Alesse (28) oral

Name: Alesse (28) oral

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Commonly used brand name(s)

In the U.S.

Alesse
Alesse-28
Altavera
Amethia
Amethia Lo
Aviane
Camrese
CamreseLo
Enpresse
Introvale
Jolessa
Lessina

Available Dosage Forms:

Tablet

Therapeutic Class: Contraceptive

Pharmacologic Class: Progestin

Uses For Alesse-28

Levonorgestrel and ethinyl estradiol combination is used to prevent pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine will not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor's prescription.

Before Using Alesse-28

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of levonorgestrel and ethinyl estradiol combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

No information is available on the relationship of age to the effects of levonorgestrel and ethinyl estradiol combination in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dasabuvir
Ombitasvir
Paritaprevir
Ritonavir
Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Anagrelide
Aprepitant
Boceprevir
Bosentan
Bupropion
Carbamazepine
Ceritinib
Dabrafenib
Darunavir
Dexamethasone
Donepezil
Efavirenz
Eliglustat
Enzalutamide
Fosaprepitant
Fosphenytoin
Glecaprevir
Griseofulvin
Idelalisib
Isotretinoin
Lesinurad
Lixisenatide
Lumacaftor
Mitotane
Modafinil
Oxcarbazepine
Paclitaxel
Paclitaxel Protein-Bound
Phenytoin
Pibrentasvir
Piperaquine
Pitolisant
Prednisone
Rifabutin
Rifampin
St John's Wort
Sugammadex
Theophylline
Tizanidine
Topiramate
Ulipristal
Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acitretin
Alprazolam
Amprenavir
Atazanavir
Bacampicillin
Betamethasone
Bexarotene
Clarithromycin
Colesevelam
Cyclosporine
Delavirdine
Efavirenz
Eslicarbazepine Acetate
Etoricoxib
Fosamprenavir
Ginseng
Lamotrigine
Licorice
Mycophenolate Mofetil
Mycophenolic Acid
Nelfinavir
Parecoxib
Perampanel
Prednisolone
Rifapentine
Ritonavir
Roflumilast
Rosuvastatin
Rufinamide
Selegiline
Tacrine
Telaprevir
Tipranavir
Troglitazone
Troleandomycin
Valdecoxib
Voriconazole
Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Caffeine
Grapefruit Juice

Precautions While Using Alesse-28

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before you start using this medicine.

If you suspect that you may be pregnant, check with your doctor right away.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

You might have some light bleeding or spotting when you first start using this medicine. This is usually normal and should not last long. However, if you have heavy bleeding or the bleeding lasts more than a few days in a row, call your doctor.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using ethinyl estradiol and norgestrel combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Using this medicine may increase your risk of having cancer of the breast or your reproductive organs (eg, endometrium, ovaries, cervix). Talk with your doctor about this risk. Check with your doctor right away if you experience abnormal vaginal bleeding.

Check with your doctor right away if you have pain or tenderness in the stomach, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Alesse-28 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Absent, missed, or irregular menstrual periods
anxiety
bloody stools
blurred vision
breast tenderness, enlargement, discharge
changes in skin color, pain, tenderness, or swelling of the foot or leg
chest pain or discomfort
chills
clay-colored stools
confusion
cough
dark or cloudy urine
decrease in urine output or decrease in urine-concentrating ability
diarrhea
difficult, burning, or painful urination
difficulty in speaking
dizziness or lightheadedness
double vision
dull ache or feeling of pressure or heaviness in the legs
fainting
fast heartbeat
fever
fluid-filled skin blisters
frequent urge to urinate
headache, severe and throbbing
inability to move the arms, legs, or facial muscles
inability to speak
itching of the vagina or outside the genitals
itching skin near damaged veins
light vaginal bleeding between regular menstrual periods
loss of appetite
nausea
nervousness
pain during sexual intercourse
pain or discomfort in the arms, jaw, back or neck
pelvic pain
pounding in the ears
sensitivity to the sun
skin thinness
slow or fast heartbeat
slow speech
stomach bloating and cramping
stomach pain and tenderness
stopping of menstrual bleeding
sweating
swelling
swelling, pain, or tenderness in the upper abdominal area
swollen feet and ankles
tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
thick, white curd-like vaginal discharge without odor or with mild odor
troubled breathing
twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
unpleasant breath odor
unusual tiredness or weakness
vomiting
vomiting of blood
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: