PIRMELLA (Generic for ORTHO-NOVUM)

Ethinyl Estradiol 0.035mg, Norethindrone 1mg, Oral tablet

Grapefruit juice

· Severity: Mild

· Notes for Consumers: Grapefruit juice and grapefruit-containing foods may increase the side effects of estrogen in some females, such as nausea, breast tenderness, headache or fluid retention. There may be no interaction. Do not significantly change your grapefruit intake while taking estrogens for hormone replacement therapy or as part of hormonal birth control products. Report any unusual side effects, like unusual non-menstrual vaginal bleeding, promptly for evaluation.

· Notes for Professionals: Grapefruit juice has been reported to decrease the metabolism of some estrogens. Grapefruit juice contains a compound that inhibits CYP3A4 in enterocytes. Estrogen levels may increase by up to 30 percent with chronic use. The clinical significance of the interaction is unknown. It is possible that estrogen induced side effects could be increased in some individuals. Patients should be advised to not significantly alter their grapefruit juice ingestion.When chronically ingesting any CYP3A4 inhibitor ( > 30 days) with estrogens, adequate diagnostic measures, including directed or random endometrial sampling when indicated by signs and symptoms of endometrial hyperplasia, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Ethinyl Estradiol 0.035mg, Norethindrone 1mg, Oral tablet

Tobacco

· Severity: Major

· Notes for Consumers: Do not smoke or use tobacco products while taking this medication. Smoking while taking this medication increases the risk for serious side effects such as blood clots, heart attack, and stroke. Call emergency services right away if you experience symptoms of a blood clot in your lung: shortness of breath or chest pain. You should also call emergency services right away if you experience symptoms of a heart attack: pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded. You should also call emergency services right away if you experience symptoms of a stroke: sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision. Contact your care team right away if you experience symptoms of a blood clot in your leg: pain, swelling, or warmth in the leg.

· Notes for Professionals: Advise patients to avoid cigarette smoking while taking estrogen hormones. Cigarette smoking increases the risk of serious cardiovascular events, such as myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism. Combined hormonal contraceptives are contraindicated in females who are over 35 years of age and smoke.

Ethinyl Estradiol 0.035mg, Norethindrone 1mg, Oral tablet

Caffeine-containing Foods/Beverages

· Severity: Mild

· Notes for Consumers: Side effects from Caffeine may get worse if you take Ethinyl Estradiol (an estrogen hormone commonly found in birth control pills). Too much Caffeine can cause effects like nausea, nervousness, or sleeplessness. Although an interaction is possible, these drugs are often used together without problems.

· Notes for Professionals: Serum concentrations of caffeine may be increased during concurrent administration with ethinyl estradiol. Patients may desire to limit products that contain high amounts of caffeine in an effort to minimize caffeine-related side effects such as nausea or tremors.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>