Sirazite 0.075 28 tablets

Product description: Cerazette® 75 micrograms coated tablets. Each tablet contains 75 micrograms of desogestrel. For oral use. Instructions for use: Tablets should be taken every day at approximately the same time so that the interval between two tablets is always 24 hours. The first tablet should be taken on the first day of menstrual bleeding. After that, one tablet should be taken continuously every day, without noticing any possible bleeding. A new blister pack begins immediately on the day following the previous one. How to start Cerazette: No previous use of hormonal contraceptives [in the past month]: The tablets should be started on the first day of the woman's natural cycle (day one is the first day of menstrual bleeding). Starting on days 2-5 is permitted, but during the first cycle, it is recommended to use a barrier method for the first seven days of taking the tablets. After miscarriage in the first trimester: After miscarriage in the first trimester of pregnancy, it is recommended to start immediately. In this case, there is no need to use an additional contraceptive method. After childbirth or miscarriage in the second trimester: The woman should be advised to start on any day between day 21 and 28 after childbirth or miscarriage in the second trimester. When starting later, she should be advised to use a barrier method in addition until the first seven days of taking the tablets are completed. However, if intercourse has already occurred, pregnancy should be ruled out before the actual start of Cerazette or the woman should wait for her first menstrual cycle. How to start Cerazette when switching from other contraceptive methods: Switching from combined hormonal contraceptives (combined oral contraceptives (COC), vaginal ring, or transdermal patch). The woman should preferably start Cerazette on the day following the last active pill (the last pill containing active substances) of the previous contraceptive or on the day of removal of the vaginal ring or patch. In these cases, no additional contraceptive method is needed: The woman can also start no later than the day following the usual interval between pill-free, patch-free, ring-free, or placebo pills of the previous combined hormonal contraceptive, but during the first seven days of taking the tablets, an additional barrier method is recommended. Switching from progestogen-only method (mini-pill, injection, implant, or intrauterine system releasing progestogen [IUS]): The woman can switch on any day from the mini-pill (from the implant or hormonal IUS on its removal day, from the injection when the next injection is due). Missed tablets control: Contraceptive protection may decrease if more than 36 hours pass between two tablets. If the user is less than 12 hours late in taking any tablet, the missed tablet should be taken as soon as remembered, and the next tablet should be taken at the usual time. If more than 12 hours late, an additional contraceptive method should be used for the next seven days. If tablets are missed in the first week after starting Cerazette and intercourse occurred in the week before missing the tablets, pregnancy should be considered. Advice in case of gastrointestinal disturbances: In case of severe gastrointestinal disturbances, absorption may be incomplete, and additional measures to prevent pregnancy should be taken. If vomiting occurs within 3-4 hours after taking the tablets, absorption may not be complete. In such cases, the advice regarding missed tablets, as mentioned in section 4.2, applies. Follow-up treatment: Before prescription, a comprehensive medical history should be taken, and a gynecological examination is recommended to exclude pregnancy. Bleeding disorders, such as oligomenorrhea and amenorrhea, should be investigated before prescribing. The interval between examinations depends on individual circumstances. If the prescribed product could potentially affect an underlying or obvious disease, monitoring should be timed accordingly. Although Cerazette is taken regularly, bleeding disturbances may occur. If bleeding is very frequent and irregular, another method of contraception should be considered. If symptoms persist, an organic cause should be ruled out. Management of menopause during treatment depends on whether tablets have been taken according to instructions and may include pregnancy testing. Treatment should be stopped if pregnancy occurs. Women should be informed that Cerazette does not protect against HIV (AIDS) or other sexually transmitted diseases. Contraindications: Active venous thromboembolism disorder. Presence or history of severe liver disease as long as liver function tests have not returned to normal. Known or suspected hormone-sensitive malignant tumors. Unexplained vaginal bleeding. Hypersensitivity to the active substance. Warnings and precautions: If any of the conditions/risk factors listed below are present, the benefits of using progestogen should be weighed against the potential risks for each woman individually and discussed with her before deciding to start Cerazette. If any of these conditions worsen, deteriorate, or occur for the first time, the woman should contact her doctor. The doctor will then decide whether to discontinue Cerazette. The risk of breast cancer generally increases with age. During combined oral contraceptive (COC) use, the risk of breast cancer slightly increases. This increased risk gradually disappears within 10 years after stopping COCs and is not related to duration of use but to the woman’s age at the time of contraceptive use. The expected number of diagnosed cases per 10,000 women using COCs (up to 10 years after stopping) compared to never-users during the same period for relevant age groups is shown in the table below. The risks associated with progestogen-only contraceptives (POCs), such as Cerazette, are likely similar in size to those with combined oral contraceptives. However, evidence for POCs is less conclusive. Compared to the lifetime risk of breast cancer, the increased risks associated with oral contraceptive use are low. Breast cancers diagnosed in contraceptive users tend to be less advanced than in non-users. The increased risk in COC users may be due to earlier diagnosis or biological effects of the pills or both. Since the biological effect of progestogen compounds on liver cancer cannot be excluded, an individual risk/benefit assessment should be performed in women with liver cancer. In cases of severe or chronic liver dysfunction, women should be referred to a specialist for examination and advice. Epidemiological studies have linked oral contraceptive use with increased incidence of venous thromboembolism (VTE, deep vein thrombosis, and pulmonary embolism). Although the clinical significance of this for desogestrel as a contraceptive in the absence of estrogen component is unknown, Cerazette should be discontinued if thrombosis occurs. Use of Cerazette should also be discontinued in case of prolonged immobilization due to surgery or illness. Women with a history of thrombotic disorders should be warned of recurrence possibility. Although progestogen compounds may affect peripheral insulin resistance and glucose tolerance, there is no evidence that diabetic patients using progestogen-only pills need to change their treatment regimen. However, diabetic patients should be carefully monitored during the first months of use. If persistent hypertension develops during Cerazette use, or if significant blood pressure increases do not respond adequately to antihypertensive therapy, discontinuation should be considered. Cerazette treatment leads to a decrease in serum estradiol levels to the early follicular phase level. It is still unknown whether this decrease has any relevant clinical effect on bone mineral density. Protection with traditional progestogen-only pills against ectopic pregnancy is not as effective as with combined oral contraceptives, which are associated with a recurrence of ovulation during progestogen-only pill use. Although Cerazette continuously prevents ovulation, ectopic pregnancy should be considered in differential diagnosis if the woman experiences amenorrhea or abdominal pain. Chloasma may occasionally occur, especially in women with a history of pregnancy-related chloasma. Women with chloasma should avoid sun exposure or UV rays while taking Cerazette. The following conditions have been reported during pregnancy and steroid use, but a link with progestogen compounds has not been established: jaundice and/or pruritus related to cholestasis, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydnema-Herpes, pregnancy-related deafness, angioedema. Depression and depressive mood are known adverse effects of hormonal contraceptive use. Depression can be severe and is a known risk factor for suicidal behavior and suicide. Women should be advised to contact their doctor if mood changes or depressive symptoms occur, including shortly after starting treatment. The effectiveness of Cerazette may be reduced if tablets are lost, gastrointestinal disturbances occur, or concomitant medications reduce plasma concentrations of etonogestrel, the active metabolite of desogestrel. Cerazette contains lactose and should not be given to patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.