Skip to Content

UK Edition. Click here for US version.

YIZNELL 0.03 MG / 3 MG FILM-COATED TABLETS

Active substance(s): DROSPIRENONE / ETHINYLESTRADIOL

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Yiznell 0.03 mg / 3 mg Film-Coated Tablets
Ethinylestradiol / Drospirenone

Yiznell 0.03 mg / 3 mg
Film-Coated Tablets
238336

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”)
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.
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
3. How to take Yiznell
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
Yiznell is a contraceptive pill and is used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones, namely
drospirenone and ethinylestradiol.
Contraceptive pills that contain two hormones are called “combination” pills.

2173

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.
Do not take 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.
• 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 a 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) an inflammation of the pancreas (pancreatitis)
• if you have (or have ever had) a 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) a tumour in the liver.
• if you have (or have ever had) or if you are suspected to 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).
Warnings and precautions
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. Tell your doctor
if any of the following conditions apply to you. If the condition develops or gets worse
while you are using Yiznell, you should also tell your doctor:
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel
disease);
• if you have systemic lupus erythematosus (SLE –; a disease affecting your natural
defence system);
• 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 Yiznell;
• If you have an inflammation in the veins under the skin (superficial
thrombophlebitis);
• If you have varicose veins.
• 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 epilepsy (see “The pill and using other medicines”)
• 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 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.
• 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.
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 clot’ (thrombosis)
section below.
For a description of the symptoms of these serious side effects please go to “How to
recognise a blood clot”
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
• 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 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?
• 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.
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)

What are you possibly
suffering from?
Deep vein thrombosis

Pulmonary embolism

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

Stroke

Blood clots blocking
other blood vessels

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
• 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).
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
contains drospirenone, 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).
Risk of developing a blood clot in a
year
Women who are not using a combined
About 2 out of 10,000 women
hormonal pill/patch/ring and are not
pregnant
Women using a combined hormonal
About 5-7 out of 10,000 women
contraceptive pill containing levonorgestrel,
norethisterone or norgestimate
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:
• if you are very overweight (body mass index or BMI over 30kg/m2);
• 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;
• 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.
• 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 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);
• 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;
• 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 then 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.
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.
The pill and cancer
Breast cancer has been observed slightly more often in women using combination pills,
but it is not known whether this is caused by the treatment. For example it may be that
more tumours are detected in women on combination pills because they are examined
by their doctor more often. The occurrence of breast tumours becomes gradually less
after stopping the combination hormonal contraceptives. It is important to regularly
check your breasts and you should contact your doctor if you feel any lump.

In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours
have been reported in pill users. Contact your doctor if you have unusually severe
abdominal pain.
Bleeding between periods
During the first few months that you are taking Yiznell, you may have unexpected
bleeding (bleeding outside the gap week). If this bleeding occurs for more than a few
months, or if it begins after some months, your doctor must find out what is wrong.
What to do if no bleeding occurs in the gap week
If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea and
you have not taken any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in succession, you may be pregnant.
Contact your doctor immediately. Only start the next strip if you are sure that you are
not pregnant.
Other medicines and Yiznell
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. This includes herbal products. Also tell any other doctor or dentist who
prescribes another medicine (or the pharmacist) that you use Yiznell. 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 Yiznell 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, nevirapin) 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
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)
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 and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, do 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 the pill at any time.
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
This product contains lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before you take this product.
3. HOW TO TAKE YIZNELL
Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Take one tablet of Yiznell every day, if necessary with a small amount of water. You may
take the tablets with or without food, but you should take the tablets every day around
the same time.
The strip contains 21 tablets. Next to each tablet is printed the day of the week that it
should be taken. If, for example you start on a Wednesday, take a tablet with “WED” next
to it. Follow the direction of the arrow on the strip until all 21 tablets have been taken.
Then take no tablets for 7 days. In the course of these 7 tablet-free days (otherwise
called a stop or gap week) bleeding should begin. This is so-called “withdrawal bleeding”
usually starts on the 2nd or 3rd day of the gap week.
On the 8th day after the last tablet of Yiznell (that is, after the 7-day gap week), you should
start with the following strip, whether your bleeding has stopped or not. This means that
you should start every strip on the same day of the week and that the withdrawal bleed
should occur on the same days each month.
If you use Yiznell in this manner, you are also protected against pregnancy during the 7

days when you are not taking a tablet.
When can you start with the first strip?
• 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.
• 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 active substances) of your previous pill, but at the latest on the day after
the tablet-free days of your previous pill (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 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 tablet-taking.
• 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.
• After having a baby
You can start 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 Yiznell use. If, after having a baby, you have had sex before starting
Yiznell (again), be sure that you are not pregnant or wait until your next period.
• 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
• 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 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:
• 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 taking the tablet-free period start next strip.
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.
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
Even though it is not recommended, you can delay your period by going straight to a
new strip of Yiznell instead of the tablet-free period, and finishing it. You may experience
light or menstruation-like bleeding while using this second strip. After the usual tabletfree period of 7 days, start the next strip.
You might ask your doctor for advice before deciding to delay your menstrual
period.
Changing of the first day of your period: what you need to know
If you take the tablets according to the instructions, then your period will begin during
the tablet-free week. If you have to change this day, reduce the number of the tablet-free
days (but never increase them – 7 is the maximum). For example, if your tablet-free days
normally begin on a Friday, and you want to change this to a Tuesday (3 days earlier)
start a new strip 3 days earlier than usual. If you make the tablet-free interval very short
(for example, 3 days or less) you may not have any bleeding during these days. You may
then experience light or menstruation-like bleeding.
If you are not sure what to do, consult your doctor.
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 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
Serious side effects: – see your doctor straight away
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:
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
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):
• depressive mood
• headache, migraine
• nausea
• breast pain, breast tenderness, menstrual disorders, bleeding between periods, thick,
whitish vaginal discharge, vaginal yeast infection.
Uncommon side effects (between 1 and 10 in every 1,000 users may be affected):
• breast enlargement
• altered interest in sex
• high blood pressure, low blood pressure
• vomiting, diarrhoea
• acne, severe itching, skin rash, hair loss (alopecia)
• vaginal infection

• fluid retention
• body weight changes
Rare side effects (between 1 and 10 in every 10,000 users may be affected):
• hearing impairment
• asthma
• breast secretion
• blockage of a blood vessel by a clot formed elsewhere in the body
• 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:
o in a leg or foot (i.e. DVT)
o in a lung (i.e. PE)
o heart attack
o stroke
o mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic
attack (TIA)
o 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 use this medicine after the expiry date which is stated on the carton and blister
after EXP. The expiry date refers to the last day of that month.
Store below 25°C. Store in the original package.
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
The active substances are drospirenone and ethinylestradiol. Each tablet contains 3
milligrams drospirenone and 0.03 milligrams ethinylestradiol.
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
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.
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 revised in (06/2014)
ID#: 238336
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency
web site: http://www.ema.europa.eu.

Expand view ⇕

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.

Hide