Estrogens and Progestins Oral Contraceptives (Systemic )

Oral contraceptives are known also as the Pill, OCs, BCs, BC tablets, or birth control pills. This medicine usually contains two types of hormones, estrogens (ES-troh-jenz ) and progestins ( proh-JES-tins) and, when taken properly, prevents pregnancy. It works by stopping a woman’s egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented. Although oral contraceptives have other effects that help prevent a pregnancy from occurring, this is the main action.

Alesse Description
Oral contraceptives are known also as the Pill, OCs, BCs, BC tablets, or birth control pills. This medicine usually contains two types of hormones, estrogens (ES-troh-jenz ) and progestins ( proh-JES-tins) and, when taken properly, prevents pregnancy. It works by stopping a woman’s egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented. Although oral contraceptives have other effects that help prevent a pregnancy from occurring, this is the main action.

Sometimes a woman’s egg can still develop even though the medication is taken once each day, especially when more than 24 hours pass between two doses. In almost all cases when the medicine was taken properly and an egg develops, fertilization can still be stopped by oral contraceptives. This is because oral contraceptives also thicken cervical mucus at the opening of the uterus. This makes it hard for the partner’s sperm to reach the egg. In addition, oral contraceptives change the uterus lining just enough so that an egg will not stop in the uterus to develop. All of these effects make it difficult to become pregnant when properly taking an oral contraceptive.

No contraceptive method is 100 percent effective. Studies show that fewer than one of each one hundred women correctly using oral contraceptives becomes pregnant during the first year of use. Birth control methods such as having surgery to become sterile or not having sex are more effective. Using condoms, diaphragms, progestin-only oral contraceptives, or spermicides is not as effective as using oral contraceptives containing estrogens and progestins. Discuss with your health care professional your options for birth control.

The triphasic cycle product of norgestimate and ethinyl estradiol (the brand name Ortho Tri-Cyclen) and norethindrone acetate and ethinyl estradiol (the brand name Estrostep ) can be used for the treatment of moderate acne only if the patient is at least 15 years old, has acne that has not improved with topical anti-acne medicines, has gotten approval from her doctor, has begun to have menstrual periods, desires an oral contraceptive for birth control, and plans to stay on it for at least 6 months.

Sometimes these preparations can be used for other conditions as determined by your doctor.

The following symptoms or side effects may be related to blood clots and require immediate medical or emergency help: chest pain; coughing up blood; dizziness or fainting spells; leg, arm or groin pain; severe or sudden headaches; stomach pain (severe); sudden shortness of breath; sudden loss of coordination, especially on one side of the body; swelling of the hands, feet or ankles, or rapid weight gain; vision or speech problems; weakness or numbness in the arms or legs, especially on one side of the body.

Other serious side effects are rare. Contact your health care provider as soon as you can if the following side effects occur: breast tissue changes or discharge; changes in vaginal bleeding during your period or between your periods; headaches or migraines; increases in blood sugar, especially if you have diabetes; increases in blood pressure, especially if you are known to have high blood pressure; symptoms of vaginal infection (itching, irritation or unusual discharge); tenderness in the upper abdomen; vomiting; yellowing of the eyes or skin.

Side effects that usually do not require medical attention (report to your health care provider if they continue or are bothersome): breakthrough bleeding and spotting that continues beyond the 3 initial cycles of pills; breast tenderness; mild stomach upset; mood changes, anxiety, depression, frustration, anger, or emotional outbursts; increased or decreased appetite; increased sensitivity to sun or ultraviolet light ;nausea; skin rash, acne, or brown spots on the skin; tiredness; weight gain.

Visit your prescriber or health care provider for regular checks on your progress. You should have a complete check-up every 6 to 12 months. If you have any unusual vaginal bleeding contact your doctor or health care provider for advice. If you miss a period, the possibility of pregnancy must be considered. See your prescriber or health care professional as soon as you can.

Use an additional method of contraception during the first cycle that you take these tablets.

If you stop taking these tablets and want to get pregnant, a return to normal ovulation can take some time. You may not return to normal ovulation and fertility for 3 to 6 months. Discuss your pregnancy plans with your health care provider.

Tobacco smoking increases the risk of getting a blood clot or having a stroke while you are taking oral contraceptives, especially if you are more than 35 years old. You are strongly advised not to smoke.

Oral contraceptives can increase your sensitivity to the sun and you may burn more easily. Use sunscreen and protective clothing during long periods outdoors. Tanning booths should be used with caution.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

In some women, tenderness, swelling, or minor bleeding of the gums may occur. Notify your dentist if this happens. Brushing and flossing your teeth regularly may help limit this. See your dentist regularly and inform your dentist of the medicines you are taking.

You may get a vaginal yeast infection. If you have never had a yeast infection before, see your prescriber or other health care provider to confirm the problem. If you have had yeast infections in the past and are comfortable with self-medicating the problem, get and use a nonprescription medication to treat the yeast infection.

If you are going to have elective surgery, you may need to stop taking your contraceptive pills one month beforehand. Consult your health care professional for advice prior to scheduling the surgery.

Taking contraceptive pills does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases.

Antibiotics or medicines for infections, especially rifampin; aprepitant; barbiturate medicines for producing sleep or treating seizures (convulsions); bosentan; carbamazepine; caffeine; clofibrate; cyclosporine; dantrolene; grapefruit juice; hydrocortisone; medicines for anxiety or sleeping problems, such as diazepam or temazepam; medicines for mental depression; medicines for diabetes, including troglitazone and pioglitazone; mineral oil; modafinil; mycophenolate; nefazodone; oxcarbazepine; phenytoin; prednisolone; ritonavir or other medicines for the treatment of the HIV virus or AIDS; selegiline; soy isoflavones supplements; St. John’s wort; tamoxifen or raloxifene; theophylline; topiramate; warfarin.

Prescriber needs to know if you have or ever had any of these conditions: blood clots; blood sugar problems, like diabetes; cancer of the breast, cervix, ovary, uterus, vagina, or unusual vaginal bleeding that has not been evaluated by a health care professional; depression; fibroids; gallbladder disease; heart or circulation problems; high blood pressure; jaundice; liver disease; menstrual problems; migraine headaches; tobacco smoker; stroke; an unusual or allergic reaction to estrogen/progestin, other hormones, medicines, foods, dyes, or preservatives; pregnant or trying to get pregnant; breast-feeding.

For all uses of this medicine: Before starting this medication, read the paper on your prescription provided by your pharmacist. This paper will tell you about the specific product you are taking. Make certain you understand the instructions.

Keep an extra month’s supply of your pills available to ensure that you will not miss the first day of the next cycle.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

If you miss a dose of an emergency contraceptive prescription, or vomit the dose within an hour of taking it, you MUST contact your health care professional for instructions.

Try not to miss a dose of your regular birth control prescription. If you do, it may be necessary to consult your prescriber or health care professional. The following information describes only some of the ways that missed doses can be handled.

21-day schedule: If you miss one dose, take it as soon as you remember and then take the next pill at the regular time as usual. You may take 2 tablets in one day. If you miss two doses (days) in a row, take 2 tablets for the next 2 days, then, continue with your regular schedule. Whenever 1 or 2 doses are missed, you should use a second method of contraception for the next 7 days in addition to taking the pills. If you miss three doses in a row, you should notify your physician or other health care professional for instructions. You will probably need to throw away the rest of the tablets in that cycle pack and start over. Another method of contraception should be used until at least 7 doses have been taken in the new cycle. Missing a pill can cause spotting or light bleeding. Make sure that no more than 7 days pass at the end of the 21 day cycle, before you start your next pack of pills.

28-day schedule: Follow the same directions as above for the first 21 days of the schedule. If you miss 1 of the last 7 pills, you can either double the dose or skip it, but it is important to start the next month’s cycle on the scheduled day.

Alesse Storage

  •   * Keep out of the reach of children.
  •   * Store away from heat and direct light.
  •   * Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat and moisture may cause the medicine to break down.
  •   * Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Alesse Warning
Alesse cream has not been evaluated for the treatment of internal genital warts and should not be used to treat urethral, intra-vaginal, cervical, rectal or intra-anal warts. Local reactions such as erythema, erosion, excoriation/flaking and oedema are expected and are believed to be the pharmacological response of the body’s immune system to Alesse. Should an intolerable skin reaction occur, the cream should be removed by washing the area with mild soap and water. Treatment with Alesse can be resumed after the skin reaction has moderated. The effect of Alesse 5% cream on the transmission of genital/perianal warts is unknown. Alesse 5% cream may weaken condoms and vaginal diaphragms. Therefore, concurrent use is not recommended.

Important Additional Information
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, oral contraceptives are used in certain patients with the following medical conditions:

  • Amenorrhea (stopping of menses for several consecutive months)  
  • Dysfunctional uterine bleeding (abnormal uterine bleeding)  
  • Dysmenorrhea (painful menstrual bleeding)  
  • Hypermenorrhea (excessive menstrual bleeding)  
  • Emergency contraception within 72 hours of unprotected intercourse  
  • Endometriosis (painful bleeding from uterine-like tissue that can grow in different parts of the female body)  
  • Hirsutism in females (male-like hair growth)  
  • Hyperandrogenism, ovarian (excessive production of male hormones)  
  • Polycystic ovary syndrome (many problems that include amenorrhea, hirsutism, infertility, and many tiny cysts or sacs usually in both ovaries)

For patients taking this medicine for emergency contraception :

  • Must be taken with food within 72 hours of unprotected sexual intercourse. One single course (2 doses 12 hours apart) is a one-time emergency protection. Using more than one course in a month will reduce the effectiveness.  
  • Because the hormones are strong, watch for danger signs. Call your doctor if you experience any severe pains in your leg, stomach, or chest; any vision or breathing changes; yellowing of skin; headaches; numbness; or trouble in speaking.  
  • You may experience nausea so take it with food and call your doctor if you vomit the medicine.  
  • Your menstrual period may start earlier than usual. If it doesn’t start, call your doctor.

For patients taking this medicine for hirsutism:

  • You may need to use oral contraceptives for 6 to 12 months before you see less new hair growth. For patients taking this medicine for endometriosis :  
  • Sometimes instead of following the directions on the oral contraceptive’s package, your doctor may ask you to follow different directions, such as taking the active tablets in the package each day without stopping for 6 to 9 months. This means that after 21 days you will start a new package of pills. If you are not sure about how to take this medicine, discuss any questions with your health care professional.  
  • Also, your symptoms of endometriosis may worsen at first but with continued use of the oral contraceptives your symptoms should lessen and your condition improve.

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Johns Hopkins patient information

Copyright 1996-2014 Cerner Multum, Inc. Version: 16.02.
Revision date: June 22, 2011
Last revised: by Dave R. Roger, M.D.

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