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YASMIN ED 0.03 MG/3 MG FILM-COATED TABLETS

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Package Booklet:
Information for the user

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

United Kingdom 80666616

Read all of this booklet carefully before you start taking this
medicine.
 Keep this booklet, you may need to read it again.
 If you have any further questions, ask your doctor or
pharmacist.
 This medicine has been prescribed for you, do not pass it on to
others. It may harm them.
 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.




In this booklet
1. What Yasmin ED is and what it is used for
2. Before you take Yasmin ED
When you should not take Yasmin ED
When to take special care with Yasmin ED
Yasmin ED and venous and arterial blood clots
Yasmin ED and cancer
Bleeding between periods
What to do if no bleeding occurs during the
placebo days
Yasmin ED and using other medicines


5
6
8
11
14
20
21
21
22

Taking Yasmin ED with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
Important information about some of the
ingredients of Yasmin ED

24
24
25
25
26

3. How to take Yasmin ED
Preparation of the strip
When can you start with the first strip?
If you take more Yasmin ED than you should

27
28
30
34

26




If you forget to take Yasmin ED
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 Yasmin ED
4. Possible side effects

35
41
42
43
44
45

5. How to store Yasmin ED

49

6. Further information

50




1. What Yasmin ED is and what it is used for
 Yasmin ED is a contraceptive pill and is used to prevent
pregnancy.
 Each of the 21 light yellow tablets contains a small amount of
two different female hormones, namely drospirenone and
ethinylestradiol.
 The 7 white tablets contain no active substances and are also
called placebo tablets.
 Contraceptive pills that contain two hormones are called
“combination” pills.



2. Before you take Yasmin ED
General notes
Before you can begin taking Yasmin ED, 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 Yasmin ED, or where the reliability of Yasmin ED 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 Yasmin ED alters the monthly
changes of body temperature and cervical mucus.
Yasmin ED, like other hormonal contraceptives, does not
protect against HIV infection (AIDS) or any other sexually
transmitted disease.



When you should not take Yasmin ED
Do not take Yasmin ED 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
 (or have ever had) a heart attack or stroke
 (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)



 a disease that may increase the risk of a blood clot in the
arteries such as:
 diabetes with damaged blood vessels
 very high blood pressure
 a very high level of fat in the blood (cholesterol or
triglycerides)
 a disturbance of blood clotting (for example, protein C
deficiency)
 (or have ever had) a certain form of migraine (with so-called
focal neurological symptoms)
 (or have ever had) an inflammation of the pancreas
(pancreatitis)



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



When to take special care with Yasmin ED
In some situations you need to take special care while using
Yasmin ED or any other combination pill, and your doctor may
need to examine you regularly. If any of the following conditions
apply to you, tell your doctor before starting to use Yasmin ED.
Consult your doctor if any of the following applies or if any of the
conditions develops or worsen while you are taking Yasmin ED:
If you have:
 a close relative who has ever had breast cancer
 a disease of the liver or the gallbladder
 diabetes
 depression


 Crohn’s disease or inflammatory bowel disease (ulcerative
colitis)
 a blood disease called HUS (haemolytic uraemic syndrome)
that causes kidney damage
 a blood disease called sickle cell anaemia
 epilepsy (see page 22 “Yasmin ED and using other medicines”)
 a disease of the immune system called SLE (systemic lupus
erythematosus)
 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)
 ever had a discolouration of the skin especially on the face or
neck known as “pregnancy patches” (chloasma). If so, avoid
direct sunlight or ultraviolet light.
 hereditary angioedema, products containing oestrogens may
cause or worsen the 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.



Yasmin ED and venous and arterial blood clots
The use of any combination pill, including Yasmin ED, increases a
woman’s risk of developing a venous blood clot (venous
thrombosis) compared with women who do not take any
contraceptive pill.
The risk of a venous blood clot in users of combination pills
increases:
 with increasing age
 if you are overweight
 if one of your close relatives has ever had a blood clot in the
leg, lung (pulmonary embolism), or other organ at a young
age


 if you need to have surgery, if you have had a serious accident
or if you are immobilised for a long time. It is important to tell
your doctor that you are taking Yasmin ED 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.
Your chances of having a blood clot are increased by taking the
Pill.
 Of 100,000 women who are not on the Pill and not pregnant,
about 5-10 may have a blood clot in a year.
 Of 100,000 women taking a Pill like Yasmin ED, 30-40 may
have a blood clot in a year, the exact number is unknown.


 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
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 if you:
 smoke. You are strongly advised to stop smoking when
you use Yasmin ED, especially if you are older than
35 years.
 have an increased fat content of your blood (cholesterol or
triglycerides)
 are overweight
 have a close relative who ever had a heart attack or stroke at
a young age
 have high blood pressure
 suffer from migraine


 have a problem with your heart (valve disorder, a disturbance
of the cardiac rhythm)
Stop taking Yasmin ED and contact your doctor
immediately if you notice possible signs of a blood clot,
such as:
 severe pain and/or swelling in one of your legs
 sudden severe pain in the chest which may reach the left
arm
 sudden breathlessness
 sudden cough without an obvious cause
 any unusual, severe or long-lasting headache or worsening
of migraine


 partial or complete blindness or double vision
 difficulty in speaking or inability to speak
 giddiness or fainting
 weakness, strange feeling, or numbness in any part of the
body



Yasmin ED 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 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 pill users. Contact
your doctor if you have unusually severe abdominal pain.


Bleeding between periods
During the first few months that you are taking Yasmin ED, you
may have unexpected bleeding (bleeding outside the placebo
days). If this bleeding occurs for more than a few months, or if it
begins after some months, contact your doctor as they must find
out if anything is wrong.
What to do if no bleeding occurs during the placebo days
If you have taken all the light yellow active 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. Only start
the next strip if you are sure that you are not pregnant.



Yasmin ED 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 are
taking Yasmin ED. 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 Yasmin ED less effective in
preventing pregnancy, or can cause unexpected bleeding.
These include medicines used for the treatment of
 epilepsy (e.g. primidone, phenytoin, barbiturates,
carbamazepine, oxcarbazepine)
 tuberculosis (e.g. rifampicin)
 HIV infections (ritonavir, nevirapine) or other infections
(antibiotics such as griseofulvin, penicillin, tetracycline)
 high blood pressure in the blood vessels in the lungs
(bosentan)
 the herbal remedy St. John’s wort


 Yasmin ED may influence the effect of other medicines, e.g.
 medicines containing ciclosporin
 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 Yasmin ED with food and drink
Yasmin ED 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
that you are taking the pill, because hormonal contraceptives can
affect the results of some tests.


Pregnancy
If you are pregnant, do not take Yasmin ED. If you become
pregnant while taking Yasmin ED stop taking it immediately and
contact your doctor. If you want to become pregnant, you can
stop taking Yasmin ED at any time (see also page 44 “If you want to
stop taking Yasmin ED”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Yasmin ED 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.


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



3. How to take Yasmin ED
Each blister contains 21 active light yellow tablets and 7 white
placebo tablets.
The two differently coloured tablets of Yasmin ED are arranged in
order. A strip contains 28 tablets.
Take one tablet of Yasmin ED 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.
Do not confuse the tablets: take a light yellow tablet for the
first 21 days and then a white tablet for the last 7 days.
Then start a new strip straightaway (21 light yellow and then 7
white tablets). There is therefore no gap between two strips.


Because of the different composition of the tablets it is necessary
to begin with the first tablet on the upper left and take the
tablets every day. For the correct order, follow the direction of the
arrows on the strip.
Preparation of the strip
To help you keep track, there are 7 stickers each with the 7 days of
the week for each strip of Yasmin ED. Choose the week sticker
that starts with the day you begin taking the tablets. For
example, if you start on a Wednesday, use the week sticker that
starts with “WED”.
Stick the memo sticker along the top of the Yasmin ED strip where
it reads “Place memo strip here”, so that the first day is above the
tablet marked “start”.


There is now a day indicated above every tablet and you can see
whether you have taken a certain pill. The arrows show the order
you are to take the pills.
During the 7 days when you are taking the white placebo tablets
(the placebo days), bleeding should begin (so-called withdrawal
bleeding). This usually starts on the 2nd or 3rd day after the last
light yellow active tablet of Yasmin ED. Once you have taken the
last white tablet, 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 Yasmin ED in this manner, you are protected against
pregnancy including during the 7 days when you are taking a
placebo tablet.
When can you start with the first strip?
 If you have not used a contraceptive with hormones in the
previous month
Begin with Yasmin ED on the first day of your cycle (that is, the
first day of your period). If you start Yasmin ED 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.


 Changing from a combination hormonal contraceptive, or
combination contraceptive vaginal ring or patch
You can start Yasmin ED preferably on the day after the last
active tablet (the last tablet containing the active substances) of
your previous pill, but at the latest on the day after the tabletfree days of your previous pill finish (or after the last inactive
tablet of your previous pill). When changing from a combination
contraceptive vaginal ring or patch, follow the advice of your
doctor.



 Changing from a progestogen-only-method (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 taking Yasmin ED.
 After a miscarriage
Follow the advice of your doctor.



 After having a baby
You can start taking Yasmin ED 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 taking Yasmin ED.
If, after having a baby, you have had sex before starting Yasmin
ED, make sure you are not pregnant or else wait until your next
period.
 If you are breast-feeding and want to start Yasmin ED after
having a baby
Read the section on “Breast-feeding”, page 25.
Ask your doctor what to do if you are not sure when to start.


If you take more Yasmin ED than you should
There are no reports of serious harmful results of taking too
many Yasmin ED tablets.
If you take several tablets at once then you may have symptoms
of nausea or vomiting. Young girls may have bleeding from the
vagina.
If you have taken too many Yasmin ED tablets, or you discover
that a child has taken some, ask your doctor or pharmacist for
advice.



If you forget to take Yasmin ED
The tablets in the 4th row of the strip are the placebo tablets. If
you forget one of these tablets, this has no effect on the
reliability of Yasmin ED. Throw away the forgotten placebo
tablet.
If you miss a light yellow, active tablet (tablets 1-21 of your
blister-strip), follow the instructions below:
 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.


 If you are more than 12 hours late taking a tablet, the
protection against pregnancy may be reduced. The greater the
number of tablets you have forgotten, the greater is the risk
of becoming pregnant.
The risk of incomplete protection against pregnancy is greatest if
you forget a light yellow tablet at the beginning or at the end of
the strip. Therefore, you should keep to the following rules (see
also the diagram on page 40):
 More than one tablet forgotten in this strip
Contact your doctor.



 One tablet forgotten between days 1 - 7 (first row)
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.
 One tablet forgotten between days 8 - 14 (second row)
Take the forgotten tablet as soon as you remember, even if that
means 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.


 One tablet forgotten between days 15 - 21 (third row)
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if
that means you have to take two tablets at the same time.
Continue taking the tablets at the usual time. Instead of taking
the white placebo tablets on this strip, throw them away, and
start the next strip.
Most likely, you will have a period at the end of the second
strip - while taking the white placebo tablets - but you may
have light or menstruation-like bleeding during the second
strip.



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



More than
1 light
yellow tablet
forgotten in
1 strip

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

Ask your doctor for advice

yes
Day 1–7

no
 Take the forgotten tablet
 Use a barrier method (condom) for the
following 7 days
 Finish strip

Day 8–14

 Take the forgotten tablet and
 Finish the strip
 Take the forgotten tablet and
 Finish taking the light yellow tablets
 Discard the 7 white tablets
 Go straight on to the next strip

Day 15–21


Had sex in the previous week before forgetting?

or

 Stop the light yellow tablets immediately
 Go on directly to the 7 white tablets
 Then go on to the next strip

What to do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking an active light yellow
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 light yellow 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 Yasmin ED” on page 35.



Delaying your period: what you need to know
Although it is not recommended, you can delay your period by not
taking the white placebo tablets from the 4th row and going
straight to a new strip of Yasmin ED and finishing it. You may
experience light or menstruation-like bleeding while using this
second strip. Finish this second strip by taking the 7 white tablets
from the 4th row. Then start your next strip.
It is advisable to consult 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 placebo days. If you have to change
this day, reduce the number of placebo days – when you take the
white placebo tablets – (but never increase them – 7 is the
maximum!). For example, if you normally start taking the placebo
tablets 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 placebo interval very short (for example, 3 days or less)
you may not have any bleeding during this time. You may then
experience light or menstruation-like bleeding.
If you are not sure what to do, consult your doctor.


If you want to stop taking Yasmin ED
You can stop taking Yasmin ED 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 Yasmin ED and wait for a menstrual 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, Yasmin ED 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 Yasmin ED:
Serious side effects (see a doctor straight away):
– signs of a blood clot (see page 14 “Yasmin ED and venous and
arterial blood clots”)
– signs of cancer (see page 20 “Yasmin ED and cancer”)
– signs of an allergic reactions (hypersensitivity ), i.e. swelling
of the face, lips, mouth, tongue or throat.


Less serious side effects starting with the more common ones:
Common side effects
(between 1 and 10 in every 100 users may be affected)
– depressive mood
– headache
– migraine
– nausea
– breast pain, breast tenderness, menstrual disorders, bleeding
between periods
– thick whitish vaginal discharge, vaginal yeast infection


Uncommon side effects
(between 1 and 10 in every 1,000 users may be affected)
– breast enlargement
– altered interest in sex
– high blood pressure, low blood pressure
– Vomiting, diarrhoea
– acne, severe itching, skin rash, hair loss (alopecia)
– vaginal infection
– fluid retention
– body weight changes


Rare side effects
(between 1 and 10 in every 10,000 users may be affected)
– hearing impairment
– asthma
– breast secretion
– blockage of a blood vessel by a clot formed elsewhere in the
body
– the skin conditions erthema nodosum (characterised by
painful reddish skin nodules) or erythema multiforme
(characterised by rash with target-shaped reddening or sores)
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 Yasmin ED
Keep Yasmin ED out of the reach and sight of children.
Do not store above 25 °C. Store in the original package.
Expiry date
Do not take Yasmin ED after the expiry date which is printed on
the pack after “ EXP.:”
The expiry date refers to the last day of that month.
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.

6. Further information
What Yasmin ED contains
Composition of the light yellow active tablets:
 The active substances are ethinylestradiol and drospirenone.
Each light yellow active tablet contains 0.030 milligrams
ethinylestradiol and 3 milligrams drospirenone .
 Other ingredients in the light yellow active tablets are
Tablet core: lactose monohydrate, maize starch,
pregelatinised maize starch, povidone K25, magnesium
stearate (E470b)


Tablet film-coating: hypromellose (E464), macrogol 6000,
talc (E553b), titanium dioxide (E 171) and iron oxide yellow
(E 172).
Composition of the white placebo tablets:
 These tablets contain no active substances.
 The ingredients in the white placebo tablets are
Tablet core: lactose monohydrate, maize starch, povidone
K25, magnesium stearate (E470b)
Tablet film-coating: hypromellose (E464), talc (E553b) and
titanium dioxide (E 171).



What Yasmin ED looks like and content of the pack
 Each blister of Yasmin ED contains 21 light yellow active
tablets in the 1st, 2nd and 3rd rows of the strip and 7 white
placebo tablets in row 4.
 Yasmin ED tablets, both the light yellow and the white, are
film-coated tablets; the core of the tablet is coated.
 The light yellow active tablet is round with convex surfaces;
one side is embossed with the letters “DO” in a regular
hexagon.
 The white placebo tablet is round with convex surfaces; one
side is embossed with the letters “DP” in a regular hexagon.


 Yasmin ED is available in packs of 1, 3, and 6 blisters each with

28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire.
RG14 1JA.
Manufacturer
Bayer Pharma AG
13342 Berlin, Germany



This medicinal product is authorised in the Member States of the
EEA under the following names:
 Denmark, Iceland, Netherlands, Norway, Sweden: Yasmin 28
 Spain: Yasmin Diario
 United Kingdom: Yasmin ED
This leaflet was last revised in March 2012

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United Kingdom 80666616

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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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