Norgestrel tablet is contraindicated for use by women who are known to have the following conditions:
Known or suspected pregnancy
Known or suspected carcinoma of the breast, or other progestin-sensitive cancer, now or in the past
Undiagnosed abnormal uterine bleeding
Hypersensitivity to any component of this product
Benign or malignant liver tumors
Pregnancy: Norgestrel Tablets are contraindicated for use in pregnant women because there is no need for pregnancy prevention in a woman who is already pregnant. Published studies report no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins in pregnant women. Discontinue Norgestrel Tablets if pregnancy is confirmed.
Nursing Mothers: Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma. No adverse effects have been reported on breastfeeding performance or infant health. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Norgestrel Tablets and any potential adverse effects on the breastfed infant from Norgestrel Tablets or from the underlying maternal condition.
Migraine/Headache: The onset or exacerbation of migraine, or development of headache with a new pattern that is recurrent, persistent, or severe requires evaluation of the cause because women with migraine may be at increased risk of stroke.
Drug Interactions:
The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as phenytoin, carbamazepine, barbiturates, rifampin, efavirenz, bosentan and herbal preparations containing St. John’s Wort (hypericum perforatum ). This could result in unintended pregnancy or breakthrough bleeding. During concomitant use of Norgestrel and substances that may affect its efficacy, it is recommended that a nonhormonal back-up method of contraception (such as condom) be used in addition to the regular intake of Norgestrel Tablets. Use of a nonhormonal back-up method is recommeded for 28 days after discontinuation of substances that have led to induction of hepatic microsomal enzymes. For women receiving long-term therapy with hepatic enzyme inducers, another method of contraception should be considered.
Effectiveness of progestin-containing hormonal contraceptives and emergency contraceptive ulipristal acetate may be decreased if progestin-containing hormonal contraceptives are used within five days after ulipristal acetate dosing. If a woman wishes to use Norgestrel Tablets after using ulipristal acetate, she should do so no sooner than 5 days after the intake of ulipristal acetate and she should use a reliable barrier method for subsequent acts of intercourse until her next menstrual period.
Gastrointestinal: Diarrhea and/or vomiting within 4 hours after taking a pill may reduce hormone absorption. Women should use of a nonhormonal back-up method of birth control (such as a condom or spermicide) during the next 48 hours.
Interactions with Laboratory Tests: The following endocrine tests may be affected by Norgestrel Tablets use:
Sex hormone-binding globulin (SHBG) concentrations may be decreased.
Total thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG). However, free thyroxine level should remain unchanged.
Pediatric Use: The safety and efficacy of Norgestrel tablets have been established in women of reproductive age, including adolescents as young as 15 years of age, and almost 30% of subjects in the clinical trials who were under 20 years of age. Use of this product before menarche is not indicated.
Geriatric Use: Norgestrel tablet Tablets have not been studied in postmenopausal women and is not indicated in this population.
Symptoms of oral contraceptive overdosage may include nausea, vomiting, breast tenderness, dizziness, somnolence ( drowsiness/fatigue), and withdrawal bleeding in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.
Oral Contraceptive preparations
Store at controlled room temperature between 20° to 25°C.
