MYPRIMOSE 0.12 mg/0.015 mg Вагинальная система доставки

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1. Myprimose 0.120 mg/0.015 mg every 24 hours, vaginal delivery device
   1. How to use Myprimose
   2. What is Myprimose and what is it used for
   3. What you need to know before using Myprimose
   4. 1 When not to use Myprimose
   5. 2 Warnings and precautions
   6. 3 Children and adolescents
   7. 4 Other medicines and Myprimose
   8. 5 Pregnancy and breastfeeding
   9. 6 Driving and operating machinery
   10. How to use Myprimose
   11. 1 How to insert and remove Myprimose
   12. 2 Three weeks with the ring inserted, one week without
   13. 3 When to start with the first ring
   14. 4 What to do if…
   15. 5 When to stop using Myprimose
   16. Possible side effects
   17. How to store Myprimose
   18. Contents of the pack and other information

Myprimose 0.120 mg/0.015 mg every 24 hours, vaginal delivery 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, 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
• Pay attention and see a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”)

Read this leaflet carefully before usingthis medicinebecause 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, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you use Myprimose

• 2.1 When you must not use Myprimose
• 2.2 Warnings and precautions Blood clots Tumors
• 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 in place, 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 vaginaThe ring remains temporarily outside the vaginaThe ring breaksMore than one ring has been insertedYou forget to insert a new ring after a ring-free intervalYou forget to remove the ringYou miss a periodYou experience unexpected bleeding

You want to change the first day of your menstrual cycle

You want to postpone your menstrual cycle

• 3.5 When you want to stop using Myprimose

4. Possible side effects

5. How to store Myprimose

6. Contents of the pack and other information

What Myprimose contains

Description of the appearance of Myprimose and contents of the pack

Marketing authorisation holder and manufacturer

1. What is Myprimose and what is it used for

Myprimose is a vaginal ring contraceptive 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 hormonal contraceptive of the so-called combined type.

Myprimose works just like a combined contraceptive pill (the Pill) but instead
of taking a pill every day, the ring is used for three weeks in a row.
Myprimose releases two female sex hormones that prevent the release of an egg
from the ovaries. If there is no release of egg cells, it is not possible to become pregnant.

2. What you need to know before using Myprimose

General notes
Before starting to use Myprimose, read the information on blood clots in
section 2. It is particularly important that you read the symptoms of a blood clot
(see section 2 “Blood clots”).
stop using Myprimose or in which Myprimose may be less reliable. In
such situations, you should not have sexual intercourse or you should adopt
additional non-hormonal contraceptive precautions, such as the use of a male condom or another
barrier method. Donot use the rhythm and basal temperature methods, which may
be unreliable, as Myprimose alters the monthly variations in body temperature
and cervical mucus.

Myprimose, like other hormonal contraceptives, does not protect against
infection with HIV (AIDS) or any other sexually transmitted disease.

2.1 When not to 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. The doctor will discuss with you other methods of birth control that may be more suitable for your case.

• if you have (or have ever had) a blood clot in a leg vessel (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE) or in other organs;
• if you know you have a disorder that affects blood coagulation, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden or antiphospholipid antibodies;
• if you are going to have surgery or if you will be bedridden for a long 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 that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
• if you have one of the following diseases, which may increase the risk of blood clots forming in the arteries:
• severe diabetes with damage to blood vessels
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a disease known as hyperhomocysteinemia
• 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) a severe liver disease and liver function has not yet returned to normal.
• if you have (or have ever had) a benign or malignant tumor of the liver.
• if you have (or have ever had), or may have, a tumor of the breast or genital organs.
• if you have vaginal bleeding of unknown origin.
• if you are allergic to ethinylestradiol or etonogestrel or any of the other ingredients of this medicine (listed in section 6).

If any of these conditions occur for the first time during the use of
Myprimose, remove the ring immediately and consult your doctor. In the meantime, use
non-hormonal contraceptive methods.
Do not use Myprimose if you suffer from 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 your leg (deep vein thrombosis), a blood clot in your lung (pulmonary embolism), a heart attack or a stroke (see the following paragraph “Blood clots”).

For a description of the symptoms of these serious side effects, refer to the paragraph “How to recognise a blood clot”.

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

• if a close relative has, or has ever had, breast cancer;
• if you have epilepsy (see paragraph 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 that affects the body’s defence system);
• if you have haemolytic-uraemic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disease);
• 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 going to have surgery or if you will be lying down for a long period (see paragraph 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after childbirth you can start using Myprimose;
• if you have inflammation of the veins in the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have a condition that occurred for the first time, or worsened, during pregnancy or during previous use of sex hormones (e.g. hearing loss, porphyria [a blood disease], herpes gestationis [blistering rash during pregnancy], Sydenham’s chorea [a nervous disease in which sudden body movements can occur]);
• If you notice symptoms of angioedema such as swelling of the face, tongue and/or pharynx and/or difficulty swallowing or hives with possible difficulty breathing, contact a doctor immediately. Products containing oestrogens can cause or worsen the symptoms of hereditary and acquired angioedema;
• if you have (or have ever had) chloasma (brownish-yellow patches, so-called “pregnancy spots”, especially on the face). In this case, avoid prolonged exposure to the sun or ultraviolet radiation;
• if you have a medical condition that makes it difficult to use Myprimose, such as constipation, uterine prolapse or pain during sexual intercourse;
• if you have an urgent need to urinate, frequently, with burning and/or pain and are unable to locate the ring in the vagina. These symptoms may indicate accidental placement of Myprimose inside the bladder.

BLOOD CLOTS
The use of a combined hormonal contraceptive like Myprimose causes an increase in 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 the veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE). Healing from blood clots is not always complete. Rarely, serious long-term effects can occur, or, very rarely, such effects can be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with Myprimose is low.
HOW TO RECOGNISE 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 linked to an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, the clot can 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 a combined hormonal contraceptive (the same medicine or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but is still 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 natural risk of 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.

• In 10,000 women who are not using any combined hormonal contraceptive and who are not pregnant, about 2 women will develop a blood clot in a year.
• In 10,000 women who use a combined contraceptive pill containing levonorgestrel, noretisterone, or norgestimate, about 5-7 women will develop a blood clot in a year.
• In 10,000 women who use a combined hormonal contraceptive containing norelgestromin or etonogestrel like Myprimose, about 6-12 women will develop a blood clot in a year.
• The risk of forming 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 some conditions increase it. Your risk is higher:

• if you are strongly overweight (body mass index or BMI greater than 30 kg/m );
• if a close relative has had a blood clot in a leg, lung or other organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you are going to have surgery or if you will be lying down for a long period due to an injury or illness or if you have a leg in plaster. You may need to stop taking Myprimose a few weeks before surgery or during the period when you are less mobile. If you need to stop taking

Myprimose, ask your doctor when you can start taking it again;

• with 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 (duration >4 hours) can temporarily increase the risk of a blood clot forming, especially if you have some of the other risk factors listed.
It is important that you tell your doctor if any of these conditions apply to you, even if you are not sure. The doctor may decide to stop you from taking Myprimose.
If any of the conditions above change while you are using Myprimose, for example if a close relative develops a thrombosis for no known reason or if you gain a lot of 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 cause a heart attack or a 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 can increase:

• with increasing age (over 35 years);
• if you smoke.When using a combined hormonal contraceptive like Myprimose, it is advisable to quit 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 about 50 years). In this case you may also be at high 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 any heart problems (valve 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 conditions above change while you are using Myprimose, for example if you start smoking, if a close relative develops a thrombosis for no known reason or if you gain a lot of weight, contact your doctor.

Tumors
The information reported below was obtained in studies on combined oral contraceptives and may also apply to Myprimose. No information is available on the vaginal administration of contraceptive hormones (such as Myprimose).
Diagnoses of breast cancer are slightly more frequent in women who use the combined pill, but it is not known whether this is caused by the treatment. For example, it may be that tumors are found more often in women treated with the combined pill because they are checked more frequently by the doctor. The increase in the occurrence of breast cancer gradually decreases following discontinuation of the combined pill.
It is important that you regularly check your breasts and contact your doctor as soon as you feel a lump. In addition, you must inform your doctor if a close relative has or has had breast cancer (see paragraph 2.2 “Warnings and precautions”).
Benign and, less frequently, malignant liver tumors have been reported in women taking the pill. Consult your doctor if you experience severe, unusual abdominal pain.
In women who use the combined pill, endometrial cancer (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 this has not been confirmed.

Psychiatric disorders
Some women who use hormonal contraceptives, including Myprimose, have reported depression or depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you experience changes in mood and depressive symptoms, 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 already taking.
Also inform all other doctors or dentists (or your pharmacist) who prescribe other medicines
that you are using Myprimose. They can tell you if you need to use additional contraceptive
methods (for example, male condoms) and, if so, for how long, or if it is necessary to change the
use of another medicine you are taking.
Some medicines

• can affect the blood levels of Myprimose
• can cause a decrease in contraceptive efficacy
• can cause unexpected bleeding.

These include medicines used for the treatment of:

• 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 blood vessels of the lungs (bosentan);
• depression (St. John's wort (Hypericum perforatum) remedy).

If you are taking medicines or herbal products that may lead to a reduction
in the effectiveness of Myprimose, you should also use a barrier contraceptive method. Because
the effect of other medicines on Myprimose can last up to 28 days after they are stopped,
an additional barrier contraceptive method should be used for the entire
period. Note: Myprimose should not be used in association with a diaphragm, a
cervical cap or a female condom.
Myprimose can affect the effect of other medicines, e.g.

• medicines containing ciclosporin
• the antiepileptic lamotrigine (this can lead to an increase in the frequency of seizures)

Do not use Myprimose if you suffer from 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
in blood tests (increased liver enzymes ALT).
Your doctor will prescribe you another type of contraception before starting treatment with
these medicines.
Myprimose can be used again approximately 2 weeks after completion of
this treatment. See section 2.1 “When to use Myprimose”.

Ask your doctor or pharmacist for advice before taking any medicine.
Tampons can be used during the use of Myprimose. Insert Myprimose
before inserting the tampon. Particular care must be taken when removing the
tampon to ensure that the ring is not accidentally expelled. If this should
happen, simply wash the ring in cold or lukewarm water and reinsert it
immediately.
The use of spermicides or vaginal yeast products does not reduce the contraceptive efficacy of
Myprimose.

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

2.5 Pregnancy and breastfeeding

Myprimose must not be used in case of established or suspected pregnancy. If a pregnancy should occur while you are using Myprimose, you must remove the ring and contact your doctor.
If you want to stop using Myprimose because you want to start a pregnancy, see section 3.5 “When you want to stop using Myprimose”.
Myprimose is not usually recommended during breastfeeding. If you wish to use Myprimose during breastfeeding, ask your doctor for advice.

2.6 Driving and operating machinery

It is unlikely that Myprimose will affect the ability to drive or operate machinery.

3. How to use Myprimose

You can insert and remove Myprimose into the vagina yourself. Your doctor will provide you with instructions on
when to start using Myprimose for the first time. The vaginal ring must be inserted
on the appropriate day of your menstrual cycle (see section 3.3 “When to start with the

first ring”) and left in the vagina for 3 weeks consecutively. It is good practice to check
regularly if the ring is still in the vagina (for example, before and after sexual intercourse) to
ensure that you are protected from pregnancy. After the third week, you must remove Myprimose and
take a one-week break. Usually your menstrual cycle will occur during this
ring-free interval.
While using Myprimose, you should not use some female barrier contraceptive methods, such as a vaginal diaphragm, a cervical cap or a female condom.
These barrier contraceptive methods should not be used as an additional method for
birth control, as Myprimose may interfere with the correct placement and
positioning of the diaphragm, cervical cap or female condom. However,
a male condom can be used as a supplementary 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 position that is most comfortable for you to insert the ring, for example by standing with one leg raised, squatting or lying down.
• 4. Remove Myprimose from its pouch. Keep the pouch for subsequent use.
• 5. Hold the ring between your thumb and index finger, compress it and gently insert it into the vagina (see Figures 1-4). Once Myprimose has been inserted, you should not feel any discomfort. If you feel any discomfort, gently push Myprimose further into the vagina. The exact position of the ring inside 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 outwards (see Figure 5). If you locate the ring in the vagina, but are unable to remove it, you should contact your doctor.
• 7. The used ring must be disposed of with normal household waste, preferably inside the resealable pouch. Do not dispose of Myprimose in the toilet.

Figure 1
Take Myprimose out of the pouch

Figure 2
Compress the ring

Figure 3
Choose a comfortable position to insert the ring

Figure 4A Figure 4B Figure 4C
Insert the ring into the vagina with one hand (Figure 4A), if necessary, the lips may be
spread with the other. Push the ring into the vagina until you feel the ring in a
comfortable position (Figure 4B). Leave the ring inserted for 3 weeks (Figure 4C).

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

3.2 Three weeks with the ring inserted, one week without

• 1. Starting on the day it is inserted, the vaginal ring must be kept in the vagina without interruptionfor 3 weeks.
• 2. After 3 weeks, remove the ring on the same day of the week it was inserted, at approximately the same time. For example, if Myprimose is inserted on Wednesday around 10 PM, the ring must be removed on the Wednesday of the third subsequent week, at approximately 10 PM.
• 3. After removal, do not use the ring for 1 week. During this week, vaginal bleeding should occur. It usually starts 2-3 days after the removal of Myprimose.
• 4. Start with a new ring exactly after the 1-week interval (again on the same day of the week and at approximately the same time) even if vaginal bleeding has not yet finished. If the new ring is inserted with a delay of 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 each month
on approximately the same days.

3.3 When to start with the first ring

• If you have not used hormonal contraception during the last monthThe first Myprimose must be inserted on the 1st day of your natural cycle (i.e. the first day of your menstrual period). Myprimose starts to exert its effect immediately. You do not need to adopt other contraceptive measures. You can also start Myprimose between day 2 and day 5, it is allowed, but if you have sexual intercourse within the first 7 days of using Myprimose, make sure to also use an additional method of contraception (e.g. a male condom). This advice should only be followed when using Myprimose for the first time.
• If you have used a combined pill during the last monthStart using Myprimose no later than the day following the pill-free interval of your current pill. If your pack also contains inactive tablets, start

using Myprimose no later than the day following the last inactive tablet. If you are not
sure what this is, consult your doctor or pharmacist. Never extend the hormone-free interval of
your current pack of pills beyond its recommended length. If you have
used the pill consistently and correctly and if you are sure you are not pregnant, you can also
stop taking the pill on any day of the current pack and
start using Myprimose immediately.

• If you have used a transdermal patch during the last monthStart using Myprimose no later than the day following your usual patch-free interval. Never extend the patch-free interval beyond the recommended period of time. If you have used the patch consistently and correctly and if you are sure you are not pregnant, you can also stop using the patch on any day and start using Myprimose immediately.
• If you have used a progestin-only pill (minipill) during the last monthYou can stop the minipill on any day and start using Myprimose the next day at the same time you would normally take the pill. Make sure to use an additional method of contraception (e.g. a male condom) during the first 7 days of using the ring.
• If you have used an injection or an implant or an IUD releasing progestin during the last monthStart using Myprimose on the day your next injection is due or on the day of removal of the implant or the progestin-releasing IUD. Make sure to use an additional method of contraception (e.g. a male condom) during the first 7 days of using the ring.
• After childbirthIf you have just had a baby, your doctor will tell you to wait for your first natural cycle before starting to use Myprimose. In some cases it is possible to start earlier. Ask your doctor for advice. Also, if you want to use Myprimose during the breastfeeding period, consult your doctor first.
• After natural or surgical abortionConsult your doctor.

3.4 What to do if…

The ring is accidentally expelled from the vagina
Myprimose may accidentally come out of the vagina if, for example, it was not inserted
correctly, during the removal of a tampon, during sexual intercourse, in
conjunction with constipation or uterine prolapse. Therefore, you should regularly check if
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 protect you
from pregnancy. Rinse the ring in 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 not protect you
from pregnancy. See what is stated in paragraph 3.4 “What to do if… The ring remains

temporarily outside the vagina”.

The ring remains temporarily outside the vagina
When 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 not protect you from
pregnancy. Therefore, the ring should not remain outside the vagina for more than 3 hours within
any 24-hour period.

• Ifthe ring has been outside the vagina for a period less than 3 hours, it may still protect you from pregnancy. Reinsert the ring as soon as possible, but no

later than 3 hours.

• Ifthe ring remains outside the vagina or you suspect it has been outside the vagina for a period longer than 3 hours, during the first and second week, it may not protect you from pregnancy. In this case, reinsert the ring as soon as you remember and leave the ring in the vagina without interruption for at least 7 days. Use a male condom if you have sexual intercourse during these 7 days. If you are in the first week and have had sexual intercourse in the previous 7 days, there is a possibility that you may be pregnant. In this case, contact your doctor.
• Ifthe ring remains outside the vagina or you suspect it has been outside the vagina for a period longer than 3 hours during the third week, it may not protect you from pregnancy. Discard that ring and choose one of the following two options:
• 1) Immediately insert a new ring. This will start the next 3-week usage period. Your menstrual period may not occur, but spotting or breakthrough bleeding may occur.
• 2) Do not insert another ring. Wait for your next menstrual period and insert a new ring no later than 7 days from when the previous ring was removed or expelled. This option should only be chosen if Myprimose has been used continuously for the previous 7 days.
• IfMyprimose has been outside the vagina for an unspecified period of time, it may not protect you from pregnancy. Perform a pregnancy test and consult your doctor before inserting a new ring.

The ring breaks
Very rarely, 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 ring as soon as possible. Use additional contraceptive precautions (e.g., a
male condom) for the next 7 days. If you had sexual intercourse before noticing
the ring breakage, consult your doctor.

More than one ring has been inserted
No serious adverse effects have been reported due to an overdose of Myprimose hormones. If you have accidentally inserted more than one ring, you may experience nausea, vomiting, or
vaginal bleeding. Remove the excess 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 intervalis longer than 7 days,insert a new ring as soon as you
remember. Also use an additional method of contraception (e.g., a male 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 should be considered.In this case, speak to your doctor immediately. The longer the ring-free interval is prolonged, the greater the risk of pregnancy.

You forget to remove the ring
If your ring has remained inserted for more than 3 but not more than 4 weeks, it can still
protect you from pregnancy. Take the regular one-week ring-free interval and
then insert a new ring.
If your ring has remained inserted for a period longer than 4 weeks, there is a possibility
that pregnancy may occur. Contact your doctor before inserting a new ring.

You have a missed period

• Myprimose has been used as indicated in the instructionsIf you have a missed period, but Myprimose has been used correctly according to the instructions and you have not taken any other medications, it is very unlikely that you are pregnant. Continue using Myprimose as usual. However, if your period does not occur for two consecutive times, you may be pregnant. Consult your doctor immediately. Do not start with a new Myprimose until your doctor has ruled out pregnancy.
• Myprimose has not been used as recommendedIf you have a missed period and you have not followed the instructions provided and have not had your expected period during the subsequent ring-free interval, you may be pregnant. Contact your doctor before starting to use a new Myprimose.

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

You want to change the first day of your menstrual period
If you use Myprimose as indicated, your menstrual period (withdrawal bleeding) will begin
during the ring-free interval. If you want to change the day your period starts, you can
shorten the ring-free interval (never lengthen this interval!).
For example, if your menstrual period usually starts on a Friday, you can 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 you may experience spotting (drops or small spots of blood) or breakthrough bleeding
during the use of the next ring.

If you are unsure about how to proceed, contact your doctor for clarification.

You want to postpone your menstrual period
Although not recommended, you can postpone your menstrual period (withdrawal bleeding) by inserting a new ring immediately after removing the previous one, without
having any ring-free interval.
The new ring can remain inserted for a maximum period of 3 weeks. During the use of the
new ring, you may experience spotting (drops or small spots of blood) or breakthrough bleeding.
Remove the ring when you decide you want to have your period. Respect the regular
one-week ring-free interval and then insert a new ring.

You can ask your doctor for advice before deciding to delay your menstrual period.

3.5 When to stop using Myprimose

You can stop using Myprimose whenever you want.
If you do not want to become pregnant, consult your doctor about other methods of birth control.
If you stop using Myprimose because you want to become pregnant, you should wait for your natural
menstrual cycle before trying to conceive. This will help you calculate your expected date of birth.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any side effect, especially if it is serious or persistent, or if you notice any change in your health that you think might be
due to Myprimose, tell your doctor.
A greater risk of developing blood clots in the veins (venous thromboembolism (VTE)) or
blood clots in the arteries (arterial thromboembolism (ATE)) is present in all women who
take 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 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 your doctor immediately if you notice any of the following symptoms of angioedema:
swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with possible
difficulty breathing (see also section “Warnings and precautions”).
Patients using the ring 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; itching in the genital area; vaginal discharge
• headache or migraine; depressed mood; decreased libido
• breast pain; pelvic pain; painful menstruation
• acne
• weight gain
• ring expulsion

Not common: may affect up to 1 in 100 women

• visual disturbances; dizziness
• bloated abdomen; vomiting, diarrhea or constipation
• feeling tired, unwell or irritable; mood changes; mood swings
• excess fluid in the tissues (edema)
• urinary tract or bladder infection
• difficulty or pain when urinating; strong urge to urinate; urinating more frequently
• problems during sexual intercourse, including pain, bleeding or feeling the ring by your partner
• increased blood pressure
• increased appetite
• back pain; muscle spasms; pain in the legs or arms
• decreased skin sensitivity
• painful or enlarged breasts; fibrocystic breast disease (breast cysts that can swell and cause pain)
• inflammation of the cervix; cervical polyps (growths on the cervix);

ectropion of the cervical border (ectropion)

• changes in the menstrual cycle (e.g., periods may be heavy, long, irregular or may stop completely); pelvic discomfort; premenstrual syndrome; uterine spasms
• vaginal infections (fungal and bacterial); burning, bad smell, pain, discomfort or dryness of the vagina or vulva
• hair loss, eczema, itching, rash or hot flushes
• hives

Rare: may affect up to 1 in 1,000

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

The possibility 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 the symptoms of a blood clot).

• nipple discharge.

Not known (frequency cannot be estimated from available data)

• chloasma (brown-yellowish skin patches, especially on the face)
• penile discomfort by 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

In association with the use of combined hormonal contraceptives, breast cancer and liver tumors have been reported. For further information see section 2.2 Warnings and

precautions, Tumors.
Very rarely the ring can break. For further information, see section 3.4 What

to do if... The ring breaks.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly
through 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 Myprimose

Keep this medicine out of the sight and reach of children.
If you discover that a child has been exposed to the hormones of Myprimose, consult a doctor.
This medicine does not require any particular 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 indicated on the
box and on the sachet after SCAD. The expiry date refers to the last day of that
month.
Do not use Myprimose if you notice a change in the color of the ring or any other visible sign of
deterioration.
This medicine may pose a risk to the environment. After being removed,
Myprimose must be placed in the sachet and closed correctly. Therefore, the closed sachet
must be disposed of in accordance with local regulations (i.e. with traditional household waste
or by returning it to the pharmacy for appropriate disposal). Myprimose
should not be disposed of in the toilet. As with other medicines, do not discard unused or
expired rings in the drain and household waste. Ask your pharmacist how to dispose of
unused rings that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Myprimose contains

• The active ingredients are: etonogestrel and ethinylestradiol. Myprimose contains 11.0 mg of etonogestrel and 3.474 mg of ethinylestradiol. The ring releases etonogestrel and ethinylestradiol in an average amount of 0.120 mg 120 micrograms and 0.015 mg 15 micrograms, every 24 hours, for a period of three weeks.
• The other ingredients 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 pack
Vaginal delivery device.
Myprimose is a flexible, transparent, colourless or almost colourless ring, with an external 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 carton box together with this leaflet and the reminder stickers provided for
marking 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 Member States of the European Economic Area with the
following denominations
Austria: SetLona 0.120 mg/0.015 mg per 24 hours, vaginal drug delivery system.
Belgium: Ringafema 0.120 mg / 0.015 mg per 24 hours, vaginal diffusion system
0.120 mg / 0.015 mg per 24 hours, vaginal delivery device
0.120 mg / 0.015 mg per 24 hours, Vaginal drug delivery system
Estonia: Setlona
Finland: Vonamyl 0.120 mg / 0.015 mg per 24 hours, depot medicine for the vagina
France: ETONOGESTREL/ETHINYLESTRADIOL VIATRIS 120 micrograms/15
micrograms/24 hours, vaginal diffusion system
Germany: SetLona 0.120 / 0.015 mg per 24 hours, vaginal drug delivery system
Iceland: Vonamyl 0.120 mg/0.015 mg/24 hours, vaginal insert
Italy: MYPRIMOSE
Latvia: Setlona 120/15 micrograms/24 hours vaginal insertion system
Lithuania: Ringafema 120/15 micrograms/24 hours, system for use in the vagina
Liechtenstein: SetLona 0.120 / 0.015 mg per 24 hours, vaginal delivery system
Luxembourg: Ringafema 0.120 mg / 0.015 mg per 24 hours, vaginal diffusion system
Netherlands: Etonogestrel/Ethinylestradiol Viatris 0.120 mg / 0.015 mg per 24 hours, device
for vaginal use
Portugal: Mystrelle
Slovenia: Setlona 0.120 mg / 0.015 mg per 24 hours vaginal delivery
Spain: Setlona 0.120 mg/0.015 mg every 24 hours, vaginal delivery system EFG
Sweden: Vonamyl 0.120 mg/0.015 mg per 24 hours, vaginal insert