Any woman who considers using oral contraceptives (the “birth control pills” 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 health care 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 health care provider's advice with regard to regular check-ups while you are on the pill. Show Oral 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: 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:
Tell your health care provider if you have ever had any of these conditions. Your health care provider can recommend a safer method of birth control. OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES Tell your health care provider if you have:
Women with any of these conditions should be checked often by their health care provider if they choose to use oral contraceptives. Also, be sure to inform your doctor or health care provider if you smoke or are on any medications. RISKS OF TAKING ORAL CONTRACEPTIVES
ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY All 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. In 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 high-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 SIGNALS If any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately:
SIDE EFFECTS OF ORAL CONTRACEPTIVES
If any of these side effects bother you, call your doctor or health care provider. GENERAL PRECAUTIONS
INSTRUCTIONS TO PATIENT The Junel ® tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in either three or four rows of seven tablets each, with the days of the week appearing on the tablet dispenser above the first row of tablets. Each light yellow tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. Each pink tablet contains 1.5 mg norethindrone acetate and 30 mcg 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. DIRECTIONS To remove a tablet, press down on it with your thumb or finger. The tablet will drop through the back of the tablet dispenser. Do not press on the tablet with your thumbnail, fingernail, or any other sharp object. HOW TO TAKE THE PILL IMPORTANT POINTS TO REMEMBER BEFORE YOU START TAKING YOUR PILLS:
BEFORE YOU START TAKING YOUR PILLS
WHEN TO START THE FIRST PACK OF PILLS You 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
SUNDAY START
WHAT TO DO DURING THE MONTH
WHAT TO DO IF YOU MISS PILLS If you MISS 1 light yellow or pink “active” pill:
If you MISS 2 light yellow or pink “active” pills in a row in WEEK 1 OR WEEK 2 of your pack:
If you MISS 2 light yellow or pink “active” pills in a row in THE 3rd WEEK:
If you MISS 3 OR MORE light yellow or pink “active” pills in a row (during the first 3 weeks):
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 LIGHT YELLOW OR PINK “ACTIVE” PILL EACH DAY until you can reach your doctor or clinic. PREGNANCY DUE TO PILL FAILURE The incidence of pill failure resulting in pregnancy is approximately 1% (i.e., one pregnancy per 100 women per year) if taken every day as directed, but more typical failure rates are about 3%. If failure does occur, the risk to the fetus is minimal. PREGNANCY AFTER STOPPING THE PILL There may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives. It may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy. There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill. OVERDOSAGE Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact you health care provider or pharmacist. OTHER INFORMATION Your health care 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 the health care provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year. Be sure to inform your health care provider if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your health care provider, because this is a time to determine if there are early signs of side effects of oral contraceptive use. Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth control pills. HEALTH BENEFITS FROM ORAL CONTRACEPTIVES In addition to preventing pregnancy, use of oral contraceptives may provide certain benefits. They are:
If you want more information about birth control pills, ask your doctor or pharmacist. They have a more technical leaflet called the “Professional Labeling”, which you may wish to read. Remembering to take tablets according to schedule is stressed because of its importance in providing you the greatest degree of protection. MISSED MENSTRUAL PERIODS FOR BOTH DOSAGE REGIMENS At times there may be no menstrual period after a cycle of pills. Therefore, if you miss one menstrual period but have taken the pills exactly as you were supposed to, continue as usual into the next cycle. If you have not taken the pills correctly and miss a menstrual period, you may be pregnant and should stop taking oral contraceptives until your doctor or health care provider determines whether or not you are pregnant. Until you can get to your doctor or health care provider, use another form of contraception. If two consecutive menstrual periods are missed, you should stop taking pills until it is determined whether or not you are pregnant. Although there does not appear to be any increase in birth defects in newborn babies if you become pregnant while using oral contraceptives, you should discuss the situation with your doctor or health care provider. Periodic Examination Your doctor or health care provider will take a complete medical and family history before prescribing oral contraceptives. At that time and about once a year thereafter, he or she will generally examine your blood pressure, breasts, abdomen, and pelvic organs (including a Papanicolaou smear, i.e., test for cancer). 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]. TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Iss. 6/2011 Additional barcode labeling by: What is the difference between loestrin 1.5 30 and 1 20?LOESTRIN® 1/20 (Each white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.) LOESTRIN® 1.5/30 (Each green tablet contains 1.5 mg norethindrone acetate and 30 mcg ethinyl estradiol.) *Ferrous fumarate tablets are not USP for dissolution and assay.
What is the difference between Junel 1/20 and junel Fe 1 20?It's monophasic, meaning all active tablets contain the same amount of hormones. This medication is available as a 21-tablet pack (Junel 1/20) or a 28-tablet pack that includes iron tablets (Junel Fe 1/20). Junel 1/20 provides a lower dose of hormones compared with other COCs with the same ingredients.
Are all junel pills the same?All types of Junel birth control contain the same active ingredients but have different dosages (TEVA, 2020-b). Some pill packs contain iron tablets as placebo pills at the end of each cycle (the Fe in Loestrin Fe is the chemical symbol for iron).
Does junel Fe 1/20 have low estrogen?Junel Fe 1/20 is a hormone-based, combination-type birth control medication with a low dose of estrogen. In addition to preventing pregnancy, Junel Fe 1/20 may also lighten your periods, and reduce pain associated with your periods.
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