Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.
Combination pills usually work by preventing a woman's ovaries from releasing eggs (ovulation). They also thicken the cervical mucus, which keeps sperm from joining with an egg. The hormones in combination and progestogen-only pills also thin the lining of the uterus. This could prevent pregnancy by interfering with implantation of a blastocyst
ORTHO TRI-CYCLENŽ Tablets are indicated for the prevention of
pregnancy in women who elect to use oral contraceptives as a method
of contraception. ORTHO TRI-CYCLEN is indicated for the treatment
of moderate acne vulgaris in females at least 15 years of age, who
have no known contraindications to oral contraceptive therapy and
have achieved menarche. ORTHO TRI-CYCLEN should be used for the
treatment of acne only if the patient desires an oral contraceptive
for birth control. Oral contraceptives are highly effective for
pregnancy prevention. Table II lists the typical accidental pregnancy
rates for users of combination oral contraceptives and other methods
of contraception. The efficacy of these contraceptive methods, except
sterilization, the IUD, and the Norplant System, depends upon the
reliability with which they are used. Correct and consistent use
of methods can result in lower failure rates.
Oral contraceptives may cause side effects. Tell your doctor if
any of these symptoms are severe or do not go away:
upset stomach
vomiting
stomach cramps or bloating
diarrhea
constipation
gingivitis (swelling of the gum tissue)
weight gain or weight loss
brown or black skin patches
acne
swelling of the hands, feet, or lower legs (fluid retention)
hair growth in unusual places
bleeding or spotting between menstrual periods
changes in menstrual flow
painful or missed periods
breast tenderness, enlargement, or discharge
difficulty wearing contact lenses
Some side effects can be seious. The following symptoms are uncommon,
but if you experience any of them, call your doctor immediately:
severe headache
shortness of breath
severe vomiting
partial or complete loss of vision
double vision
speech problems
dizziness or faintness
weakness or numbness of an arm or leg
crushing chest pain or chest heaviness
coughing up blood
calf pain
severe stomach pain
yellowing of the skin or eyes
severe depression
unusual bleeding
loss of appetite
extreme tiredness, weakness, or lack of energy
fever
dark-colored urine
light-colored stool
rash
The following non-contraceptive health benefits related to the
use of combination oral contraceptives are supported by epidemiological
studies which largely utilized oral contraceptive formulations containing
estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg
mestranol . Effects on menses: increased menstrual cycle regularity
decreased blood loss and decreased incidence of iron deficiency
anemia decreased incidence of dysmenorrhea Effects related to inhibition
of ovulation: decreased incidence of functional ovarian cysts decreased
incidence of ectopic pregnancies Other effects: decreased incidence
of fibroadenomas and fibrocystic disease of the breast decreased
incidence of acute pelvic inflammatory disease decreased incidence
of endometrial cancer decreased incidence of ovarian cancer
Your health care professional 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 professional 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 professional 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 professional, 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