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YASMINELLE 0.02 MG / 3 MG FILM-COATED TABLETS

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0.02 mg/3mg film-coated tablets
Ethinylestradiol/Drospirenone

— 21 film-coated
tablets
— oral use

81540667

PACKAGE LEAFLET: INFORMATION FOR THE USER

Yasminelle
0.02 mg / 3 mg film-coated tablets
Ethinylestradiol / Drospirenone

b
(1]

Read all of this leaflet carefully before you start taking this
medicine.
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, do not pass it on to
others. It may harm them.
R If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

C
[2)

In this leaflet
1. WHAT YASMINELLE IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE YASMINELLE
When you should not use Yasminelle
When to take special care with Yasminelle
Yasminelle and venous and arterial blood clots
Yasminelle and cancer
Bleeding between periods
What to do if no bleeding occurs during the gap week
Yasminelle and using other medicines
Taking Yasminelle with food and drink
Laboratory tests
Pregnancy
Breast-feeding

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17
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(3]

Driving and using machines
Important information about some of the ingredients of
Yasminelle
3. HOW TO TAKE YASMINELLE?
When can you start with the first strip?
If you take more Yasminelle than you should
If you forget to take Yasminelle
What to do in the case of vomiting or severe diarrhoea
Delaying your period: what you need to know
Changing the first day of your period: what you need to know
If you want to stop taking Yasminelle
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE YASMINELLE?
6. FURTHER INFORMATION
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[4)

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27
32
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34
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39
40

1. WHAT YASMINELLE IS AND WHAT IT IS USED FOR
R Yasminelle is a contraceptive pill and is used to prevent
pregnancy.
R Each tablet contains a small amount of two different female
hormones, namely drospirenone and ethinylestradiol.
R Contraceptive pills that contain two hormones are called
“combination” pills.

2. BEFORE YOU TAKE YASMINELLE
General notes
Before you can begin taking Yasminelle, 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.
f
(5]

In this leaflet, several situations are described where you should
stop using Yasminelle, or where the reliability of Yasminelle
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 Yasminelle alters the monthly changes of
body temperature and of the cervical mucus.
Yasminelle, like other hormonal contraceptives, does not
protect against HIV infection (AIDS) or any other sexually
transmitted disease.
When you should not use Yasminelle
Do not take Yasminelle:
R if you have (or have ever had) a blood clot in a blood vessel of
the leg (thrombosis), lung (pulmonary embolism) or other
organs
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[6)

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 of a heart attack in the future (for example, angina
pectoris, which causes severe pain in the chest) or of a stroke
(for example, a passing slight stroke with no residual effects)
R if you have a disease that may increase the risk of a clot in the
arteries. This applies to the following diseases:
P diabetes with damaged blood vessels
P very high blood pressure
P a very high level of fat in the blood (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) a certain form of migraine (with
so-called focal neurological symptoms)
h
(7]

R if you have (or have ever had) a liver disease and your liver
function is still not normal
R if your kidneys are not working well (renal failure)
R if you have (or have ever had) a tumour in the liver
R if you have (or have ever had) or if you are suspected of having
breast cancer or cancer of the genital organs
R if you have any unexplained bleeding from the vagina
R if you are allergic to ethinylestradiol or drospirenone, or any
of the other ingredients of Yasminelle. This may cause itching,
rash or swelling.

I
[8)

When to take special care with Yasminelle
In some situations you need to take special care while using
Yasminelle or any other combination pill, and your doctor may
need to examine you regularly. If any of the following conditions
applies to you, tell your doctor before starting to use Yasminelle.
Also, if any of the following applies or if any of the conditions
develops or worsens while you are using Yasminelle consult your
doctor:
R if a close relative has or has ever had breast cancer
R if you have a disease of the liver or the gallbladder
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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(9]

R if you have a blood disease called HUS (haemolytic uraemic
syndrome) which causes kidney damage
R if you have a blood disease called sickle cell anaemia
R if you have epilepsy (see page 19 “Yasminelle and using other
medicines”)
R if you have a disease of the immune system called SLE
(systemic lupus erythematosus)
R if you have a disease that first appeared during pregnancy or
earlier use of sex hormones (for example, hearing loss, a blood
disease called porphyria, skin rash with blisters during
pregnancy (gestational herpes), a nerve disease causing
sudden movements of the body (Sydenham’s chorea)
R if you have or have ever had chloasma (a discolouration of the
skin especially of the face or neck known as “pregnancy
patches”). If so, avoid direct sunlight or ultraviolet light.
[10)

R if you have hereditary angioedema, products containing
oestrogens may cause or worsen symptoms. You should see
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.
Yasminelle and venous and arterial blood clots
The use of any combination pill, including Yasminelle, increases a
woman’s risk of developing a venous blood clot (venous
thrombosis) compared with women who do not take any
contraceptive pill.

(11]

The risk of venous blood clots in users of combination pills
increases:
R with increasing age
R if you are overweight
R if one of your close relatives ever had a blood clot in the leg,
lung (pulmonary embolism), or other organ at a young age
R if you have to have surgery, if you have had a serious accident
or if you are immobilized for a long time. It is important to tell
your doctor that you are using Yasminelle as you may have to
stop taking it. Your doctor will tell you when to start again.
This is usually about two weeks after you are back on your
feet.

[12)

Your chances of having a blood clot are increased by taking the
Pill.
R Of 100,000 women who are not on the Pill and not pregnant,
about 5-10 may have a blood clot in a year.
R Of 100,000 women taking a Pill like Yasminelle, 30-40 may
have a blood clot in a year, the exact number is unknown.
R Of 100,000 women who are pregnant, around 60 may have a
blood clot in a year.
A blood clot in the veins may travel to the lungs and may block
blood vessels (called a lung embolus). Formation of blood clots in
the veins may be fatal in 1-2% of cases.
The level of risk may vary according to the type of pill you take.
Discuss with your doctor the available options.
The use of combination pills has been connected with an increase
of the risk of an arterial blood clot (arterial thrombosis), for
(13]

example, in the blood vessels of the heart (heart attack) or the
brain (stroke).
The risk of an arterial blood clot in users of combination pills
increases:
R if you smoke. You are strongly advised to stop smoking
when you use Yasminelle, especially if you are older than
35 years.
R if the fat content of your blood is increased (cholesterol or
triglycerides)
R if you are overweight
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
[14)

R if you have a problem with your heart (valve disorder, a
disturbance of the cardiac rhythm)

(15]

Stop taking Yasminelle and contact your doctor immediately
if you notice possible signs of a blood clot, such as:
R severe pain and/or swelling in one of your legs
R sudden severe pain in the chest which may reach the left
arm
R sudden breathlessness
R sudden cough without an obvious cause
R any unusual, severe or long-lasting headache or worsening
of migraine
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 the
body
[16)

Yasminelle and cancer
Breast cancer has been observed slightly more often in women
using combination pills, but it is not known whether this is
caused by the treatment. For example, it may be that more
tumours are detected in women on combination pills because
they are examined by their doctor more often. The occurrence of
breast tumours becomes gradually less after stopping the
combination hormonal contraceptives. It is important to regularly
check your breasts and you should contact your doctor if you feel
any lump.
In rare cases, benign liver tumours, and in even fewer cases
malignant liver tumours have been reported in pill users. Contact
your doctor if you have unusually severe abdominal pain.
Bleeding between periods
During the first few months that you are taking Yasminelle you
may have unexpected bleeding (bleeding outside the gap week). If
(17]

this bleeding occurs for more than a few months, or if it begins
after some months, your doctor must find out what is wrong.
What to do if no bleeding occurs during the gap week
If you have taken all the tablets correctly, have not had 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 succession, you
may be pregnant. Contact your doctor immediately. Do not start
the next strip until you are sure that you are not pregnant.

[18)

Yasminelle and using other medicines
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) that you use
Yasminelle. 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 Yasminelle less effective in preventing
pregnancy, or can cause unexpected bleeding. These include:
R medicines used for the treatment of
P epilepsy (e.g. primidone, phenytoin, barbiturates,
carbamazepine, oxcarbazepine)
P tuberculosis (e.g. rifampicin)
P HIV infections (ritonavir, nevirapine) or other infections
(antibiotics such as griseofulvin, penicillin, tetracycline)
(19]

P high blood pressure in the blood vessels in the lungs
(bosentan)
R the herbal remedy St. John’s wort
Yasminelle may influence the effect of other medicines, e.g.
R medicines containing ciclosporin
R the anti-epileptic lamotrigine (this could lead to an increased
frequency of seizures)
Ask your doctor or pharmacist for advice before taking any medicine.
Taking Yasminelle with food and drink
Yasminelle may be taken with or without food, if necessary with a
small amount of water.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff
[20)

that you are taking the pill, because hormone contraceptives can
affect the results of some tests.
Pregnancy
If you are pregnant, do not take Yasminelle. If you become
pregnant while taking Yasminelle stop immediately and contact
your doctor. If you want to become pregnant, you can stop taking
Yasminelle at any time (see also page 34 “If you want to stop taking
Yasminelle”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Yasminelle is generally not advisable when a woman is
breast-feeding. If you want to take the pill while you are breastfeeding you should contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
(21]

Driving and using machines
There is no information suggesting that use of Yasminelle affects
driving or use of machines.
Important information about some of the ingredients of
Yasminelle
Yasminelle contains lactose.
If you cannot tolerate certain sugars, contact your doctor before
you take Yasminelle.

3. HOW TO TAKE YASMINELLE?
Take one tablet of Yasminelle 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 every day around the same time.
The strip contains 21 tablets. Next to each tablet is printed the
day of the week that it should be taken. If, for example you start
[22)

on a Wednesday, take a tablet with “WED” next to it. Follow the
direction of the arrow on the strip until all 21 tablets have been
taken.
Then take no tablets for 7 days. In the course of these 7 tabletfree days (otherwise called a stop or gap week) bleeding should
begin. This so-called “withdrawal bleeding” usually starts on the
2nd or 3rd day of the gap week.
On the 8th day after the last Yasminelle tablet (that is, after the
7-day gap week), you should start with the following strip,
whether your bleeding has stopped or not. This means that you
should start every strip on the same day of the week and that the
withdrawal bleed should occur on the same days each month.
If you use Yasminelle in this manner, you are also protected
against pregnancy also during the 7 days when you are not
taking a tablet.
(23]

When can you start with the first strip?
R If you have not used a contraceptive with hormones in the
previous month
Begin with Yasminelle on the first day of the cycle (that is the
first day of your period). If you start Yasminelle on the first
day of your period you are immediately protected against
pregnancy. You may also begin on day 2-5 of the cycle, but
then you must use extra protective measures (for example, a
condom) for the first 7 days.
R Changing from a combination hormonal contraceptive, or
combination contraceptive vaginal ring or patch
You can start Yasminelle preferably on the day after the last
active tablet (the last tablet containing active substances) of
your previous pill, but at the latest on the day after the tabletfree days of your previous pill (or after the last inactive tablet
of your previous pill). When changing from a combination
[24)

contraceptive vaginal ring or patch, follow the advice of your
doctor.
R Changing from a progestogen-only-method (progestogen-only
pill, injection, implant or a progestogen-releasing IUD)
You may switch any day from the progestogen-only pill (from
an implant or an IUD on the day of its removal, from an
injectable when the next injection would be due) but in all of
these cases use extra protective measures (for example, a
condom) for the first 7 days of tablet-taking.
R After a miscarriage
Follow the advice of your doctor.
R After having a baby
You can start Yasminelle between 21 and 28 days after having
a baby. If you start later than day 28, use a so-called barrier
method (for example, a condom) during the first seven days of
Yasminelle use.
(25]

If, after having a baby, you have had sex before starting
Yasminelle (again), be sure that you are not pregnant or wait
until your next period.
R If you are breast-feeding and want to start Yasminelle (again)
after having a baby
Read the section on “Breast-feeding”, page 21.
Ask your doctor what to do if you are not sure when to start.
If you take more Yasminelle than you should
There are no reports of serious harmful results of taking too
many Yasminelle tablets.
If you take several tablets at once then you may have symptoms
of nausea or vomiting. Young girls may have bleeding from the
vagina.

[26)

If you have taken too many Yasminelle tablets, or you discover
that a child has taken some, ask your doctor or pharmacist for
advice.
If you forget to take Yasminelle
R If you are less than 12 hours late taking a tablet, the
protection against pregnancy is not reduced. Take the tablet
as soon as you remember and then take the following 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. The greater the
number of tablets that you have forgotten, the greater is the
risk of becoming pregnant.

(27]

The risk of incomplete protection against pregnancy is greatest if
you forget a tablet at the beginning or at the end of the strip.
Therefore, you should keep to the following rules (see the
diagram on page 31):
R More than one tablet forgotten in this strip
Contact your doctor.
R One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if that
means that you have to take two tablets at the same time.
Continue taking the tablets at the usual time and use extra
precautions for the next 7 days, for example, a condom. If you
have had sex in the week before forgetting the tablet you may be
pregnant. In that case, contact your doctor.

[28)

R One tablet forgotten in week 2
Take the forgotten tablet as soon as you remember, even if that
means that you have to take two tablets at the same time.
Continue taking the tablets at the usual time. The protection
against pregnancy is not reduced, and you do not need to take
extra precautions.
R One tablet forgotten in week 3
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that
means that you have to take two tablets at the same time.
Continue taking the tablets at the usual time. Instead of taking
the tablet-free period start the next strip.
Most likely, you will have a period at the end of the second strip
but you may have light or menstruation-like bleeding during
the second strip.
(29]

2. You can also stop the strip and go directly to the tablet-free
period of 7 days (record the day on which you forgot your
tablet). If you want to start a new strip on the day you always
start, make the tablet-free period less than 7 days.
If you follow one of these two recommendations, you will remain
protected against pregnancy.
R If you have forgotten any of the tablets in a strip, and you do
not have a bleeding during the first tablet-free period, you
may be pregnant. Contact your doctor before you start the
next strip.

[30)

More than
1 tablet
forgotten in
1 strip

Only 1
tablet
forgotten
(taken
more than
12 hours
late)

in week 1

Ask your doctor for advice
yes
Had sex in the previous week before forgetting?
no
R Take the forgotten tablet
R Use a barrier method (condom) for the
following 7 days and
R Finish the strip

in week 2

R Take the forgotten tablet
R Finish the strip

in week 3

R Take the forgotten tablet and
R Finish the strip
R Instead of the gap week
R Start the next strip
or
R Stop the strip immediately
R Begin the gap week (not longer than 7 days,
including the forgotten tablet)
R Then start the next strip
(31]

What to do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours after taking a tablet or you have
severe diarrhoea, there is a risk that the active substances in the
pill will not be fully taken up by your body. The situation is
almost the same as forgetting a tablet. After vomiting or
diarrhoea, take another tablet from a reserve strip as soon as
possible. If possible take it within 12 hours of when you normally
take your pill. If that is not possible or 12 hours have passed, you
should follow the advice given under “If you forget to take
Yasminelle”, page 27.
Delaying your period: what you need to know
Even though it is not recommended, you can delay your period by
going straight to a new strip of Yasminelle instead of the tabletfree period and finishing it. You may experience light or
menstruation-like bleeding while using this second strip. After the
usual tablet-free period of 7 days, start the next strip.
[32)

You might ask your doctor for advice before deciding to delay
your menstrual period.
Changing the first day of your period: what you need to know
If you take the tablets according to the instructions, then your
period will begin during the tablet-free week. If you have to
change this day, reduce the number of tablet-free days (but never
increase them - 7 is the maximum!). For example, if your tabletfree days normally begin on a Friday, and you want to change
this to a Tuesday (3 days earlier) start a new strip 3 days earlier
than usual. If you make the tablet-free interval very short (for
example, 3 days or less) you may not have any bleeding during
these days. You may then experience light or menstruation-like
bleeding.
If you are not sure what to do, consult your doctor.

(33]

If you want to stop taking Yasminelle
You can stop taking Yasminelle whenever you want. If you do not
want to become pregnant, ask your doctor for advice about other
reliable methods of birth control. If you want to become
pregnant, stop taking Yasminelle and wait for a period before
trying 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Yasminelle can cause side effects although not
everybody gets them.
The following is a list of the side effects that have been linked
with the use of Yasminelle.
[34)

Serious side effects – stop taking the tablets and see a doctor
straight away.
Signs of a severe allergic reaction to Yasminelle:
sudden swelling of the skin and/or mucous membranes (e.g.
tongue or throat), and/or difficulty swallowing or hives together
with difficulty breathing (angioedema).
Common side effects (between 1 and 10 in every 100 users may
be affected):
R mood swings
R headache
R abdominal pain (stomach ache)
R acne
R breast pain, breast enlargement, breast tenderness, painful or
irregular periods
(35]

R weight gain
Uncommon side effects (between 1 and 10 in every 1,000 users
may be affected):
R Candida (fungal infection)
R cold sores (herpes simplex)
R allergic reactions
R increased appetite
R depression, nervousness, sleep disorder
R feeling of ‘pins and needles’, giddiness (vertigo)
R problems with vision
R irregular heart beat or unusually fast heart rate
R a blood clot (thrombosis) in a vessel of the leg or the lungs
(pulmonary embolism)- for signs of a blood clot see page 16.
[36)

R high blood pressure, low blood pressure, migraine, varicose
veins
R sore throat
R nausea, vomiting, inflammation of stomach and/or intestine,
diarrhoea, constipation
R hair loss (alopecia), eczema, itching, rashes, dry skin, oily skin
disorders (seborrhoeic dermatitis)
R neck pain, limb pain, muscle cramps
R bladder infection
R breast lump (benign and cancer), milk production while not
pregnant (galactorrhoea), ovarian cysts, hot flushes, absence
of periods, very heavy periods, vaginal discharge, vaginal
dryness, lower abdominal (pelvic) pain, abnormal cervical
smear (Papanicolaou or Pap smear), decreased interest in sex
(37]

R fluid retention, lack of energy, excessive thirst, increased
sweating
R weight loss.
Rare side effects (between 1 and 10 in every 10,000 users may be
affected):
R asthma
R hearing impairment
R blockage of a blood vessel by a clot formed elsewhere in the
body
R erythema nodosum (characterised by painful reddish skin
nodules)
R erythema multiforme (rash with target-shaped reddening or
sores).

[38)

If any of the side effects gets serious or if you notice any side effects
not listed in this leaflet or if you think that this may be the case,
please tell your doctor or pharmacist.

5. HOW TO STORE YASMINELLE?
Keep Yasminelle out of the reach and sight of children.
This medical product does not require any special storage
conditions
Expiry date
Do not take Yasminelle after the date on the packaging after “Do not
use after:” or “ EXP.:”
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the
environment.
(39]

6. FURTHER INFORMATION
What Yasminelle contains
R The active substances are ethinylestradiol (as betadex
clathrate) and drospirenone.
Each tablet contains 0.020 milligram ethinylestradiol (as
betadex clathrate) and 3 milligram drospirenone.
R Other ingredients (excipients) are lactose monohydrate, maize
starch, magnesium stearate (E470b), hypromellose (E464),
talc (E553b), titanium dioxide (E171) and iron oxide red (E172).
What Yasminelle looks like and content of the pack
R Each blister of Yasminelle contains 21 light pink, film-coated
tablets.
R Yasminelle tablets are film-coated tablets; the core of the
tablet is coated. The tablets are light pink, round with convex
[40)

surfaces, one side is embossed with the letters “DS” in a
regular hexagon.
R Yasminelle is available in packs of 1, 3, 6 and 13 blisters each
with 21 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA

(41]

Manufacturer
Bayer Pharma AG, 13342 Berlin, Germany and
Bayer Weimar GmbH und Co. KG
Döbereinerstr. 20
99427 Weimar, Germany
This medicinal product is authorised in the Member States of the
EEA under the following names:
R Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom:
Yasminelle
R Hungary: Aliane
R France: Jasminelle
Date of the last revision of this booklet December 2012
[42)

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81540667

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