Nelova

Package leaflet: Information for the user

NELOVA, 0.120 mg/0.015 mg per 24 hours, vaginal device

Etonogestrel/Ethinylestradiol
Generic medicine

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods when used correctly.
• They slightly increase the risk of blood clots forming in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Read this entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What NELOVA is and what it is used for
2. What you need to know before using NELOVA
   2.1 Do not use NELOVA
   2.2 Warnings and precautions
   Blood clots
   Cancer
   2.3 Children and adolescents
   2.4 Other medicines and NELOVA
   Laboratory tests
   2.5 Pregnancy and breastfeeding
   2.6 Driving and use of machines
3. How to use NELOVA
   3.1 How to insert and remove NELOVA
   3.2 Three weeks with the ring inserted, one week without
   3.3 When to start with the first ring
   3.4 What to do if…
   The ring is accidentally expelled from the vagina
   The ring remains temporarily outside the vagina
   The ring breaks
   You inserted more than one ring
   You forgot to insert a new ring after a ring-free interval
   You forgot to remove the ring
   You miss a menstrual period
   You have unexpected bleeding
   You wish to change the first day of menstruation
   You wish to delay menstruation
   3.5 When you wish to stop using NELOVA
4. Possible side effects
5. How to store NELOVA
6. Contents of the pack and other information

What NELOVA contains
Description of the appearance of NELOVA and contents of the pack
Marketing authorisation holder and manufacturer

1. What NELOVA is and what it is used for

NELOVA is a vaginal contraceptive ring used to prevent pregnancy. Each ring contains a small amount of two female sex hormones: etonogestrel and ethinylestradiol. The ring slowly releases these hormones into the bloodstream. Because the amounts of hormones released are low, NELOVA is considered a low-dose hormonal contraceptive. Since NELOVA releases two different types of hormones, it is a so-called combined hormonal contraceptive.

NELOVA works just like a combined oral contraceptive pill (the Pill), but instead of taking a pill every day, the ring is used continuously for three weeks. NELOVA releases two female sex hormones that prevent the release of an egg from the ovaries. If no egg is released, pregnancy cannot occur.

2. What you should know before using NELOVA

General notes
Before starting to use NELOVA, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
This patient leaflet describes various situations in which you should stop using NELOVA or in which NELOVA may be less reliable. In such cases, you should either avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as male condoms or other barrier methods. Do not use rhythm methods or basal body temperature methods, as they may be unreliable because NELOVA alters the monthly variations in body temperature and cervical mucus.
NELOVA, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

2.1 Do not use NELOVA
Do not use NELOVA if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other birth control methods that might be more suitable for you.
Do not use NELOVA:

• if you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a blood clotting disorder, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are about to undergo surgery or if you need to remain bedridden for a prolonged period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and which may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which may increase the risk of developing a clot in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have had) inflammation of the pancreas (pancreatitis) associated with high levels of fats in the blood;
• if you have (or have had) a serious liver disease and liver function has not yet returned to normal;
• if you have (or have had) a benign or malignant liver tumour;
• if you have (or have had), or may have, breast cancer or cancer of the genital organs;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or etonogestrel or to any of the other ingredients of this medicine (listed in section 6). If any of these conditions occurs for the first time while using NELOVA, remove the ring immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods.

Do not use NELOVA if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section 2.4 “Other medicines and NELOVA”).

2.2 Warnings and precautions
When should you contact your doctor?
Contact your doctor urgently

• if you notice signs that may indicate a blood clot, which could mean you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clots”). For a description of the symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
You must also inform your doctor if the condition develops or worsens while you are using NELOVA.

• if a close relative has or has had breast cancer;
• if you have epilepsy (see section 2.4 “Other medicines and NELOVA”);
• if you have liver disease (e.g. jaundice) or gallbladder disease (e.g. gallstones);
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are about to undergo surgery or if you need to remain bedridden for a long time (see section 2 “Blood clots”);
• if you have recently given birth, as your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start using NELOVA;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have a condition that occurred for the first time or worsened during pregnancy or during previous use of sex hormones (e.g. hearing loss, porphyria [a blood disorder], herpes gestationis [a blistering skin rash during pregnancy], Sydenham’s chorea [a nerve disorder causing sudden involuntary movements], hereditary angioedema [you must see a doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives associated with breathing difficulties]);
• if you have (or have ever had) chloasma (brownish-yellow patches, so-called “pregnancy mask”, especially on the face). In this case, avoid prolonged exposure to sunlight or ultraviolet rays;
• if you have a medical condition that makes the use of NELOVA difficult, such as constipation, uterine cervical prolapse, or pain during sexual intercourse;
• if you urinate urgently, frequently, with burning and/or pain and cannot locate the ring in the vagina. These symptoms may indicate accidental placement of NELOVA inside the bladder.

BLOOD CLOTS
Using a combined hormonal contraceptive such as NELOVA increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop:

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE);
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE). Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects can be fatal.

It is important to remember that the overall risk of a harmful blood clot caused by NELOVA is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or foot, Deep vein thrombosis, especially if accompanied by:
  • pain or tenderness in the leg, which may only be felt when standing or walking
  • increased warmth in the affected leg
  • change in skin colour of the leg, such as paleness, redness or bluish discolouration.

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and travels to the lung, it can cause a pulmonary embolism.
• Very rarely, the clot may form in a vein of another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking NELOVA, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk for VTE and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with NELOVA is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot over one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot over one year.
• Among 10,000 women who use a combined hormonal contraceptive containing norelgestromine or etonogestrel, such as NELOVA, about 6–12 will develop a blood clot over one year.
• The risk of developing a blood clot depends on your personal medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with NELOVA is low, but certain conditions can increase it. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (before approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you are due to undergo surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in plaster. You may need to stop using NELOVA several weeks before surgery or during periods of reduced mobility. If you need to stop using NELOVA, ask your doctor when you can start using it again;
• as you get older (especially over 35 years);
• if you gave birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting > 4 hours) may temporarily increase the risk of blood clot formation, especially if you have any of the other listed risk factors.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to stop your use of NELOVA.
If any of the above conditions change while you are using NELOVA—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they can lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of NELOVA is very low but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like NELOVA, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (before approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using NELOVA—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Cancer
The information below comes from studies on combined oral contraceptives and may also apply to NELOVA. There is no specific information available on vaginal administration of hormonal contraceptives (as with NELOVA).

Breast cancer diagnoses are slightly more frequent in women using combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, tumours may be detected more often in women taking the pill because they are examined more frequently by their doctor. The increased occurrence of breast cancer gradually decreases after stopping the combined pill. It is important that you regularly examine your breasts and contact your doctor if you feel a lump. Additionally, you should inform your doctor if a close relative has or has had breast cancer (see section 2.2 “Warnings and precautions”).

In rare cases, benign liver tumours and even more rarely malignant liver tumours have been reported in women taking the pill. Consult your doctor if you experience unusual, severe abdominal pain.

Women using combined oral contraceptives have been reported to develop endometrial cancer (cancer of the lining of the uterus) and ovarian cancer less frequently. This may also be the case with NELOVA, but it has not been confirmed.

Psychiatric disorders
Some women using hormonal contraceptives, including NELOVA, have reported depression or depressed mood. Depression can be serious and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further advice.

2.3 Children and adolescents
The safety and efficacy of NELOVA in adolescents under 18 years of age have not been studied.

2.4 Other medicines and NELOVA
Always inform your doctor about any medicines or herbal products you are currently taking. Also inform any other doctors or dentists (or pharmacists) who prescribe medicines for you that you are using NELOVA.
They may advise you whether you need to use additional contraceptive methods (e.g., male condom), and if so, for how long, or whether you need to adjust the use of another medicine you are taking.

Some medicines:

• can affect blood levels of NELOVA;
• can reduce its contraceptive effectiveness;
• can cause unexpected bleeding.

These include medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin);
• HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz);
• hepatitis C virus infection (e.g., boceprevir, telaprevir);
• other infections (e.g., griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depressive mood (herbal remedy St. John’s wort (Hypericum perforatum)).

If you are taking medicines or herbal products that may reduce the effectiveness of NELOVA, you must also use a barrier contraceptive method (e.g., male condom). Because the effect of other medicines on NELOVA may last up to 28 days after stopping them, you must use an additional barrier contraceptive method throughout this period.
Note: NELOVA must not be used in combination with a diaphragm, cervical cap, or female condom.

NELOVA can affect the action of other medicines, for example:

• medicines containing ciclosporin;
• the antiepileptic lamotrigine (this may lead to an increased frequency of seizures).

Do not use NELOVA if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause increases in liver function blood tests (elevation of liver enzyme ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
NELOVA may be resumed approximately 2 weeks after completion of such treatment. See section 2.1 “Do not use NELOVA”.
Ask your doctor or pharmacist for advice before taking any medicine.

You may use tampons while using NELOVA. Insert NELOVA before inserting the tampon.
Take particular care when removing the tampon to ensure the ring is not accidentally expelled. If this happens, simply wash the ring with cold or lukewarm water and reinsert it immediately.

Cases of ring breakage have been reported with concomitant use of vaginal products such as lubricants or infection treatments (see section 3.4 “What to do if… the ring breaks”).

The use of spermicidal products or vaginal yeast-based treatments does not reduce the contraceptive effectiveness of NELOVA.

Laboratory tests
If you undergo blood or urine tests, inform the healthcare professional that you are using NELOVA, as it may alter the results of certain tests.

2.5 Pregnancy and breastfeeding
NELOVA must not be used if you are pregnant or suspect you may be pregnant. If pregnancy occurs while using NELOVA, you must remove the ring and contact your doctor.
If you wish to stop using NELOVA because you want to become pregnant, see section 3.5 “When you wish to stop using NELOVA”.
NELOVA is not recommended during breastfeeding. If you wish to use NELOVA while breastfeeding, consult your doctor.

2.6 Driving and using machines
It is unlikely that NELOVA will affect your ability to drive or use machinery.

3. How to use NELOVA

You can insert and remove NELOVA yourself. Your doctor will give you instructions on when to start using NELOVA for the first time. The vaginal ring must be inserted on the appropriate day of the menstrual cycle (see section 3.3 "When to start with the first ring") and left in the vagina for 3 consecutive weeks. Regularly check that NELOVA is in the vagina (e.g. before and after sexual intercourse) to ensure protection against pregnancy. After the third week, remove NELOVA and have a one-week ring-free interval. Usually, menstruation will occur during this ring-free interval.

While using NELOVA, do not use certain female barrier contraceptive methods such as a vaginal diaphragm, cervical cap, or female condom. These barrier contraceptive methods should not be used as an additional method of birth control, as NELOVA may interfere with the correct placement and positioning of the diaphragm, cervical cap, or female condom. However, you may use the male condom as an additional barrier contraceptive method.

3.1 How to insert and remove NELOVA

1. Before inserting the ring, check that it is not expired (see section 5 "How to store NELOVA").

2. Wash your hands before inserting or removing the ring.

3. Choose the most comfortable position for insertion, for example standing with one leg raised, squatting, or lying down.

4. Remove NELOVA from the pouch.

5. Hold the ring between your thumb and index finger, compressing opposite sides, and gently insert it into the vagina (see Figures 1–4). Once NELOVA is in place, you should not feel anything. If you experience discomfort, gently adjust the position of NELOVA (for example, by pushing it slightly deeper into the vagina) until the discomfort is gone. The exact position of the ring inside the vagina is not important.

6. After 3 weeks, remove NELOVA from the vagina. You can do this by hooking your index finger under the front edge of the ring or by grasping the edge of the ring and pulling outward (see Figure 5). If you can locate the ring in the vagina but have difficulty removing it, contact your doctor.

7. The used ring should be disposed of with normal household waste, preferably inside the resealable pouch. Do not flush NELOVA down the toilet.

Figure 1

Remove NELOVA from the pouch

Figure 3
Choose a comfortable position for inserting the ring
Figure 2
Compress the ring

Figure 4A Figure 4B Figure 4C
Insert the ring into the vagina with one hand (Figure 4A); if necessary, the labia can be parted with the other hand. Push the ring into the vagina until you feel it is in a comfortable position (Figure 4B). Leave the ring in place for 3 weeks (Figure 4C).
Figure 5

NELOVA can be removed by hooking the index finger under the ring or by grasping the ring between the index and middle fingers and pulling outward.

3.2 Three weeks with the ring inserted, one week without

1. Starting from the day it is inserted, the vaginal ring must be kept in the vagina without interruption for 3 weeks.
2. After 3 weeks, remove the ring on the same day of the week it was inserted, approximately at the same time. For example, if you inserted NELOVA on a Wednesday around 10 p.m., the ring should be removed 3 weeks later, on a Wednesday, approximately at 10 p.m.
3. After removal, do not use the ring for 1 week. During this week, vaginal bleeding should occur. It usually starts 2–3 days after removal of NELOVA.
4. Start with a new ring exactly after the 1-week interval (again on the same day of the week and approximately at the same time), even if vaginal bleeding has not yet stopped.
5. If insertion of the new ring is delayed by more than 3 hours, protection against pregnancy may be reduced. In this case, follow the instructions provided in section 3.4 "What to do if… you forget to insert a new ring after a ring-free interval".

If you use NELOVA as described above, vaginal bleeding will occur approximately on the same days every month.

3.3 When to start with the first ring

• If you have not used a hormonal contraceptive during the past month Insert the first NELOVA on day 1 of your natural cycle (i.e. the first day of menstruation). NELOVA begins to exert its effect immediately. No additional contraceptive measures are necessary. You may also start using NELOVA between day 2 and day 5 of the cycle, but if you have sexual intercourse during the first 7 days of using NELOVA, make sure to use an additional contraceptive method (e.g. a male condom). You need to follow this advice only when using NELOVA for the first time.

• If you have used a combined oral contraceptive (pill) during the past month Start using NELOVA no later than the day after the pill-free interval of your current pill pack. If your pack also contains inactive tablets, start using NELOVA no later than the day after the last inactive tablet. If you are unsure which tablet this is, consult your doctor or pharmacist. Never extend the hormone-free interval of your current pill pack beyond the recommended duration. If you have taken the pill consistently and correctly and are sure you are not pregnant, you may also stop taking the pill on any day of the current pack and start using NELOVA immediately.

• If you have used a transdermal patch during the past month Start using NELOVA no later than the day after the usual patch-free interval. Never extend the patch-free interval beyond the recommended duration. If you have used the patch consistently and correctly and are sure you are not pregnant, you may also stop using the patch on any day and start using NELOVA immediately.

• If you have used a progestin-only pill ( minipill ) during the past month You may stop taking the minipill on any day and start using NELOVA the next day at the same time you would normally have taken the pill. Make sure to use an additional contraceptive method (e.g. a male condom) during the first 7 days of ring use.

• If you have used a progestin-releasing injection, implant, or IUD during the past month Start using NELOVA on the day the next injection is due or on the day of removal of the implant or progestin-releasing IUD. Make sure to use an additional contraceptive method (e.g. a male condom) during the first 7 days of ring use.

• After childbirth If you have recently given birth, your doctor will advise you to wait for your first natural cycle before starting to use NELOVA. In some cases, earlier initiation may be possible. Ask your doctor for advice. If you are breastfeeding and wish to use NELOVA, consult your doctor first.

• After a spontaneous or induced abortion Consult your doctor.

3.4 What to do if…

The ring is accidentally expelled from the vagina
NELOVA may accidentally come out of the vagina, for example, if it was not inserted correctly, during removal of a tampon, during sexual intercourse, in association with constipation or uterine prolapse. Therefore, you should regularly check whether the ring is still in the vagina (e.g. before and after sexual intercourse).

The ring remains temporarily outside the vagina
NELOVA may still protect you from pregnancy, but this depends on how long it has been outside the vagina.

If the ring has been outside the vagina for:

• less than 3 hours, it will still protect you from pregnancy. Rinse the ring with cold or lukewarm (not hot) water and reinsert it as soon as possible, but only if it has been outside the vagina for less than 3 hours.
• more than 3 hours, during week 1 or 2, it may not protect you from pregnancy. Rinse the ring with cold or lukewarm (not hot) water and reinsert it as soon as you remember. Leave the ring in the vagina without interruption for at least 7 days. Use a male condom if you have sexual intercourse during these 7 days. If you are in week 1 and have had sexual intercourse in the previous 7 days, there is a possibility that pregnancy may have occurred. In this case, contact your doctor.
• more than 3 hours during week 3, it may not protect you from pregnancy. Discard that ring and choose one of the following two options:
  1. Insert a new ring immediately. This will start the next 3-week usage period. Menstruation may not occur, but spotting or intermenstrual bleeding may occur.
  2. Do not insert a new ring. Wait until you have your period and insert a new ring no later than 7 days after the previous ring was removed or expelled. This option should only be chosen if NELOVA has been used continuously for the previous 7 days.
• an unknown period of time, it may not protect you from pregnancy. Perform a pregnancy test and consult your doctor before inserting a new ring.

The ring breaks
Very rarely, NELOVA may break. Vaginal injuries associated with ring breakage have been reported. If you notice that NELOVA has broken, discard that ring and start with a new ring as soon as possible. Use additional contraceptive precautions (e.g. a male condom) for the next 7 days. If you had sexual intercourse before noticing the breakage, consult your doctor.

You inserted more than one ring
No serious adverse effects due to overdose of NELOVA hormones have been reported. If you accidentally inserted more than one ring, you may experience nausea, vomiting, or vaginal bleeding. Remove the extra rings and consult your doctor if symptoms persist.

You forgot to insert a new ring after a ring-free interval
If the ring-free interval has been longer than 7 days, insert a new ring as soon as you remember. Also use an additional contraceptive method (e.g. a male condom) if you have sexual intercourse in the next 7 days. If you had sexual intercourse during the interval period, the possibility of pregnancy should be considered. Discuss this immediately with your doctor. The longer the ring-free interval, the greater the risk of pregnancy.

You forgot to remove the ring

• If the ring has been left in for more than 3 but not more than 4 weeks, it may still protect you from pregnancy. Proceed with the regular one-week ring-free interval and then insert a new ring.
• If the ring has been left in for more than 4 weeks, there is a possibility that pregnancy may have occurred. Contact your doctor before inserting a new ring.

You missed a period

• NELOVA has been used as directed in the instructions If you missed a period but NELOVA has been used correctly according to instructions and no other medications have been taken, it is very unlikely that pregnancy has occurred. Continue using NELOVA as usual. However, if you miss two consecutive periods, pregnancy may have occurred. Consult your doctor immediately. Do not start a new NELOVA until your doctor has ruled out pregnancy.
• NELOVA has not been used as recommended If you missed a period and did not follow the instructions, and you did not have the expected period during the first ring-free interval, pregnancy may have occurred. Contact your doctor before starting to use a new NELOVA.

You have unexpected bleeding
During use of NELOVA, some women may experience unexpected vaginal bleeding between periods. You may need to use sanitary protection. In any case, leave the ring in the vagina and continue using it normally. Consult your doctor if irregular bleeding persists, becomes heavy, or recurs.

You want to change the first day of your period
If you use NELOVA as directed, your period (withdrawal bleeding) will begin during the ring-free interval. If you wish to change the day your cycle starts, you may shorten the ring-free interval (never extend this interval!).
For example, if your period usually starts on Friday, you can shift it to Tuesday (3 days earlier) starting next month. Simply insert the next ring 3 days earlier than usual.
If the ring-free interval is very short (e.g. 3 days or less), you may not have the usual bleeding, but you may experience spotting (drops or small blood stains) or intermenstrual bleeding during use of the next ring.
If you are unsure how to proceed, contact your doctor for clarification.

You want to delay your period
Although not recommended, it is possible to delay your period (withdrawal bleeding) by inserting a new ring immediately after removing the previous one, without taking a ring-free interval. The new ring may remain inserted for a maximum of 3 weeks. During use of the new ring, you may experience spotting (drops or small blood stains) or intermenstrual bleeding.
Remove the ring when you decide to have your period. Observe the regular one-week ring-free interval and then insert a new ring.
You may consult your doctor before deciding to delay your period.

3.5 When you want to stop using NELOVA
You may stop using NELOVA at any time. If you do not wish to become pregnant, consult your doctor about other methods of birth control.
If you stop using NELOVA because you wish to become pregnant, wait for a natural cycle before trying to conceive. This will help you calculate the expected date of delivery.

4. Possible side effects

Like all medicines, NELOVA can cause side effects, although not everyone experiences them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to NELOVA, inform your doctor.
There is an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 "What you need to know before using NELOVA".
If you are allergic to any of the components of NELOVA (hypersensitivity), you may experience the following symptoms (frequency not known): angioedema and/or anaphylaxis [swelling of the face, lips, tongue and/or throat and/or difficulty swallowing] or urticaria associated with breathing difficulties. If this occurs, remove NELOVA and consult your doctor immediately.
The following side effects have been reported during use of NELOVA:
Common: may affect up to 1 in 10 women

• abdominal pain, feeling unwell (nausea)
• vaginal fungal infection (e.g. "Candida"); vaginal discomfort due to the ring; genital itching; vaginal discharge
• headache or migraine; depressed mood; decreased libido
• breast pain; pelvic pain; painful menstruation
• acne
• weight gain
• expulsion of the ring.

Uncommon: may affect up to 1 in 100 women

• visual disturbances; dizziness
• bloated abdomen; vomiting, diarrhoea or constipation
• feeling of fatigue, malaise or irritability; mood changes; mood swings
• fluid retention in tissues (oedema)
• urinary tract or bladder infection
• difficulty or pain when urinating; strong need to urinate; increased frequency of urination
• problems during sexual intercourse, including pain, bleeding or partner awareness of the ring
• increased blood pressure
• increased appetite
• back pain; muscle spasms; leg or arm pain
• reduced skin sensitivity
• tender or enlarged breasts; fibrocystic mastopathy (breast cysts that may swell or become painful)
• cervical inflammation; cervical polyps (growths in the cervix); eversion of the cervical margin (ectropion)
• menstrual changes (e.g. heavy, prolonged, irregular menstruation or periods may stop completely); pelvic discomfort; premenstrual syndrome; uterine spasms
• vaginal infections (fungal and bacterial); burning, bad odour, pain, discomfort or dryness of the vagina or vulva
• hair loss, eczema, itching, skin rash or hot flushes.

Rare: may affect up to 1 in 1,000 women

• harmful blood clots in a vein or an artery, for example:
  • in a leg or foot (DVT)
  • in a lung (PE)
  • heart attack
  • stroke
  • mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestines, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

• breast secretion. Not known (frequency cannot be estimated from the available data)
• chloasma (brown-yellowish pigmented skin patches, particularly on the face)
• penile discomfort in the partner (such as irritation, rash, itching)
• inability to remove the ring without medical assistance (e.g., due to adhesion to the vaginal wall)
• vaginal lesion associated with ring rupture. Breast cancer and liver tumours have been reported in users of combined hormonal contraceptives. For further information, see section 2.2 "Warnings and precautions, Cancer".

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NELOVA

Keep this medicine out of the sight and reach of children.
If you know that a child has been exposed to the hormones in NELOVA, consult your doctor.
Do not use NELOVA after the expiry date stated on the pack and on the sachet. The expiry date is printed on the box and on the sachet.
Do not use NELOVA if you notice any colour changes in the ring or any other visible signs of deterioration.
Dispose of the used ring with ordinary household waste, preferably placed in the resealable sachet. NELOVA must not be flushed down the toilet. As with other medicines, do not dispose of unused or expired rings via wastewater or household waste. Ask your pharmacist how to dispose of rings that you no longer use. This will help protect the environment.
The resealable zipper pouch is intended solely for disposal of the product at the end of treatment, and must not be used for storage during use.

6. Package contents and other information

What NELOVA contains

• The active substances are: etonogestrel and ethinylestradiol. Each ring contains 11.7 mg of etonogestrel and 2.7 mg of ethinylestradiol.
• The other components are: ethylene vinylacetate copolymer with 28% vinylacetate and ethylene vinylacetate copolymer with 9% vinylacetate (a type of plastic that does not dissolve in the body) and magnesium stearate.

Daily release of 0.120 mg of etonogestrel and 0.015 mg of ethinylestradiol (over 3 weeks).
Description of the appearance of NELOVA and package contents
NELOVA is a flexible, transparent, colourless ring with a diameter of 54 mm.
Each ring is packaged in a resealable aluminium pouch. The pouch is contained in a cardboard box. Each box contains either 1 or 3 rings.
Marketing Authorization Holder
LABORATOIRES BAILLEUL S.A.
10-12, Avenue Pasteur
L-2310 Luxembourg
Luxembourg
Manufacturer
KERN PHARMA, S.L.
Venus, 72 – Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Etonogestrel/Ethinylestradiol Kappler Pharma 0.120 mg / 0.015 mg per 24 hours
vaginal drug delivery system
France ETHINYLESTRADIOL/ETONOGESTREL KAPPLERPHARMA 15 micrograms/120
micrograms/24 hours, vaginal delivery system
Italy NELOVA