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CILIQUE 250/35 MICROGRAM TABLETS

Active substance(s): ETHINYLESTRADIOL / NORGESTIMATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CILIQUE®

250/35 microgram tablets
norgestimate and ethinylestradiol

Important things to know about the Pill (combined
hormonal contraceptives).
• The Pill is one of the most reliable reversible methods of
contraception if used correctly.
• This medicine slightly increases your risk of having a blood
clot in the veins and arteries (especially in the first year or
when restarting the Pill after 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 2.3 ‘The Pill and blood
clots’, ‘How to recognise a blood clot’).
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 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.
What is in this leaflet
1. What Cilique is and what it is used for
2. What you need to know before you take Cilique
3. How to take Cilique
3.3 A missed pill
4. Possible side effects
5. How to store Cilique
6. Contents of the pack and other information

1. WHAT CILIQUE IS AND WHAT IT IS
USED FOR
Cilique is a combined hormonal contraceptive pill (‘the Pill’).
You take it to stop getting pregnant.
This contraceptive contains two types of female sex hormones,
oestrogen and progestogen. These hormones prevent an egg
being released from your ovaries so you can’t get pregnant.
Also, Cilique makes the fluid (mucus) in your cervix thicker
which makes it more difficult for sperm to enter the womb.
Cilique is a 21-day Pill - you take one each day for 21 days,
followed by 7 days when you take no pills.
The benefits of taking the Pill include:
• it is one of the most reliable reversible methods of
contraception if used correctly
• it doesn’t interrupt sex
• it usually makes your periods regular, lighter and less painful
• it may help with pre-menstrual symptoms.
Cilique will not protect you against sexually transmitted
infections, such as Chlamydia or HIV. Only condoms can help
to do this. Cilique needs to be taken as directed to prevent
pregnancy.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CILIQUE
General notes
Before you start using Cilique you should read the information
on blood clots in section 2.3. It is particularly important to read
the symptoms of a blood clot - see Section 2.3 ‘The Pill and
blood clots’.
It’s important that you understand the benefits and risks of taking
the Pill before you start taking it, or when deciding whether to
carry on taking it. Although the Pill is suitable for most healthy
women it isn’t suitable for everyone.
Tell your doctor if you have any of the illnesses or risk factors
mentioned in this leaflet.

Before you start taking the Pill
• Your doctor will ask about you and your family’s medical
problems and check your blood pressure. You may also need
other checks, such as a breast examination but only if these are
necessary for you or you have any special concerns.
While you’re on the Pill
• You will need regular check-ups with your doctor or family
planning nurse, usually when you need another prescription of
the Pill.
• You should go for regular cervical smear tests.
• Check your breasts and nipples every month for changes - tell
your doctor if you can see or feel anything odd, such as lumps
or dimpling of the skin.
• If you need a blood test tell your doctor that you are taking
the Pill, because the Pill can affect the results of some tests.
• If you’re going to have an operation, make sure your doctor
knows about it. You may need to stop taking the Pill about
4-6 weeks before the operation. This is to reduce the risk of a
blood clot (see section 2.3). Your doctor will tell you when
you can start taking the Pill again.

2.1 When you should not use Cilique
You should not use Cilique 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.
Do not take Cilique if any of the following applies to you:
• If you have (or have ever had) a blood clot in a blood vessel
of your legs (deep vein thrombosis, DVT), your lungs
(pulmonary embolism, 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 2.3 ‘The Pill and blood clots’)
• If you have ever had a heart attack or stroke
• If you have (or have ever had) angina pectoris (a condition
that causes severe chest pain which 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
– very high level of fat in the blood (cholesterol or
triglycerides)
– a condition called hyperhomocysteinaemia
• If you have (or have ever had) a type of migraine called
‘migraine with aura’
• If you have breast or liver cancer
• If you have or have recently had a severe liver disease
• If you are allergic (hypersensitive) to any of the ingredients
in Cilique.
• If you have vaginal bleeding that has not been explained by
your doctor.
If you suffer from any of these, or get them for the first time
while taking Cilique, contact your doctor as soon as possible.
Do not take Cilique as it may put your health at risk.

2.2 When to take special care with Cilique

a blood clot in the lung (pulmonary embolism), a heart attack
or a stroke (see Section 2.3 ‘The Pill and blood clots’).
For a description of the symptoms of these serious side effects
please go to “How to recognise a blood clot”.
Tell your doctor if any of the following conditions applies
to you
If the condition develops, or gets worse while you are using
Cilique, you must also tell your doctor. You may still be able to
take Cilique but you need to take special care and have checkups more often:
• If you have problems with your heart, circulation or blood
clotting, such as high blood pressure
• If you have diabetes without secondary problems
• If you have liver problems or gall bladder disease
• 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 porphyria
• If you have a history of migraines
• 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 Section 2.3 ‘The Pill and blood clots’)
• If you have had any of the following problems while
pregnant or during previous Pill use, such as itchy skin or
blister-like rash, yellowing of skin or eyes, hearing problem,
systemic lupus erythematosus (SLE), severe headaches,
uncontrollable jerky movements
• 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 Cilique
• 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 varicose veins
• If you have inflammation in the veins under the skin
(superficial thrombophlebitis).
Tell your doctor or family planning nurse if any of these
applies to you. Also tell them if you get any of these for the
first time while taking the Pill, or if any get worse or come
back, because you may need to stop taking Cilique and use
another method of contraception, such as condoms.
Other conditions
Chloasma (yellow-brownish patches on your skin, pigment
spots during pregnancy, especially on your face) occasionally
occur, especially if you have had a history of it. You may need
to keep out of the sun or away from sunbeds (these patches may
not completely disappear again).

2.3. The Pill and blood clots
Using a Pill such as Cilique 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 an ‘venous thrombosis’, ‘venous
thromboembolism’ or VTE)
• in the arteries (referred to as a ‘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 caused by Cilique is small.

How to recognise a blood clot
When should you contact your doctor?
Seek urgent medical attention if you notice any of the following
Seek urgent medical attention
signs or symptoms.
• if you notice possible signs of a blood clot that may mean you
are suffering from a blood clot in the leg (deep vein thrombosis),

Do you have any of these signs?

What could
you be
suffering from?

• swelling of one leg or along a vein
in the leg or foot especially with:
- 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 such as turning pale, red or blue.

Deep vein
thrombosis
(DVT) (blood
clot in the large
vein of the leg)

• 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
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’).

Pulmonary
embolism (PE)
(blood clot in
the lungs)

symptoms most commonly in one eye:
• immediate loss of vision or
• painless blurring of vision which can
become a loss of vision.

Retinal vein
thrombosis
(blood clot
in the eye)

• chest pain or discomfort, pressure,
• heaviness
• sensation of squeezing or fullness in
the chest, arm or below the breastbone
• fullness, indigestion or choking feeling
• upper body discomfort spreading out to
the back, jaw, throat, arm and stomach
• sweating, nausea, vomiting or dizziness
• extreme weakness, anxiety, or
shortness of breath
• rapid or irregular heartbeats.

Heart attack

• 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.

Stroke
(blood clot in
the brain)

Sometimes the symptoms of a 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 such as hands and feet
• 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 the Pill for the first time. The risk may
also be higher if you restart taking the Pill (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 the Pill. When you stop using
Cilique, 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
Pill you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE)
with Cilique 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 taking a Pill containing levonorgestrel
or norethisterone, or norgestimate such as Cilique, about 5-7
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).
Risk of developing
a blood clot in
a year
Women who are not using a
combined hormonal Pill/patch/ring
and are not pregnant

About 2 out of
10,000 women

Women using a Pill containing
levonorgestrel, norethisterone or
norgestimate

About 5-7 out of
10,000 women

Women using Cilique

About 5-7 out of
10,000 women

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Cilique 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 (such as, below the age
of about 50 years old). 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 Cilique may need to be stopped
for several weeks before surgery or while you are less mobile.
If you need to stop Cilique 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 (for longer than 4 hours) may temporarily increase
your risk of a blood clot, particularly if you have some of the
other risk factors listed.
It is important to tell your doctor if any of these risk factors
apply to you, even if you are unsure. Your doctor may decide
that Cilique needs to be stopped.
If any of the above conditions change while you are using
Cilique, for example a close family member has 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 Cilique is very small but can increase:
• with increasing age (particularly above about 35 years old)
• if you smoke. When using a Pill like Cilique 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 has 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.
Tell your doctor if any of these risk factors applies to you. If
any of the above conditions change while you are using Cilique,
for example you start smoking, a close family member has a
thrombosis for no known reason, or you gain a lot of weight, tell
your doctor. Taking the Pill may add to these risks so Cilique
may not be suitable for you.

2.4 The Pill and cancer
The Pill reduces your risk of cancer of the ovary and womb if
used for a long time. However, it also seems to slightly increase
your risk of cancer of the cervix - although this may be due to
having sex without a condom, rather than the Pill. All women
should have regular smear tests.
If you have breast cancer, or have had it in the past, you should
not take the Pill. The Pill slightly increases your risk of breast
cancer. This risk goes up the longer you’re on the Pill, but
returns to normal within about 10 years of stopping it. Because
breast cancer is rare in women under the age of 40, the extra
cases of breast cancer in current and recent Pill users are small.

Your risk of breast cancer is higher:
• as you get older
• if you have a close relative (mother, sister or grandmother)
who has had breast cancer
• if you are seriously overweight.
See a doctor as soon as possible if you notice any changes in
your breasts, such as dimpling of the skin, changes in the
nipple or any lumps you can see or feel.
Taking the Pill has also been linked to liver diseases, such as
jaundice and non-cancer liver tumours, but this is rare. Very
rarely, the Pill has also been linked with some forms of liver
cancer in women who have taken it for a long time.
See a doctor as soon as possible if you get severe pain in
your stomach, or yellow skin or eyes (jaundice). You may
need to stop taking Cilique.

2.5 Other medicines and Cilique
If you ever need to take another medicine at the same time as
being on the Pill, always tell your doctor, pharmacist or dentist
that you’re taking Cilique. Also check the leaflets that come
with all your medicines to see if they can be taken with
hormonal contraceptives.
Some medicines can stop Cilique from working properly for example:
• some medicines used to treat epilepsy (such as topiramate,
carbamazepine, phenytoin, fosphenytoin, oxcarbazepine,
felbamate, primidone, eslicarbazepine acetate, rufinamide)
• bosentan (for high blood pressure in the blood vessels of the
lungs)
• antibiotics including rifampicin and rifabutin (for treatment
of TB) also ampicillin and tetracyclines

• anti-HIV medicines
• boceprevir and telaprevir (for treatment of Hepatitis C
infections)
• aprepitant and fosaprepitant (for prevention of nausea and
vomiting caused by certain cancer drug treatment)
• griseofulvin (for fungal infections)
• modafinil (for excessive daytime sleepiness)
• certain sedatives (called ‘barbiturates’)
• St. John’s Wort (a herbal remedy)
• metoclopramide (to increase movement through the gut)
• charcoal
• colesevelam (to treat high cholesterol levels)
• paracetamol (for pain and fever relief)
• etoricoxib (to help with pain and inflammation of arthritis)
• vitamin C (ascorbic acid)
• drugs for fungal infections such as itraconazole,
ketoconazole, voriconazole, fluconazole
• atorvastatin and rosuvastatin (for high cholesterol levels).
If you do need to take one of these medicines, Cilique may not
be suitable for you or you may need to use extra contraception
for a while. Your doctor, pharmacist or dentist can tell you if this
is necessary and for how long:
• If you are taking rifampicin, you should use extra contraception
for 4 weeks after finishing treatment
• If you are taking aprepitant or fosaprepitant you should use
extra contraception for 8 weeks after finishing treatment
• In particular if you or your partner are taking telaprevir or
boceprevir, talk to your doctor as you must use extra
contraception during treatment and after finishing treatment.
Cilique can also affect other medicines - for example:
• ciclosporin (to prevent transplant rejection and for rheumatoid
arthritis or some skin problems)
• omeprazole (to reduce production of acid in the stomach)
• lamotrigine (for epilepsy)
• prednisolone (a steroid to reduce inflammation)
• selegiline (for Parkinson’s disease)
• theophylline (for asthma, bronchitis and emphysema)
• voriconazole (for fungal infections)
• tizanidine (used to relax muscles)
• paracetamol and aspirin (for pain and fever relief)
• clofibric acid (for high cholesterol levels)
• morphine (a strong painkiller)
• temazepam (for anxiety)
• insulin or other anti-diabetic drugs.
Cilique may also affect the results of certain blood and urine
tests. Tell your doctor that you are taking Cilique before you
have any such tests.

2.6 Taking Cilique with food and drink

Do not drink grapefruit juice while taking Cilique.

2.7 Pregnancy and breast-feeding

Do not start to use Cilique if you are pregnant. If you think
you might be pregnant while taking Cilique, do a pregnancy test
to confirm that you are before you stop taking it.

Take Cilique every day for 21 days
Cilique comes in a strip of 21 pills, each marked with a day of
the week.
• Take your pill at the same time every day.
• Start by taking a pill marked with the correct day of the week.
• Follow the direction of the arrows on the strip. Take one pill
each day.
• Swallow each pill whole, with water if necessary. Do not
chew the pill.
Then have seven pill-free days
After you have taken all 21 pills in the strip, you have seven
days when you take no pills. So if you take the last pill of one
pack on a Friday, you will take the first pill of your next pack
on the Saturday of the following week.
Within a few days of taking the last pill from the strip, you
should have a withdrawal bleed like a period. This bleed may
not have finished when it is time to start your next strip of pills.
You don’t need to use extra contraception during these seven
pill-free days - as long as you have taken your pills correctly
and start the next strip of pills on time.
Then start your next strip
Start taking your next strip of Cilique after the seven pill-free
days - even if you are still bleeding. Always start the new strip
on time.
As long as you take Cilique correctly, you will always start each
new strip on the same day of the week.

3.2 Starting Cilique

As a new user or starting the Pill again after a break
Either take your first Cilique pill on the first day of your next
period. This way, you will have contraceptive protection with
your first pill.
Or if your period has already begun, start taking Cilique up to
day 5 (counting the first day of your period as day 1) whether
or not your bleeding has stopped. You must also use extra
contraception, such as condoms, until you have taken the first
seven pills correctly.

Changing from a combination hormonal contraceptive,
or combination contraceptive vaginal ring or patch
You can start Cilique preferably on the day after the last active
tablet (the last tablet containing the active substances) of your
previous pill, but at the latest on the day after the tablet-free days
of your previous pill (or after the last inactive tablet of your
previous pill). When changing from a combination contraceptive
vaginal ring or patch, follow the advice of your doctor.
Changing from a progestogen-only-method (progestogenonly pill, injection, implant or a progestogen-releasing
intrauterine system (IUS)
You may switch any day from the progestogen-only pill (from
an implant or an IUS on the day of its removal, from an
injectable when the next injection would be due) but in all of
these cases use extra protective measures (for example, a
condom) for the first 7 days of tablet-taking.

If you are breast-feeding, your doctor or family planning nurse
may advise you not to take Cilique. Talk to them about
alternative contraception. Breast- feeding may not stop you
getting pregnant.

Starting Cilique after a miscarriage or abortion
If you have had a miscarriage or an abortion, your doctor may
tell you to start taking Cilique straight away. This means that
you will have contraceptive protection with your first pill.

2.8 Driving and using machines

Contraception after having a baby
If you have just had a baby, you are more at risk of blood clots
(see Section 2.3 ‘The Pill and blood clots’).
Ask your doctor when you can start taking Cilique again. If it is
21 days after the birth, you will have contraceptive protection
with your first pill.

Cilique has no known effect on the ability to drive or use
machines.

2.9 Important information about some of the ingredients
of Cilique
Cilique contains lactose. If you have been told by your doctor
that you have intolerance to some sugars, contact your doctor
before using Cilique.

3. HOW TO TAKE CILIQUE
3.1 How to take it

To prevent pregnancy, always take Cilique as described below.
Check with your doctor or family planning nurse if you are
not sure.

3.3 A missed pill

Missing pills or starting a strip late may make your pill less
effective. The chance of pregnancy after missing pills depends
on when pills are missed and how many pills are missed.
Missing one pill anywhere in your strip or starting a new strip
one day late is not a problem. Missing more than one or starting
a strip more than one day late may affect your contraceptive
cover.
It is more risky to start a strip late and miss more than one pill.

How late are you?
You are less than 12 hours late

If you are still sick or have diarrhoea for more than 1 day,
follow the instructions for a missed pill - see section 3.3, A
missed pill.
Talk to your doctor if your stomach upset carries on or gets
worse. He or she may recommend another form of contraception.

3.6 Missed a period - could you be pregnant?
• Take the missed pill straight away, and further
pills as usual. This may mean taking two pills in
one day.
• Continue taking the rest of the strip as usual.
• Don’t worry - your contraceptive protection
should not be reduced.

How late are you?
You are more than 12 hours late or have missed
more than one pill
• Take the most recently missed pill straight away.
• Leave any earlier missed pills in the strip.
• Take your next pill at the usual time. This may
mean taking two pills in one day.
• Continue taking the rest of the strip as usual.
• Use extra precautions (condoms, for instance) for
the next 7 days.
• Check how many pills are left in the strip after the
most recently missed pill.
7 or more pills left
in the pack

Fewer than 7 pills
left in the pack

• Use extra precautions
for the next 7 days.
• When you have finished
the strip, leave the usual
7-day break before
starting the next strip.
• If you have missed any
pills from the first week
of your strip and you
had sex in that week,
you could become
pregnant. Contact your
doctor, family planning
nurse or pharmacist for
advice as soon as
possible. They may
recommend you
use emergency
contraception.

• Use extra precautions
for the next 7 days.
• When you finish the
strip, start the next
strip the next day
without a break.
• If you do not have a
withdrawal bleed
after you have
finished the second
strip, do a pregnancy
test.

If you have missed any of the pills in a strip, and you do not
bleed in the first pill-free break, you may be pregnant. Contact
your doctor or family planning clinic, or do a pregnancy test
yourself.

Occasionally, you may miss a withdrawal bleed. This could mean
that you are pregnant, but that is very unlikely if you have taken
your pills correctly. Start your next strip at the normal time. If
you think that you might have put yourself at risk of pregnancy
(for example, by missing pills or taking other medicines), or if
you miss a second bleed, you should do a pregnancy test. You
can buy these from the chemist or get a free test at your family
planning clinic or doctor’s surgery. If you are pregnant, stop
taking Cilique and see your doctor.

3.7 Taking more than one pill should not cause harm

It is unlikely that taking more than one pill will do you any harm,
but you may feel sick, vomit or have some vaginal bleeding. Talk
to your doctor if you have any of these symptoms.

3.8 You can delay a period

If you want to delay having a period, finish the strip of pills you
are taking. Start the next strip the next day without a break. Pill
taking should then continue as usual.
When you use the second strip, you may have some unexpected
bleeding or spotting on the days that you take the pill, but don’t
worry. Take the next strip after the usual 7 day break even if you
are still bleeding or spotting.

3.9 When you want to get pregnant

If you are planning a baby, it’s best to use another method of
contraception after stopping Cilique until you have had a proper
period. Your doctor or midwife relies on the date of your last
natural period to tell you when your baby is due. The Pill may
reduce the levels of folic acid in the blood. Talk to your doctor,
nurse or pharmacist as this could be important if you get
pregnant straight after stopping the Pill.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Cilique can cause side effects, although not
everybody gets them.
Tell your doctor, pharmacist or family planning nurse if you
get any side effect particularly if they are severe and persistent,
or you have any change in your health which you think may be
due to Cilique.

4.1 Serious side effects - see a doctor straight away

Harmful blood clots in a vein or artery (frequency not known)
for example:
• in a leg or foot (DVT)
• in a lung (PE)
• heart attack
• stroke
• mini-stroke or temporary stroke-like symptoms, known as a
transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestines, kidneys or eye.

An increased risk of blood clots in your veins (venous
thromboembolism, VTE) or arteries (arterial thromboembolism,
If you start a new strip of pills late, or make your ‘week off’
ATE) is present for all women taking the Pill. For more detailed
longer than eight days, you may not be protected from pregnancy. information on the different risks from taking the Pill, please see
If you had sex in the last seven days, ask your doctor, family
Section 2 ‘Make sure Cilique is OK for you’. The chance of
planning nurse or pharmacist for advice. You may need to
having a blood clot may be higher if you have any other
consider emergency contraception. You should also use extra
conditions that increase this risk (see Section 2.3 ‘The Pill and
contraception, such as a condom, for seven days.
blood clots’ for more information on the conditions that increase
risk for blood clots and the symptoms of a blood clot).
3.4 A lost pill
If you lose a pill, just take a pill from a spare strip. Then take all
the other pills from your current strip as usual. You can then keep
the opened spare strip in case you lose any more pills.

3.5 If you are sick or have diarrhoea

If you are sick or have very bad diarrhoea, your body may not
get its usual dose of hormones from that pill. If you have been
sick within 2 hours of taking Cilique, just take a pill from a
spare strip. Carry on taking your pills as normal if you can. You
won’t need to use extra contraception.

Breast cancer (frequency not known) signs include:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel.

Severe liver problems (rare - may affect up to 1 in 1,000
people) signs include:
• severe pain in your upper abdomen
• yellow skin or eyes (jaundice).

Other serious side effects include:
• increased blood pressure (uncommon - may affect up to 1 in
100 people)
• fits (convulsions) (frequency not known)
• hives (urticaria) (uncommon - may affect up to 1 in 100
people), swelling of the face, lips, mouth, tongue or throat
which may cause difficulty in swallowing or breathing.
These may be signs of allergy.
If you think you may have any of these, see a doctor straight
away. You may need to stop taking Cilique.

4.2 Other possible side effects - tell your doctor
Very common (may affect more than 1 in 10 people)

• Headache (but if severe, unusual or long lasting, see a doctor
as soon as possible)
• Stomach problems such as nausea, vomiting and diarrhoea
• Bleeding and spotting between your periods for the first few
months (though this usually stops when your body adjusts to
Cilique) - see section 4.3, Bleeding between periods should
not last long
• Painful or unusual periods.
Common (may affect up to 1 in 10 people)
• Migraine (see a doctor as soon as possible if this is your first
migraine or it’s worse than usual)
• Swollen hands, ankles or feet
• Depression; mood changes; feeling nervous or dizzy
• Difficulty sleeping (insomnia)
• Stomach ache and bloating; constipation; wind
• Acne; rash
• Muscle spasms; pain in the legs, arms and back
• Painful breasts
• Urinary tract infections (pain on passing urine)
• Vaginal infections such as thrush
• Vaginal discharge
• No menstrual periods
• Feeling weak
• Weight gain.
Uncommon (may affect up to 1 in 100 people)
• Breast problems, such as fuller breasts; producing fluid from
the nipples
• Abnormal cells in the cervix (identified by a smear test)
• Feeling anxious or faint; tingling sensation or numbness
• Changes in skin colour
• Skin problems such as redness and itchiness
• Hair thinning (alopecia), excessive hair growth
• Changes in appetite
• Weight may vary
• Change in sex drive
• Dry eyes
• Changes in vision
• Palpitations (feeling your heart beat)
• Hot flushes
• Muscle pain
• Vaginal dryness
• Ovarian cysts (may cause pain and swelling of the abdomen,
changes in periods).
Rare (may affect up to 1 in 1,000 people)
• Lumpy breasts
• Loss of sex drive
• Feeling giddy
• Faster heart beat
• Pancreatitis (inflammation of the pancreas, which causes
severe pain in the abdomen and back)
• Increased sweating
• Sensitivity to light.
Not known: frequency cannot be estimated from the
available data
• Reduced amount of breast milk (if breast feeding)
• Contact lenses may feel uncomfortable
• Red painful lumpy swellings on the legs
• Changes in fat levels in the blood (seen by blood tests)
• Night sweats.

4.3 Bleeding between periods should not last long

Usually you should only have a withdrawal bleed like a period
during the seven pill-free days. However, a few women have a

little unexpected bleeding or spotting while they are taking
Cilique, especially during the first few months. Normally, this
bleeding is nothing to worry about and will stop after a day or
two. Keep taking Cilique as usual. The problem should disappear
after the first few strips.
You may also have unexpected bleeding if you are not taking
your pills regularly, so try to take your pill at the same time
every day. Also, unexpected bleeding can sometimes be caused
by other medicines.
Make an appointment to see your doctor if you get
breakthrough bleeding or spotting that:
• carries on for more than the first few months
• starts after you’ve been taking Cilique for a while
• carries on even after you’ve stopped taking Cilique.
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:
U.K.: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace,
IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. HOW TO STORE CILIQUE
Keep this medicine out of the sight and reach of children.
Do not store above 25ºC. Store in the original packaging to
protect from light.
Do not use Cilique after the expiry date shown on the strip. The
expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater of 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 Cilique contains:
The active substances are 250 micrograms of norgestimate and
35 micrograms of ethinylestradiol.
Cilique also contains the other ingredients: maize starch, lactose,
magnesium stearate (E470b), indigo carmine (E132).
The tablets are blue, round and biconvex.
Each pack contains 3 or 6 blister strips each containing 21 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Consilient Health Ltd.,
5th floor, Beaux Lane House,
Mercer Street Lower, Dublin 2, Ireland
Manufacturer
CYNDEA PHARMA, S.L.
Polígono Industrial Emiliano Revilla Sanz.
Avenida de Ágreda, 31, Olvega,
42110 Soria
Distributor in UK:
Consilient Health (UK) Ltd.,
No.1 Church Road, Richmond upon Thames,
Surrey TW9 2QE
Distributor in Ireland:
Consilient Health Limited,
Block 2A Richview Office Park, Clonskeagh, Dublin 14
Ireland
This leaflet was last revised in November 2015.
P0315

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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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