QLAIRA

Active substance: NO ACTIVES PRESENT

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film-coated tablets
Estradiol valerate/Dienogest

— 28 film-coated
tablets
— oral use

Packaging Technology Berlin dy
page U 1
Bayer Pharma AG
client: 0086
item-no.: 81566887
PZ: 2668A-4B
code-no.: 0
name: LF-BRO-Qlaira FTB 28
country: GB BPH
colors: Black / Pant 2995 C / Pant 470 C / Pant478 C / Pant 124 C /Pant 2707 C
version: 25.07.2013/05
approval:

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Packaging Technology Berlin dy
page U 2
Bayer Pharma AG
client: 0086
item-no.: 81566887
PZ: 2668A-4B
code-no.: 0
name: LF-BRO-Qlaira FTB 28
country: GB BPH
colors: Black / Pant 2995 C / Pant 470 C / Pant478 C / Pant 124 C /Pant 2707 C
version: 25.07.2013/05
approval:

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25.07.2013 12:05:2

Packaging Technology Berlin dy
page U 3
Bayer Pharma AG
client: 0086
item-no.: 81566887
PZ: 2668A-4B
code-no.: 0
name: LF-BRO-Qlaira FTB 28
country: GB BPH
colors: Black / Pant 2995 C / Pant 470 C / Pant478 C / Pant 124 C /Pant 2707 C
version: 25.07.2013/05
approval:

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81566887

Packaging Technology Berlin dy
page U 4
Bayer Pharma AG
client: 0086
item-no.: 81566887
PZ: 2668A-4B
code-no.: 0
name: LF-BRO-Qlaira FTB 28
country: GB BPH
colors: Black / Pant 2995 C / Pant 470 C / Pant478 C / Pant 124 C /Pant 2707 C
version: 25.07.2013/05
approval:

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Package leaflet: Information for the user

Qlairaa®
Qlair®

film-coated tablets
Estradiol valerate/Dienogest

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Packaging Technology Berlin dy
page 1
client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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.

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page 2
client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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
Qlaira and venous/arterial 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

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

What is in this leaflet:
Driving and using machines
Qlaira contains lactose
3. 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
4. Possible side effects
5. How to store Qlaira
6. Contents of the pack and other information

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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”.

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

2. What you need to know before you take Qlaira
General notes
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, 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.
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

Qlaira, like other hormonal contraceptives, does not
protect against HIV infection (AIDS) or any other sexually
transmitted disease.
When not to take Qlaira
Do not take Qlaira:
R if you have (or have ever had) a blood clot in a blood vessel
of the leg (thrombosis), of the lung (pulmonary embolism) or
other organs
R if you have (or have ever had) a heart attack or stroke
R if you have (or have ever had) a disease that can be an
indicator (i) of a future heart attack (for example, angina
pectoris which causes severe chest pain) or (ii) of a stroke
(for example, a minor stroke with no residual effects)
R if you have (or have ever had) a certain kind of migraine
(with so-called focal neurological symptoms)

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

R if you have a disease that may increase the risk of a clot in the
arteries. This applies to the following diseases:
– diabetes with damaged blood vessels
– very high blood pressure
– a very high level of blood fats (cholesterol or triglycerides)
R if you have a disturbance of blood clotting (for example,
protein C deficiency)
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
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
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Packaging Technology Berlin dy
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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
Warnings and precautions
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. Consult your doctor before starting to
use Qlaira if any of the following conditions apply to you or if
any of them develop or worsen while you are taking Qlaira:
R if a close relative has or has ever had breast cancer
R if you have a disease of the liver or gall bladder
R if you have jaundice
R if you have diabetes
R if you have depression
R if you have Crohn’s disease or inflammatory bowel disease
(ulcerative colitis)

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Packaging Technology Berlin dy
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

R if you have a blood disease called haemolytic uraemic
syndrome (HUS) that causes kidney damage
R if you have sickle cell disease
R if you have epilepsy (see “Other medicines and Qlaira”)
R if you have a disease of the immune system called systemic
lupus erythematosus (SLE)
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
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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
Talk to your doctor before taking Qlaira.
Qlaira and venous/arterial blood clots
The following warnings and precautions are derived from studies
with combined pills containing ethinylestradiol. It is not yet
known whether or not they apply to Qlaira:
The use of any combined pill (including Qlaira) increases a
woman’s risk of developing a venous blood clot (venous
thrombosis) compared with women who do not take any
contraceptive pill.

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Packaging Technology Berlin dy
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

Very occasionally, blood clots may cause serious permanent
disabilities or may even be fatal. The main locations of blood clots
are, for example, the veins of the legs (venous thrombosis), the
arteries of the heart (heart attack), the lungs (pulmonary
embolism) or the brain (stroke).
The risk of venous blood clots in users of combined pills
increases:
R with increasing age
R if you are overweight
R if one of your close relatives had a blood clot in the leg, lung
(pulmonary embolism), or other organ at a young age
R if you need surgery, if you have had a serious accident or if
you have any prolonged period of immobilisation. It is
important to tell your doctor that you are using Qlaira as the
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

treatment may have to be stopped. Your doctor will tell you
when to start Qlaira again. This is usually about two weeks
after you have recovered.
The use of combined pills has been linked to an increased risk of
an arterial blood clot (arterial thrombosis), for example, in
the blood vessels of the heart (heart attack) or the brain (stroke).
The risk of arterial blood clots in users of combined pills
increases:
R with increasing age
R if you smoke. You are strongly advised to stop smoking
when you use the pill, especially if you are over 35 years
old
R if you have a high level of blood cholesterol or triglycerides
R if you are overweight

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Packaging Technology Berlin dy
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

R if one of your close relatives ever had a heart attack or stroke
at a young age
R if you have high blood pressure
R if you suffer from migraine
R if you have a problem with your heart (valve disorder, a
disturbance of the heart rhythm)
Stop taking Qlaira and contact your doctor immediately if
you notice possible signs of a blood clot or a stroke such
as:
R severe pain and/or swelling in one of your legs
R sudden severe pain in the chest which may spread to the
left arm
R sudden breathlessness
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

R sudden cough with no obvious cause
R any unusual, severe or long-lasting headache, or worsening
of migraines
R partial or complete blindness, or double vision
R difficulty in speaking, or inability to speak
R giddiness or fainting
R weakness, strange feeling, or numbness in any part of your
body
R sudden severe stomach ache
Directly after giving birth, women are at an increased risk of blood
clots so you should ask your doctor how soon after delivery you
can start taking a combined pill.

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Packaging Technology Berlin dy
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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 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 lifethreatening internal bleeding. Contact your doctor if you have
unusually severe abdominal pain.

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Packaging Technology Berlin dy
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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.

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Packaging Technology Berlin dy
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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
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.

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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
your doctor immediately. Do not start the next wallet until you
are sure that you are not pregnant.

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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:
R medicines used for the treatment of:
– epilepsy (e.g. primidone, phenytoin, barbiturates,
carbamazepine, oxcarbazepine, topiramate, felbamate)
– tuberculosis (e.g. rifampicin)
– HIV infections (e.g. ritonavir, nevirapine) other infections
(antibiotics such as penicillins, tetracyclines, griseofulvin).
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

R 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:
R anti-fungal medicines containing ketoconazole
R antibiotics containing erythromycin
R Qlaira may influence the effect of other medicines, e.g.
– medicines containing cyclosporin
– the anti-epileptic lamotrigine (this could lead to an
increased frequency of seizures).
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.

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item-no.: 81566887
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name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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
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 breastfeeding. 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.

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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.

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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”.

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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”.
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

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item-no.: 81566887
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name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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.
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
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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
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.

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item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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.
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.

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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.
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.

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item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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.

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
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colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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.

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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)

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PZ: 2668A-4B
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colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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 tablettaking pattern take the corresponding tablet from another
wallet.

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item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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.

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Serious side effects
Serious reactions associated with the use of the pill, as well as
the related symptoms, are described in the following sections:
“Qlaira and venous/arterial blood clots” and “Qlaira and cancer”.
Please read these sections carefully and consult your doctor at
once where appropriate.
Other possible side effects
The following side effects have been linked with the use of
Qlaira:

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item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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
R depression, depressed mood, emotional disorder, problems
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

R
R
R
R
R
R
R

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sleeping, decreased interest in sex, mental disorder, mood
swings
dizziness, migraine
hot flush, high blood pressure
diarrhoea, vomiting
increased liver enzymes
hair loss, excessive sweating (hyperhidrosis), itching, rash
muscle cramps
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
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item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:2

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, nightmare, restlessness,
problems sleeping, stress
R reduced attention, “pins and needles”, giddiness
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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:3

R contact lens intolerance, dry eye, eye swelling
R heart attack (myocardial infarction), palpitations
R bleeding in a varicose vein, blood clot in a vein (venous
thromboembolism), low blood pressure, inflammation
of superficial veins, painful veins
R constipation, dry mouth, indigestion, heartburn
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

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:3

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
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
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PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:3

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.
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.

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item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:3

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.

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item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:3

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

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item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:3

2 dark red tablets each containing 1mg estradiol valerate
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)
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PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:3

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.

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:3

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
Manufacturer
Bayer Weimar GmbH und Co. KG and Bayer Pharma AG
99427 Weimar
13342 Berlin
Germany
Germany

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:3

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 07/2013.

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PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:3

81566887

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client: 0086
item-no.: 81566887
PZ: 2668A-4B
name: LF-BRO-Qlaira FTB 28
colors: Black /
version: 25.07.2013/05
approval:

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

25.07.2013 12:05:3

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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