ZOVIA 1-35 (Generic for DEMULEN 1/35-21)

Ethynodiol Diacetate 1mg, Ethinyl Estradiol 0.035mg, 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.

Ethynodiol Diacetate 1mg, Ethinyl Estradiol 0.035mg, 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.

Ethynodiol Diacetate 1mg, Ethinyl Estradiol 0.035mg, Oral tablet

Tobacco

· Severity: Major

· Notes for Consumers: You are strongly advised not to smoke while taking this medication. Tobacco smoking can increase the risk of a blood clot, stroke, heart attack or other serious problem while taking this medication. This is especially true if you are a female over 35 years of age or if you smoke > 15 cigarettes per day. While taking this medication, you should report any of the following "ACHES" to your prescriber immediately: Abdominal pain, Chest pain, severe or frequent Headaches or migraines; Eye pain or Severe leg pain in the calves or the thighs.

· Notes for Professionals: Females receiving combined hormonal contraceptives should be advised not to smoke tobacco. Tobacco smoking appears to enhance the procoagulant effect of estrogens. Tobacco smoking pharmacodynamically increases the risk of DVT, myocardial infarction, stroke and other thromboembolic disease. Risk is especially high for female smokers 35 years of age or older and in those who smoke greater than or equal to 15 cigarettes per day.

<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>