Alesse

Ethinyl Estradiol and Levonorgestrel tablet

What is it used for?

ETHINYL ESTRADIOL/LEVONORGESTREL products are effective as the oral contraceptives (birth control pills or 'the pill'). These products combine natural and synthetic estrogens and progestins, similar to the natural sex hormones (estrogen and progesterone) produced in a woman's body.

Ethinyl estradiol is an estrogen and levonorgestrel is a progestin. These products can prevent ovulation and pregnancy. In general, a combination of estrogen and progestin works better than a single-ingredient product. After consultation with a health care professional, these products can be used under specific circumstances for emergency contraception after unprotected sex, contact your health care prescriber for information.

Ethinyl estradiol/levonorgestrel tablets can also help to regulate menstrual flow, treat acne, or may be used for other hormone related problems in females. The type and amount of estrogen and/or progestin may be different from one product to another.

What should I discuss with my physician prior to taking this medicine?

They need 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
• strokes
• systemic lupus erythematosus (SLE)
• tobacco smoker
• an unusual or allergic reaction to estrogen/progestin, other hormones, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How is this medicine should be taken?

For the routine prevention of pregnancy.

The usage of the most products should be started on the first Sunday after the begining of your period or on the first day of your period. You may need to ask your health care provider on which day you should start the course.

Take ethinyl estradiol/levonorgestrel pills orally. Before you start taking these pills, decide what is a suitable time of the day for you and always take them at the same time of day and in the exact order as directed by your doctor. Swallow the pills with a drink of water. Take with food to reduce stomach upset. You shouldn’t take the pills more often than directed.

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

NOTE: This medicine is only for you, don't share it with the others.

What to do if I missed a dose?

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

If you miss one dose, take it as soon as you remember about it and then take the next pill at the regular time as usual. You may take 2 tablets on the same day. If you miss two doses (days) in a row, take 2 tablets on the day you remember about it and 2 tablets on the next day, 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 and request additional instructions from them. 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 once when 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.

What are the possible interactions with the other medicine/food/etc?

• anastrozole
• antibiotics or medicines for infections, especially rifampin
• aprepitant
• barbiturate medicines for producing sleep or treating seizures (convulsions)
• bosentan
• carbamazepine
• caffeine
• clofibrate
• cyclosporine
• dantrolene
• doxercalciferol
• exemestane
• grapefruit juice
• hydrocortisone
• letrozole
• 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
• testolactone
• theophylline
• topiramate
• warfarin

Provide your physician with the list of all the medicine, including herbs and non-prescription drugs, or dietary supplements that you are using. Do let them know if you smoke, drink alcohol, or use any of the illegal drugs or drinks with caffeine or alcohol. Some of those items may also interact with your medicine, causing undesired consequenses. Check with your doctor prior to giving up on or taking up any medicines.

What should I watch for while taking this medicine?

Visit your prescriber or health care provider for the 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 straightaway. 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 additional method of contraception during the first 7 days of the course.

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

If you are taking oral contraceptives for the treatment of acne, hirsutism (male-like hair growth), endometriosis or other hormone related problems, it may take several months of continued treatment to notice improvement in your symptoms or condition.

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

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

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

For 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 to limit this. See your dentist regularly and inform your dentist of all the medicines that 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 a elective surgery, you may need to stop taking your contraceptive pills one month in advance. Consult with your health care professional for advice prior to scheduling the surgery.

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

Does this medicine have any possible side effects?

Severe side effects are relatively rare among women who are healthy and do not smoke while they are taking oral contraceptives. On average, more women have problems due to the complications from pregnancy than actually with the oral contraceptives. Many of the minor side effects may go away as your body adjusts to the medicine. However, the potential for severe side effects does exist and you may want to discuss these with your health care provider.

The following symptoms or side effects may be related to blood clots and require immediate medical or emergency help:

• chest pains
• 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

This list may not include all side effects.

Where should I store it?

Keep this medicine out of the children’s reach.

This medicine should be stored at the room temperatures between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Dispose of any unused medicine after the expiry date is reached.