Ovrette (Oral)

Norgestrel is used to prevent pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept sperm, which prevents fertilization (pregnancy).

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 birth control options with your doctor.

This medicine does not protect against HIV infection or other sexually transmitted diseases. It will not work as emergency contraception, such as after unprotected sexual contact.

This medicine is available over-the-counter.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood and urine tests may also be needed to look for unwanted effects.

Even though 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 might be pregnant while using this medicine, tell your doctor right away.

Contact your doctor immediately if you miss a menstrual period. Missed periods can happen if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.

You may have a higher risk of developing an ovarian cyst or an ectopic pregnancy (which occurs outside the womb) if you get pregnant while using this medicine. These can be serious and life-threatening conditions. They can also cause issues that may make it harder for you to become pregnant in the future. Call your doctor right away if you experience sudden or severe lower abdominal or stomach pain.

Contact your doctor immediately if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellowing of the eyes or skin. These could be signs of a serious liver problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having certain medical tests.

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision that you and your doctor will make together. 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 inform your healthcare 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 norgestrel have not been performed in children. However, there are no expected pediatric-specific issues that would limit the usefulness of this medicine in teenagers. This medicine may be used for birth control in teenage females but should not be used before menstruation begins.

Geriatric

Appropriate studies on the relationship of age to the effects of norgestrel have not been performed in older adults. This medicine is not indicated for use in elderly women.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below when using this medicine. The following interactions are selected based on 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.

• Tranexamic Acid

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

• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Apalutamide
• Aprepitant
• Aprobarbital
• Armodafinil
• Artemether
• Bacampicillin
• Barbital
• Belzutifan
• Betamethasone
• Bexarotene
• Bosentan
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Clobazam
• Cloxacillin
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Doxycycline
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Eterobarb
• Etravirine
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Griseofulvin
• Guar Gum
• Heptabarbital
• Hexobarbital
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rufinamide
• Secobarbital
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Tetracycline
• Theophylline
• Thiopental
• Ticarcillin
• Tigecycline
• Tirzepatide
• Tizanidine
• Topiramate
• Ulipristal

Using this medicine with any of the following medicines may increase the 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 adjust the dose or frequency of one or both of the medicines.

• Amitriptyline
• Atazanavir
• Clomipramine
• Diazepam
• Doxepin
• Imipramine
• Lamotrigine
• Licorice
• Lorazepam
• Selegiline
• Temazepam
• Triazolam
• Troleandomycin
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

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

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

• Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Breast cancer, either active or a history of or
• Liver disease, including tumors or cancer—Should not be used in patients with these conditions.

• Allergy to aspirin—Use with caution. This medicine contains a yellow dye called tartrazine, which may cause allergic reactions (including asthma) in patients with this condition.

• Diabetes or
• Dyslipidemia (high cholesterol or fats in the blood) or
• Migraine headache—Use with caution. May worsen these conditions.

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

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

More common

• Change in vision
• dizziness
• heavy bleeding
• severe headache
• stomach pain, cramps, or bloating
• white or brownish vaginal discharge

Incidence not known

• Absent, missed, or irregular menstrual periods
• bloating
• dark urine
• loss of appetite
• menstrual changes
• nausea or vomiting
• stomach or pelvic discomfort, aching, or heaviness
• stopping of menstrual bleeding
• yellow eyes or skin
• unusual tiredness or weakness

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:

More common

• Backache
• blemishes on the skin
• breast discomfort
• increased appetite
• nervousness
• pimples

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.

• Opill
• Ovrette

Pharmacologic Class: Progestin

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.

To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.

This medicine comes with patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Follow the instructions on the medicine label if you are using this medicine without a prescription.

This medicine is available in blister packs. Each blister pack contains 28 tablets that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 2 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 2 days of your first cycle of pills.

Take this medicine at the same time each day.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may have light bleeding or spotting when you first take the pill.

If you vomit or have diarrhea within 4 hours of taking this medicine, you should use another method of birth control during the next 48 hours.

If you are switching from a combined pills to using Opill®, take the medicine on the day you finish the last active combined pill. Do not take any of the inactive pills from the previous birth control pack.

If you are switching to another brand, you may start taking it any time.

If you are switching from another type of progestin-only method (eg, implant, injection, intrauterine system), take the medicine on the day your implant is removed, or on the day you would have your next injection. You must also use a second method of birth control (eg, condom, diaphragm, spermicide) for the first 48 hours you take this medicine.

If you have a miscarriage or an abortion, you may take the pills the next day. You should use a second form of birth control for the first 48 hours.

If you use this medicine after giving birth and choose not to breastfeed, you may take the pills the next day. You should use a second form of birth control for the first 48 hours.

Take this medicine at least 5 days after using ulipristal acetate. Use another form of birth control (eg, condom, spermicide) until your next menstrual period.

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.

You can start taking your first pill on any day. You need to use another form of birth control (eg, condom, spermicide) for the first 48 hours if you start taking this medicine.

• For oral dosage forms (tablets):For contraception (to prevent pregnancy): Adults and teenagers—One tablet taken at the same time each day for 28 days. Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

• If you miss a dose, and it is less than 3 hours from your usual time you take the pill, take the tablet as soon as possible and take the next tablet at your regular schedule.
• If you miss a dose, and it is more than 3 hours from your usual time you take the pill, take the tablet as soon as possible and take the next tablet at your regular schedule. This means you may take 2 tablets in 1 day. Use a second form of birth control (eg, condom, spermicide) for 48 hours after restarting the dose.
• If you miss more than one tablet: Take two tablets as soon as possible and take the next tablet at your regular schedule. Use a second form of birth control (eg, condom, spermicide) for 48 hours after restarting the dose.
• If you miss three tablets or more: You might be pregnant. You may keep taking the tablet. Use a second form of birth control (eg, condom, spermicide) for 48 hours after restarting the dose.

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.

• How do I use Opill birth control?
• How effective is Opill OTC birth control?
• When will Opill be available?