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

Active substance(s): ETHINYLESTRADIOL / LEVONORGESTREL

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TEVA UK Ref:

231-30-20606-B LEA SEASONIQUE 0.1-0.03/0.15MG FC TABS TUK Dimensions:
Length:
Width:
Depth:

408 mm
406 mm
-

Colours Used:

SEASONIQUE® 150 micrograms/30 micrograms AND immediately. Your doctor will discuss with you what other form
of birth control would be more appropriate.
10 micrograms FILM-COATED TABLETS
levonorgestrel/ethinylestradiol
ethinylestradiol

Do not take Seasonique

• 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
▼This medicine is subject to additional monitoring. This will
• if you know you have a disorder affecting your blood clotting –
allow quick identification of new safety information. You can help
for instance, protein C deficiency, protein S deficiency,
by reporting any side effects you may get. See the end of section
antithrombin-III deficiency, Factor V Leiden or antiphospholipid
4 for how to report side effects.
antibodies; if you need an operation or if you are off your feet
for a long time (see section ‘Blood clots’)
Read all of this leaflet carefully before you start taking this
• if you have ever had a heart attack or stroke
medicine because it contains important information for you.
• if you have (or have ever had) angina pectoris (a condition
• Keep this leaflet. You may need to read it again.
that causes severe chest pain and may be a first sign of a heart
• If you have any further questions, ask your doctor or pharmacist.
attack or transient ischaemic attack (TIA – temporary stroke
• This medicine has been prescribed for you only. Do not pass it
symptoms)
on to others. It may harm them, even if their signs of illness
• if you have any of the following diseases that may increase
are the same as yours.
your risk of a clot in the arteries:
• If you get any side effects, talk to your doctor or pharmacist.
• severe diabetes with blood vessel damage
This includes any possible side effects not listed in this leaflet.
• very high blood pressure
See section 4.
• a very high level of fat in the blood (cholesterol or
Important things to know about combined hormonal
triglycerides)
contraceptives (CHCs):
• a condition known as hyperhomocysteinaemia
• They are one of the most reliable reversible methods of
• if you have (or have ever had) a type of migraine called
contraception if used correctly.
‘migraine with aura’
• They slightly increase the risk of having a blood clot in the
• if you have (had) an inflammation of the pancreas
veins and arteries, especially in the first year or when
(pancreatitis)
restarting a combined hormonal contraceptive following a
• if you have or have had in the past a liver disease and your
break of 4 or more weeks.
liver function is still not normal
• Please be alert and see your doctor if you think you may have • if you have or have had a tumour in the liver
symptoms of a blood clot (see section 2 “Blood clots”).
• if you have (had) or if you are suspected of having breast
cancer or cancer of the genital organs
What is in this leaflet
• if you have any unexplained bleeding from the vagina
• if you are taking the herbal product St. John's Wort
1. What Seasonique is and what it is used for
• if you are allergic to ethinylestradiol or levonorgestrel, or any
2. What you need to know before you take Seasonique
of the other ingredients of this medicine (listed in section 6).
3. How to take Seasonique
This can be recognised by itching, rash or swelling.
4. Possible side effects
5. How to store Seasonique
Warnings and precautions
6. Contents of the pack and other information
When to take special care with Seasonique
PACKAGE LEAFLET: INFORMATION FOR THE USER

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Version:

7

05 February 2016

PANTONE® GREEN C
BLACK

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 Seasonique 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 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.

Deep vein
thrombosis.

• sudden unexplained breathlessness or
rapid breathing
• 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.

Pulmonary
embolism.

Each of the 84 pink tablets contains a small amount of two
different female hormones, namely levonorgestrel and
ethinylestradiol.

• 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 clot’
(thrombosis) section below).

Symptoms most commonly occur in one
eye:
• immediate loss of vision or
• painless blurring of vision which can
progress to loss of vision.

The 7 white tablets contain a small amount of female hormone
ethinylestradiol.

For a description of the symptoms of these serious side effects
please go to “How to recognise a blood clot”.

Heart attack.
• 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.

Seasonique is an extended-regimen contraceptive pill taken
continuously for 91 days and is used to prevent pregnancy.

2

What you need to know before you take Seasonique

General notes
Before you start using Seasonique 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”).
Before you can begin taking Seasonique, your doctor will ask
you some questions about your personal health history and
that of your close relatives. The doctor will also measure your
blood pressure and depending upon your personal situation,
may also carry out some other tests.
In this leaflet, several situations are described where you
should stop using Seasonique, or where the reliability of
Seasonique may be decreased. In such situations you should
either not have sex or you should take additional
non-hormonal contraceptive precautions, e.g. use a condom or
another barrier method. Do not use rhythm or temperature
methods. These methods can be unreliable because
Seasonique alters the monthly changes of body temperature
and cervical mucus.

When should you contact your doctor?

Tell your doctor if any of the following conditions apply to you.
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 gets worse while
you are using Seasonique, you should also tell your doctor:










Seasonique, like other hormonal contraceptives, does not
protect against HIV infection (AIDS) or any other sexually
transmitted disease.
When you should not use Seasonique



You should not use Seasonique if you have any of the conditions •
listed below. Should any of the conditions appear for the first
time during use of Seasonique, you must tell 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 (chronic
inflammatory bowel disease)
if you have systemic lupus erythematosus (SLE - a disease
affecting your natural defence 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 taking Seasonique
if you have an inflammation in the veins under the skin
(superficial thrombophlebitis)
if you have varicose veins
if you have epilepsy (see “Other medicines and Seasonique”)
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”).

• sudden weakness or numbness of the
face, arm or leg, especially on one side
of the body
• sudden confusion, trouble speaking or
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.

Retinal vein
thrombosis (blood
clot in the eye).

Stroke.

Women who are not using a
combined hormonal pill and are not
pregnant

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 Seasonique

Not yet known

• if you are very overweight (body mass index or BMI over 30kg/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 Seasonique may need to be stopped
several weeks before surgery or while you are less mobile. If
you need to stop Seasonique 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
Seasonique needs to be stopped.
If any of the above conditions change while you are using
Seasonique, 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 Seasonique is very small but can increase:

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).

• 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.
• It is not yet known how the risk of a blood clot with
Seasonique compares to the risk with other
levonorgestrel-containing CHCs.
• 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).
Risk of developing a
blood clot in a year

The risk of a blood clot with Seasonique is small but some
conditions will increase the risk. Your risk is higher:

Seek urgent medical attention:

What Seasonique is and what it is used for

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
Seasonique is small.

Factors that increase your risk of a blood clot in a vein

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’).

1

What is the risk of developing a blood clot?

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).

• with increasing age (beyond about 35 years)
• if you smoke. When using a combined hormonal contraceptive
like Seasonique 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 then 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
Seasonique, 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.

Seasonique and cancer
Breast cancer has been observed 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 more tumours are
detected in women on combined pills because they are
When is the risk of developing a blood clot in a vein highest?
examined by their doctor more often. The occurrence of breast
The risk of developing a blood clot in a vein is highest during the tumours becomes gradually less after stopping the combination
first year of taking a combined hormonal contraceptive for the
hormonal contraceptives. It is important to regularly check your
first time. The risk may also be higher if you restart taking a
breasts and you should contact your doctor if you feel any lump.

combined hormonal contraceptive (the same product or a
In rare cases, benign liver tumours, and in even fewer cases
different product) after a break of 4 weeks or more
malignant liver tumours have been reported in contraceptive pill
Blood clots
After the first year, the risk gets smaller but is always slightly
users. Contact your doctor if you have unusual severe
higher than if you were not using a combined hormonal
Using a combined hormonal contraceptive such as Seasonique
abdominal pain.
contraceptive.
increases your risk of developing a blood clot compared with not
When you stop Seasonique your risk of a blood clot returns to
Bleeding between periods
using one. In rare cases a blood clot can block blood vessels and
normal within a few weeks.
When you take Seasonique, which has a 91-day extended dosing
cause serious problems.
cycle, you should expect to have 4 scheduled periods per year

TEVA UK Ref:

231-30-20606-B LEA SEASONIQUE 0.1-0.03/0.15MG FC TABS TUK Dimensions:
Length:
Width:
Depth:

(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. 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, topiramate, felbamate)
• tuberculosis (e.g. rifampicin)
• HIV infections (ritonavir, nevirapine) or other infections (an
antibiotic named griseofulvin)
• high blood pressure in the blood vessels in the lungs (bosentan)
• cancer (vemurafenib).
The herbal product St. John's Wort may also stop Seasonique
from working properly.
Seasonique may influence the effect of other medicines, e.g.:
• the anti-epileptic lamotrigine (this could lead to an increased
frequency of seizures).
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff
that you are taking Seasonique, because oral contraceptives can
affect the results of some tests.
Pregnancy and breast-feeding
If you are pregnant, you must not take Seasonique. If you
become pregnant while taking Seasonique you must stop
immediately and contact your doctor.
Use of Seasonique is generally not advisable when a woman is
breast-feeding as it may decrease quantity of breast milk and
change its composition. If you want to take contraceptive pills
while you are breast-feeding you should contact your doctor.
Driving and using machines
There is no information suggesting that use of Seasonique
affects driving or use of machines.

408 mm
406 mm
-

Colours Used:

If you use Seasonique in this manner, you are protected against
pregnancy during the whole 91 days.

How to take Seasonique

Chart: if you are more than 12 hours late taking pink tablets

Day 1-7

You may also begin on day 2-5 of the cycle, but then you must
use additional contraceptive precautions (for example, a
condom) for the first 7 days of tablet taking.
• Changing from a combined hormonal contraceptive, or
combined contraceptive vaginal ring or patch:
You can start Seasonique preferably on the day after the last
active tablet (the last tablet containing the active substances) of
your previous pill. When changing from a combined
contraceptive vaginal ring or patch, follow the advice of your
doctor.
Pink tablet(s)
forgotten (taken
more than 12
hours late)

Day 8-77

Day 78-84

If you are not sure when to start, check with your doctor.

Take the pink tablets according to the following principles:

Pink tablet(s) forgotten between days 1-7
Take the last missed tablet as soon as you remember even if this
Each pack contains 84 pink tablets and 7 white tablets placed in 3 means taking two tablets at the same time. Continue taking the
following tablets at the usual time. Use additional contraceptive
blisters in a pack.
precautions for the following 7 days e.g. a barrier method such
How to take the tablets
as a condom. If you have had sex in the week before forgetting
Take one tablet of Seasonique every day, if necessary with a
the tablet you may be pregnant. So contact your doctor
small amount of water. You should take the tablets every day
immediately.
around the same time.
Pink tablet(s) forgotten between days 8-77
Which tablets to take
Take the tablet as soon as you remember even if this means
Do not confuse the tablets: take a pink tablet for the first 84 days taking two tablets at the same time. Continue taking the
and then a white tablet for the last 7 days.
following tablets at the usual time. If you have taken your tablets
A new pack is started straightaway (84 pink and then 7 white
correctly in the 7 days preceding the first missed tablet, the
tablets). There is therefore no gap between two packs.
protection against pregnancy is not reduced and you do not
Because of the different composition of the tablets it is necessary need to take additional contraceptive precautions. However, if
to begin with the first tablet on the upper left corner of the first
this is not the case or if you have missed more than one tablet,
blister in the pack and that you take the tablets every day. For the use additional contraceptive precautions for the following 7 days
correct order, follow the direction of the arrows on the blister.
e.g. a barrier method such as a condom.
Preparation of the pack
Pink tablet(s) forgotten between days 78-84
To help you keep track, there are 7 weekday sticker strips marked There is a particularly high risk of becoming pregnant if you miss
with the 7 days of the week. Choose the week sticker that starts
the pink tablets close to the white tablet phase. By adjusting your
with the day you begin taking the tablets. For example, if you
tablet-intake schedule this higher risk can be prevented.
start on a Wednesday, use the week sticker that starts with “WED”. Take the last tablet as soon as you remember even if this means
Stick the week sticker along the top of the Seasonique pack
taking two tablets at the same time. Continue taking the
where it reads “Place week sticker here”, so that the first day is
following tablets at the usual time. If you have taken your tablets
above the tablet marked “1”.
correctly in the 7 days preceding the first missed tablet, the
There is now a day indicated above every tablet and you can see protection against pregnancy is not reduced and you do not
whether you have taken a certain pill. The arrows show the order need to take additional contraceptive precautions. However, if
you are to take the pills.
this is not the case stop taking the pink tablets and take white
Usually, so-called withdrawal bleeding starts when you are
tablets minus the number of tablets you have missed. Use
taking white tablets.
additional contraceptive precautions for the following 7 days e.g.
Once you have taken the last white tablet, you should start with a barrier method such as a condom.
the following Seasonique pack, whether your bleeding has
You can then start a new cycle of Seasonique.
stopped or not. This means that you should start every pack on
the same day of the week, and that the withdrawal bleed should Contact your doctor for further advice.
occur on the same days each time.

YES
Tablets taken correctly in the
7 days preceding the first
missed tablet?
NO
• Stop taking pink tablets.
Take white tablets minus
the number of tablets
missed. Use a barrier
method (condom) for the
following 7 days.
• Then start a new cycle of
Seasonique

• If you are breast-feeding and want to start Seasonique (again)
after having a baby:
Read the section on “Pregnancy and breast-feeding”.

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.

If you have forgotten more
than one tablet or you have
not taken the tablets
correctly in the preceding 7
days use a barrier method
(condom) for the following 7
days
Take the last forgotten tablet
and continue taking the
tablets as usual. No additional
contraception necessary.

• After having a baby:
After having a baby, you can start Seasonique between 21 and 28
days later. If you start later than day 28, you must use additional
contraceptive precautions (for example, a condom) during the
first 7 days of Seasonique use. If, after having a baby, you have
had intercourse before starting Seasonique (again), you must
first be sure that you are not pregnant or you must wait until the
next menstrual bleed.

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.

Ask your doctor for advice.
YES
Had sex in the previous
week before forgetting?
NO
• Take the last forgotten
tablet and continue taking
the tablets as usual.
• Use a barrier method
(condom) for the following
7 days
• Finish strip
Take the forgotten tablet and
continue taking the tablets
as usual. No additional
contraception necessary.

• After a miscarriage or abortion:
Follow the advice of 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.

05 February 2016

BLACK

• If you have not used a contraceptive with hormones in the
previous month:
Begin with Seasonique on the first day of the cycle (that is the
first day of your menstruation).

• Changing from a progestogen-only-method (progestogen-only
pill, injection, implant or a progestogen-releasing IUD):
You may switch any day from the progestogen-only pill (from an
implant or the IUD on the day of its removal, from an injectable
when the next injection would be due).
In all of these cases you must use additional contraceptive
precautions (for example, a condom) for the first 7 days of tablet
taking.

7

PANTONE® GREEN C

When can you start with the first strip?

• If you are less than 12 hours late when taking a tablet, the
Seasonique contains lactose
protection against pregnancy is not reduced. Take the tablet as
Seasonique contains lactose. If you have been told by your
soon as you remember and then continue taking the tablets
doctor that you have an intolerance to some sugars, contact your
again at the usual time.
doctor before taking this medicinal product.
• If you are more than 12 hours late taking a tablet, the
Seasonique contains allura red AC (E129) and brilliant blue FCF
protection against pregnancy may be reduced. The greater the
(E133)
number of tablets you have forgotten the greater is the risk of
Seasonique pink tablets contain a red colour called allura red AC
becoming pregnant. There is a particularly high risk of
(E129) and a blue colour called brilliant blue FCF (E133), which
becoming pregnant if you miss pink tablets at the beginning of
may cause allergic reactions.
the pack. Therefore you should follow the rules given below.

3

Template

Version:

If you have forgotten any of the pink tablets, and you have no
bleeding during 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.
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 reliable methods of birth control.
If you have any further questions on the use of this product, ask
your doctor, midwife or pharmacist.

4

Possible side effects

Like all medicines, Seasonique can cause side-effects although
not everybody gets them.
If you get any side effect, particularly if severe and persistent, or
have any change to your health that you think may be due to
Seasonique, 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 Seasonique”.
Serious side effects – see a doctor straight away:
• hypersensitivity reaction (allergic reaction) - signs include
swelling of the face, lips, mouth, tongue or throat; a red bumpy
rash (hives) and itching
• blood clot in a blood vessel of the leg (thrombosis), of the lung
(pulmonary embolism) or other organs. For signs of a blood
clot (see section 2 ‘Blood clots’).
If you think you may have any of these, see a doctor straight
away. You may need to stop taking Seasonique.
Very common: may affect more than 1 in 10 people
• bleeding between your periods.
Common: may affect up to 1 in 10 people
• mood change, decreased interest in sex, depression
• headache, migraine
• nausea, stomach ache
• acne
• heavy prolonged menstrual bleeding, breast tenderness,
painful periods
• weight increased.
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 (benign tumour)
occurrence or aggravation
• anaemia

• increased appetite, anorexia, decreased appetite, diabetes
mellitus, resistance to insulin
• irritability, anxiety, depressed mood, worsening of depression
emotional distress, difficulty sleeping, abnormal orgasm,
paranoia
• dizziness, skin feeling more sensitive, absent or reduced
sensitivity to skin stimulation
• vertigo
• irregular heartbeat, fast heartbeat
• hot flushes, high blood pressure, worsening of 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, flu-like symptoms, feeling unwell, fever
• blood pressure increased, increase in blood fats
• weight loss.
Rare: may affect up to 1 in 1,000 people
• Harmful blood clots in a vein or artery for example:
• in a leg or foot (i.e. DVT)
• in a lung (i.e. PE)
• heart attack
• stroke
• mini-stroke or temporary stroke-like symptoms, known as a
transient ischaemic attack (TIA)
• 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).
Not known: frequency cannot be estimated from the available
data
• hypersensitivity reaction (allergic reaction)
• loss of consciousness
• baldness
• pains in arms or legs.
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 carton, foil pouch, blister pack holder and blister after
EXP. 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 total- 28
pink tablets and 7 white tablets.
Three blisters are placed inside a carton folder, placed into foil
pouch and box with leaflet.
The pink tablet is round, biconvex tablet, around 5.7 mm in
diameter, embossed “172” on one side and “T” on the other side.
The white tablet is round, biconvex tablet, around 5.7 mm in
diameter, embossed “173” on one side and “T” on the other side.
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 02/2016
PL 00289/1900
20606-B

408 x 406

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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