Microlenyn 30 ED

Each round, biconvex, yellow sugar coated tablet contains Levonorgestrel 0.15 mg, Ethinyl estradiol 0.03 mg.
Each round, biconvex, white sugar coated tablet contains Lactose monohydrate 40.00 mg, Corn starch 29.00 mg, Magnesium stearate 1.00 mg.

Pharmacology: Pharmacodynamics: Ethinyl estradiol and levonorgestrel are contraceptives that suppress gonadotropins. In combination, it primarily prevents ovulation and induces changes in the endometrium and cervical mucus to decrease the possibility of fertilization and implantation.
Pharmacokinetics: Ethinyl estradiol is rapidly absorbed with peak concentration attained within 2 hours.
Ethinyl estradiol is 97% to 98% bound to plasma albumin. Half-life varies from 6 to 20 hours. It is excreted in bile and urine as conjugates and undergoes some enterohepatic recirculation.
Levonorgestrel reaches peak concentrations between 0.5 to 2 hours, does not undergo a first-followed by conjugation. Terminal half-life of the levonorgestrel is 11 to 45 hours.

Contraception: Prevention of pregnancy.

Recommended Dose: For the first course only, the patient must employ an additional, non-hormonal method of contraception (with the exception of the rhythm and the temperature methods) during the first 14 days of tablet-taking to ensure that the patient is protected against pregnancy from the first day of taking the tablets.
First package: Wait for the next menstruation to start, take the first yellow tablet from the left top of the package on day 5, whether bleeding has stopped or not (1st day of bleeding = 1st of the cycle), from now on the woman must take a tablet every day in the direction indicated by the arrows on the pack at the same time each day, preferably at the evening meal or at bedtime, until the pack is empty.
Subsequent courses: When the woman has finished the first pack of MICROLENYN 30 ED, start a new pack without interruption on the very next day from the left top of the package.
Mode of Administration: Oral.

Overdose and Treatments: Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; vaginal bleeding may occur in females.
There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

Thrombophlebitis, thromboembolic disorders (e.g. valvular heart disease with thrombogenic complications or atrial fibrillation), history of deep vein thrombophlebitis or pulmonary embolism, cerebral vascular disease, myocardial infarction, coronary artery disease, known or suspected breast carcinoma or estrogen dependent neoplasia, carcinoma of endometrium, hepatic adenomas/carcinomas, undiagnosed abnormal genital bleeding, known or suspected pregnancy, cholestatic jaundice of pregnancy/jaundice with prior pill use, hypersensitivity to any component of the product, acute liver disease, uncontrolled hypertension, headaches with focal neurological symptoms, diabetes with vascular complications, major surgery with prolonged immobility.

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptives. This risk increases with age and with heavy smoking (at least 15 cigarettes daily) and is quite marked in women older than 35 years of age. Women who use oral contraceptives should not smoke.
The use of oral contraceptives is associated with increased risk of thromboembolism, stroke, myocardial infarction, hypertension, hepatic neoplasia, and gallbladder disease. Risk of morbidity/mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes.
Be alert to the earliest symptoms of thromboembolic and thrombotic disorders. Should any of these occur or be suspected, discontinue the drug immediately.
Myocardial infarction risk associated with oral contraceptive use is increased. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes. The risk is very low in women younger than 30 years of age.
Data suggest that the increased risk of myocardial infarction persists after discontinuation of long-term oral contraceptive use, the highest risk group includes women 40 to 49 years of age who used oral contraceptives for at least 5 years.
Oral contraceptives increase the risk of cerebrovascular events (thrombotic and hemorrhagic stokes), in general, the risk is greatest in hypertensive women older than 35 years of age who also smoke.
A positive association is observed between the amount of estrogen and progestin in oral contraceptives and the risk of vascular disease. A decline in serum high-density lipoproteins (HDL) has occurred with progestins and has been associated with an increased incidence of ischemic heart disease.
The risk of cerebrovascular and circulatory disease in oral contraceptives users is substantially increased in woman at least 35 years of age with other risk factor (eg, smoking, uncontrolled hypertension, hypercholesterolemia, obesity, diabetes).
Subarachnoid hemorrhage has been increased by oral contraceptives use.
Ocular lesions such as retinal thrombosis have been associated with the use of oral contraceptives. Discontinue medication if there is unexplained loss of vision, onset of proptosis or diplopia, papilledema, or retinal vascular lesions. Immediately undertake appropriate diagnostic therapeutic measures.
Close clinical surveillance of all women taking oral contraceptives is essential; they should be reexamined at least once a year. In all cases of undiagnosed persistent or recurrent abnormal vaginal bleeding, rule out malignancy. Monitor women with a strong family history of breast cancer or who have breast nodules, fibrocystic disease of the breast, cervical dysplasia, or abnormal mammograms.
Earlier studies have reported an increased risk of gallbladder surgery in oral contraceptives users.
Glucose tolerance may decrease, which is directly related to estrogen dose. Progestins increase insulin secretion and create insulin resistance. These effects vary with different agents. However, oral contraceptives appear to have no effect on fasting blood glucose in nondiabetic women. Observe prediabetic and diabetic patients receiving oral contraceptives. In a recent study, oral contraceptive users were less likely to develop diabetes than nonusers.
A small proportion of women will have persistent hypertriglyceridemia while using oral contraceptives. Changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.
Elevated blood pressure and hypertension may occur within a few months of beginning use, The prevalence increases with the duration of use and age. Incidence of hypertension may directly correlate with increasing dosages of progestin.
Encourage women with a history of hypertension, renal disease, or hypertension-related diseases during pregnancy to use another method of contraception. Monitor these patients if they choose to use oral contraceptives. Discontinue the oral contraceptive if elevated blood pressure occurs. High blood pressure returns to normal in most women after oral contraceptive discontinuation.
Onset or exacerbation of migraine or development of headache with focal neurological symptoms of a new pattern that is recurrent, persistent, or severe, requires oral contraceptive discontinuation and evaluation.
Breakthrough bleeding and spotting are sometimes encountered in oral contraceptive patients, especially during the first 3 months of use. Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for discontinuing oral contraceptives.
Some extensive epidemiological studies have revealed no increased risk of birth defects in oral contraceptive users prior to pregnancy.
In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
Closely follow women taking oral contraceptives who are being treated for hyperlipidemias. Some progestins may elevate LDL levels and decrease HDL levels, making hyperlipidemia control more difficult. Consider withholding the oral contraceptive if the dyslipidemia does not respond.
HDL and total cholesterol may be increased, LDL may be increased or decreased, while LDL/HDL ratio may be decreased and triglycerides unchanged.
In patients with a history of depression, discontinue if depression recurs to a serious degree. Patients becoming significantly depressed should discontinue medication to determine if the symptom is drug-related.
Oral contraceptives may cause fluid retention, prescribe with caution and monitor patients with conditions that might be aggravated by fluid retention such as convulsive disorder, migraine, asthma, cardiac, hepatic and renal dysfunction.
Patients with a history of jaundice during pregnancy have an increased risk of recurrent jaundice, if jaundice develops should discontinue use.
Serum folate levels may be depressed by therapy. Although oral contraceptives may impair folate metabolism, the effect is mild and unlikely to cause anemia or megaloblastic changes in woman who have a good dietary folate intake. Because the pregnant woman is predisposed to folate deficiency, a woman who becomes pregnant shortly after stopping therapy may have a greater chance of developing folate deficiency and its attendant complications. Folic acid supplements are recommended.
Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking oral contraceptives.
Estrogen has been reported to precipitate attacks of acute intermittent porphyria, use with caution in susceptible patients.
If significant GI disturbance occurs, a backup method of contraception for the remainder of the cycle is recommended.
Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using oral contraceptives.
Oral contraceptives do not protect against HIV infection and other sexually transmitted diseases.

Pregnancy: Pregnancy category X.
Lactation: Combination oral contraceptives given in the postpartum period may interfere with lactation, decreasing the quantity and quality of breast milk. Furthermore, a small amount of oral contraceptive steroids is excreted in breast milk. A few adverse effects on the breast-feeding infant have been reported, including jaundice and breast enlargement. If possible, defer use until the infant has been weaned, however, in some situations, breast-feeding is the only real alternative.

Serious: Arterial thromboembolism, cerebral hemorrhage, cerebral thrombosis, coronary thrombosis, focal nodular hyperplasia of the liver, gall bladder disease, hepatic adenomas or benign liver tumors, hypertension, mesenteric thrombosis, myocardial infarction, pulmonary embolism, ruptured cyst, thrombophlebitis and venous thrombosis with or without embolism, uterine leiomyoma.
CNS: Dizziness, headache, mental depression, migraine.
Dermatologic: Melasma, rash.
Endocrine: Breast pain, tenderness, enlargement, secretion diminution in lactation when given immediately postpartum.
GI: Abdominal cramp, bloating, cholestatic jaundice, nausea and vomiting.
GU: Amenorrhea during and after treatment, breakthrough bleeding, spotting, change in menstrual flow, change in cervical erosion and secretions, invasive cervical cancer, temporary infertility after discontinuation, vaginal candidiasis.
Ophthalmic: Changes in corneal curvature, contact lens intolerance, neuro-ocular lesions.
Miscellaneous: Edema, reduced carbohydrate tolerance, weight change, prevalence of cervical Chlamydia trachomatis may be increased, hirsutism.

Avoid concomitant use of ethinyl estradiol and levonorgestrel with any of the following: anastrozole, griseofulvin, pimozide, pirfenidone.
Ethinyl estradiol and levonorgestrel may increase the level of aripiprazole, benzodiazepines (metabolized by oxidation), corticosteroids, CYP1A2 substrates such as lomitapide, pimozide, pirfenidone, ropinirole, selegiline, theophylline derivatives such as tipranavir, tizanidine, tranexamic acid, voriconazole.
The level of ethinyl estradiol and levonorgestrel may be increased by ascorbic acid, boceprevir, cobicistat, mifepristone, NSAID, voriconazole.
Ethinyl estradiol and levonorgestrel may decrease the level of anastrozole, chenodiol, hyaluronidase, lamotrigine, thyroid product, ursodiol, vitamin K antagonists.
The level of ethinyl estradiol and levonorgestrel may be decreased by acitretin, aminoglutethimide, aprepitant, armodafinil, artemether, barbiturate, bexarotene, bile acid sequestrants, boceprevir, bosentan, carbamazepine, clobazam, cobicistat, colesevelam, deferasirox, elvitegravir, exenatide, felbamate, fosaprepitant, fosphenytoin, griseofulvin, lamotrigine, mifepristone, modafinil, mycophenolate, nafcillin, nevirapine, oxcarbazepine, perampanel, phenytoin, protease inhibitors, prucalopride, retinoic acid derivatives, rifamycin derivatives, rufinamide, St. John's wort, telaprevir, tipranavir, tocilizumab, topiramate.

Preserve in tight, light resistant container and store below 30°C.

Oral Contraceptives

G03AA07 - levonorgestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

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