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1 #

(Package Booklet:

Information for the user

lycisinin ed

0.03 mg / 3 mg film-coated tablets Ethinylestradiol / Drospirenone

Packaging Technology Berlin gbkop '^^e U 1	Bayer Pharma AG
client: 0021 material-no.: 84729132 PZ: 2537A-4C	code-no.: 294
name: LF-BRO-Yasmin ED FTB 28	country: GB/-/BPH
colors: Black / Pantone 1375 C / Pantone 116 C / Pantone 1788 C / Pantone 233 C

version: 27.08.2015/03    approval:    dimension: 85 x 60 mm

Anja

Bern wald

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

►    Keep this booklet. You may need to read it again.

►    If you have any further questions, ask your doctor or pharmacist.

►    Th is medicine has been prescribed for you only. Do not pass it on to others. It may harm them.

►    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this booklet. See section 4.

1

Packaging Technology Berlin gbkop	sat 1	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

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”).

2

Packaging Technology Berlin gbkop	sat 2	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

What is in this booklet
1.	What Yasmin ED is and what it is used for	6
2.	What you need to know before you take Yasmin ED	7
	When you should not use Yasmin ED	9
	Warnings and precautions	13
	Blood clots	17
	Yasmin ED and cancer	33
	Bleeding between periods	34
	What to do if no bleeding occurs during the placebo days	35
	Other medicines and Yasmin ED	36
	Yasmin ED with food and drink	38

3

Packaging Technology Berlin gbkop	sat 3	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

	Delaying your period: what you need to know	53
	Changing the first day of your period: what you need to know	54
	If you stop taking Yasmin ED	55
4.	Possible side effects	56
5.	How to store Yasmin ED	62
6.	Contents of the pack and other information	63

5

Packaging Technology Berlin gbkop	sat 5	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

1. What Yasmin ED is and what it is used for

►    Yasmin ED is a contraceptive pill and is used to prevent pregnancy.

►    Each of the 21 light yellow tablets contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.

►    The 7 white tablets contain no active substances and are also called placebo tablets.

►    Contraceptive pills that contain two hormones are called “combination” pills.

6

Packaging Technology Berlin gbkop	sat 6	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

2. What you need to know before you take Yasmin ED

General notes

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

Before you can begin taking Yasmin ED, 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.

7

Packaging Technology Berlin gbkop	sat 7	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

In this booklet, several situations are described where you should stop using Yasmin ED, or where the reliability of Yasmin ED may be decreased. In such situations you should either not have sex or you should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because Yasmin ED alters the monthly changes of the body temperature and cervical mucus.

Yasmin ED, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

8

Packaging Technology Berlin gbkop	sat 8	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

When you should not use Yasmin ED

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

Do not take Yasmin ED:

►    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;

9

Packaging Technology Berlin gbkop	sat 9	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

►    if you need an operation or if you are off your feet for a long time (see section ‘Blood clots’);

►    if you have ever had a heart attack or stroke;

►    if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA - temporary stroke symptoms);

►    if you have any of the following diseases that may increase your risk of a clot in the arteries:

P severe diabetes with blood vessel damage P very high blood pressure

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

10

Packaging Technology Berlin gbkop	rn 10	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

P a condition known as hyperhomocysteinaemia

►    if you have (or have ever had) a type of migraine ‘migraine with aura’;

►    if you have (or have ever had) liver disease and your liver function is still not normal

►    if you have poorly functioning kidneys (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 have an allergy to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash or swelling.

11

Packaging Technology Berlin gbkop	rn 11	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

Additional information on special populations

Use in children

Yasmin ED 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”.

13

Packaging Technology Berlin gbkop	rn 13	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

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

Talk to your doctor before taking Yasmin ED. In some situations you need to take special care while using Yasmin ED or any other combination pill, and your doctor may need to examine you regularly. If the condition develops, or gets worse while you are using Yasmin ED, 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);

14

Packaging Technology Berlin gbkop	rn 14	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

►    if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys);

►    if you have sickle cell anaemia (an inherited disease of the red blood cells);

►    if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);

►    if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots’);

►    if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Yasmin ED;

15

Packaging Technology Berlin gbkop	rn 15	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

►    if you have an inflammation in the veins under the skin (superficial thrombophlebitis);

►    if you have varicose veins;

►    if you have epilepsy (see page 36 “Other medicines and Yasmin ED ”)

►    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 nerve disease causing sudden movements of the body (Sydenham’s chorea)).

16

Packaging Technology Berlin gbkop	rn 16	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

►    if you have ever had a discolouration of the skin especially on the face or neck known as “pregnancy patches” (chloasma). If so, avoid direct sunlight or ultraviolet light.

►    if you have hereditary angioedema, products containing oestrogens may cause or worsen the symptoms. You should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing.

BLOOD CLOTS

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

17

Packaging Technology Berlin gbkop	rn 17	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

Blood clots can develop

►    in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE);

►    in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or ATE);

Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal; It is important to remember that the overall risk of a harmful blood clot due to Yasmin ED is small.

HOW TO RECOGNISE A BLOOD CLOT

Seek urgent medical attention if you notice any of the

following signs or symptoms.

18

Packaging Technology Berlin gbkop	rn 18	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

►    sudden unexplained breathlessness or Pulmonary

rapid breathing;    embolism

►    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;

20

Packaging Technology Berlin gbkop	rn 20	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

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	Retinal vein thrombosis (blood clot in the eye)

21

Packaging Technology Berlin gbkop	rn 21	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

►    chest pain, discomfort, pressure,    Heart attack

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

22

Packaging Technology Berlin gbkop	rn 22	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

►    sudden weakness or numbness of the Stroke 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.

23

Packaging Technology Berlin gbkop	rn 23	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

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

24

Packaging Technology Berlin gbkop	rn 24	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

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

25

Packaging Technology Berlin gbkop	rn 25	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more.

After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.

When you stop Yasmin ED 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 Yasmin ED is small.

26

Packaging Technology Berlin gbkop	rn 26	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

►    Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.

►    Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a blood clot in a year.

►    Out of 10,000 women who are using a combined hormonal contraceptive that contains drospirenone such as Yasmin ED, 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)

27

Packaging Technology Berlin gbkop	rn 27	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

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

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

28

Packaging Technology Berlin gbkop	rn 28	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

►    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 (eg. below the age of about 50). In this case you could have a hereditary blood clotting disorder;

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

29

Packaging Technology Berlin gbkop	rn 29	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

The risk of developing a blood clot increases the more conditions you have.

Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed.

It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that Yasmin ED needs to be stopped.

If any of the above conditions change while you are using Yasmin ED, for example a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.

30

Packaging Technology Berlin gbkop	rn 30	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

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 Yasmin ED is very small but can increase:

►    with increasing age (beyond about 35 years);

►    if you smoke. When using a combined hormonal contraceptive like Yasmin ED, 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;

31

Packaging Technology Berlin gbkop	rn 31	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

►    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.

32

Packaging Technology Berlin gbkop	rn 32	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

If you have more than one of these conditions or if any of them are particularly severe the risk of developing a blood clot may be increased even more.

If any of the above conditions change while you are using Yasmin ED, for example you start smoking, a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.

Yasmin ED 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

33

Packaging Technology Berlin gbkop	rn 33	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

combination hormonal contraceptives. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.

In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in pill users. Contact your doctor if you have unusually severe abdominal pain.

Bleeding between periods

During the first few months that you are taking Yasmin ED, you may have unexpected bleeding (bleeding outside the placebo 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.

34

Packaging Technology Berlin gbkop	rn 34	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

What to do if no bleeding occurs during the placebo days

If you have taken all the light yellow active 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.

35

Packaging Technology Berlin gbkop	rn 35	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

Other medicines and Yasmin ED

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 ED. 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

►    can have an influence on the blood levels of Yasmin ED

►    can make it less effective in preventing pregnancy

►    can cause unexpected bleeding

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Packaging Technology Berlin gbkop	rn 36	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

These include:

medicines used for the treatment of

P epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)

P tuberculosis (e.g. rifampicin)

P HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)

P fungal infections (griseofulvin, ketoconazole)

P arthritis, arthrosis (etoricoxib)

P high blood pressure in the blood vessels in the lungs (bosentan)

P the herbal remedy St. John’s wort

37

Packaging Technology Berlin gbkop	rn 37	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

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

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

P theophylline (used to treat breathing problems)

P tizanidine (used to treat muscle pain and/or muscle cramps).

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

Yasmin ED with food and drink

Yasmin ED may be taken with or without food, if necessary with a small amount of water.

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Packaging Technology Berlin gbkop	rn 38	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because hormonal contraceptives can affect the results of some tests.

Pregnancy

If you are pregnant, you must not take Yasmin ED. If you become pregnant while taking Yasmin ED you must stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Yasmin ED at any time (see also page 55 “If you stop taking Yasmin ED”).

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

	39
Packaging Technology Berlin gbkop	^e 39	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

Breast-feeding

Use of Yasmin ED 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 Yasmin ED affects driving or the use of machines.

Yasmin ED contains lactose

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

40

Packaging Technology Berlin gbkop	rn 40	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

3. How to take Yasmin ED

Each blister contains 21 active light yellow tablets and 7 white placebo tablets.

The two differently coloured tablets of Yasmin ED are arranged in order. A strip contains 28 tablets.

Take one tablet of Yasmin ED 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.

Do not confuse the tablets: take a light yellow tablet for the first 21 days and then a white tablet for the last 7 days.

Then start a new strip straightaway (21 light yellow and then 7 white tablets). There is therefore no gap between two strips.

41

Packaging Technology Berlin gbkop	rn 41	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

Because of the different composition of the tablets it is necessary to begin with the first tablet on the upper left and take the tablets every day. For the correct order, follow the direction of the arrows on the strip.

Preparation of the strip

To help you keep track, there are 7 stickers each with the 7 days of the week for each strip of Yasmin ED. Choose the week sticker that starts with the day you begin taking the tablets.

For example, if you start on a Wednesday, use the week sticker that starts with “WED”.

Stick the memo sticker along the top of the Yasmin ED strip where it reads “Place memo strip here”, so that the first day is above the tablet marked “start”.

42

Packaging Technology Berlin gbkop	rn 42	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

There is now a day indicated above every tablet and you can see whether you have taken a certain pill. The arrows show the order you are to take the pills.

During the 7 days when you are taking the white placebo tablets (the placebo days), bleeding should begin (so-called withdrawal bleeding). This usually starts on the 2nd or 3rd day after the last light yellow active tablet of Yasmin ED. Once you have taken the last white tablet, 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 Yasmin ED in this manner, you are protected against pregnancy during the 7 days when you are taking a placebo tablet.

43

Packaging Technology Berlin gbkop	rn 43	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

When can you start with the first strip?

►    If you have not used a contraceptive with hormones in the previous month

Begin with Yasmin ED on the first day of the cycle (that is, the first day of your period). If you start Yasmin ED on the first day of your period you are immediately protected against pregnancy. You may also begin on day 2-5 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.

►    Changing from a combination hormonal contraceptive, or combination contraceptive vaginal ring or patch

You can start Yasmin ED 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

44

Packaging Technology Berlin gbkop	rn 44	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

(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 IUD)

You may switch any day from the progestogen-only pill (from an implant or an IUD on the day of its removal, from an injectable when the next injection would be due) but in all of these cases use extra protective measures (for example, a condom) for the first 7 days of taking Yasmin ED.

►    After a miscarriage

Follow the advice of your doctor.

►    After having a baby

You can start taking Yasmin ED between 21 and 28 days after having a baby. If you start later than day 28, use a

45

Packaging Technology Berlin gbkop	rn 45	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

so-called barrier method (for example, a condom) during the first seven days of taking Yasmin ED.

If, after having a baby, you have had sex before starting Yasmin ED, make sure you are not pregnant or else wait until your next period.

► If you are breast-feeding and want to start Yasmin ED after having a baby

Read the section on “Breast-feeding”, page 40.

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

If you take more Yasmin ED than you should

There are no reports of serious harmful results of taking too

many Yasmin ED tablets.

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Packaging Technology Berlin gbkop	rn 46	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

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

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

If you forget to take Yasmin ED

The tablets in the 4^th row of the strip are the placebo tablets. If you forget one of these tablets, this has no effect on the reliability of Yasmin ED. Throw away the forgotten placebo tablet.

If you miss a light yellow, active (tablets 1-21 of your blister-strip), follow the instructions below:

47

Packaging Technology Berlin gbkop	rn 47	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

►    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 light yellow tablet at the beginning or at the end of the strip. Therefore, you should keep to the following rules (see also the diagram on page 52):

►    More than one tablet forgotten in this strip

Contact your doctor.	48
Packaging Technology Berlin gbkop	^e 48	Bayer Pharma AG
client: 0021 material-no.: 84729132 PZ: 2537A-4C		code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH

version: 27.08.2015/03    approval:    dimension: 85 x 60 mm

►    One tablet forgotten between days 1-7 (first row)

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 (second row) Take the forgotten tablet as soon as you remember, even if that means 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.

49

Packaging Technology Berlin gbkop	rn 49	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

► One tablet forgotten between days 15 - 21 (third row) You can choose between two possibilities:

1.    Take the forgotten tablet as soon as you remember, even if that means you have to take two tablets at the same time. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets on this strip, throw them away, and start the next strip.

Most likely, you will have a period at the end of the second strip - while taking the white placebo tablets - but you may have light or menstruation-like bleeding during the second strip.

2.    You can also stop the active light yellow tablets and go directly on to the 7 white placebo tablets (before taking the placebo tablets, record the day on which you forgot

50

Packaging Technology Berlin gbkop	rn 50	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

your tablet). If you want to start a new strip on the day you always start, take the placebo tablets for less than 7 days.

If you follow one of these two recommendations, you will remain protected against pregnancy.

► If you have forgotten any of the tablets in a strip, and you do not have a bleeding during the placebo days, you may be pregnant. Contact your doctor before you start the next

51

What to do in the case of vomiting or severe diarrhoea

If you vomit within 3-4 hours of taking an active light yellow 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 light yellow tablet from a reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your pill. If that is not possible or 12 hours have passed, you should follow the advice given under “If you forget to take Yasmin ED” on page 47.

Delaying your period: what you need to know

Although it is not recommended, you can delay your period by not taking the white placebo tablets from the 4^th row and

53

Packaging Technology Berlin gbkop	rn 53	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

going straight to a new strip of Yasmin ED and finishing it. You may experience light or menstruation-like bleeding while using this second strip. Finish this second strip by taking the 7 white tablets from the 4^th row. Then start your 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 placebo days. If you have to change this day, reduce the number of placebo days - when you take the white placebo tablets - (but never increase them -7 is the maximum!). For example, if you normally start taking the placebo tablets on a Friday, and you want to change this to

54

Packaging Technology Berlin gbkop	rn 54	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

a Tuesday (3 days earlier) start a new strip 3 days earlier than usual. If you make the placebo interval very short (for example, 3 days or less) you may not have any bleeding during this time. You may then experience light or menstruation-like bleeding.

If you are not sure what to do, consult your doctor.

If you stop taking Yasmin ED

You can stop taking Yasmin ED whenever you want. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control. If you want to become pregnant, stop taking Yasmin ED 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.

55

Packaging Technology Berlin gbkop	rn 55	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

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 Yasmin ED, please talk to your doctor.

An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you take Yasmin ED”.

56

Packaging Technology Berlin gbkop	rn 56	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

The following is a list of side effects that have been linked with the use of Yasmin ED:

Serious side effects (see a doctor straight away):

►    signs of a blood clot (see page 17 “BLOOD CLOTS”)

►    signs of cancer (see page 33 “Yasmin ED and cancer”)

►    signs of an allergic reaction (hypersensitivity ), i.e. swelling of the face, lips, mouth, tongue or throat.

Less serious side effects starting with the more common ones:

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

►    depressive mood

►    headache

57

Packaging Technology Berlin gbkop	rn 57	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

►    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	58
Packaging Technology Berlin gbkop	^e 58	Bayer Pharma AG
client: 0021 material-no.: 84729132 PZ: 2537A-4C		code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH

version: 27.08.2015/03    approval:    dimension: 85 x 60 mm

►    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

►    the skin conditions erthema nodosum (characterised by painful reddish skin nodules) or erythema multiforme (characterised by rash with target-shaped reddening or sores)

►    harmful blood clots in a vein or artery for example:

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

59

Packaging Technology Berlin gbkop	rn 59	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

P in a lung (i.e. PE)

P heart attack P stroke

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

P 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).

60

Packaging Technology Berlin gbkop	rn 60	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

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 booklet. 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 Yasmin ED

Keep this medicine out of the sight and reach of children.

Do not store above 25 °C. Store in the 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.

62

Packaging Technology Berlin gbkop	rn 62	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

6. Contents of the pack and other information

What Yasmin ED contains

Composition of the light yellow active tablets:

►    The active substances are ethinylestradiol and drospirenone. Each light yellow active tablet contains 0.030 milligrams ethinylestradiol and 3 milligrams drospirenone.

►    Other ingredients in the light yellow active tablets are

Tablet core:    lactose monohydrate, maize starch,

pregelatinised maize starch, povidone K25, magnesium stearate (E470b)

Tablet film-coating: hypromellose (E464), macrogol 6000, talc (E553b), titanium dioxide (E 171) and iron oxide yellow (E 172).

63

Packaging Technology Berlin gbkop	rn 63	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

Composition of the white placebo tablets:

►    These tablets contain no active substances.

►    The ingredients in the white placebo tablets are

Tablet core:    lactose monohydrate, macrocrystalline

cellulose, magnesium stearate (E470b)

Tablet film-coating: hypromellose (E464), talc (E553b) and titanium dioxide (E 171).

What Yasmin ED looks like and content of the pack

►    Each blister of Yasmin ED contains 21 light yellow active tablets in the 1st, 2nd and 3rd rows of the strip and 7 white placebo tablets in row 4.

►    Yasmin ED tablets, both the light yellow and the white, are film-coated tablets; the core of the tablet is coated.

64

Packaging Technology Berlin gbkop	rn 64	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

►    The light yellow active tablet is round with convex surfaces; one side is embossed with the letters “DO” in a regular hexagon.

►    The white placebo tablet is round with convex surfaces; one side is embossed with the letters “DP” in a regular hexagon.

►    Yasmin ED is available in packs of 1, 3, and 6 blisters each with 28 tablets.

Not all pack sizes may be marketed.

65

Packaging Technology Berlin gbkop	rn 65	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

Marketing Authorisation Holder

Bayer pic, Bayer House, Strawberry Hill, Newbury, Berkshire. RG14 1JA.

Manufacturer

Bayer Pharma AG 13342 Berlin, Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

►    Denmark, Iceland, Netherlands, Norway, Sweden: Yasmin 28

►    Spain: Yasmin Diario

►    United Kingdom: Yasmin ED

This leaflet was last revised in July 2015

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Packaging Technology Berlin gbkop	rn 66	Bayer Pharma AG
client: 0021 material-no.: 84729132		PZ: 2537A-4C code-no.: 294
name: LF-BRO-Yasmin ED FTB 28		country: GB/-/BPH
version: 27.08.2015/03	approval:	dimension: 85 x 60 mm

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