YASMIN 0.03 MG/3 MG FILM-COATED TABLETS

Active substance: ETHINYLESTRADIOL

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Yasmin® 0.03 mg/3 mg Film-Coated Tablets
(ethinylestradiol/drospirenone)
Patient Information Leaflet
This medicine is available using the above name but will be
referred to as Yasmin throughout this leaflet.
Read all of this leaflet carefully before you start taking this
medicine.
- Keep this leaflet, 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 leaflet
1. What Yasmin is and what it is used for
2. Before you take Yasmin
When you should not use Yasmin
When to take special care with Yasmin
Yasmin and venous and arterial blood clots
Yasmin and cancer
Bleeding between periods
What to do if no bleeding occurs during the
seven pill-free days
Yasmin and using other medicines
Taking Yasmin with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
Important information about some of the
ingredients of Yasmin
3. How to take Yasmin
When can you start with the first strip?
If you take more Yasmin than you should
If you forget to take Yasmin
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
4. Possible side effects
5. How to store Yasmin
6. Further information
1. WHAT YASMIN IS AND WHAT IT IS USED FOR
● Yasmin is a contraceptive pill and is used to prevent
pregnancy.
● Each light yellow tablet contains a small amount of two
different female hormones, namely drospirenone and
ethinylestradiol.
● Contraceptive pills that contain two hormones are
called “combination” pills.
2. BEFORE YOU TAKE YASMIN
General notes
Before you can begin taking Yasmin, 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, or where the reliability of Yasmin
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 alters the
monthly changes of body temperature and cervical mucus.
Yasmin, like other hormonal contraceptives, does not
protect against HIV infection (AIDS) or any other sexually
transmitted disease.
When you should not use Yasmin
Do not take Yasmin
● 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
● if you have (or have ever had) a heart attack or stroke
● 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)
● if you have a disease that may increase the risk of a
blood clot in the arteries. This applies to the following
diseases:
- diabetes with damaged blood vessels
- very high blood pressure
- a very high level of fat in the blood (cholesterol or
triglycerides)
● if you have a disturbance of blood clotting (for example,
protein C deficiency)
● if you have (or have ever had) a certain form of migraine
(with so-called focal neurological symptoms)
● if you have (or have ever had) an inflammation of the
pancreas (pancreatitis)
● if you have (or have ever had) liver disease and your
liver function is still not normal
● if your kidneys are not working well (renal failure)
● if you have (or have ever had) had a tumour in the liver
● if you have (or have ever had) or if you are suspected of
having breast cancer or cancer of the genital organs
● if you have any unexplained bleeding from the vagina
● if you are allergic to ethinylestradiol or drospirenone, or
any of the other ingredients of Yasmin. This may cause
itching, rash or swelling.
When to take special care with Yasmin
In some situations you need to take special care while using
Yasmin 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 Yasmin.
Also, if any of the following applies or if any of the conditions
develops or worsens while you are taking Yasmin consult your
doctor:
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 section “Yasmin 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, yellowing of the skin
or eyes (jaundice), itching of the whole body (pruritis),
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 and venous and arterial blood clots
The use of any combination pill, including Yasmin, 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
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, 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, 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 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
● severe pain in the abdomen (known as acute
abdomen)
Yasmin 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, you
may have unexpected bleeding (bleeding outside the seven
pill-free 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 seven pill-free
days
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. Only
start the next strip if you are sure that you are not pregnant.
Yasmin 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. 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 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 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 with food and drink
Yasmin 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. If you become
pregnant while taking Yasmin stop taking it immediately and
contact your doctor. If you want to become pregnant, you can
stop taking Yasmin at any time (see also section “If you want
to stop taking Yasmin”).
Ask your doctor or pharmacist for advice before taking any
medicine.
Breast-feeding
Use of Yasmin 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 affects
driving or the use of machines.
Important information about some of the ingredients of
Yasmin
Yasmin contains lactose.
If you cannot tolerate certain sugars, contact your doctor
before you take Yasmin.
3. HOW TO TAKE YASMIN
Take Yasmin every day for 21 days
Yasmin comes in strips of 21 pills, each marked with a day of
the week.
● Take your pill at the same time every day.
● Start by taking a pill marked with the correct day of the
week.
● Follow the direction of the arrows on the strip. Take one
pill each day, until you have finished all 21 pills.
● Swallow each pill whole, with water if necessary. Do not
chew the pill.
The days of the week are shown in Dutch and are translated as
follows:
MA
DI
WO
DO
VR
ZA
ZO
Mon
Tue
Wed
Thu
Fri
Sat
Sun
Then have seven pill-free days
After you have taken all 21 pills in the strip, you have seven
days when you take no pills. So, if you take the last pill of one
pack on a Friday, you will take the first pill of your next pack on
the Saturday of the following week.
Continued overleaf

Within a few days of taking the last pill from the strip, you
should have a withdrawal bleed like a period.
This bleed may not have finished when it is time to start your
next strip of pills.
You don’t need to use extra contraception during these seven
pill-free days – as long as you have taken your pills correctly
and start the next strip of pills on time.
Then start your next strip
Start taking your next strip of Yasmin after the seven pill-free
days – even if you are still bleeding. Always start the new strip
on time.
During the seven pill-free days, when you take no tablets,
bleeding should begin (so-called withdrawal bleeding). This
usually starts on the 2nd or 3rd day after the last tablet of
Yasmin. Start the following strip after the last day of the seven
pill-free days, whether your bleeding has stopped or not.
When can you start with the first strip?
● If you have not used a contraceptive with hormones in
the previous month
Begin with Yasmin on the first day of your cycle (that is, the
first day of your period). If you start Yasmin 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 preferably on the day after the last
active tablet (the last tablet containing the active
substances) of your previous pill, but at the latest on the
day after the tablet-free days of your previous pill 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 intrauterine system IUS)
You may switch any day from the progestogen-only pill
(from an implant or an IUS on the day of its removal, from
an injectable when the next injection would be due) but in
all of these cases use extra protective measures (for
example, a condom) for the first 7 days of taking Yasmin.
● After a miscarriage or abortion
If you have had a miscarriage or abortion during the first
three months of pregnancy, your doctor may tell you to start
taking Yasmin straight away. This means that you will have
contraceptive protection with your first pill.
● After having a baby
You can start taking Yasmin 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.
If, after having a baby, you have had sex before starting
Yasmin (again), you must first be sure that you are not
pregnant or wait until your next period.
● If you are breast-feeding and want to start Yasmin after
having a baby
Read the section on “Breast-feeding”.
Ask your doctor what to do if you are not sure when to start.
If you take more Yasmin than you should
There are no reports of serious harmful results of taking too
many Yasmin 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 tablets, or you discover that
a child has taken some, ask your doctor or pharmacist for
advice
If you forget to take Yasmin
● 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 tablet at the beginning or at the end of the strip.
Therefore, you should keep to the following rules (see also the
diagram below):
● More than one tablet forgotten in this strip
Contact your doctor.
● One tablet forgotten between days 1 - 7
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
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. If you forget more than
one tablet use an additional barrier method such as a
condom for 7 days.
● One tablet forgotten between days 15 - 21
● 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 having seven pill-free days start the next strip as soon as
you have taken the last tablet.
Most likely, you will have a period at the end of the second
strip – but you may also have light or menstruation-like
bleeding during the second strip.
2. You can also stop the tablets and go directly to the
tablet-free period (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.
● 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.
More than 1 tablet
forgotten in 1 strip

Yes

Had sex in the previous week before
forgetting?

● Take the forgotten tablet
● Use a barrier method (condom)

the following 7 days and
strip

for

● Finish

Days 8-14

● Take the forgotten
● Finish the strip

tablet

● Take the forgotten tablet and
● Finish the strip
● Instead of the 7 tablet-free days
● Start the next strip

Days 15-21

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 seven pill-free days. If you have to
change this day, make the pill-free period shorter – (but never
longer – 7 days is the maximum!). For example, if you start the
seven pill-free days 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 pill-free period 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
You can stop taking Yasmin 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 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
a doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Yasmin 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:
Serious side effects: – see your doctor straight away
Signs of a blood clot:
- a migraine for the first time, a migraine that is worse
than normal, or unusually frequent or severe
headaches
- any sudden changes to your eyesight (such as loss of
vision or blurred vision)
- any sudden changes to your hearing, speech, sense
of smell, taste or touch
- pain or swelling in your leg
- stabbing pain when you breathe
- coughing for no apparent reason
- pain and tightness in the chest
- sudden weakness or numbness in one side or part of
your body
- dizziness or fainting
Signs of a severe allergic reaction to Yasmin:
- swelling of the face, lips, mouth, tongue or throat
Signs of breast cancer include:
- dimpling of the skin
- changes in the nipple
- any lumps you can see or feel.
Signs of cancer of the cervix include:
- vaginal discharge that smells and/or contains blood
- unusual vaginal bleeding
- pelvic pain
- painful sex
Signs of severe liver problems include:
- severe pain in your upper abdomen
- yellow skin or eyes (jaundice)
- inflammation of the liver (hepatitis)
- your whole body starts itching
If you think you may have any of these, see a
doctor straight away. You may need to stop taking
Yasmin.
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 clot formed elsewhere in
the body
- allergic reactions (hypersensitivity)
- the skin conditions erythema nodosum (characterized
by painful reddish skin nodules) or erythema multiforme
(characterized 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
Keep Yasmin out of the sight and reach of children.
Do not store above 25 °C. Store in the original package.
Expiry date
Do not take Yasmin 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
medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION

No

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

It is advisable to consult your doctor for advice before
deciding to delay your menstrual period.

If the tablets become discoloured or show signs of any
deterioration, consult your doctor or pharmacist who will tell
you what to do.

Ask your doctor for advice

Days 1-7

Delaying your period: what you need to know
Although it is not recommended, you can delay your period by
skipping the seven pill-free days and going straight to a new
strip of Yasmin and finishing it. You may experience light or
menstruation-like bleeding while using this second strip. After
the usual pill-free period of 7 days start your next strip.

Or

● Stop the strip immediately
● Begin the gap week (not longer

than 7 days)
start the next strip

● Then

What to do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of 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 Yasmin” above.

What Yasmin contains
● The
active substances are drospirenone and
ethinylestradiol.
Each active tablet contains 0.03 milligrams
ethinylestradiol and 3 milligrams drospirenone.
● Other ingredients in the active tablets are lactose
monohydrate, maize starch, pregelatinised maize
starch,
povidone
K25,
magnesium
stearate,
hypromellose, macrogol 6000, talc, titanium dioxide
(E171) and iron oxide yellow (E172).
What Yasmin looks like and content of the pack
● Yasmin tablets are film-coated tablets; the core of the
tablet is coated. The tablets are light yellow, round with
convex faces; one side embossed with the letters
"DO" in a regular hexagon.
● Yasmin is available in packs of 3 blisters each with 21
tablets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James' House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Bayer Pharma AG, 13342 Berlin, Germany
Yasmin 0.03 mg/3 mg Film-Coated Tablets
PL No: 18067/0417

POM

Yasmin is a registered of Bayer Schering Pharma.
This leaflet was last revised on 27th March 2013.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 693000.

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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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