Read all of this leaflet carefully before you start using NuvaRing.
- Keep this leaflet, You may need to read it again.
- If you have any questions, Consult your doctor or pharmacist.
- This medicine has been prescribed for you Do not pass it on to others.
- If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
- Likewise, Leaflet regularly but already using NuvaRing. This is important, because the information in the prospectus may change.
1. NUVARING WHAT IS AND WHAT IT IS USED
NuvaRing is a vaginal ring contraceptive used to prevent pregnancy. Each ring contains a small amount of two female sex hormones, etonogestrel and ethinyl estradiol. The ring slowly releases these hormones into the bloodstream. Given the small number of hormones released, NuvaRing is a low-dose hormonal contraceptive. As NuvaRing releases of different types of hormones, is a combined hormonal contraceptive.
NuvaRing acts as the combined pill (the "Pill"), but instead of taking a pill every day, the ring is used for 3 consecutive weeks. NuvaRing releases two female sex hormones that prevent the ovaries from releasing an egg. If not released any eggs, can not get pregnant.
2. Before using NUVARING
In this leaflet describes various situations in which you must stop using NuvaRing, or in which it may be less reliable NuvaRing. In these situations, should not have sex, or should take extra non-hormonal contraceptive measures, such as a condom or other barrier method. Do not use the rhythm method or the temperature. These methods can be unreliable because NuvaRing alters the monthly changes of body temperature and cervical mucus.
NuvaRing, like other hormonal contraceptives, does not protect against HIV infection (PAGE) or any other sexually transmitted disease.
Do not use NuvaRing happens if any of the conditions described below. Then, your doctor may advise another method of birth control other than (nonhormonal):
• If you have (or have ever had) clot (venous thrombosis) in a blood vessel in the legs, lungs (pulmonary embolism) or other organs. Watch for signs of thrombosis in the "Clots (thrombosis)”.
• If you have ever had a heart attack, or stroke, or have (or have ever had) a disorder that could be an early sign of heart attack (as angina, or severe pain in the chest), or stroke (as transient ischemic attack or small stroke temporal).
• If you have a serious risk factor, or more risk factors for developing a clot (See also "Clots (thrombosis)”.
• If having a disorder that affects the blood clotting, for example, a protein C deficiency. • If you have or have had a type of migraine called "migraine with aura".
• If you are diabetic and are affected blood vessels.
• If you have or have had inflammation of the pancreas (pancreatitis), associated with high levels of blood fats.
• If you have or have had a severe liver disease and your liver is still not functioning normally.
• If you have or have had a benign or malignant tumor in the liver.
• If you have, has or may have breast cancer or genital.
• If you have any unexplained vaginal bleeding.
• If you are allergic to ethinyl estradiol or etonogestrel, or any of the other ingredients of NuvaRing.
If any of these conditions appear for the first time while using NuvaRing, remove the ring immediately and consult your doctor. While, use non-hormonal contraceptive measures.
In some situations it is necessary to take extra care when using combined hormonal contraceptives. Tell your doctor if any of the points affect following. Likewise, if any of the following conditions occurs or worsens while using NuvaRing, tell your doctor.
• Any immediate family has or has ever had breast cancer;
• Sufra epilepsy (see section 2.2. "Taking other medicines");
• You have liver disease (por ejemplo, jaundice) or gall (por ejemplo, gallstones);
• have Crohn's disease or ulcerative colitis (chronic intestinal inflammation);
• Has a disease called systemic lupus erythematosus (a disease that affects your natural defense system);
• Has a disease called hemolytic uremic syndrome (a disorder of the blood clotting causing kidney failure);
• have a disease that first appeared or worsened during pregnancy or previous use of sex hormones (por ejemplo, Hearing loss, porphyria [a blood disease], herpes in pregnancy [rash with blisters during pregnancy], The core of the Sydenham [nerve disease in involuntary movements that occur]; angioedema hereditario [see your doctor immediately if you experience symptoms of angioedema, as swelling of the face, o lengua Garganta, or difficulty swallowing, or hives together with difficulty breathing]). • have or have ever had chloasma (spots yellowish-brown skin, called "pregnancy patches", particularly in the face); if this is the case, Avoid excessive exposure to sunlight or ultraviolet rays; • have disorders that make it difficult to use NuvaRing, for example if you have constipation, uterine prolapse (descent of the matrix or cervix) or pain during sex.
• Le of a operar, or if you can not walk for long (see section "Clots (thrombosis)”).
Potentially serious diseases:
- Blood clot in a vein
A blood clot in a vein (called venous thrombosis), can block. May occur in the veins of the leg, lung (pulmonary embolism) or other organs.
Use any combination hormonal contraceptive, including NuvaRing, increases the risk in women of developing these clots, compared with a woman who does not take any combined hormonal contraceptive. The risk is not as high as the risk of a clot during pregnancy.
It is still unknown how NuvaRing influences the risk of having a clot compared with birth control pills.
If you use a combined hormonal contraceptive, may increase the risk that you have to be a blood clot in a vein:
• with increasing age;
• if one of your family members have had a clot in the leg, lung, or other body being young;
• if you are overweight;
• if you have to operate, or if you can not walk for a while due to injury or illness, or has a leg cast. If this happens, is important to tell your doctor that you are using NuvaRing, as it may be to stop treatment. Your doctor may tell you to stop your hormonal contraception several weeks before surgery or while unable to walk. Your doctor will tell you when you can start using NuvaRing is restored when.
- Blood clot in an artery
A clot in an artery can cause serious problems. Por ejemplo, a clot in an artery of the heart causes a heart attack or brain causing a stroke.
The use of combined hormonal contraceptives has been associated with increased risk of blood clots increases in risk arterias.El:
• with increasing age;
• if a smoker. By using a hormonal contraceptive like NuvaRing is strongly recommended to stop smoking, especially if you have more than 35 años;
• if you are overweight;
• if you have high blood pressure. If your blood pressure increases while using NuvaRing your doctor may advise you to leave him;
• If a family member has had a heart attack or stroke at a young age;
• if you have high levels of blood fats (cholesterol or triglycerides);
• if you have diabetes;
• if you have migraines;
• if you have a heart problem (valve abnormalities or heart rhythm).
Remove NuvaRing and see your doctor immediately if you notice possible signs of thrombosis, such as:
• severe pain and / or swelling in one leg;
• Severe chest pain that can affect the left arm;
• sudden difficulty breathing;
• sudden cough without apparent cause;
• any unusual headache, intense prolonged, or worsening of migraine;
• partial or complete loss of vision or double vision;
• difficulty speaking or inability to speak;
• dizziness or fainting;
• weakness, strange feeling, or numbness in any part of your body;
After having a clot, recovery is not always complete. Very occasionally, can be severe and permanent disabilities or the clot can be fatal.
The following information was obtained from studies with combined oral contraceptives and could apply to NuvaRing. No information is available on the vaginal administration of contraceptive hormones (as NuvaRing).
There have been reports of breast tumors with a frequency slightly higher in women using contraceptive pills, but whether this is due to treatment. Por ejemplo, could be that more tumors were found in women who use birth control pills because they attend more often medical. This increase in frequency gradually decreases after stopping treatment. It is important to examine their breasts regularly and tell your doctor if you notice a lump. Tell your doctor if a close relative has or had breast cancer (see "Take special care with NuvaRing”).
Rarely been reported benign liver tumors, and still fewer cases malignant liver tumors, in women using the pill. Contact your doctor if you have severe pain and unusual in the abdomen.
In combination pill users has been shown to occur with less frequency of endometrial cancer (the tissue that lines the uterus) to ovaries. This could also be the case of NuvaRing, but has not been confirmed.
Taking other medicines
Always tell the doctor to prescribe what drugs NuvaRing or herbs you are taking. Also tell any doctor or dentist who prescribes another medicine (or if this farmacéutico handouts) you are using NuvaRing. They can tell you whether you need any additional contraceptive measure and for how long, if necessary. Some medications can cause problems if you use hormonal contraceptives such as NuvaRing.
There are medications that make NuvaRing less effective in preventing pregnancy or unexpected bleeding appears. These drugs can be to treat:
– Epilepsy (eg primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepina, topiramate, felbamato);
– Tuberculosis (eg rifampicin);
– HIV infection (ritonavir);
– Other infectious diseases (except antibiotic amoxicillin and doxycycline, have shown no influence hormone release from NuvaRing).
The herb St. John's wort can also make NuvaRing not operate correctly. If you take Herbal preparations with St. John's Wort while using NuvaRing, consult your doctor first.
NuvaRing can also interfere with the activity of other drugs, eg cyclosporine and antiepileptic lamotrigine.
You can use tampons while using NuvaRing. Please first NuvaRing and then the buffer. Take special care when removing the buffer so that the ring is not accidentally ejected. If it is ejected, simply rinse the ring with cool or lukewarm water and reinsert it immediately.
Using spermicides or vaginal yeast products will not reduce the contraceptive efficacy of NuvaRing.
If you do blood or urine, tell your doctor you use NuvaRing, because it can affect the outcome of some tests.
They should not use NuvaRing pregnant or who suspect they may be pregnant. If you become pregnant while using NuvaRing should remove the ring and see your doctor. If you want to leave because he wants to get pregnant NuvaRing, see "If you want to stop using NuvaRing”.
Generally it is not recommended to use NuvaRing if you are breast-feeding. To use NuvaRing breast-feeding consult your doctor.
Driving and using machines
NuvaRing is unlikely to affect your ability to drive or operate machinery.
3. USING NUVARING
You can register and remove NuvaRing yourself. Your doctor will tell you when to start using it for the first time. The vaginal ring must be inserted into the correct day of your monthly cycle (see section "When starting the first ring”) and remain in the vagina for 3 consecutive weeks. It is a good habit to get into the habit of regularly checking whether the ring is still in your vagina. After the third week, remove NuvaRing and miss a week of rest. You usually have your monthly period or rule during this pause ringless.
Method of donning and doffing the NuvaRing
1. Before wearing the ring, check if it is expired (see section 5 “NuvaRing Conservation”).
2. Wash hands before putting on or taking off the ring.
3. Choose the position that is most comfortable for you to insert it, eg standing with one leg raised up, squatting or lying.
4 Remove your NuvaRing on.
5. Hold the ring between your thumb and forefinger, press the opposite sides and insert the ring into the vagina. When NuvaRing is in place should not notice anything. If you feel uncomfortable gently push NuvaRing into the vagina. The exact position of the ring inside the vagina is important. The vaginal ring must remain in the vagina from the day he puts in 3 consecutive weeks, continuously.
6. After 3 semanas, Remove the ring on the same day of the week and put it on the same hour. Por ejemplo, if you put it on a Wednesday at about 22.00 h, it should be removed 3 weeks later, on Wednesday, approximately 22.00 h. You can do this by engaging the ring finger or index finger holding and stretching out. In the event that the ring can not be removed despite having located, contact your doctor. Once the ring is removed, do not use it for a week. During this week there should be a vaginal bleeding. It usually begins 2-3 days after removing the NuvaRing.
7. Remove the ring used with regular household trash, preferably in an envelope. No tire NuvaRing al inodoro. 8. Put a new ring just after the interval 1 week (again the same day of the week and at about the same time), even if you have not stopped bleeding. If the new ring is placed over 3 hour delay, contraceptive efficacy may be reduced.
Follow the instructions in "What to do if you forget to put a new ring after ring-free”.
If using NuvaRing as described above, his bleeding takes place about the same day each month.
When you start with the first ring
If you have not used hormonal contraception in the previous month:
Please NuvaRing on the first day of their natural life (ie, the first day of your period). NuvaRing starts acting immediately. No need to take additional contraceptive. You can also start using NuvaRing between day 2 and the,es 5 of its cycle, but if you have sex during the first 7 days of NuvaRing use, be sure to use an additional contraceptive method (condom). Just follow this recommendation when using NuvaRing for the first time.
You have used a combination pill in the previous month:
Start using NuvaRing at the latest the next day after the break with your current pill. If your pill pack also contains inactive tablets, start NuvaRing at the latest the day after the last inactive tablet. If you are not sure what is compressed, consult your doctor or your pharmacist. Do not lengthen never rest days your current pill beyond recommended. If you have taken your pill continuously present and correct, and is sure that she is not pregnant, also can stop taking the pill every day of their current cycle and start using NuvaRing immediately.
If using a transdermal patch last month
Start using NuvaRing at the latest the next day after the break without patch. No rest days lengthen unpatched beyond recommended. If you used the patch continuously and correct and is sure that she is not pregnant, patch can leave any day and immediately start using NuvaRing.
You have used a minipill in the previous month
You can stop taking minipill NuvaRing any day and start the next day at the same time. But make sure you also use an additional contraceptive method (condom) during the first 7 days of using the ring.
If you used an injectable, an implant or releasing intrauterine systems [SLI] hormonal load (progestogen) in the previous month
Start using NuvaRing at the time you should get the next shot or the day he removed the implant or SLI. But be sure to use an additional contraceptive method (a condom) during the first 7 days of using the ring.
If you have just one child, your doctor may advise you to wait until your first normal period before starting NuvaRing. It is sometimes possible to start earlier, your doctor will advise you how to do it. If you are breast feeding and want to use NuvaRing should consult with your doctor first.
Consult your doctor.
What to do if…
Your ring is accidentally expelled from the vagina:
NuvaRing may accidentally eject out of the vagina, for example if it is not inserted decuadamente, to remove a tampon, during sex, if you are constipated or have uterine prolapse (descent of the matrix). Por ello, should regularly check if the ring is on her vagina.
If the ring is expelled and have not been 3 hours, still protect you from pregnancy. You can wash the ring with cool or lukewarm water (Do not use hot water) and reinserting put. If the ring is expelled and spend more than 3 hours, could not protect you from pregnancy, see recommendation in section "What to do if … the ring has been out of the vagina temporarily”.
Your ring has been out of the vagina temporarily:
In 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, could not protect you from pregnancy. Por tanto, the ring can not be out of the vagina for more than 3 hours (twenty-four hours).
• If the ring has been out of the vagina and have been less than 3 hours, still protect pregnancy. You must enter the ring as soon as possible provided within 3 hours.
• If the ring is out of the vagina or suspected of having been out of the vagina for more than 3 hours in the 1st or 2nd week, could not protect you from pregnancy. Put the ring as soon as you remember and leave it in the vagina for at least 7 consecutive days. Use a condom if you have sex during those 7 days. If in the first week, and had sex in the 7 days prior, the possibility exists that were pregnant. Then, ask your doctor.
• If the ring has been out of the vagina or suspected to have been out of the vagina for more than 3 hours in the 3rd week, could not protect you from pregnancy. You must remove the ring and choose one of the following two options: 1. Put a new ring immediately:
When putting a new ring will start a new cycle of three weeks use and may not display the period. Nevertheless, can cause bleeding and spotting during that cycle.
2. Do not put a new ring: Allow breakthrough bleeding and insert a new ring no later than 7 days from the time the previous ring is removed or expelled. Choose this option only if you have used NuvaRing in quick succession during the 7 days prior.
The ring is opened:
Rarely NuvaRing can be opened. If you notice that NuvaRing is open, Remove the ring and put on a new one as soon as possible. Take additional contraceptive precautions (for example condoms) during 7 days. If you have had sex before noticing that the ring had been opened, Tell your doctor.
It has more than one ring:
No reports of major damage due to overdose of the hormones in NuvaRing. If you accidentally put a ring over, may feel sick (nausea), vomit or have vaginal bleeding. Remove the ring more and contact your doctor if these symptoms do not disappear.
If you forget to insert a new ring after the ring-free
Its ring-free has lasted more than 7 days. Put a new ring in the vagina as you remember tadaysnto. Take additional contraceptive measures (as a condom) Having sex for the next 7 days. If you had sex without a ring in this pause is possible that had become pregnant. In such a case, tell your doctor immediately. The longer the ring-free, the risk of pregnancy increases.
If you have forgotten to remove the ring:
• If the ring has been in your vagina 3 and 4 semanas, still protect pregnancy. Skip the week off and then apply a new one.
• If the ring has been in the vagina for more than 4 semanas, the possibility of pregnancy. Contact your doctor before starting a new ring.
If no period or rule:
• Did you use NuvaRing as directed:
If no period, but have used NuvaRing as directed and did not take other medicines, is very unlikely that you are pregnant. Continue to use the usual way NuvaRing. Nevertheless, if you have two fouls in a row may be pregnant, so you should see your doctor immediately. Do not let the next NuvaRing until your doctor has checked you are not pregnant.
• If you have deviated from the recommendations for use of NuvaRing:
If not filed their usual bleeding in one week break without a ring and has deviated from the recommended regimen, the possibility that there may be pregnant, so you should contact your doctor before getting a new ring.
If you have unexpected bleeding:
In some women, during use of NuvaRing may appear unexpected vaginal bleeding between menstrual periods. May need hygienic. Anyway, continue using the ring as normal, do not take it away. If bleeding continues, becomes more intense or begin again, ask your doctor.
To change the day your period begins or rule:
If you use NuvaRing as directed, of menstrual period (withdrawal bleeding) start in the ring-free week. If you want to change the day that begins, needs to be shortened (Never lengthen!) the ring-free. Por ejemplo, if your period usually starts on a Friday, can change it to a Tuesday, ie 3 days before starting the following month. Simplemente, please ring the following three days before the regular day. If the pause is too short (por ejemplo 3 days or less), might not have their usual bleeding. You can have a stained (drops or spotting) or breakthrough bleeding during the use of the next ring.
If you are not sure how, ask your doctor.
If you want to delay your period or rule
Although not the recommended regimen, can delay your period (withdrawal bleeding) getting a new ring immediately after removing the current ring, while the pause between rings. It can be left in place for the new ring 3 weeks maximum. During use of the new ring, may experience spotting (drops or spotting) or irregular bleeding. When you want to start your period simply remove the ring. Leave the normal break week off and put a new ring after.
You can consult your doctor before deciding to delay your period.
If you want to stop using NuvaRing
You can stop using NuvaRing at any time you want. If you do not want to become pregnant consult your doctor about other contraceptive methods. If you stop using NuvaRing because you want to get pregnant, you should wait until she has her first period before trying to conceive naturally. This will help you calculate your due date.
4. Possible adverse effects
Like all medicines, NuvaRing can cause side effects, although not everybody gets them.
We describe severe reactions observed with NuvaRing, and related symptoms in "Clots (thrombosis)"And"Cancer” (the main symptoms of a clot are: unusual pain and swelling in a leg, chest pain or difficulty breathing. If you think you have signs of a blood clot, remove NuvaRing and contact your doctor immediately).
If allergic to any component of NuvaRing (hypersensitivity), may have the following symptoms: angioedema [swelling of face, o lengua Garganta, difficulty swallowing] or urticaria, with breathing difficulties. If this happens, remove NuvaRing and contact your doctor immediately.
NuvaRing users have reported the following side effects:
Common adverse effects (may affect up 1 each 10 people):
• abdominal pain, discomfort (nausea)
• vaginal infection Yeast (like oral candidiasis), vaginal discomfort due to ring, picor genital, vaginal
• headache or migraine, depressed mood, less sexual desire
• breast pain, painful menstruation
• weight gain
• removal of the ring
Uncommon side effects (may affect up 1 each 100 people):
• changes in vision, dizziness
• swollen abdomen, vomiting, diarrhea or constipation
• feeling tired, annoyed or irritable, mood swings, changes in mood
• fluid retention in the body (edema)
• urinary tract infection or bladder
• dificultad, painful urination; urge to urinate. More frequent urination
• sexual problems such as pain, bleeding or the couple noticed the ring
• increased blood pressure
• increased appetite
• back pain, muscle cramps, pain in the legs or arms
• less sensitive skin
• stress or breast pain or enlargement; fibrocystic breast enfremedad (cysts in the breast that can become swollen or painful) • inflammation of the cervix, polyps grow on the cervix, displacement toward the outside of the inner tissue of the cervix (ectropion)
• changes in menstrual periods (more intense, long, irregular or disappear), pelvic discomfort, premenstrual syndrome, uterine cramping
• vaginal infection (the bacteria by fungi), burning, odor, pain, discomfort or dryness of the vagina or vulva
• Hair loss, eczema, itching, the eruption sofocos
• ring breakage
The following side effects have been reported with the use of NuvaRing in daily practice: urticaria, discomfort in the penis of the couple (irritation, eruption, itching).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. NUVARING STORE
Keep this medicine out of the sight and reach of children.
If you discover that a child has been exposed to hormones in NuvaRing, seek advice from your doctor.
NuvaRing Store in the original package below 30 º C to protect from light and moisture.
Use in 4 months from the date of dispensing, and before the expiration date printed on the packaging. The date of dispensing and the expiry date shown on the carton and on each envelope.
Do not use NuvaRing if you notice changes in the color of the ring or any visible sign of deterioration.
Medicines should not be disposed of via wastewater or household waste. Place containers and medicines no longer required in the pharmacy SIGRE Point. If in doubt, ask your pharmacist how to dispose of medicines no longer required. Thus, help protect the environment.
6. ADDITIONAL INFORMATION
Composition of NuvaRing
– The active substances are etonogestrel (11,7 mg) ethinylestradiol and (2,7 mg).
– The other ingredients are: vinyl acetate copolymer and ethylene (a type of plastic which does not dissolve in the body) and magnesium stearate.
Etonogestrel and ethinyl estradiol released from the ring in a proportion of 0,120 mg / day 0,015 mg / day respectively, three weeks.
NuvaRing appearance and contents of container
NuvaRing is a flexible ring, almost transparent and colorless, measuring 54 mm the ancho.
Each ring is packaged in an aluminum laminate resealable. The above is presented in a cardboard box along with this leaflet. Each box contains 1 O 3 rings.
Holder of the marketing authorization
Merck Sharp & Dohme of Spain, SA.
Josefa Valcárcel, 38
Tel.: 91 3210600
Responsible for manufacturing
PO Box 20
5340 BH Oss
Organon (Ireland) Ltd.,
PO Box 2857
Swords, What. Dublin
This leaflet was approved in 04/2012.