Myprimose

Package leaflet: Information for the patient

Myprimose 0.120 mg/0.015 mg every 24 hours, vaginal ring

etonogestrel/ethinylestradiol
Generic medicine

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods when used correctly.
• They slightly increase the risk of developing blood clots 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 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; 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 Myprimose is and what it is used for
2. What you need to know before using Myprimose
2.1 When not to use Myprimose
2.2 Warnings and precautions
Blood clots
Tumours
2.3 Children and adolescents
2.4 Other medicines and Myprimose
Laboratory tests
2.5 Pregnancy and breastfeeding
2.6 Driving and using machines

3. How to use Myprimose

3.1 How to insert and remove Myprimose
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 Myprimose
4. Possible side effects
5. How to store Myprimose
6. Package contents and other information
What Myprimose contains
Description of the appearance of Myprimose and package contents
Marketing Authorisation Holder and Manufacturer

1. What Myprimose is and what it is used for

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

Myprimose 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. Myprimose 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 Myprimose

General information
Before starting to use Myprimose, 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 certain situations in which you should stop using Myprimose or in which Myprimose may be less reliable. In such situations, 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 or basal body temperature methods, as they may be unreliable because Myprimose alters monthly fluctuations in body temperature and cervical mucus.
Myprimose, like other hormonal contraceptives, does not protect against
HIV infection (AIDS) or any other sexually transmitted disease.

2.1 When you must not use Myprimose
Do not use Myprimose 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 methods of birth control that might be more suitable for your situation.

• 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 disorder affecting blood clotting, 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 will be confined to bed 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 ever had) inflammation of the pancreas (pancreatitis) associated with high levels of fats in the blood;
• if you have (or have ever had) severe liver disease and liver function has not yet returned to normal;
• if you have (or have ever had) a benign or malignant liver tumour;
• if you have (or have ever had), or suspect you 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 excipients of this medicine (listed in section 6).

If any of these conditions occurs for the first time while using
Myprimose, remove the ring immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods.
Do not use Myprimose if you have hepatitis C and are taking medicines containing ombitasvir/
paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir
(see also section 2.4 Other medicines and Myprimose).

2.2 Warnings and precautions
When should you contact a 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, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
Consult your doctor or pharmacist before using Myprimose.
If any condition develops or worsens while you are using Myprimose, inform your doctor.

• if a close family member has or has ever had breast cancer;
• if you have epilepsy (see section 2.4 “Other medicines and Myprimose”);
• 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 will be confined to bed 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 Myprimose;
• 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 [skin rash with blisters during pregnancy], Sydenham's chorea [a nerve disorder causing sudden involuntary movements]);
• if you notice symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties, contact a doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if you have (or have ever had) chloasma (brownish-yellow pigmented patches, so-called “pregnancy mask”, especially on the face). In such cases, avoid prolonged exposure to sunlight or ultraviolet radiation;
• if you have a medical condition that makes using Myprimose difficult, such as constipation, uterine cervical prolapse, or pain during sexual intercourse;
• if you feel a sudden need to urinate, urinate frequently, experience burning and/or pain, and cannot locate the ring in the vagina. These symptoms may indicate accidental placement of Myprimose into the bladder.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Myprimose 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 events may be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately 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 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, 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
in which you take a combined hormonal contraceptive for the first time. The risk may also
be higher if you restart taking a combined hormonal contraceptive (the same
medication or a different one) 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 Myprimose, 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 individual baseline risk of venous thromboembolism (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 Myprimose 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 in 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 in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing norelgestromine or etonogestrel such as Myprimose, about 6–12 women will develop a blood clot in one year.
• Your 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 Myprimose 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 may have an inherited blood clotting disorder;

• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Myprimose several weeks before surgery or during periods of reduced mobility. If you need to stop taking Myprimose, 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 some 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 have you stop taking Myprimose.
If any of the above conditions change while you are using Myprimose—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 Myprimose is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Myprimose, it is advisable to stop smoking. If you cannot stop smoking and you are over 35 years old, your doctor may advise you to use 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 Myprimose—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 reported below comes from studies on combined oral contraceptives and may also apply to Myprimose. There is no available information on the vaginal administration of contraceptive hormones (such as Myprimose).
Diagnoses of breast cancer 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 frequently in women taking the combined pill because they undergo more frequent medical check-ups. 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 as soon as you feel a lump. In addition, you should 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 reported rarely 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 have been reported to occur less frequently. This may also be the case with Myprimose, but it has not been confirmed.

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

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

2.4 Other medicines and Myprimose
Always inform your doctor about any medicines or herbal products you are currently taking. Also inform any other doctors, dentists, or pharmacists who prescribe other medicines that you are using Myprimose. They may advise you whether you need to use additional contraceptive methods (e.g., male condoms), 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 Myprimose;
• may cause 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 infectious diseases (e.g., griseofulvin);
• high blood pressure in the lung vessels (pulmonary hypertension) (bosentan);
• depression (St. John’s wort (Hypericum perforatum)).

If you are taking medicines or herbal products that may reduce the effectiveness of Myprimose, you must also use a barrier contraceptive method. Because the effect of other medicines on Myprimose may last up to 28 days after stopping them, you must continue using an additional barrier contraceptive method throughout this period. Note: Myprimose should not be used in combination with a diaphragm, cervical cap, or female condom.
Myprimose 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 Myprimose if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this could cause increases in liver function test results (elevated liver enzymes ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
Myprimose may be used again approximately 2 weeks after completing this treatment. See section 2.1 “When to use Myprimose”.
Ask your doctor or pharmacist for advice before taking any medicine.

Sanitary tampons may be used during the use of Myprimose. Insert Myprimose 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.
The use of spermicidal or vaginal yeast-based products does not reduce the contraceptive effectiveness of Myprimose.

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

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

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

3. How to use Myprimose

You can insert and remove Myprimose yourself. Your doctor will give you instructions on
when to start using Myprimose 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. It is good practice to regularly check whether the ring
is still in place (for example, before and after sexual intercourse) to ensure you are protected
against pregnancy. After the third week, you must remove Myprimose and take a one-week break.
Your menstrual period usually occurs during this ring-free interval.
While using Myprimose, you should 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 Myprimose may interfere with the correct
positioning and placement of the diaphragm, cervical cap, or female condom. However, you may
use a male condom as an additional barrier contraceptive method.

3.1 How to insert and remove Myprimose

1. Before inserting the ring, check that it has not expired (see section 5 “How to store Myprimose”).
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 Myprimose from its pouch. Keep the pouch for later use.
5. Hold the ring between your thumb and index finger, compress it gently, and insert it into the vagina (see Figures 1–4). Once Myprimose is inserted, you should not feel any discomfort. If you experience discomfort, gently push the ring further into the vagina. The exact position of the ring within the vagina is not important.
6. After 3 weeks, remove Myprimose from the vagina. Myprimose 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 it 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 resealable pouch. Do not flush Myprimose down the toilet.

Figure 1
Remove Myprimose 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 it feels comfortably in place (Figure 4B).
Leave the ring in place for 3 weeks (Figure 4C).

Figure 5:
Myprimose can be removed by hooking the index finger under the ring or by grasping the ring
between the index and middle finger and pulling it outward.

3.2 Three weeks with the ring in place, one week without

1. Starting from the day of insertion, 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 and approximately at the same time as it was inserted. For example, if Myprimose is inserted on a Wednesday around 10 p.m., the ring should be removed on the Wednesday of the third week, 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 starts 2–3 days after removal of Myprimose.
4. Start a new ring exactly one week after the previous ring was removed (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 section 3.4 “What to do if… You forget to insert a new ring after a ring-free interval”.

If you use Myprimose 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 in the past month The first Myprimose should be inserted on day 1 of your natural cycle (i.e., the first day of your menstrual period). Myprimose begins to be effective immediately. No additional contraceptive measures are necessary. You may also start Myprimose between day 2 and day 5, but if you have sexual intercourse during the first 7 days of using Myprimose, you must use an additional contraceptive method (e.g., a male condom). This advice applies only when using Myprimose for the first time.
• If you have used a combined oral contraceptive in the past month Start using Myprimose no later than the day after the pill-free interval of your current oral contraceptive. If your pack contains inactive tablets, start using Myprimose no later than the day after the last inactive tablet. If you are unsure, 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 Myprimose immediately.
• If you have used a transdermal patch in the past month Start using Myprimose 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 on any day and start using Myprimose immediately.
• If you have used a progestogen-only pill (mini-pill) in the past month You may stop taking the mini-pill on any day and start using Myprimose 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 progestogen-releasing injection, implant, or IUD in the past month Start using Myprimose 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 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 until your first natural menstrual cycle before starting Myprimose. In some cases, earlier initiation may be possible. Consult your doctor. If you wish to use Myprimose during breastfeeding, consult your doctor first.
• After a spontaneous or surgical abortion Consult your doctor.

3.4 What to do if…
The ring is accidentally expelled from the vagina
Myprimose 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 place (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 cool 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 section 3.4 “What to do if… The ring remains temporarily outside the
vagina”.

The ring remains temporarily outside the vagina
While in the vagina, Myprimose 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 may still protect you against pregnancy. Reinsert the ring as soon as possible, but no later than within 3 hours.

• If the ring has been outside the vagina, or you suspect it has been outside the vagina, for more than 3 hours during the first or second week, 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 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 may be pregnant. In this case, contact your doctor.

• If the ring has been outside the vagina, or you suspect it has been outside the vagina, for more than 3 hours during the third week, 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 use period. Your menstrual period may not occur, but spotting or breakthrough bleeding may occur.
2. Do not insert a new ring. Wait until your menstrual period starts, then insert a new ring no later than 7 days after the previous ring was removed or expelled. This option should only be chosen if Myprimose has been used continuously during the previous 7 days.

• If Myprimose has been outside the vagina for an unknown period of time, it may no longer protect you against pregnancy. Perform a pregnancy test and consult your doctor before inserting a new ring.

The ring breaks
Very rarely, Myprimose may break. Vaginal injuries associated with ring breakage have been
reported. If you notice that Myprimose 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 is inserted
No serious adverse effects due to overdose of Myprimose hormones have been reported. If you
accidentally insert more than one ring, you may experience nausea, 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 is longer than 7 days, insert a new ring as soon as you remember. Also
use an additional contraceptive method (e.g., male condom) if you have sexual intercourse, for the
next 7 days. If you had sexual intercourse during the interval, the possibility of pregnancy must
be considered. In this case, speak to your doctor immediately. The longer the ring-free interval,
the higher the risk of pregnancy.

You forget to remove the ring
If your ring has remained in place for more than 3 weeks but not longer than 4 weeks, it may still
protect you against pregnancy. Complete the regular one-week ring-free interval and then insert a
new ring.
If your ring has remained in place for longer than 4 weeks, there is a possibility of pregnancy.
Contact your doctor before inserting a new ring.

You miss your period

• Myprimose has been used as directed in the instructions If you miss a period but have used Myprimose correctly and have not taken any other medications, it is very unlikely that you are pregnant. Continue using Myprimose as usual. However, if you miss two periods in a row, pregnancy may have occurred. Consult your doctor immediately. Do not start a new Myprimose until your doctor has ruled out pregnancy.

• Myprimose has not been used as recommended If you miss a 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 Myprimose.

You have unexpected bleeding
While using Myprimose, some women may experience unexpected vaginal bleeding between
periods. You may need to use sanitary protection. However, leave the ring in the vagina and
continue using it as usual. Consult your doctor if irregular bleeding persists, becomes heavy, or
recurs.

You want to change the first day of your menstrual cycle
If you use Myprimose as directed, your menstrual cycle (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 Myprimose 3 days earlier than usual.
If the ring-free interval is very short (e.g., 3 days or less), you may not have your usual bleeding,
but may experience spotting or breakthrough bleeding during use of the next ring.
If you are unsure how to proceed, contact your doctor for advice.

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

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

4. Possible side effects

Like all medicines, this medicine 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 Myprimose, inform 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 taking Myprimose”.
If you notice any of the following side effects, you may need urgent medical attention. Stop using Myprimose and contact a doctor immediately.
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 hives with possible breathing difficulties (see also section “Warnings and precautions”).
The following side effects have been reported in women using the ring containing etonogestrel/ethinylestradiol:

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’s sensation 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 cervix; cervical polyps (growths in the cervix)

• ectropion of the cervical margin (ectropion)

• menstrual cycle changes (e.g. periods may be heavy, prolonged, irregular or may stop completely); pelvic discomfort; premenstrual syndrome; uterine spasms

• vaginal infections (fungal and bacterial); burning, unpleasant odour, pain, discomfort or dryness of the vagina or vulva

• hair loss, eczema, itching, skin rash or hot flushes

• urticaria

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

• harmful blood clots in a vein or 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), 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 (yellowish-brown 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 injuries associated with ring breakage

Cancers of the breast and liver tumours have been reported in association with the use of combined hormonal contraceptives. For further information, see section 2.2 Warnings and precautions, Tumours.
Very rarely, the ring 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 the website
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 Myprimose

Keep this medicine out of the sight and reach of children.
If you discover that a child has been exposed to Myprimose hormones, consult your doctor.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light.
Myprimose must be inserted at least one month before the expiry date stated on the box and on the pouch after EXP. The expiry date refers to the last day of that month.
Do not use Myprimose 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, Myprimose must be placed back into the pouch and properly sealed. The sealed pouch should then be disposed of in accordance with local regulations (i.e. with traditional household waste or returned to a pharmacy for proper disposal). Do not flush Myprimose 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 Myprimose contains

• The active substances are: etonogestrel and ethinylestradiol. Myprimose contains 11.0 mg of etonogestrel and 3.474 mg of ethinylestradiol. The ring releases etonogestrel and ethinylestradiol at an average rate of 0.120 mg (120 micrograms) and 0.015 mg (15 micrograms), respectively, every 24 hours for a period of three 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 Myprimose and contents of the package
Vaginal delivery system.
Myprimose 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 pouch. The pouch is packaged in a cardboard box together with this leaflet and reminder stickers provided to mark 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
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: SetLona 0,120 mg/0,015 mg pro 24 Stunden, vaginales Wirkstofffreisetzungssystem
Belgium: Ringafema 0,120 mg / 0,015 mg par 24 heures, système de diffusion vaginale / 0,120 mg / 0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik / 0,120 mg / 0,015 mg pro 24 Stunden, Vaginales Wirkstofffreisetzungssystem
Estonia: Setlona
Finland: Vonamyl 0,120 mg / 0,015 mg per 24 tuntia, depotlääkevalmiste, emättimeen
France: ETONOGESTREL/ETHINYLESTRADIOL VIATRIS 120 microgrammes/15 microgrammes/24 heures, système de diffusion vaginale
Germany: SetLona 0.120 / 0.015 mg pro 24 Stunden, vaginales Wirkstofffreisetzungssystem
Iceland: Vonamyl 0,120 mg/0,015 mg/24 klst. Skeiðarinnlegg
Italy: MYPRIMOSE
Latvia: Setlona 120/15 mikrogrami/24 stundās vaginālās ievadīšanas sistēma
Lithuania: Ringafema 120/15 mikrogramų/24 valandas, vartojimo į makštį sistema
Liechtenstein: SetLona 0.120 / 0.015 mg per 24 hours, vaginal delivery system
Luxembourg: Ringafema 0,120 mg / 0,015 mg par 24 heures, système de diffusion vaginale
Netherlands: Etonogestrel/Ethinylestradiol Viatris 0,120 mg / 0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik
Portugal: Mystrelle
Slovenia: Setlona 0,120 mg / 0,015 mg na 24 ur vaginalni dostavni sistem
Spain: Setlona 0,120 mg/0,015 mg cada 24 horas, sistema de liberación vaginal EFG
Sweden: Vonamyl 0,120 mg/0,015 mg per 24 timmar, vaginalinlägg