inconvenience during treatment with Cerazette may be irregular bleeding. Bleeding may also not occur at all.
The likelihood 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 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).
• 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 in the past jaundice (yellowing of the skin) or severe liver disease until liver function parameters return to normal.
• If you currently have or have had in the past hormone-dependent tumours (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 in 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 in the past;
• Have a liver tumour; 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 (brownish pigmentation patches on the skin, particularly 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 cycle, but reduced compared to its concentration in the second half of the natural cycle. It is not known whether this affects bone mass.
Breast cancer
All women are at risk of developing breast cancer, regardless of whether they use contraceptive pills. Breast cancer occurs slightly more frequently in women using contraceptive pills than in women of the same age who do not use them. After stopping contraceptive pills, this risk gradually decreases, and after 10 years from stopping, the risk is the same for women who used pills and those who never used them. Breast cancer is rare in women under 40 years of age, but the risk increases with age. Therefore, a higher number of breast cancer cases occurs in women using contraceptive pills at an older age. The duration of use is less significant than age.
For every 10,000 women under 20 years of age who used contraceptive pills for no more than 5 years, 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 under 30 years of age who used contraceptive pills for up to 5 years, 5 additional cases of breast cancer were diagnosed compared to 44 cases usually diagnosed in this age group. Among 10,000 women over 40 years of age who used contraceptive pills for up to 5 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 using contraceptive pills seem to be less advanced than those in women not using them. It is not known whether this difference is related to contraceptive pill use. It may be due to more frequent monitoring of women using contraception, 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, 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 without using contraceptive pills and may occur during pregnancy. The risk of venous thromboembolic disease is higher in women using contraceptive pills than in those not using them.
It is believed that the risk of venous thromboembolic disease in women using progestogen-only pills, such as Cerazette, is lower than in women using combined pills containing oestrogens. If symptoms of venous thromboembolic disease occur, contact 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 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), how long to use them, and whether adjustment of the prescribed medicine is necessary.
Some medicines:

• may affect the concentration of Cerazette in the blood,
• may reduce its contraceptive effectiveness,
• may cause unexpected bleeding. These include medicines used to treat:
  • epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate, and phenobarbital),
  • tuberculosis (e.g. rifampicin, rifabutin),
  • HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz),
• hepatitis C virus (HCV) infection (e.g. boceprevir, telaprevir),
• other infections (e.g. griseofulvin),
• high blood pressure in the pulmonary blood vessels (bosentan),
• depressive mood disorders (St John's wort (Hypericum perforatum)),
• certain bacterial infections (e.g. clarithromycin, erythromycin),
• fungal infections (e.g. ketoconazole, itraconazole, fluconazole),
• high blood pressure (hypertension), angina, or certain heart rhythm disorders (e.g. diltiazem).

If you are taking medicines or herbal products that may reduce the effectiveness of Cerazette,
you should also use a mechanical contraceptive method. 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
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 required, 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 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 decrease in milk production has occasionally occurred while using Cerazette. Small amounts of the active substance pass into breast milk.
Observations on the health of children up to 2.5 years of age whose mothers used Cerazette for 7 months have shown no adverse effects on the child's growth and development.
If 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 monohydrate lactose.
Cerazette contains monohydrate 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
You should be informed by your doctor about the need for regular check-ups while using Cerazette. The frequency and type of examinations usually depend on your individual 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 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 symbols for days of the week located next to each tablet on the immediate packaging" in section 6. at the end of this leaflet), and on the other side arrows indicate the direction in which the tablets should be taken. Each time starting a new pack of Cerazette, always 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 empty. For example, if starting on a Wednesday, the first tablet should be the one in the top row marked "Mi". This allows easy checking whether the tablet marked for a particular day of the week has been taken on that day. The tablets should be taken at the same time each day. Swallow the tablet whole with water.

Breakthrough bleeding may occur while taking Cerazette tablets. In such cases, however, continue taking the tablets as prescribed. After finishing a pack, start the next pack the following day without any break and without waiting for bleeding to occur.

You may stop taking Cerazette tablets at any time. Contraceptive effectiveness ends on the day you stop taking the tablets.

Starting the first pack of Cerazette

• If you are currently not taking any contraceptive tablets: Wait for your next 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 tablet-taking 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 any break or hormone-free interval). If your current contraceptive 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). 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 of insertion of the next vaginal contraceptive system or contraceptive patch, or the day after taking the last placebo tablet of your current contraceptive. In these cases, you must use an additional contraceptive method (barrier method) for the first 7 days of taking Cerazette tablets.

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

• If you were previously using a progestogen-only contraceptive 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 tablet-taking. Before starting Cerazette, after any sexual intercourse, confirm that you are not pregnant, or wait until your first 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 you should

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

If you forget to take 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. 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 tablet. Consult your doctor.

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

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 substance may be reduced. If you experience 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 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 any changes that seem to be caused by taking
Cerazette tablets.
Serious adverse effects associated with the use of Cerazette are described in the sections
"Breast cancer" and "Venous thromboembolic disease" in section 2 "Important information before
using Cerazette". Please read 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 slight spotting
not requiring the use of sanitary protection, or heavier bleeding resembling a light menstrual period,
when 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.
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 sex 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 not known (frequency cannot be estimated from available data)

• allergic reaction

In addition to the above-mentioned adverse effects, breast discharge may occur.
Reporting of adverse effects
If any adverse effects occur, including any 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, 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 in the original packaging to protect from light and moisture. After opening the sachet, the product should be used within 1 month.
The active substance poses a risk of environmental hazard with regard to fish.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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: anhydrous colloidal silicon dioxide, all-rac-α-tocopherol, lactose monohydrate, maize starch, povidone K 30, stearic acid; coating: hypromellose, macrogol 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.
The PVC/Al blister pack contains 28 tablets and is packed in a laminated aluminium foil sachet. 1 or 3 blisters per cardboard box.
A sachet is included in the package, 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 Germany, the country of export:
Organon Healthcare GmbH
Neuturmstr. 5
80331 Munich
Germany
Manufacturer:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Germany, the country of export: 43300.00.00
Parallel Import Authorisation Number: 196/19
Translation of the weekday symbols printed next to each tablet on the immediate packaging:
Mo - Monday
Tu - Tuesday
We - Wednesday
Th - Thursday
Fr - Friday
Sa - Saturday
Su - Sunday