Haloette

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, patch, ring). The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.

Refer to the product package information for instructions. You may need to use backup birth control (such as condoms, spermicide) to prevent pregnancy. Ask your doctor or pharmacist if you have any questions.

If you have trouble remembering to remove and reinsert the ring as directed, or if it falls out repeatedly, contact your doctor to discuss switching to another form of birth control.

This product may be harmful if swallowed. Overdose with this product is highly unlikely. Do not use more than one ring at a time. If someone has overdosed, remove the ring if possible. For serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information on how to properly use and dispose of the vaginal ring. If you have any questions, ask your doctor or pharmacist.

This product is for vaginal use only. Before use, wash and dry your hands. Remove the ring from the reclosable foil pouch, keeping the pouch for later disposal of the used ring. Fold the ring in half and gently push it into your vagina as directed, until it feels comfortable. Although some women may be aware of the ring in the vagina, most women do not feel it once it is in place; it will not interfere with sexual intercourse (though your partner may be able to feel the ring). Unlike a diaphragm, the ring's exact position in the vagina does not affect how well it works. Once inserted, keep the ring in place for 3 weeks in a row.

If this is the first time you are using the ring, use a backup form of non-hormonal birth control (such as condoms, spermicide) for the first 7 days to prevent pregnancy until the ring has enough time to work. Do not use a diaphragm, female condom, or cervical cap for backup birth control since the ring may interfere with proper placement. If you start using the ring on the first day of your period, you do not need to use backup birth control the first week.

After using the ring for 3 weeks, remove it on the same day of the week and about the same time that you placed it. Place the used ring back into the foil pouch and discard in the trash. Do not flush the used ring down a toilet. If you have pain/bleeding when trying to remove the ring, or if you cannot remove it, tell your doctor right away.

Next, do not wear a ring for 1 week (7 days). You should have your period within 2 to 3 days after the ring is removed. After 1 ring-free week, insert a new ring on the same day of the week that you removed the old ring, whether or not you have your period. If you do not get your period, consult your doctor. Do not go longer than 7 days without a ring. Doing so will increase your risk of pregnancy.

Regularly check that the ring is in your vagina, such as before and after sexual intercourse. The ring may accidentally fall out during sexual intercourse, during a bowel movement, or while removing a tampon. If this happens and the ring has been out of your vagina for less than 3 hours, rinse it with cool to lukewarm (not hot) water and re-insert the ring as soon as possible. If the ring has been out longer than 3 hours, you could become pregnant. Re-insert it or insert a new ring as directed and use a backup form of non-hormonal birth control (such as condoms, spermicide) for the next 7 days to prevent pregnancy. If you are not sure how long the ring has been out of your vagina, you may not be protected from pregnancy. Contact your doctor for a pregnancy test before inserting a new ring and use a backup form of non-hormonal birth control (such as condoms, spermicide) for 7 days.

If you have left the ring in place longer than directed, up to an extra week (4 weeks total), you will still be protected from pregnancy. Remove the ring and insert a new ring after 1 ring-free week. However, if you have left the ring in place longer than 4 weeks, you may not be protected from pregnancy. Remove the ring and contact your doctor for a pregnancy test before inserting a new ring and use a backup form of non-hormonal birth control (such as condoms, spermicide) for 7 days.

Rarely, the vaginal ring has broken at the weld joint after placement. This increases the chance of it slipping out of the vagina. If this happens, throw it away and use a new ring.

Ask your doctor or pharmacist about how to switch from other forms of hormonal birth control (such as birth control pills) to this product. If any information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.

Vaginal discomfort/irritation, nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change may occur. Vaginal bleeding between periods (spotting) may occur, especially during the first few months of use. If any of these effects last or get worse, tell your doctor or pharmacist promptly. If you miss 2 periods in a row (or 1 period if the ring has not been used properly), talk to your doctor about a pregnancy test.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new/worsening depression), severe stomach/abdominal pain, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), dark urine, yellowing eyes/skin.

Very rarely, the ring has been accidentally placed into the bladder. Tell your doctor right away if you have urgent/frequent/burning/painful urination and cannot find the ring in your vagina.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have: chest/jaw/left arm pain, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, trouble speaking, shortness of breath/rapid breathing, sudden/severe headaches, unusual sweating, weakness on one side of the body, sudden vision changes.

Rarely, a very serious (possibly fatal) bacterial infection (toxic shock syndrome-TSS) has occurred in women using vaginal rings. Remove this product and get medical help right away if you develop symptoms of toxic shock syndrome, including: sudden high fever, severe/sudden dizziness, fainting, unusual muscle pain, sunburn-like rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using this product, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or etonogestrel; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (for example, in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), high cholesterol or triglyceride (blood fat) levels, depression, diabetes, family or personal history of a certain swelling disorder (angioedema), gallbladder problems, severe headaches/migraines, heart problems (such as heart valve disease, irregular heartbeat, previous heart attack), history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch), liver disease (including tumors), obesity, stroke, swelling (edema), thyroid problems, vaginal conditions (such as unexplained vaginal bleeding, vaginal stenosis, prolapsed uterus).

If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Tell your doctor if you just had or will be having surgery or if you will be confined to a bed or chair for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using hormonal birth control. You may need to stop this medication for a time or take special precautions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

The hormones in this product may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.

A small amount of this medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aromatase inhibitors (such as anastrozole, exemestane), fezolinetant, ospemifene, tamoxifen, tizanidine, tranexamic acid, certain combination products used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir with or without dasabuvir).

Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), ritonavir, St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine), among others.

Tell your doctor when you start any new drug, and discuss if you should use reliable non-hormonal backup birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain lab tests (such as blood clotting factors, thyroid), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Different brands of this product have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Do not use after 4 months or after the expiration date, whichever comes first. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. (See also How to Use section.)