This combination tablet is indicated for the prevention of pregnancy in women who choose this method of contraception. Oral contraceptives are highly effective, and their success depends on correct and consistent use. Except for sterilization, intrauterine devices (IUDs), and implants, the effectiveness of most contraceptive methods is influenced by how reliably they are used. Proper and regular use can significantly reduce the failure rate.

Each package contains

• 21 active tablets, each containing 0.3 mg norgestrel and 0.03 mg ethinylestradiol,
• along with 7 inert brown tablets, each containing 75 mg ferrous fumarate.

Combined oral contraceptives (COCs) work mainly by suppressing gonadotropin hormones, thereby inhibiting ovulation. In addition, they cause changes in cervical mucus, making it more difficult for sperm to enter the uterus, and alter the endometrium, reducing the likelihood of implantation of a fertilized egg.

To achieve maximum contraceptive effectiveness, Norgestrel & Ethinyl Estradiol and ferrous fumarate must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. The dosage of Norgestrel & Ethinyl Estradiol and ferrous fumarate is one white tablet daily for 21 consecutive days, followed by one brown tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that tablets be taken at the same time each day.

The contraceptive effectiveness of oral contraceptives may be reduced when used with antibiotics, anticonvulsants, and other drugs that increase steroid clearance. These include bosentan, rifampicin, rifabutin, barbiturates, primidone, phenytoin, carbamazepine, oxcarbazepine, topiramate, griseofulvin, and aprepitant. Concurrent use with troleandomycin may cause severe itching and jaundice and should be avoided. Ursodeoxycholic acid may have reduced effectiveness due to increased biliary cholesterol elimination. Hormonal effects of danazol or gestrinone may be altered or reduced when used together and should be avoided.

Anti-HIV protease inhibitors may decrease contraceptive efficacy. Ethinyl estradiol may increase tacrolimus levels. Oral contraceptives may also increase plasma levels of theophylline, selegiline, and tizanidine.

This combination is contraindicated in pregnancy, unexplained vaginal bleeding, severe arterial disease or strong family history of atherogenic lipid disorders, liver adenoma, porphyria, history of hydatidiform mole evacuation, breast cancer, hepatic impairment, thromboembolic disorders, estrogen-dependent tumors, heavy smoking (>40 cigarettes/day), age above 50 years, complicated diabetes, BMI above 39 kg/m², migraine with focal aura, uncontrolled hypertension (>160/100 mmHg), transient ischemic attacks, systemic lupus erythematosus, gallstones, history of hemolytic uremic syndrome, cholestatic jaundice, pregnancy-related pruritus, chorea, otosclerosis worsening, pemphigoid, and during breastfeeding in the first 6 months postpartum.

Common side effects include edema, weakness, amenorrhea, breakthrough bleeding, changes in menstrual flow, spotting, anorexia, deep vein thrombosis (DVT), thrombophlebitis, depression, dizziness, headache, nervousness, drowsiness, breast tenderness, galactorrhea, abdominal pain, nausea, vomiting, weight changes, and cholestatic jaundice.

Large epidemiological studies show no increased risk of birth defects in infants whose mothers used oral contraceptives before pregnancy. No teratogenic effects have been confirmed, even if used accidentally in early pregnancy. Oral contraceptives should not be used to test pregnancy or to treat threatened or habitual abortion.

If two consecutive periods are missed, pregnancy should be ruled out before continuing use. If doses were not taken correctly, pregnancy should be considered after the first missed period. Use should be discontinued if pregnancy is confirmed.

Use with caution in patients with sex-steroid dependent cancers, previous ectopic pregnancy, malabsorption syndromes, ovarian cysts, active or recurrent liver disease, history of cholestatic jaundice, cardiovascular or renal impairment, diabetes, asthma, epilepsy, migraine, depression, and lactation. Caution is required in conditions worsened by fluid retention, hypercalcemia, cardiovascular and gallbladder disease, lipid metabolism disorders, and familial lipoprotein defects. Patients at risk of venous thromboembolism, breast cancer, uterine fibroids, or benign liver adenoma require careful monitoring. It should be used cautiously in women over 35 years, smokers, or those with high BMI. Gastrointestinal upset, missed pills, or drug interactions may reduce effectiveness and require additional contraception. It should be taken at the same time every day.

During lactation, small amounts of hormones may pass into breast milk and may reduce its quality and quantity; alternative contraception is recommended until breastfeeding is completed.

Oral contraceptive preparations