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Not a member yet? Create free account. Email Address. Log In. Remember Me. Forgot password? Thromboembolic and thrombotic disorders and other vascular problems including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis , carcinoma of the reproductive organs and breasts, hepatic neoplasia including hepatic adenomas or benign liver tumors , ocular lesions including retinal vascular thrombosis , gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related alphabetically listed :.

The following adverse reactions have been reported in users of oral contraceptives:. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral-contraceptive formulations containing doses exceeding 0.

The dosage of Delyla is one white tablet daily for 21 consecutive days, followed by one yellow inert tablet daily for 7 consecutive days, according to the prescribed schedule.

It is recommended that Delyla be taken at the same time each day. The blister should be kept in the wallet supplied to avoid possible fading of the pills.

If the pills fade, patients should continue to take them as directed. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should be instructed to begin taking Delyla on either the first Sunday after the onset of menstruation Sunday Start or on Day 1 of menstruation Day 1 Start.

The patient is instructed to begin taking Delyla on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet white is taken that day.

One white tablet should be taken daily for 21 consecutive days, followed by one yellow inert tablet daily for 7 consecutive days.

Withdrawal bleeding should usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started.

During the first cycle, contraceptive reliance should not be placed on Delyla until a white tablet has been taken daily for 7 consecutive days, and a nonhormonal back-up method of birth control should be used during those 7 days.

During the first cycle of medication, the patient is instructed to begin taking Delyla during the first 24 hours of her period day one of her menstrual cycle.

If medication is begun on day one of the menstrual cycle, no back-up contraception is necessary. If Delyla tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on Delyla tablets until after the first 7 consecutive days of administration, and a nonhormonal back-up method of birth control should be used during 7 days.

After the first cycle of use. The patient begins her next and all subsequent courses of tablets on the day after taking her last yellow tablet.

She should follow the same dosing schedule: 21 days on white tablets followed by 7 days on yellow tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a nonhormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.

Switching from another hormonal method of contraception. When the patient is switching from a 21—day regimen of tablets, she should wait 7 days after her last tablet before she starts Delyla.

She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21—day regimen.

When the patient is switching from a day regimen of tablets, she should start her first pack of Delyla on the day after her last tablet.

She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Delyla the next day.

If switching from an implant or injection, the patient should start Delyla on the day of implant removal or, if using an injection, the day the next injection would be due.

In switching from a progestin-only pill, injection, or implant, the patient should be advised to use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking.

If spotting or breakthrough bleeding occurs. If spotting or breakthrough bleeding occur, the patient is instructed to continue on the same regimen.

This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.

Risk of pregnancy if tablets are missed. While there is little likelihood of ovulation occurring if only one or two white tablets are missed, the possibility of ovulation increases with each successive day that scheduled white tablets are missed.

Although the occurrence of pregnancy is unlikely if Delyla is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered.

If the patient has not adhered to the prescribed schedule missed one or more tablets or started taking them on a day later than she should have , the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken.

If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. The risk of pregnancy increases with each active white tablet missed.

Use after pregnancy, abortion or miscarriage. The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet taking.

Delyla may be initiated immediately after a first trimester abortion or miscarriage. If the patient starts Delyla immediately, back-up contraception is not needed.

Brief Summary Patient Package Insert. This product like all oral contraceptives is intended to prevent pregnancy. For most women oral contraceptives are also free of serious or unpleasant side effects.

However, forgetting to take pills considerably increases the chances of pregnancy. For the majority of women, oral contraceptives can be taken safely.

But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability or death.

The risks associated with taking oral contraceptives increase significantly if you:. You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.

Although cardiovascular disease risks may be increased with oral-contraceptive use after age 40 in healthy, nonsmoking women, there are also greater potential health risks associated with pregnancy in older women.

Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses.

These side effects, especially nausea and vomiting, 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 do not smoke.

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 and lungs pulmonary embolism , blockage or rupture of a blood vessel in the brain stroke , blockage of blood vessels in the heart heart attack and 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. Women with migraine also may be at increased risk of stroke with pill use.

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 health-care 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, herbal preparations containing St. Various studies give conflicting reports on the relationship between breast cancer and oral contraceptive use.

Oral contraceptive use may slightly increase your chance of having breast cancer diagnosed, particularly if you started using hormonal contraceptives at a younger age.

After you stop using hormonal contraceptives, the chances of having breast cancer diagnosed begin to go down and disappear 10 years after stopping use of the pill.

It is not known whether this slightly increased risk of having breast cancer diagnosed is caused by the pill. It may be that women taking the pill were examined more often, so that breast cancer was more likely to be detected.

You should have regular breast examinations by a health-care provider and examine your own breasts monthly.

Tell your health-care provider if you have a family history of breast cancer or if you have had breast nodules or an abnormal mammogram. Women who currently have or have had breast cancer should not use oral contraceptives because breast cancer is usually a hormone sensitive tumor.

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.

Taking the pill provides some important noncontraceptive 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 health-care provider. Your health-care provider will take a medical and family history before prescribing oral contraceptives and will examine you.

The physical examination may be delayed to another time if you request it and the health-care provider believes that it is appropriate 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 health-care provider.

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.

If you feel sick to your stomach, do not stop taking Delyla. The problem will usually go away. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.

Use a back-up nonhormonal method such as condoms or spermicide until you check with your health-care provider. It is important to take it at about the same time every day.

You have a choice of which day to start taking your first pack of pills. Decide with your health-care provider which is the best day for you.

Pick a time of day which will be easy to remember. Pick the day label strip that starts with the first day of your period. Place this day label strip over the area that has the days of the week starting with Sunday pre-printed on the blister pack.

Note: if the first day of your period is a Sunday, you can skip step 1. You will not need to use a back-up nonhormonal method of birth control, since you are starting the pill at the beginning of your period.

If your period begins on Sunday, start the pack that same day. Use a nonhormonal method of birth control such as condoms or spermicide as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday 7 days.

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. Do not wait any days between packs. If your previous brand had 21 pills: Wait 7 days to start taking Delyla.

You will probably have your period during that week. 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.

You MUST use a nonhormonal birth-control method such as condoms or spermicide as a back-up for those 7 days. Take 2 pills on the day you remember and 2 pills the next day.

Then take 1 pill a day until you finish the pack. If you are a Day 1 Starter :. If you are a Sunday Starter :. 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 health-care provider because you might be pregnant. If you are a Sunday Starter:.

Keep taking 1 pill each day until the pack is empty. You do not need a back-up nonhormonal birth-control method if you start your next pack on time.

If you do not wish to become pregnant after stopping the pill speak to your health-care provider about another method 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.

The chance of becoming pregnant increases with each missed pill during each day cycle of use. In comparison, average 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 have any of the following conditions:.

Tell your health-care provider if you have had any of these conditions. Your health-care provider can recommend another method of birth control.

Tell your health-care provider if you or any family member has ever had:. 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 health-care provider if you smoke or are on any medications. Although cardiovascular disease risks may be increased with oral contraceptive use in healthy, non-smoking women over 40 even with the newer low-dose formulations , there are also greater potential health risks associated with pregnancy in older women.

Risks of developing blood clots. Blood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives and can cause death or serious disability.

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.

Users of combination oral contraceptives have a higher risk of developing blood clots compared to non-users.

This risk is highest during the first year of combination oral-contraceptive use. If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness or injury, or have recently delivered a baby, you may be at risk of developing blood clots.

You should consult your health-care provider 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 or after a midtrimester pregnancy termination. It is advisable to wait for at least four weeks after delivery if you are not breast-feeding.

If you are breast-feeding, you should wait until you have weaned your child before using the pill. The risk of blood clots is greater in users of combination oral contraceptives compared to nonusers.

This risk may be higher in users of high-dose pills those containing 50 mcg or more of estrogen and may also be greater with longer use.

In addition, some of these increased risks may continue for a number of years after stopping combination oral contraceptives.

The risk of abnormal blood clotting increases with age in both users and nonusers of combination oral contraceptives, but the increased risk from the oral contraceptive appears to be present at all ages.

The excess risk of blood clots is highest during the first year a woman ever uses a combined oral contraceptive. This increased risk is lower than blood clots associated with pregnancy.

The use of combination oral contraceptives also increases the risk of other clotting disorders, including heart attack and stroke.

The risk of clotting is further increased in women with other conditions. Examples include: smoking, high blood pressure, abnormal lipid levels, certain inherited or acquired clotting disorders, obesity, surgery or injury, recent delivery or second trimester abortion, prolonged inactivity or bed rest.

If possible, combination oral contraceptives should be stopped before surgery and during prolonged inactivity or bedrest. Cigarette smoking increases the risk of serious cardiovascular events.

This risk increases with age and amount of smoking and is quite pronounced in women over Women who use combination oral contraceptives should be strongly advised not to smoke.

If you smoke you should talk to your health care professional before taking combination oral contraceptives. Heart attacks and strokes.

Oral contraceptives may increase the tendency to develop strokes or transient ischemic attacks blockage 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 serious 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. Gallbladder disease.

Oral-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.

Oral contraceptives may worsen existing gallbladder disease or accelerate the development of gallbladder disease in women previously without symptoms.

Liver tumors. In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding.

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