CERAZETTE 75 MICROGRAMS Coated tablet

Зміст інструкції

1. Cerazette 75 microgram tablets film-coated
   1. What is Cerazette and what is it used for
   2. What you need to 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

Cerazette 75 microgram tablets film-coated

desogestrel

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Cerazette is and what it is used for
• 2. What you need to know before you take 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 is Cerazette and what is it used for

Cerazette is used for the prevention of pregnancy. Cerazette contains a small amount of a
type of female sex hormone, the progestin desogestrel. For this reason Cerazette is
called a progestin-only pill (POP). Unlike the combined pill, the POP does not
contain an estrogenic hormone in addition to the progestin.
Most POPs primarily work by preventing sperm from entering the uterus,
but do not always prevent the maturation of egg cells, which is the primary action of combined pills.
Cerazette differs from most POPs in that it has a dosage that in
most cases is high enough to prevent the maturation of egg cells. As
a consequence, Cerazette provides high contraceptive efficacy.
Unlike combined pills, Cerazette can be used by women intolerant to
estrogens and by breastfeeding women. During the use of Cerazette, a disadvantage may be
that vaginal bleeding may occur at irregular intervals, such as not having
any bleeding at all.

2. What you need to know before taking Cerazette

Cerazette, like all other hormonal contraceptives, does not protect against infection with
HIV (AIDS) or any other sexually transmitted disease.

Do not take Cerazette

• if you are allergic to desogestrel or any of the other ingredients of Cerazette (listed in section 6).
• if you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel [e.g. in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism)].
• if you have jaundice (yellowing of the skin), present or previous, or severe liver disease and liver function is not yet normal.
• if you have a cancer sensitive to the influence of sex steroids, present or suspected, such as certain types of breast cancer.
• if you have unexplained vaginal bleeding.

Tell your doctor before taking Cerazette if you have any of these conditions. Your doctor may
advise you to use a non-hormonal contraceptive method.
See your doctor immediately if any of these conditions appear for the first time while you are taking Cerazette.

Warnings and precautions
Tell your doctor before taking Cerazette if:

• you have or have had breast cancer
• you have liver cancer, as a possible effect of Cerazette cannot be excluded
• you have ever had a thrombosis
• you suffer from diabetes
• you suffer from epilepsy (see section “Other medicines and Cerazette”)
• you suffer from tuberculosis (see section “Other medicines and Cerazette”)
• you have high blood pressure
• you have or have had chloasma (yellowish-brown skin patches, especially on the face); in this case avoid excessive exposure to the sun or ultraviolet radiation.

When Cerazette is used in the presence of any of the above conditions, close medical supervision may be
necessary. Your doctor will explain what to do.
Breast cancer
Check your breasts regularly and contact your doctor as soon as possible if you feel any
lump in your breast.
Breast cancer has been found slightly more often in women who take the pill
compared to those of the same age who do not take it. If the woman stops taking the pill, the
risk gradually decreases, so that 10 years after stopping the pill the risk is the same
as that observed in women who have never taken it. Breast cancer is rare under
40 years of age but the risk increases with age. Therefore, the extra number of cases of breast cancer
diagnosed is the higher the longer the woman continues to
take the pill. Less important is the duration of use of the pill.
For every 10,000 women who take the pill for periods up to 5 years, but who stop doing so within
20 years of age, there would be less than 1 additional case of breast cancer detected up to 10 years after
stopping treatment, in addition to the 4 cases normally diagnosed in women of this age. Similarly, in 10,000 women who take the pill for periods up to 5 years, but stop
within 30 years of age, there would be 5 additional cases in addition to the 44 normally diagnosed. In 10,000 women
who take the pill for periods up to 5 years but who stop within 40 years of age there would be
20 additional cases in addition to the 160 normally diagnosed.
The risk of breast cancer in users of progestin-only pills like
Cerazette is believed to be similar to that of women who use the pill, but the evidence is less
conclusive.
Breast cancer found in women who take the pill appears to be less advanced than
that found in women who do not use the pill. It is not known whether the difference in the risk of
breast cancer is due to the pill. Perhaps women who use the pill are examined more
often, and therefore breast cancer can be diagnosed earlier. It is important
to undergo regular breast screenings and you should contact your doctor if you feel any lumps
in your breast.
Thrombosis
Contact your doctor immediately if you notice possible signs of thrombosis (see also “Regular medical checks”).
Thrombosis is the formation of a blood clot that can block a blood vessel. A
thrombosis can sometimes occur in the deep veins of the legs (deep vein thrombosis). If
this clot detaches from the vein where it formed, it can reach and block the pulmonary artery
causing a so-called pulmonary embolism. Consequently, life-threatening situations can occur. Deep
vein thrombosis is a rare event. It can develop independently of taking
the pill and can also occur during pregnancy.
The risk is higher in women who use the pill compared to those who do not use it.
The risk with progestin-only pills, such as Cerazette, is believed to be lower than
that found in women who use pills that also contain estrogen (combined pills).
Psychiatric disorders
Some women who use hormonal contraceptives including Cerazette have reported depression or
low mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you
experience changes in mood and depressive symptoms, see your doctor as soon as possible for
further medical advice.

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

Other medicines and Cerazette
Tell your doctor if you are taking, have recently taken or might take any other
medicines or herbal products. Also tell all other doctors or dentists who prescribe other
medicines (or the pharmacist) that you are taking Cerazette, so that they can establish whether it is
necessary to use additional contraceptive methods (for example, a condom) and, if so, for
how long, or whether it is necessary to change the use of another medicine you are taking.
Some medicines

• can affect the blood levels of Cerazette
• may lead to a decrease in contraceptive effectiveness
• may cause unexpected bleeding.

These include medicines used in the treatment of:

• epilepsy (e.g., primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital),
• tuberculosis (e.g., rifampicin, rifabutin),
• HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz),
• hepatitis C virus infection (e.g., boceprevir, telaprevir)
• other infectious diseases (e.g., griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• low mood (St. John's wort herbal remedy),
• some bacterial infections (e.g., clarithromycin, erythromycin),
• fungal infections (e.g., ketoconazole, itraconazole, fluconazole),
• high blood pressure (hypertension), angina or some heart rhythm disorders (e.g., diltiazem).

If you are taking medicines or herbal products that may lead to a reduction
in the effectiveness of Cerazette, you must also use a barrier contraceptive method. Because the effect of
other medicines on Cerazette can last up to 28 days after they are stopped, it is necessary
to use an additional barrier contraceptive method for the entire period. Your doctor can tell you
if you need to take additional contraceptive precautions and for how long.
Cerazette can also interfere with the functioning of other medicines by causing or an increase (e.g.
medicines containing cyclosporine) or a decrease in the effect (e.g. lamotrigine).

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy and breastfeeding
Pregnancy
Do not use Cerazette if you are pregnant or think you might be.
Breastfeeding
Cerazette can be used during breastfeeding. Cerazette does not appear to affect the production or
quality of breast milk. However, infrequent cases of decreased
breast milk production have been reported during the use of Cerazette. A small amount of the active ingredient of
Cerazette passes into breast milk.
The health of breastfed babies up to 7 months of age whose mothers used Cerazette has been
studied up to 2 and a half years of age. No effect on growth and development was observed
of the children.
If you are breastfeeding and want to use Cerazette, contact your doctor.

Driving and operating machinery
There is no evidence of any effect of Cerazette use on alertness and concentration.

Cerazette contains lactose
Cerazette contains lactose (milk sugar). If your doctor has diagnosed you with lactose
intolerance, contact him before taking this medicine.

Regular medical checks
While using Cerazette, your doctor will tell you to return for regular medical checks. The
frequency and type of these checks depend normally on your personal situation.

Contact your doctor as soon as possible if:

• you have severe pain or swelling in one of your legs, unexplained chest pain, shortness of breath, unusual cough, especially if accompanied by coughing up blood (possible signs of a thrombosis);
• you have a sudden severe abdominal pain or jaundice (which may indicate possible liver problems);
• you feel a lump in your breast (which may indicate breast cancer);
• you have sudden or severe abdominal pain or in the area of the stomach (which may indicate an ectopic pregnancy, i.e. a pregnancy outside the uterus);
• in case of immobilization or surgery (consult your doctor at least 4 weeks before);
• you have unusual, heavy vaginal bleeding;
• you think you are pregnant.

3. How to take Cerazette

When and how to take the tablets?
The Cerazette pack contains 28 tablets. Arrows are printed on the front of the blister between the tablets. By turning the blister over and looking at the back, you can see the days of the week printed on the foil. Each day corresponds to one tablet.
Each time you start a new pack of Cerazette, take one tablet from the top row of the blister. Do not start with any tablet. For example, if you start taking the tablets on Wednesday, you must take the tablet marked (on the back) with WED from the top row. Continue to take one tablet a day until you have finished the pack, always following the direction of the arrows. Looking at the back of the blister, you can easily check if the tablet for a particular day has already been taken. Take the tablet every day at approximately the same time. The tablet must be swallowed whole, with a little water.
During use of Cerazette, you may experience bleeding; however, continue to take the tablets normally. Once a pack is finished, start the new pack the next day, without any interruption and without waiting for any bleeding.

When you start the first pack of Cerazette
When you have not used any hormonal contraception in the previous month:
Wait for your menstrual period before starting. Take the first Cerazette tablet on the first day of your period. You do not need to use any additional contraceptive precautions.
You can also start between the second and fifth day of your cycle, but in this case, it is recommended to also use an additional contraceptive method (barrier method) for the first seven days of taking the tablets.

When switching from a combined pill, vaginal ring or transdermal patches:
You can start taking Cerazette the day after the last tablet from your previous pack of pills, or the day the vaginal ring or patch is removed (this means you do not observe any pill-free, ring-free or patch-free interval). If the contraceptive you are switching from also contains inactive tablets (placebo), you can start Cerazette the day after taking the last “active” tablet (if in doubt, ask your doctor or pharmacist). If you follow these instructions, no additional contraceptive precautions are necessary.
You can start taking Cerazette at the latest on the day following the pill-free, ring-free, patch-free or inactive tablet-free interval of your current contraceptive. If you follow these instructions, be sure to use an additional contraceptive method (barrier method) for the first 7 days of taking the tablets.

When switching from another progestin-only pill:
You can stop taking the minipill at any time and start taking Cerazette directly. You do not need to use any additional contraceptive precautions.

When switching from an injectable contraceptive, implant or an intrauterine device releasing a progestin (IUD):
Start using Cerazette on the day the injection is due or the day the doctor removes the implant or intrauterine system. You do not need to use any additional contraceptive precautions.

Immediately after childbirth:
You can start Cerazette between 21 and 28 days after the birth of your baby. If you start later, be sure to use an additional contraceptive method (barrier method) until you have completed the first 7 days of taking the tablets. However, if you have already had sexual intercourse, you should rule out pregnancy before starting Cerazette. For further information for breastfeeding women, see "Pregnancy and breastfeeding" in paragraph 2.
The doctor will give you the necessary instructions.

Immediately after a spontaneous or induced abortion:
The doctor will give you the necessary instructions.

If you forget to take Cerazette
If less than 12 hourshave passed since your usual time for taking the tablet, the reliability of Cerazette remains. Take the forgotten tablet as soon as you remember it and take the subsequent tablets as usual.
If more than 12 hourshave passed, the reliability of Cerazette may be reduced. The more consecutive tablets you forget, the higher the risk that the contraceptive effectiveness is diminished. Take the forgotten tablet as soon as you remember it and take the subsequent tablets as usual. For the next 7 days of taking the tablets, you must also use an additional contraceptive method (barrier method). If one or more tablets have been forgotten in the first week of starting the tablets and you have had sexual intercourse during the previous week, it is possible that you may be pregnant. Ask your doctor for advice.

If you suffer from gastrointestinal disorders (e.g. vomiting or severe diarrhea)
Follow the instructions given for forgotten tablets. In case of vomiting within 3-4 hours after taking a Cerazette tablet or in case of severe diarrhea, the active ingredient may not have been completely absorbed.

If you take more Cerazette than you should
There are no reports of serious harmful effects resulting from taking more Cerazette tablets in one go. The symptoms that may occur are nausea, vomiting and, in young girls, mild vaginal bleeding. For further information, contact your doctor.

If you stop taking Cerazette
You can stop taking Cerazette at any time. From the day you stop taking the pill, you are no longer protected against pregnancy.
If you have any doubts about using Cerazette, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cerazette can cause side effects, although not everybody gets them.
Serious side effects associated with the use of Cerazette are described in paragraph 2 “What you need to know
before you take Cerazette”, paragraphs “Breast cancer” and “Thrombosis”. Read carefully
the paragraph for further information and consult your doctor promptly when necessary.
During the use of Cerazette, vaginal bleeding may occur at irregular intervals. This may be
only mild spotting that does not require the use of a sanitary pad or heavier
bleeding, more like a light period and requiring the use of a sanitary pad. It is
also possible to have no bleeding at all. Irregular bleeding is not a sign that the
contraceptive protection of Cerazette has decreased. Usually no intervention is necessary and you can
continue to take Cerazette; however, if the bleeding is heavy or prolonged, you should consult
your doctor.
Women using Cerazette have reported the following side effects:
Apart from these side effects, breast secretion may occur.

You should seek immediate medical attention if you experience symptoms of angioedema, such as (i) swelling of the
face, tongue or pharynx, (ii) difficulty swallowing or (iii) urticaria and difficulty breathing.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Cerazette

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store the blister
in the original bag to protect the medicine from light and moisture. Use within 1 month from the
date of the first opening of the bag.
The active substance shows an environmental risk for fish.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cerazette contains

• The active substance is: desogestrel (75 micrograms).
• The excipients are: anhydrous colloidal silica; all-rac-α-tocopherol; corn starch; povidone; stearic acid; hypromellose; macrogol 400; talc; titanium dioxide (E171); lactose monohydrate (see also “Cerazette contains lactose”, in paragraph 2).

Description of the appearance of Cerazette and contents of the pack
A blister of Cerazette contains 28 white, round, film-coated tablets, bearing the code KV 2 on one side and the inscription ORGANON* on the other side.
Each pack contains 1, 3, 6 or 13 blisters, each packaged separately in a sachet.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Roma
Manufacturer:
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands,
Norway, Portugal, Sweden, United Kingdom: Cerazette.
Spain: Cerazet.