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Generic Name
Norethindrone Acetate
Brand Names
24FE, Abigale, Activella, Affodel, Alyacen, Aranelle, Aurovela, Aurovela 24, Balziva, Blisovi, Blisovi 24, Briellyn, Camila, Cyonanz, Dasetta, Deblitane, Emzahh, ERRIN, Etyqa, Feirza, Femlyv, Finzala, Fyavolv, Galbriela, Gallifrey, Hailey, Hailey 24, Incassia, Jencycla, Jinteli, Junel, Junel 21, Kaitlib, Loestrin, Loestrin 21, Lopreeza, Luizza, Lyleq, Meleya, Melodetta 24, Mibelas 24, Microgestin, Microgestin 24, Mimvey, Myfembree, Necon, Nexesta, Norethindrone, Nortrel, Nortrel 21, Nortrel 28, Nylia, Orquidea, OSHIH, Philith, Rhuzdah, Sharobel, Tarina, Tarina 24, Taytulla, Tri-Legest, Vyfemla, Wera, Wymzya, XARAH, Xelria, Zenchent
FDA approval date: May 25, 2001
Classification: Progestin
Form: Tablet, Kit
What is 24FE (Norethindrone Acetate)?
Charlotte 24 Fe is indicated for use by females of reproductive age to prevent pregnancy. The efficacy of Charlotte 24 Fe in women with a body mass index of more than 35 kg/m 2 has not been evaluated. Charlotte 24 Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy , The efficacy in females of reproductive potential with a body mass index of more than 35 kg/m 2 has not been evaluated ( 1.
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Brand Information
Charlotte 24Fe (norethindrone acetate and ethinyl estradiol and ferrous fumarate)
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 should not be used by women who are over 35 years of age and smoke
1INDICATIONS AND USAGE
Charlotte 24 Fe is indicated for use by females of reproductive age to prevent pregnancy
The efficacy of Charlotte 24 Fe in women with a body mass index (BMI) of more than 35 kg/m
2DOSAGE FORMS AND STRENGTHS
Charlotte 24 Fe is available in blister packs.
Each blister pack contains 28 tablets in the following order:
- 24 white to off-white, round, flat faced beveled edge, (active) chewable uncoated tablets debossed with “21” on one side and “Y” on the other side and each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP.
- 4 brown to dark brown, round, flat faced beveled edge, (non-hormonal placebo) uncoated tablets debossed with “18” on one side and “G” on the other side and each containing 75 mg ferrous fumarate, USP. The ferrous fumarate tablets, USP do not serve any therapeutic purpose.
3CONTRAINDICATIONS
Charlotte 24 Fe 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 women who are known to:
- Liver tumors, benign or malignant, or liver disease
- Undiagnosed abnormal uterine bleeding
- Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive
- Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
4ADVERSE REACTIONS
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
- Serious cardiovascular events and stroke
- Vascular events
- Liver disease
Adverse reactions commonly reported by COC users are:
- Irregular uterine bleeding
- Nausea
- Breast tenderness
- Headache
4.1Clinical Trial 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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data presented in Section 6.1 are from a clinical trial conducted with a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 20 mcg tablets. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are bioequivalent to these norethindrone acetate/ethinyl estradiol tablets.
Common Adverse Reactions (Greater Than or Equal to 2% of all Treated Subjects): The most common adverse reactions reported by at least 2% of the 743 women using norethindrone acetate/ethinyl estradiol tablets were the following, in order of decreasing incidence: headache (6.3%), vaginal candidiasis (6.1%), nausea (4.6%), menstrual cramps (4.4%), breast tenderness (3.4%), bacterial vaginitis (3.1%), abnormal cervical smear (3.1%), acne (2.7%), mood swings (2.2%), and weight gain (2%).
Adverse Reactions Leading to Study Discontinuation: Among the 743 women using norethindrone acetate/ethinyl estradiol tablets, 46 women (6.2%) withdrew because of an adverse event. Adverse events occurring in 3 or more subjects leading to discontinuation of treatment were, in decreasing order: abnormal or irregular bleeding (1.3%), nausea (0.8%), menstrual cramps (0.5%), and increased blood pressure (0.4%).
4.2Postmarketing Experience
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 to 10 years of COC use.
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 adverse reactions have been identified during post approval use of a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 20 mcg tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or evaluate a causal relationship to drug exposure.
Adverse reactions are grouped into System Organ Classes.
Vascular disorders: thrombosis/embolism (coronary artery, pulmonary, cerebral, deep vein).
Hepatobiliary disorders: cholelithiasis, cholecystitis, hepatic adenoma, hemangioma of liver.
Immune system disorders: hypersensitivity reaction.
Skin and subcutaneous disorders: alopecia, rash (generalized and allergic), pruritus, skin discoloration.
GI disorders: nausea, vomiting, abdominal pain.
Musculoskeletal and connective tissue disorders: myalgia.
Eye disorders: blurred vision, visual impairment, corneal thinning, change in corneal curvature (steepening).
Infections and infestations: fungal infection, vaginal infection.
Investigations: change in weight or appetite (increase or decrease), fatigue, malaise, peripheral edema, blood pressure increased.
Nervous system disorders: headache, dizziness, migraine, loss of consciousness.
Psychiatric disorders: mood swings, depression, insomnia, anxiety, suicidal ideation, panic attack, changes in libido.
Renal and urinary disorders: cystitis-like syndrome.
Reproductive system and breast disorders: breast changes (tenderness, pain, enlargement, and secretion), premenstrual syndrome, dysmenorrhea.
Cardiovascular: chest pain, palpitations, tachycardia, myocardial infarction.
5DRUG INTERACTIONS
Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations.
No drug-drug interaction studies were conducted with norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets.
5.1Effects of Other Drugs on Combined Oral Contraceptives
Substances diminishing the efficacy of COCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease 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 and products containing St. John’s wort. Interactions between oral 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.
Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin and certain COCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole 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 progestin have been noted in some cases of co-administration of HIV/HCV protease inhibitors or of non-nucleoside reverse transcriptase inhibitors.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.
5.2Effects of Combined Oral Contraceptives on Other Drugs
COCs containing ethinyl estradiol may inhibit the metabolism of other compounds. COCs have been shown to significantly decrease plasma concentrations of lamotrigine, 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.
5.3Concomitant Use with HCV Combination Therapy–Liver Enzyme Elevation
Do not co-administer norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations
5.4Interference with Laboratory Tests
The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.
6OVERDOSAGE
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.
7DESCRIPTION
Charlotte 24 Fe provides an oral contraceptive regimen consisting of 24 white to off-white active chewable tablets that contain the active ingredients, followed by 4 brown to dark brown non-hormonal placebo tablets as specified below:
- 24 white to off-white, round, flat faced beveled edge, (active) chewable uncoated tablets debossed with “21” on one side and “Y” on the other side and each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP.
- 4 brown to dark brown, round, flat faced beveled edge, (non-hormonal placebo) uncoated tablets debossed with “18” on one side and “G” on the other side and each containing 75 mg ferrous fumarate, USP.
Each white to off-white active chewable tablet also contains the following inactive ingredients: acacia, corn starch, lactose monohydrate, magnesium stearate, spearmint flavor, sucralose, sucrose and talc.
Each brown to dark brown placebo tablet contains acacia, corn starch, ferrous fumarate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sucralose and talc. The ferrous fumarate tablets, USP do not serve any therapeutic purpose.
The empirical formula of ethinyl estradiol, USP is C
The chemical name of ethinyl estradiol, USP is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The molecular weight of ethinyl estradiol, USP is 296.40.
The empirical formula of norethindrone acetate, USP is C
The chemical name of norethindrone acetate, USP is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The molecular weight of norethindrone acetate, USP is 340.46.
8CLINICAL STUDIES
The data presented in Section 14 are from a clinical trial conducted with a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 20 mcg tablets. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are bioequivalent to these norethindrone acetate/ethinyl estradiol tablets.
In a clinical study, 743 women 18 to 45 years of age were studied to assess the efficacy of norethindrone acetate/ethinyl estradiol tablets, for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. The racial demographic of all enrolled women was: 70% Caucasian, 16% African-American, 10% Hispanic, 2% Asian and 2% Other. Women with body mass index (BMI) greater than 35 kg/m
A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment cycles during which no backup contraception was used. The Pearl Index for norethindrone acetate and ethinyl estradiol tablets was 1.82 (95% confidence interval 0.59 to 4.25).
9PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information)
Counsel patients on the following information:
- Cigarette smoking increases the risk of serious cardiovascular events from COC use, and women who are over 35 years old and smoke should not use COCs.
- Charlotte 24 Fe does not protect against HIV infection (AIDS) and other sexually transmitted infections.
- The Warnings and Precautions associated with COCs.
- Charlotte 24 Fe is not to be used during pregnancy; if pregnancy occurs during use of Charlotte 24 Fe, instruct the patient to stop further intake.
- Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event tablets are missed. See “
- Use a back-up or alternative method of contraception when enzyme inducers are used with Charlotte 24 Fe.
- COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established.
- Women who start COCs postpartum, and who have not yet had a period, should use an additional method of contraception until they have taken a white to off-white tablet for 7 consecutive days.
- Amenorrhea may occur. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles.
Distributed by:
Glenmark Pharmaceuticals Inc., USA
Elmwood Park, NJ 07407
Questions? 1 (888) 721-7115
May 2025
10FDA-Approved Patient Labeling
Guide for Using Charlotte 24 Fe (SHÄR-lǝt 24 Fe)
(Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, USP)
Birth control pills help to lower the chances of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.
What is Charlotte 24 Fe?
Charlotte 24 Fe is a birth control pill. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called norethindrone acetate.
How well does Charlotte 24 Fe work?
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 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 20 mcg tablets lasting six months, about 1 to 4 out of 100 women may get pregnant during the first year they use Charlotte 24 Fe.
Women with a BMI above 35 kg/m
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.
How do I take Charlotte 24 Fe?
1.
2. The tablets may be chewed and swallowed or swallowed whole. You should drink a full glass (8 ounces) of water immediately after chewing or swallowing.
3. The right way to take the tablet is to take one tablet every day at the same time in the order directed on the package. Charlotte 24 Fe can be taken without regard to meals.
If you miss tablets you could get pregnant. This includes starting the pack late. The more tablets you miss, the more likely you are to get pregnant. See “What to Do if You Miss Tablets” below.
4. Many women have spotting or light bleeding at unexpected times, or may feel sick to their stomach during the first 1 to 3 packs of tablets.
If you do have spotting or light bleeding or feel sick to your stomach, do not stop taking the tablets. The problem will usually go away. If it does not go away, check with your healthcare provider.
5. Missing tablets can also cause spotting or light bleeding, even when you make up these missed tablets.
On the days you take two tablets, to make up for missed tablets, you could also feel a little sick to your stomach.
6. If you have vomiting (within 3 to 4 hours after you take your tablet), you should follow the instructions for “
Use a back-up method (such as condoms and spermicides) until you check with your healthcare provider.
7. If you have trouble remembering to take Charlotte 24 Fe, talk to your healthcare provider about how to make tablet-taking easier or about using another method of birth control.
8. If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.
Before You Start Taking Your Charlotte 24 Fe Tablets
1. Decide What Time of Day You Want to Take Your Tablet. It is important to take Charlotte 24 Fe tablets in the order directed on the package at the same time every day. Charlotte 24 Fe can be taken without regard to meals.
2. Look at Your Tablet Pack – It has 28 Tablets
The Charlotte 24 Fe pack has
3. Also look for:
4. Be sure you have ready at all times
When to Start the First Pack of Tablets
You have a choice for which day to start taking your first pack of tablets. Decide with your healthcare provider which is the best day for you. Pick a time of day which will be easy to remember.
Day 1 Start:
1. Pick the day label strip that starts with the first day of your period (this is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins).
2. Place this day label strip on the tablet dispenser over the area that has the days of the week (starting with Sunday) printed on the plastic.
3. Take the first white to off-white tablet of the 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 tablet at the beginning of your period. However, if you start Charlotte 24 Fe later than the first day of your period, you should use another method of birth control (such as a condom and spermicide) as a back-up method until you have taken 7 white to off-white tablets.
Sunday Start:
1. Take the first white to off-white tablet of the pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day.
2. Use another method of birth control (such as a condom and spermicide) as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). This also applies if you start Charlotte 24 Fe after having been pregnant, and you have not had a period since your pregnancy.
When You Switch From a Different Birth Control Tablet or Capsule
When switching from another birth control pill, finish all the tablets or capsules, then Charlotte 24 Fe should be started on the same day that a new pack of the previous birth control tablet or capsule would have been started.
When You Switch From Another Type of Birth Control Method
When switching from a transdermal patch or vaginal ring, finish the 21 days of use, wait 7 days, then Charlotte 24 Fe should be started when the next application would have been due. When switching from an injection, Charlotte 24 Fe should be started when the next injection would have been due. When switching from an intrauterine device or an implant, Charlotte 24 Fe should be started on the day of removal.
What to Do During the Month
1. Take one tablet at the same time every day until the pack is empty.
Do not skip tablets even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).
2. Do not skip tablets even if you do not have sex very often.
When you finish a pack of tablets, start the next pack on the day after your last brown to dark brown tablet. Do not wait any days between packs.
What to Do if You Miss Tablets
Charlotte 24 Fe may not be as effective if you miss any white to off-white tablets, especially if you miss the first few or the last few white to off-white tablets in a pack.
If you miss 1 white to off-white tablet:
1. Take the tablet as soon as you remember. Take the next tablet at your regular time. This means you may take two tablets in one day.
2. You do not need to use a back-up birth control method if you have sex.
If you miss 2 white to off-white tablets in a row in week 1 OR week 2 of your pack:
1. Take two tablets on the day you remember and two tablets the next day.
2. Then take one tablet a day until you finish the pack.
3.
If you miss 2 white to off-white tablets in a row in week 3 or week 4 of your pack:
1.
Throw out the rest of the tablet pack and start a new pack that same day.
If you are a Sunday Starter:
Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day.
Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day.
2.
3. You may not have your period this month but this is expected.
If you miss 3 or more white to off-white tablets in a row during any week:
1. If you are a Day 1 Starter:
Throw out the rest of the tablet pack and start a new pack that same day.
If you are a Sunday Starter:
Keep taking 1 tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day.
2.
3. You may not have your period this month but this is expected.
If you miss any of the 4 brown to dark brown tablets in Week 4:
1. Throw away the tablets you missed.
2. Keep taking one tablet each day until the pack is empty.
3. You do not need a back-up method.
4. Start the next pack of Charlotte 24 Fe as scheduled.
Finally, if you are still not sure what to do about the tablets you have missed:
1. Use a back-up method (such as a condom and spermicide) anytime you have sex.
2. Contact your healthcare provider and continue taking one active white to off-white tablet each day until otherwise directed.
Who should not take Charlotte 24 Fe?
Your healthcare provider will not give you Charlotte 24 Fe if you have:
- Ever had blood clots in your arms, legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
- Ever had a stroke
- Ever had a heart attack
- Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
- An inherited problem with your blood that makes it clot more than normal
- High blood pressure that medicine cannot control
- Diabetes with kidney, eye, nerve, or blood vessel damage
- Ever had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or have any migraine headache if you are over age 35.
- Ever had breast cancer, which may be sensitive to female hormones
- Liver disease, including liver tumors
- 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
Also, do not take birth control pills if you:
- Smoke and are over 35 years old
- Are or suspect you are pregnant
- Have any unexplained bleeding from the vagina
Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy, also called cholestasis of pregnancy.
Tell your healthcare provider if you have ever had any of the above conditions (your healthcare provider may recommend another method of birth control).
What else should I know about taking Charlotte 24 Fe?
Birth control pills do
Do not skip any tablets, even if you do not have sex often.
If you miss a period, you could be pregnant. However, some women miss periods or have light periods on birth control pills, even when they are not pregnant. Contact your healthcare provider for advice if you:
- Think you are pregnant
- Miss one period and have not taken your birth control pills every day
- Miss two periods in a row
Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.
You should stop Charlotte 24 Fe at least four weeks before you have surgery and not restart it until at least two weeks after the surgery, due to an increased risk of blood clots.
If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Charlotte 24 Fe, may decrease the amount of milk you make. A small amount of the pill's hormones passes into breast milk.
Tell your healthcare provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including:
- barbiturates
- bosentan
- carbamazepine
- felbamate
- griseofulvin
- oxcarbazepine
- phenytoin
- rifampin
- St. John’s wort
- topiramate
Use a back-up or alternative birth control method when you take medicines that may make birth control pills less effective.
Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.
If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like a condom and spermicide, until you check with your healthcare provider.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone.
If you are scheduled for any laboratory tests, tell your healthcare provider that you are taking birth control pills. Certain blood tests may be affected by birth control pills.
What are the most serious risks of taking Charlotte 24 Fe?
Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more.
It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke.
Some examples of serious blood clots are blood clots in the:
- Legs (deep vein thrombosis)
- Lungs (pulmonary embolus)
- Eyes (loss of eyesight)
- Heart (heart attack)
- Brain (stroke)
Women who take birth control pills may get:
- High blood pressure
- Gallbladder problems
- Rare cancerous or noncancerous liver tumors
All of these events are uncommon in healthy women.
Call your healthcare provider right away if you have:
- Persistent leg pain
- Sudden shortness of breath
- Sudden blindness, partial or complete
- Severe pain or pressure in your chest
- Sudden, severe headache unlike your usual headaches
- Weakness or numbness in an arm or leg, or trouble speaking
- Yellowing of the skin or eyeballs
What are the common side effects of birth control pills?
The most common side effects of birth control pills are:
- Spotting or bleeding between menstrual periods
- Nausea
- Breast tenderness
- Headache
These side effects are usually mild and usually disappear with time.
Less common side effects are:
- Acne
- Less sexual desire
- Bloating or fluid retention
- Blotchy darkening of the skin, especially on the face
- High blood sugar, especially in women who already have diabetes
- High fat (cholesterol, triglyceride) levels in the blood
- Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself
- Problems tolerating contact lenses
- Weight gain
This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.
No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.
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 hormonal birth control 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 should I know about my period when taking Charlotte 24 Fe?
Irregular vaginal bleeding or spotting may occur while you are taking Charlotte 24 Fe. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding, which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your tablets on schedule. If the bleeding occurs in more than one cycle, is unusually heavy, or lasts for more than a few days, call your healthcare provider.
Some women may not have a menstrual period but this should not be cause for alarm as long as you have taken the tablets according to direction.
What if I miss my scheduled period when taking Charlotte 24 Fe?
It is not uncommon to miss your period. However, if you go two or more months in a row without a period, or you miss your period after a month where you did not take all your tablets correctly, call your healthcare provider because you may be pregnant. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. Stop taking Charlotte 24 Fe if you are pregnant.
What if I want to become pregnant?
You may stop taking the tablets whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the tablets.
General Advice about Charlotte 24 Fe
Your healthcare provider prescribed Charlotte 24 Fe for you. Please do not share Charlotte 24 Fe with anyone else. Keep Charlotte 24 Fe out of the reach of children.
If you have concerns or questions, ask your healthcare provider. You may also ask your pharmacist for a more detailed label written for healthcare professionals.
Distributed by:
Glenmark Pharmaceuticals Inc., USA
Elmwood Park, NJ 07407
Questions? 1 (888) 721-7115
May 2025
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