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SYRENIRING 0.120 MG/0.015 MG PER 24 HOURS VAGINAL DELIVERY SYSTEM

Active substance(s): ETHINYLESTRADIOL / ETONOGESTREL / ETHINYLESTRADIOL / ETONOGESTREL

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Package leaflet: Information for the user
SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system
etonogestrel/ethinylestradiol

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 having a blood clot in the veins and arteries,
especially in the first year or when restarting a combined hormonal contraceptive
following a break of 4 or more weeks.
 Please be alert and see your doctor if you think you may have symptoms of a blood
clot (see section 2 “Blood clots”).
Read all of this leaflet carefully before you start using SyreniRing because it contains
important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them.
 If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
Your medicine is available as the above name but will be referred to as SyreniRing
throughout this leaflet

What is in this leaflet
1. What SyreniRing is and what is it used for
2. What you need to know before you use SyreniRing
2.1 When you should not use SyreniRing
2.2 Warnings and precautions
Blood clots
Cancer
2.3 Children and adolescents
2.4 Other medicines and SyreniRing
Laboratory tests
2.5 Pregnancy and breast-feeding
2.6 Driving and using machines
3. How to use SyreniRing
3.1 How to insert and remove SyreniRing
3.2 Three weeks in, one week out
3.3 When to start with the first ring
3.4 What to do if…
Your ring is accidentally expelled from the vagina
Your ring has temporarily been out of the vagina
Your ring breaks
You have inserted more than one ring
You have forgotten to insert a new ring after the ring-free interval

You have forgotten to remove the ring
You have missed a menstrual period
You have unexpected bleeding
You want to change the first day of your menstrual period
You want to delay your menstrual period
3.5 When you want to stop using SyreniRing
4. Possible side effects
5. How to store SyreniRing
6. Contents of the pack and other Information
What SyreniRing contains
What SyreniRing looks like and contents of the pack
Manufacturer and Product Licence Holder

1. What SyreniRing is and what it is used for
SyreniRing 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 blood circulation. Because of the low amount of
hormones that is released, SyreniRing is considered a low-dose hormonal contraceptive. Since
SyreniRing releases two different types of hormones it is a so-called combined hormonal
contraceptive.

SyreniRing works just like a combined contraceptive pill (the Pill) but instead of taking a pill
every day, the ring is used for 3 weeks in a row.
SyreniRing releases two female sex hormones that prevent the release of an egg cell from the
ovaries. If no egg cell is released you cannot become pregnant.
2. What you need to know before you use SyreniRing
General notes
Before you start using SyreniRing you should read the information on blood clots in section 2.
It is particularly important to read the symptoms of a blood clot – see section 2 “Blood clots”.
In this leaflet, several situations are described where you should stop using SyreniRing, or
where SyreniRing may be less reliable. In such situations you should not have intercourse or
you should take extra non-hormonal contraceptive precautions – such as using a condom or
another barrier method. Do not use rhythm or temperature methods. These methods can be

unreliable because SyreniRing alters the monthly changes of the body temperature and of the
cervical mucus.
SyreniRing, like other hormonal contraceptives, does not protect against HIV infection
(AIDS) or any other sexually transmitted disease.
2.1 When you should not use SyreniRing
You should not use SyreniRing if you have any of the conditions listed below. If you do have
any of the conditions listed below, you must tell your doctor. Your doctor will discuss with
you what other form of birth control would be more appropriate.
• if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein
thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;
• if you know you have a disorder affecting your blood clotting – for instance, protein C
deficiency, protein S deficiency, antithrombin – III deficiency, Factor V Leiden or
antiphospholipid antibodies;
• if you need an operation or if you are off your feet for a long time (see section ‘Blood
clots’);
• if you have ever had a heart attack, or a 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 transient ischaemic attack (TIA – temporary
stroke symptoms);
• if you have any of the following diseases that may increase your risk of a clot in the
arteries:
- severe diabetes with blood vessel damage
- very high blood pressure
- a very high level of fat in the blood (cholesterol or triglycerides)
- a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called ‘migraine with aura’;
• if you have (had) inflammation of the pancreas (pancreatitis) associated with high levels
of fat in your blood.
• if you have (had) severe liver disease and your liver is not yet working normally.
• if you have (had) a benign or malignant tumour in the liver.
• if you have (had), or if you may have, cancer of the breast or the genital organs.
• if you have any unexplained vaginal bleeding.
• 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 appear for the first time while using SyreniRing, remove the ring
immediately and contact your doctor. In the meantime, use non-hormonal contraceptive
measures.
Do not use SyreniRing if you have hepatitis C and are taking the medicinal products
containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section 2.4 Other
medicines and SyreniRing).
2.2 Warnings and precautions
When should you contact your doctor?
Seek urgent medical attention

• if you notice possible signs of a blood clot that may mean you are suffering from a
blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary
embolism), a heart attack or a stroke (see ‘Blood clots’ section below).
For a description of the symptoms of these serious side effects please go to “How to recognize
a blood clot”.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using SyreniRing, you should also tell
your doctor.
• if a close relative has or has ever had breast cancer;
• if you have epilepsy (see section 2.4:‘Other Medicines and SyreniRing’);
• if you have liver disease (for instance jaundice) or gallbladder disease (for instance
gallstones);
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE - a disease affecting your natural
defense system);
• if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing
failure of the kidneys);
• if you have sickle cell anaemia (an inherited disease of the red blood cells);
• if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive
family history for this condition. Hypertriglyceridaemia has been associated with an
increased risk of developing pancreatitis (inflammation of the pancreas);
• if you need an operation, or you are off your feet for a long time (see in section 2
‘Blood clots’);
• if you have just given birth you are at an increased risk of blood clots.You should ask
your doctor how soon after delivery you can start using SyreniRing;
• if you have an inflammation in the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have a condition that occurred for the first time or worsened during pregnancy
or previous use of sex hormones (e.g. hearing loss, porphyria [a disease of the blood],
herpes gestationis [skin rash with vesicles during pregnancy], Sydenham’s chorea [a
disease of the nerves in which sudden movements of the body occur], hereditary
angioedema [you should see your doctor immediately if you experience symptoms of
angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or
hives together with difficulty breathing];
• if you have (or have ever had) chloasma (yellowish-brown pigment patches, so called
‘pregnancy patches’, particularly on the face). If so, avoid too much exposure to the sun
or ultraviolet light;
• if you have a medical condition that makes it difficult to use SyreniRing – for
example, if you are constipated, have a prolapse of the uterine cervix or have pain
during intercourse.
BLOOD CLOTS
Using a combined hormonal contraceptive such as SyreniRing increases your risk of
developing a blood clot compared with not using one. In rare cases a blood clot can block
blood vessels and cause serious problems.
Blood clots can develop
• in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE)

• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or
ATE).
Recovery from blood clots is not always complete. Rarely, there may be serious lasting
effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful blood clot due to
SyreniRing is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.
Are you experiencing any of these signs?

What are you possibly suffering
from?

• swelling of one leg or along a vein in the leg or
Deep vein thrombosis
foot especially when accompanied by:
• pain or tenderness in the leg which may be
felt only when standing or walking
• increased warmth in the affected leg
• change in colour of the skin on the leg e.g.
turning pale, red or blue
• sudden unexplained breathlessness or rapid breathing;
Pulmonary embolism
• sudden cough without an obvious cause, which may bring up
blood;
• sharp chest pain which may increase with deep breathing;
• severe light headedness or dizziness;
• rapid or irregular heartbeat;
• severe pain in your stomach;
If you are unsure, talk to a doctor as some of these
symptoms such as coughing or being short of breath may
be mistaken for a milder condition such as a respiratory
tract infection (e.g. a ‘common cold’).
Symptoms most commonly occur in one eye:
• immediate loss of vision or
• painless blurring of vision which can progress
to loss of vision
• chest pain, discomfort, pressure, heaviness
• sensation of squeezing or fullness in the chest,
arm or below the breastbone;
• fullness, indigestion or choking feeling;
• upper body discomfort radiating to the back, jaw
throat, arm and stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety, or shortness of
breath;
• rapid or irregular heartbeats
• sudden weakness or numbness of the face, arm
or leg, especially on one side of the body;
• sudden confusion, trouble speaking or

Retinal vein thrombosis
(blood clot in the eye)

Heart attack

Stroke

understanding;
• sudden trouble seeing in one or both eyes;
• sudden trouble walking, dizziness, loss of
balance or coordination;
• sudden, severe or prolonged headache with no
known cause;
• loss of consciousness or fainting with or without seizure.
Sometimes the symptoms of stroke can be brief
with an almost immediate and full recovery, but
you should still seek urgent medical attention as
you may be at risk of another stroke.
• swelling and slight blue discolouration of an
extremity;
• severe pain in your stomach (acute abdomen).

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 connected with an increase in the
risk of blood clots in the vein (venous thrombosis). However, these side effects are rare.
Most frequently, 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 a 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 a vein in another organ such as the eye (retinal vein
thrombosis).
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a
combined hormonal contraceptive for the first time. The risk may also be higher if you restart
taking a combined hormonal contraceptive (the same product or a different product) after a
break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if you were not
using a combined hormonal contraceptive.
When you stop using SyreniRing your risk of a blood clot returns to normal 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 a blood clot in the leg or lung (DVT or PE) with SyreniRing is small.
• Out of 10,000 women who are not using any combined hormonal contraceptive and are not
pregnant, about 2 will develop a blood clot in a year.

• Out of 10,000 women who are using a combined hormonal contraceptive that contains
levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a
year.
• Out of 10,000 women who are using a combined hormonal contraceptive that contains
norelgestromin, or etonogestrel such as SyreniRing, between about 6 and 12 women will
develop a blood clot in a year.
• The risk of having a blood clot will vary according to your personal medical history (see
“Factors that increase your risk of a blood clot” below).

Women who are not using a combined
hormonal pill/patch/ring and are not
pregnant

Risk of developing a blood clot in a year
About 2 out of
10,000 women

Women using a combined hormonal
contraceptive pill containing
levonorgestrel, norethisterone or
norgestimate

About 5-7 out of
10,000 women

Women using SyreniRing

About 6-12 out of
10,000 women

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with SyreniRing is small but some conditions will increase the risk.
Your risk is higher:
• if you are very overweight (body mass index or BMI over 30 kg/m2);
• if one of your immediate family has had a blood clot in the leg, lung or other organ at a
young age (e.g. below the age of about 50). In this case you could have a hereditary blood
clotting disorder;
• if you need to have an operation, or if you are off your feet for a long time because of an
injury or illness, or you have your leg in a cast. The use of SyreniRing may need to be
stopped several weeks before surgery or while you are less mobile. If you need to stop using
SyreniRing ask your doctor when you can start using it again.
• as you get older (particularly above about 35 years);
• if you gave birth less than a few weeks ago.
The risk of developing a blood clot increases the more conditions you have.
Air travel (> 4 hours) may temporarily increase your risk of a blood clot, particularly if you
have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you, even if you are
unsure. Your doctor may decide that SyreniRing needs to be stopped.
If any of the above conditions change while you are using SyreniRing, for example a close
family member experiences a thrombosis for no known reason, or you gain a lot of weight,
tell your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can
cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using SyreniRing is very
small but can increase:
• with increasing age (beyond about 35 years);
• if you smoke. When using a combined hormonal contraceptive like SyreniRing you are
advised to stop smoking. If you are unable to stop smoking and are older than 35 your doctor
may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a member of your immediate family has had a heart attack or stroke at a young age (less
than about 50). In this case you could also have a higher risk of having a heart attack or
stroke;
• if you, or someone in your immediate family, have a high level of fat in the blood
(cholesterol or triglycerides);
• if you get migraines, especially migraines with aura;
• if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial
fibrillation)
• if you have diabetes.
If you have more than one of these conditions or if any of them are particularly severe, the
risk of developing a blood clot may be increased even more.
If any of the above conditions change while you are using SyreniRing, for example, you start
smoking, a close family member experiences a thrombosis for no known reason, or you gain a
lot of weight, tell your doctor.
Cancer
The information given below was obtained in studies with combined oral contraceptives and it
may also apply to SyreniRing. Information about vaginal administration of contraceptive
hormones (as in SyreniRing) is not available.
Breast cancer has been found slightly more often in women using combined pills, but it is not
known whether this is caused by the treatment. For example, it may be that tumours are found
more in women on combined pills because they are examined by the doctor more often.
The increased occurrence of breast cancer becomes gradually less after stopping the combined
pill.
It is important to regularly check your breasts and you should contact your doctor if you feel
any lump. You should also tell your doctor if a close relative has, or ever had breast cancer
(see section 2.2 ‘Warnings and precautions’).
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have
been reported in pill users. Contact your doctor if you have unusual severe abdominal pain.
For users of the combined Pill it has been reported that cancer of the endometrium (the lining
of the womb) and cancer of the ovaries occur less frequently. This may also be the case for
SyreniRing but this has not been confirmed.

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

2.4 Other medicines and SyreniRing
Always tell the doctor who prescribes SyreniRing which medicines or herbal products you are
already using. Also tell any other doctor or dentist who prescribes another medicine (or the
dispensing pharmacist) that you use SyreniRing. They can tell you if you need to take
additional contraceptive precautions and, if so, for how long or, whether the use of another
medicine you need must be changed.
Some medicines
– can have an influence on the blood levels of SyreniRing
– can make it less effective in preventing pregnancy
– can cause unexpected bleeding.
These include medicines used to treat:
 Epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine,
oxcarbamazepine, topiramate, felbamate);
 Tuberculosis (e.g. rifampicin);
 HIV infections (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);
 Depressive moods (the herbal remedy St. John’s wort (Hypericum perforatum)).
If you are taking medicines or herbal products that might make SyreniRing less
effective, a barrier contraceptive method should also be used. Since the effect of another
medicine on SyreniRing may last up to 28 days after stopping the medicine, it is
necessary to use the additional barrier contraceptive method for that long. Note: Do not
use SyreniRing with a female condom.
SyreniRing may influence the effect of other medicines, e.g.
- medicines containing ciclosporin
- the anti-epileptic lamotrigine (this could lead to an increased frequency of
seizures)
Do not use SyreniRing if you have Hepatitis C and are taking the medicinal products
containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this may cause increases in
liver function blood test results (increase in ALT liver enzyme).
Your doctor will prescribe another type of contraceptive prior to start of the treatment
with these medicinal products.
SyreniRing can be restarted approximately 2 weeks after completion of this treatment. See
section 2.1 ‘When you should not use SyreniRing’.
Ask your doctor or pharmacist for advice before taking any medicine.
You can use tampons while using SyreniRing. Insert SyreniRing before inserting a tampon.

You should be careful when removing a tampon to be sure that the ring is not accidentally
pulled out. If the ring does come out, simply rinse the ring in cool to lukewarm water and
immediately reinsert it.
Using spermicides or vaginal yeast products will not reduce the contraceptive efficacy of
SyreniRing.
Laboratory tests
If you are having any blood or urinary test, tell your health care professional that you are
using SyreniRing as it may affect the results of some tests.
2.5 Pregnancy and breast-feeding
SyreniRing must not be used by women who are pregnant, or who think they may be
pregnant. If you get pregnant while using SyreniRing you should remove the ring and contact
your doctor.
If you want to stop SyreniRing because you want to get pregnant, see section 3.5 ‘When you
want to stop using SyreniRing’.
SyreniRing is not usually recommended for use during breast-feeding. If you wish to use
SyreniRing while breast-feeding, please seek the advice of your doctor.
2.6 Driving and using machines
SyreniRing is unlikely to affect your ability to drive or use machines.

3. How to use SyreniRing
You can insert and remove SyreniRing yourself. Your doctor will tell you when to start using
SyreniRing for the first time. The vaginal ring must be put in on the correct day in your
monthly cycle (see section 3.3 ‘When to start with the first ring’) and left in place for 3 weeks
in a row. Regularly check that SyreniRing is in your vagina (for example, before and after
intercourse) to ensure that you are protected from pregnancy. After the third week, you take
SyreniRing out and have a one week break. You will usually have your monthly period during
this ring-free interval.
3.1 How to insert and remove SyreniRing
1. Before inserting the ring, check it is not out of date (see section 5 ‘How to store
SyreniRing’).
2. Wash your hands before inserting or removing the ring.
3. Choose the position for inserting that is most comfortable to you, like standing with one leg
up, squatting, or lying down.
4. Remove SyreniRing from its sachet. Store the sachet for later use.
5. Hold the ring between your thumb and index finger, press the opposite sides together and
insert the ring into the vagina (see Figures 1– 4).
When SyreniRing is in place you should not feel anything. If you feel uncomfortable,
gently push SyreniRing a bit further into the vagina. The exact position of the ring inside
the vagina is not important.
6. After 3 weeks you remove SyreniRing from the vagina. You can do this by hooking your
index finger under the front rim of the ring or by grasping the rim and pulling it out (see

Figure 5). If you locate the ring in your vagina, but are unable to remove it, you should
contact your doctor.
7. Dispose of the used ring with the normal household waste, preferably inside the sachet. Do
not flush SyreniRing down the toilet.

Figure 1
Take SyreniRing out of the sachet

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 labia may be spread
with the other. Push the ring into the vagina until the ring feels comfortable (Figure 4B). Leave
the ring in place for 3 weeks (Figure 4C).

Figure 5:
SyreniRing 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 out.

3.2 Three weeks in, one week out
1. Starting with the day you put it in, the vaginal ring must be left in place without
interruption for 3 weeks.
2. After 3 weeks you remove the ring on the same day of the week and at approximately the
same time as it was put in. For example, if you put SyreniRing in on a Wednesday at about
22.00 h, you should remove the ring 3 weeks later, on Wednesday, at about 22.00 h.
3. After you have removed the ring, you do not use a ring for 1 week. During this week a
vaginal bleed should occur. Usually this starts 2–3 days after removal of SyreniRing.
4. Start a new ring exactly after the 1 week interval (again on the same day of the week and
approximately the same time), even if you have not stopped bleeding.

If the new ring is inserted more than 3 hours too late, the protection from pregnancy may be
reduced. Follow the instructions in section 3.4 ‘What to do if you have forgotten to insert a
new ring after the ring-free interval’.
If you use SyreniRing as described above, your vaginal bleed will take place every month on
roughly the same days.
3.3 When to start with the first ring
• You have not used a hormonal contraceptive during the last month
Insert the first SyreniRing on the first day of your natural cycle (i.e. the first day of your
menstrual period). SyreniRing starts working straight away. You don’t need to take any
other contraceptive precautions.
You can also start SyreniRing between day 2 and day 5 of your cycle, but if you have sexual
intercourse during the first 7 days of SyreniRing use make sure that you also use an
additional contraceptive method (such as a condom). You only have to follow this advice
when you use SyreniRing for the first time.
• You have used a combined Pill during the last month
Start using SyreniRing at the latest the day following the tablet-free period of your present
Pill. If your Pill pack also contains inactive tablets, start SyreniRing at the latest on the day
after the last inactive tablet. If you are not sure which tablet this is, ask your doctor or
pharmacist. Never extend the hormone-free interval of your current Pill pack beyond its
recommended length. If you have used the Pill consistently and correctly and if you are sure
that you are not pregnant, you can also stop taking the Pill on any day of your current Pill
pack and start using SyreniRing immediately.
• You have used a transdermal patch during the last month
Start using SyreniRing at the latest the day following your usual patch-free break. Never
extend the patch-free break beyond its recommended length.
If you have used the patch consistently and correctly and if you are sure that you are not
pregnant, you can also stop using the patch on any day and start using SyreniRing
immediately.
• You have used a minipill (progestagen-only pill) during the last month.
You can stop taking the minipill any day and start SyreniRing the next day, at the same time
you would normally have taken your pill. But make sure you also use an additional
contraceptive method (such as a condom) for the first 7 days of ring use.
• You have used an injectable or implant or a progestagen-releasing IUD during the last
month.
Start using SyreniRing when your next injection is due or on the day that your implant or
your progestagen-releasing IUD is removed. But make sure you also use an additional
contraceptive method (such as a condom) for the first 7 days of ring use.
• After having a baby.
If you have just had a baby, your doctor may tell you to wait until after your first normal
period before you start using SyreniRing. Sometimes it is possible to start sooner. Your
doctor will advise you. If you are breast-feeding and want to use SyreniRing, you should
discuss this first with your doctor.
• After a miscarriage or an abortion.
Your doctor will advise you.
3.4 What to do if….
Your ring is accidentally expelled from the vagina

SyreniRing may accidentally be expelled from the vagina – for example, if it has not been
inserted properly, while removing a tampon, during sexual intercourse, during constipation, or
if you have a prolapse of the womb. Therefore, you should regularly check whether the ring is
still in your vagina (for example, before and after intercourse)
If the ring is out for less than 3 hours it will still protect you from pregnancy. You can rinse
the ring with cold to lukewarm water (do not use hot water) and put it back in. If the ring is
out for more than 3 hours, it may not protect you from pregnancy, see the advice in section
3.4 ‘What to do if… Your ring has temporarily been out of the vagina’.
Your ring has temporarily been out of the vagina
When it is in the vagina, SyreniRing slowly releases hormones into the body to prevent
pregnancy. If the ring has been out of the vagina for more than 3 hours, it may not protect you
from pregnancy. So, the ring must not be outside the vagina for longer than 3 hours in every
twenty-four hour period.
• If the ring has been out of the vagina for less than 3 hours, it will still protect you from
pregnancy. You should put the ring back in as soon as possible but at the latest within 3
hours.
• If the ring has been out of the vagina, or you suspect that the ring has been out of the vagina,
for more than 3 hours during the 1st and 2nd week, it may not protect you from
pregnancy. Put the ring back in the vagina as soon as you remember, and leave the ring in
place without interruption for at least 7 days. Use a condom if you have sexual intercourse
during these 7 days. If you are in your 1st week, and you had sexual intercourse during the
past 7 days, there is a possibility you may be pregnant. In that case contact your doctor.
• If the ring has been out of the vagina, or you suspect that the ring has been out of the vagina,
for more than 3 hours in the 3rd week it may not protect you from pregnancy. You should
discard that ring and choose between one of the following two options:
1 - Insert a new ring immediately
This will start the next three-week use period. You may not have your period, but
breakthrough bleeding and spotting may occur.
2 - Do not insert the ring again. Have your period first and insert a new ring no later
than 7 days from the time the previous ring was removed or fell out.
You should only choose this option if you have used SyreniRing continuously
during the previous 7 days.
• If SyreniRing was out of the vagina for an unknown amount of time, you may not be
protected from pregnancy. Perform a pregnancy test and consult your doctor prior to
inserting a new ring.
Your ring breaks
Very rarely SyreniRing may break. If you notice that your SyreniRing has broken, discard it
and start with a new ring as soon as possible. Use extra contraceptive precautions (e.g. a
condom) during the next 7 days. If you had sexual intercourse before you noticed the ring
breakage, please contact your doctor.
You have inserted more than one ring
There have been no reports of serious harmful effects due to an overdose of the hormones in
SyreniRing. If you have accidentally inserted more than one ring, you may feel sick (nausea)
or have vomiting or vaginal bleeding. Remove excess rings and contact your doctor if these
symptoms persist.

You have forgotten to insert a new ring after the ring-free interval
If your ring-free interval was longer than 7 days, put a new ring as soon as you remember.
Use extra contraceptive precautions (such as a condom) if you have sexual intercourse during
the next 7 days. If you had sexual intercourse in the ring-free interval, there is a
possibility you may be pregnant. In that case contact your doctor immediately. The longer
the ring-free interval, the higher the risk that you have become pregnant.
You have forgotten to remove the ring
• If your ring has been left in place for between 3 and 4 weeks, it will still protect you from
pregnancy. Have your regular ring-free interval of one week and subsequently insert a new
ring.
• If your ring has been left in place for more than 4 weeks there is a possibility of becoming
pregnant. Contact your doctor before you start with a new ring.
You have missed a menstrual period
• You have followed the instructions for SyreniRing
If you have missed a menstrual period but you followed the instructions for SyreniRing, and
have not used other medicines, it is very unlikely that you are pregnant. Continue to use
SyreniRing as usual. If you miss your menstrual period twice in a row, however, you may be
pregnant. Tell your doctor immediately. Do not start the next SyreniRing until your doctor
has checked you are not pregnant.
• If you have not followed the instructions for SyreniRing
If you have missed a menstrual period and you did not follow the instructions, and you do
not have your expected period in the first normal ring-free interval, you may be pregnant.
Contact your doctor before you start with a new SyreniRing.
You have unexpected bleeding
While using SyreniRing, some women have unexpected vaginal bleeding between menstrual
periods. You may need to use sanitary protection. In any case, leave the ring in the vagina
and continue to use the ring as normal. If the irregular bleeding continues, becomes heavy or
starts again, tell your doctor.
You want to change the first day of your menstrual period.
If you follow the instructions for SyreniRing, your menstrual period (withdrawal bleed) will
begin in the ring-free interval. If you want to change the day it starts, you can make the ringfree interval shorter (but never longer!).
For example, if your period usually begins on a Friday, you can change this to a Tuesday (3
days earlier) from next month onwards. Simply insert your next ring 3 days earlier than usual.
If you make your ring-free interval very short (for example, 3 days or less), you may not have
your usual bleeding. You may have spotting (drops or flecks of blood) or breakthrough
bleeding while using the next ring.
If you are not sure how to proceed, contact your doctor for advice.
You want to delay your menstrual period

Although it is not the recommended regimen, delay of your menstrual period (withdrawal
bleed) is possible by inserting a new ring immediately after removing the current ring, with no
ring-free interval between rings.
You can leave the new ring inserted for up to a maximum of 3 weeks. You may experience
spotting (drops or flecks of blood) or breakthrough bleeding while using this new ring. When
you want your period to begin, just remove the ring. Have your regular ring free interval of
one week and subsequently insert a new ring.
You can ask your doctor for advice before deciding to delay your menstrual period.
3.5 When you want to stop using SyreniRing
You can stop using SyreniRing any time you want.
If you do not want to become pregnant, ask your doctor about other methods of birth control.
If you stop using SyreniRing because you want to get pregnant, you should wait until you
have had a natural period before trying to conceive. This helps you calculate when the baby
will be due.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If
you get any side effect, particularly if severe or persistent, or have any change to your health
that you think may be due to SyreniRing, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood
clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking
combined hormonal contraceptives. For more detailed information on the different risks from
taking combined hormonal contraceptives, please see section 2, “What you need to know
before you use SyreniRing”.
If you are allergic to one of the ingredients of SyreniRing (hypersensitivity) you may
experience the following symptoms (frequency not known):
angioedema [swollen face, tongue and/or throat and/or difficulty swallowing] or hives
together with difficulty breathing. If this happens, remove SyreniRing and contact your doctor
immediately.
Users of ring containing Etonogestrel / Ethinylestradiol have reported the following side
effects.
Common: may affect up to 1 in 10 women
• abdominal pain, feeling sick (nausea)
• yeast infection of the vagina (such as ‘thrush’); discomfort in the vagina due to the ring;
genital itching; secretion from the vagina
• headache or migraine; depressive moods; lower sex drive
• breast pain; pelvic pain; painful menstrual periods
• acne
• weight gain
• the ring falling out

Uncommon: may affect up to 1 in 100 women
• disturbed vision; dizziness
• swollen abdomen; vomiting, diarrhoea or constipation
• feeling tired, unwell or irritable; mood changes; mood swings
• extra fluid in the body (oedema)
• bladder or urinary tract infection
• difficulty or pain when passing urine; strong desire or need to pass urine; passing urine
more often
• problems during intercourse, including pain, bleeding or partner feeling the ring
• increased blood pressure
• increased appetite
• back pain; muscle spasms; pain in legs or arms
• less sensitive skin
• sore or larger breasts; fibrocystic breast disease (cysts in the breasts which may become
swollen or painful)
• inflammation of the cervix; cervical polyps (growths in the cervix); rolling outward of the
margin of the cervix (ectropion)
• changes to menstrual periods (e.g. periods can be heavy, long, irregular or stop
altogether); pelvic discomfort; premenstrual syndrome; spasm of the uterus
• vaginal infection (fungal and bacterial); burning feeling, smell, pain, discomfort or dryness
in the vagina or vulva
• hair loss, eczema, itching, rash or hot flushes.
• ring breakage
Rare: may affect up to 1 in 1,000 women
• harmful blood clots in a vein or artery, for example:
o in a leg or foot (i.e. DVT)
o in a lung (i.e. PE)
o heart attack
o stroke
o mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic
attack (TIA)
o blood clots in the liver, stomach/intestine, kidneys or eye.
The chance of having a blood clot may be higher if you have any other conditions that
increase this risk. (See section 2 for more information on the conditions that increase risk for
blood clots and the symptoms of a blood clot.)
• breast discharge
Not known (cannot be estimated from the available data)
• chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face)
• penis discomfort of the partner (such as irritation, rash, itching)
Breast cancer and liver tumours have been reported in users of combined hormonal
contraceptives. For more information, see section 2.2 Warnings and precautions, Cancer.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.
.

5. How to store SyreniRing
Keep this medicine out of the sight and reach of children.
If you discover that a child has been exposed to the hormones from SyreniRing, ask your
doctor for advice.
This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from light.
SyreniRing should be inserted at least one month prior to the expiry date, which is stated on
the carton and sachet after EXP. The expiry date refers to the last day of that month.
Do not use SyreniRing if you notice a colour change in the ring or any visible signs of
deterioration.
This medicinal product may pose a risk to the environment. After removal, SyreniRing
should be placed in the sachet and properly closed. The closed sachet should be
disposed with the normal household waste or it should be taken back to the pharmacy
for its proper destruction according to local requirements.
Do not flush SyreniRing down the toilet. As with other medicines, do not throw away any
unused or outdated rings via wastewater or household waste. Ask your pharmacist how to
throw away any unused rings no longer required. These measures will help protect the
environment.

6. Contents of the pack and other information
What SyreniRing contains
• The active substances are: etonogestrel and ethinylestradiol.
SyreniRing contains 11.0 mg etonogestrel and 3.474 mg ethinylestradiol. The ring releases
etonogestrel and ethinylestradiol at an average amount of 0.120 mg/0.015 mg, respectively
per 24 hours, over a period of 3 weeks.
• The other ingredients are: ethylene vinyl acetate copolymer 28% vinyl acetate and
polyurethane (a type of plastic that will not dissolve in the body).
What SyreniRing looks like and contents of the pack
Vaginal delivery system.
SyreniRing is flexible, transparent, and colourless to almost colourless ring, with an outer
diameter of 54 mm and a cross-sectional diameter of 4 mm.
Each ring is packed in an aluminum sachet. The sachet is packed in a cardboard box together
with this package leaflet and stickers for your calendar to help you to 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 Authorization Holder and Manufacturer
Marketing Authorization Holder
Crescent Pharma Limited
3&4 Quidhampton Business Units
Polhampton Lane, Overton
Hampshire, RG25 3ED
UK
Manufacturer
Laboratorios León Farma, S.A.
Calle La Vallina s/n,
Polígono Industrial Navatejera,
Villaquilambre, León 24008
Spain
This medicinal product is authorised in the Member States of the EEA under the
following names
The Netherlands:
Nillho 0,120 mg / 0,015 mg per 24 uur, hulpmiddel voor vaginaal
gebruik
Sweden:
Nillho 0,120 mg/0,015 mg per 24 timmar, vaginalinlägg
Czech Republic:
Teyla
Finland:
Etonogestrel /Ethinylestradiol Chemo 0,120 mg / 0,015 mg per 24
tuntia, depotlääkevalmiste, emättimeen
Denmark:
Nillho 0.120 / 0.015 mg mikrog./24 timer
Ireland:
Etonogestrel /Ethinylestradiol 0.120 / 0.015 mg per 24 hours,
vaginal delivery system
Hungary:
Nillho 0,120 mg/0,015 mg/24 óra hüvelyben alkalmazott
gyógyszerleadó rendszer
Norway:
Etonogestrel /Ethinylestradiol Chemo
Slovakia:
Teyla 0,120 mg/0,015 mg za 24 hodín vaginálny inzert
Romania:
Teyla 0,120mg/ 0,015 mg / 24 de ore sistem cu cedare vaginala
Poland:
Adaring
This leaflet was last revised in June 2017.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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