YAZ FLEX ethinylestradiol (as betadex clathrate) 20 micrograms / drospirenone 3 mg tablet dispenser pack

Main information

  • Trade name:
  • YAZ FLEX ethinylestradiol (as betadex clathrate) 20 micrograms / drospirenone 3 mg tablet dispenser pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • YAZ FLEX ethinylestradiol (as betadex clathrate) 20 micrograms / drospirenone 3 mg tablet dispenser pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 179878
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

179878

YAZ FLEX ethinylestradiol (as betadex clathrate) 20 micrograms / drospirenone 3 mg tablet dispenser pack

ARTG entry for

Medicine Registered

Sponsor

Bayer Australia Ltd

Postal Address

PO Box 182,Gordon NSW 2072,Gordon, NSW, 2072

Australia

ARTG Start Date

6/03/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. YAZ FLEX ethinylestradiol (as betadex clathrate) 20 micrograms / drospirenone 3 mg tablet dispenser pack

Product Type

Single Medicine Product

Effective date

20/02/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

YAZ Flex is indicated for use as: - an oral contraceptive. - Treatment of moderate acne vulgaris in women who seek oral contraception

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Dispenser Pack

Plastic

36 Months

Store below 30

degrees Celsius

Not recorded

See Product

information for shelf

life

Pack Size/Poison information

Pack Size

Poison Schedule

4 x 30 dispenser pack

(S4) Prescription Only Medicine

1 x 30 dispenser pack

(S4) Prescription Only Medicine

3 x 30 dispenser pack

(S4) Prescription Only Medicine

(1 x 30 dispenser pack + 1 x tablet dispenser: starter kit to be separately

included on the register as a procedure pack device)

(S4) Prescription Only Medicine

Components

1. YAZ FLEX ethinyloestradiol (as betadex clathrate) 20 mcg, drospirenone 3 mg tablet dispenser pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

Light pink round tablets debossed on one side with the letters "DS" in a

regular hexagon.

Active Ingredients

Drospirenone

3 mg

ethinylestradiol

20 microgram

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 08:41:03 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

1802 YAZ

Flex

CMI AU

YAZ

®

Flex

drospirenone and ethinyloestradiol (as betadex clathrate)

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some

common questions about YAZ

Flex. It does not contain all the

available information. It does not

take the place of talking to your

doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking YAZ Flex

against the benefits they expect it

will have for you.

If you have any concerns, or are

unsure about taking this

medicine, ask your doctor or

pharmacist for more advice.

Keep this leaflet with the

medicine.

You may need to read it again.

WHAT YAZ FLEX IS

USED FOR

YAZ Flex is a combined oral

contraceptive, commonly known

as a ‘birth control pill’ or ‘the

Pill’.

YAZ Flex is used to prevent

pregnancy.

It is also used to treat moderate

acne in women seeking oral

contraception.

You may also experience the

following benefits:

improvement in symptoms like

bloating, swelling or weight

gain related to fluid retention

fewer bleeding/spotting days

a decrease in anaemia (iron

deficiency)

a decrease in period pain.

Some conditions such as pelvic

inflammatory disease, ovarian

cysts, ectopic pregnancy (where

the foetus is carried outside of

your womb, lumpy breasts and

cancer of the uterus (womb), and

ovaries may be less common in

women taking the Pill.

When taken correctly, it prevents

you from becoming pregnant in

various ways, including:

inhibiting the egg release by

stopping it maturing

changing the cervical mucus

consistency, making it more

difficult for the sperm to reach

the egg.

When the Pill is taken by women

under close observation in clinical

trials, it is more than 99%

effective in preventing pregnancy.

However, in real life the Pill is

around 92% effective. This is

because pills might be missed, or

taken with medicines that may

interfere with their effectiveness

or may not be absorbed due to

vomiting and diarrhoea.

Like all oral contraceptives, YAZ

Flex is intended to prevent

pregnancy. It does not protect

against HIV infection (AIDS) and

other sexually transmitted

infections.

This means that with YAZ Flex,

you may not have a menstrual

period every month for up to 4

months. When you start to take

YAZ Flex, you must take one

tablet daily for 24 days without a

tablet free break. This is called the

fixed phase.

YAZ Flex allows you to schedule

when you want to have your

period. You can choose to take a 4

day tablet free break (have your

period) during day 25 - 120. This

is called the flexible phase.

Ask your doctor if you have any

questions about why this

medicine has been prescribed

for you.

Your doctor may have prescribed

it for another reason.

BEFORE YOU TAKE

YAZ FLEX

When you must not take it

Do not take YAZ Flex if you

have an allergy to

drospirenone

and/or ethinyloestradiol , the

active ingredients in YAZ Flex

any of the ingredients listed at

the end of this leaflet.

Some of the symptoms of an

allergic reaction may include:

shortness of breath

wheezing or difficulty in

breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the

skin.

Do not take YAZ Flex if you are

taking

antiviral medicines

which contain ombitasvir,

paritaprevir, or dasabuvir, and

1802 YAZ

Flex

CMI AU

combinations of these.

These

antiviral medicines are used to

treat chronic (long-term) hepatitis

C (an infectious disease that

affects the liver, caused by the

hepatitis C virus).

Do not take YAZ Flex if you

have or have had a blood clot

in:

the blood vessels of the legs

(deep vein thrombosis - DVT)

the lungs (pulmonary embolism

- PE)

the heart (heart attack)

the brain (stroke)

other parts of the body.

Do not take YAZ Flex if you

have or are concerned about or

have an increased risk of blood

clots.

Blood clots are rare. Very

occasionally blood clots may

cause serious permanent

disabilities, or may even be fatal.

You are more at risk of having a

blood clot when you take the Pill.

But the risk of having a blood clot

when taking the Pill is less than

the risk during pregnancy.

Do not take YAZ Flex if you are

concerned about an increased

risk of blood clots because of

age or smoking.

The risk of having a heart attack

or stroke increases as you get

older. It also increases if you

smoke. You should stop smoking

when taking the Pill, especially if

you are older than 35 years of age.

Do not take YAZ Flex if you

have, or have had:

any blood clotting disorders

such as Protein C deficiency,

Protein S deficiency, Leiden

Factor V mutation,

Antithrombin III deficiency or

other inherited blood clotting

conditions

a confirmed blood test showing:

increased levels of

homocysteine

antiphospholipid

antibodies (APLAs) e.g.

anticardiolipin-antibodies

and lupus anticoagulant.

These may increase your

risk for blood clots or

pregnancy losses

(miscarriage)

major surgery after which you

have not been able to move

around for a period of time

angina (chest pain)

mini-stroke (also known as TIA

or transient ischaemic attack)

severe kidney insufficiency or

an acute failure of your kidney

migraine, where you have also

had problems with seeing,

speaking or had weakness or

numbness in any part of your

body

high risk of blood clots due to

conditions such as diabetes with

blood vessel damage, severe

high blood pressure or severe

high or low level of fats in your

blood

pancreatitis (an inflammation of

the pancreas) associated with

high levels of fatty substances

in your blood

severe liver disease and your

liver function has not returned

to normal

cancer that may grow under the

influence of sex hormones (e.g.

of the breast or the genital

organs)

a benign or malignant liver

tumour

unexplained vaginal bleeding.

If any of these conditions

appear for the first time while

using the Pill, stop taking it at

once and tell your doctor. In the

meantime use non-hormonal

(barrier) methods of

contraception (such as condoms

or a diaphragm).

Do not take this medicine if you

are pregnant or think you might

be pregnant.

Do not give this medicine to a

child.

Do not open the foil containing

the cartridge of YAZ Flex

tablets until you have a CLYK

device and are ready to take

your first Pill.

Once opened, the tablets last 40

days, so any unused tablets should

be disposed of after this time.

Do not take this medicine after

the expiry date printed on the

pack and blister.

The expiry date is printed on the

carton and on each blister after

“EXP” (e.g. 11 18 refers to

November 2018). The expiry date

refers to the last day of that

month. If it has expired return it to

your pharmacist for disposal.

Do not take this medicine if the

packaging is torn or shows signs

of tampering.

If the packaging is damaged,

return it to your pharmacist for

disposal.

If you are not sure whether you

should start taking this

medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if:

you smoke

you or anyone in your

immediate family has had blood

clots in the legs (DVT) or lungs

(PE), a heart attack, a stroke,

breast cancer or high

cholesterol.

1802 YAZ

Flex

CMI AU

Tell your doctor if you have, or

have had any of the following

medical conditions:

depression

diabetes

high blood pressure

heart valve disorders or certain

heart rhythm disorders

migraine

an increased potassium blood

level (e.g. due to problems with

your kidney/s) and also use

diuretics or other drugs that may

increase the potassium in your

blood

cancer

hyperhomocysteinaemia, a

condition characterised by high

levels of the amino acid

homocysteine in the blood.

Ask your doctor to check if you:

are overweight

have any hereditary or acquired

conditions that may make it

more likely for you to get blood

clots

have high cholesterol or

triglycerides

have liver disease

have high potassium in your

blood

have jaundice (yellowing of the

skin) and/or pruritus (itching of

the skin) related to cholestasis

(condition in which the flow of

bile from the liver stops or

slows)

have gall bladder disease

have Crohn’s disease or

ulcerative colitis

(chronic inflammatory bowel

disease)

have systemic lupus

erythematosus (SLE – a disease

affecting the skin all over the

body)

have haemolytic uraemic

syndrome (HUS– a disorder of

blood coagulation causing

failure of the kidneys)

have sickle cell disease

have a condition that occurred

for the first time, or worsened

during pregnancy or previous

use of sex hormones (e.g.

hearing loss, a metabolic disease

called porphyria, a skin disease

called

herpes gestationis

neurological disease called

Sydenham’s chorea)

have chloasma (yellowish-

brown pigmentation patches on

the skin, particularly of the face)

– if so, avoid exposure to the

sun or ultraviolet radiation

have hereditary angioedema –

you should see your doctor

immediately if you experience

symptoms of angio-oedema,

such as swollen face, tongue

and/or pharynx and/or difficulty

swallowing, or hives together

with difficulty in breathing.

If any of the above conditions

appear for the first time, or

recur or worsen while taking

YAZ Flex, you should tell your

doctor.

Tell your doctor if you are

breastfeeding.

YAZ Flex

is generally not

recommended if you are

breastfeeding.

YAZ Flex contains lactose.

If you have an intolerance to some

sugars, tell your doctor before you

start taking YAZ Flex.

If you have not told your doctor

about any of the above, tell

him/her before you start taking

YAZ Flex.

Taking other medicines

Tell your doctor or pharmacist

if you are taking any other

medicines, including any that

you get without a prescription

from your pharmacy,

supermarket or health food

shop.

Some medicines and YAZ Flex

may interfere with each other.

These include:

medicines used to treat

tuberculosis such as rifampicin,

rifabutin

macrolide antibiotics (e.g.

clarithromycin, erythromycin)

medicines used to treat fungal

infections, such as griseofulvin,

ketoconazole, itraconazole,

voriconazole, fluconazole

medicines used to treat HIV,

such as ritonavir or nevirapine

some medicines used to treat

Hepatitis C Virus (HCV) such

as boceprevir, telaprevir

medicines used to treat epilepsy

such as phenytoin, primidone,

barbiturates (e.g.

phenobarbitone),

carbamazepine, oxcarbazepine,

topiramate, felbamate,

lamotrigine

cyclosporin, an

immunosuppressant medicine

some medicines used to treat

high blood pressure, chest pain,

or irregular heartbeats such as

verapamil, diltiazem

herbal medicines containing St

John’s Wort

grapefruit juice.

These medicines may be affected

by YAZ Flex, or may affect how

well it works. Your doctor may

need to alter the dose of these

medicines, or prescribe a different

medicine.

You might have an increase in

potassium in the blood if you are

taking YAZ Flex with medicines

that may increase potassium levels

in the blood. These include:

medicines used to treat high

blood pressure, such as ACE

inhibitors, angiotensin-II-

receptor antagonists and

diuretics

certain anti-inflammatory

medicines, such

as indomethacin

1802 YAZ

Flex

CMI AU

aldosterone antagonists, such as

spironolactone and eplerenone.

In a study of women taking

drospirenone together with an

ACE inhibitor, no significant

differences were observed in the

potassium levels when compared

to the placebo.

You may need to use additional

barrier methods of

contraception (such as condoms

or a diaphragm) while you are

taking any of these medicines

and for some time after

stopping them.

Your doctor will be able to tell

you about how long you will need

to use additional contraceptive

methods.

Your doctor and pharmacist have

more information on medicines

that you need to be careful with or

avoid while taking this medicine.

HOW TO TAKE YAZ

FLEX

Follow all directions given to

you by your doctor or

pharmacist carefully.

They may differ from the

information contained in this

leaflet. The information contained

in this leaflet tells you how you

should take the Pill.

A separate set of instructions is

enclosed with the CLYK tablet

dispenser. Please follow these

instructions carefully on how to

use the CLYK tablet dispenser.

The CLYK tablet dispenser is a

dispensing system for YAZ Flex;

it tells you when it is time to take

your Pill and helps you keep track

of your intake regimen.

If you do not understand the

instructions provided, ask your

doctor or pharmacist for help.

How to take it

Take your first YAZ Flex tablet

by dispensing the Pill from the

CLYK tablet dispenser.

Insert the narrow end of the

cartridge into the dispenser so that

the tablets in the cartridge can be

seen through the window of the

dispenser (see Fig. 1).

Fig. 1: Preparing the CLYK tablet

dispenser for use

Note: There is a grey coloured disc

on top of the pink YAZ Flex tablets in

the cartridge. This is not a tablet. It is

a plastic stopper that is part of the

cartridge unit.

Unpack and insert the cartridge on

the day you want to start taking

your Pill.

Make sure the day and time you

release your first Pill is

convenient for you.

The dispenser will automatically

record when the first tablet is

released by setting this time as the

reference time.

Slowly press the two soft sides of

the dispenser, firmly and

completely (at the Bayer logo), at

the same time to release the tablet.

Take one tablet daily at about the

same time every day. You must

take YAZ Flex every day

regardless of how often you have

sex. This will also help you

remember when to take it. Take

the tablets for the first 24 days

(fixed phase) without a tablet free

break.

A 4 day tablet free break can be

taken between the flexible phase -

days 25 – 120. A tablet free break

should not be longer than 4 days.

A 4 day tablet free interval must

be taken after taking the Pill for

120 consecutive days.

After each 4 day tablet free

interval, a new cycle of Pill taking

starts with a minimum of 24 days

and a maximum of 120 days.

Swallow the tablet whole with a

full glass of water.

It does not

matter if you take it before or after

food.

If you see an exclamation mark

symbol (!) on the CLYK tablet

dispenser screen, this means you

must use additional barrier

contraceptive precautions (e.g.

1802 YAZ

Flex

CMI AU

condoms, diaphragm) until this

symbol (!) disappears.

If you do not understand the

instructions ask your doctor or

pharmacist for help.

When to take it

If you are starting YAZ Flex after

a natural cycle, and you have not

used a hormonal contraceptive in

the past month, start on the first

day of your period, i.e. on the first

day of your menstrual bleeding.

You may also start on days 2-5 of

your period, but in that case make

sure you also use additional

barrier contraceptive precautions

(e.g. condom) for the first 7 days

of tablet-taking.

Your doctor will advise you

when to start if you

are taking YAZ Flex after

having a baby

have had a miscarriage or an

abortion.

Changing from a combined oral

contraceptive:

Start taking YAZ Flex on the day

after taking the last placebo tablet

in your previous Pill pack.

Changing from a vaginal ring:

Start taking YAZ Flex on the day

after the removal is due.

Changing from a progestogen-

only pill:

Stop taking the minipill on any

day and start taking YAZ Flex at

the same time the day after you

took your last minipill.

You must also use additional

barrier contraceptive

precautions (e.g. condoms or a

diaphragm) for the first 7 days

of tablet-taking when having

intercourse.

Changing from a progestogen-

only injection, implant or-

intrauterine system (IUS):

Start YAZ Flex when your next

injection is due, or on the day that

your implant or IUS is removed.

You must also use additional

barrier contraceptive

precautions (e.g. condoms or a

diaphragm) for the first 7 days

of tablet-taking when having

intercourse.

Stopping YAZ Flex

You can stop taking YAZ Flex at

any time. If you are considering

becoming pregnant, it is

recommended that you begin

taking a vitamin supplement

containing folic acid. It is best that

you start taking folic acid tablets

before you stop taking YAZ Flex

and not stop until your doctor

advises this. Ask your doctor or

pharmacist about suitable

supplements. It is both safe and

recommended that you take folic

acid during pregnancy.

If you forget to take it

If you are late taking a tablet but

still take it within 24 hours,

contraception is maintained. If

you are more than 24 hours late,

this is called a missed Pill.

The CLYK tablet dispenser will

guide you through what to do in

this situation. If you want further

information follow these

instructions:

For YAZ Flex to be effective, the

tablets need to be taken

uninterrupted for 7 days.

FIXED PHASE: Days 1 – 7

If you miss one or more YAZ

Flex tablets during the first 7 days

of tablet taking, take the last

missed tablet as soon as you

remember, even if this means

taking two YAZ Flex tablets at the

same time. Then, take the next

tablet at the usual time when the

CLYK prompts you. Use extra

contraceptive precautions (barrier

method such as a condom) for the

next 7 days. If you had sexual

intercourse in the week before

missing the tablets, there is a

possibility of becoming pregnant.

Tell your doctor immediately.

The chance of pregnancy after

missing a YAZ Flex tablet

depends on when you missed the

tablet. There is a higher risk of

becoming pregnant if you miss a

tablet at the beginning of a cycle

or directly before or directly after

a 4 day tablet free break.

FIXED PHASE: Days 8 – 24

If you miss one or more YAZ

Flex tablets during days 8 – 24 of

tablet taking, take the last missed

YAZ Flex tablet as soon as you

remember, even if this means

taking two YAZ Flex tablets at the

same time. Then, take the next

tablet at the usual time when the

CLYK prompts you. Use

additional contraceptive

precautions if the CLYK prompts

you.

FLEXIBLE PHASE:

Days 25 - 120

If you have missed one or more

YAZ Flex tablets during days 25

– 120, you can choose either

option:

1.

Take the last missed tablet as

soon as you remember, even if it

means taking two YAZ Flex

tablets at the same time. Then,

take the next tablet at the usual

time when the CLYK prompts

until you have taken at least

7 YAZ Flex tablets in a row

without interruption.

2.

You can stop taking your Pill,

take a 4 day tablet free break,

including the days where tablets

were missed, and then continue

1802 YAZ

Flex

CMI AU

with a new cycle of YAZ Flex.

The total tablet free break should

be no longer than 4 days.

The

CLYK may prompt you to use

additional contraceptive

precautions. It is important that

you follow this advice.

If you have forgotten to take your

tablets and you do not have your

expected menstrual bleed (that

should start while having a 4 day

Pill free break), you may be

pregnant. Contact your doctor

before you continue tablet-taking.

Please see the end of this leaflet

for “Summary of advice if you

missed a tablet more than 24

hours ago”.

Ask your doctor or pharmacist

to answer any questions you

may have.

If you take too much

(overdose)

Immediately telephone your

doctor or the Poisons

Information Centre (Australia:

13 11 26) for advice, or go to

Accident and Emergency at the

nearest hospital, if you think

that you or anyone else may

have taken too much YAZ Flex.

Do this even if there are no signs

of discomfort or poisoning.

may need urgent medical

attention.

If you take several light pink

active tablets at once, you may

feel sick or vomit or may bleed

from the vagina. Even girls who

have not yet started to menstruate

but have accidentally taken this

medicine may experience such

bleeding.

WHILE YOU ARE

TAKING YAZ FLEX

Things you must do

Tell any doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

If you are about to have any

blood tests, tell your doctor that

you are taking this medicine.

may interfere with the results of

some tests.

Have regular check-ups with

your doctor.

When you are taking

the Pill, your doctor will tell you

to return for regular check-ups,

including getting a Cervical

Screening Test. Your doctor will

advise how often you need a

Cervical Screening Test. A

Cervical Screening Test can detect

abnormal cells lining the cervix.

Sometimes abnormal cells can

progress to cancer.

If you are about to start on any

new medicine, remind your

doctor and pharmacist that you

are taking YAZ Flex.

Stop taking YAZ Flex and see

your doctor immediately if you

notice the following signs:

one-sided swelling of the leg

and/or foot or along a vein in

the leg

pain or tenderness in the leg

which may be felt only when

standing or walking

increased warmth in the

affected leg; red or discoloured

skin on the leg

sudden onset of unexplained

shortness of breath or rapid

breathing

sudden coughing or coughing

up of blood

sharp chest pain or sudden

severe pain in the chest which

may increase with deep

breathing

severe light headedness or

dizziness

rapid or irregular heartbeat

sudden pain, swelling and

slight blue discoloration of an

extremity

sudden numbness or weakness

of the face, arm or leg,

especially on one side of the

body

sudden trouble walking,

dizziness, loss of balance or

coordination

sudden confusion, slurred

speech or aphasia; sudden

partial or complete loss of

vision, double vision, painless

blurring of vision which can

progress to loss of vision

sudden, severe or prolonged

headache with no known cause

loss of consciousness or

fainting with or without seizure

pain, discomfort, pressure,

heaviness, sensation of

squeezing or fullness in the

chest arm, or below the

breastbone

discomfort radiating to the

back, jaw, throat, arm, stomach

feeling of being full, having

indigestion or choking

sweating, nausea, vomiting

extreme weakness and anxiety.

If you are going to have surgery,

tell the surgeon or anaesthetist

beforehand that you are taking

this medicine.

The risk of having blood clots is

temporarily increased as a result

of major surgery, any surgery to

the legs or pelvis, neurosurgery or

major trauma. In women who take

YAZ Flex, the risk may be higher.

In women at risk of prolonged

immobilisation (including major

surgery, any surgery to the legs or

1802 YAZ

Flex

CMI AU

pelvis, neurosurgery, or major

trauma), your doctor may tell you

to stop taking (in the case of

elective surgery at least four

weeks in advance) and not resume

until two weeks after complete

remobilisation. Another method of

contraception should be used to

avoid unintentional pregnancy.

Your doctor may prescribe other

treatment (e.g. treatment for blood

clots) if YAZ Flex has not been

discontinued in advance.

Other risk factors for blood

clotting include temporary

immobilisation including air

travel of greater than 4 hours,

particularly in women with

other risk factors.

Consult your

doctor if you plan to air travel for

greater than 4 hours.

Consult your doctor if you

develop high blood pressure

while taking YAZ Flex – you

may be told to stop taking it.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

If you vomit within 3-4 hours or

have severe diarrhoea after

taking a YAZ Flex tablet, the

active ingredients may not have

been completely absorbed. This

is like missing a tablet. Follow

the advice for missed tablets.

In the event of spotting and/or

bleeding on three consecutive

days during the flexible phase

(days 25 – 120), it is

recommended to take the 4 day

tablet free interval.

This will

reduce the total number of days

with bleeding.

If you have unexpected bleeding

and it continues, becomes heavy,

or occurs again, tell your

doctor.

When taking these tablets for the

first few months, you can have

irregular vaginal bleeding

(spotting or breakthrough

bleeding), even during the fixed

phase of the cycle between days 1

– 24. You may need to use

sanitary products, but continue to

take your tablets as normal.

Irregular vaginal bleeding usually

stops once your body has adjusted

to the Pill, usually after about

3 months.

If you have missed a period, but

you have taken all your tablets,

it is very unlikely that you are

pregnant, as long as:

you have taken the tablets at the

right time

you have not been taking

medicine(s) that may interfere

with YAZ Flex

you have not vomited or had

severe diarrhoea during this

cycle.

If this is so, continue to take YAZ

Flex as usual. If you have any

concerns consult your doctor or

pharmacist.

If you miss your period twice in

a row, you may be pregnant

even if you have taken the Pill

correctly. Stop taking YAZ Flex

and seek advice from your

doctor. You must use a non-

hormonal method of

contraception (such as condoms

or a diaphragm) until your

doctor rules out pregnancy.

YAZ Flex will not protect you

from HIV-AIDS or any other

Sexually Transmitted Infections

(STIs), such as chlamydia, genital

herpes, genital warts, gonorrhoea,

hepatitis B, human papilloma

virus and syphilis.

To protect yourself from STIs,

you will need to use additional

barrier contraceptives

(e.g. condoms).

Things you must not do

Do not take YAZ Flex to treat

any other conditions, unless

your doctor tells you to.

Do not give your medicine to

anyone else.

Do not stop taking your

medicine or change the dosage

without checking with your

doctor.

You may become

pregnant if you are not using any

other contraceptive and you stop

taking YAZ Flex, or do not take a

tablet every day.

SIDE EFFECTS

Tell your doctor or pharmacist

as soon as possible if you do not

feel well while you are taking

YAZ Flex.

This medicine helps most people,

but it may have unwanted side

effects in a few people.

All medicines can have side

effects. Sometimes they are

serious, most of the time they are

not. You may need medical

attention if you get some of the

side effects.

Do not be alarmed by the

following lists of side effects.

You may not experience any of

them.

Ask your doctor or pharmacist

to answer any questions you

may have.

The following list includes the

more common side effects of your

Pill. These are usually mild

and lessen with time.

If you notice any of the

following side effects and they

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Flex

CMI AU

worry you, tell your doctor or

pharmacist:

nausea

headache, including migraines

mood changes, including

depression

unscheduled vaginal bleeding

abnormal periods

irregular bleeding between

periods

decrease and loss of libido

breast tenderness or pain.

The following list includes very

serious but rare side effects. You

may need urgent medical attention

or hospitalisation.

If you experience any of the

following, tell your doctor

immediately, or go to the

Emergency Department at your

nearest hospital:

pain in the chest, arm or below

the breastbone

pain or discomfort that goes to

your back

breathlessness and/or difficulty

breathing

swelling, pain or tenderness of

one leg

sudden weakness, numbness or

bad ‘pins and needles’ of the

face, arm or leg, especially on

one side of the body

sudden trouble walking,

dizziness, loss of balance or

coordination

severe, sudden stomach pains

a bad fainting attack, or you

collapse

unusual headaches or migraines

that are worse than usual

sudden problems with your

speech or eyesight

The side effects listed above are

possible signs of a blood clot

(thrombosis).

jaundice (yellowing skin or

yellowing eyes)

you cough up blood

breast lumps

unexplained vaginal bleeding.

Tell your doctor or pharmacist

if you notice anything else that

is making you feel unwell.

Other

side effects not listed on the

following pages may also occur in

some people.

Blood clots and the Pill

Blood clots may block blood

vessels in your body. This type of

blood clot is also called

thrombosis.

Blood clots sometimes occur in

the deep veins of the legs (DVT).

If a blood clot breaks away from

the veins where it has formed, it

may reach and block the blood

vessels of the lungs, causing

pulmonary embolism (PE).

Blood clots can also occur in the

blood vessels of the heart (causing

a heart attack) or the brain

(causing a stroke).

Blood clots are a rare occurrence

and can develop whether or not

you are taking the Pill. They can

also happen during pregnancy.

The risk of having blood clots is

higher in Pill users than in non

users, but not as high as during

pregnancy.

The risk of a blood clot is highest

during the first year of taking the

Pill for the first time, or when re-

starting after having a break from

the Pill for 4 weeks or more.

If you notice possible signs of a

blood clot, stop taking YAZ Flex

and consult your doctor

immediately.

To prevent pregnancy, you must

also use additional barrier

contraceptive precautions (e.g.

condoms or a diaphragm).

If you are concerned about an

increased risk of blood clots

while on YAZ Flex, speak to

your doctor.

Cancer and the Pill

Breast cancer has been diagnosed

slightly more often in women who

take the Pill than in women of the

same age who do not take the Pill.

This slight increase in the

numbers of breast cancer

diagnoses gradually disappears

during the course of the 10 years

after women stop taking the Pill.

It is not known whether the

difference is caused by the Pill. It

may be that these women were

examined more often, so that the

breast cancer was noticed earlier.

It is important that you check

your breasts regularly and

contact your doctor if you feel

any lumps.

In rare cases benign liver tumours

and, even more rarely, malignant

liver tumours have been reported

in users of the Pill. These tumours

may lead to internal bleeding.

Contact your doctor

immediately if you have severe

pain in your abdomen.

Cervical cancer has been reported

to occur more often in women

who have been taking the Pill for

a long time. This finding may not

be caused by the Pill, but may be

related to sexual behaviour and

other factors.

AFTER TAKING YAZ

FLEX

Storage

Keep the YAZ Flex cartridge in

the blister foil until you have a

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Flex

CMI AU

CLYK device and are ready to

start taking your Pill.

Once the cartridge is taken out

of the foil, YAZ Flex tablets

only keep for 40 days, including

the time they are in the CLYK

device.

Any unused tablets must

be disposed of after this time.

Keep your tablets and the

CLYK device in a cool dry place

where the temperature stays

below 30°C.

Do not store it or any other

medicine in the bathroom, near

a sink, or on a window-sill.

Do not leave it in the car.

Heat and damp can destroy some

medicines.

Keep YAZ Flex where children

cannot reach it.

A locked

cupboard at least one-and-a-half

metres above the ground is a good

place to store medicines.

Disposal

If your doctor tells you to stop

taking this medicine or the

expiry date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Return any unused medicine to

your pharmacist.

PRODUCT

DESCRIPTION

What it looks like

YAZ Flex is available in

dispenser packs containing either

1, 3 or 4 refills. Each dispenser

pack contains 30 light pink

tablets.

Ingredients

Each YAZ Flex light pink tablet

contains:

Active ingredients:

3 milligram of drospirenone

20 microgram of

ethinyloestradiol (as betadex

clathrate)

Inactive ingredients:

lactose

maize starch

hypromellose

magnesium stearate

purified talc

titanium dioxide

iron oxide red

YAZ Flex tablets do not contain

gluten. Tablets also do not

contain tartrazine or any other

azo dyes.

Supplier

Made in Germany for:

Bayer Australia Ltd.

ABN 22 000 138 714

875 Pacific Highway

Pymble NSW 2073

Australian Registration

Number

YAZ Flex - AUST R 179878

Date of Preparation

February 2018

See TGA website

(www.ebs.tga.gov.au) for latest

Australian Consumer Medicine

Information.

Missed a pill?

See the end of this leaflet

® Registered Trademark of the

Bayer Group, Germany

© Bayer Australia Ltd

All rights reserved.

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Flex

CMI AU

Summary of advice if you missed a tablet more than

24 hours ago.

Always follow the instructions given on the screen of your CLYK tablet dispenser.

If you see an exclamation mark symbol (!) on the CLYK tablet dispenser screen, this

means you must use additional barrier contraceptive precautions (e.g. condoms,

diaphragm) until this symbol (!) disappears.

If you are concerned, contact your doctor or pharmacist for advice. In addition, you may

contact Bayer Medical Information on 1800 673 270.