(120 mcg etonogestrel / 15 mcg ethinylestradiol)
Consumer Medicine Information
Read all of this leaflet carefully before you start using NuvaRing.
The information you will find in here can assist you in its safe and proper use. Read the leaflet also regularly if you are already using NuvaRing. This is important because the information in the leaflet may change. Also it is important to stay alert on matters that do not affect you now, but may affect you in the future. If you have any questions or if something is unclear, please ask your doctor, professional health care provider or pharmacist.
In this leaflet:
1. What is NuvaRing and what is it used for
Composition and type of contraceptive
2. When should you not use NuvaRing?
3. What do you need to know before using NuvaRing?
General notes
Before you start to use NuvaRing
Hormonal Contraceptives and Thrombosis
Hormonal Contraceptives and Cancer
NuvaRing and Other Medicines
NuvaRing and Breastfeeding
NuvaRing and Pregnancy
NuvaRing and Ability to Drive and to Use Machines
4. When should you contact your doctor?
5. How do you use NuvaRing?
7. What side effects might you have while using NuvaRing
8. More about hormonal contraceptives
9. Pharmaceutical particulars of NuvaRing
Composition in Full
NuvaRing contains:
active substances: etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg)
other substances: ethylene vinylacetate copolymer (a type of plastic that will not dissolve in the body), magnesium stearate.
Etonogestrel and ethinylestradiol are released from the ring at a rate of 0.120 mg/day and 0.015 mg/day respectively, during 3 consecutive weeks.
1. WHAT IS NUVARING AND WHAT IS IT USED FOR
Composition and type of contraceptive
NuvaRing is a hormonal contraceptive for vaginal use. It is a flexible, transparent, almost colourless ring with an outer diameter of 54 mm and a cross sectional diameter of 4 mm. Each ring contains two female sex hormones, etonogestrel (a progestogen) and ethinylestradiol (an estrogen). The ring slowly releases these hormones into the blood circulation. Because of the low amount of hormones that is released, NuvaRing is considered a low-dose hormonal contraceptive. Since NuvaRing releases two different types of hormones it is a so-called combined hormonal contraceptive.
Each ring is packed in a reclosable sachet. The sachet is made of aluminum foil and packed in a cardboard box together with this package leaflet. Each box contains 1 or 3 rings.
Why use NuvaRing?
To prevent pregnancy.
NuvaRing is an effective method of birth control. When used correctly, as indicated in this leaflet, NuvaRing will be effective in preventing pregnancy - see next section.
How does it work?
NuvaRing works just like a combined contraceptive pill (the Pill). NuvaRing releases two female sex hormones that prevent the release of an egg cell from the ovaries. If no egg cell is released you cannot become pregnant. An advantage of NuvaRing is that you do not have to remember to take a pill every day.
NuvaRing is very reliable, but as for all contraceptive methods, protection is never 100%. If NuvaRing is used according to the directions, your chance of getting pregnant is less than 0.7% per year. For comparison purposes, if combined oral contraceptives are used diligently, the chance of getting pregnant is expected to be about 0.1% and if progestogen only pills ("mini pills") are used about 0.3%. Your chance of getting pregnant increases if NuvaRing is not used exactly according to the directions.
2. WHEN SHOULD YOU NOT USE NUVARING?
Do not use NuvaRing if you have any of the conditions listed below. If any of these conditions apply to you, tell your doctor before starting to use NuvaRing. Your doctor may advise you to use an entirely different (non-hormonal) method of birth control.
If you have, or have ever had a disorder affecting the blood vessels. In particular, this applies to conditions relating to thrombosis. Thrombosis is the formation of a blood clot. This may occur in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart attack), the brain (stroke), or other parts of the body. (See also the section later in this leaflet '3.3 'Hormonal Contraceptives and Thrombosis').
If you have or have ever had a condition that may be a first sign of a heart attack (such as angina pectoris, which manifests itself by severe chest pain) or stroke (such as transient ischemic attack, a small reversible stroke).
If you have an inherited or acquired disorder affecting the blood circulation.
If you have diabetes mellitus with blood vessel damage.
If you have jaundice (yellowing of the skin) or if you have or ever had severe liver disease (as long as the liver is not yet functioning normally).
If you have or ever had inflammation of the pancreas.
If you have or ever have had a type of migraine called "migraine with aura". Ask your doctor if you are unsure.
If you have or have had cancer of the breast or the genital organs.
If you have or have had a benign or malignant tumour in the liver.
If you have any unexplained vaginal bleeding.
If you are pregnant or think you might be pregnant.
If you are allergic to any of the ingredients of NuvaRing.
If any of these conditions appear for the first time while using NuvaRing, stop using it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures. See also section 3.1 'General Notes'.
3. WHAT DO YOU NEED TO KNOW BEFORE USING NUVARING?
General notes
In this leaflet, several situations are described where you should stop using NuvaRing, or where the reliability of NuvaRing may be decreased. In such situations you should not have intercourse or you should take extra non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because NuvaRing alters the monthly changes of the body temperature and of the cervical mucus.
NuvaRing, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Before you start to use NuvaRing
In certain situations, you may need to be kept under close observation while using a combined hormonal contraceptive like NuvaRing. If any of the following conditions applies to you, you must inform your doctor before starting to use NuvaRing. Also if any of the following conditions develops or worsens during the use of NuvaRing you must consult your doctor. Your doctor can explain the nature of these risks to you.
you smoke. When using a hormonal contraceptive like NuvaRing you should stop smoking, especially if you are older than about 35 years of age.
The risk of having a heart attack or stroke increases as you get older. It also increases the more you smoke. When using hormonal contraception this risk may be still slightly higher;
you breast-feed a baby. The use of a hormonal contraceptive containing an estrogen is generally not recommended until the nursing mother has completely weaned her child;
you have diabetes;
you are overweight;
you have high blood pressure;
you have a heart valve disorder or a certain heart rhythm disorder;
you have an inflammation of your veins (superficial phlebitis);
you have varicose veins;
anyone in your immediate family has had a thrombosis, a heart attack or a stroke;
you suffer from migraine;
you suffer from epilepsy;
you or someone in your immediate family has or had high blood levels of fatty substances (cholesterol or triglycerides);
anyone in your immediate family has (or has ever had) breast cancer;
you have liver disease (for instance jaundice with or without itching) or gallbladder disease (for instance gallstones);
you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
you have SLE (systemic lupus erythematosus); a disease affecting your natural defence system;
you have HUS (hemolytic uremic syndrome); a disorder of blood coagulation causing failure of the kidneys;
you have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, a neurological disease called Sydenham's chorea);
you have (or have ever had) chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation;
you have a medical condition that makes it difficult to use NuvaRing, e.g. if you are constipated, have a prolapse or have pain during intercourse;
you have a history of toxic shock syndrome (TSS)
Even if none of the conditions listed above applies to you, it is sensible to see your doctor regularly for a medical check-up, e.g. once every year.
Hormonal Contraceptives and Thrombosis
A thrombosis is the formation of a blood clot, which may block a blood vessel.
A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "pulmonary embolism". The risk of getting blood clots may be greater with the type of progestin in NuvaRing than with some other progestins in certain low-dose birth control pills. Deep venous thrombosis is a rare occurrence. It can develop whether or not you are using hormones for contraception. It can also happen if you are pregnant. The risk is higher in users of combined oral contraceptives than in non-users, but it is not as high as the risk during pregnancy. The chance of getting a thrombosis is highest during the first year of use of the Pill. The risk in users of NuvaRing is not known, but it is assumed to be similar to that in users of other hormonal contraceptives.
Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely blood clots can occur in the liver, gut, kidney or eye.
Following an episode of thrombosis recovery is not always complete. Very occasionally serious permanent disabilities may occur or the thrombosis may even be fatal.
If you develop high blood pressure while using NuvaRing, you may be told to stop using it.
If you have to undergo an operation, are bedridden for some time, or you are not supposed to walk (for example, when you have your leg or legs in plaster, or a bandage is put on to treat varicose veins) the risk of having a thrombosis may be temporarily higher. In women who use contraceptive hormones, the risk may be yet higher. In such a case ask your doctor well in advance about what you should do. Your doctor may tell you to stop using your hormonal contraceptive several weeks before surgery or at the time of immobilization. Your doctor will also tell you when you can start using NuvaRing again after you are back on your feet.
If you notice possible signs of a thrombosis, stop using NuvaRing and consult your doctor immediately (See for possible symptoms also section 4 'When should you contact your doctor?').
Hormonal Contraceptives and Cancer
Specific studies with vaginal administration of contraceptive hormones (as in NuvaRing) are not available. The information given below was obtained in studies with oral contraceptives (the Pill) and it may also apply to NuvaRing.
Breast cancer has been found slightly more often in women that take the Pill than in women of the same age that do not take the Pill. If a woman stops using a hormonal contraceptive, the risk of getting breast cancer slowly declines, so that 10 years after stopping the excess risk is gone. It is not known whether the excess risk of breast cancer is caused by the use of a hormonal contraceptive. It may be that the women taking such a hormonal contraceptive were examined more often, so that the breast cancer is noticed earlier.
In rare cases benign liver tumours and even more rarely, malignant liver tumours have been reported in users of the Pill. These tumours may lead to internal bleeding. Contact your doctor immediately if you have severe pain in your abdomen.
Chronic infection with Human Papilloma Virus (HPV) is the single most important risk factor for cervical cancer. HPV is a sexually transmitted infection. In women who use combined oral contraceptives for a long time the chance of getting cervical cancer may be slightly higher. This finding may not be caused by the Pill itself but may be related to sexual behaviour and other factors.
NuvaRing and Other Medicines
Some medicines may prevent NuvaRing from working properly. This can lead to decrease in contraceptive efficacy or unexpected bleeding (spotting or breakthrough bleeding). These include medicines used for the treatment of epilepsy (e.g. carbamazepine, oxcarbazapine, topiramate, felbamate, primidone, phenytoin barbiturates), and tuberculosis (e.g. rifampicin) or HIV infections (ritonavir), some antibiotics (except amoxicillin and doxycycline) for the treatment of some other infectious diseases, and the herbal remedy, St. John's wort. Always tell the doctor, who prescribes NuvaRing, which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use NuvaRing. They can tell you if you need to take additional contraceptive precautions and if so, for how long.
If you want to use herbal products containing St. John's wort while you are using NuvaRing you should consult your doctor first.
The use of spermicides or vaginal yeast products will not reduce the contraceptive efficacy of NuvaRing.
NuvaRing and Breastfeeding
NuvaRing is generally not recommended for use during breast-feeding. If you wish to use NuvaRing while breastfeeding, please seek the advice of your doctor.
NuvaRing and Pregnancy
NuvaRing must not be used by women, who are pregnant, or who think they may be pregnant.
If you get pregnant while using the ring you should remove the ring.
NuvaRing and Ability to Drive and to Use Machines
NuvaRing is unlikely to affect the ability to drive and the capability to use machines.
4. WHEN SHOULD YOU CONTACT YOUR DOCTOR?
Regular check-ups
When you are using NuvaRing, your doctor may tell you to return for regular check-ups. In general, you should have a check-up every year.
Contact your doctor as soon as possible if:
you notice any changes in your own health, especially involving any of the items mentioned in this leaflet (see also section 2 'When should you not use NuvaRing' and section 3.2 'Before you start to use NuvaRing'; do not forget about the items related to your immediate family);
you feel a lump in your breast. This symptom may indicate breast cancer. (see also section 3.4 'Hormonal Contraceptives and Cancer');
you are going to use other medications (see also section 3.5 'NuvaRing and Other Medicines');
you are to be immobilized or are to have surgery (consult your doctor at least four weeks in advance);
you have unusual, heavy vaginal bleeding. This symptom may indicate cervical cancer (see also section 3.4 'Hormonal Contraceptives and Cancer');
you extended the ring-free interval to more than 1 week, or if NuvaRing was out of the vagina for longer than 3 hours in the first week of use and you had intercourse in the seven days before;
you left NuvaRing in place for more than 4 weeks (do not start the next ring until told to by your doctor);
you missed your period twice in a row or suspect you are pregnant (do not start the next ring until told to by your doctor).
Remove NuvaRing and see your doctor immediately if you notice possible signs of thrombosis, such as:
an unusual cough (e.g. with blood);
severe pain in the chest which may reach the left arm;
breathlessness;
any unusual, severe, or prolonged headache or migraine attack;
partial or complete loss of vision, or double vision;
slurring or speech disability;
sudden changes to your hearing, sense of smell, or taste;
dizziness or fainting
weakness or numbness in any part of your body;
severe pain in your abdomen;
severe pain or swelling in either of your legs.
The situations mentioned above are described and explained in more detail in section 3 in this leaflet.
5. HOW DO YOU USE NUVARING?
NuvaRing has been prescribed for you personally. Do not share it with others.
To achieve the most effective protection when using NuvaRing you must ensure that the following instructions are closely observed.
When and how do you use NuvaRing?
You can insert NuvaRing into the vagina yourself, and also remove it. The doctor will instruct you when you start using NuvaRing for the first time. The vaginal ring must be inserted on the appropriate day (see 'when to start with the first ring') and left in place for 3 consecutive weeks.
How to insert and remove NuvaRing
Wash your hands before inserting or removing the ring. Choose the position for inserting that is most comfortable to you, like standing with one leg up, squatting, or lying down. Remove NuvaRing from its sachet. Hold the ring between your thumb and index finger, press the opposite sites together and insert the ring into the vagina. When NuvaRing is in place you should not feel anything. If you feel uncomfortable, gently push NuvaRing further into the vagina. The exact position of the ring inside the vagina is not important.
After 3 weeks you remove NuvaRing from the vagina. You can do this by hooking the index finger under the forward rim of the ring or by grasping the rim between the index and middle finger and pull it out. The used ring should be placed in the sachet and disposed of via the normal household waste. Do not flush NuvaRing down the toilet.
Starting with the day of insertion the vaginal ring must be left in place without interruption for 3 consecutive weeks. After 3 weeks you remove the ring on the same day of the week and at approximately the same time as it was inserted. For example, when you have inserted NuvaRing on a Wednesday at about 10.00 pm, you should remove the ring 3 weeks later, on Wednesday, at about 10.00 pm.
After you have removed the ring, you do not insert another ring for 1 week. In the course of this week a vaginal bleed should occur (the so-called withdrawal bleed). Usually this starts 2-3 days after removal of NuvaRing. Start exactly after the 1 week interval (again on the same day of the week and approximately the same time) with a new ring, even if the vaginal bleed has not finished yet. If the ring is inserted more than 3 hours too late, contraceptive efficacy of the ring may be reduced. In such case, follow the instructions in section 6 'WHAT TO DO IF....you have forgotten to insert a new ring after the ring-free period'.
If you use NuvaRing as described above, your withdrawal bleed will take place every 4 weeks at about the same days.
NuvaRing and tampons
You can use tampons while using 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 water and immediately reinsert it.
When to start with the first ring
You have not used a hormonal contraceptive during the last month.
Insert the first NuvaRing on the first day of your natural cycle (i.e. the first day of your menstrual period). If you start NuvaRing in this way it starts working straight away and you don't need to take any other contraceptive precautions. You can also start NuvaRing between day 2 and day 5 of your cycle, but if you have sexual intercourse during the first 7 days of NuvaRing use you should also use an additional contraceptive method (barrier method), such as male condoms or spermicide. You only have to follow this advice during the use of this first ring.
You have used a combined Pill during the last month.
Start using NuvaRing at the latest the day following the tablet-free break of your present Pill. If your Pill pack also contains inactive tablets, start NuvaRing at the latest on the day after the last inactive tablet. If you are not sure which tablet this is, ask your doctor or pharmacist.
You have used a minipill (progestagen-only pill) during the last month.
You can stop taking the minipill any day and start NuvaRing the next day, at the same time. But make sure you also use an additional contraceptive method (e.g. a condom) for the first 7 days of ring use.
You have used an injectable or an implant or a progestagen-releasing intrauterine system during the last month.
Start using NuvaRing when your next injection is due or on the day that your implant or intrauterine system is removed. But make sure you also use an additional contraceptive method (e.g. a condom) for the first 7 days of ring use.
After having a baby.
If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking NuvaRing. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to use NuvaRing, you should discuss this first with your doctor.
After a miscarriage or an abortion.
Your doctor will advise you.
When you have had irregular cycles or no bleeding
Your doctor will advise you.
Overdose
There have been no reports of serious harmful effects due to an overdose of the hormones in NuvaRing. If you have accidentally inserted more than one ring, you may experience nausea, vomiting or vaginal bleeding. If you discover that a child has been exposed to the hormones from NuvaRing, ask your doctor for advice.
When you want to stop using NuvaRing
You can stop using NuvaRing any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control.
If you stop using NuvaRing because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive. This helps you calculate when the baby will be due.
6. WHAT TO DO IF
you have forgotten to insert a new ring after the ring-free period
Your ring-free period was longer than 7 days.
Insert a new ring in the vagina as soon as you remember. Use extra contraceptive precautions (e.g. a condom) if you have sexual intercourse during the next 7 days. If you had sexual intercourse in the ring-free period, there is a possibility you may be pregnant. In that case contact your doctor immediately. The longer the ring-free period, the higher the risk that you have become pregnant.
the ring has temporarily been out of the vagina
NuvaRing slowly releases hormones into the body to prevent pregnancy.
If the ring has been out of the vagina for more than 3 hours, the hormones have not been released for too long a time, and contraceptive efficacy may be reduced. Therefore, the ring may not be outside the vagina for longer than 3 hours in every twenty-four hour period.
If the vaginal ring has been out of the vagina for less than 3 hours, contraceptive efficacy is not reduced. You should reinsert the ring as soon as possible but at the latest within 3 hours.
If the ring has been out of the vagina for more than 3 hours during the 1st and 2nd week, contraceptive efficacy may be reduced. Insert the ring in the vagina as soon as you remember, and leave the ring in place without interruption for at least 7 days. Use a condom if you have sexual intercourse during these 7 days.
When the ring has been out of the vagina for more than 3 hours in the 3rd week contraceptive efficacy may be reduced. You should discard that ring and choose between one of the following options:
1. Insert a new ring immediately
Note: this will start the next 3-week use period. You may not get your period but breakthrough bleeding and spotting may occur.
2. Do not insert the ring again. Have your period first and insert a new ring no later than 7 days from the time the previous ring was removed or expelled.
Note: you should only chose this option if you have used NuvaRing continuously during the past 7 days.
you have forgotten to remove the ring
If your ring has been left in place for more than 3 but maximally for 4 weeks, then contraceptive efficacy is not reduced. Have your regular ring-free interval of one week and subsequently insert a new ring.
If your ring has been left in place for more than 4 weeks, contraceptive efficacy may be reduced and there is a possibility of becoming pregnant. Contact your doctor before you start with a new ring.
NuvaRing is accidentally expelled from the vagina
NuvaRing may accidentally be expelled from the vagina e.g. when it has not been inserted properly, while removing a tampon, by movement of the bowels, or during straining. It may also happen when you for example experience constipation, or if you have a prolapse. If the ring is expelled, you can rinse the ring with cold to lukewarm water (do not use hot water) and reinsert it.
you want to change the starting day of your period permanently
If you use NuvaRing as directed, you will have your period on about the same day every 4 weeks. You can change the starting day of your period just by shortening the interval between two rings. So, you do not start with a new ring until after 7 days but sooner. For example, if your period usually starts on a Friday and in future you want it to start on Tuesday (3 days earlier) you should now insert your next ring 3 days sooner than you usually do. Then your next period will also start on another day, in this case 3 days earlier. If you make your ring-free period very short (e.g. 3 days or less), you may not have bleeding during this period. You may have some breakthrough bleeding or spotting during the use of the next ring. The ring-free period must never be longer than 7 days.
You may only shorten the ring-free period but never lengthen it.
you want to delay your period
You can delay your period by inserting a new ring immediately after removing the current ring, with no ring-free period between rings. You can leave the new ring inserted for up to 3 weeks. While using the new ring, you may experience spotting or breakthrough bleeding during ring-use. When you wish your period to begin, just remove the ring. Start with a new ring after the usual one-week ring-free period.
you have unexpected bleeding
During the use of NuvaRing, in some women unexpected vaginal bleeding (spotting or breakthrough bleeding) between your periods may occur. You may need to use sanitary protection, but continue to use the ring as normal. If the irregular bleeding continues becomes heavy or starts again, tell your doctor.
you have missed a period
You have used NuvaRing according to the instructions.
If you have missed a period but used NuvaRing in accordance with the instructions and have not used other medicines it is very unlikely that you are pregnant. Continue to use NuvaRing as usual. If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next NuvaRing until your doctor has checked you are not pregnant.
If you have deviated from the recommended use of NuvaRing.
If you have deviated from the recommended regimen and you do not have your expected period in the first normal ring-free interval, you may be pregnant. Contact your doctor before you start with a new NuvaRing
if your ring breaks
Very rarely NuvaRing may break. A broken ring is unlikely to cause an overdose because the ring will not release a higher amount of contraceptives hormones.
If NuvaRing breaks, expulsion is likely to occur (see 'What to do if the ring has been temporarily out of the vagina'). Therefore, if you notice that your NuvaRing has broken, discard that ring and replace it with a new ring as soon as possible and use the new ring until the original ring was due to be removed.
7. WHAT SIDE EFFECTS MIGHT YOU HAVE WHILE USING NUVARING
Serious Side Effects
Serious reactions associated with the use of NuvaRing, as well as the related symptoms, are described in the following sections: '3.3 Hormonal Contraceptives and Thrombosis' and '3.4 Hormonal Contraceptives and Cancer'. Please read these sections for additional information and consult your doctor if you suffer from any of these conditions or symptoms.
Other possible side effects
The following side effects have been reported by users of NuvaRing, although they need not be caused by NuvaRing.
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;
In rare cases the following undesirable effects were reported during use of NuvaRing: itching in the genital area, rash, inflammation of the cervix, urinary tract infection, bladder infection, dizziness, anxiety, diarrhea and vomiting, breast tumour formation, ring related problems in the male (e.g. during intercourse), back pain, enlarged abdomen and fatigue.
Tell your doctor if you notice any unwanted effect. Especially tell your doctor if any side effect is severe or persistent, or if you notice a change in your health that you think might be caused by NuvaRing.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Male exposure to ring
The exposure of male sexual partners to the female hormones in the ring through absorption through the penis has not been examined.
8. MORE ABOUT HORMONAL CONTRACEPTIVES
Combined hormonal contraceptives (like NuvaRing) may also have non-contraceptive health benefits. Your periods may be lighter and shorter. As a result, the risk of anaemia may be lower. Your period pains may become less severe or may completely disappear. Your period may be more confined to the ring-free period when you use NuvaRing.
In addition, the following serious disorders have been reported to occur less frequently in users of hormonal contraceptives with 50 micrograms of ethinyloestradiol ('high-dose Pills') than in non-users. This may also be the case for NuvaRing but this has not been confirmed.
Benign breast disease
Ovarian cysts
Pelvic infections (pelvis inflammatory disease or PID)
Ectopic pregnancy (pregnancy in which the embryo implants outside of the womb)
Cancer of the endometrium (the lining of the womb)
Cancer of the ovaries
9. PHARMACEUTICAL PARTICULARS OF NUVARING
Storage Instructions
You should not start using NuvaRing after the expiration date or 4 months after the date of dispensing, whichever comes first.
Store your NuvaRing in the original sachet below 30 degrees C.
Protect from light and freezing.
Do not use the product if you notice, for example, colour change in the ring or any visible signs of deterioration.
Keep NuvaRing out of the reach of children.
IF YOU HAVE ANY FURTHER QUESTIONS, PLEASE CONSULT YOUR DOCTOR OR PHARMACIST.
Sponsor
Merck Sharp & Dohme (Australia) Pty Limited
54-68 Ferndell Street
South Granville NSW 2142
Australia
This CMI was prepared in September 2011
AUST R 96229
