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SEASONIQUE 150 MICROGRAMS/30 MICROGRAMS AND 10 MICROGRAMS FILM-COATED TABLETS

Active substance(s): ETHINYLESTRADIOL / LEVONORGESTREL

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SEASONIQUE® 150 micrograms/30 micrograms
AND 10 micrograms FILM-COATED TABLETS
levonorgestrel/ethinylestradiol
ethinylestradiol
PACKAGE LEAFLET: INFORMATION FOR THE USER

▼This medicine is subject to additional monitoring. This will
allow quick identification of new safety information. You can
help by reporting any side effects you may get. See the end of
section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this
medicine 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, even if their signs of illness
are the same as yours.
• 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.
WHAT IS IN THIS LEAFLET:

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

1

WHAT SEASONIQUE IS AND WHAT IT IS USED FOR

Seasonique is an extended-regimen contraceptive pill taken
continuously for 91 days and is used to prevent pregnancy.
Each of the 84 pink tablets contains a small amount of two
different female hormones, namely levonorgestrel and
ethinylestradiol.
The 7 white tablets contain a small amount of female hormone
ethinylestradiol.

Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Seasonique.
In some situations you need to take special care while using
Seasonique or any other combined hormonal contraceptive, and it
may be necessary that you are regularly checked by your doctor.
If any of the following conditions applies to you, you must inform
your doctor before starting to use Seasonique. Also if any of the
following conditions develops or worsens during the use of
Seasonique you must consult your doctor:















if a close relative has or has had breast cancer
if you have a disease of the liver or the gallbladder
if you have diabetes
if you have depression
if you have Crohn’s disease or ulcerative colitis (inflammatory
bowel disease)
if you have HUS (haemolytic uraemic syndrome; a blood
disease that causes kidney damage)
if you have sickle cell anaemia (an inherited disease of the red
blood cells)
if you have epilepsy (see “Taking other medicines”)
if you have SLE (systemic lupus erythematosus; a disease of the
immune system)
if you have a disease that first appeared during pregnancy or
earlier use of sex hormones, for example hearing loss,
porphyria (a disease of the blood), gestational herpes (skin rash
with vesicles during pregnancy), Sydenham’s chorea (a disease
of the nerves in which sudden movements of the body occur)
if you have or have ever had chloasma (golden brown pigment
patches, so called “pregnancy patches”, especially on the face). If
this is the case, avoid direct exposure to sunlight or ultraviolet
light
if you have hereditary angioedema, products containing
estrogens may induce or worsen symptoms of angioedema. You
should see your doctor immediately if you experience
symptoms of angioedema such as swollen face, tongue and/or
pharynx and/or difficulty swallowing or hives together with
difficulty breathing
if you are breast-feeding (See “Pregnancy and breast-feeding”).

Bleeding between periods
When you take Seasonique, which has a 91-day extended
dosing cycle, you should expect to have 4 scheduled periods
per year (bleeding when you are taking the 7 white pills). Each
period is likely to last about 3 days.
During the first few months that you are taking Seasonique, you
may have unexpected bleeding. The information from the
Seasonique clinical studies show that it is not unusual to
experience unexpected bleeding especially during the first
Seasonique pack. This bleeding or spotting tends to decrease with
time. Do not stop taking Seasonique because of this bleeding or
spotting. If the spotting continues for more than 7 consecutive
days or if the bleeding is heavy, contact your doctor.
What you must do if no bleeding occurs after Day 84
You should consider the possibility that you are pregnant if you
miss your scheduled period (no bleeding on the days when you
are taking white tablets). Since scheduled periods are less
frequent when you are taking Seasonique, notify your doctor
that you have missed your period and that you are taking
Seasonique. Also notify your doctor if you have symptoms of
pregnancy such as morning sickness or unusual breast
tenderness. It is important that your healthcare provider
evaluates you to determine if you are pregnant.
Do not start the next Seasonique pack until you are sure that
you are not pregnant.
Other medicines and Seasonique
Always tell the doctor, who prescribes Seasonique, 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 Seasonique. They
can tell you if you need to take additional contraceptive
precautions (for example condoms) and if so, for how long.

Some medicines can make Seasonique less effective in
preventing pregnancy, or can cause unexpected bleeding. These
include medicines used for the treatment of:
• epilepsy (e.g. primidone, phenytoin, barbiturates,

carbamazepine, oxcarbazepine)
Seasonique and venous and arterial blood clots
• tuberculosis (e.g. rifampicin)
Venous thrombosis
• HIV infections (ritonavir, nevirapine) or other infections (an
The use of any combination pill, including Seasonique, increases a
antibiotic named griseofulvin)
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
2 SEASONIQUE
woman’s risk of developing a venous thrombosis (formation of a
• high blood pressure in the blood vessels in the lungs (bosentan)
blood clot in vessels) compared with a woman who does not take • cancer (vemurafenib)
any contraceptive pill.
The herbal product St. John's wort may also stop Seasonique
General notes
The risk of venous thrombosis in users of combined pills
from working properly.
Before you can begin taking Seasonique, your doctor will ask
increases:
Seasonique may influence the effect of other medicines, e.g.:
you some questions about your personal health history and
• with increasing age
• the anti-epileptic lamotrigine (this could lead to an increased
that of your close relatives. The doctor will also measure your
• if you are overweight
frequency of seizures)
blood pressure and depending upon your personal situation,
• if one of your close relatives has had a blood clot (thrombosis)
may also carry out some other tests.
Ask your doctor or pharmacist for advice before taking any
in the leg, lung, or other organ at a young age
In this leaflet, several situations are described where you
medicine.
• if you must have an operation (surgery), any prolonged period
should stop using Seasonique, or where the reliability of
of immobilisation, or if you have had a serious accident. It is
Laboratory tests
Seasonique may be decreased. In such situations you should
important to tell your doctor in advance that you are using
If you need a blood test, tell your doctor or the laboratory staff
either not have sex or you should take extra non-hormonal
Seasonique as the treatment may have to be stopped. Your
that you are taking Seasonique, because oral contraceptives
contraceptive precautions, e.g. use a condom or another
doctor will tell you when to start Seasonique again. This is
can affect the results of some tests.
barrier method. Do not use rhythm or temperature methods.
usually about two weeks after you are back on your feet.
These methods can be unreliable because Seasonique alters
Pregnancy and breast-feeding
the monthly changes of body temperature and cervical mucus. Your chances of having a blood clot are increased by taking a
If you are pregnant, you must not take Seasonique. If you
Seasonique, like other hormonal contraceptives, does not
contraceptive pill.
become pregnant while taking Seasonique you must stop
protect against HIV infection (AIDS) or any other sexually
• Of 100,000 women who are not on a contraceptive pill and not
immediately and contact your doctor.
transmitted disease.
pregnant, about 5-10 may have a blood clot in a year.
Use of Seasonique is generally not advisable when a woman is
• Of 100,000 women taking a contraceptive pill containing
breast-feeding. If you want to take the pill while you are
Do NOT take Seasonique
levonorgestrel and ethinylestradiol, 20 may have a blood clot in
breast-feeding you should contact your doctor.
a year.
• if you have (or have had in the past) a blood clot (thrombosis)

Of
100,000
women
who
are
pregnant,
around
60
may
have
a
Ask your doctor or pharmacist for advice before taking any
in a blood vessel of the leg, lung (embolus) or other organs
blood clot in a year.
medicine.
• if you have (or have had in the past) a heart attack or stroke
• if you have (or have had in the past) a disease that can be a
It is not known how Seasonique influences the occurrence of such Driving and using machines
predictor of a heart attack (for example, angina pectoris,
events in comparison to other levonorgestrel-containing COCs.
There is no information suggesting that use of Seasonique
which causes severe pain in the chest) or of a stroke (for
affects driving or use of machines.
Arterial thrombosis
example, a transient slight stroke with no residual effects)
The
use
of
combination
pills
has
been
connected
with
an
increase
Seasonique contains lactose
• if you have a disease that may increase the risk of a
of the risk of arterial thrombosis (obstruction of an artery), for
Seasonique contains lactose. If you have been told by your
thrombosis in the arteries. This applies to the following
example, in the blood vessels of the heart (heart attack) or the
doctor that you have an intolerance to some sugars, contact
diseases:
brain (stroke).
your doctor before taking this medicinal product.
• diabetes with damaged blood vessels
The risk of arterial thrombosis in users of combined pills
• very high blood pressure
Seasonique contains allura red AC (E129) and brilliant blue FCF
increases:
• a very high level of fat in the blood (cholesterol or
(E133)

if
you
smoke.
You
are
strongly
advised
to
stop
smoking
when
triglycerides)
Seasonique pink tablets contain a red colour called allura red
you use Seasonique, especially if you are older than 35 years
• if you have a disturbance of blood clotting (for example,
AC (E129) and a blue colour called brilliant blue FCF (E133),

if
you
have
an
increased
fat
content
in
your
blood
(cholesterol
or
protein C deficiency)
which may cause allergic reactions.
triglycerides)
• if you have (had) a certain form of migraine (with so-called

if
you
have
high
blood
pressure
focal neurological symptoms)
3 HOW TO TAKE SEASONIQUE
• if you have migraines
• if you have (had) an inflammation of the pancreas
• if you have a problem with your heart (valve disorder, a
(pancreatitis)
Each pack contains 84 pink tablets and 7 white tablets placed in
disturbance of the heart rhythm).
• if you have or have had in the past a liver disease and your
3 blisters in a pack.
liver function is still not normal
Stop taking Seasonique and contact your doctor immediately if
How to take the tablets
• if you have or have had a tumour in the liver
you notice possible signs of a blood clot, such as:
Take one tablet of Seasonique every day, if necessary with a
• if you have (had) or if you are suspected of having breast
• severe pain and/or swelling in one of your legs
small amount of water. You may take the tablets with or without
cancer or cancer of the genital organs
• sudden severe pain in the chest which may reach the left arm
food, but you should take the tablets every day around the
• if you have any unexplained bleeding from the vagina
• sudden breathlessness
same time.
• if you are taking the herbal product St. John's wort
• sudden cough without an obvious cause
• if you are allergic to ethinylestradiol or levonorgestrel, or any • any unusual, severe or long-lasting headaches or worsening of
Which tablets to take
of the other ingredients of this medicine (listed in section 6).
migraines
Do not confuse the tablets: take a pink tablet for the first
This can be recognised by itching, rash or swelling.
• partial or complete blindness or double vision
84 days and then a white tablet for the last 7 days.
• difficulty in speaking or inability to speak
A new pack is started straightaway (84 pink and then 7 white
• giddiness or fainting
tablets). There is therefore no gap between two packs.
• weakness, strange feeling, or numbness in any part of the body. Because of the different composition of the tablets it is
necessary to begin with the first tablet on the upper left corner
Seasonique and cancer
of the first blister in the pack and that you take the tablets every
Breast cancer has been observed slightly more often in women
using combined pills, but it is not known whether this is caused by day. For the correct order, follow the direction of the arrows on
the blister.
the treatment. For example it may be that more tumours are
detected in women on combined pills because they are examined
by their doctor more often. The occurrence of breast tumours
becomes gradually less after stopping the combination hormonal
contraceptives. It is important to regularly check your breasts and
you should contact your doctor if you feel any lump.
In rare cases, benign liver tumours, and in even fewer cases
malignant liver tumours have been reported in contraceptive pill
users. Contact your doctor if you have unusual severe abdominal
pain.

Preparation of the pack
To help you keep track, there are 7 weekday sticker strips
marked with the 7 days of the week. Choose the week sticker
that starts with the day you begin taking the tablets. For
example, if you start on a Wednesday, use the week sticker that
starts with “WED”.
Stick the week sticker along the top of the Seasonique pack
where it reads “Place week sticker here”, so that the first day is
above the tablet marked “1”.

There is now a day indicated above every tablet and you can
see whether you have taken a certain pill. The arrows show the
order you are to take the pills.
Usually, so-called withdrawal bleeding starts when you are
taking white tablets.
Once you have taken the last white tablet, you should start with
the following Seasonique pack, whether your bleeding has
stopped or not. This means that you should start every pack on
the same day of the week, and that the withdrawal bleed should
occur on the same days each time.

In any case use additional contraceptive precautions for the
following 7 days e.g. a barrier method such as a condom. If you
have had sex in the week before forgetting tablets you may be
pregnant. So contact your doctor immediately.
Days 8-84
If two pink tablets are missed, take two tablets as soon as you
remember and additional two on the next day. Continue taking the
following tablets at the usual time. Use additional contraceptive
precautions for the following 7 days e.g. a barrier method such as
a condom.

If you use Seasonique in this manner, you are protected against
If 3 or more pink tablets are missed, do not take the forgotten
pregnancy during the whole 91 days.
tablets and continue taking the following tablets at the usual time.
You may experience bleeding during the week following the
When can you start with the first strip?
missed tablets. Use additional contraceptive precautions for the
• If you have not used a contraceptive with hormones in the
following 7 days e.g. a barrier method such as a condom. If you
previous month:
have had sex during the days of missed tablets you may be
Begin with Seasonique on the first day of the cycle (that is the
pregnant. So contact your doctor immediately.
first day of your menstruation).
You may also begin on day 2-5 of the cycle, but then you must Contact your doctor for further advice.
use extra protective measures (for example, a condom) for the
Chart: if you are more than 12 hours late taking pink tablets
first 7 days.
Ask your doctor for advice.
• Changing from a combined hormonal contraceptive, or
YES
combined contraceptive vaginal ring or patch:
Had sex in the previous week
You can start Seasonique preferably on the day after the last
Day 1-7
before forgetting?
active tablet (the last tablet containing the active substances) of
your previous pill, but at the latest on the day after the
NO
tablet-free days of your previous pill finish (or after the last
Take the forgotten tablet and
Only 1 pink tablet
inactive tablet of your previous pill). When changing from a
continue taking the tablets as
combined contraceptive vaginal ring or patch, follow the advice forgotten (taken
usual. Use a barrier method
more than
of your doctor.
(condom) for the following
12 hours late)
7 days
• Changing from a progestogen-only-method
(progestogen-only pill, injection, implant or a
Take the forgotten tablet and
progestogen-releasing IUD):
continue taking the tablets as
Day 8-84
You may switch any day from the progestogen-only pill (from
usual. No additional
an implant or the IUD on the day of its removal, from an
contraception necessary.
injectable when the next injection would be due).
In all of these cases you must use extra protective measures
Ask your doctor for advice.
(for example, a condom) for the first 7 days of tablet-taking.
YES
• After a miscarriage:
Had sex in the previous week
Days 1-7
Follow the advice of your doctor.
before forgetting?
NO
• After having a baby:
2 pink tablets
Take
two
tablets
as soon as
After having a baby, you can start Seasonique between 21 and
forgotten
you remember and additional
28 days later. If you start later than day 28, you must use a
two on the next day. Continue
so-called barrier method (for example, a condom) during the
Days 8-84
taking the following tablets
first 7 days of Seasonique use. If, after having a baby, you have
as usual. Use a barrier
had intercourse before starting Seasonique (again), you must
method (condom) for the
first be sure that you are not pregnant or you must wait until
following 7 days
the next menstrual bleed.
• If you are breast-feeding and want to start Seasonique
(again) after having a baby:
Read the section on “Breast-feeding”.

Days 1-7

If you are not sure when to start, check with your doctor.
If you take more Seasonique than you should
There are no reports of serious harmful results of taking too
many Seasonique tablets.
If you take several tablets at once then you may have
symptoms of nausea or vomiting. Young girls may have
bleeding from the vagina.
If you have taken too many Seasonique tablets, or you discover
that a child has taken some, ask your doctor or pharmacist for
advice.

3 or more pink
tablets forgotten

If you forget to take Seasonique
White tablets: If you forget any of the white tablets (last 7
tablets in the pack), this has no effect on the reliability of
Seasonique. Do not take the forgotten white tablet(s) and
continue with the next tablet at the usual time.

Days 8-84

Pink tablets: If you miss a pink tablet, depending on the day of
the cycle on which the tablet has been missed, you may need to
take additional contraceptive precautions, for example a barrier
method such as a condom.
Take the pink tablets according to the following principles:
• If you are less than 12 hours late when taking a tablet, the
protection against pregnancy is not reduced. Take the tablet
as soon as you remember and then continue taking the
tablets again at the usual time.
• If you are more than 12 hours late taking a tablet, the
protection against pregnancy may be reduced. The greater
the number of tablets you have forgotten the greater is the
risk of becoming pregnant. There is a particularly high risk of
becoming pregnant if you miss pink tablets at the beginning
of the pack. Therefore you should follow the rules given below.
One pink tablet forgotten
One pink tablet forgotten between days 1-7
Take the tablet as soon as you remember even if this means
taking two tablets at the same time. Continue taking the
following tablets at the usual time. Use additional contraceptive
precautions for the following 7 days e.g. a barrier method such
as a condom. If you have had sex in the week before forgetting
the tablet you may be pregnant. So contact your doctor
immediately.
One pink tablet forgotten between days 8-84
Take the tablet as soon as you remember even if this means
taking two tablets at the same time. Continue taking the
following tablets at the usual time. The protection against
pregnancy is not reduced and you do not need to take extra
contraceptive precautions.
More than one pink tablet forgotten in this pack
Days 1-7
If two pink tablets are missed, take two tablets as soon as you
remember and additional two on the next day. Continue taking
the following tablets at the usual time.
If 3 or more pink tablets are missed, do not take the forgotten
tablets and continue taking the following tablets at the usual
time. You may experience bleeding during the week following
the missed tablets.

Ask your doctor for advice.
YES
Had sex in the previous week
before forgetting?
NO
Do not take the forgotten
tablets and continue taking
the following tablets as
usual. Use a barrier method
(condom) for the following
7 days.
Ask your doctor for advice.
YES
Had sex in the days of
missed tablets?
NO
Do not take the forgotten
tablets and continue taking
the following tablets as
usual. Use a barrier method
(condom) for the following
7 days.

If you have forgotten any of the pink tablets, and you have no
bleeding during the week 13, you may be pregnant. Contact your
doctor before you start the next pack.
What you must do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking a tablet or you have severe
diarrhoea, there is a risk that the active substances in the pill are
not fully absorbed into your body. The situation is similar to if you
forget a tablet. After vomiting or diarrhoea, you must take another
tablet as soon as possible. The advice given under “If you forget to
take Seasonique” should be followed.
If you don’t want to change your normal tablet-taking pattern take
the extra pink tablet from the last row in the pack.

Uncommon: may affect up to 1 in 100 people
• fungal infection, fungal and bacterial vaginal infection
(including candidiasis), bladder infection, gastroenteritis,
throat and sinus infection
• fibrocystic breast disorder, uterine fibroids
• anaemia
• increased appetite, anorexia, decreased appetite, diabetes
mellitus, resistance to insulin
• irritability, anxiety, depressed mood, emotional distress,
difficulty sleeping, orgasm abnormal, paranoia
• dizziness, skin feeling more sensitive, problems with skin
sensations
• vertigo
• irregular heart beat, fast heart beat
• hot flushes, high blood pressure, low blood pressure when
standing up
• sinus congestion
• vomiting, indigestion, diarrhoea, constipation
• inflammation of the gallbladder, gallstones
• rash, changes in hair growth and texture, unusual hair loss or
thinning, nail disorder, night sweats, skin sensitivity to light,
skin hyperpigmentation
• peripheral swelling, back pain, muscle cramps, pain in joints,
joint stiffness, muscle pain, neck pain
• vulvovaginal dryness, spasm of uterus, breast pain, irregular
periods, breast swelling, breast enlargement, painful
intercourse, bleeding following intercourse, vaginal
discharge, breast discharge, genital itching, genital rash,
pelvic pain, polycystic ovaries, vulvar disorder, vulvovaginal
discomfort
• feeling tired, swelling of parts of your body, pain, chest pain,
feeling hot, feeling unwell, increased body temperature
• blood pressure increased, increase in blood fats
• weight loss.
Not known: frequency cannot be estimated from the available
data
• hypersensitivity reaction (allergic reaction)
• loss of consciousness
• blood clot in a blood vessel of the leg (thrombosis), of the
lung (pulmonary embolism) or other organs
• baldness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. 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 SEASONIQUE

Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from light and
moisture.
Do not use this medicine after the expiry date that is stated on
the outer packaging. The expiry date refers to the last day of
that month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Seasonique contains
Active substances:
One pink film-coated tablet contains 150 micrograms
levonorgestrel and 30 micrograms ethinylestradiol.
One white film-coated tablet contains 10 micrograms
ethinylestradiol.
Other ingredients (excipients) in the pink tablet:
Tablet core: Anhydrous lactose, Hypromellose, Microcrystalline
Cellulose, Magnesium Stearate.
Tablet coating: Hypromellose, Titanium Dioxide (E171),
Macrogol 400, Allura Red AC Aluminium Lake (E129),
Polysorbate 80, Brilliant Blue FCF Aluminium Lake (E133).
Other ingredients (excipients) in the white tablet:
Tablet core: Anhydrous lactose, Polacrilin Potassium,
Microcrystalline Cellulose, Magnesium Stearate
Tablet coating: Titanium Dioxide (E171), Polydextrose FCC,
Hypromellose, Triacetin, Macrogol 8000.
What Seasonique looks like and contents of the pack
Seasonique pack contains 3 blisters in total: 2 blisters each
holding 28 pink tablets and 1 blister holding 35 tablets in total28 pink tablets and 7 white tablets.
Three blisters are placed inside a carton folder, placed into foil
pouch and box with leaflet.

If you want to stop taking Seasonique
You can stop taking Seasonique whenever you want. If you do not
want to become pregnant, ask your doctor for advice about other The pink tablet is round, biconvex tablet, around 5.7 mm in
diameter, embossed “172” on one side and “T” on the other
reliable methods of birth control.
side.
If you have any further questions on the use of this product, ask
The white tablet is round, biconvex tablet, around 5.7 mm in
your doctor, midwife or pharmacist.
diameter, embossed “173” on one side and “T” on the other
side.

4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side-effects although
not everybody gets them.
Very common: may affect more than 1 in 10 people
• bleeding between your periods.

Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Teva Operations Poland Sp. z.o.o, ul. Mogilska 80., Krakow,
31-546, Poland

This leaflet was last revised in 10/2015
Common: may affect up to 1 in 10 people
• mood change, decreased interest in sex, depression
PL 00289/1900
• headache, migraine
• nausea, stomach ache
• acne
• heavy prolonged menstrual bleeding, breast tenderness, painful
periods
• weight increased.

20606-A

160 x 320

Expand view ⇕

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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