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Annovera (Generic Estrogen and Progestin (Vaginal Ring Contraceptives))

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WARNING

The risk of significant side effects from oestrogen and progestin vaginal rings, such as heart attacks, blood clots, and strokes, is increased by smoking cigarettes. Women over 35 who smoke heavily are at an increased risk (15 or more cigarettes per day). You shouldn’t smoke if you use oestrogen and/or progesterone.

Why is this medication prescribed?

Vaginal rings that contain both oestrogen and progestin are used to prevent pregnancy. Two female sex hormones are oestrogen (ethinyl estradiol) and progestin (etonogestrel or segesterone). Combination hormonal contraceptives are a family of drugs that contain both oestrogen and progestin (birth control medications). In order to prevent ovulation, oestrogen and progestin combinations are effective (the release of eggs from the ovaries). Additionally, they alter the uterine lining (womb) to stop pregnancy from occurring as well as the mucus at the cervix (uterine opening) to stop sperm (male reproductive cells) from entering. Although contraceptive vaginal rings are a very efficient means of birth control, they are unable to stop the spread of the HIV virus, which is the cause of AIDS, and other sexually transmitted diseases.

How should this medicine be used?

Vaginal rings with oestrogen and progestin are flexible rings that are used as contraceptives. The vaginal oestrogen and progestin ring contraceptives are typically inserted and left in place for three weeks. Remove the vaginal ring for a week after using it for three weeks. After 3 weeks of use, wash the Annovera® vaginal ring with mild soap and warm water, pat it dry with a soft cloth or paper towel, and then store it in the included case for the subsequent 1 week. You can discard the NuvaRing® vaginal ring after three weeks of use and replace it with a new one after the break of one week. At the conclusion of the 1-week hiatus, make sure you put your vaginal ring in at the same time and on the same day as you normally do, even if you are still bleeding. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the contraceptive ring’s instructions exactly. Never wear more than one contraceptive ring at once, and always put on and take off the ring as directed by your doctor.

There are various brands of vaginal contraceptive rings. Different kinds of contraceptive rings use somewhat different techniques, have slightly different risks, and slightly different benefits. They also contain slightly different drugs or doses. Make sure you are aware of the brand of vaginal contraceptive ring you are using and the proper usage instructions. Request a copy of the manufacturer’s information for the patient from your doctor or pharmacist and carefully study it.

When to place your first vaginal contraceptive ring will be determined by your doctor. This depends on whether you recently gave birth, had an abortion, miscarriage, or used another form of birth control over the previous month. It also relies on if you weren’t taking birth control at all. For the first seven days after starting to use the contraceptive ring, you may occasionally need to use another form of birth control. Male condoms and/or spermicides are a few options that your doctor can advise you on if you need to utilise backup birth control. When a contraceptive ring is in place, you shouldn’t use a female condom, cervical cap, or diaphragm.

In order to repeat the cycle of 3 weeks of use with a 1-week break while using a new vaginal ring for each cycle, if you are using the NuvaRing® vaginal ring, insert a new ring after the break.

If you are using an Annovera® vaginal ring, insert the clean ring once you have rested for a week. You can repeat this cycle of 3 weeks of use followed by a week off for up to 13 cycles.

Until you take the contraceptive ring out of your vagina, it usually remains there. It might occasionally come out while you’re removing a tampon, engaging in sexual activity, or having a bowel movement. If your contraceptive ring frequently comes off, contact your doctor.

If your NuvaRing® contraceptive ring comes off, you should try to replace it within three hours after rinsing it with cool or lukewarm water (not hot). However, if your NuvaRing® vaginal ring breaks or comes off and is damaged, throw it away and get a new one. If your ring is lost or falls out, you should replace it with a new one and take the new one off at the same time that you were going to take the lost one off. You must use a non-hormonal backup method of birth control (such as condoms with spermicide) if you don’t replace your NuvaRing® vaginal ring in a timely manner. This requirement applies until you have worn the ring for seven consecutive days.

Try to replace your Annovera® contraceptive vaginal ring within two hours after it has been washed with mild soap and warm water, rinsed, and pat dried with a fresh cloth towel or paper towel. You must use a non-hormonal backup method of birth control (such as condoms with spermicide) until you have had the ring in place for 7 days in a row if your vaginal ring is out of place for more than a total of 2 hours over the cycle of 3 weeks during which the vaginal ring is to be inserted.

Before and after sex, routinely check to see if the vaginal ring is still there.

Only when frequently worn will vaginal contraceptive rings be effective. Without consulting your doctor, never discontinue wearing vaginal rings for contraception.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before using the estrogen and progestin vaginal ring,

  • If you have an allergy to etonogestrel, segesterone, ethinyl estradiol, any other drugs, or any of the components in the oestrogen and progestin vaginal ring, let your doctor and pharmacist know right away. For a list of the components in the oestrogen and progestin vaginal ring, ask your pharmacist.
  • Inform your physician whether you are taking dasabuvir with or without ombitasvir, paritaprevir, and ritonavir (Technivie) (in Viekira Pak). If you are on one or more of these medications, your doctor generally won’t let you use an oestrogen or progestin vaginal ring.
  • Inform your doctor and pharmacist about all the vitamins, nutritional supplements, and prescription and non-prescription drugs you are using. Any of the following should be mentioned: Aprepitant (Emend), ascorbic acid (vitamin C), atorvastatin (Lipitor), barbiturates, and boceprevir (Victrelis; no longer available in the United States); acetaminophen (Tylenol, others); antifungals such as fluconazole (Diflucan), griseofulvin (Gris-Peg), itraconazole (Onmel, Sporanox), drugs for HIV or AIDS such as atazanavir (Reyataz), darunavir (Prezista) with ritonavir (Norvir), delavirdine (Rescriptor), and efavirenz; bosentan (Tracleer); clofibric acid; cyclosporine (Gengraf, Neoral, Sandimmune); (Sustiva), morphine (Astramorph, Kadian, etc); prednisolone (Orapred); etravirine (Intelence), indinavir (Crixivan), lopinavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), and tipranavir (Aptivus); drugs to treat seizures like carbamazepine (Tegretol, Teril, others), felbamate (Felbatol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and topiramate (Topamax); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane) thyroid hormone, tizanidine, thyroid supplement, and theophylline (Elixophyllin, Theo-24, and other brands) (Zanaflex). The dosage of your drugs may need to be adjusted, and your health may need to be closely watched for any negative effects. If you take some of these medications in addition to using the contraceptive ring, you may need to utilise another method of birth control.
  • Inform your doctor about any herbal medications you are taking, particularly any that contain St. John’s wort.
  • Inform your doctor if you have or have ever had any of the following conditions: blood clots in your legs or lungs; high cholesterol or triglycerides; high blood pressure; cerebrovascular disease (clogging or weakening of the blood vessels within the brain or leading to the brain); a stroke or mini-stroke; chest pain; a heart attack; high cholesterol or triglycerides; high blood pressure; or cerebrovascular disease, any condition that affects your heart valves (flaps of tissue that open and close to regulate blood flow in the heart); atrial fibrillation; an irregular pulse; if you have diabetes and are over 35; if you have diabetes and have high blood pressure or issues with your kidneys, blood vessels, eyes, or nerves; if you have had diabetes for more than 20 years; if you have diabetes that has affected your circulation; if you have migraines; if you have liver tumours or liver disease; if you have bleeding or blood clotting issues; if you have unexplained vaginal bleeding; or if you have hepatitis Most likely, your doctor will advise against using an oestrogen and progestin vaginal ring.
  • If you recently had a baby, a miscarriage, or an abortion, let your doctor know. Inform your physician if you have or have ever had jaundice (yellowing of the skin or eyes), breast issues such as an abnormal mammography or breast x-ray, breast nodules, or fibrocystic breast disease, a history of breast cancer in your family, seizures, or depression; melasma (brown patches on the face), a bulging or drooping uterus, bladder, or rectum, as well as any condition that increases the likelihood of vaginal irritation; Among the conditions that might induce episodes of swelling in the hands, feet, face, airway, or intestines include toxic shock syndrome (a bacterial infection), hereditary angioedema, renal, thyroid, or gallbladder disorders.
  • If you are pregnant or want to become pregnant, let your doctor know. Call your doctor right away if you become pregnant while using an oestrogen and progestin vaginal ring. If you have used the contraceptive ring as directed and you miss two periods in a row, or if you have not used the contraceptive ring as directed and you miss one period, you should be concerned that you may be pregnant and contact your doctor. Using the contraceptive ring while nursing is not advised.
  • Inform the surgeon that you are wearing an oestrogen and progestin vaginal ring if you are having surgery. For some surgeries, your doctor might advise you to refrain from using the vaginal ring at least 4 weeks beforehand and for up to 2 weeks afterwards.

What special dietary instructions should I follow?

If you plan to consume grapefruit juice while taking this medicine, consult your doctor.

What should I do if I forget a dose?

There are unique instructions for when to remove and/or put the vaginal contraceptive ring for each brand. Read the manufacturer’s material for the patient that was included with your contraceptive ring very carefully to understand the guidelines. Use a backup method of birth control if you don’t insert the vaginal ring correctly or forget to take a dose. Using more than one vaginal ring at once is not advised. Call your physician or pharmacist with any inquiries.

What side effects can this medication cause?

Vaginal rings containing oestrogen and progestin may have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Vaginal swelling, redness, irritability, burning, itching, or infection
  • Yellow or white vaginal discharge
  • When your period is not due, there is vaginal bleeding or spotting
  • Abnormal breast sensitivity
  • Headache
  • Nausea
  • Vomiting
  • Diarrhea
  • Loss or increase of weight
  • Breast soreness, tenderness, or pain
  • Foreign body discomfort or pain in the vagina
  • Abdominal pain
  • Acne
  • Variations in sexual aversion

Some adverse effects can be very harmful. Although the following signs are not common, if you notice any of them, consult your doctor right away:

  • Back of the lower leg discomfort
  • Chest discomfort that is severe, sudden, or crushing
  • Chest heaviness
  • Sudden breathlessness
  • Sudden fainting, vomiting, dizziness, or a strong headache
  • Sudden speech problems
  • Arm or leg weakness or numbness
  • Any other visual changes, such as double vision or blurry vision
  • Dark skin spots on the chin, upper lip, cheeks, and/or forehead
  • Yellowing of the skin or eyes, lack of appetite, dark urine, excessive fatigue, weakness, or pale stools are some symptoms that you might experience
  • Sudden onset of a high temperature, nausea, vomiting, feeling lightheaded or dizzy on standing up, rash, muscle aches, or faintness
  • Depression, trouble falling or staying asleep, fatigue, or other mood swings
  • Rash, itching, hives, or swelling of the hands, feet, ankles, or lower legs

Your risk of developing liver tumours may increase if you use vaginal oestrogen and progestin rings. Although these tumours are not cancerous, they have the potential to rupture and result in significant internal bleeding. Discuss the dangers of wearing the contraceptive ring with your doctor.

Other negative effects could result from progestin and oestrogen vaginal rings. If you experience any strange issues while taking this drug, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it at room temperature away from moisture, heat, and sunshine (not in the bathroom). Do not freeze or chill it. In the accompanying sachet (foil bag) and then into a trash can, throw away the NuvaRing® if it hasn’t been used by the expiration date. The vaginal ring should not be flushed down the toilet.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Overdose symptoms could include:

  • Bleeding
  • Nausea
  • Vomiting

What other information should I know?

Keep all of your appointments with your physician and the lab. When checking your breasts, according to your doctor’s instructions and report any lumps right away.

Inform the lab staff and your doctor that you are using an oestrogen and progestin vaginal ring prior to any laboratory test.

Use the Annovera® vaginal ring without any oil-based (including silicone-based) vaginal lubricants.

Do not share your medication with anybody else. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

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