CRYSELLE- norgestrel and ethinyl estradiol
Teva Pharmaceuticals USA, Inc.
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].
Cryselle® is a combination oral contraceptive containing the progestational compound norgestrel, USP and the estrogenic compound ethinyl estradiol, USP. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Cryselle tablet contains 0.3 mg norgestrel, USP and 0.03 mg ethinyl estradiol, USP. The inactive ingredients present are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and pregelatinized corn starch. The light-green inactive tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake.
C21H28O2 MW: 312.45
Ethinyl Estradiol, USP
C20H24O2 MW: 296.40
Mechanism of Action
Combined oral contraceptives (COCs) prevent pregnancy primarily by suppressing ovulation.
Cryselle is indicated for use by females of reproductive potential to prevent pregnancy.
In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.
Cryselle is contraindicated in females who are known to have or develop the following conditions:
Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings, Risk of liver enzyme elevations with concomitant hepatitis c treatment).
Impaired Liver Function
Do not use Cryselle in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of the liver [see Contraindications]. 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 Cryselle if jaundice develops.
Cryselle is contraindicated in women with benign and malignant liver tumors [see Contraindications]. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 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 approaches less than one case per million users.
Risk Of Liver Enzyme Elevations With Concomitant Hepatitis C Treatment
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 Cryselle prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications]. Cryselle can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen.
Cryselle is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications]. For women with well-controlled hypertension, monitor blood pressure and stop Cryselle 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 quantities 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 Cryselle. 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 Cryselle develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Cryselle if indicated.
Consider discontinuation of Cryselle 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.
In 1,287 patients (pooled data from a number of studies), unscheduled bleeding was recorded in 15% of first cycles and by Cycle 12 was 5%. In total, 23% of subjects reported spotting, 20% reported unscheduled bleeding, and 2% reported change in menstrual flow at some point in the studies.
In the studies, 1.2% discontinued use of the product due to breakthrough bleeding and 1% discontinued due to spotting.
Amenorrhea and Oligomenorrhea
Women who use Cryselle may experience amenorrhea. A total of 9% of subjects in the studies reported amenorrhea in one or more cycles.
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.
Carefully observe women with a history of depression and discontinue Cryselle if depression recurs to a serious degree.
Cryselle is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications].
Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer. However, some studies report a small increase in the risk of breast cancer among current or recent users (<6 months since last use) and also among current users with longer duration of COC use [see Postmarketing Experience].
Some studies suggest that COC use has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.
In females with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking Cryselle.
Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation:
Do not coadminister Cryselle with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see Warnings, Risk of liver enzyme elevations with concomitant hepatitis c treatment).
Effects of Other Drugs on Combined Oral Contraceptives
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. Concomitant administration of 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 the estrogen and/or progestin have been noted when COCs are coadministered with some 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]).
Effects of Combined Oral Contraceptives on Other Drugs
COCs containing EE may inhibit the metabolism of other drugs (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 the 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 serum concentration of thyroid-binding globulin increases with use of COCs.
The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.
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 nongenital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.
Discontinue Cryselle use if pregnancy is confirmed.
Do not administer 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 Cryselle tablets have been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal adolescents under the age of 16 and for users 16 years and older. Use of Cryselle before menarche is not indicated.
Cryselle has not been studied in postmenopausal women and is not indicated in this population.
See FDA-approved patient labeling (Patient Information and Instructions for Use). Counsel patients about the following information:
An increased risk of the following serious adverse reactions (see Warnings section for additional information) has been associated with the use of oral contraceptives:
Adverse reactions commonly reported by COC users are:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of Cryselle was evaluated in 1,343 healthy women of child-bearing potential who participated in 9 clinical trials and received at least one dose of Cryselle for contraception. Subjects were exposed for a total of 11,085 cycles, with 429 women completing one year of exposure. Subjects ranged in age from 15 to 40 years. Demographics were 69% Caucasian, 28% Black, and 3% other.
Common Adverse Reactions (≥ 2% of women):
A total of 8% of subjects discontinued the trials prematurely due to an adverse reaction, most commonly due to unscheduled bleeding, spotting, headache (including migraine), nausea, acne, changes in menstrual flow, weight increase, nervousness, high blood pressure, and depression.
Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 1).
Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. 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 8-10 years of COC use.
Figure 1: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives
RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.
The following additional adverse drug reactions have been reported from worldwide postmarketing experience with Cryselle. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Arterial Events: Arterial thromboembolism, Myocardial infarction, Cerebral hemorrhage
Eye Disorder: Optic neuritis, which may lead to partial or complete loss of vision, Intolerance to contact lenses, Change (steepening) in corneal curvature
Gastrointestinal Disorders: Colitis, Nausea, Pancreatitis
Hepatobiliary Disorders: Gallbladder disease, Cholestatic jaundice, Budd-Chiari syndrome
Immune System Disorders: Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms
Metabolism and Nutrition Disorders: Carbohydrate and lipid effects, Porphyria, exacerbation of Porphyria
Neoplasms, Benign, Malignant, and Unspecified: Carcinoma of the reproductive organs and breasts, Hepatic neoplasia (including hepatic adenomas or benign liver tumors)
Psychiatric Disorders: Mood changes
Reproductive System and Breast Disorders: Temporary infertility after discontinuation of treatment, Changes in libido, Vaginitis, including candidiasis; Breast secretion
Skin and Subcutaneous Tissue Disorders: Melasma/chloasma, which may persist; Erythema multiforme, Erythema nodosum, Hemorrhagic eruption, Hirsutism
Vascular Events: Venous thrombosis, Pulmonary embolism, Cerebral thrombosis, Mesenteric thrombosis, Retinal vascular thrombosis
There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, Cryselle (norgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Cryselle is one white tablet daily for 21 consecutive days, followed by one light-green colored inert tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that Cryselle tablets be taken by mouth at the same time each day.
How to Start Cryselle
Consider the possibility of ovulation and conception prior to initiation of medication.
Instruct the patient to begin taking Cryselle on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. The patient should take one white tablet daily for 21 consecutive days followed by one light-green colored inert tablet daily for 7 consecutive days. Withdrawal bleeding will usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle, the patient should not rely on Cryselle for contraception until a white tablet has been taken daily for 7 consecutive days and she should use a non-hormonal back-up method of birth control during those 7 days.
After the first cycle of use
The patient is to begin her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days of white tablets, followed by 7 days of light-green colored inert tablets. If in any cycle the patient starts tablets later than the proper day, instruct her to protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.
Switching from another hormonal method of contraception
Use after pregnancy, abortion, or miscarriage
If spotting or breakthrough bleeding occurs
If spotting or breakthrough bleeding occurs, instruct the patient to continue on the same regimen. This type of bleeding is usually transient and without significance; however, advise the patient to consult her healthcare provider if the bleeding is persistent or prolonged.
The possibility of ovulation and pregnancy increases with each successive day that scheduled white tablets are missed. If withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (if she missed one or more tablets or started taking them on a day later than she should have), consider the probability 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.
For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in FDA-Approved Patient Labeling below.
Advice in Case of Gastrointestinal Disturbances
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].
Cryselle® (norgestrel and ethinyl estradiol tablets USP), 0.3 mg/0.03 mg are available in packages of 6 blister card dispensers (NDC 0555-9049-58), each containing 28 tablets as follows: 21 active, white, round, film-coated, biconvex tablets debossed with dp on one side and 543 on the other side and 7 inert, round, light-green colored, uncoated tablets debossed dp and 331.
Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. G 7/2022
FDA-Approved Patient Labeling
Cryselle® (norgestrel and ethinyl estradiol tablets)
What is the most important information I should know about Cryselle?
Do not use Cryselle if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal 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 Cryselle?
Cryselle is a birth control pill (oral contraceptive) used by women to prevent pregnancy.
How does Cryselle 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 clinical studies, about 1 out of 100 women may get pregnant during the first year they use Cryselle.
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 Cryselle?
Do not take Cryselle if you:
You should not take the pill if you take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.
If any of these conditions happen while you are taking Cryselle, stop taking Cryselle right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Cryselle.
What should I tell my healthcare provider before taking Cryselle?
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.
Cryselle may affect the way other medicines work, and other medicines may affect how well Cryselle 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 should I take Cryselle?
Read the Instructions for Use at the end of this Patient Information.
What are the possible serious side effects of Cryselle?
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 Cryselle?
These are not all the possible side effects of Cryselle. 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 Cryselle?
How should I store Cryselle?
General information about the safe and effective use of Cryselle:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Cryselle for a condition for which it was not prescribed. Do not give Cryselle to other people, even if they have the same symptoms that you have. This Patient Information summarizes the most important information about Cryselle. You can ask your pharmacist or healthcare provider for information about Cryselle that is written for health professionals. For more information, call 1-888-838-2872.
Do birth control pills cause cancer?
It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.
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 Cryselle?
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 Cryselle, 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 Cryselle?
Each white pill contains norgestrel and ethinyl estradiol.
White pills: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and pregelatinized corn starch.
Light-green pills: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake.
INSTRUCTIONS FOR USE
Cryselle® (norgestrel and ethinyl estradiol tablets)
Important Information about taking Cryselle
BEFORE YOU START TAKING CRYSELLE
4. BE SURE YOU HAVE READY AT ALL TIMES:
WHEN TO START THE FIRST PACK OF PILLS
You have a choice of which day to start taking your first pack of pills. (See DAY 1 START or SUNDAY START directions below.) Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember.
DAY 1 START:
Note: If the first day of your period is a Sunday, you can skip steps #1 and #2.
3. Take the first "active" [white] pill of the first pack during the first 24 hours of your period.
4. You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period.
WHAT TO DO DURING THE MONTH
IF YOU SWITCH FROM ANOTHER BRAND OF COMBINATION PILLS:
If your previous brand had 21 pills: Wait 7 days to start taking Cryselle. You will probably have your period during that week. Ideally, be sure that no more than 7 days pass between the 21-day pack and taking the first white Cryselle pill (“active” with hormone). If you start Cryselle more than 7 days after taking the last pill of your previous contraceptive, you must use a non-hormonal back-up method of birth control during the first 7 days of Cryselle use.
If your previous brand had 28 pills: Start taking the first white Cryselle pill (“active” with hormone) on the day after your last reminder pill. Ideally, do not wait any days between packs. If you do skip any days between the last pill of your previous contraceptive and starting Cryselle, you must use a non-hormonal back-up method of birth control during the first 7 days of Cryselle use.
IF YOU SWITCH FROM ANOTHER TYPE OF BIRTH CONTROL METHOD:
If you were previously taking a progestin-only PILL: You may switch to Cryselle on any day from a progestin-only pill and should start taking the first white Cryselle pill (“active” with hormone) the day after you take your last progestin-only pill. In addition, use a non-hormonal back-up method of birth control for the first 7 days of tablet-taking.
If you are switching from a contraceptive vaginal ring or transdermal patch: Start taking the first white Cryselle pill (“active” with hormone) on the day that you would have inserted a new ring or applied a new patch.
If you are switching from a contraceptive implant: Start taking the first white Cryselle pill (“active” with hormone) on the day that the implant is removed.
If you are switching from a contraceptive injection: Start taking the first white Cryselle pill (“active” with hormone) on the day that the next contraceptive injection is due.
If you are switching from an Intrauterine device (IUD) or Intrauterine system (IUS): Start taking the first white Cryselle pill (“active” with hormone) on the day the IUD/IUS is removed. If your IUD/IUS is removed on the first day of your period you do not need to use an additional non-hormonal back up method of birth control. If the IUD/IUS is removed on any other day, use a non-hormonal back-up method of birth control for the first 7 days of tablet-taking.
WHAT TO DO IF YOU MISS PILLS
Cryselle may not be as effective if you miss white “active” pills, and particularly if you miss the first few or the last few white “active” pills in a pack.
If you MISS 1 white “active” pill:
If you MISS 2 white “active” pills in a row in WEEK 1 OR WEEK 2 of your pack:
If you MISS 2 white “active” pills in a row in THE 3rd WEEK:
If you MISS 3 OR MORE white “active” pills in a row (during the first 3 weeks):
If you forget any of the 7 light-green “reminder” pills in Week 4:
Throw away the pills you missed. Keep taking 1 pill each day until the pack is empty. You do not need a back-up non-hormonal birth control method if you start your next pack on time.
FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED
Use a back-up non-hormonal birth control method anytime you have sex.
Keep taking one pill each day until you can reach your healthcare provider.
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. F 7/2022
6 Blister Card Dispensers, 28 Tablets Each
(norgestrel and ethinyl estradiol tablets USP)
0.3 mg/0.03 mg
21 white tablets, each containing 0.3 mg norgestrel, USP with 0.03 mg
ethinyl estradiol, USP, and 7 light-green inert tablets.
norgestrel and ethinyl estradiol kit
|Labeler - Teva Pharmaceuticals USA, Inc. (001627975)|