Cryselle (Oral)

Ethinyl estradiol and norgestrel 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 like surgery to become sterile or abstaining from 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 work as emergency contraception, such as after unprotected sexual contact.

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

It is very important for your doctor to monitor your progress at regular visits to ensure this medicine is effective and does not cause unwanted side effects. Your doctor may also want to check your blood pressure while you are using this medicine.

Even though you are using this medicine to prevent pregnancy, you should be aware that using this medicine while pregnant could harm your unborn baby. If you think you might be pregnant while taking this medicine, inform your doctor immediately.

You may be pregnant if:

• You do not take the pills regularly and have missed a menstrual period.
• You have missed 2 menstrual periods.

If you suspect you may be pregnant, stop using this medicine and consult your doctor right away. You may have a higher risk of an ectopic pregnancy if you become pregnant while using this medicine. An ectopic pregnancy can be serious and life-threatening. It may also lead to future difficulties in becoming pregnant.

Do not use this medicine along with any medicine for treating hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

This medicine will not protect you from HIV/AIDS, herpes, or other sexually transmitted diseases. Inform your doctor if you or your partner start having sexual intercourse with other people, or if you or your partner test positive for a sexually transmitted disease. If this is a concern for you, discuss it with your doctor.

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

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

Using this medicine may raise your risk of blood clotting problems. Contact your doctor immediately if you experience chest pain, groin or leg pain (especially in the calves), difficulty breathing, a sudden severe headache, slurred speech, sudden unexplained shortness of breath, sudden loss of coordination, or vision changes while taking this medicine.

Using this medicine may increase your risk of breast cancer or cancer of your reproductive organs (e.g., endometrium, ovaries, cervix). Discuss this risk with your doctor. Contact your doctor right away if you notice abnormal vaginal bleeding.

Contact your doctor immediately if you have stomach pain or tenderness, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellowing of your eyes or skin. These could be signs of a serious liver issue.

Check with your doctor right away if you experience blurred vision, difficulty reading, or any other changes in vision during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to examine your eyes.

This medicine may increase your risk of gallbladder disease. Consult your doctor if you begin to experience stomach pain, nausea, and vomiting.

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

Do not take other medicines unless you have discussed them with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medicines, as well as herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor will need to weigh the risks against the benefits. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients closely.

Pediatric

Studies on how ethinyl estradiol and norgestrel combination affects children have not been done. However, there are no expected problems that would limit the use of this medicine in teenagers. This medicine can be used for birth control in teenage females but should not be used before menstruation begins.

Geriatric

Studies on how ethinyl estradiol and norgestrel combination affects elderly patients have not been done. This medicine is not meant for use in elderly women.

Breast Feeding

Research shows that this medicine can cause harmful effects in breastfeeding infants. You should either stop breastfeeding or use a different medication.

Interactions with Medicines

Some medicines should never be used together, while others might be used together with caution. If you are taking this medicine, it is very important that your healthcare professional knows if you are taking any of the following medicines. The interactions listed below are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or may change other medicines you are taking.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Aprobarbital
• Armodafinil
• Artemether
• Bacampicillin
• Barbital
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Eterobarb
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Heptabarbital
• Hexobarbital
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both may be necessary for your treatment. If both are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Roflumilast
• Selegiline
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines can also cause interactions. The following interactions are significant but may not cover all possibilities.

Using this medicine with any of the following may increase the risk of certain side effects, but it may be necessary in some cases. If used together, your doctor may adjust the dose or how often you use this medicine or provide specific instructions about food, alcohol, or tobacco use.

• Caffeine

Other Medical Problems

Other medical conditions may affect how this medicine works for you. Be sure to tell your doctor if you have any other medical issues, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, or history of or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (e.g., coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure), uncontrolled or
• Jaundice during pregnancy or from past hormonal therapy or
• Liver disease, including tumors or cancer or
• Major surgery planned soon, with long periods of immobility or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Depression, history of or
• Epilepsy, history of or
• Gallbladder disease, history of or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease—May worsen these conditions.

• Diarrhea or
• Vomiting—May reduce how much ethinyl estradiol and norgestrel combination is absorbed in the body.

Along with its needed effects, Cryselle (Oral) may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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
• backache
• belching
• bleeding between periods
• blurred vision
• breast tenderness, pain, enlargement, or secretion
• change in the amount of bleeding during periods
• change in the pattern of monthly periods
• changes in skin color, pain, tenderness, swelling of the foot or leg
• chest pain or discomfort
• chills
• clay-colored stools
• clear or bloody discharge from the nipple
• cough
• dark urine
• diarrhea
• difficulty swallowing
• dimpling of the breast skin
• dizziness
• dull ache or feeling of pressure or heaviness in the legs
• fast heartbeat
• fever
• full or bloated feeling or pressure in the stomach
• headache
• headache, severe and throbbing
• heartburn
• hives
• inability to speak
• indigestion
• inverted nipple
• itching of the vagina or genital area
• itching skin near damaged veins
• light vaginal bleeding between periods and after intercourse
• loss of appetite
• lump in the breast or under the arm
• nausea and vomiting
• nervousness
• pain during sexual intercourse
• pain or discomfort in the arms, jaw, back or neck
• persistent crusting or scaling of the nipple
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness or swelling of the breast
• seizures
• severe or sudden headache
• slow or fast heartbeat
• slurred speech
• sore on the skin of the breast that does not heal
• stomach discomfort, upset, or pain
• stopping of menstrual bleeding
• sweating
• swelling, pain, or tenderness in the upper abdominal area
• swollen feet and ankles
• temporary blindness
• thick, white vaginal discharge with no odor or with a mild odor
• tightness in the chest
• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
• unpleasant breath odor
• unusual stopping of menstrual bleeding
• unusual tiredness or weakness
• vomiting of blood
• weakness in the arm or leg on one side of the body, sudden and severe
• 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 Cryselle (Oral). Your health care professional may also 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:

Incidence not known

• Acne
• changes in weight or appetite
• decreased interest in sexual intercourse
• inability to have or keep an erection
• increased hair growth, especially on the face
• intolerance to contact lenses
• loss in sexual ability, desire, drive, or performance
• loss of hair on the scalp

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Cryselle
• Lo/Ovral
• Low-Ogestrel
• Ogestrel
• Ovral

Available Dosage Forms:

• Tablet

Therapeutic Class: Contraceptive

Pharmacologic Class: Estrogen

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You may begin taking the pills on the first day of your menstrual period, or on the first Sunday after your period begins.

You should use a second form of birth control (eg, condoms, diaphragms, or contraceptive foams and jellies) when you first start using this medicine.

It is very important that you take this medicine on time every day. Birth control pills work best when there is no more than 24 hours between doses.

You could have light bleeding or spotting 3 days after you stop taking a white tablet, or when you switch to ethinyl estradiol and norgestrel combination from another birth control pill or implant, or injection.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For prevention of pregnancy:For oral dosage form (tablets): Adults—One white tablet each day for 21 days. Then one peach tablet per day for 7 days. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss one white pill, take it as soon as you can. Then take your next pill at the regular time. This means, you may take two pills in one day. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you miss two white pills in a row during Week 1 or 2, take two pills as soon as you can. Take two more pills on the next day. Then go back to your regular schedule of taking one pill every day. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you started this medicine on Day 1 of your period and you miss two white pills in a row during Week 3, throw out the rest of your pills and start a new pack the same day. If you miss three or more white pills in a row during any week, throw out the rest of your pills and start a new pack the same day. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you started this medicine on the Sunday after your period started and you miss two white pills in a row during Week 3, keep taking one pill every day until the next Sunday. Then throw away the rest of your pills and start a new pack on that same Sunday. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you started this medicine on the Sunday after your period started and you miss three or more white pills in a row during any week, keep taking one pill every day until the next Sunday. Then throw away the rest of your pills and start a new pack on that same Sunday. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you miss your pills and change your schedule, you may not have a period for that month. Make sure your doctor knows if you miss your period two months in a row, because you may be pregnant.

You could have light bleeding or spotting any time you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.