The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Rx onlyTarina® Fe 1/20(Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg*)*Ferrous Fumarate Tablets are not USP for dissolution and assay.Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population (adapted from References 8 and 9 with the author's permission). For further information, the reader is referred to a text on epidemiological methods.
- Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea, vomiting, and breakthrough bleeding may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris) or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences.Liver tumors, which may rupture and cause severe bleeding. A possible but not definite association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.High blood pressure, although blood pressure usually returns to normal when the pill is stopped.The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics, may decrease oral contraceptive effectiveness.Most of the studies to date on breast cancer and pill use have found no increase in the risk of developing breast cancer, although some studies have reported an increased risk of developing breast cancer in certain groups of women. However, some studies have found an increase in the risk of developing cancer of the cervix in women taking the pill, but this finding may be related to differences in sexual behavior or other factors not related to use of the pill. Therefore, there is insufficient evidence to rule out the possibility that the pill may cause cancer of the breast or cervix.Taking the pill provides some important non-contraceptive benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history and examine you before prescribing oral contraceptives. The physical examination may be delayed to another time if you request it and your healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient information leaflet gives you further information which you should read and discuss with your healthcare provider.This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis.
INSTRUCTIONS TO PATIENTTABLET BLISTER PACKThe Tarina Fe 1/20 blister pack has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in four rows of seven tablets each, with the days of the week appearing on the tablet blister pack above the first row of tablets.If your TABLET BLISTER PACK contains:You are taking:21 white to off-white tablets and 7 brown tabletsTarina Fe 1/20Each white to off-white tablet contains 1 mg norethindrone acetate and 0.02 mg ethinyl estradiol.Each brown tablet contains 75 mg ferrous fumarate and is intended to help you remember to take the tablets correctly. These brown tablets are not intended to have any health benefit.DIRECTIONSTo remove a tablet, press down on it with your thumb or finger. The tablet will drop through the back of the tablet blister. Do not press with your thumbnail, fingernail, or any other sharp object.HOW TO TAKE THE PILLIMPORTANT POINTS TO REMEMBERBEFORE YOU START TAKING YOUR PILLS:1. BE SURE TO READ THESE DIRECTIONS:Before you start taking your pills.Anytime you are not sure what to do.2. THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.3. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH, DURING THE FIRST 1 TO 3 PACKS OF PILLS.If you do have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your doctor or clinic.4. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.5. IF YOU HAVE VOMITING OR DIARRHEA, for any reason, or IF YOU TAKE SOME MEDICINES, including some antibiotics, your birth control pills may not work as well. Use a back-up birth control method (such as condoms or foam) until you check with your doctor or clinic.6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or clinic about how to make pill taking easier or about using another method of birth control.7. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your doctor or clinic.
BEFORE YOU START TAKING YOUR PILLS1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day.2. LOOK AT YOUR PILL PACK TO SEE IF IT HAS 28 PILLS:The 28-pill pack has 21 "active" white to off-white pills (with hormones) to take for 3 weeks, followed by 1 week of reminder brown pills (without hormones).3. ALSO FIND:1) where on the pack to start taking pills,2) in what order to take the pills (follow the arrows), and3) the week numbers as shown in the following picture:Tarina Fe 1/20 will contain: 21 WHITE TO OFF-WHITE PILLS for WEEKS 1, 2, and 3. WEEK 4 will contain BROWN PILLS ONLY.4. BE SURE YOU HAVE READY AT ALL TIMES:ANOTHER KIND OF BIRTH CONTROL (such as condoms or foam) to use as a back-up in case you miss pills.AN EXTRA, FULL PILL PACK.WHEN TO START THE FIRST PACK OF PILLSYou have a choice of which day to start taking your first pack of pills. Decide with your doctor or clinic 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 blister card over the area that has the days of the week (starting with Sunday) printed on the blister card.3. Take the first "active" white to off-white pill 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, since you are starting the pill at the beginning of your period.SUNDAY START:1. Take the first "active" white to off-white pill of the first 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 as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). Condoms or foam are good back-up methods of birth control.WHAT TO DO DURING THE MONTH1. TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY.Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).Do not skip pills even if you do not have sex very often.2. WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS:Start the next pack on the day after your last "reminder" pill. Do not wait any days between packs.
WHAT TO DO IF YOU MISS PILLSIf you MISS 1 white to off-white "active" pill:1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 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 "active" pills in a row in WEEK 1 OR WEEK 2 of your pack:1. Take 2 pills on the day you remember and 2 pills the next day.2. Then take 1 pill a day until you finish the pack.3. You COULD GET PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up method of birth control until you have taken a white to off-white "active" pill every day for 7 days.If you MISS 2 white to off-white "active" pills in a row in THE 3rd WEEK:1. If you are a Day-1 Starter:THROW OUT the rest of the pill pack and start a new pack that same day.If you are a Sunday Starter:Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.2. 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 doctor or clinic because you might be pregnant.3. You COULD GET PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up method of birth control until you have taken a white to off-white "active" pill every day for 7 days.If you MISS 3 OR MORE white to off-white "active" pills in a row (during the first 3 weeks):1. If you are a Day-1 Starter:THROW OUT the rest of the pill pack and start a new pack that same day.If you are a Sunday Starter:Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.2. 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 doctor or clinic because you might be pregnant.3. You COULD GET PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up method of birth control until you have taken a white to off-white "active" pill every day for 7 days.A REMINDER FOR THOSE ON 28-DAY PACKS:IF YOU FORGET ANY OF THE 7 BROWN “REMINDER” PILLS IN WEEK 4:THROW AWAY THE PILLS YOU MISSED.KEEP TAKING 1 PILL EACH DAY UNTIL THE PACK IS EMPTY.YOU DO NOT NEED A BACK-UP METHOD.FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED:Use a BACK-UP METHOD anytime you have sex.KEEP TAKING ONE WHITE TO OFF-WHITE “ACTIVE” PILL EACH DAY until you can reach your doctor or clinic.Based on his or her assessment of your medical needs, your doctor or healthcare provider has prescribed this drug for you. Do not give this drug to anyone else.
Keep this and all drugs out of the reach of children.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.DETAILED PATIENT PACKAGE INSERTWhat You Should Know About Oral ContraceptivesAny woman who considers using oral contraceptives (the "birth control pill" or "the pill") should understand the benefits and risks of using this form of birth control. This leaflet will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your healthcare provider. You should discuss the information provided in this leaflet with him or her, both when you first start taking the pill and during your revisits. You should also follow your healthcare provider's advice with regard to regular check-ups while you are on the pill.EFFECTIVENESS OF ORAL CONTRACEPTIVESOral contraceptives or "birth control pills" or "the pill" are used to prevent pregnancy and are more effective than other non-surgical methods of birth control. When they are taken correctly, the chance of becoming pregnant is less than 1% (1 pregnancy per 100 women per year of use) when used perfectly, without missing any pills. Typical failure rates are actually 3% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.In comparison, typical failure rates for other methods of birth control during the first year of use are as follows:Implant: less than 1%Male sterilization: less than 1%Injection: less than 1%Cervical Cap: 20% to 40%IUD: less than 1% to 2%Condom alone (male): 14%Diaphragm with spermicides: 20%Condom alone (female): 21%Spermicides alone: 26%Periodic abstinence: 25%Vaginal Sponge: 20% to 40%Withdrawal: 19%Female sterilization: less than 1%No method: 85%WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES
- Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You should also not use the pill if you have any of the following conditions:A history of heart attack or strokeBlood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyesA history of blood clots in the deep veins of your legsChest pain (angina pectoris)Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vaginaUnexplained vaginal bleeding (until a diagnosis is reached by your doctor)Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the pillLiver tumor (benign or cancerous)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.Known or suspected pregnancyTell your healthcare provider if you have ever had any of these conditions. Your healthcare provider can recommend a safer method of birth control.OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVESTell your healthcare provider if you have: Breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogramDiabetesElevated cholesterol or triglyceridesHigh blood pressureMigraine or other headaches or epilepsyMental depressionGallbladder, heart, or kidney diseaseHistory of scanty or irregular menstrual periodsWomen with any of these conditions should be checked often by their healthcare provider if they choose to use oral contraceptives.Also, be sure to inform your doctor or healthcare provider if you smoke or are on any medications.RISKS OF TAKING ORAL CONTRACEPTIVES1. Risk of Developing Blood ClotsBlood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives; in particular, a clot in the legs can cause thrombophlebitis, and a clot that travels to the lungs can cause a sudden blocking of the vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision.If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness, or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor about stopping oral contraceptives three to four weeks before surgery and not taking oral contraceptives for two weeks after surgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby. It is advisable to wait for at least four weeks after delivery if you are not breastfeeding. If you are breastfeeding, you should wait until you have weaned your child before using the pill. (See also the section on breastfeeding in GENERAL PRECAUTIONS.)2. Heart Attacks and StrokesOral contraceptives may increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain) and angina pectoris and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or disability.Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore, smoking and the use of oral contraceptives greatly increase the chances of developing and dying of heart disease.3. Gallbladder DiseaseOral contraceptive users probably have a greater risk than nonusers of having gallbladder disease, although this risk may be related to pills containing high doses of estrogens.4. Liver TumorsIn rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with the pill and liver cancers in two studies, in which a few women who developed these very rare cancers were found to have used oral contraceptives for long periods. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.5. Cancer of the Reproductive Organs and BreastsThere is, at present, no confirmed evidence that oral contraceptive use increases the risk of developing cancer of the reproductive organs. Studies to date of women taking the pill have reported conflicting findings on whether pill use increases the risk of developing cancer of the breast or cervix. Most of the studies on breast cancer and pill use have found no overall increase in the risk of developing breast cancer, although some studies have reported an increased risk of developing breast cancer in certain groups of women. Women who use oral contraceptives and have a strong family history of breast cancer or who have breast nodules or abnormal mammograms should be closely followed by their doctors.Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives.ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCYAll methods of birth control and pregnancy are associated with a risk of developing certain diseases which may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table.ANNUAL NUMBER OF BIRTH-RELATED OR METHOD-RELATED DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NONSTERILE WOMEN BY FERTILITY CONTROL METHOD ACCORDING TO AGE*Deaths are birth related.**Deaths are method related.Method of control and outcome15 to 1920 to 2425 to 2930 to 3435 to 3940 to 44No fertility control methods*7.07.49.114.825.728.2Oral contraceptives non-smoker**0.30.50.91.913.831.6Oral contraceptives smoker**18.104.22.1683.551.1117.2IUD**0.80.81.01.01.41.4Condom*22.214.171.124.20.30.4Diaphragm/ spermicide*126.96.36.199.32.22.8Periodic abstinence*188.8.131.52.72.93.6In the above table, the risk of death from any birth control method is less than the risk of childbirth, except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen in the table that for women aged 15 to 39, the risk of death was highest with pregnancy (7 to 26 deaths per 100,000 women, depending on age). Among pill users who do not smoke, the risk of death was always lower than that associated with pregnancy for any age group, although over the age of 40, the risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the age of 35, the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is four times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group.The suggestion that women over 40 who don't smoke should not take oral contraceptives is based on information from older higher dose pills and on less selective use of pills than is practiced today. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of oral contraceptive use by healthy, non-smoking women over 40 years of age may outweigh the possible risks. However, all women, especially older women, are cautioned to use the lowest dose pill that is effective.WARNING SIGNALSIf any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately:Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)Pain in the calf (indicating a possible clot in the leg)Crushing chest pain or heaviness in the chest (indicating a possible heart attack)Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)Sudden partial or complete loss of vision (indicating a possible clot in the eye)Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your doctor or healthcare provider to show you how to examine your breasts)Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor)Difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark colored urine, or light colored bowel movements (indicating possible liver problems)SIDE EFFECTS OF ORAL CONTRACEPTIVES1. Vaginal BleedingIrregular vaginal bleeding or spotting may occur while you are taking the pills. 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 serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle or lasts for more than a few days, talk to your doctor or healthcare provider.2. Contact LensesIf you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or healthcare provider.3. Fluid RetentionOral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid