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PRODUCTS |
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TECHNICAL FILE |
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INDICATIONS |
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Oral contraceptive. |
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DOSAGE AND ADMINISTRATION |
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SECRET 28 should be administered once daily (preferably at night) and uninterruptedly for 28 days (a yellow tablet the first 24 days and a red tablet the remaining four days) without any intervals between the two packs. Treatment should be initiated with the yellow tablet located in a space marked as Number l (the first yellow tablet should be taken the first day of the menstrual cycle corresponding to the first day of bleeding). At the same time, the patient should mark the day of the week of that first tablet in the printed bar of the envelope (Mon Tues Wed Thurs Fri Sat Sun) Take one yellow tablet daily, following the numerical order, leaving the four red tablets for the end. If you are not sure whether you have taken the pill, check by counting the days in the printed bar and beginning the marked day, (e.g. if today is Tuesday and the last tablet taken is number l5, and you do not remember if you took the tablet corresponding to Monday, count 15 starting the marked day to see if it corresponds to Monday). The menses will occur during the four red tablets period. If you wish to continue with treatment, it should be started the day after the last red tablet was taken, starting the first yellow tablet from a new pack. It is very important to follow the right order; always take the yellow tablets first, and when there are no yellow pills left, take the red ones. With this schedule, you must take one tablet every day with no interruptions if you want to maintain contraception. The first yellow tablet should be taken the first day of the menstrual cycle (first day of bleeding). If you start treatment with SECRET 28 and you were using another contraceptive formulation with 21 tablets, you should take the first yellow tablet, after a 7-day interruption. If the pack contained 22 tablets, the first yellow tablet should be taken after a 6-day break. Finally, if you were on a 28 tablet schedule, you should take the first yellow tablet of SECRET 28 uninterruptedly. If there is no menstrual bleeding the first 6 or 7 days after finishing the blister card of previous contraceptives, talk to your doctor to rule out pregnancy, before initiating treatment with SECRET 28.
MISSED TABLETS: missing a tablet entails a risk of pregnancy. If you notice you have missed a tablet before the twelfth hour of the usual dosing, take it right away and continue with the usual regimen, taking the next tablet that same day at the usual time. Taking the tablet l2 hours or more hours late entails risk of pregnancy; if that happens, take the missed tablet right away. The treatment should be continued until you finish the blister. A non-hormonal contraceptive method should be added at the same time, until a new pack is started, including the days of the period. Patients are advised to visit their doctors in such cases. |
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CONTRAINDICATIONS |
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Absolute CI: OCs should not be used by women presenting with the following conditions: Thrombophlebitis or thromboembolic disorders (particularly myocardial infarction and stroke; a past history of deep venous thrombophlebitis or thromboembolic disorders (pulmonary embolism). Cardiovascular disease: hypertension, coronary artery disease, and thrombogenic arrhythmias. Vascular eye disorders. Diabetes presenting with small or large artery disease. Breast or uterus cancer. Recently diagnosed or severe liver disease. Pituitary tumors. Undiagnosed genital hemorrhage, connectivitis. Porphyria. Ritonavir (See interactions).
Relative CI: Cigarette smoking, metabolic disorders, uncomplicated diabetes and hyperlipidemia (increased serum triglycerides, increased serum cholesterol). Obesity. Otosclerosis. Benign breast tumors and uterine dystrophies (hyperplasia, fibroma). Hyperprolactinemia with or without galactorrhea, renal failure. Recurring cholestasis or recidivant itching following pregnancy. Herpes genitalis. Pregnancy and breastfeeding. |
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HOW SUPPLIED |
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SECRET 28 is available in packs containing 24 yellow tablets and 4 red tablets. |
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