WYMZYA Fe by is a Prescription medication manufactured, distributed, or labeled by Lupin Pharmaceuticals, Inc., LUPIN LIMITED. Drug facts, warnings, and ingredients follow.
WYMZYA Fe consists of 28 tablets in the following order (3):
The most common adverse reactions were: irregular uterine bleeding, nausea, breast tenderness, and headache. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
WYMZYA Fe can decrease milk production. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2017
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS (4)].
WYMZYA Fe is dispensed in a wallet [see HOW SUPPLIED/STORAGE AND HANDLING (16)]. WYMZYA Fe may be started using either a Day 1 start or a Sunday start (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.
WYMZYA Fe (white active tablets and brown placebo tablets) may be swallowed whole or chewed and swallowed. If the tablet is chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing.
Table 1: Instructions for Administration of WYMZYA Fe
|
|
Starting CHCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start)
Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: ● WYMZYA Fe active tablets are white (Day 1 to Day 21). ● WYMZYA Fe placebo tablets are brown (Day 22 to Day 28). | Day 1 Start:
● Take first white active tablet on the first day of menses. ● Take subsequent white active tablets once daily at the same time each day for a total of 21 days. ● Take one brown placebo tablet daily for 7 days and at the same time of day that active tablets were taken. ● Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet). |
| Sunday Start:
● Take first active tablet on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of WYMZYA Fe. ● Take subsequent white active tablets once daily at the same time each day for a total of 21 days. ● Take one brown placebo tablet daily for the following 7 days and at the same time of day that active tablets were taken. ● Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. |
Switching to WYMZYA Fe from another hormonal contraceptive
| Start on the same day that a new pack of the previous hormonal contraceptive would have started. |
Switching from another contraceptive method to WYMZYA Fe
| Start WYMZYA Fe :
|
● Transdermal patch
| ● On the day when next application would have been scheduled |
● Vaginal ring
| ● On the day when next insertion would have been scheduled |
● Injection
| ● On the day when next injection would have been scheduled |
● Intrauterine contraceptive
| ● On the day of removal ● If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack. |
● Implant
| ● On the day of removal |
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.
|
Starting WYMZYA Fe after Abortion or Miscarriage
First-trimester:
Starting WYMZYA Fe after Childbirth
Table 2: Instructions for Missed WYMZYA Fe Tablets
|
|
● If one white active tablet is missed in Weeks 1, 2, or 3
| Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished.
|
● If two white active tablets are missed in Week 1 or Week 2
| Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
|
● If two white active tablets are missed in Week 3 or three or more white active tablets are missed in a row in Weeks 1, 2, or 3
| Day 1 start: Throw out the rest of the pack and start a new pack that same day. 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. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. |
In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-APPROVED PATIENT LABELING].
WYMZYA Fe [norethindrone and ethinyl estradiol tablets USP (chewable) and ferrous fumarate tablets] is available in wallet.
Each wallet contains 28 tablets in the following order:
Do not prescribe WYMZYA Fe to women who are known to have the following conditions:
■ Women over age 35 with any migraine headaches [see WARNINGS AND PRECAUTIONS (5.7)]
Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). The risk increases with age, particularly in women over 35 years of age who smoke.
Do not use WYMZYA Fe in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see CONTRAINDICATIONS (4)]. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue WYMZYA Fe if jaundice develops.
Liver Tumors
WYMZYA Fe is contraindicated in women with benign and malignant liver tumors [see CONTRAINDICATIONS (4)]. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However, the risk of liver cancers in COC users is less than one case per million users.
During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN),including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs. Discontinue WYMZYA Fe prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see CONTRAINDICATIONS (4)].
WYMZYA Fe can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
WYMZYA Fe is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see CONTRAINDICATIONS (4)]. For women with well-controlled hypertension, monitor blood pressure and stop WYMZYA Fe if blood pressure rises significantly.
An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin.
Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for COC related cholestasis.
Carefully monitor prediabetic and diabetic women who take WYMZYA Fe. COCs may decrease glucose tolerance.
Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs.
Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
If a woman taking WYMZYA Fe develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue WYMZYA Fe if indicated.
Consider discontinuation of WYMZYA Fe in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).
Unscheduled Bleeding and Spotting
Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different contraceptive product.
Amenorrhea and Oligomenorrhea
Women who use WYMZYA Fe may experience amenorrhea. Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was preexistent.
If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.
Extensive epidemiologic studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue WYMZYA Fe use if pregnancy is confirmed.
Administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy [see USE IN SPECIFIC POPULATIONS (8.1)].
Carefully observe women with a history of depression and discontinue WYMZYA Fe if depression recurs to a serious degree.
The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sec hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.
A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
The following adverse reactions are commonly reported by COC users. Because these reactions are voluntarily reported by from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs
Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
Colesevelam
Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly decrease the AUC of EE. The drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart.
Substances Increasing the Plasma Concentrations of COCs
Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20 to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors, such as itraconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.
Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) Protease Inhibitors and Non- nucleoside Reverse Transcriptase Inhibitors
Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]).
COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because the serum concentration of thyroid-binding globulin increases with use of COCs [see WARNINGS AND PRECAUTIONS (5.12)].
Do not co-administer WYMZYA Fe with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see WARNINGS AND PRECAUTIONS (5.3)].
There is little or no increased risk of birth defects in women who inadvertently use COCs during early 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 low dose COCs prior to conception or during early pregnancy.
Do not use COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion.
Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.
Safety and efficacy of WYMZYA Fe have been established in women of reproductive age. Efficacy is expected to be the same in post-pubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.
WYMZYA Fe has not been studied in postmenopausal women and is not indicated in this population.
The pharmacokinetics of WYMZYA Fe has not been studied in women with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded [see CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.2)].
WYMZYA Fe is a combinational contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol. The packaging includes 21 white tablets composed of norethindrone and ethinyl estradiol followed by 7 brown ferrous fumarate (placebo) tablets. The chemical name for norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one and for ethinyl estradiol the chemical name is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. The structural formulas are:
The active white WYMZYA Fe tablets contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and the following inactive ingredients: lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, sucralose, vanillin and vitamin E.
The brown tablets contain ferrous fumarate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate and sucrose. The ferrous fumarate tablets do not serve any therapeutic purpose.
COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
Ethinyl estradiol and norethindrone are rapidly absorbed with maximum plasma concentrations occurring within 2 hours after WYMZYA Fe administration (see Table 1). Norethindrone appears to be completely absorbed following oral administration; however, it is subject to first-pass metabolism resulting in an absolute bioavailability of approximately 65 percent. Large intersubject variability is reflected in a 3- to 5-fold variation in norethindrone bioavailability. Ethinyl estradiol bioavailability is approximately 43 percent due to small-intestinal and hepatic first-pass metabolism.
|
||||
Norethindrone/Ethinyl Estradiol | tmax (h) | Cmax (pg/mL) | AUC0 to ∞
(pgh/mL) | t1/2 (h) |
Norethindrone 0.4 mg | 1.24 ± 0.40*
| 4210.6 ± 1628.8*
| 18034.9 ± 7852.9†
| 8.6 ± 3.7†
|
Ethinyl Estradiol 35 mcg | 1.44 ± 0.33†
| 131.4 ± 34.2†
| 1065.8 ± 276.2†
| 17.1 ± 4.4†
|
Cmax = maximum plasma concentration; tmax = time to reach Cmax; AUC = area under the curve;
t1/2 = elimination half- life.
Single-dose administration of WYMZYA Fe tablets with food decreased the maximum norethindrone and ethinyl estradiol concentration by 53 percent and 47 percent, respectively; the extent of norethindrone and ethinyl estradiol absorption (AUC values) was not affected by food administration.
Distribution
Norethindrone is 36 percent bound to sex hormone-binding globulin (SHBG) and 61 percent bound to albumin. Ethinyl estradiol is not bound to SHBG but is highly (98.5 percent) bound to albumin. Volume of distribution of norethindrone and ethinyl estradiol ranges from 2 to 4 L/kg.
Metabolism
Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation; less than 5 percent of a norethindrone dose is excreted unchanged; greater than 50 percent and 20 to 40 percent of a dose is excreted in urine and feces, respectively. The majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites.
Ethinyl estradiol is also extensively metabolized, both by oxidation and by conjugation with sulfate and glucuronide. Sulfates are the major circulating conjugates of ethinyl estradiol, and glucuronides predominate in urine. The primary oxidative metabolite is 2-hydroxy-ethinyl estradiol, which is formed by the CYP3A4 isoform of cytochrome P450.
Excretion
Plasma clearance values for norethindrone and ethinyl estradiol are similar (approximately 0.4 L/hr/kg). Ethinyl estradiol and norethindrone are excreted in both urine and feces, primarily as metabolites. Ethinyl estradiol is excreted in urine and feces as glucuronides and sulfates, and about 28 to 43 percent undergoes enterohepatic circulation. The mean terminal elimination half- lives of norethindrone and ethinyl estradiol following single dose administration of WYMZYA Fe are approximately 9 hours and 17 hours, respectively.
The data presented in Section 14 are from a clinical trial conducted with norethindrone 0.4 mg/ethinyl estradiol 35 mcg tablets. WYMZYA Fe is bioequivalent to these norethindrone acetate/ethinyl estradiol tablets.
In a multicenter open-label clinical trial, 1,970 women, 98% of whom were 16 to 39 years of age, were studied for up to 31 cycles (28 days per cycle) to assess the efficacy of norethindrone /ethinyl estradiol tablets, completing the equivalent of 20,230 cycles of exposure. The racial demographic of all enrolled women was: Caucasian (56%), African-American (14%), and Other (30%) (Hispanic, Native American, etc.). Of treated women, 10% were lost to follow-up, 11% discontinued related to cycle control and 7% discontinued due to other adverse events
The pregnancy rate (Pearl Index [PI]) in all 1,970 women was 1.48 pregnancies per 100 women- years of use (95% confidence interval 0.94 –2.22), based on 23 pregnancies that occurred after the onset of treatment of norethindrone /ethinyl estradiol tablets.
WYMZYA Fe [norethindrone and ethinyl estradiol tablets USP (chewable) and ferrous fumarate tablets] is available in a wallet pack (NDC: 68180-873-11) containing 28 tablets packed in a pouch (NDC: 68180-873-11). Such three pouches are packaged in a carton (NDC: 68180-873-13).
Each wallet contains 28 tablets in the following order:
See FDA-Approved Patient Labeling (Patient Information and Instructions for Use)
Counsel patients about the following information:
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
United States
Manufactured by:
Lupin Limited
Pithampur (M.P.) - 454 775
India
December 2017 ID#: 253420
WYMZYATM Fe
[WYM-zee-yah EFF-EE]
[norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets]
What is the most important information I should know about WYMZYA Fe?
Do not use WYMZYA Fe if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
What is WYMZYA Fe?
WYMZYA Fe is a birth control pill (oral contraceptive) used by women to prevent pregnancy.
How does WYMZYA Fe work for contraception?
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
Based on the results of one clinical study of a 28-day regimen of norethindrone 0.4 mg/ethinyl estradiol 35 mcg tablets, about 1 to 2 out of 100 women may get pregnant during the first year they use WYMZYA Fe.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
Who should not take WYMZYA Fe?
Do not take WYMZYA Fe if you:
If any of these conditions happen while you are taking WYMZYA Fe , stop taking WYMZYA Fe right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking WYMZYA Fe.
What should I tell my healthcare provider before taking WYMZYA Fe?
Tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
WYMZYA Fe may affect the way other medicines work, and other medicines may affect how well WYMZYA Fe works.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How do I take WYMZYA Fe?
Read the Instructions for Use at the end of this Patient Information.
What are the possible serious side effects of WYMZYA Fe?
Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. 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:
Other serious side effects include:
What are the most common side effects of WYMZYA Fe?
The most common side effects of WYMZYA Fe include:
These are not all the possible side effects of WYMZYA Fe . For more information, ask your healthcare provider or pharmacist.
You may report side effects to the FDA at 1-800-FDA-1088.
What else should I know about taking WYMZYA Fe?
General information about the safe and effective use of WYMZYA Fe.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use WYMZYA Fe for a condition for which it was not prescribed. Do not give WYMZYA Fe to other people.
This Patient Information summarizes the most important information about WYMZYA Fe. You can ask your pharmacist or healthcare provider for information about WYMZYA Fe that is written for health professionals.
For more information, call Lupin Pharmaceuticals, Inc. at 1-800-399-2561.
Do birth control pills cause cancer?
Birth control pills do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.
Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.
What if I want to become pregnant?
You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.
What should I know about my period when taking WYMZYA Fe?
Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking WYMZYA Fe, especially during the first few months of use. This usually is not a serious problem. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.
What are the ingredients in WYMZYA Fe?
Active ingredients:
White pills: norethindrone and ethinyl estradiol
Brown pills: ferrous fumarate
Inactive ingredients:
White pills: lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, sucralose, vanillin and vitamin E.
Brown pills: magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate and sucrose.
WYMZYATM Fe
[WYM-zee-yah EFF-EE]
[norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets]
Important Information about taking WYMZYA Fe
Before you start taking WYMZYA Fe:
When should I start taking WYMZYA Fe?
If you start taking WYMZYA Fe and you have not used a hormonal birth control method before:
If you start taking WYMZYA Fe and you are switching from another birth control pill:
If you start taking WYMZYA Fe and previously used a vaginal ring or transdermal patch:
If you start taking WYMZYA Fe and you are switching from a progestin-only method such as an implant or injection:
If you start taking WYMZYA Fe and you are switching from an intrauterine device or system (IUD or IUS):
Keep a calendar to track your period:
If this is the first time you are taking birth control pills, read, "When should I start taking WYMZYA Fe?" above. Follow these instructions for either a Sunday Start or a Day 1 Start.
Sunday Start:
You will use a Sunday Start if your healthcare provider told you to take your first pill on a Sunday.
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.
Instructions for using your wallet (pill pack):
Step 1.
Look at your WYMZYA Fe pill pack. See Figure A.
The WYMZYA Fe pill pack has:
Find:
Remove the white pill by pressing the pill through the foil in the bottom of the pill pack. Continue taking the white pills for 21 days.
Step 4.
On the first day of Week 4 start taking the brown pills. Take the brown pill for 7 days.Your period should start during this time.
Step 5.
When you have taken all of the brown pills in your pill pack, get a new pill pack and start taking the white pills.
Begin your next pill pack on the same day of the week as your first cycle pill pack.
Begin your next pill pack on Sunday.
What should I do if I miss any WYMZYA Fe pills?
If you miss 1 pill in Weeks 1, 2, or 3, follow these steps:
If you miss 2 pills in Week 1 or Week 2 of your pack, follow these steps:
If you miss 2 pills in a row in Week 3, or you miss 3 or more pills in a row during Weeks 1, 2, or 3 of the pack, follow these steps:
If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
WYMZYA™ Fe is a trademark of Lupin Pharmaceuticals, Inc.
Distributed by:
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
United States
Manufactured by:
Lupin Limited
Pithampur (M.P.) - 454 775
India
Revised: December 2017 ID#: 253421
WYMZYATM Fe [norethindrone and ethinyl estradiol tablets USP (chewable), 0.4 mg/0.035 mg and ferrous fumarate tablets, 75 mg]
Rx only
NDC: 68180-873-11
Wallet Label: 28 Tablets
WYMZYATM Fe [norethindrone and ethinyl estradiol tablets USP (chewable), 0.4 mg/0.035 mg and ferrous fumarate tablets, 75 mg]
Rx only
NDC: 68180-873-11
Pouch Label: 1 wallet of 28 Tablets
WYMZYATM Fe [norethindrone and ethinyl estradiol tablets USP (chewable), 0.4 mg/0.035 mg and ferrous fumarate tablets, 75 mg]
Rx only
NDC: 68180-873-13
Carton Label: 3 wallets of 28 Tablets
WYMZYA FE
norethindrone and ethinyl estradiol kit |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
Labeler - Lupin Pharmaceuticals, Inc. (089153071) |
Registrant - LUPIN LIMITED (675923163) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
LUPIN LIMITED | 650582310 | MANUFACTURE(68180-873) , PACK(68180-873) |