Aurovela Fe 1/20 is a prescription combination birth control pill containing a progestin (norethindrone acetate) and an estrogen (ethinyl estradiol). The seven inactive tablets taken at the end of the cycle contain a daily iron supplement. Tablets are arranged in a blister pack and taken once per day in order: 21 active tablets for the first 21 days and seven inactive tablets for the last week of the cycle.
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Aurovela Fe 1/20
Norethindrone acetate-ethinyl estradiol, ferrous fumarate
Prevents pregnancy.
Hormonal contraceptive, monophasic contraceptive combination, iron supplement
Tablet
By mouth
Aurovela Fe 1/20 prevents pregnancy in women of reproductive age.
Tablet
1 mg norethindrone acetate / 0.020 mg ethinyl estradiol (active tablets)
75 mg ferrous sulfate (inactive tablets)
For pregnancy prevention: One tablet daily starting on the first day of the menstrual period or the first Sunday following the onset of menstruation
Aurovela 1/20
1 package (21 tablets), 1-20mg-mcg disp pack
Please read the Patient Information sheet that comes with this medicine.
Follow the instructions in the Patient Information sheet.
Take Aurovela Fe 1/20 pills at the same time each day.
Take all the pills in their numbered order.
There are 21 yellow 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 pill.
The first pill should be taken on the same day of the week each cycle.
Ask the prescriber for special instructions about taking Aurovela Fe 1/20 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 three to four hours after taking a tablet, consider that to be a missed dose. See the section on missed doses below.
Store Aurovela Fe 1/20 at room temperature in the original carton. Protect from light.
Forgetting to take a tablet increases the possibility of getting pregnant. Depending on the situation, you may need to use another form of birth control after a dose is missed.
If a yellow pill is missed:
Take it as soon as possible.
Take the next dose at its regular time.
You may take two pills on the same day to make up for a single missed dose.
You don’t have to use backup birth control.
If you miss two yellow 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 pills in a row in the third or fourth weeks:
Start over with a new Aurovela Fe 1/20 pack.
If you are a Day 1 starter, start the new pack immediately.
If you are a Sunday starter, continue taking pills from the old pack and start the new pack on Sunday.
Use backup birth control for seven days after starting a new pack.
If you miss three or more yellow pills in a row in any week:
You will have to start a new pack.
If you are a Day 1 starter, start the new pack immediately.
If you are a Sunday starter, continue taking pills from the old pack and start the new pack on Sunday.
Use backup birth control for seven days after starting a new pack.
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
Because of the risk of serious blood clots, Aurovela Fe 1/20 is contraindicated in anyone with:
A history of blood clots
A history of stroke
Coronary artery disease
Uncontrolled blood pressure
Certain types of heart valve problems
Certain types of abnormal heart rhythms
Diabetes with blood vessel problems
Aurovela Fe 1/20 is also contraindicated in anyone with:
Abnormal uterine bleeding that has not been checked by a doctor
Liver disease
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 severe migraine headaches
Tell any doctor or other healthcare provider who treats you that you are using this medicine.
Birth control pills can alter the results of several important blood tests.
Aurovela Fe 1/20 doses may need to stop a few weeks before and after surgical procedures.
The prescriber may require regular visits or lab tests to check on the effects of this medicine. Keep all appointments.
Immediately tell the doctor if you become pregnant, think you’re pregnant, or if you miss two periods in a row.
Before starting oral contraceptives, make sure the doctor 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 hereditary condition that causes facial and skin swelling (hereditary angioedema)
Given birth in the last four weeks
Developed dark skin patches on the face during pregnancy (chloasma)
Aurovela Fe 1/20 can cause serious problems including:
Increased risk of blood clots
Increased risk of breast or cervical cancer
Liver problems
Gallbladder problems
High blood pressure
High cholesterol
You might have some light bleeding or spotting between your 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.
You may have no bleeding or only a little bleeding during your period. If it is accompanied by pregnancy symptoms (like morning sickness) or happens twice in a row, talk to the doctor.
This medicine may cause patches of dark skin. Use sunscreen and avoid exposure to the sun or tanning lights.
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.
Aurovela Fe 1/20 can never be taken with any hepatitis C drug that contains ombitasvir/paritparevir/ritonavir.
Before starting Aurovela Fe 1/20, tell the prescribing healthcare provider about all prescription drugs, over-the-counter medicines, and supplements being taken, particularly:
Drugs that treat other types of infections
Drugs that treat high cholesterol
Barbiturates
HIV/AIDS or hepatitis C drugs
Thyroid hormone pills
St. John’s wort
Vitamin C
Acetaminophen, clofibric acid, morphine, salicylic acid, temazepam
Avoid grapefruit or grapefruit juice when taking Aurovela Fe 1/20.
Tell other healthcare providers you are using this medicine 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)
Sudden vision changes, sudden loss of vision
Numbness or weakness on one side of your body, sudden or severe headache, sudden vomiting, vision changes, trouble walking, trouble speaking
Sharp chest pain, chest tightness, sudden trouble breathing, coughing up blood
Yellow skin or eyes, fatigue, dark urine, pale stools, appetite loss, fever
Breast lumps, breast tenderness, breast discharge
Stomach pain, nausea, vomiting
Heavy vaginal bleeding
Depressed mood, difficulty sleeping, lack of energy
Allergic reaction: Itching, skin rash, hives, swelling of the face, mouth, or throat, chest tightness, trouble breathing
Aurovela Fe 1/20 may cause significant side effects without symptoms including:
High blood pressure
Elevated cholesterol or fats
Decreased glucose tolerance
Less serious side effects
Vaginal spotting or light bleeding
Headache
Appetite changes
Nervousness
Vaginal infections
Nausea
Menstrual cramps
Breast tenderness
Aurovela Fe 1/20 prescribing information, DailyMed (NIH National Library of Medicine)
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