Solvetta

Package leaflet: Information for the user

Solvetta 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 methods of contraception 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 have symptoms of a blood clot (see section 2 "Blood clots").

Read all of this leaflet carefully before using this medicine because 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 their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet
1. What Solvetta is and what it is used for
2. What you need to know before using Solvetta
3. How to use Solvetta
4. Possible side effects
5. How to store Solvetta
6. Contents of the pack and other information

1. What Solvetta is and what it is used for
Solvetta is a contraceptive vaginal 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, Solvetta is considered a low-dose hormonal contraceptive. Since Solvetta releases two different types of hormones, it is a so-called combined hormonal contraceptive.

Solvetta 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 3 weeks. Solvetta releases two female sex hormones that prevent the release of an egg from the ovaries. If no eggs are released, pregnancy cannot occur.

2. What you should know before using Solvetta

General information
Before starting to use Solvetta, 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 “Blood clots”).
This patient information leaflet describes certain situations in which you should stop using Solvetta or when Solvetta may be less effective. In these 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, which may be unreliable, since Solvetta alters the monthly variations in body temperature and cervical mucus.
Solvetta, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted infections.

Do not use Solvetta
If you have (or have ever had) any of the conditions listed below, consult your doctor. Your doctor will discuss with you other birth control methods that may 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;
• 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;
• you are due to undergo surgery or will be bedridden for a prolonged period (see section “Blood clots”);
• you have ever had a heart attack or stroke;
• you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of a heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
• you have one of the following conditions, which may increase the risk of developing blood 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
• you have (or have ever had) a type of migraine called “migraine with aura”;
• you have (or have had) inflammation of the pancreas (pancreatitis) associated with high levels of fats in the blood;
• you have (or have had) a serious liver disease and liver function has not yet returned to normal;
• you have (or have had) a benign or malignant liver tumour;
• you have (or have had), or may have, a tumour of the breast or genital organs;
• you have vaginal bleeding of unknown origin;
• you are allergic to ethinylestradiol or etonogestrel, or to any of the excipients of this medicine (listed in section 6).

If any of these conditions occurs for the first time while using Solvetta, remove the ring immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods.
Do not use Solvetta if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section “Other medicines and Solvetta”).

Warnings and precautions
When should you contact a doctor?
Seek urgent medical advice if:

• you notice signs suggestive 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, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions develops or worsens while you are using Solvetta, inform your doctor if:

• a close relative has, or has ever had, breast cancer;
• you have epilepsy (see section 2.4 “Other medicines and Solvetta”);
• you have liver disease (e.g. jaundice) or gallbladder disease (e.g. gallstones);
• you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system);
• you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• you have sickle cell anaemia (an inherited red blood cell disorder);
• 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);
• you are due to undergo surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• 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 Solvetta;
• you have inflammation of veins under the skin (superficial thrombophlebitis);
• you have varicose veins;
• 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 [skin rash with blisters during pregnancy], Sydenham’s chorea [a nerve disorder causing sudden involuntary movements], hereditary angioedema [seek immediate medical attention 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]);
• you have (or have ever had) chloasma (brown-yellowish pigmented patches, so-called “pregnancy mask”, especially on the face). In this case, avoid prolonged exposure to sunlight or ultraviolet rays;
• you have a medical condition that makes using Solvetta difficult, such as constipation, uterine cervical prolapse, or pain during sexual intercourse;
• you experience urgency, frequent urination, burning and/or pain, and cannot locate the ring in the vagina. These symptoms may indicate accidental placement of Solvetta into the bladder.

Blood clots
Using a combined hormonal contraceptive such as Solvetta 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 effects can be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Solvetta is low.

How to recognize a blood clot
Seek immediate medical advice if you notice any of the following signs or symptoms.

What condition do you have?
Do you have any of these signs?
Likely diagnosis?

• swelling in one leg or along a vein in the leg or foot, 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
  → Deep vein thrombosis

• sudden and unexplained shortness of breath or rapid breathing

• sudden cough without an obvious cause, possibly with coughing up of blood

• sharp chest pain that may worsen when breathing deeply

• severe dizziness or lightheadedness

• rapid or irregular heartbeat

• severe stomach pain
  → Pulmonary embolism

• sudden vision loss or painless blurring of vision that may progress to vision loss in one eye
  → Retinal vein thrombosis (blood clot in the eye)

• pain, discomfort, pressure, or heaviness in the chest

• squeezing sensation or fullness in the chest, arm, or under the breastbone

• feeling of fullness, indigestion, or choking

• discomfort in the upper body spreading to the back, jaw, throat, arms, or stomach

• sweating, nausea, vomiting, or dizziness
  → Heart attack

If you are unsure, inform your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition such as a respiratory tract infection (e.g. a “common cold”).

extreme weakness, anxiety or shortness of breath; -rapid or irregular heartbeat
sudden numbness or weakness of the face, arm or leg, especially on one side of the body; -sudden confusion, difficulty speaking or understanding; -sudden trouble seeing with one or both eyes; -sudden difficulty walking, dizziness, loss of balance or coordination; -sudden severe or prolonged headache with no known cause; -loss of consciousness or fainting with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you must still seek urgent medical attention as you may be at risk of another stroke.	Stroke
swelling and pale blue coloration of a limb; -severe stomach (abdominal) pain	Blood clots blocking other blood vessels

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 travels from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, a 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
when first starting to take a combined hormonal contraceptive. The risk may also
be higher if you restart taking a combined hormonal contraceptive (the same or a different
medication) 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 Solvetta, 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 Solvetta is low.

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

	Risk of developing a blood clot in one year
Women who are not using a combined hormonal pill, patch or vaginal ring and who are not pregnant	About 2 women in 10,000
Women using a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 women in 10,000
Women using Solvetta	About 6-12 women in 10,000

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Solvetta 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 scheduled for surgery or need to remain bedridden for a long time due to injury or illness, or if you have a leg in a cast. You may need to stop taking Solvetta several weeks before surgery or during periods of reduced mobility. If you need to stop taking Solvetta, 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 clot formation, 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 have you stop taking Solvetta.
If any of the above conditions change while you are using Solvetta—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?
As with blood clots in a vein, clots in an artery can cause serious problems, for example, they may 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 Solvetta is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Solvetta, it is advisable to stop smoking. If you cannot stop smoking and you 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 Solvetta—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 Solvetta. Information on vaginal administration of contraceptive hormones (such as Solvetta) is not available.
Breast cancer is diagnosed slightly more frequently in women taking the pill, but it is not known whether this is due to the treatment. For example, more tumors may be detected in women taking combined pills because they undergo medical check-ups more frequently. The risk 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. You should also inform your doctor if a close relative has or has had breast cancer (see section “Warnings and precautions”).
Benign liver tumors have been rarely reported in women taking the pill, and even more rarely, malignant liver tumors. Consult your doctor if you experience unusual, severe abdominal pain.
In women using combined oral contraceptives, endometrial cancer (cancer of the inner lining of the uterus) and ovarian cancer occur less frequently. This may also be the case with Solvetta, but this has not been confirmed.

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

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

Other medicines and Solvetta
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 Solvetta. They may advise you whether you need to use additional contraceptive methods (e.g., male condoms), and for how long, or whether you need to adjust the use of another medicine you are taking.
Some medicines:

• may affect blood levels of Solvetta;
• may lead to a reduction 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 infections (e.g., griseofulvin);
• high blood pressure in the lung arteries (pulmonary hypertension) (bosentan);
• depression (St. John’s wort (Hypericum perforatum) herbal remedy).

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

Solvetta may affect the action of other medicines, for example:

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

Do not use Solvetta if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause increases in liver function test results (elevated liver enzyme ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
You may resume using Solvetta approximately 2 weeks after completing this treatment. See section “Do not use Solvetta”.
Ask your doctor or pharmacist before taking any medicine.

You may use sanitary tampons while using Solvetta. Insert Solvetta before inserting the tampon.
Special care should be taken when removing the tampon to ensure that the ring is not accidentally expelled. If this happens, simply wash the ring with cold or lukewarm water and reinsert it immediately.

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

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

Pregnancy and breastfeeding
Solvetta must not be used during confirmed or suspected pregnancy. If you become pregnant while using Solvetta, remove the ring and contact your doctor.
If you wish to stop using Solvetta because you want to become pregnant, see section 3 “When you want to stop using Solvetta”.
Solvetta is generally not recommended during breastfeeding. If you wish to use Solvetta while breastfeeding, consult your doctor.

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

3. How to use Solvetta

You can insert and remove Solvetta yourself. Your doctor will tell you when to start using Solvetta for the first time. The vaginal ring must be inserted on the appropriate day of the monthly menstrual cycle (see section “When to start with the first ring”) and left in the vagina continuously for 3 weeks. Regularly check that Solvetta is still in your vagina (e.g. before and after sexual intercourse) to ensure you are protected against pregnancy. After the third week, remove Solvetta and take a one-week break. Your menstrual period usually occurs during this ring-free interval. While using Solvetta, do not use certain female barrier contraceptive methods such as a vaginal diaphragm, cervical cap, or female condom. These barrier methods should not be used as an additional method of birth control, as Solvetta may interfere with the correct placement and positioning of the diaphragm, cervical cap, or female condom. However, you may still use a male condom as an additional barrier contraceptive method.

How to insert and remove Solvetta

1. Before inserting the ring, check that it has not expired (see section 5 “How to store Solvetta”).

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 Solvetta 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 Solvetta is in place, you should not feel any discomfort. If you do feel discomfort, gently push Solvetta further into the vagina. The exact position of the ring within the vagina is not important.

6. After 3 weeks, remove Solvetta from the vagina. Solvetta can be removed by hooking your index finger under the front edge of the ring or by grasping the edge and pulling outward (see Figure 5). If you can feel the ring in the vagina but are unable to remove it, contact your doctor.

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

Figure 1
Remove Solvetta from the 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
Solvetta 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.

Three weeks with the ring in place, one week without

1. Starting from the day it is inserted, the vaginal ring must remain in the vagina continuously 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 Solvetta is inserted on Wednesday around 10 p.m., the ring should be removed 3 weeks later, on Wednesday around 10 p.m.
3. After removal, do not use a ring for 1 week. During this week, you should experience vaginal bleeding. This usually begins 2–3 days after removal of Solvetta.
4. Start 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 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 the section “What to do if… You forget to insert a new ring after a ring-free interval”.
If you use Solvetta as described above, vaginal bleeding will occur approximately on the same days each month.

When to start with the first ring

• If you have not used a hormonal contraceptive during the past month Insert the first Solvetta on day 1 of your natural cycle (i.e. the first day of your menstrual period). Solvetta begins to work immediately. No additional contraceptive measures are necessary. You may also start using Solvetta between day 2 and day 5, but if you have sexual intercourse during the first 7 days of using Solvetta, make sure to use an additional contraceptive method (e.g. a condom). This advice applies only when using Solvetta for the first time.
• If you have used a combined oral contraceptive during the past month Start using Solvetta no later than the day after the pill-free interval of your current pill pack. If the pack contains inactive tablets, start using Solvetta 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 at any point in the current pack and start using Solvetta immediately.
• If you have used a transdermal patch during the past month Start using Solvetta no later than the day after the 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 also stop using the patch at any time and start using Solvetta immediately.
• If you have used a progestogen-only pill (mini-pill) during the past month You may stop taking the mini-pill at any time and start using Solvetta 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 IUD during the past month Start using Solvetta 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 period before starting to use Solvetta. In some cases, earlier initiation may be possible. Ask your doctor for advice. If you are breastfeeding and wish to use Solvetta, consult your doctor first.
• After a spontaneous or surgical abortion Consult your doctor.

What to do if…

The ring is accidentally expelled from the vagina
Solvetta may accidentally come out of the vagina, for example, if it was not inserted correctly, during tampon removal, 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).
If the ring remains outside the vagina for less than 3 hours, it will still continue to protect you against pregnancy. Rinse the ring with cold or lukewarm water (do not use hot water) and reinsert it. If the ring remains outside the vagina for more than 3 hours, it may no longer protect you against pregnancy. See the instructions in the section “What to do if… The ring remains temporarily outside the vagina”.

The ring remains temporarily outside the vagina
When in the vagina, Solvetta slowly releases hormones into the body to prevent pregnancy. If the ring remains outside the vagina for more than 3 hours, it may no longer protect you against pregnancy. Therefore, the ring should not remain outside the vagina for more than 3 hours within any 24-hour period.

• If the ring has been outside the vagina for less than 3 hours, it can still protect you against pregnancy. Reinsert the ring as soon as possible, but no later than within 3 hours.
• If the ring remains outside the vagina, or you suspect it has been outside the vagina for more than 3 hours during week 1 or 2, it may no longer protect you against pregnancy. In this case, reinsert the ring as soon as you remember and leave it in the vagina continuously for at least 7 days. Use a 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 you could be pregnant. In this case, contact your doctor.
• If the ring remains outside the vagina, or you suspect it has been outside the vagina for more than 3 hours during week 3, it may no longer protect you against 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 treatment period. Your menstrual period may not occur, but you may experience spotting or breakthrough bleeding.
  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 Solvetta has been used continuously during the previous 7 days.
• If Solvetta has been outside the vagina for an unknown period of time, you may not be protected against pregnancy. Perform a pregnancy test and consult your doctor before inserting a new ring.

The ring breaks
Very rarely, Solvetta may break. Vaginal injury associated with ring breakage has been reported. If you notice that Solvetta 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 break, consult your doctor.

More than one ring has been inserted
No serious adverse effects due to overdose of Solvetta’s hormones have been reported. If you have 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 forget to insert a new ring after a ring-free interval
If the ring-free interval lasts more 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, for the next 7 days. If you had sexual intercourse during the interval, the possibility of pregnancy should be considered. In this case, speak to your doctor immediately. The longer the ring-free interval, the greater the risk of pregnancy.

You forget 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 against pregnancy. Complete the usual 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 of pregnancy. Contact your doctor before inserting a new ring.

You miss a menstrual period

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

You experience unexpected bleeding
While using Solvetta, 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 Solvetta as directed, your menstrual period (withdrawal bleeding) will occur 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 can change it to Tuesday (3 days earlier) starting next month. Simply insert the next Solvetta 3 days earlier than usual.
If you make the ring-free interval very short (e.g. 3 days or less), you may not have the usual bleeding, but may experience spotting (drops or small blood stains) or breakthrough bleeding during use of the next ring.
If you are unsure how to proceed, contact your doctor for advice.

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 remain inserted for a maximum of 3 weeks. During use of the new ring, you may experience spotting (drops or small blood stains) or breakthrough bleeding. Remove the ring when you decide you want your period to start. Observe the usual one-week ring-free interval and then insert a new ring.
You may wish to consult your doctor before deciding to delay your menstrual period.

When you wish to stop using Solvetta
You may stop using Solvetta at any time.
If you do not wish to become pregnant, consult your doctor about other methods of birth control.
If you stop using Solvetta because you wish to become pregnant, wait until your natural menstrual cycle returns 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 everybody gets 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 Solvetta, 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 need to
know before using Solvetta”.
If you are allergic to any of the components of Solvetta (hypersensitivity), you may experience
the following symptoms (frequency not known):
angioedema [swelling of the face, tongue and/or throat and/or difficulty swallowing] or
urticaria associated with breathing difficulties. If this occurs, remove Solvetta and consult your
doctor immediately.
The following side effects have been reported by women using an etonogestrel/ethinylestradiol
containing ring.

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 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
• sore or enlarged breasts; fibrocystic mastopathy (breast cysts that may swell and cause pain)
• inflammation of the cervix; cervical polyps (growths in the cervix); eversion of the cervical margin (ectropion)
• menstrual cycle disturbances (e.g. periods may be heavy, prolonged, irregular or 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), 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 (brownish-yellow 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 adherence to the vaginal wall)
• vaginal injury associated with ring rupture

Breast cancer and liver tumour have been reported in association with the use of combined
hormonal contraceptives. For further information, see section 2 “Warnings and precautions,
Tumours”.
Very rarely, Solvetta may break. For further information, see section 3 “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
http://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 Solvetta

Keep this medicine out of the sight and reach of children.
If you discover that a child has been exposed to Solvetta hormones, consult a doctor.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light.
Solvetta must be inserted at least 1 month before the expiry date stated on the box and on the sachet after “Exp”. The expiry date refers to the last day of that month.
Do not use Solvetta 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, Solvetta must be placed back into the sachet and properly sealed. The re-closed sachet should be disposed of with household waste or returned to a pharmacy for appropriate destruction in accordance with current regulations.
Do not dispose of Solvetta via the toilet. As with other medicines, do not throw expired or unused rings into 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 Solvetta contains

• The active substances are etonogestrel and ethinylestradiol. Solvetta contains 11.0 mg of etonogestrel and 3.474 mg of ethinylestradiol. The ring releases etonogestrel and ethinylestradiol at average rates of 0.120 mg and 0.015 mg per 24 hours, respectively, 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 Solvetta and contents of the pack
Vaginal device.
Solvetta is a flexible, transparent ring ranging from colourless to almost colourless, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm.
Each ring is contained in an aluminium pouch, packed in a cardboard box together with this package leaflet and adhesive labels for your calendar to help you remember when to insert and remove the ring.
Each box contains:
1 ring
3 rings
6 rings.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer
Laboratorios León Farma, S.A.
Calle La Vallina s/n. Polígono Industrial Navatejera Villaquilambre, León 24008
Spain
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
Sachsen-Anhalt, 39179 Barleben
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:

Austria: Solvetta 0.120 mg/0.015 mg pro 24 Stunden vaginales Wirkstofffreisetzungssystem
Belgium: Daniciah 0.120 mg / 0.015 mg per 24 uur, hulpmiddel voor vaginaal gebruik
Estonia: Solvetta
Finland: Solvetta 0.120 mg / 0.015 mg per 24 tuntia, depotlääkevalmiste, emättimeen
France: Etonogestrel/Ethinylestradiol Sandoz 120 microgrammes / 15 microgrammes /24 heures, système de diffusion vaginal
Germany: Cyclelle
Italy: Solvetta
Latvia: Solvetta 120/15 mikrogramu 24 stundās vaginālās ievadīšanas sistēma
Lithuania: Solvetta 120 mikrogramų/15 mikrogramų/24 valandas vartojimo į makštį sistema
Norway: Solvetta
Netherlands: Etonogestrel / Ethinylestradiol Sandoz 0.120 mg /0.015 mg per 24 uur, hulpmiddel voor vaginaal gebruik
Czech Republic: Daniciah
Slovenia: Etonogestrel/etinilestradiol Lek 0.120 mg/0.015 mg na 24 ur vaginalni dostavni sistem
Spain: Gynara Sandoz 0.120 mg/0.015 mg cada 24 horas, sistema de liberación vaginal EFG
Sweden: Solvetta 0.120 mg/0.015 mg per 24 timmar, vaginalinlägg
Hungary: Ringerina 0.120 mg/0.015 mg/24 óra hüvelyben alkalmazott gyógyszerleadó rendszer