Vagan

Package leaflet: Information for the user

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

etonogestrel/ethinylestradiol
Equivalent medicine

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

• They are one of the most reliable reversible contraceptive methods, if 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 have symptoms of a blood clot (see section 2 “Blood clots”)

Read this 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 other people; it could be dangerous for them.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet
1. What VAGAN is and what it is used for
2. What you need to know before using VAGAN
2.1 When you must not use VAGAN
2.2 Warnings and precautions
Blood clots
Tumours
2.3 Children and adolescents
2.4 Other medicines and VAGAN
Laboratory tests
2.5 Pregnancy and breastfeeding
2.6 Driving and using machines

3. How to use VAGAN

3.1 How to insert and remove VAGAN
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
More than one ring has been inserted
You forget to insert a new ring after a ring-free interval
You forget to remove the ring
You miss a menstrual period
You experience unexpected bleeding
You wish to change the first day of your menstrual cycle
You wish to delay your menstrual period
3.5 When you want to stop using VAGAN
4. Possible side effects
5. How to store VAGAN
6. Package contents and other information
What VAGAN contains
Description of the appearance of VAGAN and package contents
Marketing Authorization Holder and Manufacturer

1. What VAGAN is and what it is used for

VAGAN 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, VAGAN is considered a low-dose hormonal contraceptive.
Since VAGAN releases two different types of hormones, it is a combined hormonal contraceptive.

VAGAN works in the same way as a combined oral contraceptive pill (the Pill), but instead of
taking a pill every day, the ring is used continuously for three weeks. VAGAN releases
two female sex hormones that prevent the release of an egg from the ovaries. If there is
no release of eggs, pregnancy cannot occur.

2. What you should know before using VAGAN

General notes
Before starting to use VAGAN, 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 leaflet describes certain situations in which you should stop using VAGAN or in which VAGAN may be less reliable. In such situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as condoms or other barrier methods. Do not use rhythm or basal body temperature methods, as they may be unreliable because VAGAN alters the monthly fluctuations in body temperature and cervical mucus.
VAGAN, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted infection.

2.1 Do not use VAGAN
Do not use VAGAN if you have (or have ever had) any of the conditions listed below. If any of the following conditions apply to you, consult your doctor. Your doctor will discuss with you other birth control methods that might be more suitable for you.

• if you have (or have ever had) a blood clot in a vein of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a condition affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or will be 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 could increase the risk of developing clots 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) pancreatitis (inflammation of the pancreas) associated with high levels of fats in the blood;
• if you have (or have had) severe 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, a tumour of the breast or genital organs;
• if you have vaginal bleeding of unknown origin;
• 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 occur for the first time while using VAGAN,
remove the ring immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods.
Do not use VAGAN if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/
ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section
Other medicines and VAGAN).

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

• if you notice possible signs of a blood clot which may indicate that 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, see section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using VAGAN, inform your doctor.

• if a close family member has or has had breast cancer;
• if you have epilepsy (see section 2.4 “Other medicines and VAGAN”);
• 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 due to undergo surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start using VAGAN;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins;
• if you have a condition that first occurred or worsened during pregnancy or during previous use of sex hormones (e.g. hearing loss, porphyria [a blood disorder], herpes gestationis [blistering skin rash during pregnancy], Sydenham’s chorea [a nerve disorder causing sudden, involuntary movements]);
• if you have (or have ever had) chloasma (brownish-yellow pigmented patches, so-called “pregnancy mask”, especially on the face). In this case, avoid prolonged exposure to sunlight or ultraviolet radiation;
• if you have a medical condition that makes using VAGAN difficult, such as constipation, uterine cervical prolapse, or pain during sexual intercourse;
• if you experience urgent, frequent urination with burning and/or pain and cannot locate the ring in the vagina. These symptoms may indicate accidental placement of VAGAN into the urinary bladder;
• If you develop symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or potentially hives with breathing difficulties, contact a doctor immediately.

Products containing oestrogens may cause or worsen symptoms of hereditary and
acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as VAGAN 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, these may be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with
VAGAN is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.

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 blood clots forming 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 travels from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, the clot may form in 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 first-time use of a combined hormonal contraceptive. The risk may also be higher when restarting a combined hormonal contraceptive (either 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 VAGAN, 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 of VTE (venous thromboembolism) 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 VAGAN 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 in 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 in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing norelgestromine or etynodiol diacetate, such as VAGAN, about 6–12 will develop a blood clot in one year.
• The risk of developing a blood clot depends on your 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 VAGAN 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 (under 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
  an injury or illness, or if you have a plaster cast on your leg. You may need to stop using VAGAN several weeks before surgery or during periods of reduced mobility. If you need to stop taking VAGAN, ask your doctor when you can start taking it again;

• with increasing age (especially over 35 years);

• if you have given 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 clots, especially if you have 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 VAGAN. If any of the above conditions change while you are using VAGAN—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 VAGAN is very low but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as VAGAN, it is advisable to stop smoking. If you cannot 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 (under 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 VAGAN—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.

Tumors
The information below comes from studies on combined oral contraceptives and may also apply to VAGAN. Information on the vaginal administration of contraceptive hormones (such as VAGAN) is not available.
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, tumors may be detected more often in women taking the combined 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 to regularly examine your breasts and contact your doctor as soon as you feel a lump. You should also inform your doctor if a close relative has or has had breast cancer (see section 2.2 “Warnings and precautions”).
Benign liver tumors have been rarely reported in women taking the pill, and malignant liver tumors even more rarely. 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 inner lining of the uterus) and ovarian cancer less frequently. This may also be the case with VAGAN, but it has not been confirmed.

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

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

2.4 Other medicines and VAGAN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Always inform your doctor about any medicines or herbal products you are currently taking. Also inform any other doctors or dentists (or pharmacist) who prescribe other medicines that you are using VAGAN. They will advise you whether you need to use additional contraceptive methods (e.g., condom), and if so, for how long, or whether you need to adjust the use of another medicine you are taking.
Some medicines:

• may affect blood levels of VAGAN;
• may cause a decrease in contraceptive effectiveness;
• may 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 infectious diseases (e.g., griseofulvin);
  • high blood pressure in the lung's blood vessels (bosentan);
  • depressed mood (St. John’s wort (Hypericum perforatum)).

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

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

Do not use VAGAN if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir, as this may cause increases in liver function blood test results (elevated liver enzyme ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
VAGAN may be restarted approximately 2 weeks after completion of this treatment. See section 2.1 "When must VAGAN not be used."
Ask your doctor or pharmacist for advice before taking any medicine.
Sanitary tampons may be used during the use of VAGAN. Insert VAGAN before inserting the tampon. Special care should be taken when removing the tampon to ensure that the ring is not accidentally expelled. If this occurs, simply wash the ring with cold or lukewarm water and reinsert it immediately.
The ring may break when also using a vaginal product such as a lubricant or treatment for infection (see section 3.4 "What to do if... the ring breaks").
The use of spermicidal products or vaginal yeast treatments does not reduce the contraceptive effectiveness of VAGAN.

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

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

2.6 Driving and use of machines
It is unlikely that VAGAN will affect your ability to drive or operate machinery.

3. How to use VAGAN

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
You yourself must insert VAGAN into the vagina and you yourself must remove it. Your doctor will tell you when to start using VAGAN 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 continuously for 3 weeks. Check regularly that VAGAN is still in the vagina (e.g. before and after intercourse) to ensure you are protected against pregnancy. After the third week, remove VAGAN and take a one-week break. Usually, your menstrual period will occur during this ring-free interval.
While using VAGAN, you do not need to use any female barrier contraceptive methods, such as a vaginal diaphragm, cervical cap, or female condom. These barrier methods should not be used as a backup method of birth control, as VAGAN may interfere with the correct placement and positioning of a diaphragm, cervical cap, or female condom. However, you may still use a male condom as an additional barrier contraceptive method.

3.1 How to insert and remove VAGAN

1. Before inserting the ring, check that it has not expired (see section 5 “How to store VAGAN”).
2. Wash your hands before inserting or removing the ring.
3. Choose the most comfortable position for inserting the ring, for example standing with one leg raised, squatting, or lying down.
4. Remove VAGAN from its pouch. Keep the pouch for later use.
5. Hold the ring between your thumb and index finger, compress it on opposite sides, and gently insert it into the vagina (see Figures 1–4). Once VAGAN is inserted and in place, you should not feel any discomfort. If you do feel discomfort, gently push VAGAN a little deeper into the vagina. The exact position of the ring inside the vagina is not important.
6. After 3 weeks, remove VAGAN from the vagina. VAGAN can be removed 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, you must contact your doctor.
7. The used ring should be disposed of with ordinary household waste, preferably inside the original pouch. Do not flush VAGAN down the toilet.

Figure 1
Remove VAGAN from its pouch

Figure 2
Compress the ring

Figure 3
Choose a comfortable position for inserting the ring

Figure 4A Figure 4B Figure 4C
Insert the ring into the vagina with one hand (Figure 4A); if necessary, the labia may be parted with the other hand. Push the ring into the vagina until you feel it is comfortably in place (Figure 4B). Leave the ring inserted for 3 weeks (Figure 4C).
Figure 5
VAGAN can be removed by hooking your index finger under the ring or by grasping the edge of the ring between your index and middle finger and pulling outward.

3.2 Three weeks with the ring inserted, one week without

1. Starting from the day of insertion, the vaginal ring must be kept in the vagina continuously for 3 weeks.
2. After 3 weeks, remove the ring on the same day of the week and approximately at the same time as it was inserted. For example, if VAGAN is inserted on Wednesday around 10 p.m., the ring should be removed on the Wednesday of the third following week, approximately at 10 p.m.
3. After removal, do not use a ring for 1 week. During this week, you may experience vaginal bleeding. Usually, this starts 2–3 days after removal of VAGAN.
4. Insert 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. If the new ring is inserted more than 3 hours late, 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 VAGAN 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 The first VAGAN should be inserted on day 1 of your natural cycle (i.e. the first day of your menstrual period). VAGAN starts to work immediately. No additional contraceptive measures are needed. Starting VAGAN between day 2 and day 5 of the cycle is allowed, but if you have sexual intercourse during the first 7 days of using VAGAN, you must also use an additional contraceptive method (e.g. a condom). This advice applies only when using VAGAN for the first time.
• If you have used a combined oral contraceptive (pill) during the past month Start using VAGAN no later than the day after the pill-free interval of your current pill pack. If your pack also contains inactive tablets, start using VAGAN no later than the day after the last inactive tablet. If you are unsure which tablet is inactive, consult your doctor or pharmacist. Never extend the hormone-free interval of your current pill pack beyond the recommended period. 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 VAGAN immediately.
• If you have used a transdermal patch during the past month Start using VAGAN no later than the day after your usual patch-free interval. Never extend the patch-free interval beyond the recommended period. If you have used the patch consistently and correctly and are sure you are not pregnant, you may stop using the patch on any day and start using VAGAN immediately.
• If you have used a progestogen-only pill (mini-pill) during the past month You may stop the mini-pill on any day and start using VAGAN 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 condom) during the first 7 days of using the ring.
• If you have used a progestogen-releasing injection, implant, or intrauterine device (IUD) during the past month Start using VAGAN on the day the next injection is due, or on the day of removal of the implant or progestogen-releasing IUD. Make sure to use an additional contraceptive method (e.g. a condom) during the first 7 days of using the ring.
• After childbirth If you have recently given birth, your doctor will advise you to wait until your first natural menstrual cycle before starting to use VAGAN. In some cases, earlier initiation may be possible. Ask your doctor for advice. If you wish to use VAGAN during breastfeeding, consult your doctor first.
• After spontaneous or surgical abortion Consult your doctor.

3.4 What to do if…
The ring is accidentally expelled from the vagina
VAGAN may accidentally come out of the vagina, for example if it was not inserted correctly, during removal of a tampon, during sexual intercourse, or 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
VAGAN may still protect you from pregnancy, but this depends on how long it has been outside your vagina.
If the ring remains outside the vagina for
less than 3 hours, it may still protect you from pregnancy. Rinse the ring with cold or lukewarm water (do not use 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 the first and second week, it may not protect you from pregnancy. Rinse the ring with cold or lukewarm water (do not use hot water), reinsert it as soon as you remember, and leave the ring in the vagina continuously for at least 7 days. Use a male condom if you have sexual intercourse during these 7 days. If you are in the first week and have had sexual intercourse in the previous 7 days, there is a possibility you could be pregnant. In this case, contact your doctor.
more than 3 hours during the third week, it may not protect you from pregnancy.
Dispose of that ring and choose one of the following two options:

1. Insert a new ring immediately.
   This will start the next 3-week treatment period. Your menstrual period may not occur, but spotting or breakthrough bleeding may happen.
2. Do not insert a new ring. Wait until you have your menstrual 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 VAGAN has been used continuously for the previous 7 days.

• If VAGAN has been outside the vagina for an unknown length of time, you may not be protected from pregnancy. Perform a pregnancy test and consult your doctor before inserting a new ring.

The ring breaks
VAGAN may break. Vaginal injuries associated with ring breakage have been reported. If you notice that VAGAN has broken, discard that ring and start with a new one 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.

More than one ring has been inserted
No serious adverse effects due to overdose of VAGAN's hormones have been reported. If you have accidentally inserted more than one ring, you may feel unwell (nausea), experience vomiting, or vaginal bleeding. Remove the extra rings and consult your doctor if these symptoms persist.

You forget to insert a new ring after a ring-free interval
If the ring-free interval has lasted more than 7 days, insert a new ring as soon as you remember. Also use an additional contraceptive method (e.g. a condom) if you have sexual intercourse, for the next 7 days. If you have had sexual intercourse during the interval period, the possibility of pregnancy must be considered. Speak to your doctor immediately. The longer the ring-free interval, the greater the risk of pregnancy.

You forget to remove the ring

• If your ring has remained inserted for more than 3 weeks but not longer than 4 weeks, you may still be protected from pregnancy. Complete the regular one-week ring-free interval and then insert a new ring.
• If your ring has remained inserted for longer than 4 weeks, there is a possibility of pregnancy. Contact your doctor before inserting a new ring.

You miss a menstrual period

• VAGAN has been used as instructed If you miss a menstrual period but have used VAGAN correctly as directed and have not taken any other medicines, it is very unlikely that you are pregnant. Continue using VAGAN as usual. However, if you miss two consecutive periods, pregnancy may have occurred. Consult your doctor immediately. Do not start a new VAGAN until your doctor has ruled out pregnancy.
• VAGAN has not been used as recommended If you miss a menstrual period and have not followed the instructions, and you did not have your expected period during the subsequent ring-free interval, you may be pregnant. Contact your doctor before starting a new VAGAN.

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

You wish to delay your menstrual period
Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) by inserting a new ring immediately after removing the previous one, without taking a ring-free interval. The new ring may be left in place for a maximum of 3 weeks. During use of the new ring, you may experience spotting (small drops or stains of blood) or breakthrough bleeding. Remove the ring when you decide you want your period to occur. Then observe the regular one-week ring-free interval before inserting a new ring.
You may consult your doctor before deciding to delay your menstrual period.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think may be due to VAGAN, tell your doctor.
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists 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 should know before using VAGAN".
Contact a doctor immediately if you experience any of the following symptoms of angioedema:
swelling of the face, tongue and/or throat and/or difficulty swallowing or potentially hives
with breathing difficulties (see also section “Warnings and precautions”).
Users of rings containing etonogestrel/ethinylestradiol have reported the following side effects:

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 tenderness; 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 tired, unwell or irritable; mood changes; mood swings
• fluid retention (oedema)
• urinary tract or bladder infection
• difficulty or pain when urinating; strong urge or 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 and cause pain)
• inflammation of the uterine cervix; cervical polyps (growths in the cervix); eversion of the cervical margin (ectopia)
• menstrual cycle changes (e.g. periods may be heavy, prolonged, irregular or may stop altogether); pelvic discomfort; premenstrual syndrome; uterine cramps
• vaginal infections (fungal and bacterial); burning sensation, unpleasant odour, pain, discomfort or dryness of the vagina or vulva
• hair loss, eczema, itching, 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), or in a lung (PE), or heart attack, or stroke, or mini-stroke, or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA), or 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 discharge

Not known (frequency cannot be estimated from the available data)

• chloasma (brown-yellowish pigmented skin patches, particularly on the face)
• penile discomfort in 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 breakage

Breast cancer and liver tumour have been reported in users of combined hormonal contraceptives. For further information, see section 2.2 “Warnings and precautions, Tumours”.
VAGAN may break. For further information, see section 3.4 What to do if... the ring breaks.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: “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 VAGAN

Keep this medicine out of the sight and reach of children.
If you know that a child has been exposed to the hormones in VAGAN, consult your doctor.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the device from light.
VAGAN should be inserted at least one month before the expiry date indicated on the box and on the pouch after Exp..
The expiry date refers to the last day of the month.
Do not use VAGAN if you notice any colour changes in the ring or any other visible signs of deterioration.
This medicine may pose a risk to the environment.
After removal, VAGAN must be placed back into the pouch and sealed properly.
The sealed pouch should be disposed of with household waste or returned to a pharmacy for proper destruction according to local requirements. Do not flush VAGAN 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What VAGAN contains

• The active substances are: etonogestrel and ethinylestradiol. VAGAN contains 8.25 mg of etonogestrel and 2.60 mg of ethinylestradiol. The rings release etonogestrel and ethinylestradiol at an average rate of 0.120 mg and 0.015 mg respectively every 24 hours, over a period of 3 weeks.
• The other components are: ethylene vinyl acetate copolymer (28% vinyl acetate) and polyurethane (a type of plastic that does not dissolve in the body).

Description of the appearance of VAGAN and package contents
Vaginal device.
VAGAN is a flexible, transparent, colourless or almost colourless ring, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm.
Each ring is contained in an aluminium sachet. The sachet is packaged in a cardboard box together with this leaflet and calendar stickers to help you remember when to insert and remove the ring.
Each box contains:
1 ring
3 rings
6 rings
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
S&R Farmaceutici S.p.A.
Via dei Pioppi, 2
06083 Bastia Umbra (PG)
Italy

Manufacturer
Laboratorios León Farma S.A
Calle La Vallina s/n, Polígono Industrial Navatejera
24193 Villaquilambre, León
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Etonogestrel/Ethinylestradiol Leon Farma 0.120 mg / 0.015 mg per 24 hours, vaginal delivery system
Belgium: Etonogestrel/Ethinylestradiol Laboratorios Leon Farma 0.120 mg / 0.015 mg per 24 hours, vaginal aid / 24 hours, système de diffusion vaginale / 24 hours vaginal aid
Austria: FemLoop – Vaginalring
Spain: Dolna 0.120 mg / 0.015 mg every 24 hours, vaginal delivery system EFG
Germany: VeRi-Aristo
France: ETORING 15 microgrammes/120 microgrammes/24 heures, système de diffusion vaginale
Italy: VAGAN
Luxembourg: Etonogestrel/Ethinylestradiol Leon Farma 0.120 / 0.015 mg per 24 hours vaginal delivery system
Norway: Etonogestrel/Ethinylestradiol Leon Farma
Poland: PolaRing
Portugal: Etonogestrel/Ethinylestradiol Leon Farma 0.120 / 0.015 mg per 24 hours vaginal delivery system