Microgynon 30 Tablet

Iclevia TM (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Iclevia is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

• Take one tablet daily by mouth at the same time every day for 91 days
• Take tablets in the order directed on the Extended-Cycle Wallet
• How to Start and Take Iclevia Iclevia is dispensed in an Extended-Cycle Wallet [see How Supplied/Storage and Handling ]
• Iclevia should be started on a Sunday (see Table 1)
• For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration
• Table 1: Instructions for Administration of Iclevia Starting Iclevia in females with no current use of hormonal contraception (Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product
• Tablet Color: Iclevia active tablets are white (Day 1 to Day 84)
• Iclevia inactive tablets are green (Day 85 to Day 91)
• Sunday Start: For each 91-day course, take in the following order: Take the first white tablet (0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol) on the first Sunday after the onset of menstruation
• If menstruation begins on a Sunday, take the tablet on that day
• Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms or spermicide) for the first 7 days of treatment
• Take subsequent white tablets once daily at the same time each day for a total of 84 days
• Take one green tablet (inert) daily for the following 7 days and at the same time of day that active tablets were taken
• A scheduled period should occur during the 7 days that the green tablets are taken. …

Iclevia (levonorgestrel and ethinyl estradiol tablets USP) are available in Extended-Cycle Wallets, each containing a 13-week supply of tablets in the following order: 84 white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol; round, biconvex, beveled-edge tablets debossed with “S” on one side and “27” on other side. …

• Safety and efficacy of levonorgestrel and ethinyl estradiol tablets have been established in women of reproductive age
• Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of levonorgestrel and ethinyl estradiol tablets before menarche is not indicated

Levonorgestrel and ethinyl estradiol tablets has not been studied in postmenopausal women and is not indicated in this population.

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• Cigarette Smoking Cigarette smoking increases the risk of serious cardiovascular events from COC use
• Women who are over 35 years old and smoke should not use Iclevia [see Boxed Warning and Warnings and Precautions ]
• Venous Thromboembolism The increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions ]. …

• Iclevia is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases
• Examples include females who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ]
• Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions ]
• Have cerebrovascular disease [see Warnings and Precautions ]. …

The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested. Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations. …

Vascular risks: Stop if a thrombotic or thromboembolic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years. ( 5.1 , 5.5 ) Liver disease: Discontinue if jaundice occurs. ( 5.2 ) Hypertension: If used in women with well-controlled hypertension, monitor blood pressure and stop if blood pressure rises significantly. ( 5.4 ) Gallbladder disease: May cause or worsen gallbladder disease. …

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.2) ] The most common adverse reactions (≥2%) reported during clinical trials were headache, menorrhagia, nausea, dysmenorrhea, acne, migraine, breast tenderness, weight increased, and depression. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

8.1 Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, Iclevia should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy. In the U.S. …

There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.