Synphasic

How does this medication work? What will it do for me?

Norethindrone - ethinyl estradiol belongs to the class of medications called oral contraceptives (birth control pills). It is an estrogen (ethinyl estradiol) and progestin (norethindrone) combination pill used to prevent pregnancy.

Norethindrone - ethinyl estradiol works by preventing ovulation (the release of an egg from an ovary) and by causing changes in the mucus of the cervix, which make it difficult for sperm to penetrate the egg and for an egg to implant in the wall of the uterus.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

0.5 mg/35 µg
Each blue circular tablet, impressed "SEARLE" on one side and "BX" on the other side, contains 0.5 mg of norethindrone and 0.035 mg (35 µg) of ethinyl estradiol. Nonmedicinal ingredients: cornstarch, FD&C Blue No. 2, lactose hydrous, magnesium stearate, and polyvidone.

1 mg/35 µg
Each white circular tablet, impressed "SEARLE" on one side and "BX" on the other side, contains 1 mg of norethindrone and 0.035 mg (35 µg) of ethinyl estradiol. Nonmedicinal ingredients: cornstarch, FD&C Blue No. 2, lactose hydrous, magnesium stearate, and polyvidone.

In the 28-day pack there are 7 orange tablets, impressed "SEARLE" on one side and "P" on the other, which contain no active ingredients. Nonmedicinal ingredients: FD&C Yellow No. 6 Lake, lactose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

How should I use this medication?

21-day pack: Take 1 tablet daily for 21 days, then take no pills for 7 days. After 7 days, start a new pack.

28-day pack: Take 1 tablet daily for 21 days, then 1 "reminder" pill daily for 7 days. When all the tablets have been taken, start a new pack.

Talk with your doctor about the best time to start your pills. The first day of your menstrual period (bleeding) is known as "Day 1." Your doctor may have you start your pills on the first Sunday after your period starts or on Day 1 of your period. The pills should be taken at approximately the same time every day.

It may be advisable to use a second method of birth control (e.g., latex condoms and spermicidal foam or gel) for the first 7 days of the first cycle of pill use.

Many women have spotting or light bleeding or may feel nauseous during the first 3 months of taking the pill. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic.

If you experience vomiting or diarrhea, or if you take certain medications (such as antibiotics), your pills may not work as well. If your doctor prescribes other medications, ask your doctor or pharmacist whether these medications could reduce the effectiveness of your birth control pills. Use a backup method, such as latex condoms and spermicidal foam or gel, until you can check with your doctor or clinic.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is very important to take this medication exactly as prescribed by your doctor. If you miss pills at any time, the risk of becoming pregnant increases.

If you miss one pill, take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day.

If you miss 2 pills in a row during the first 2 weeks of your cycle, take 2 pills the day you remember and 2 pills the next day, then take one pill a day until you finish the pack. Use a second method of birth control if you have sex in the 7 days after you miss the pills.

If you miss 2 pills in a row during the third week of your cycle or 3 or more pills in a row anytime in your cycle and you start your pills on Sunday, keep taking one pill a day until Sunday. On Sunday, safely discard the rest of the pack and start a new pack that day. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.

If you miss 2 pills in a row during the third week of your cycle or 3 or more pills at anytime during your cycle and you start your pills on Day 1, safely dispose of the rest of the pill pack and start a new pack that same day. Use another method of birth control if you have sex in the 7 days after you miss the pills. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.

If you are not sure what to do after missing pills, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children. Leave the medication in the original packaging until you are ready to use it.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take norethindrone - ethinyl estradiol if you:

• are allergic to norethindrone, ethinyl estradiol, or any ingredients of the medication
• are or may be pregnant
• have eye damage resulting from blood vessel disease of the eye, such as a partial or complete loss of vision
• have had a heart attack
• have coronary artery disease or angina
• have, have had, or may have breast cancer
• have too much or too little lipoprotein in the blood
• have migraine headaches
• have or have had pancreatitis (inflammation of the pancreas) as a result of high levels of triglycerides
• have heart valve disease with complications
• have an irregular heart rhythm
• have or have had liver disease, jaundice (yellowing of the skin or eyes), or liver problems during pregnancy
• have multiple risk factors for a blood clot, such as:
• diabetes with blood vessel damage
• heavy smoking (more than 15 cigarettes per day) and age over 35
• inherited blood clotting problems
• major surgery
• prolonged bed rest
• severe high blood pressure (blood pressure of 160/100 or higher)
• have or have had cancerous or non-cancerous liver tumours
• have or have had cerebrovascular disorders (e.g., stroke)
• have or have had thrombophlebitis or thromboembolic disorders (blood clotting problems)
• have, may have, or have had endometrial cancer (cancer of the lining of the uterus)
• have or may have a tumour dependent on estrogen
• have undiagnosed abnormal vaginal bleeding
• are taking a combination of medications to treat Hepatitis C virus that contain ombitasvir, paritaprevir, ritonavir, and dasabuvir, with or without ribavirin

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• acne (usually less common after 3 months of treatment, and may improve if acne already exists)
• bloating, fluid retention
• breast pain, tenderness, or swelling
• brown, blotchy spots on exposed skin
• changes in appetite
• discomfort wearing contact lenses
• dizziness
• gain or loss of body or facial hair
• increased or decreased interest in sexual activity
• irritability
• nausea
• vaginal discharge
• vomiting
• weight gain or loss

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal or stomach pain (sudden, severe, or continuing)
• breast lumps
• changes in hearing
• changes in the uterine bleeding pattern at or between periods, such as:
• breakthrough bleeding or spotting between periods
• complete stopping of menstrual bleeding that occurs over several months in a row
• decreased bleeding during periods
• prolonged bleeding at periods
• stopping of menstrual bleeding that only occurs sometimes
• headaches or migraines
• increased blood pressure
• pain and numbness, change in colour or feeling cold in the hands and feet
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• swelling of the feet, ankles, or lower leg
• swelling, pain, or tenderness in the upper abdominal area
• symptoms of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of inflammatory bowel disease (Crohn’s disease; abdominal pain, severe diarrhea, fatigue, weight loss)
• symptoms of lupus (e.g., fever, general feeling of being unwell, joint pain, confusion, muscle aches, skin rash)
• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)
• vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• loss of vision or change in vision (sudden)
• pains in chest, groin, or leg (especially in calf of leg)
• rash
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a blood clot in the lung (e.g., coughing up blood, sudden/unexplained shortness of breath)
• signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities. If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Breast cancer: Increasing age and a strong family history are the most significant risk factors for the development of breast cancer. Other established risk factors include obesity, not having had children, and a late age at first full-term pregnancy. The identified groups of women that may be at increased risk of developing breast cancer before menopause are women who have used birth control pills for more than 8 years or who started using them at an early age. For a few women, the use of birth control pills may accelerate the growth of an existing but undiagnosed breast cancer.

If you are taking birth control pills, learn how to perform a breast self-examination. Notify your doctor any time you detect a lump. A yearly clinical breast examination is also recommended because, if breast cancer develops, medications that contain estrogen may cause it to grow quickly.

Depression: Hormones, such as estrogen, have been known to cause mood swings and symptoms of depression. If you have had clinical depression in the past, you may be more likely to experience it again while taking this medication. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.

Diabetes: Current low-dose birth control pills affect glucose control very little. If you have diabetes or a family history of diabetes, monitor your blood glucose closely to detect any worsening of blood sugar control after starting birth control pills.

Epilepsy: Women with a history of epileptic seizures should speak to their doctor about the possibility of this medication increasing the numbers of epileptic seizures they may experience.

Eyes: Women who are pregnant or who take birth control pills may experience fluid build-up in the cornea of the eye, which may cause visual disturbances and changes in tolerance to contact lenses, especially rigid contact lenses. Wearers of soft contact lenses usually do not experience difficulties. If you experience visual changes or alterations in tolerance to contact lenses, you may need to stop wearing the lenses temporarily or permanently.

Fibroids: If you have fibroids (leiomyomata), your doctor should closely monitor your condition. If sudden enlargement, pain, or tenderness occurs, contact your doctor to see if you need to stop taking the medication.

Headache: Birth control pills may cause the development or worsening of migraine symptoms. If you have a history of migraine headache, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease: Cigarette smoking increases the risk of serious heart disease and death. Taking birth control pills increases this risk, especially with increasing age. Studies show evidence that women who smoke and are over 35 years old should not use birth control pills.

Other women who have a high risk for heart disease include those with diabetes, high blood pressure, or abnormal cholesterol levels, or those with a family history of these conditions. Whether taking birth control pills increases this risk is unclear.

For low-risk, non-smoking women of any age, the benefits of birth control pill use outweigh the possible cardiovascular risks of low-dose pills.

Liver function: If you have reduced liver function or have had liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Other cancers: There is some evidence that long-term use of oral contraceptives may increase the risk of cervical cancer or liver cancer. There is some debate about how significant this risk is. If you have concerns, discuss this with your doctor.

Regular check-ups: You should have a yearly physical examination and follow-up visit with your doctor.

Return to fertility: After stopping birth control therapy, you should delay pregnancy until at least one normal menstrual cycle has occurred in order to date the pregnancy. An alternative birth control method (e.g., condoms) should be used during this time.

If you do not menstruate for 6 months or more after stopping birth control pills, notify your doctor.

Sexually transmitted infections: Birth control pills do not protect against sexually transmitted infections, including HIV/AIDS. For protection against these, use latex condoms.

Stroke: This medication increases the risk of a stroke or "mini-strokes" occurring. If you experience signs of a stroke or mini-stroke, such as confusion, difficulty speaking, loss of coordination, sudden headache, or vision changes, contact your doctor as soon as possible.

Surgery: Certain situations such as long-term bed confinement may make blood clots more likely. Discuss with your doctor the risks and benefits of temporarily stopping this medication. If you are scheduled for surgery, let all doctors involved in your care know that you are taking this medication.

Pregnancy: The hormones in birth control pills can affect the developing fetus if taken by a woman who is pregnant. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: The use of birth control pills while breast-feeding is not recommended. The hormonal components of the medication pass into breast milk and may reduce the quantity and quality of the breast milk. The long-term effects on the developing child are not known.

What other drugs could interact with this medication?

There may be an interaction between norethindrone - ethinyl estradiol and any of the following:

• acitretin
• ampicillin
• anastrozole
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
• antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine, olopatadine)
• antihypertensive medications (medications that are used to treat high blood pressure)
• aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• barbiturates (e.g., butalbital, phenobarbital)
• bosentan
• cannabis
• celecoxib
• ceritinib
• cholestyramine
• clozapine
• cobicistat
• colesevelam
• colestipol
• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• cyclosporine
• dabrafenib
• deferasirox
• dehydroepiandrosterone
• diabetes medications (e.g., acarbose, canagliflozin. glyburide, insulin, linagliptin, lixisenatide, metformin, rosiglitazone)
• echinacea
• elagolix
• elexacaftor, tezacaftor and ivacaftor
• erlotinib
• exemestane
• exenatide
• folic acid
• flibanserin
• glecaprevir and pibrentasvir
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• isotretinoin
• lenalidomide
• lomitapide
• lumacaftor and ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• melatonin
• metronidazole
• mifepristone
• modafinil
• mycophenolate
• nitrofurantoin
• octreotide
• ospemifene
• other estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• penicillin
• phenothiazines (e.g., chlorpromazine, perphenazine, prochlorperazine)
• pomalidomide
• other progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone)
• proguanil
• rifabutin
• rifampin
• rivaroxaban
• roflumilast
• ropinirole
• St. John's wort
• selegiline
• seizure medications (e.g., carbamazepine, gabapentin, levetiracetam, phenytoin, rufinamide, topiramate)
• somatropin
• soybean
• sulfonamides (e.g., sulfamethoxazole)
• tacrolimus
• tetracyclines (e.g., minocycline, tetracycline)
• thalidomide
• theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
• thyroid replacements (e.g., dessicated thyroid, levothyroxine)
• tizanidine
• tranexamic acid
• tretinoin
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine)
• vitamin B12
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Synphasic