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YACELLA 0.03 MG/3 MG TABLETS

Active substance(s): DROSPIRENONE / ETHINYLESTRADIOL

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Artwork No.

251114/3

Colours Used

Customer

Morningside

Black

Description

Yacella 0.03 mg/3 mg Pil

Keyline

Market

UK

Language

English

Size

860 x 430 mm

Min. Font Size

10 pt

Page No.

1 of 2

Version No.

10

Date

01-04-15

Software

Coreldraw 12

Packaging Development

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Production

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96 mm

5

181 mm
Package Leaflet: Information for the user

Yacella 3 mg / 0.03 mg Tablets
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Drospirenone and Ethinylestradiol
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 effect, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not
listed in this leaflet.
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”).

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What is in this leaflet:
1. What Yacella is and what it is used for
2. What you need to know before you take Yacella
3. How to take Yacella
4. Possible side effects
5. How to store Yacella
6. Contents of the pack and other information
1. What Yacella is and what it is used for

430 mm

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Yacella
3 mg / 0.03 mg
Tablets

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Yacella 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.

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Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Yacella, you should also tell your doctor.
! 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 Yacella;
! If you have an inflammation in the veins under the skin (superficial thrombophlebitis);
! If you have varicose veins;
! if you have epilepsy;
! 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, skin rash with blisters during pregnancy (gestational herpes), a
disease of the nerves in which sudden movements of the body occur (Sydenham's chorea);
! if you have or have ever had chloasma (a discolouration of the skin especially of the face or neck known as
“pregnancy patches”). 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.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Yacella 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).

2. What you need to know before you take Yacella

Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they
may be fatal.

Before you start using Yacella 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”.

It is important to remember that the overall risk of a harmful blood clot due to Yacella is small.

Before you can begin taking Yacella, 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.

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?

In this leaflet, several situations are described where you should stop using Yacella, or where the reliability of
Yacella may be decreased. In such situations you should either not have sex or you should take extra nonhormonal contraceptive precautions, e.g. use a condom or another barrier method. Do not use rhythm or
temperature methods. These methods can be unreliable because Yacella alters the monthly changes of body
temperature and cervical mucus. Yacella, like other hormonal contraceptives, does not protect against HIV
infection (AIDS) or any other sexually transmitted disease.
Do not take Yacella
You should not use Yacella 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 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.
Additional information on special populations
Use in children
Yacella is not intended for use in females whose periods have not yet started.

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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”.
Talk to your doctor or pharmacist or nurse before taking Yacella.
In some situations you need to take special care while using Yacella or any other combination pill, and your doctor
may need to examine you regularly.

! 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 you are possibly
suffering from?
Deep vein thrombosis

Pulmonary embolism

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

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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 Yacella 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 Yacella is small.

! Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2

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Other medicines and Yacella
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you are taking this
medicine. 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 Yacella less effective in preventing pregnancy, or can cause unexpected bleeding.
These include medicines used for the treatment of:
! epilepsy (e.g. barbiturates, carbamazepine, phenytoin, primidone, oxcarbazepine),
! tuberculosis (e.g. rifampicin),
! HIV infections (e.g. ritonavir, nevirapine) or other infections (antibiotics such as griseofulvin, penicillin,
tetracycline),
! high blood pressure in the blood vessels in the lungs (bosentan),
! the herbal remedy St. John's wort.

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
Yacella, 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/patch/ring and
are not pregnant
Women using a combined hormonal contraceptive pill containing
levonorgestrel, norethisterone or norgestimate
Women using Yacella

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 Yacella 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 Yacella may need to be stopped several weeks before surgery or while you
are less mobile. If you need to stop Yacella 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 Yacella needs to be stopped.
If any of the above conditions change while you are using Yacella, 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 Yacella is very small but can increase:
! with increasing age (beyond about 35 years);
! if you smoke. When using a combined hormonal contraceptive like Yacella 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.
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.

Yacella may influence the effect of other medicines, e.g.

! medicines containing ciclosporin,
! the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures).
Ask your doctor or pharmacist for advice before taking any medicine.
Taking Yacella with food and drink
Yacella may be taken with or without food, if necessary with a small amount of water.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because hormonal
contraceptives can affect the results of some tests.
Pregnancy breast-feeding and fertility
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 Yacella. If you become pregnant while taking Yacella stop taking it immediately
and contact your doctor. If you want to become pregnant, you can stop taking Yacella at any time (see also “If you
want to stop taking Yacella”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Yacella 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 Yacella affects driving or use of machines.
Yacella contains lactose monohydrate. If your doctor has told you that you have intolerance to sugars, contact
the doctor before taking this medicinal product.
Yacella also contains E110, sunset yellow FCF and E102, tartrazine which may cause allergic reactions.
3. How to take Yacella
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 Yacella 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 so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap week.
On the 8th day after the last Yacella tablet (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 Yacella 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 any of the above conditions change while you are using Yacella, 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.
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).

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Yacella 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 Yacella, 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, contact your
doctor so that they can 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.

! If you have not used a contraceptive with hormones in the previous month.
Begin with Yacella on the first day of your cycle (that is the first day of your period). If you start Yacella 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 combined hormonal contraceptive, or combined contraceptive vaginal ring or patch.
You can start Yacella 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 combined contraceptive vaginal ring or a transdermal patch, follow the advice of your
doctor.
! Changing from a progestogen-only-method (progestogen only pill, injection, implant or a
progestogen-releasing intrauterine system (IUS))
You may switch any day from the progestogen-only pill (from an implant or an IUS on the day of its removal, from
an injectable when the next injection would be due) but in all of these cases use extra protective measures (for
example, a condom) for the first 7 days of taking Yacella.

! After a miscarriage or abortion
Follow the advice of your doctor.

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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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