QLAIRA

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82_04.indd cover:1

film-coated tablets
Estradiol valerate/Dienogest

— 28 film-coated
tablets
— oral use

page U 1
Packaging Technology Berlin dy
Bayer Pharma AG
client: 0086
item-no.: 82539182
PZ: 2668A-4B
code-no.: 0
name: LF-BRO-Qlaira FTB 28
country: GB/-/BPH
colors: Black / pant 124 C / pant 2707 C / pant 478 C / pant 470 C / pant 2995 C
version: 17.06.2014/04
approval:

17.06.2014 14:45:23

82_04.indd cover:2

page U 2
Packaging Technology Berlin dy
Bayer Pharma AG
client: 0086
item-no.: 82539182
PZ: 2668A-4B
code-no.: 0
name: LF-BRO-Qlaira FTB 28
country: GB/-/BPH
colors: Black / pant 124 C / pant 2707 C / pant 478 C / pant 470 C / pant 2995 C
version: 17.06.2014/04
approval:

17.06.2014 14:45:55

82_04.indd cover:3

page U 3
Packaging Technology Berlin dy
Bayer Pharma AG
client: 0086
item-no.: 82539182
PZ: 2668A-4B
code-no.: 0
name: LF-BRO-Qlaira FTB 28
country: GB/-/BPH
colors: Black / pant 124 C / pant 2707 C / pant 478 C / pant 470 C / pant 2995 C
version: 17.06.2014/04
approval:

17.06.2014 14:45:55

82_04.indd cover:4

82539182

page U 4
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Bayer Pharma AG
client: 0086
item-no.: 82539182
PZ: 2668A-4B
code-no.: 0
name: LF-BRO-Qlaira FTB 28
country: GB/-/BPH
colors: Black / pant 124 C / pant 2707 C / pant 478 C / pant 470 C / pant 2995 C
version: 17.06.2014/04
approval:

17.06.2014 14:45:55

82_04.indd 1

Package leaflet: Information for the user

Qlaira
film-coated tablets
Estradiol valerate/Dienogest

b
(1]

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Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
R Keep this leaflet. You may need to read it again.
R If you have any further questions, ask your doctor or
pharmacist.
R This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them.
R If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.

C
[2)

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Important things to know about combined hormonal
contraceptives (CHCs):
R They are one of the most reliable reversible methods of
contraception if used correctly
R They slightly increase the risk of having a blood clot in the veins
and arteries, especially in the first year or when restarting a
combined hormonal contraceptive following a break of 4 or
more weeks
R Please be alert and see your doctor if you think you may have
symptoms of a blood clot (see section 2 “Blood clots”)

d
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82_04.indd 4

What is in this leaflet:
1. What Qlaira is and what it is used for
2. What you need to know before you take Qlaira
When not to take Qlaira
Warnings and precautions
Blood clots
Qlaira and cancer
Bleeding between periods
What to do if no bleeding occurs on day 26 or the
following day(s)
Other medicines and Qlaira
Qlaira with food and drink
Laboratory tests
Pregnancy and breast-feeding

6
7
8
12
16
30
31
32
33
35
35
35

E
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3.

4.
5.
6.

Driving and using machines
Qlaira contains lactose
How to take Qlaira
Preparation of the wallet
When can you start with the first wallet?
If you take more Qlaira than you should
If you forget to take Qlaira
Use in children
What to do if you vomit or have severe diarrhoea
If you stop taking Qlaira
Possible side effects
How to store Qlaira
Contents of the pack and other information

36
36
37
37
39
41
41
45
45
46
47
55
56
f
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1. What Qlaira is and what it is used for
R Qlaira is a contraceptive pill and is used to prevent pregnancy.
R Qlaira is used for the treatment of heavy menstrual bleeding
(not caused by any disease of the womb) in women who wish to
use oral contraception.
R Each coloured, active tablet contains a small amount of female
hormones, either estradiol valerate, or estradiol valerate
combined with dienogest.
R The 2 white tablets contain no active substances and are called
inactive tablets
R Contraceptive pills that contain two hormones are called
“combined pills”.

G
[6)

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2. What you need to know before you take Qlaira
General notes
Before you start using Qlaira 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 Qlaira, 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 Qlaira, or where the reliability of Qlaira may be
decreased. In such situations you should either not have sex or
you should take extra non-hormonal contraceptive precautions,
h
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e.g. use a condom or another barrier method. Do not use rhythm
or temperature methods. These methods can be unreliable
because Qlaira alters the monthly changes of body temperature
and cervical mucus.
Qlaira, like other hormonal contraceptives, does not protect
against HIV infection (AIDS) or any other sexually transmitted
disease.
When not to take Qlaira
You should not use Qlaira 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.

I
[8)

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Do not take Qlaira:
R 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;
R 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;
R if you need an operation or if you are off your feet for a long
time (see section ‘Blood clots’)
R if you have ever had a heart attack or a stroke;
R if you have (or have ever had) angina pectoris (a condition that
causes severe chest pain and may be a first sign of a heart
attack) or transient ischaemic attack (TIA – temporary stroke
symptoms);
j
(9]

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R if you have any of the following diseases that may increase your
risk of a clot in the arteries:
P severe diabetes with blood vessel damage
P very high blood pressure
P a very high level of fat in the blood (cholesterol or
triglycerides)
P a condition known as hyperhomocysteinaemia
R if you have (or have ever had) a type of migraine called
‘migraine with aura’;
R if you have (or have ever had) inflammation of the pancreas
(pancreatitis)
R if you have (or have ever had) liver disease and your liver
function is still not normal
R if you have (or have ever had) a tumour of the liver
[10)

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R if you have (or have ever had) cancer or suspected cancer of
the breast or genital organs
R if you have any unexplained bleeding from the vagina
R if you are allergic (hypersensitive) to estradiol valerate or
dienogest, or any of the other ingredients of this medicine
(listed in section 6). This may cause itching, rash or swelling.

(11]

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Warnings and precautions
When should you contact your doctor?
Seek urgent medical attention
R if you notice possible signs of a blood clot that may mean you
are suffering from a blood clot in the leg (i.e. deep vein
thrombosis), a blood clot in the lung (i.e. pulmonary
embolism), a heart attack or a stroke (see ‘Blood clots’ section
below).
For a description of the symptoms of these serious side effects
please go to “How to recognise a blood clot”.
Tell your doctor if any of the following conditions apply to you.
In some situations you need to take special care while taking Qlaira
or any other combined pill, and your doctor may need to examine
you regularly. If the condition develops, or gets worse while you are
using Qlaira, you should also tell your doctor.
[12)

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if a close relative has or has ever had breast cancer
if you have a disease of the liver or gall bladder
if you have jaundice
if you have diabetes
if you have depression
if you have Crohn’s disease or ulcerative colitis (chronic
inflammatory bowel disease);
R if you have systemic lupus erythematosus (SLE – a disease
affecting your natural defence system);
R if you have haemolytic uraemic syndrome (HUS - a disorder of
blood clotting causing failure of the kidneys);
R if you have sickle cell anaemia (an inherited disease of the red
blood cells);
R
R
R
R
R
R

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R 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);
R if you need an operation, or you are off your feet for a long time
(see in section 2 ‘Blood clots’).
R 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 Qlaira.
R if you have an inflammation in the veins under the skin
(superficial thrombophlebitis).
R if you have varicose veins.
R if you have epilepsy (see “Other medicines and Qlaira”)
[14)

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R 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
blisters during pregnancy), Sydenham’s chorea (a nerve disease
causing sudden movements of the body)
R if you have (or have ever had) golden brown pigment patches
so-called “pregnancy patches” especially on the face
(Chloasma). If this is the case, avoid direct exposure to sunlight
or ultraviolet light
R if you have hereditary angioedema. Consult your doctor
immediately if you experience symptoms of angioedema such
as swollen face, tongue and/or throat and/or difficulty
swallowing or hives, together with difficulty breathing. Products
containing oestrogens may induce or worsen symptoms of
angioedema
R if you have cardiac or renal insufficiency.
(15]

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Talk to your doctor before taking Qlaira.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Qlaira 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
R in veins (referred to as a ‘venous thrombosis’, ‘venous
thromboembolism’ or VTE)
R 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 having a
harmful blood clot due to Qlaira is small.
[16)

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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?
R swelling of one leg or along a vein in the Deep vein
leg or foot especially when accompanied thrombosis
by:
P pain or tenderness in the leg which
may be felt only when standing or
walking
P increased warmth in the affected leg
P change in colour of the skin on the
leg e.g. turning pale, red or blue
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Are you experiencing any of these signs?

R sudden unexplained breathlessness or
rapid breathing;
R sudden cough without an obvious cause,
which may bring up blood;
R sharp chest pain which may increase
with deep breathing;
R severe light headedness or dizziness;
R rapid or irregular heartbeat
R severe pain in your stomach;

What are you
possibly suffering
from?
Pulmonary
embolism

[18)

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Are you experiencing any of these signs?

What are you
possibly suffering
from?

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’).
Retinal vein
Symptoms most commonly occur in one
thrombosis (blood
eye:
clot in the eye)
R immediate loss of vision or
R painless blurring of vision which can
progress to loss of vision

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Are you experiencing any of these signs?

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

What are you
possibly suffering
from?
Heart attack

[20)

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Are you experiencing any of these signs?

R sudden weakness or numbness of the
face, arm or leg, especially on one side of
the body;
R sudden confusion, trouble speaking or
understanding;
R sudden trouble seeing in one or both
eyes;
R sudden trouble walking, dizziness, loss
of balance or coordination;
R sudden, severe or prolonged headache
with no known cause;

What are you
possibly suffering
from?
Stroke

(21]

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Are you experiencing any of these signs?

R loss of consciousness or fainting with or
without seizure.
Sometimes the symptoms of stroke can be
brief with an almost immediate and full
recovery, but you should still seek urgent
medical attention as you may be at risk of
another stroke.
R swelling and slight blue discolouration
of an extremity;
R severe pain in your stomach (acute
abdomen)

What are you
possibly suffering
from?

Blood clots
blocking other
blood vessels

[22)

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BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
R 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.
R If a blood clot forms in a vein in the leg or foot it can cause a
deep vein thrombosis (DVT).
R If a blood clot travels from the leg and lodges in the lung it can
cause a pulmonary embolism.
R Very rarely a clot may form in a vein in another organ such as
the eye (retinal vein thrombosis).

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When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the
first year of taking a combined hormonal contraceptive for the first
time. The risk may also be higher if you restart taking a combined
hormonal contraceptive (the same product or a different product)
after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly
higher than if you were not using a combined hormonal
contraceptive.
When you stop Qlaira your risk of a blood clot returns to normal
within a few weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of
combined hormonal contraceptive you are taking.

[24)

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The overall risk of a blood clot in the leg or lung (DVT or PE) with
Qlaira is small.
R 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.
R 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.
R It is not yet known how the risk of a blood clot with Qlaira
compares to the risk with a combined hormonal contraceptive
that contains levonorgestrel.
R 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)

(25]

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Women who are not using a combined
hormonal pill and are not pregnant
Women using a combined hormonal
contraceptive pill containing
levonorgestrel, norethisterone or
norgestimate
Women using Qlaira

Risk of developing a
blood clot in a year
About 2 out of
10,000 women
About 5-7 out of
10,000 women

Not yet known.

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Qlaira is small but some conditions
will increase the risk. Your risk is higher:
R if you are very overweight (body mass index or BMI over
30 kg/m2);
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R 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;
R 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 Qlaira may need to be stopped several weeks
before surgery or while you are less mobile. If you need to stop
Qlaira ask your doctor when you can start using it again.
R as you get older (particularly above about 35 years);
R 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.
(27]

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:57

82_04.indd 28

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 Qlaira
needs to be stopped.
If any of the above conditions change while you are using Qlaira,
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 Qlaira is very small but can increase:
R with increasing age (beyond about 35 years);
[28)

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:57

82_04.indd 29

R if you smoke. When using a combined hormonal contraceptive
like Qlaira 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;
R if you are overweight;
R if you have high blood pressure;
R 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;
R if you, or someone in your immediate family, have a high level
of fat in the blood (cholesterol or triglycerides);
R if you get migraines, especially migraines with aura;
R if you have a problem with your heart (valve disorder,
disturbance of the rhythm called atrial fibrillation)
(29]

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:57

82_04.indd 30

R 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 Qlaira,
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.
Qlaira 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 itself. 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 risk of breast tumours becomes
gradually less after stopping the combination hormonal
[30)

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:57

82_04.indd 31

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. In isolated cases, these tumours have led to life-threatening
internal bleeding. Contact your doctor if you have unusually severe
abdominal pain.
Some studies suggest that long-term use of the pill increases a
woman’s risk of developing cervical cancer. However, it is not clear
to what extent sexual behaviour or other factors such as Human
Papilloma Virus (HPV) increases this risk.
Bleeding between periods
During the first few months of taking Qlaira, you may have
unexpected bleeding. Usually bleeding starts on day 26, the day
you take the second dark red tablet, or the following day(s). The
information provided by women in the diaries they kept during a
(31]

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:57

82_04.indd 32

clinical study of Qlaira shows that it is not unusual to experience
unexpected bleeding in a given cycle (10-18 % of users). If
unexpected bleeding occurs more than 3 months in a row, or if it
begins after some months, your doctor will have to investigate the
cause.
What to do if no bleeding occurs on day 26 or the following
day(s)
The information provided by women in the diaries they kept during
a clinical study of Qlaira shows that it is not unusual to miss your
regular bleeding after day 26 (observed in about 15 % of cycles).
If you have taken all the tablets correctly, have not had any
vomiting or severe diarrhoea and you have not taken any other
medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in a row or you
have taken the tablets incorrectly, you may be pregnant. Contact
[32)

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:58

82_04.indd 33

your doctor immediately. Do not start the next wallet until you are
sure that you are not pregnant.
Other medicines and Qlaira
Always tell your doctor which medicines or herbal products you
are already using. Also tell any other doctor or dentist who
prescribes another medicine (or the pharmacist from whom you
got the medicine) that you take Qlaira. 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 Qlaira less effective in preventing
pregnancy, or can cause unexpected bleeding. These include:
P medicines used for the treatment of:
– epilepsy (e.g. primidone, phenytoin, barbiturates,
carbamazepine, oxcarbazepine,
topiramate, felbamate)
(33]

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:58

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– tuberculosis (e.g. rifampicin)
– HIV infections (e.g. ritonavir, nevirapine) other infections
(antibiotics such as
penicillins, tetracyclines, griseofulvin).
P the herbal remedy St. John’s wort
Some medicines can increase the levels of the active substances
of Qlaira in the blood. Inform your doctor if you are using:
P anti-fungal medicines containing ketoconazole
P antibiotics containing erythromycin
R Qlaira may influence the effect of other medicines, e.g.
P medicines containing cyclosporin
P the anti-epileptic lamotrigine (this could lead to an
increased frequency of seizures).

[34)

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:58

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Ask your doctor or pharmacist for advice before taking any medicine.
Your doctor or pharmacist may advise on extra protective measures
while you are taking other medication together with Qlaira.
Qlaira with food and drink
Qlaira may be taken with or without food, if necessary with a small
amount of water.
Laboratory tests
If you need a blood test or other laboratory tests tell your doctor or
the laboratory staff that you are taking the pill because oral
contraceptives can affect the results of some tests.
Pregnancy and breast-feeding
Do not take Qlaira if you are pregnant. If you become pregnant
while taking Qlaira, stop taking it immediately and contact your
(35]

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PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

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doctor. If you want to become pregnant, you can stop taking Qlaira
at any time (see also “If you stop taking Qlaira”).
In general you should not take Qlaira while you are breast-feeding.
If you want to take the pill while you are breast-feeding you should
contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine
when you are pregnant or breast-feeding.
Driving and using machines
There is nothing to suggest that the use of Qlaira affects driving or
use of machines.
Qlaira contains lactose
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking Qlaira.

[36)

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:58

82_04.indd 37

3. How to take Qlaira
Each wallet contains 26 coloured active tablets and 2 white
inactive tablets.
Take one tablet of Qlaira every day, if necessary with a small
amount of water. You may take the tablets with or without food,
but you should take the tablets at around the same time every day.
Preparation of the wallet
To help you keep track, there are 7 weekday sticker strips marked
with the 7 days of the week.
Choose the weekday sticker strip that starts with the day you begin
taking the tablets. For example, if you start on a Wednesday, use
the weekday sticker strip that starts with “WED”.
Stick the weekday sticker strip along the top of the Qlaira wallet
where it reads “Place weekday sticker strip here”, so that the first
day is above the tablet marked “1”.
(37]

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:58

82_04.indd 38

There is now a day shown above every tablet and you can see
whether you have taken a pill on a particular day. Follow the
direction of the arrow on the wallet until all 28 tablets have been
taken.
Usually, so-called withdrawal bleeding starts when you are taking
the second dark red tablet or the white tablets and may not have
finished before you start the next wallet. Some women still
experience bleeding after taking the first tablets of the new wallet.
Start the following wallet without a gap, in other words the day
after you have finished your current wallet, even if the bleeding has
not stopped. This means that you should start your following
wallet on the same day of the week as the current wallet and that
the withdrawal bleed should occur on the same weekdays each
month.
If you use Qlaira in this manner, you are protected against
pregnancy even during the 2 days when you take inactive tablets.
[38)

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:58

82_04.indd 39

When can you start with the first wallet?
R If you have not used a contraceptive with hormones during the
previous month.
Start taking Qlaira on the first day of the cycle (that is, the first
day of your period).
R Changing from another combined hormonal contraceptive pill, or
combined contraceptive vaginal ring or patch.
Start Qlaira the day after taking 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, start using Qlaira on the day of removal or, follow the
advice of your doctor.
R Changing from a progestogen-only-method (progestogen-only pill,
injection, implant or a progestogen-releasing ‘IUS’, intrauterine
system).
You may switch from the progestogen-only pill any day (from
(39]

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:58

82_04.indd 40

an implant or the IUS on the day of its removal, from an
injectable when the next injection would be due) but in all of
these cases you must use extra protective measures (for
example, a condom) during the first 9 days of Qlaira use.
R After a miscarriage.
Follow the advice of your doctor.
R After having a baby.
You can start Qlaira between 21 and 28 days after having a
baby. If you start later than day 28, use a barrier method (for
example, a condom) during the first 9 days of Qlaira use.
If, after having a baby, you have had sex before re-starting
Qlaira, be sure that you are not pregnant or wait until the next
menstrual period.
If you want to start Qlaira after having a baby and are breastfeeding, read the section on “Pregnancy and breast-feeding”.
Ask your doctor what to do if you are not sure when to start.
[40)

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:58

82_04.indd 41

If you take more Qlaira than you should
There are no reports of serious harmful effects of taking too many
Qlaira tablets.
If you take several active tablets at once, you may feel sick or throw
up. Young girls may have bleeding from the vagina.
If you have taken too many Qlaira tablets, or you discover that a
child has taken some, ask your doctor or pharmacist for advice.
If you forget to take Qlaira
Inactive tablets: If you miss a white tablet (2 tablets at the end of
the wallet), you do not need to take it later because they do not
contain any active substances. However, it is important that you
discard the missed white tablet(s) to make sure that the number of
days when you take inactive tablets is not increased as this would
increase the risk of pregnancy. Continue with the next tablet at the
usual time.
(41]

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Packaging Technology Berlin dy
client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:58

82_04.indd 42

Active tablets: Depending on the day of the cycle on which one
active tablet has been missed, you may need to take additional
contraceptive precautions, for example a barrier method such as
a condom. Take the tablets according to the following
principles. See also the ‘missed pill chart’ for details.
R 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.
R If you are more than 12 hours late taking a tablet, the
protection against pregnancy may be reduced. Depending on
the day of the cycle on which one tablet has been missed, use
additional contraceptive precautions e.g. a barrier method such
as a condom. See also the ‘missed pill chart’ for details.
R More than one tablet forgotten in this wallet
Contact your doctor.
[42)

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:58

82_04.indd 43

Do not take more than 2 active tablets on a given day.
If you have forgotten to start a new wallet, or if you have missed
one or more tablets during days 3 - 9 of your wallet, there is a risk
that you are already pregnant (if you had sex in the 7 days before
forgetting the tablet). In that case, contact your doctor. The more
tablets you have forgotten (especially those on days 3 – 24) and
the closer they are to the inactive tablet phase, the greater the risk
that the protection from pregnancy is reduced. See also the
‘missed pill chart’ for details.
If you have forgotten any of the active tablets in a wallet, and you
have no bleeding at the end of a wallet, you may be pregnant.
Contact your doctor before you start the next wallet.

(43]

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:58

82_04.indd 44

Missed more than
1 coloured pill

Contact your doctor straight away

Forgot to start a
new wallet

YES
Day 1-9

Have had sex in the 7 days before forgetting?

Day 10-17

R Take the missed tablet and continue taking the
R tablets as usual (this may mean 2 tablets in one day)
R Use a barrier method (condom) for the next 9 days

Day 18-24

R Do not take the missed tablet
R Start immediately with the next wallet
R Use a barrier method (condom) for the next 9 days

Day 25-26

R Take the missed tablet and continue taking the
R tablets as usual (this may mean 2 tablets in one day)
R No additional contraception necessary

Day 27-28

R Discard the missed tablet and continue taking the
R tablets as usual
R No additional contraception necessary

NO

Only missed 1 pill
(more than
12 hours late)

[44)

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:58

82_04.indd 45

Use in children
No data available in adolescents below 18 years.
What to do if you vomit or have severe diarrhoea
If you throw up within 3-4 hours of taking an active tablet or you
have severe diarrhoea, there is a risk that the active substances in
the pill are not fully absorbed by your body.
The situation is almost the same as forgetting a tablet. After
throwing up or having diarrhoea, take the next tablet as soon as
possible. If possible, take it within 12 hours of when you normally
take your pill. If this is not possible or 12 hours have passed, you
should follow the advice given under “If you forget to take Qlaira”.
If you do not want to change your normal tablet-taking pattern
take the corresponding tablet from another wallet.

(45]

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:59

82_04.indd 46

If you stop taking Qlaira
You can stop taking Qlaira at any time. If you do not want to
become pregnant, ask your doctor for advice about other reliable
methods of birth control. If you want to become pregnant, stop
taking Qlaira and wait for a menstrual period before starting to try
to become pregnant. You will be able to calculate the expected
delivery date more easily.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

[46)

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:59

82_04.indd 47

4. Possible side effects
Like all medicines, Qlaira 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 Qlaira, 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 take
Qlaira”.
Serious side effects
Serious reactions associated with the use of the pill, as well as the
related symptoms, are described in the following sections: “Blood
clots” and “Qlaira and cancer”. Please read these sections carefully
and consult your doctor at once where appropriate.
(47]

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

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Other possible side effects
The following side effects have been linked with the use of Qlaira:
Common side effects (between 1 and 10 in every 100 users may be
affected):
R headache
R abdominal pain, nausea
R acne
R no periods, breast discomfort, painful periods, irregular bleeding
(heavy irregular bleeding)
R weight gain
Uncommon side effects (between 1 and 10 in every 1,000 users
may be affected):
R fungal infections, fungal infection of the vulva and vagina,
vaginal infection
R increased appetite
[48)

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Packaging Technology Berlin dy
client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:59

82_04.indd 49

R depression, depressed mood, emotional disorder, problems
sleeping, decreased interest in sex, mental disorder, mood
swings
R dizziness, migraine
R hot flush, high blood pressure
R diarrhoea, vomiting
R increased liver enzymes
R hair loss, excessive sweating (hyperhidrosis), itching, rash
R muscle cramps
R swollen breasts, lumps in the breast, abnormal cell growth on
the neck of the womb (cervical dysplasia), dysfunctional genital
bleeding, pain with intercourse, fibrocystic breast disease, heavy
periods, menstrual disorders, ovarian cyst, pelvic pain,
premenstrual syndrome, growth in the uterus, contractions of
the uterus, uterine/vaginal bleeding incl. spotting, vaginal
discharge, vulvovaginal dryness
(49]

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Packaging Technology Berlin dy
client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:59

82_04.indd 50

R fatigue, irritability, swelling of parts of your body, e.g. ankles
(oedema)
R weight loss, blood pressure changes.
Rare side effects (between 1 and 10 in every 10,000 users may be
affected):
R candida infection, oral herpes, pelvic inflammatory disease, a
vessel disease of the eye resembling a fungal infection
(presumed ocular histoplasmosis syndrome), a fungal infection
of the skin (tinea versicolor), urinary tract infection, bacterial
inflammation of the vagina
R fluid retention, increase in certain blood fats (triglycerides)
R aggression, anxiety, feelings of unhappiness, increased interest
in sex, nervousness, night mare, restlessness, problems sleeping,
stress
R reduced attention, “pins and needles”, giddiness
R contact lens intolerance, dry eye, eye swelling
[50)

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:59

82_04.indd 51

R heart attack (myocardial infarction), palpitations
R bleeding in a varicose vein, low blood pressure, inflammation of
superficial veins, painful veins
R harmful blood clots in a vein or artery for example:
P in a leg or foot (i.e. DVT)
P in a lung (i.e. PE)
P heart attack
P stroke
P mini-stroke or temporary stroke-like symptoms, known as a
transient ischaemic attack (TIA)
P 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).
R constipation, dry mouth, indigestion, heartburn
(51]

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:59

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R liver nodules (focal nodular hyperplasia), chronic inflammation
of gallbladder
R allergic skin reactions, golden brown pigment patches
(chloasma) and other pigmentation disorders, male pattern hair
growth, excessive hair growth, skin conditions such as
dermatitis and neurodermatitis, dandruff and oily skin
(seborrhoea) and other skin disorders
R back pain, pain in jaw, sensation of heaviness
R urinary tract pain
R abnormal withdrawal bleeding, benign breast nodules, breast
cancer in early stage, breast cysts, breast discharge, polyp on
the neck of the womb, reddening on the neck of the womb,
bleeding during intercourse, spontaneous milk flow, genital
discharge, lighter periods, delayed periods, rupture of an ovarian
cyst, vaginal odour, burning sensation in the vulva and vagina,
vulvovaginal discomfort
[52)

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client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:59

82_04.indd 53

R swollen lymph nodes
R asthma, difficulty in breathing, nose bleeding
R chest pain , tiredness and feeling generally unwell, fever
R abnormal smear from the neck of the womb
Further information (taken from the diaries women kept during a
Qlaira clinical trial) on the possible side effects “irregular bleeding
(heavy irregular bleeding)” and “no periods” is given in the sections
“Bleeding between periods” and “What to do if no bleeding occurs
on day 26 or the following day(s)”.
In addition to the above mentioned side effects, the skin disorders
erythema nodosum, erythema multiforme, as well as breast
discharge and hypersensitivity have occurred in women using
combined pills containing ethinylestradiol. Although these
symptoms were not reported during the clinical studies performed
with Qlaira, the possibility that they might also occur under
treatment cannot be ruled out.
(53]

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Packaging Technology Berlin dy
client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

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82_04.indd 54

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly (see details below). By reporting side
effects you can help provide more information on the safety of this
medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
E-mail: postlicensing.medicinesauthority@gov.mt
[54)

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Packaging Technology Berlin dy
client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

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82_04.indd 55

5. How to store Qlaira
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.
Do not use this medicine after the expiry date which is stated on
the wallet 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.

(55]

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Packaging Technology Berlin dy
client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

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82_04.indd 56

6. Contents of the pack and other information
What Qlaira contains
The active substances are estradiol valerate, or estradiol valerate
combined with dienogest.
Each wallet (28 film-coated tablets) of Qlaira contains 26 active
tablets in 4 different colours in rows 1, 2, 3 and 4, as well as 2
white inactive tablets in row 4.
Composition of the coloured tablets containing one or two active
substances:
2 dark yellow tablets each containing 3 mg estradiol valerate
5 medium red tablets each containing 2 mg estradiol valerate and
2 mg dienogest
17 light yellow tablets each containing 2 mg estradiol valerate and
3 mg dienogest
2 dark red tablets each containing 1mg estradiol valerate
[56)

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Packaging Technology Berlin dy
client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:59

82_04.indd 57

Composition of the white inactive tablets:
These tablets do not contain any active substances.
Other ingredients in the coloured active tablets are:
Tablet core: lactose monohydrate, maize starch, pregelatinised
maize starch, povidone K25 (E1201), magnesium stearate (E572)
Tablet film-coating: hypromellose type 2910 (E464), macrogol
6000, talc (E553b), titanium dioxide (E171), iron oxide yellow
(E172) and/or iron oxide red (E172)
Other ingredients in the white inactive tablets are:
Tablet core: lactose monohydrate, maize starch, povidone K25
(E1201), magnesium stearate (E572)
Tablet film-coating: hypromellose type 2910 (E464), talc (E553b),
titanium dioxide (E171)

(57]

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Packaging Technology Berlin dy
client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:59

82_04.indd 58

What Qlaira looks like and content of the pack
Qlaira tablets are film-coated tablets; the core of the tablet is
covered with a coating.
Each wallet (28 film-coated tablets) contains 2 dark yellow tablets
in row 1, 5 medium red tablets in row 1, 17 light yellow tablets in
rows 2, 3 and 4, 2 dark red tablets in row 4 as well as 2 white
tablets in row 4.
The dark yellow active tablet is round with biconvex faces, one side
is embossed with the letters “DD” in a regular hexagon.
The medium red active tablet is round with biconvex faces, one side
is embossed with the letters “DJ” in a regular hexagon.
The light yellow active tablet is round with biconvex faces, one side
is embossed with the letters “DH” in a regular hexagon.
The dark red active tablet is round with biconvex faces, one side is
embossed with the letters “DN” in a regular hexagon.
[58)

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Packaging Technology Berlin dy
client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:59

82_04.indd 59

The white inactive tablet is round with biconvex faces, one side is
embossed with the letters “DT” in a regular hexagon.
Qlaira is available in packs of 1, 3, or 6 wallets each containing 28
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA

(59]

page 59
Packaging Technology Berlin dy
client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:59

82_04.indd 60

Manufacturer
Bayer Weimar GmbH und Co. KG
and Bayer Pharma AG
99427 Weimar
13342 Berlin
Germany
Germany
This medicinal product is authorised in the Member States of
the EEA under the following names:
R Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia,
Spain, Sweden, United Kingdom: QLAIRA/Qlaira
R Italy: KLAIRA
This leaflet was last revised in 06/2014.

82539182

[60)

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Packaging Technology Berlin dy
client: 0086
item-no.: 82539182
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 17.06.2014/04
approval:

Bayer Pharma AG
code-no.: 0
country: GB/-/BPH

17.06.2014 14:45:59

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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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