Blisovi Fe is a prescription combination birth control pill. The 21 active pills contain a progestin (norethindrone acetate) and an estrogen (ethinyl estradiol). The last seven inactive tablets contain iron. Doses are taken once daily at the same time every day.
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Norethindrone acetate-ethinyl estradiol, ferrous fumarate
Prevents pregnancy.
Hormonal contraceptive, monophasic contraceptive combination, iron supplement
Tablet
By mouth
Blisovi Fe prevents pregnancy in women of reproductive age.
Tablet
1 mg norethindrone acetate/20 mcg ethinyl estradiol
1.5 mg/30 mcg
For pregnancy prevention: One tablet daily starting on the first day of the menstrual period or the first Sunday following the onset of menstruation
Blisovi Fe
1 package (28 tablets), 1-20mg-mcg disp pack
Blisovi Fe
1 package (28 tablets), 1.5-30mg-mcg disp pack
Blisovi Fe
28 tablets disp pack
Please read the Patient Information sheet before starting this medicine.
Follow the instructions in the Patient Information sheet.
Take Blisovi Fe pills at the same time every day.
Take all the pills in their numbered order.
Blisovi Fe 1/20 has 21 yellow tablets containing active ingredients and seven inert brown tablets with iron.
Blisovi Fe 1.5/30 has 21 pink tablets containing active ingredients and seven inert brown tablets with iron.
Take the first tablet (number 1) either on the day your period starts or the first Sunday after your period starts.
Tablets can be taken without regard to food.
Swallow the tablet whole with a drink of water. Do not crush, break, or chew it.
When the last brown pill is taken, start the next pack with the first yellow/pink pill.
The first pill in the blister pack should always be taken on the same day of the week each cycle.
Ask the prescriber for special instructions about taking Blisovi Fe if:
You’re switching from another birth control pill or contraceptive method
You have had an abortion or miscarriage
You have given birth
If you vomit or have diarrhea for any reason, use backup birth control and contact the prescriber.
Store Blisovi Fe away from light at room temperature.
Forgetting doses increases the risk of pregnancy.
In addition to taking missed doses, you may sometimes need to use backup birth control whenever you have sex for seven days.
If a yellow/pink pill is missed:
Take the missed dose as soon as possible.
Take the next tablet at its regular time.
If necessary, two doses can be taken on the same day to make up for a missed dose.
Pregnancy is not a risk if just one pill is missed. Backup birth control is not needed.
If you miss two yellow/pink pills in a row:
Take two tablets as soon as possible.
Take two tablets the next day.
Use backup birth control for the next seven days.
If you miss two yellow/pink pills in a row in the third week:
Start over with a new Blisovi Fe pack.
Day 1 starters should start the new pack immediately.
Sunday starters should continue taking pills from the old pack and start the new pack on Sunday.
Use backup birth control until you’ve taken seven yellow/pink pills.
If you miss three or more yellow pills in a row in any week:
You will have to start a new pack.
Day 1 starters will start the new pack immediately.
Sunday starters will continue taking pills from the old pack and start the new pack on Sunday.
Use backup birth control until you’ve taken seven yellow/pink pills.
If you miss any of the seven brown pills:
Throw away the unused brown pills
Take all the remaining pills as scheduled.
Start the next pack as scheduled.
You do not need backup birth control.
If you’re not sure about a missed pill, use backup birth control.
This medicine is not right for everyone.
Do not use it if you are pregnant, older than 35 and smoke, or have:
Current or past blood clot problems, including deep vein thrombosis, heart attack, or stroke
Coronary artery disease
Certain types of heart valve or heart rhythm problems
Uncontrolled high blood pressure
Blood vessel damage due to diabetes
Abnormal uterine bleeding that has not been checked by a doctor
Liver cancer
A history of jaundice while pregnant or on birth control pills
A history of hormone-sensitive breast cancer
Endometrial or other estrogen-receptive cancers
Certain types of headaches (focal headaches) or migraine headaches with aura
Tell any doctor or other healthcare provider who treats you that you are using hormonal birth control.
Birth control pills can affect several important lab tests.
Blisovi Fe doses may need to stop a few weeks before and after surgical procedures.
The use of hormonal birth control requires regular visits and tests. Keep all appointments.
Immediately tell the doctor if you become pregnant, think you’re pregnant, or if you miss two periods in a row.
If you miss one period, tell the doctor about it if you have missed doses during that month.
Before starting any birth control pill, make sure the prescriber knows if you smoke, are breastfeeding, or have:
Heart or blood vessel disease
High blood pressure
Diabetes
High cholesterol
Migraines
A history of depression
A congenital condition that causes facial and skin swelling (hereditary angioedema)
Yellowing of the eyes or skin during pregnancy or while taking birth control pills
Given birth in the last four weeks
Blisovi Fe can cause serious problems, including:
Increased risk of blood clots
Increased risk of breast or other hormone-sensitive cancers
Liver problems
Gallbladder problems
High blood pressure
High cholesterol and fats
Birth control pills can cause some light bleeding or spotting between periods.
This is usually normal in the first couple of months.
Call the prescriber if the bleeding is heavy or lasts longer than seven days.
Birth control pills can cause periods with light bleeding or no bleeding. This is not normally a cause for concern, but talk to a doctor if it:
Is accompanied by pregnancy symptoms (like morning sickness)
Happens in a month where doses were missed
Happens two months in a row
This medicine may cause patches of dark skin.
Use sunscreen or protective clothing when exposed to the sun
Avoid tanning booths or sunlamps
Birth control pills do not protect against HIV/AIDS infection or other sexually transmitted diseases.
Birth control pills may decrease lactation in women who are breastfeeding.
Some women may experience temporary infertility after quitting an oral contraceptive.
Blisovi Fe can never be taken with any hepatitis C drug that contains ombitasvir/paritaprevir/ritonavir.
Before starting Blisovi Fe, tell the prescribing healthcare provider about all prescription drugs, over-the-counter medicines, and supplements being taken, particularly:
Drugs that treat bacterial infections
Barbiturates
Thyroid hormones
Acetaminophen, aprepitant, ascorbic acid, atorvastatin, bosentan, clofibric acid, cyclosporine, morphine, phenylbutazone, prednisolone, rosuvastatin, salicylic acid, temazepam, theophylline, troglitazone
Avoid grapefruit or grapefruit juice when taking Blisovi Fe.
Tell other healthcare providers about hormonal birth control use before they prescribe new medications.
Serious side effects
Talk to a healthcare provider if you notice any signs or symptoms of a possible serious side effect, including:
Persistent leg pain, pain in your lower leg (calf)
Numbness or weakness on one side of your body, sudden or severe headache, sudden vomiting, problems with walking, speech, or eyesight
Sharp chest pain, chest tightness, sudden problems breathing, coughing up blood
Sudden vision changes, sudden loss of vision, double vision, bulging eyes
Blurred vision, intolerance to contact lenses
Heavy vaginal bleeding
Breast lumps
Yellow skin or eyes
Depressed mood, difficulty sleeping, lack of energy
Allergic reaction: Itching, skin rash, hives, swelling of the face, mouth, tongue, or neck, trouble breathing
Blisovi Fe may cause significant side effects without symptoms:
High blood pressure
High cholesterol or fats
Decreased glucose tolerance
Less serious side effects
Nausea
Vomiting
Bloating, abdominal cramps
Breakthrough bleeding, spotting
Light periods
Nervousness
Weight changes
Breast tenderness
Blisovi 24 Fe prescribing information, DailyMed (NIH National Library of Medicine)
Blisovi Fe 1/20 prescribing information, DailyMed (NIH National Library of Medicine)
Blisovi Fe 1.5/30 prescribing information, DailyMed (NIH National Library of Medicine)
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