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YIZNELL 0.03 MG / 3 MG FILM-COATED TABLETS

Active substance(s): DROSPIRENONE / ETHINYLESTRADIOL / DROSPIRENONE / ETHINYLESTRADIOL / DROSPIRENONE / ETHINYLESTRADIOL

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60 mm
4248

Package leaflet: Information for the user

40 mm
40 mm

1st Fold : 141 mm

Yiznell 0.03 mg / 3 mg Film-Coated Tablets

Yiznell 0.03 mg / 3 mg
Film-Coated Tablets
251671

4248

Ethinylestradiol / Drospirenone
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, even if their signs of illness are the same as yours.
- 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):
l They are one of the most reliable reversible methods of contraception if used correctly
l 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
l 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. What Yiznell is and what it is used for
2. What you need to know before you take Yiznell
When you should not use Yiznell
Warnings and precautions
Blood clots
Yiznell and cancer
Bleeding between periods
What to do if no bleeding occurs during the seven pill-free days
Other medicines and Yiznell
Yiznell with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
3. How to take Yiznell
When can you start with the first strip?
If you take more Yiznell than you should
If you forget to take Yiznell
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
4. Possible side effects
5. How to store Yiznell
6. Contents of the pack and other information
1. What Yiznell is and what it is used for
l Yiznell is a contraceptive pill and is used to prevent pregnancy.
l Each tablet contains a small amount of two different female hormones, namely drospirenone and
ethinylestradiol.
l Contraceptive pills that contain two hormones are called “combination” pills.
2. What you need to know before you take Yiznell
General notes
Before you start using Yiznell 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 Yiznell, 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 Yiznell, or where the
reliability of the pill 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
Yiznell alters the monthly changes of body temperature and of cervical mucus.
Yiznell, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or
any other sexually transmitted disease.
When you should not use Yiznell
You should not use Yiznell 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 Yiznell
l 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;
l 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;
l if you need an operation or if you are off your feet for a long time (see section 'Blood clots');
l if you have ever had a heart attack or a stroke;
l 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);
l 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
l if you have (or have ever had) a type of migraine called 'migraine with aura';
l if you have (or have ever had) a liver disease and your liver function is still not normal.
l if your kidneys are not working well (renal failure)
l if you have (or have ever had) a tumour in the liver.
l if you have (or have ever had) or if you are suspected to having breast cancer or cancer of the
genital organs.
l if you have any unexplained bleeding from the vagina.
l 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.
l If you have hepatitis C and are taking the medicinal products containing
ombitasvir/paritaprevir/ritonavir and dasabuvir (see also in section Other medicines and
Yiznell).
Additional information on special populations
Use in children
Yiznell 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”.
Tell your doctor if any of the following conditions apply to you
Talk to your doctor before taking Yiznell. In some situations you need to take special care while using
Yiznell 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 Yiznell, you should also tell your doctor:
l if a close relative has or has ever had breast cancer
l if you have a disease of the liver or the gallbladder
l if you have diabetes
l if you have depression
l if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
l if you have systemic lupus erythematosus (SLE –; a disease affecting your natural defence
system);
l if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of
the kidneys);
l if you have sickle cell anaemia (an inherited disease of the red blood cells);
l 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);
l if you need an operation, or you are off your feet for a long time (see in section 2 'Blood clots');
l 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 Yiznell;
l If you have an inflammation in the veins under the skin (superficial thrombophlebitis);
l If you have varicose veins.
l if you have epilepsy (see “Other medicines and Yiznell”)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)
l if you have or have ever had a discoloration of the skin especially of the face or neck known as
“pregnancy patches” (chloasma). If so, avoid direct sunlight or ultraviolet light.
l 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.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Yiznell increases your risk of developing a blood
clot compared with not using one. In rare cases a blood clot can block blood vessels and cause
serious problems.
Blood clots can develop
l in veins (referred to as a 'venous thrombosis', 'venous thromboembolism' or VTE)
l 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 Yiznell 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?

What are you possibly suffering from?

Ÿ swelling of one leg or along a vein in the Deep vein thrombosis

leg or foot especially when accompanied by:
Ÿ pain or tenderness in the leg which may be felt
only when standing or walking
Ÿ increased warmth in the affected leg
Ÿ change in colour of the skin on the leg e.g.
turning pale, red or blue

Risk of developing a blood clot in a year

Ÿ sudden unexplained breathlessness or rapid Pulmonary embolism

breathing;
Ÿ sudden cough without an obvious cause,

which may bring up blood;
Ÿ sharp chest pain which may increase with

deep breathing;
Ÿ severe light headedness or dizziness;
Ÿ rapid or irregular heartbeat
Ÿ 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:

-

containsdrospirenone, such as Yiznell, 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).

Retinal vein thrombosis (blood clot in the eye)

Ÿ immediate loss of vision or
Ÿ painless blurring of vision which can progress

to loss of vision
Ÿ chest pain, discomfort, pressure, heaviness
Heart attack
Ÿ sensation of squeezing or fullness in the

chest, arm or below the breastbone;
Ÿ fullness, indigestion or choking feeling;
Ÿ upper body discomfort radiating to the back,

jaw, throat, arm and stomach;
Ÿ sweating, nausea, vomiting or dizziness;
Ÿ extreme weakness, anxiety, or shortness of

breath;
Ÿ rapid or irregular heartbeats
Ÿ sudden weakness or numbness of the face, Stroke

arm or leg, especially on one side of the body;
Ÿ sudden confusion, trouble speaking or

understanding;
Ÿ sudden trouble seeing in one or both eyes;
Ÿ sudden trouble walking, dizziness, loss of

balance or coordination;
Ÿ sudden, severe or prolonged headache with

no known cause;
Ÿ loss of consciousness or fainting with or

without seizure.
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.
Ÿ swelling and slight blue discolouration of an Blood clots blocking other blood vessels
extremity;
Ÿ severe pain in your stomach (acute abdomen)
BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
l 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.
l If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).
l If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.
l Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).
When is the risk of developing a blood clot in a vein highest?
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 Yiznell your risk of a blood clot returns to normal within a few weeks.
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 Yiznell 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

Women who are not using a combined
hormonal pill/ and are not pregnant

About 2 out of 10,000 women

Women using a combined hormonal
contraceptive pill containing levonorgestrel,
norethisterone or norgestimate

About 5-7 out of 10,000 women

Women using Yiznell

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 Yiznell is small but some conditions will increase the risk. Your risk is
higher:
2
l if you are very overweight (body mass index or BMI over 30kg/m );
l if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age
(e.g. below the age of about 50). In this case you could have a hereditary blood clotting disorder;
l 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 Yiznell may need to be stopped several weeks
before surgery or while you are less mobile. If you need to stop Yiznell ask your doctor when you
can start using it again.
l as you get older (particularly above about 35 years);
l 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 Yiznell needs to be stopped.
If any of the above conditions change while you are using Yiznell, 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
What can happen if a blood clot forms 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
It is important to note that the risk of a heart attack or stroke from using Yiznell is very small but can
increase:
with increasing age (beyond about 35 years);
l if you smoke. When using a combined hormonal contraceptive like Yiznell 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;
l if you are overweight;
l if you have high blood pressure;
l if a member of your immediate family has had a heart attack or stroke at a young age (less then
about 50). In this case you could also have a higher risk of having a heart attack or stroke;
l if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or
triglycerides);
l if you get migraines, especially migraines with aura;
l if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial
fibrillation)
l if you have diabetes.
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 Yiznell, 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.
Yiznell 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 Yiznell, you may have unexpected bleeding (bleeding
outside theseven 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.

Other medicines and Yiznell
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 take Yasmin.
They can tell you if you need to take additional contraceptive precautions (for example condoms)
and if so, for how long, or, whether the use of another medicine you need must be changed.
Some medicines
l Can have influence on the blood levels of Yiznell.
l Can make it less effective in preventing pregnancy
l Can cause unexpected bleeding
These include
l medicines used for the treatment of:
¡ epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
¡ tuberculosis (e.g. rifampicin)
¡ HIV and Hepatitis infections (so-called protease inhibitors and non-nucleoside reverse
transcriptase inhibitors, such as ritonavir, neviraoin, efavurenz) fungal infections
(griseofulvin, ketoconazole)
¡ arthritis, arthrosis (etoricoxib)
¡ high blood pressure in the blood vessels in the lungs (bosentan)
¡ The herbal remedy St. John's wort
Yiznell may influence the effect of other medicines, e.g.
¡ medicines containing cyclosporin
¡ the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)
¡ theophylline (used to treat breathing problems)
¡ tizanidine (used to treat muscle pain and/or muscle cramps).
Do not use Yiznell if you have Hepatitis C and are taking the medicinal products containing
ombitasvir/paritaprevir/ritonavir and dasabuvir as this may cause increases in liver function blood
test results (increase in ALT liver enzyme).
Your doctor will prescribe another type of contraceptive prior to start of the treatment with these
medicinal products.
Yiznell can be restarted approximately 2 weeks after completion of this treatment. See section “Do
not use Yiznell”.
Ask your doctor or pharmacist for advice before taking any medicine.
Yiznell with food and drink
Yiznell 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
hormone contraceptives can affect the results of some tests.
Pregnancy
If you are pregnant, you must not take Yiznell. If you become pregnant while taking Yiznell stop
immediately and contact your doctor. If you want to become pregnant, you can stop taking Yiznell at
any time (see also “If you stop taking Yiznell”)
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Yiznell is generally not advisable when a woman is breast-feeding. 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 Yiznell affects driving or use of machines.
Yiznell contains lactose
If you cannot tolerate certain sugars, contact your doctor before you take Yiznell.
3. How to take Yiznell
Take Yiznell every day for 21 days
Yiznell comes in strips of 21 pills, each marked with a day of the week.
l Take your pill at the same time every day.
l Start by taking a pill marked with the correct day of the week.
l Follow the direction of the arrows on the strip. Take one pill each day, until you have finished all
21 pills.
l Swallow each pill whole, with water if necessary. Do not chew the pill.
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.
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 Yiznell 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 Yiznell. 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?
l If you have not used a contraceptive with hormones in the previous month

Begin with Yiznell on the first day of the cycle (that is the first day of your period). If you start
Yiznell 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.
l Changing from a combination hormonal contraceptive, or combination contraceptive vaginal
ring or patch
You can start Yiznell 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.
l 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 Yiznell.
l 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 Yiznell straight away. This means that you will have contraceptive
protection with your first pill.
l After having a baby
You can start taking Yiznell 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 Yiznell. If, after having a baby, you have had sex before starting Yiznell (again), you must
first be sure that you are not pregnant or wait until your next period.
l If you are breastfeeding and want to start Yiznell (again) 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 Yiznell than you should
There are no reports of serious harmful results of taking too many Yiznell 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 Yiznell tablets, or you discover that a child has taken some, ask your
doctor or pharmacist for advice.
If you forget to take Yiznell
l 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.
l 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.
The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning
or the end of the strip. Therefore, you should keep to the following rules(see also the diagram):
l More than one tablet forgotten in this strip
Contact your doctor.
l 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.
l 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.
l 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 taking
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 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.
If you have forgotten any of the tablets in a strip, and you do not have bleeding in the first tablet-free
period, you may be pregnant. Contact your doctor before you start the next strip.

Ask your doctor for advice

More than 1 tablet
Forgotten in 1 strip

yes
Had sex in the previous
week before forgetting?

Days 1–7

no
Ÿ Take the forgotten tablet
Ÿ Use a barrier method (condom)
for following 7 days and
Ÿ Finish strip
Only 1 tablet
Forgotten (taken more
than 12 hours late)

Days 8–14

Ÿ Take the forgotten Tablet
Ÿ Finish the strip
Ÿ
Ÿ
Ÿ
Ÿ

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

Days 15–21
Ÿ
Ÿ
Ÿ

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

What to do in 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 this is not possible
or 12 hours have passed, you should follow the advice given under “If you forget to take Yiznell.”
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 Yiznell 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.
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 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 Yiznell
You can stop taking Yiznell 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 Yiznell 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 medicine, ask your doctor or pharmacist
4. Possible side effects
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 Yiznell, 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 use Yiznell”.
The following is a list of the side effects that have been linked with the use of Yiznell:
Serious side effects: – see your doctor straight away
Signs of a severe allergic reaction to Yiznell:
- 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
Ø If you think you may have any of these, see a doctor straight away. You may need to stop taking
Yiznell.
Common side effects (between 1 and 10 in every 100 users may be affected):
l depressive mood
l headache, migraine
l nausea
l 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):
l breast enlargement
l altered interest in sex
l high blood pressure, low blood pressure
l vomiting, diarrhoea
l acne, severe itching, skin rash, hair loss (alopecia)
l vaginal infection
l fluid retention
l body weight changes
Rare side effects (between 1 and 10 in every 10,000 users may be affected)
l hearing impairment
l asthma
l breast secretion
l allergic reactions (hypersensitivity)
l the skin conditions erythema nodosum (characterized by painful reddish skin nodules) or
erythema multiforme (characterized by rash with target-shaped reddening or sores)
l 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 via the Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Yiznell
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in Original Package.
Do not use this medicine after the expiry date which is stated on the packaging after “Do not use
after:” or “EXP”.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Yiznell contains
l The active substances are drospirenone and ethinylestradiol. Each tablet contains 3 milligrams
drospirenone and 0.03 milligrams ethinylestradiol.
l Other ingredients (excipients) are lactose monohydrate, corn starch, pregelatinised maize
starch, magnesium stearate, croscarmellose sodium, hypromellose (E464), macrogol, talc
(E553b), titanium dioxide (E 171), iron oxide, yellow (E 172).
What Yiznell looks like and content of the pack
l Yiznell tablets are film-coated tablets. The tablets are yellow, round, biconvex, one side is
debossed with the letters "DR" and the other side is plain.
l Yiznell 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 and Manufacturer
Lupin (Europe) Limited
Victoria Court
Bexton Road
Knutsford
Cheshire
Wa16 0PF
United Kingdom
This leaflet was last revised in 04/2017
Code No. MP/DRUGS/28/6/2010
ID#: 251671
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu

251671 INS YIZNELL .03/3MG FC TABS 21'S UK R1 (BACK)
Market/Customer :

UK

Location :

Pithampur

Prepared On :

12/04/2017

Version No. :

03

Product Name :

INS YIZNELL .03/3MG FC TABS 21'S UK R1

Material Code :

251671

Supersedes Material code :

238336

Open Size :

520 x 280 mm (L x W)

Barcode value :

NA

Folded Size :

60 x 40 mm (L x W)

Barcode Type (Ex. NDC, PZN, EAN-13)

NA

Substrate :

GSM : 40 gsm

Component :

Leaflet

Paper : Bible Paper

Font Size :

8 PT

Font Name :

Helvetica Condensed

Gluing :

YES

Perforation :

NA

Pharmacode :

4248

Cover Page
Substrate :

NA

Pantone Colours :
Reason for Change :

Black
Change in Textmatter.

Unicorn Creation
D/Lupin/Regulatory/UK/Yiznell/

Expand Transcript

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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