Lo Minastrin Fe

Ethinyl estradiol and norethindrone is a combination drug that contains female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone is used as contraception to prevent pregnancy.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

Do not use birth control pills if you are pregnant or if you have recently had a baby.

You should not take birth control pills if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart attack, a stroke, or a blood clot.

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions, or if you are overweight.

Smoking can increase your risk of blood clot, stroke, or heart attack while taking birth control pills. You should not take ethinyl estradiol and norethindrone if you smoke and are older than 35 years of age.

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take combination birth control pills if you smoke and are over 35 years old.

Do not use if you are pregnant or think you might be pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take birth control pills if you have:

• untreated or uncontrolled high blood pressure;
• heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);
• a blood-clotting disorder or circulation problems;
• problems with your eyes, kidneys or circulation caused by diabetes;
• a history of hormone-related cancer such as breast or uterine cancer;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
• a history of jaundice caused by pregnancy or birth control pills; or
• if you smoke and are over 35 years old.

To make sure birth control pills are safe for you, tell your doctor if you have:

• high blood pressure, varicose veins;
• high cholesterol or triglycerides, or if you are overweight;
• a history of depression;
• underactive thyroid;
• gallbladder disease;
• diabetes;
• seizures or epilepsy;
• a history of irregular menstrual cycles;
• tuberculosis; or
• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast feeding a baby.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--chest pain, sudden cough, wheezing, coughing up blood, swelling or warmth in one or both legs;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• vision changes;
• a change in the pattern or severity of migraine headaches;
• swelling in your hands, ankles, or feet;
• a breast lump; or
• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

• nausea, vomiting;
• breast tenderness or swelling;
• freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
• changes in weight or appetite;
• problems with contact lenses;
• vaginal itching or discharge; or
• changes in your menstrual periods, decreased sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Norethindrone, ethinyl estradiol, and ferrous fumarate combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and norethindrone, and when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

This medicine also contains ferrous fumarate. Ferrous fumarate is an iron supplement.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not protect against HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of norethindrone, ethinyl estradiol, and ferrous fumarate combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medicine in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of norethindrone, ethinyl estradiol, and ferrous fumarate combination have not been performed in the geriatric population. This medicine should not be used in elderly women.

Pregnancy

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anagrelide
• Aprepitant
• Boceprevir
• Bosentan
• Bupropion
• Carbamazepine
• Ceritinib
• Dabrafenib
• Darunavir
• Dexamethasone
• Dimercaprol
• Donepezil
• Eliglustat
• Eltrombopag
• Enzalutamide
• Fosphenytoin
• Griseofulvin
• Idelalisib
• Isotretinoin
• Lesinurad
• Lixisenatide
• Lumacaftor
• Mitotane
• Modafinil
• Oxcarbazepine
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenytoin
• Piperaquine
• Pitolisant
• Prednisone
• Rifabutin
• Rifampin
• St John's Wort
• Sugammadex
• Theophylline
• Tizanidine
• Topiramate
• Ulipristal
• Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam
• Amprenavir
• Atazanavir
• Bacampicillin
• Betamethasone
• Bexarotene
• Carbidopa
• Cefdinir
• Clarithromycin
• Colesevelam
• Cyclosporine
• Delafloxacin
• Delavirdine
• Demeclocycline
• Dolutegravir
• Doxycycline
• Efavirenz
• Eslicarbazepine Acetate
• Etoricoxib
• Fosamprenavir
• Fosaprepitant
• Gatifloxacin
• Ginseng
• Grepafloxacin
• Lamotrigine
• Levodopa
• Levofloxacin
• Levothyroxine
• Licorice
• Lomefloxacin
• Methyldopa
• Minocycline
• Moxifloxacin
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nelfinavir
• Norfloxacin
• Ofloxacin
• Omeprazole
• Parecoxib
• Penicillamine
• Prednisolone
• Rifapentine
• Ritonavir
• Roflumilast
• Rosuvastatin
• Rufinamide
• Selegiline
• Telaprevir
• Temafloxacin
• Tetracycline
• Tipranavir
• Troglitazone
• Troleandomycin
• Trovafloxacin Mesylate
• Valdecoxib
• Voriconazole
• Warfarin
• Zinc

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine
• Dairy Food
• Grapefruit Juice
• Phytic Acid Containing Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, active or history of or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems) or
• Heart rhythm problems (atrial fibrillation) or
• Hypertension (high blood pressure), poorly controlled or
• Liver disease, including tumors or cancer or
• Migraine headache, new or worse or a new kind of headache or
• Problems with circulation or blood clots, now or in the past or
• Stroke, history of—Should not be used in patients with these conditions.

• Angioedema (swelling of the face, tongue, or throat), inherited or
• Cervical cancer or intraepithelial neoplasia or
• Chloasma gravidarum (skin disorder during pregnancy), history of or
• Cholestasis (bile problem) during pregnancy, history of or
• Depression, history of or
• Diabetes or
• Dyslipidemia (high cholesterol or fats in the blood), uncontrolled or
• Gallbladder disease or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

Lo Minastrin Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. 

The efficacy of Lo Minastrin Fe in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.

2.1       How to Take Lo Minastrin Fe

To achieve maximum contraceptive effectiveness, Lo Minastrin Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The blue tablet should be chewed and swallowed. The patient should drink a full glass (8 ounces) of water immediately after chewing and swallowing the blue tablet. The white tablet and the brown tablet are swallowed. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets [see FDA-approved patient labeling]. Lo Minastrin Fe may be administered without regard to meals [see Clinical Pharmacology (12.3)].

2.2       How to Start Lo Minastrin Fe

Instruct the patient to begin taking Lo Minastrin Fe on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding) [see FDA-approved patient labeling]. One blue tablet should be taken daily for 24 consecutive days, followed by one white tablet daily for 2 consecutive days, followed by one brown tablet daily for 2 consecutive days. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Lo Minastrin Fe other than on the first day of her menstrual cycle.

For postpartum women who do not breastfeed or after a second trimester abortion, Lo Minastrin Fe may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 7 days. When COCs are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered [see Warnings and Precautions (5.1)]. The possibility of ovulation and conception before starting COCs should also be considered.

Lo Minastrin Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Lo Minastrin Fe immediately, additional contraceptive measures are not needed. 

2.3       Switching from another Hormonal Method of Contraception

If the patient is switching from a combination hormonal method such as:
      ° Another pill
      ° Vaginal ring
      ° Patch

• Instruct her to take the first blue tablet on the day she would have taken her next COC pill. She should not continue taking the tablets from her previous birth control pack, and should not skip any days between packs. If she does not have a withdrawal bleed, rule out pregnancy before starting Lo Minastrin Fe.
  
• If she previously used a vaginal ring or transdermal patch, she should start using Lo Minastrin Fe on the day she would have resumed the previous product.

If the patient is switching from a progestin-only method such as a:
      ° Progestin-only pill
      ° Implant
      ° Intrauterine system
      ° Injection

• She may switch any day from a progestin-only pill; instruct her to take the first blue tablet on the day she would have taken her next progestin-only pill.
  
• If switching from an implant or injection, start the first blue tablet on the day her next injection would have been due or on the day of removal of her implant. 
  
• If switching from an IUD, depending on the timing of removal, back-up contraception may be needed.

2.4       Advice in Case of Gastrointestinal Disturbances

If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a blue or white tablet), she should follow the instructions in the “What to Do if You Miss Tablets” section [see FDA-approved patient labeling]. 

Do not prescribe Lo Minastrin Fe to women who are known to have the following conditions:

• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
  • Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]
  • Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]
  • Have cerebrovascular disease [see Warnings and Precautions (5.1)]
  • Have coronary artery disease [see Warnings and Precautions (5.1)]
  • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]
  • Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
  • Have uncontrolled hypertension [see Warnings and Precautions (5.4)]
  • Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6)]
  • Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions (5.7)]
  ○ Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)]
  
• Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)]
  
• Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]
  
• Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)]
  
• Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.11)]
  
• Hypersensitivity to any ingredients in Lo Minastrin Fe
  
• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3)]

8.1       Pregnancy

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.

The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion.

8.3       Nursing Mothers

When possible, advise the nursing mother to use other forms of contraception 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. 

8.4       Pediatric Use

Safety and efficacy of Lo Minastrin Fe have been established in women of reproductive age. Efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.

8.5       Geriatric Use

Lo Minastrin Fe has not been studied in postmenopausal women and is not indicated in this population.

8.6       Hepatic Impairment

The pharmacokinetics of Lo Minastrin Fe has not been studied in subjects 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)].

8.7       Renal Impairment

The pharmacokinetics of Lo Minastrin Fe has not been studied in subjects with renal impairment. 

8.8       Body Mass Index

The safety and efficacy of Lo Minastrin Fe in women with a BMI greater than 35 kg/m2 has not been evaluated [see Clinical Studies (14)]. 

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.

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.
  
• Lo Minastrin Fe does not protect against HIV infection (AIDS) and other sexually transmitted infections.
  
• The Warnings and Precautions associated with COCs.
  
• Lo Minastrin Fe is not to be used during pregnancy; if pregnancy occurs during use of Lo Minastrin 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 FDA-approved patient labeling; “What to Do if You Miss Tablets” section].
  
• Use a back-up or alternative method of contraception when enzyme inducers are used with Lo Minastrin 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 blue tablet for 7 consecutive days.
  
• Amenorrhea may occur. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles.

FDA-Approved Patient Labeling

Guide for Using Lo Minastrin Fe

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 Lo Minastrin Fe?

Lo Minastrin 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 Lo Minastrin 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 28-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 10 mcg tablets, ethinyl estradiol 10 mcg tablets and ferrous fumarate tablets, about 2 to 4 out of 100 women may get pregnant during the first year they use Lo Minastrin Fe.

Women with a body mass index (BMI) above 35 kg/m2 were not studied in the clinical trial, so it is not known how well Lo Minastrin Fe protects against pregnancy in such women. If you are overweight, discuss with your healthcare provider whether Lo Minastrin Fe is the best choice for you.

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 Lo Minastrin Fe?

• Take one tablet every day at the same time in the order directed on the package. 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. Lo Minastrin Fe can be taken without regard to meals.
  
• The blue tablet should be chewed and swallowed. You should drink a full glass (8 ounces) of water immediately after swallowing. The white tablet and the brown tablet are swallowed.  
  
• You may have spotting or light bleeding, or may feel sick to your stomach during the first few months of taking Lo Minastrin Fe. If you have spotting or light bleeding or feel sick to your stomach, do not stop taking the tablet. The problem will usually go away. If it doesn't go away, check with your healthcare provider.
  
• Missing tablets can also cause spotting or light bleeding, even when you take these missed tablets later. On the days you take 2 tablets to make up for missed tablets, you could also feel a little sick to your stomach.
  
• If you have trouble remembering to take Lo Minastrin Fe, talk to your healthcare provider about how to make tablet-taking easier or about using another method of birth control.
  
• If you have vomiting or diarrhea (within 3 to 4 hours after you take your tablet), you should follow the instructions for “What to Do if You Miss Tablets”. 
  
• If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.

1.       Decide what time of day you want to take your tablet. It is important to take it at the same time every day.

2.       Look at your tablet pack: The Lo Minastrin Fe tablet pack has 24 "active" blue tablets (with hormones) and 2 “active” white tablets (with hormones) for Weeks 1, 2, 3 and part of Week 4. The tablet pack also has 2 "reminder" brown tablets (without hormones) for the last part of Week 4.

3.       Find:

• Where on the pack to start taking tablets,
  
• In what order to take the tablets (follow the arrows), and
  
• The week numbers as shown in the picture above

4.       Have ready at all times:

• Another kind of birth control (such as a condom and spermicide) to use as a back-up in case you miss tablets
  
• An extra tablet pack

1.       Take 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 the 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 blue tablet 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, because you are starting the tablet at the beginning of your period. However, if you start Lo Minastrin Fe later than the first day of your period, or if you start after having a baby and you have not yet resumed your periods, you should use another method of birth control (such as a condom and spermicide) as a back-up method until you have taken 7 blue tablets.

When You Switch from a Different Method of Hormonal Contraception       

• When you switch from another birth control pill, start Lo Minastrin Fe on the first day you would have started your previous birth control pack.
  
• When you switch from a vaginal ring or skin patch, finish the 21 days of use, and wait 7 days after removal of the ring or patch before starting Lo Minastrin Fe.
  
• When you switch from a progestin-only pill, start Lo Minastrin Fe the next day.
  
• When you switch from an implant, start Lo Minastrin Fe on the day of implant removal. 
  
• If you switch from an injectable contraceptive, start Lo Minastrin Fe on the day on which the next injection would be due.
  
• If you switch from an IUD, start Lo Minastrin Fe on the day of IUD removal.

• 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).
  • Do not skip tablets even if you do not have sex very often.
  
• When you finish a pack of Lo Minastrin Fe, start the next pack on the day after your last brown “reminder" tablet. Do not skip any days between packs.

Birth control tablets may not be as effective if you miss any blue or white tablets, especially if you miss the first few or the last few blue tablets in a pack.

If you miss ONE blue tablet, follow these steps:

• Take it as soon as you remember. Take the next tablet at your regular time. This means you may take two tablets in 1 day.
  
• You do not need to use a back-up birth control method if you have sex. 

If you miss TWO blue tablets in a row in Week 1 or Week 2 of your pack, follow these steps:

• Take
  1.       Two tablets on the day you remember and two tablets the next day.
  2.       One tablet a day until you finish the pack.
  
• You could become pregnant if you have sex during the first 7 days after you restart your tablets. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back-up for those 7 days.
  

If you miss TWO tablets (blue or white) in a row in Week 3 or Week 4 of your pack, follow these steps:

• Throw out the rest of the tablet pack and start a new pack that same day.
  
• You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant.
  
• You could become pregnant if you have sex during the first 7 days after you restart your tablets. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back-up for those 7 days after you restart your tablets.

If you miss THREE OR MORE tablets (blue or white) in a row at any time, follow these steps:

• Throw out the rest of the tablet pack and start a new pack that same day.
  
• You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant.
  
• You could become pregnant if you have sex on the days when you missed tablets or during the first 7 days after restarting your tablets. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back-up the next time you have sex and for the first 7 days after you restart your tablets.

If you forget either of the 2 brown "reminder" tablets in Week 4, follow these steps:

• Throw away the tablets you missed.
  
• Keep taking one tablet each day until the pack is empty.
  
• You do not need to use a back-up method of birth control.
  
• Start the next pack of Lo Minastrin Fe as scheduled.

If you are still not sure what to do about the tablets you have missed:

• Use a back-up method of birth control anytime you have sex.
  
• Keep taking one tablet each day until you can reach your healthcare provider.

Who should not take Lo Minastrin Fe?

Your healthcare provider will not give Lo Minastrin 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 can't 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 or any cancer that is 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 Lo Minastrin Fe if you:

• Smoke and are over 35 years old
  
• Are or suspect you are pregnant
  
• Have any unexplained bleeding from the vagina
  
• Are allergic to anything in Lo Minastrin Fe

Birth control tablets 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 Lo Minastrin Fe?

Birth control tablets do not protect you against any sexually transmitted infection, including HIV, the virus that causes AIDS.

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 Lo Minastrin 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 Lo Minastrin Fe, may decrease the amount of milk you make. A small amount of the tablet's hormones pass 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 Lo Minastrin 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. 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 tablet overdose, even when accidentally taken by children.

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 should I know about my period when taking Lo Minastrin Fe?

When you take Lo Minastrin Fe you may have bleeding and spotting between periods, called unscheduled bleeding. Approximately half of the women who use Lo Minastrin Fe have unscheduled bleeding or spotting in the first months of use, and about one-third of users continue to have unscheduled bleeding or spotting after one year of use. 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 unscheduled bleeding or spotting is heavy or lasts for more than a few days, you should discuss this with your healthcare provider.   

What if I miss my scheduled period when taking Lo Minastrin 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 Lo Minastrin 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 tablet.

General Advice about Lo Minastrin Fe

Your healthcare provider prescribed Lo Minastrin Fe for you. Please do not share Lo Minastrin Fe with anyone else. Keep Lo Minastrin 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:
Allergan USA, Inc.
Irvine, CA 92612
1-800-678-1605

PI – 73288US11

MG – 73289US11

LO MINASTRIN™ is a trademark of Allergan Pharmaceuticals International Limited.

Allergan® and its design are trademarks of Allergan, Inc.

© 2017 Allergan. All rights reserved.

PRINCIPAL DISPLAY PANEL
NDC 0430-0537-50
Lo Minastrin Fe
1 mg/ 10 mcg and 10 mcg
Chewable
5 blister cards of 28 tablets each
Rx Only