Active ingredients: Desogestrel
Cerazette 75 microgram film-coated tablets
Why is Cerazette used? What is it 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 progestogen-only pill (POP). Unlike the combined pill, POP does not contain an estrogenic hormone alongside the progestin.
Most POPs mainly work by preventing sperm from entering the uterus, but they do not always prevent egg cells from maturing, which is the primary action of combined pills. Cerazette differs from most POPs by having a dosage which in most cases is high enough to prevent egg cell maturation. As a consequence, Cerazette provides a "highly effective contraceptive".
Unlike combined pills, Cerazette can be used by estrogen intolerant women and breastfeeding women. While using Cerazette, a disadvantage may be that vaginal bleeding may occur at irregular intervals, such as not having any bleeding at all.
Contraindications When Cerazette should not be used
Cerazette, like all other hormonal contraceptives, does not protect against HIV infection (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 [eg. of the legs (deep vein thrombosis) or of the lungs (pulmonary embolism)].
- if you have previous or present jaundice (yellowing of the skin) or severe liver disease and your liver function is still not normal.
- if you have present or suspected sex-steroid-sensitive cancer 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 method of birth control.
Consult your doctor immediately if any of these conditions appear for the first time while taking Cerazette.
Precautions for use What you need to know before taking Cerazette
Tell your doctor before taking Cerazette if:
- have or have had breast cancer
- have liver cancer, as a possible effect of Cerazette cannot be excluded
- have ever had a thrombosis
- suffer from diabetes
- suffer from epilepsy (see section "Other medicines and Cerazette")
- suffer from tuberculosis (see section "Other medicines and Cerazette")
- have high blood pressure
- have or have had chloasma (yellow-brown patches on the skin, 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 conditions listed above, close medical supervision may be required. The 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 breasts.
Breast cancer has been found slightly more often in women who take the pill than in women 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 in women who have never taken the pill. Breast cancer is rare under 40. years of age but the risk increases with advancing age. Therefore, the extra number of breast cancers diagnosed is higher the higher the age until which the woman continues to take the Pill. The less important is the duration of use of the Pill.
For every 10,000 women who take the Pill for up to 5 years but stop taking the Pill by age 20, there would be less than 1 additional case of breast cancer found 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 up to 5 years but stop taking the pill by the age of 30, there would be 5 more cases in addition to the 44 normally diagnosed.
In 10,000 women who take the Pill for up to 5 years but stop by the age of 40, there would be 20 more cases in addition to the 160 normally diagnosed. The risk of breast cancer in progestogen-only pill users such as Cerazette is believed to be similar to that in women using the pill, but the evidence is less conclusive.
Breast cancer found in women who take the Pill appears to be less common than that found in women who do not take the Pill. It is not known whether the difference in breast cancer risk 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 have regular breast checks and you should contact your doctor if you feel any lump in your breast.
Thrombosis
Contact your doctor immediately, if you notice possible signs of a thrombosis (see also "Regular medical check-ups").
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 has formed, it can reach and block the pulmonary artery causing the so-called pulmonary embolism. Consequently, fatal situations can occur. Deep vein thrombosis is a rare event. It can develop independently of the intake of the pill and can also occur during pregnancy.
The risk is higher in women who use the pill than in those who don't.
The risk with progestogen-only pills, such as Cerazette, is believed to be lower than in women who use pills that also contain estrogen (combination pills).
Children and adolescents
There are no data on efficacy and safety in adolescents below 18 years of age.
Interactions Which drugs or foods may change the effect of Cerazette
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines or herbal products, including those obtained without a prescription.
Some medicines can stop Cerazette from working properly. Among them, the drugs used in the treatment of
- epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate and phenobarbital)
- tuberculosis (e.g. rifampicin)
- HIV infections (e.g. ritonavir) or other infectious diseases (e.g. griseofulvin)
- stomach upset (medicinal charcoal)
- depressed mood (herbal products based on St. John's wort).
Your doctor can tell you if you need to take extra contraceptive precautions and for how long.
Cerazette can also interfere with the way some medicines work by causing either an increase (eg medicines containing cyclosporine) or a decrease in effect.
Warnings It is important to know that:
Pregnancy and breastfeeding
Pregnancy
Do not use Cerazette if you are pregnant or think you may be.
Breastfeeding
Cerazette can be used while you are breastfeeding. Cerazette does not affect the production or quality of breast milk. However, small amounts of the active substance in Cerazette pass into breast milk.
The health of breastfed infants up to the age of 7 months, whose mothers used Cerazette, was studied up to the age of 2.5 years. No effects on the growth and development of the children were observed.
If you are breastfeeding and want to use Cerazette, please contact your doctor.
Driving and using machines
There is no evidence of any effect of using Cerazette on alertness and concentration.
Cerazette contains lactose
Cerazette contains lactose (milk sugar). You should contact your doctor before starting Cerazette if you have been diagnosed with "intolerance to some sugars."
Regular medical check-ups
While using Cerazette your doctor will tell you to come back for regular medical check-ups. The frequency and type of these check-ups usually depend on your personal situation.
Contact your doctor as soon as possible if:
- have severe pain or swelling in one of your legs, unexplained chest pains, shortness of breath, unusual cough, especially if accompanied by bleeding (possible signs of a thrombosis);
- have sudden severe stomach pain or jaundice (which may indicate liver problems);
- you feel a lump in your breast (which may indicate breast cancer);
- have sudden or severe pain in the lower abdomen or stomach area (which may indicate an ectopic pregnancy, ie a pregnancy outside the uterus);
- in case of immobilization or surgery (consult your doctor at least 4 weeks before);
- have unusual, profuse vaginal bleeding;
- think you are pregnant.
Dose, Method and Time of Administration How to use Cerazette: Posology
When and how to take the tablets?
The pack of Cerazette contains 28 tablets. Arrows are printed on the front of the blister between the tablets. By turning the blister and looking at the back side, you can see the days of the week printed on the aluminum 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 just any tablet. If, for example, you start taking your tablets on a Wednesday, you should take the tablet marked WED (on the back) from the top row. Continue to take one tablet a day until the pack is finished, always following the direction of the arrows. By 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 at approximately the same time each day. The tablet should be swallowed whole with some water.
You may have bleeding while using Cerazette, but continue to take the tablets as normal. Once you have finished a pack, start the new one the next day, without interruption and without waiting for any bleeding.
When starting the first pack of Cerazette
- When no hormonal contraceptive has been used in the past month: Wait for your period before starting. Take the first Cerazette tablet on the first day of your period. It is not necessary to take additional contraceptive precautions. It is also possible to start between the second and fifth day of the cycle but, in this case, it is recommended to also use an additional contraceptive method (barrier method) during the first seven days of taking the tablets.
- When coming from a combination pill, vaginal ring or transdermal patches: You can start taking Cerazette the day after the last tablet of the previous pill pack, or the day after the vaginal ring or patch is removed (this means say that no pill, ring or patch-free interval is observed). If the contraceptive you are coming 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 needed. You can start taking Cerazette at the latest the day after the pill, ring, patch or tablet-free interval of your current contraceptive. If you follow these instructions, make sure you use an additional contraceptive method (barrier method) for the first 7 days of taking the tablets.
- When you are coming from another progestogen-only pill: You can stop taking the minipill at any time and start taking Cerazette directly. It is not necessary to take additional contraceptive precautions.
- When coming from a contraceptive for injection, implant or a progestogen releasing intrauterine device (IUD): Start using Cerazette on the day the injection is due or the day the doctor removes the implant or the intrauterine delivery system. It is not necessary to take additional contraceptive precautions.
- Immediately after giving birth: Cerazette can be started between day 21 and day 28 after the baby is born. In case 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, pregnancy should be ruled out before starting Cerazette. For more information for women who are breastfeeding, see "Pregnancy and breastfeeding" in section 2. Your doctor will give you the necessary instructions.
- Immediately after a miscarriage or induced abortion: Your doctor will give you the necessary instructions. If you forget to take Cerazette
- If less than 12 hours have passed since the usual tablet-taking time, the reliability of Cerazette remains. Take the forgotten tablet as soon as you remember and take the next tablets as usual.
- If more than 12 hours have passed, the reliability of Cerazette may be reduced. The greater the number of consecutive missed tablets, the higher the risk that contraceptive efficacy has decreased. Take the last missed tablet as soon as you remember and take the next tablets as usual. During the next 7 days of tablet-taking you should also use an additional contraceptive method (barrier method). If one or more tablets are were forgotten in the first week of use and had sexual intercourse in the previous week, it is possible that you are pregnant Ask your doctor for advice.
If you suffer from gastrointestinal complaints (e.g. vomiting or severe diarrhea)
Follow the instructions for forgotten tablets.If you vomit or use medicinal charcoal within 3-4 hours after taking the Cerazette tablet, or if you have severe diarrhea, the active substance may not have been completely absorbed.
Overdose What to do if you have taken too much Cerazette
If you take more Cerazette than you should
There are no reports of serious harmful effects from taking multiple Cerazette tablets at one time. Symptoms that may occur are nausea, vomiting and, in young girls, mild vaginal bleeding. For more 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 further questions on the use of Cerazette, ask your doctor or pharmacist.
Side Effects What are the side effects of Cerazette
Like all other medicines, Cerazette can cause side effects, although not everybody gets them.
Serious side effects associated with the use of Cerazette are described in section 2 "What you need to know before you take Cerazette", sections "Breast cancer" and "Thrombosis". Read this section carefully for further information and consult your doctor promptly when necessary. .
Vaginal bleeding may occur at irregular intervals during the use of Cerazette. It may be only mild spotting that does not require the use of sanitary napkin or more intense bleeding, more like a light period and requiring the use of a sanitary napkin. You may also not have any bleeding. Irregular bleeding is not a sign that the contraceptive protection of Cerazette has decreased. Normally no intervention is necessary and you can continue to take Cerazette; however, if the bleeding is intense or prolonged , you should consult your doctor.
Women using Cerazette have reported the following side effects:
Apart from these side effects, breast discharge may occur.
You should see your doctor immediately if you have symptoms of angioedema, such as (i) swelling of the face, tongue or pharynx, (ii) difficulty swallowing or (iii) hives and difficulty breathing.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at "www.agenziafarmaco.gov.it/it/responsabili". By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage temperatures. Store the blister in the original sachet to protect from light and moisture. Use within 1 month from the date of first opening of the sachet.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Cerazette contains
- The active substance is: desogestrel (75 micrograms)
- The other ingredients are: anhydrous colloidal silica; all-rac-α-tocopherol; cornstarch; povidone; stearic acid; hypromellose; macrogol 400; talc; titanium dioxide (E171); lactose monohydrate (see also "Cerazette contains lactose", section 2).
What Cerazette looks like and contents of the pack
One blister of Cerazette contains 28 white, round coated tablets with KV code on 2 on one side and ORGANON * on the other side. Each carton contains 1, 3 or 6 blisters, each packaged separately in a sachet.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CERAZETTE 75 mcg TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mcg of desogestrel.
Excipient (s) with known effect: each tablet contains approximately 55 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Film-coated tablets.
The tablet is white, round, biconvex, 5 mm in diameter, with the code KV on 2 on one side and the inscription ORGANON * on the other side.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Prevention of conception.
04.2 Posology and method of administration
Dosage
To achieve contraceptive efficacy, Cerazette must be used according to the instructions (see "How to take Cerazette" and "How to start Cerazette").
Special populations
Kidney damage
No clinical studies have been performed in patients with renal impairment.
Hepatic impairment
No clinical studies have been performed in patients with hepatic insufficiency. Since the metabolism of steroid hormones may be impaired in patients with severe liver disease, the use of Cerazette in these women is not indicated until liver function values have returned to normal (see section 4.3).
Pediatric population
The safety and efficacy of Cerazette in adolescents below 18 years of age have not been established. There are no data available.
Method of administration
Oral use.
How to take Cerazette
The tablets should be taken at approximately the same time each day, so that the interval between two tablets is always 24 hours. The first tablet should be taken on the first day of your period. It should then be continued with one tablet a day, every day, even if any vaginal bleeding occurs. Each new blister should be started directly the day after the previous one.
How to start Cerazette
No hormonal contraceptive treatment [in the previous month]
Taking the tablets should begin on the first day of the natural menstrual cycle (ie the first day of menstruation). It is also possible to start between the second and fifth day of the cycle but, in this case, during the first cycle it is also recommended to use a barrier method in the first seven days of taking the tablets.
After a first trimester abortion
After a first trimester abortion it is recommended to start treatment immediately. In this case it is not necessary to use an additional method of contraception.
After a birth or second-trimester abortion
The woman should be advised to start any day between day 21 and day 28 after delivery or second-trimester abortion. When starting later, the woman should be advised of the need to use an additional barrier method for the first 7 days of taking the tablet. However, if intercourse has already occurred, pregnancy must be ruled out before the actual start of Cerazette use or the woman must wait for her first menstrual period.
For further information for breastfeeding women, see section 4.6.
How to start Cerazette when coming from another contraceptive method
Changing from another combined contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch)
The woman should start Cerazette preferably on the day after the last active tablet (the last tablet containing the active substances) of the previous combined oral contraceptive (COC) or on the day of removal of her vaginal ring or transdermal patch. In these cases it is not necessary to use an additional method of contraception. Not all contraceptive methods may be available in all countries of the European Union.
The woman can also start the day after the usual pill, patch or ring-free interval at the latest or the day after the last placebo tablet of the previous combined hormonal contraceptive, but it is recommended to use an additional barrier method during the first few 7 days of taking the tablets.
Changing from a progestogen-only method of contraception (minipill, injection, implant, or from a progestogen-releasing intrauterine device [IUS])
The woman can switch from the minipill at any time (in the case of an implant or a progestogen releasing intrauterine device, the day the implant or device is removed or, in the case of an injectable, the day that the next injection should be given).
Management of forgotten tablets
Contraceptive protection may be reduced if more than 36 hours have elapsed between taking 2 tablets. If you are less than 12 hours late in taking any tablet, the forgotten tablet should be taken as soon as you remember. ; the next one must be taken according to the usual scheme. If the delay is more than 12 hours, the woman must use additional contraception for the next 7 days. If you forgot to take tablets in the first week and had sexual intercourse in the previous week, the possibility of a pregnancy should be considered.
Advice in case of gastrointestinal disorders
In the event of a severe gastrointestinal disturbance, absorption may not be complete and additional contraceptive measures must be taken. If vomiting occurs within 3-4 hours of taking the tablet, absorption may not be complete. case, the advice on missed tablets given in section 4.2 applies.
Treatment monitoring
Before prescribing the product it is necessary to carry out a "thorough medical history; a careful gynecological examination is also recommended to rule out an ongoing pregnancy. Cycle disorders such as oligomenorrhea and amenorrhea should be evaluated before prescribing the product. The interval between checks" doctors depends on each individual case. If the prescribed product is capable of substantially influencing a latent or manifest disease (see section 4.4), related medical examinations should be scheduled.
Even when Cerazette is taken regularly, cycle disturbances can occur. If bleeding is very frequent and irregular, another contraceptive method should be considered. If symptoms persist, an organic cause must be ruled out.
In case of amenorrhea during therapy it is necessary to investigate whether or not the tablets have been taken according to the instructions; in such cases a pregnancy test may be indicated.
In the event of pregnancy, the treatment should be discontinued.
Women should be advised that Cerazette does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
04.3 Contraindications
• Venous thromboembolism in progress.
• Previous or current severe liver disease, until liver function values have returned to normal.
• Known or suspected malignant tumors dependent on sex steroids.
• Undiagnosed vaginal bleeding.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
If any of the following conditions / risk factors are present, the benefits of using the progestogen should be weighed against the possible risks of each individual case and discussed with the woman before deciding to start Cerazette. In case of aggravation, exacerbation o first appearance of any of these conditions, the woman should contact her doctor. The doctor should then decide whether the use of Cerazette should be discontinued.
The risk of breast cancer generally increases with age. The risk of having breast cancer diagnosed is slightly increased when using combined oral contraceptives (COCs). This increased risk gradually disappears over 10 years after stopping the COC and does not depend on the duration of use but on the age of the woman taking the COC. The expected number of diagnosed cases per 10,000 women using COCs (up to 10 years after stopping treatment), compared to women who have never used contraceptives in the same time period, was thus calculated in the respective groups. of age and is shown in the table below
The risk in women using progestogen-only contraceptives (POCs), such as Cerazette, is likely to be similar to that associated with taking COCs. However, for progestogen-only contraceptives the evidence is less clear. L "The increased risk associated with COCs is low compared to the risk of having breast cancer diagnosed later in life. Breast cancer diagnosed in COC users tend to be less advanced than in COC users. The increased risk in COC users may be due to an earlier diagnosis, the biological effects of the pill, or a combination of both.
Since a biological effect of progestogens on liver cancer cannot be excluded, an individual benefit / risk assessment should be made in women with liver cancer.
If acute or chronic liver function disorders occur, refer the woman to a specialist for medical examination and consultation.
Epidemiological studies have shown the association between the use of combined oral contraceptives and an increased incidence of venous thromboembolism (VTE deep vein thrombosis and pulmonary embolism). Although the clinical relevance of this finding for desogestrel used as a contraceptive in the absence of an estrogen component is unknown, treatment with Cerazette should be discontinued in the event of thrombosis. Interruption of Cerazette treatment should also be considered in the event of prolonged immobilization following surgery or illness. Women with a history of thromboembolic disorders should be advised of the possibility of the disease returning.
Although progestogens may affect peripheral insulin resistance and glucose tolerance, there is no evidence for the need to change the treatment regimen in diabetic women using the progestogen-only pill. However, diabetic patients should be closely monitored. during the first months of use of Cerazette.
If sustained hypertension develops during use of Cerazette, or if a significant increase in blood pressure does not respond adequately to antihypertensive therapy, discontinuation of Cerazette should be considered.
Treatment with Cerazette causes a reduction in estradiol serum levels up to values corresponding to an initial follicular phase. It is still unknown whether this reduction has any clinically relevant effect on bone mineral density.
With conventional progestogen-only pills, protection against ectopic pregnancy is not as good as with combined oral contraceptives, and has been associated with the frequent occurrence of ovulation while using the progestogen-only pill. Since Cerazette regularly inhibits ovulation, if the woman has amenorrhea or abdominal pain, the possibility of an ectopic pregnancy should be taken into account in the differential diagnosis.
Occasionally chloasma may occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to sunlight or ultraviolet radiation while taking Cerazette.
Both during pregnancy and while taking sex steroids, the following conditions have been reported, but an association with progestogen use has not been established: jaundice and / or cholestatic pruritus; gallstone formation, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea, herpes gestationis, otosclerosis hearing loss; angioedema (hereditary).
Cerazette contains lactose and therefore should not be used in patients with rare hereditary diseases of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
04.5 Interactions with other medicinal products and other forms of interaction
Interactions
Interactions between hormonal contraceptives and other medicinal products can lead to withdrawal bleeding and / or contraceptive failure. The following interactions have been reported in the literature (mainly with combined contraceptives but occasionally also with progestogen-only contraceptives).
Hepatic metabolism: Interactions may occur with medicinal products that induce microsomal enzymes, which may result in increased clearance of sex hormones, such as hydantoins (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, rifampicin and possibly also oxcarbazepine , topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin and products based on St. John's wort (Hypericum Perforatum). Maximal enzyme induction is not observed for 2-3 weeks but may then persist for at least 4 weeks after discontinuation of therapy. Women being treated with one of these medicinal products should temporarily use a barrier method in addition to Cerazette. With microsomal enzyme inducing drugs, the barrier method should be used during the time of concomitant drug administration and for 28 days after discontinuation. A non-hormonal method of contraception should be considered for women on long-term therapy with hepatic enzyme inducers.
During treatment with medicinal charcoal, the absorption of the active ingredient may be reduced and, consequently, the contraceptive efficacy may be reduced. In these cases see the recommendations given for missed tablets in section 4.2.
Hormonal contraceptives can interfere with the metabolism of other drugs.
Consequently, plasma and tissue concentrations may either increase (e.g. cyclosporine) or decrease.
Note: The package leaflets of concomitant medications should be consulted to identify possible interactions.
Laboratory analysis
Data obtained with COCs have shown that contraceptive steroids can affect the results of certain laboratory tests, including biochemical parameters of the liver, thyroid, renal and adrenal function, serum levels of (transporter) proteins, eg. corticosteroid-binding globulin and lipid / lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Changes generally remain within the normal range. It is not known to what extent this can be applied to progestogen-only contraceptives.
04.6 Pregnancy and lactation
Pregnancy
Cerazette is not indicated during pregnancy. Should pregnancy occur during treatment with Cerazette, further intake of the medicinal product should be stopped.
Studies in animals have shown that very high doses of progestogens can cause masculinization of female fetuses.
Extensive epidemiological studies have not found an increased risk of birth defects in children born to women who had taken COCs prior to pregnancy, nor a teratogenic effect if the COC was inadvertently taken in early pregnancy.
Pharmacovigilance data collected for several desogestrel-based COCs also do not indicate an increased risk.
Pregnancy
Cerazette does not affect the production or quality (protein, lactose or fat concentrations) of breast milk. However, small amounts of etonogestrel are excreted in breast milk. As a result, 0.01-0.05 mcg of etonogestrel per kg of body weight per day may be ingested by the infant (based on an assumed milk ingestion of 150 ml / kg / day).
Limited long-term follow-up data are available on children whose mothers started using Cerazette from the fourth to eighth week postpartum. These infants were breastfed for 7 months and followed up to age 1.5 years (n = 32) or up to age 2.5 years (n = 14). Assessment of growth and physical and psychomotor development did not indicate any difference compared to infants whose mothers used a copper IUD. Based on the available data, Cerazette can be used during lactation. The development and growth of the infant whose mother uses Cerazette should however be closely monitored.
Fertility
Cerazette is indicated for the prevention of pregnancy. For information on return to fertility (ovulation), see section 5.1.
04.7 Effects on ability to drive and use machines
Cerazette has no or negligible influence on the ability to drive and use machines.
04.8 Undesirable effects
The most commonly reported side effect in clinical trials is irregular bleeding.
Some types of bleeding irregularities have been reported in women using Cerazette, up to 50%. Because Cerazette, unlike other progestogen-only contraceptives, causes near 100% "inhibition of ovulation", irregular bleeding is a more common phenomenon than other progestogen-only preparations. In 20-30% of women, bleeding may become more frequent, while in another 20% it may be less frequent or completely absent. The duration of vaginal bleeding can also be longer. After a couple of months of treatment, bleeding tends to be less frequent. Correct information, some recommendations and a bleeding diary can improve the acceptability of the event by the woman.
The other most commonly reported undesirable effects in clinical trials with Cerazette (> 2.5%) were acne, mood changes, breast pain, nausea and weight gain.
The undesirable effects are listed in the following table.
All undesirable effects are listed by system organ class and frequency: common (≥1 / 100,
* MedDRA version 9.0
Breast discharge may occur during use of Cerazette. In rare cases, ectopic pregnancies have been reported (see section 4.4).
In addition, (worsening of) angioedema and / or worsening of hereditary angioedema may occur (see section 4.4).
Some (serious) side effects have been reported in women using oral contraceptives (combined type). They include venous thromboembolic disorders, arterial thromboembolic disorders, hormone-dependent tumors (e.g. liver tumors, breast cancer) and chloasma, some of which are discussed in more detail in section 4.4.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address:" www.agenziafarmaco.gov.it/it/responsabili ".
04.9 Overdose
There are no reports of serious effects following overdose. Symptoms that can occur in this case are nausea, vomiting and, in young women, slight vaginal bleeding. There is no antidote and any treatment should be symptomatic.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: hormonal contraceptives for systemic use.
ATC code: G03AC09.
Mechanism of action
Cerazette is a progestogen-only pill containing the progestogen desogestrel. Like other progestogen-only pills, Cerazette is best suited for use during breastfeeding and for women who are unable or unwilling to use estrogen. Unlike traditional progestogen-only pills, the contraceptive effect of Cerazette is achieved primarily through the inhibition of ovulation. Other effects include an increase in the viscosity of the cervical mucus.
Clinical efficacy and safety
In a study conducted for 2 cycles, in which a progesterone level higher than 16 nmol / L was used to define ovulation for 5 consecutive days, an "ovulation incidence of 1% (1/103) was found." , with a 95% confidence interval of 0.02% -5.29% in the ITT group (woman and method failure). Ovulation inhibition was achieved from the first cycle of use. In this study, when Cerazette treatment was stopped after 2 cycles (56 consecutive days), recovery of ovulation occurred on average after 17 days (range 7 - 30 days).
In a comparative efficacy study (which allowed a maximum period of 3 hours for the forgotten tablet), the ITT overall Pearl Index calculated for Cerazette was 0.4 (95% confidence interval of 0.09-1, 20), compared to the value of 1.6 (95% confidence interval of 0.42-3.96), calculated for 30 mcg of levonorgestrel.
The Pearl Index for Cerazette is comparable to that historically calculated for COCs in the general COC-using population.
Treatment with Cerazette also results in a reduction in estradiol levels to values corresponding to the onset of the follicular phase. No clinically relevant effects on glucose metabolism, lipid metabolism and haemostasis have been observed.
Pediatric population
There are no data on efficacy and safety in adolescents below 18 years of age.
05.2 Pharmacokinetic properties
Absorption
After oral administration of Cerazette, desogestrel (DSG) is rapidly absorbed and converted to etonogestrel (ENG). In steady state conditions, peak serum levels are reached 1.8 hours after tablet intake and the absolute bioavailability of ENG is approximately 70%.
Distribution
ENG is 95.5-99% bound to plasma proteins, mainly albumin and, to a lesser extent, SHBG.
Biotransformation
DSG is metabolized by hydroxylation and dehydrogenation to ENG, the active metabolite. ENG is metabolized through sulfur- and glucurono-conjugation.
Elimination
ENG is eliminated with a mean half-life of approximately 30 hours, with no difference between single and multiple administrations. Steady state plasma levels are reached after 4-5 days. Serum clearance after i.v. of ENG is about 10 l / h. The excretion of ENG and its metabolites, in the form of free steroid or conjugation products, occurs through urine and faeces (in the ratio 1.5: 1). In breastfeeding women, ENG is excreted in breast milk with a milk / serum ratio of 0.37-0.55. Based on these data and an estimated milk ingestion of 150 ml / kg / day, an amount equal to 0.01-0.05 mcg of etonogestrel can be ingested by the newborn.
Special populations
Effect of kidney damage
No studies have been performed to evaluate the effect of renal disease on the pharmacokinetics of DSG.
Effect of hepatic impairment
No studies have been conducted to evaluate the effect of liver disease on the pharmacokinetics of DSG. However, steroid hormones may be poorly metabolised in women with impaired liver function.
Ethnic groups
No studies have been performed to evaluate pharmacokinetics in ethnic groups.
05.3 Preclinical safety data
Toxicological studies did not reveal any effects other than those foreseeable on the basis of the hormonal properties of desogestrel.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Nucleus
Anhydrous colloidal silica
All-rac-alpha-tocopherol
Lactose monohydrate
Cornstarch
Povidone
Stearic acid
Coating
Hypromellose
Macrogol 400
Talc
Titanium dioxide (E171)
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
Shelf life after first opening the sachet: 1 month.
06.4 Special precautions for storage
This medicinal product does not require any special storage temperatures. Store the blister in the original sachet in order to protect from light and moisture. For storage conditions after first opening the sachet, see section 6.3.
06.5 Nature of the immediate packaging and contents of the package
PVC / aluminum blister.
Each blister contains 28 tablets. Each carton contains 1, 3 or 6 blisters packed separately in an aluminum sachet.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
Representative in Italy:
MSD Italia S.r.l.
Via Vitorchiano, 151
00189 Rome
08.0 MARKETING AUTHORIZATION NUMBER
1 blister pack containing 28 A.I.C. n. 034118012
Carton of 3 blisters each containing 28 A.I.C. n. 034118024
Box of 6 blisters each containing 28 A.I.C. n. 034118036
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 12 December 1997
Date of most recent renewal: December 12, 2007
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of 11/2013
