Syrup 0.075 28 tablets

Product description: Cerazette® tablets 75 micrograms coated. Each tablet contains 75 micrograms desogestrel. Use by mouth. Usage instructions: 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 bleeding. After that, one tablet should be taken continuously every day, without noticing any possible bleeding. A new blister starts 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 start on the first day of the woman's natural cycle (the first day 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 abortion in the first trimester: After abortion 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 abortion in the second trimester: The woman should be advised to start any day between day 21 and 28 after childbirth or abortion 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 excluded 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 the day after 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 after the usual interval between pill-free days, patch-free days, ring-free days, 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 pills: Contraceptive protection may be reduced if more than 36 hours pass between two tablets. If the user delays taking any tablet less than 12 hours, the missed tablet should be taken as soon as remembered, and the next tablet should be taken at the usual time. If delayed more than 12 hours, an additional contraceptive method should be used during 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 be incomplete. In such cases, the advice regarding missed tablets, as mentioned in section 4.2, applies. Follow-up treatment: Before prescription, a full medical history should be taken, and a gynecological examination is recommended to exclude pregnancy. Bleeding disorders, such as scanty menstruation and amenorrhea, should be investigated before prescribing. The interval between examinations depends on the individual circumstances. If the prescribed product may potentially affect an underlying disease or obvious condition, monitoring should be timed accordingly. Despite the fact that 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 excluded. Management of menopause during treatment depends on whether the 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 following conditions/risk factors are present, the benefits of using progestogen should be weighed against the potential risks for each woman and discussed before deciding to start Cerazette. If any of these conditions worsen or appear 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 use of combined oral contraceptives (COCs), the risk of breast cancer slightly increases. This increased risk gradually disappears within 10 years after stopping COCs and is not related to the 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 associated 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 a combination of both. Since the biological effect of progestogen compounds on liver cancer cannot be excluded, individual risk/benefit assessments should be performed in women with liver cancer. In case of acute or chronic liver function disturbances, women should be referred to a specialist for examination and advice. Epidemiological studies have linked oral contraceptive use with increased 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 blood clots occur. Discontinuation should also be considered in case of prolonged immobilization due to surgery or illness. Women with a history of thrombotic disorders should be warned of the possibility of recurrence. Although progestogen compounds may affect peripheral insulin resistance and glucose tolerance, there is no evidence that management of diabetic patients using progestogen-only pills needs to be changed. 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 good 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. Caution is advised as melasma may occur, especially in women with a history of pregnancy-related melasma. Women with melasma should avoid sun exposure or UV radiation while taking Cerazette. Cases reported during pregnancy and steroid use, but no proven link with progestogen compounds: cholestatic jaundice and/or pruritus, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sidney-Herpes, pregnancy-related deafness associated with ear stiffening, hereditary 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 symptoms of depression occur, including shortly after starting treatment. The effectiveness of Cerazette may be reduced in case of missed pills, gastrointestinal disturbances, or concomitant drugs that 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, Lapp lactase deficiency, or glucose-galactose malabsorption. Product details: Product form: Tablets Product type: Tablets Brand: Cerazette Quantity: 28 tablets