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YASMIN 0.03MG/3MG FILM-COATED TABLETS

Active substance(s): DROSPIRENONE / ETHINYLESTRADIOL

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Assessed against UK PIL dated July 2014

MOCK-UP

By rajeevkumarj at 12:21 pm, May 06, 2015

PATIENT INFORMATION LEAFLET

Yasmin® 0.03mg/3mg film-coated tablets
(Ethinylestradiol / Drospirenone)
Your medicine is available using the name Yasmin 0.03mg/3mg
film-coated tablets but will be referred to as Yasmin throughout
this leaflet.

Tell your doctor if any of the following conditions
apply to you

Talk to your doctor before taking 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 the condition develops, or gets worse while you are
using Yasmin, you should also tell your doctor.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.















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 only. Do not pass
it on to others. It may harm them.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not listed
in this leaflet. See section 4.

Important things to know about combined
hormonal contraceptives (CHCs):





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

What is in this leaflet:

1.
2.

3.

4.
5.
6.

What is Yasmin and what is it used for
What you need to know before you take Yasmin
When you should not use Yasmin
Warnings and precautions
Blood clots
Yasmin and cancer
Bleeding between periods
What to do if no bleeding occurs during the seven pill-free
days
Other medicines and Yasmin
Yasmin with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
Yasmin contains lactose
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 stop taking Yasmin
Possible side effects
How to store Yasmin
Contents of the pack and other information

1. What is Yasmin and what is it 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.

















Blood clots

Using a combined hormonal contraceptive such as Yasmin
increases your risk of developing a blood clot compared with not
using one. In rare cases a blood clot can block vessels and cause
serious problems.
Blood clots can develop

in veins (referred to as a 'venous thrombosis', 'venous
thromboembolism' or VTE);

in the arteries (referred to as an 'arterial thrombosis',
'arterial thromboembolism' or ATE);
Recovery from blood clots is not always complete. Rarely, there
may be serious lasting effects or, very rarely, they may be fatal;
It is important to remember that the overall risk of a
harmful blood clot due to Yasmin is small.

HOW TO RECOGNISE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following
signs or symptoms.
Are you experiencing any of these signs?

2. What you need to know before you take
Yasmin

swelling of one leg or along a vein in
the leg or foot especially when
accompanied by:

pain or tenderness in the leg which
may be felt only when standing or
walking

increased warmth in the affected leg

change in colour of the skin on the
leg e.g. turning pale, red or blue

sudden unexplained breathlessness or
rapid breathing;

sudden cough without an obvious
cause, which may bring up blood;

sharp chest pain which may increase
with deep breathing;

severe light headedness or dizziness;

rapid or irregular heartbeat;

severe pain in your stomach;
If you are unsure, talk to a doctor as some
of these symptoms such as coughing or
being short of breath may be mistaken for a
milder condition such as a respiratory tract
infection (e.g. a 'common cold').
Symptoms most commonly occur in one
eye:

immediate loss of vision or

painless blurring of vision which can
progress to loss of vision

chest pain, discomfort, pressure,
heaviness

sensation of squeezing or fullness in
the chest, arm or below the
breastbone;

fullness, indigestion or choking feeling;

upper body discomfort radiating to the
back, jaw, throat, arm and stomach;

sweating, nausea, vomiting or
dizziness;

extreme weakness, anxiety, or
shortness of breath;

rapid or irregular heartbeats

sudden weakness or numbness of the
face, arm or leg, especially on one side
of the body;

sudden confusion, trouble speaking or
understanding;

sudden trouble seeing in one or both
eyes;

sudden trouble walking, dizziness, loss
of balance or coordination;

sudden, severe or prolonged headache
with no known cause;

loss of consciousness or fainting with
or without seizure.


General notes

Before you start using Yasmin, you should read the information on
blood clots in section 2. It is particularly important to read the
symptoms of a blood clot – see section 2 “Blood clots”.
Before you can begin taking 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

You should not use Yasmin if you have any of the conditions listed
below. If you do have any of the conditions listed below, you must
tell your doctor. Your doctor will discuss with you what other form
of birth control would be more appropriate.

Do not take Yasmin


















if you have (or have ever had) a blood clot in a blood vessel
of your legs (deep vein thrombosis, DVT), your lungs
(pulmonary embolus, PE) or other organs;
if you know you have a disorder affecting your blood clotting
– for instance, protein C deficiency, protein S deficiency,
antithrombin- III deficiency, Factor V Leiden or
antiphospholipid antibodies;
if you need an operation or if you are off your feet for a long
time (see section 'Blood clots');
if you have ever had a heart attack or stroke;
if you have (or have ever had) angina pectoris (a condition
that causes severe chest pain and may be a first sign of a
heart attack) or transient ischaemic attack (TIA – temporary
stroke symptoms);
if you have any of the following diseases that may increase
your risk of a clot in the arteries;

severe diabetes with blood vessel damage

very high blood pressure

a very high level of fat in the blood (cholesterol or
triglycerides)

a condition known as hyperhomocysteinaemia
if you have (or have ever had) a type of migraine called
'migraine with aura';
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 this medicine (listed in section 6).
This may cause itching, rash or swelling.

Sometimes the symptoms of stroke can be
brief with an almost immediate and full
recovery, but you should still seek urgent
medical attention as you may be at risk of
another stroke.

swelling and slight blue discolouration
of an extremity;

severe pain in your stomach (acute
abdomen)

Additional information on special populations
Use in children
Yasmin is not intended for use in females whose periods have not
yet started.

Warnings and precautions
When should you contact your doctor?
Seek urgent medical attention

if you notice possible signs of a blood clot that may
mean you are suffering from a blood clot in the leg
(i.e. deep vein thrombosis), a blood clot in the lung
(i.e. pulmonary embolism), a heart attack or a
stroke (see ‘Blood clots’ section below).
For a description of the symptoms of these serious side
effects please go to “How to recognise a blood clot”.

if a close relative has or has ever had breast cancer
if you have a disease of the liver or the gallbladder
if you have diabetes
if you have depression
if you have Crohn’s disease or ulcerative colitis (chronic
inflammatory bowel disease);
if you have haemolytic uraemic syndrome (HUS – a disorder
of blood clotting causing failure of the kidneys);
if you have sickle cell anaemia (an inherited disease of the
red blood cells);
if you have elevated levels of fat in the blood
(hypertriglyceridaemia) or a positive family history for this
condition. Hypertriglyceridaemia has been associated with
an increased risk of developing pancreatitis (inflammation of
the pancreas);
if you need an operation, or you are off your feet for a long
time (see in section 2 'Blood clots');
if you have just given birth you are at an increased risk of
blood clots. You should ask your doctor how soon after
delivery you can start taking Yasmin;
if you have an inflammation in the veins under the skin
(superficial thrombophlebitis);
if you have varicose veins;
if you have epilepsy (see page 1 “Other medicines and
Yasmin”);
if you have systemic lupus erythematosus (SLE – a disease
affecting your natural defence system);
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, 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))
if you have 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.
if you have 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.

What are you
possibly
suffering from?
Deep vein
thrombosis





What is the risk of developing a blood clot?

The risk depends on your natural risk of VTE and the type of
combined hormonal contraceptive you are taking. The overall risk
of a blood clot in the leg or lung (DVT or PE) with Yasmin is small.
Out of 10,000 women who are not using any combined
hormonal contraceptive and are not pregnant, about 2 will
develop a blood clot in a year.
Out of 10,000 women who are using a combined hormonal
contraceptive that contains levonorgestrel, norethisterone, or
norgestimate about 5-7 will develop a blood clot in a year.
Out of 10,000 women who are using a combined hormonal
contraceptive that contains drospirenone such as Yasmin,
between about 9 and 12 women will develop a blood clot in a
year.
The risk of having a blood clot will vary according to your
personal medical history (see “Factors that increase your risk
of a blood clot” below).









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

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

About 9-12 out of
10,000 women

Factors that increase your risk of a blood clot in a
vein

The risk of a blood clot with Yasmin is small but some conditions
will increase the risk. Your risk is higher:

if you are very overweight (body mass index or BMI over
30kg/m);

if one of your immediate family has had a blood clot in the
leg, lung or other organ at a young age (eg. below the age
of about 50). In this case you could have a hereditary blood
clotting disorder;

if you need to have an operation, or if you are off your feet
for a long time because of an injury or illness, or you have
your leg in a cast. The use of Yasmin may need to be
stopped several weeks before surgery or while you are less
mobile. If you need to stop Yasmin ask your doctor when
you can start using it again.

as you get older (particularly above about 35 years);

if you gave birth less than a few weeks ago.
The risk of developing a blood clot increases the more conditions
you have.
Air travel (>4 hours) may temporarily increase your risk of a
blood clot, particularly if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply
to you, even if you are unsure. Your doctor may decide that
Yasmin needs to be stopped.
If any of the above conditions change while you are using Yasmin,
for example a close family member experiences a thrombosis for
no known reason; or you gain a lot of weight, tell your doctor.

BLOOD CLOTS IN AN ARTERY
Like a blood clot in a vein, a clot in an artery can cause serious
problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an
artery
Pulmonary
embolism

It is important to note that the risk of a heart attack or stroke
from using Yasmin is very small but can increase:

with increasing age (beyond about 35 years);
if you smoke. When using a combined hormonal
contraceptive like Yasmin, you are advised to stop smoking.
If you are unable to stop
smoking and are older than 35 your doctor may advise you
to use a
different type of contraceptive;
if you are overweight;
if you have high blood pressure;
if a member of your immediate family has had a heart attack
or stroke at a young age (less than about 50). In this case
you could also have a higher risk of having a heart attack or
stroke;
if you, or someone in your immediate family, have a high
level of fat in the blood (cholesterol or triglycerides);
if you get migraines, especially migraines with aura;
if you have a problem with your heart (valve disorder,
disturbance of the rhythm called atrial fibrillation);
if you have diabetes.











Retinal vein
thrombosis
(blood clot in the
eye)
Heart attack





If you have more than one of these conditions or if any of them
are particularly severe the risk of developing a blood clot may be
increased even more.
If any of the above conditions change while you are using Yasmin,
for example you start smoking, a close family member
experiences a thrombosis for no known reason; or you gain a lot
of weight, tell your doctor.

Yasmin and cancer

Stroke

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.

Blood clots
blocking other
blood vessels

The use of combined hormonal contraceptives has been
connected with an increase in the risk of blood clots in the
vein (venous thrombosis). However, these side effects are
rare. Most frequently, they occur in the first year of use of a
combined hormonal contraceptive.
If a blood clot forms in a vein in the leg or foot it can cause
a deep vein thrombosis (DVT).
If a blood clot travels from the leg and lodges in the lung it
can cause a pulmonary embolism.
Very rarely a clot may form in a vein in another organ such
as the eye (retinal vein thrombosis).

Page 1 of 2

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

What can happen if a blood clot forms in an artery?

Blood clots in a vein
What can happen if a blood clot forms in a vein?


When is the risk of developing a blood clot in a vein
highest?

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.

Other medicines and Yasmin
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) and the herbal remedy St. John’s wort





Yasmin may influence the effect of other medicines, e.g.
medicines containing ciclosporin

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



the anti-epileptic lamotrigine (this could lead to an
increased frequency of seizures)

Ask your doctor or pharmacist for advice before taking any
medicine.

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.




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.
You can also stop the tablets and go directly to the tabletfree 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.

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 page 2 “If you 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 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.

Driving and using machines

There is no information suggesting that use of Yasmin affects
driving or the use of machines.

Yasmin contains lactose

2.

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

Ask your doctor for
advice

If you cannot tolerate certain sugars, contact your doctor before
you take Yasmin.

yes

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.

Days
1-7

Had sex in the previous
week before forgetting?

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

no




There is a memory aid on the blister pack for daily intake.
Translations of the days of the week:
MA = Mon WO = Wed VR = Fri ZO = Sun
DI = Tue
DO = Thu
ZA = Sat



Take the
forgotten tablet
Use a barrier
method (condom)
for following 7
days and
Finish strip

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.



Days
8-14



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.




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.



Days
15-21



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 (progestogenonly 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”, page 1.



Ask your doctor what to do if you are not sure when to start.

If you take more Yasmin than you should

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

or

When can you start with the first strip?




Stop the strip
immediately
Begin the gap
week (not longer
than
7 days)
Then start the
next strip

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” on page 2.

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.



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 on
page 2):

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.

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).

harmful blood clots in a vein or artery for example:

in a leg or foot (i.e. DVT)

in a lung (i.e. PE)

heart attack

stroke

mini-stroke or temporary stroke-like symptoms, known as
a transient ischaemic attack (TIA)

blood clots in the liver, stomach/intestine, kidneys or eye.
The chance of having a blood clot may be higher if you have any
other conditions that increase this risk (See section 2 for more
information on the conditions that increase risk for blood clots and
the symptoms of a blood clot).





Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly (see details below). By reporting
side effects, you can help provide more information on the safety
of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to store Yasmin
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.
If your doctor decides to stop treatment, return any leftover
tablets to the pharmacist. Only keep them if the doctor tells you
to.
If your medicine appears to be discoloured or shows any other
signs of deterioration, please return to your pharmacist.
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. Contents of the pack and other
information
What Yasmin contains

The active substances are drospirenone and ethinylestradiol.
Each film-coated tablet contains 0.03mg ethinylestradiol and 3mg
drospirenone.
Also contains: lactose monohydrate, maize starch, pregelatinised
maize starch, povidone K25, magnesium stearate (E470b),
hypromellose (E464), macrogol 6000, talc (E553b),
titanium dioxide (E171) and yellow iron oxide (E172).

What Yasmin looks like and content of the pack

Yasmin are light yellow, round film-coated tablets with convex
faces, embossed with the letters 'DO' in a regular hexagon on one
face and plain on the reverse.
Yasmin is available in packs of 3x21 tablets.

Manufacturer:

Manufactured by: Bayer Pharma AG, 13342 Berlin, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

PL No: 21828/0578

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 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.

4. Possible side effects

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.






Changing the first day of your period: what you
need to know

If you take several tablets at once then you may have symptoms
of nausea or vomiting. Young girls may have bleeding from the
vagina.



Common side effects (between 1 and 10 in every 100
users may be affected):

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.

If you have any further questions on the use of this medicine, ask
a doctor or pharmacist.

If you forget to take Yasmin

If you think you may have any of these, see a doctor
straight away. You may need to stop taking Yasmin

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

There are no reports of serious harmful results of taking too many
Yasmin tablets.

If you have taken too many Yasmin tablets, or you discover that a
child has taken some, ask your doctor or pharmacist for advice



Keep out of the sight and reach of children.


You don’t need to use extra contraception during these seven pillfree days – as long as you have taken your pills correctly and
start the next strip of pills 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.

Take the
forgotten tablet
Finish the strip

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

Like all medicines, this medicine can cause side effects, although
not everybody gets them. If you get any side effect, particularly if
severe and persistent, or have any change to your health that you
think may be due to Yasmin, please talk to your doctor.
An increased risk of blood clots in your veins (venous
thromboembolism (VTE)) or blood clots in your arteries (arterial
thromboembolism (ATE)) is present for all women taking
combined hormonal contraceptives. For more detailed information
on the different risks from taking combined hormonal
contraceptives please see section 2 “What you need to know
before you take Yasmin”.
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 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

Page 2 of 2

POM

Leaflet issue and revision date (Ref): 26.02.15
Yasmin® is a registered trademark of Bayer Intellectual Property
GmbH.

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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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