Carefully observe females with a history of depression and discontinue Portia if depression recurs to a serious degree. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. There have been no reports of serious adverse outcomes from overdose of COCs, including ingestion by children. Cigarette smoking increases the risk of serious cardiovascular events from COC use. Please take the medication as instructed by your provider. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8 to 10 years of COC use. In one trial, 33 subjects out of 1084 (3.0%) discontinued due to bleeding irregularities (i.e., breakthrough bleeding and spotting); in the other trial, 6 subjects out of 238 (2.5%) discontinued due to bleeding irregularities. Get medical help right away if you experience abnormal vaginal bleeding, discharge, or pain during sex, since these could be signs of cervical cancer. If you have vomiting or diarrhea or take certain medications, Portia might not work as well for you. It's important to take your pills in the order that's in the blister pack. Contains 6 blister cards, each containing 28 tablets. The absolute risk of breast cancer associated with any hormonal contraceptive use was 13 per 100,000 women-years, which corresponds to 1 extra case of breast cancer . Studies suggest an increased risk of developing gallbladder disease among COC users. Concomitant use with ethinyl estradiol-containing COCs may increase systemic exposure of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole). Decide what time of day you want to take your pill. Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Many women find that taking Portia before bedtime or just after their largest meal of the day helps reduce nausea and other side effects. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, Portia Serious blood clots are more likely to happen when you: Call your healthcare provider or go to a hospital emergency room right away if you have: What are the most common side effects of oral contraceptives? White, round, biconvex, unscored inert tablets, debossed with stylized b on one side and 208 on the other side. If you have hepatitis C and need to be treated with Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir), let your provider know right away that you're taking a COC. What should I know about my period when taking Portia? Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Some of these unwanted effects include benign (not cancerous) liver tumors, liver cancer, or blood clots or related problems, such as a stroke. Your chance of getting pregnant is higher if you don't take the medication as directed (e.g., missed or late doses). Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: acne (usually less common after first 3 months and may improve if acne already exists), increased or decreased interest in sexual intercourse, increased sensitivity of skin to sunlight. They also change the lining of the uterus (womb) to prevent pregnancy from developing and change the mucus at the . Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult [see WARNINGS (7)]. Set an alarm to help you remember to take Portia at the same time every day. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS. Table 2 provides significant drug interaction information for drugs co-administered with Portia. Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. You'll likely need to use a back-up method or other form of birth control for several weeks after stopping any of these medications. If you're not currently taking another hormonal birth control, the two most common ways to start taking Portia are the Day 1 Start and the Sunday Start methods. You will use a Day 1 Start if your doctor told you to take your first pill (Day 1) on the first day of your period. But, if you experience a new migraine, a migraine that's worse than normal, or a new headache that keeps coming back or is severe, call your provider so you can be checked out. Females with a history of pregnancy-related cholestasis may be at an increased risk for COC-related cholestasis. 40 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Study results are mixed, but there's a possibility that Portia and other COCs can raise your risk for breast and cervical cancer. Based on the results of clinical studies, about 1 to 5 out of 100 women may get pregnant during the first year they use Portia. Although not all of these side effects may occur, if they do occur they may need medical attention.The following side effects may be caused by blood clots. Portia is a birth control pill (oral contraceptive) used by women to prevent pregnancy. If you smoke, talk with your provider about safer birth control alternatives. The typical dose is to take 1 active tablet by mouth daily for 21 days, followed by 1 placebo tablet daily for the remaining 7 days. At these increased levels, these hormones can generate changes in your body, such as a temporary increase in breast size or weight gain. If you are taking birth . Data on the association of COCs with onset of depression or exacerbation of existing depression are limited. Rupture of hepatic adenomas may cause death from abdominal hemorrhage. This is comforting to hear. In a few women, the use of birth control pills may speed up the growth of an existing but undiagnosed breast cancer. While Portia shouldn't cause any birth defects if you accidentally take it during early pregnancy, you'll no longer need to take it when you're pregnant. 4. Portia should be available at just about any pharmacy in your area. Your healthcare provider should tell you when to start taking your birth control pill. It contains 2 hormones: a progestin and an estrogen .Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your. 5 Random Sexual Health Facts We Bet You Didnt Know. If you feel sick to your stomach, do not stop taking the pill. What makes Portia different from some other birth control pills that also contain levonorgestrel and ethinyl estradiol? Natural family planning relies on you figuring out the days you're most likely to. Equivalent generic brands: If you are usually a 7 day person, it goes down to like 5 days. You could become pregnant if you have sex during the first 7 days after you restart your pills. In addition, some progesterones could raise LDL levels ("bad" cholesterol). Overdose may cause uterine bleeding in females and nausea. Portia is contraindicated in females with acute viral hepatitis or severe (decompensated) cirrhosis of liver (see CONTRAINDICATIONS). Portia is a birth control pill that uses a combination of estrogen and progestin to prevent pregnancy and regulate menstrual cycle. Portia (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/ 0.03 mg) 28 tablets are packaged in cartons of six blister cards (NDC 0555-9020-58), each card containing 28 tablets: Pink, round, film-coated, biconvex, unscored active tablets, debossed with stylized b on one side and 992 on the other side. The risk of VTE is highest during the first year of use of a COC and when restarting hormonal contraception after a break of four weeks or longer. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy. Additional nonhormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Copyright (c) 2023 First Databank, Inc. Concomitant use of COCs with thyroid hormone replacement therapy or corticosteroid replacement therapy may increase systemic exposure of thyroid-binding and cortisol-binding globulin (see Warnings, EFFECT ON BINDING GLOBULINS). You do not need back-up contraception if you use the Day 1 Start. Discontinue Portia if pregnancy occurs because there is no reason to use COCs in pregnancy. Estrogen, when produced by the ovaries during puberty, leads to the natural collection of fat in the connective tissues around the chest. Portia is a combined hormonal birth control pill that's taken by mouth every day. ever COC are females with current or past COC use; never COC use are females that never used COCs. If vomiting occurs within 3 to 4 hours after taking Portia, the patient should proceed as if she missed a tablet. Counsel patients to take one tablet daily by mouth at the same time every day. Additional comment actions. Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Breast tenderness, pain, enlargement, secretion; Nausea, vomiting and gastrointestinal symptoms (such as abdominal pain, cramps and bloating); Change in menstrual flow; Temporary infertility after discontinuation of treatment; Change in weight or appetite (increase or decrease); Change in cervical erosion and secretion; Cholestatic jaundice; Rash (allergic); Vaginitis, including candidiasis; Change in corneal curvature (steepening); Intolerance to contact lenses; Mesenteric thrombosis; Decrease in serum folate levels; Exacerbation of systemic lupus erythematosus; Exacerbation of porphyria; Exacerbation of chorea; Aggravation of varicose veins; Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms. The inactive/placebo/bleeding week pills are there to help you in the habit of taking your pill every day. Package insert / product label You may report side effects to the FDA at 1-800-FDA-1088. Theyre fast, easy-to-use and free! Store Portia at room temperature between 68F to 77F (20C to 25C). Dosage. Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. 0. Make sure to go to all of your check-ups so your provider can monitor any changes. Portia is contraindicated in females who have headaches with focal neurological symptoms or have migraine headaches with aura, and in women over age 35 years who have migraine headaches with or without aura (see CONTRAINDICATIONS).
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