Nuvaring Vaginal Ring (Ethinyl Estradiol/ Etonogestrel)

Serious Warnings and Precautions

Cigarette smoking increases the risk of cardiovascular side effects (heart and blood vessel problems) associated with the use of hormonal contraceptives. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, NuvaRing should not be used by women who are over 35 years of age and smoke.

NuvaRing (as with other hormonal contraceptives) DOES NOT PROTECT against HIV infection (AIDS) and other Sexually Transmitted Infections (STIs). For protection against STIs, it is advisable to use latex or polyurethane condoms while using NuvaRing.

BEFORE you use NuvaRing talk to your doctor or pharmacist if:

• you are taking any other prescription or nonprescription drugs as these may interfere with the actions of NuvaRing
• you are or will be having major surgery
• you have breast conditions
• you have a family history of breast cancer
• you have breast disorders including pain, discharge from the nipples, thickenings, or lumps
• you have a family history of circulatory disorders including blood clots, heart attacks or strokes
• you have diabetes
• you are overweight
• you have high blood pressure
• you have abnormal levels of fats in the bloodstream (high cholesterol or triglycerides)
• you are a cigarette smoker
• you have migraine headaches
• you have heart or kidney disease
• you have a history of seizures or epilepsy
• you have a history of mental depression
• you have fibroid tumors of the uterus
• you have gallbladder or pancreatic disease
• you have plans for forthcoming surgery
• you have a history of jaundice or other liver disease

Your doctor can advise you if you have any conditions that would pose a risk to you. The use of combination hormonal contraceptives (including NuvaRing) should always be supervised by your doctor, with regular follow up to identify side effects associated with its use. Your visits may include a blood pressure check, a breast exam, an abdominal exam and a pelvic exam, including a Pap smear. Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year. Use NuvaRing only on the advice of your doctor and carefully follow all directions given to you. Use NuvaRing exactly as prescribed or you could become pregnant.

If you see another doctor, inform him or her that you are using NuvaRing.

NuvaRing may not be suitable for women with conditions that make the vagina more susceptible to vaginal irritation or ulceration. In some cases, vaginal (fibrous) tissue may grow over the ring, necessitating removal by a doctor.

Pregnancy is almost always more risky than using combination hormonal contraceptives. However, this risk with hormonal contraceptives can be higher if you are over 35 and you smoke.

Combination hormonal contraceptives (including NuvaRing) are not suitable for every woman.

In a small number of women, serious side effects may occur. The most serious side effects of combined hormonal contraceptives include:

• circulatory disorders (including blood clots in legs, lungs, heart, eyes, or brain)
• breast cancer
• gall bladder disease or liver tumors

Contact your doctor as soon as possible if you notice any changes in your own health. Do not forget about the items related to your immediate family.

Be alert for the following symptoms and signs of serious adverse effects. Call your doctor immediately if they occur:

• sharp pain in the chest, coughing blood, or sudden shortness of breath. These symptoms could indicate a possible blood clot in the lung.
• pain and/or swelling in the calf. These symptoms could indicate a possible blood clot in the leg.
• crushing chest pain or heaviness. These symptoms could indicate a possible heart attack.
• sudden severe or worsening headache or vomiting, dizziness or fainting, disturbances of vision or speech, or weakness or numbness in an arm or leg. These symptoms could indicate a possible stroke.
• sudden partial or complete loss of vision. This symptom could indicate a blood clot in the eye.
• severe pain or lump in the abdomen. These symptoms could indicate a possible tumor of the liver.
• severe depression.
• yellowing of the skin (jaundice).
• unusual swelling of the extremities.
• breast lumps.

With all hormonal contraceptives, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to use NuvaRing as normal. Irregular vaginal bleeding usually stops once your body has adjusted (usually after about 3 cycles). If it continues, becomes heavy or starts again, tell your doctor.

Users of NuvaRing have reported the following side effects:

• headache;
• vaginal discomfort (e.g. vaginal secretion, infection of the vagina);
• weight increase;
• nausea;
• breast pain;
• mood changes (e.g. depressive moods and emotional lability);
• painful menstruation;
• acne;
• decreased libido;
• abdominal pain;
• migraine;
• expulsion of the ring, problems during intercourse and feeling of the ring.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In rare cases the following undesirable effects were reported during use of NuvaRing: itching in the genital area, rash, allergic reaction, inflammation of the cervix, urinary tract infection, bladder infection, dizziness, anxiety, diarrhea and vomiting, breast tumor formation, breast discharge, back pain, enlarged abdomen, fatigue and penis discomfort of the partner (such as irritation, rash, itching).

Certain drugs may interact with hormonal contraceptives (including NuvaRing) and prevent NuvaRing from working properly. This can make hormonal contraceptives less effective in preventing pregnancy or cause unexpected bleeding (spotting or breakthrough bleeding). Hormonal contraceptives may also interfere with the working of other drugs.

Please inform your doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products, even those without a prescription. Also, tell any other doctor or dentist who prescribes another drug (or the dispensing pharmacist) that you use NuvaRing. They can tell you if you need to use an additional method of contraception and if so, for how long.

Drugs that may interact with NuvaRing include:

• drugs used for the treatment of epilepsy (e.g. lamotrigine, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate); tuberculosis (e.g. rifampicin, rifabutin), HIV infections (e.g. ritonavir, nevirapine), and Hepatitis C Virus infections (e.g., boceprevir, telaprevir)
• antibiotics (e.g. penicillins, tetracyclines, metronidazole) for infectious diseases
• antifungals (e.g. griseofulvin)
• anticoagulants (blood thinners)
• the herbal remedy, St. John's wort
• antihypertensive drugs (for high blood pressure)
• antidiabetic drugs and insulin (for diabetes)
• prednisone
• sedatives and hypnotics (e.g. benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate)
• antacids
• other drugs such as phenylbutazone, antihistamines, analgesics, antimigraine preparations, or Vitamin E
• cholesterol-lowering drugs (e.g. clofibrate)
• cyclosporine
• antidepressants (e.g. clomipramine)
• Vitamin B12

Can I use tampons when using NuvaRing?

The blood levels of the hormones released by NuvaRing were not changed when women used tampons along with NuvaRing. It is unknown how this affects the safety and the pregnancy protection of NuvaRing. Insert NuvaRing before inserting a tampon. You should pay particular attention when removing a tampon to be sure that the ring is not accidentally pulled out. If this should occur, simply rinse the ring in cool to lukewarm (not hot) water and immediately reinsert it.

Can I use vaginal medications?

The blood levels of the hormones released by NuvaRing were not changed when women used vaginal, water-based spermicides (nonoxynol or N-9 products) along with NuvaRing.

The blood levels of the hormones released by NuvaRing were increased when women used either an oil-based or water-based vaginal medication (miconazole nitrate) for a yeast infection while NuvaRing was in place. Therefore, this may also happen with other yeast infection medications. The clinical relevance of this increase is unknown. It is unknown how long-term use of spermicide or yeast infection medication with NuvaRing affects the safety and the pregnancy protection of NuvaRing.

If you decide to use hormonal contraceptives:

If you and your doctor decide that, for you, the benefits of hormonal contraceptives outweigh the risks, you should be aware of the following:

1. Your doctor will advise you of the appropriate time to start the use of hormonal contraceptives after childbirth, miscarriage, or therapeutic abortion.
2. There is no need to stop taking hormonal contraceptives for a rest period.

If you want more information about contraceptive vaginal rings, ask your doctor or pharmacist.

Usual dose:

NuvaRing is designed to be a once-a-month contraceptive regimen. The ring has to be inserted in your vagina. You can verify the presence of NuvaRing yourself, whenever you wish. After the ring is inserted, it releases a continuous low dose of hormones into your body. The ring stays in place for 3 weeks and then is removed for a one week ring free period. It is not necessary or recommended to remove NuvaRing during intercourse.

READ THESE DIRECTIONS CAREFULLY:

For the best protection from pregnancy, use NuvaRing exactly as directed. Insert one NuvaRing in the vagina and keep it in place for three weeks in a row. Remove it for a one-week break and then insert a new ring. During the one-week break, you will usually have your menstrual period. Your healthcare provider should examine you at least once a year.

Do not use NuvaRing for a condition for which it was not prescribed. Do not give NuvaRing to anyone else who may want to use it.

You should not use a NuvaRing if it was dispensed to you more than 4 months before or if the expiry date has passed. The dispensing date and expiry date are both shown on the carton and sachet.

Do not use the ring if you notice a colour change in the ring or any visible signs of deterioration.

While using NuvaRing, you should not rely upon a diaphragm or cervical cap when you need a back-up method of birth control because NuvaRing may interfere with the correct placement and position of these devices.

When should I start NuvaRing?

Follow the instructions in one of the sections below to find out when to start using NuvaRing:

If you did not use a hormonal contraceptive in the preceding cycle:

Insert NuvaRing within the first five days of your cycle. (i.e. Day 1-5 of the menstrual bleeding). Make sure you also use an extra method of birth control (barrier method), such as male condoms or spermicides during the first seven days of NuvaRing use in the first cycle.

If you are switching from a combined hormonal contraceptive containing both progestin and estrogen:

Switch from your previous combined hormonal contraceptive on any day, but at the latest on the day you would have started a new cycle, by inserting NuvaRing. If you have been using your hormonal contraceptive method consistently and correctly, no extra birth control method should be needed.

If you are switching from a progestin-only contraceptive (mini-pill, implant, injection, or from a progestagen-releasing intra-uterine system {IUS}):

• When switching from a mini-pill, you can stop using the pill on any day of the month and switch to NuvaRing. Insert NuvaRing on the day immediately after your last pill.
• When switching from an implant, progestin-containing IUS or injectable contraceptive, start using NuvaRing on the same day you have your implant or IUS removed or on the day your next injection is due.

When you are switching from a progestin-only contraceptive, use an extra method of birth control, such as condoms and/or spermicide, for the first seven days after inserting NuvaRing.

Use after pregnancy, miscarriage or abortion:

Talk to your doctor about using NuvaRing following an abortion, miscarriage or childbirth or under any other circumstances that are not listed in this Consumer Information.

How do I insert NuvaRing?

1. After washing and drying your hands, remove NuvaRing from its foil pouch. Keep the foil pouch for proper disposal of the ring after use. Choose a position that is most comfortable for you.
2. Press the sides of NuvaRing together between your thumb and index finger and gently push the folded ring into your vagina. The exact position of NuvaRing in the vagina is not important for it to work.
3. Although some women may be aware of NuvaRing in the vagina, most women do not feel it once it is in place. If you feel discomfort, use your finger to gently push NuvaRing further into your vagina. There is no danger of NuvaRing being pushed too far up in the vagina or getting lost.
4. Once inserted, keep NuvaRing in place for three weeks in a row.

How do I remove NuvaRing?

1. Remove the ring three weeks after insertion on the same day of the week as it was inserted, at about the same time. For example, when NuvaRing is inserted on a Sunday at about 10:00 PM, the ring should be removed on the Sunday three weeks later at about 10:00 PM.
2. Remove NuvaRing by hooking the index finger under the forward rim or by holding the rim between the index and middle finger and pulling it out.
3. Place the used ring in the reclosable foil pouch and properly dispose of it in a waste receptacle, out of the reach of children and pets. Do not throw it in the toilet.

If you are unable to remove NuvaRing, please contact your healthcare provider.

Your menstrual period will usually start two to three days after the ring is removed and may not have finished before the next ring is inserted. To continue to have pregnancy protection, you must insert the new ring one week after the last one was removed, even if your menstrual period has not stopped.

When do I insert a new ring?

After a one-week ring-free break, insert a new ring on the same day, at the same time of the week as it was removed in the last cycle. For example, if NuvaRing was removed on a Sunday at about 10:00 PM, after the one-week break you should insert a new ring on a Sunday at about 10:00 PM.

If NuvaRing is in your vagina too long:

If NuvaRing has been left in your vagina for an extra week or less (up to four weeks total), you will remain protected. Remove NuvaRing and insert a new ring after a one-week ring-free break.

If NuvaRing has been left in place for more than four weeks total, there is a possibility that you could become pregnant. You must rule out pregnancy before inserting a new NuvaRing. You must use an extra method of birth control, such as condoms and/or spermicide, until the new NuvaRing has been in place for seven days in a row.

What should I do if NuvaRing disconnects?

On rare occasions, NuvaRing may disconnect at the weld joint during use. Since the ring's core is solid its contents will remain intact and release of hormones will not be significantly affected. If NuvaRing does disconnect, expulsion (slipping out) is likely to occur (see If NuvaRingslips out:). If you discover the ring has disconnected you should discard the ring and replace it with a new ring.

How to change the NuvaRing start day to another day of the week:

If you wish to change the day on which you start a new NuvaRing cycle to another day of the week, complete the current cycle, removingNuvaRing on the same day of the week as the one on which you started. During the ring-free period, a new start day may be selected by inserting the new NuvaRing on the first occurrence of the desired day. This will be your new Day 1. In no case should there be more than 7 consecutive ring-free days.

The shorter the ring-free interval, the higher the risk that you do not have a period from your previous cycle. However, spotting or bleeding may occur during the use of the next ring. This practice is for a one-time only change and should not to be used as a standard dosing regimen, as there are no long-term safety data available on the continuous use of NuvaRing.

If you miss a menstrual period:

You must check to be sure that you are not pregnant if:

1. you miss a period and NuvaRing was out of the vagina for more than three hours during the three weeks of ring use
2. you miss a period and you had waited longer than one week to insert a new ring
3. you have followed the instructions and you miss two periods in a row
4. you have left NuvaRing in place for longer than four weeks

Overdose:

Overdosage of combination hormonal contraceptives may cause nausea, vomiting, vaginal bleeding, or other menstrual irregularities. Given the nature and design of NuvaRing it is unlikely that overdosage will occur. If NuvaRing is broken, it does not release a higher dose of hormones. There are no antidotes and further treatment should be symptomatic.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If NuvaRing slips out:

NuvaRing can slip out of the vagina if it has not been inserted properly, or while removing a tampon, during intercourse or straining during a bowel movement.

• If NuvaRing slips out of the vagina, and it has been out for less than three hours, you should still be protected from pregnancy.NuvaRing can be rinsed with cool to lukewarm (not hot) water and should be re-inserted as soon as possible, and at the latest within three hours of expulsion (slipping out). If you have lost NuvaRing, you must insert a new NuvaRing and use it on the same schedule as you would have used the lost ring.
• If NuvaRing has been out of the vagina for more than three hours during the 1st or 2nd week, you may not be adequately protected from pregnancy. Re-insert the ring as soon as you remember and use an extra method of birth control, such as male condoms or spermicides, until the NuvaRing has been in place continuously for seven days in a row.

If NuvaRing slips out of the vagina for more than 3 hours during the 3rd week contraceptive efficacy may be reduced. Throw the ring away and choose one of the following two options:

1. Insert a new ring immediately. Note: Inserting a new ring will start the next three-week use period. You may not experience a period from your previous cycle. However, breakthrough spotting or bleeding may occur.
2. Have your period and insert a new ring no later than 7 days from the time the previous ring was removed or expelled. Note: This option should only be chosen if the ring was used continuously for the preceding 7 days.

In addition, a barrier method such as condoms and/or spermicides must be used until the new ring has been used continuously for seven days.

Women with conditions affecting the vagina, such as a prolapsed uterus, may be more likely to have NuvaRing slip out of the vagina.

If the ring-free period is extended:

If the ring-free interval has been extended beyond one week, the possibility of pregnancy should be considered and an extra method of birth control, such as male condoms or spermicide MUST be used until NuvaRing has been used continuously for seven days. Contact your doctor immediately. The longer the ring-free interval, the higher the risk that you have become pregnant.

How well tolerated is NuvaRing?

More than 2100 women were questioned in a survey of their experiences using NuvaRing for several months.

Nearly all of the women found NuvaRing easy to insert (96%) and remove (98%). Most women did not feel NuvaRing once it was in place and 83% of women said they never or rarely felt NuvaRing during intercourse. Similarly, 68% of women said their partners never or rarely felt the ring during intercourse, and 91% reported that their partner did not mind them using the ring.

Of the 1499 women who completed one year treatment (13 cycles) with NuvaRing, 96% reported they were satisfied with NuvaRing, and 97% reported they would recommend NuvaRing to others. 85% of all women surveyed were satisfied with the use of NuvaRing and 90% would recommend this method to others.

Non-contraceptive benefits of hormonal contraceptives:

Several health advantages have been linked to the use of hormonal contraceptives.

• Reduction in the incidence of cancer of the uterus and ovaries.
• Reduction in the likelihood of developing benign (non-cancerous) breast disease and ovarian cysts.
• Less menstrual blood loss and more regular cycles. The risk of developing iron-deficiency anemia is thus reduced.
• There may be a decrease in painful menstruation and premenstrual syndrome (PMS).
• Acne, excessive hair growth and male-hormone-related disorders also may be improved.
• Ectopic (tubal) pregnancy may occur less frequently.
• Acute pelvic inflammatory disease may occur less frequently.

This may also be the case for NuvaRing but this has not been confirmed.