LENEST

Main information

  • Trade name:
  • LENEST 20 ED levonorgestrel/ethinylestradiol 100 microgram/20 microgram tablet blister composite pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LENEST 20 ED levonorgestrel/ethinylestradiol 100 microgram/20 microgram tablet blister composite pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219146
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219146

LENEST 20 ED levonorgestrel/ethinylestradiol 100 microgram/20 microgram tablet blister composite pack

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

21/11/2014

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. LENEST 20 ED levonorgestrel/ethinylestradiol 100 microgram/20 microgram tablet blister composite pack

Product Type

Composite Pack

Effective date

21/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Lenest 20 ED is indicated for the prevention of pregnancy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Not recorded

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

2 x 28 (21 active and 7 placebo)

(S4) Prescription Only Medicine

3 x 28 (21 active and 7 placebo)

(S4) Prescription Only Medicine

1 x 28 (21 active and 7 placebo)

(S4) Prescription Only Medicine

4 x 28 (21 active and 7 placebo)

(S4) Prescription Only Medicine

Components

1. Active

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

Round, pink, uncoated flat tablets debossed 405 on one side and other side

plain

Active Ingredients

ethinylestradiol

.02 mg

Levonorgestrel

.1 mg

2. Inert

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

Round, green, uncoated flat tablets debossed 471 on one side and other

side plain.

© 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 26.11.2017 at 03:53:58 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

Public Summary

Page 2 of

Produced at 26.11.2017 at 03:53:58 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

LENEST 20 ED

contains the active ingredients levonorgestrel and ethinyloestradiol

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about LENEST 20 ED. It

does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking LENEST 20 ED

against the benefits expected 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 your

medicine.

You may need to read it again.

What LENEST 20 ED

is used for

LENEST 20 ED is a combined oral

contraceptive, commonly known as

'birth control pill' or 'the Pill'.

LENEST 20 ED is used to prevent

pregnancy.

When taken correctly, it prevents you

from becoming pregnant in several

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

changing the lining of the uterus,

making it less suitable for

implantation.

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.

Like all oral contraceptives,

LENEST 20 ED is intended to

prevent pregnancy. It does not

protect against HIV infection (AIDS)

and other sexually transmitted

diseases.

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

LENEST 20 ED

When you must not take it

Do not take LENEST 20 ED if you

have an allergy to:

ethinyloestradiol and/or

levonorgestrel, the active

ingredients in LENEST 20 ED

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 breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin

Do not take LENEST 20 ED if you

have or have had a blood clot in:

the blood vessels of the legs

(deep vein thrombosis)

the lungs (pulmonary embolism)

the heart (heart attack)

the brain (stroke)

other parts of the body

Do not take LENEST 20 ED if you

are concerned about 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 LENEST 20 ED 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 LENEST 20 ED if you

have, or have had:

angina (chest pain)

mini-stroke (also known as TIA

or transient ischaemic attack)

migraine, accompanied by visual

symptoms, speech disability, or

weakness or numbness in any part

of your body

diabetes mellitus with blood

vessel damage

LENEST 20 ED

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)

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.

LENEST 20 ED is not intended for

use in females whose periods have

not yet started.

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 are anyone in your

immediate family has had blood

clots in the legs (thrombosis), a

heart attack, a stroke, breast

cancer or high cholesterol.

Tell your doctor if you have, or

have had any of the following

medical conditions:

diabetes

high blood pressure

heart valve disorders or certain

heart rhythm disorders

inflammation of your veins

(superficial phlebitis)

varicose veins

migraine

epilepsy

Ask your doctor to check if you:

are overweight

have high cholesterol or

triglycerides

have liver disease

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, a 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 angio-oedema -

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, recur or worsen

while taking LENEST 20 ED, you

should contact your doctor.

Tell your doctor if you are

breastfeeding.

LENEST 20 ED is generally not

recommended if you are

breastfeeding.

LENEST 20 ED contains lactose.

If you have been told by your doctor

that you have intolerance to some

sugars, contact your doctor before

you start taking LENEST 20 ED.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

LENEST 20 ED.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from a

pharmacy, supermarket or health

food shop.

Some medicines and LENEST 20 ED

may interfere with each other. These

include:

medicines used to treat

tuberculosis such as rifampicin,

rifabutin

a class of antibiotics known as

macrolides, such as

clarithromycin, erythromycin

medicines used to treat fungal

infections, such as ketoconazole,

griseofulvin

medicines used to treat HIV, such

as ritonavir or nevirapine

some medicines used to treat

Hepatitis C Virus (HCV) such as

boceprevir, telaprevir, ombitasvir,

paritaprevir, dasabuvir

medicines used to treat epilepsy

such as phenytoin, primidone,

LENEST 20 ED

barbiturates (e.g.

phenobarbitone), carbamazepine,

oxcarbazepine, topiramate,

felbamate, lamotrigine

cyclosporin, an

immunosuppressant medicine

etoricoxib, a medicine used to

treat painful joint disease

melatonin, a hormone used as a

sleep aid

midazolam, a medicine used as a

sedative

theophylline, a medicine used to

treat respiratory disease

tizanidine, a medicine used as a

muscle relaxant

some medicines used to treat high

blood pressure, chest pain or

irregular heartbeats such as

diltiazem, verapamil

herbal medicines containing St

John's Wort.

grapefruit juice

These medicines may be affected by

LENEST 20 ED or may affect how

well it works. You may need

different amounts of your medicines,

or you may need to take different

medicines.

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 advise

you about how long you will need to

use additional contraceptive methods

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take LENEST

20 ED

Follow all directions given to you

by your doctor and pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the label or in this

leaflet, ask your doctor or

pharmacist for help.

How to take it

Take one tablet daily at about the

same time every day. You must take

LENEST 20 ED every day regardless

of how often you have sex. It will

also help you remember when to take

Swallow the tablet whole with

water.

It does not matter if you take it

before or after food.

Each blister pack is marked with the

day of the week.

Take your first pink (active) tablet

from the green area on the blister

pack corresponding to the day of

the week.

Follow the direction of the arrows on

the blister pack until all the tablets

have been taken.

A period should begin 2 to 3 days

after starting to take the green

inactive tablets (last row) and may

not have finished before the next

pack is started.

Always start a new blister pack on

the same day of the week as your

previous pack.

Taking LENEST 20 ED for

the first time

If you are starting LENEST 20 ED

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 LENEST 20 ED after

having a baby

have had a miscarriage or an

abortion

Changing from another

contraceptive

1.

Changing from a combined oral

contraceptive:

Start taking LENEST 20 ED on the

day after taking the last active tablet

in your previous Pill pack. Bleeding

may not occur until the end of the

first pack of LENEST 20 ED.

You can also switch to LENEST 20

ED after taking one or more inactive

tablets in your previous Pill pack, but

no later than the day after taking the

last inactive tablet.

If you are not sure which were the

active/inactive tablets were in your

previous Pill pack, ask your doctor

or pharmacist.

Your previous Pill pack may have

different colour tablets to those of

LENEST 20 ED.

2.

Changing from a progestogen-

only pill ('minipill'):

Stop taking the minipill on any day

and start taking LENEST 20 ED at

the same time the next day.

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.

3.

Changing from a progestogen

only injection, implant or

intrauterine system (IUS):

Start taking LENEST 20 ED 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.

4.

Changing from a vaginal ring

Start taking LENEST 20 ED on the

day of removal of the ring but at the

LENEST 20 ED

latest when the next application

would have been due.

Stopping LENEST 20 ED

You can stop taking LENEST 20 ED

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 LENEST 20 ED and not stop

until your doctor advises this. Seek

advice from your doctor or

pharmacist about suitable

supplements. It is both safe and

recommended that you take folic acid

during pregnancy.

Additional contraceptive

precautions

When additional contraceptive

precautions are required you should

either abstain from sex, or use a

barrier method of contraception, a

cap (or diaphragm) plus spermicide,

or a condom. Rhythm methods are

not advised as the Pill disrupts the

cyclical changes associated with the

natural menstrual cycle e.g. changes

in temperature and cervical mucus.

If you forget to take LENEST

20 ED

If you miss a tablet and take the

missing tablet within 12 hours of

missing it, you will be protected

against pregnancy. If you are more

than 12 hours late follow these

detailed instructions:

For LENEST 20 ED to be most

effective, pink active tablets need

to be taken uninterrupted for 7

days.

If you have been taking the pink

active tablets for 7 uninterrupted

days and miss a pink active tablet,

take the missed tablet as soon as

you remember, then go back to

taking your medicine as you would

normally, even if this means taking

two tablets in one day.

You will be protected against

pregnancy.

The chance of pregnancy after

missing a pink active tablet depends

on when you missed the tablet. There

is a higher risk of becoming pregnant

if you miss a tablet at the beginning

or end of a pack.

If after taking your missed tablet

you have less than 7 days of pink

active tablets left in a row, you

should finish the active tablets in

your pack but skip the green

inactive tablets. Start taking the

pink active tablets in your next

pack corresponding to the correct

day of the week.

This is the best way to maintain

contraceptive protection. However,

you may not have a period until the

end of the pink active tablets of the

second pack. You may have spotting

or breakthrough bleeding on tablet-

taking days.

If you have been taking the pink

active tablets for less than 7 days

and miss a pink active tablet, take

the missed tablet as soon as you

remember, then go back to taking

your pill as you would normally,

even if this means taking two

tablets in one day, at the same

time. In addition, you must also use

additional barrier contraceptive

precautions (e.g. condoms or a

diaphragm) for the next 7 days.

If you have had sexual intercourse

during that time, there is a possibility

of pregnancy and you may need

emergency contraception. You

should discuss this with your doctor

or pharmacist.

If you forget to take more than one

pink active tablet, seek advice from

your doctor or pharmacist about

what to do.

If you have had sexual intercourse in

the week before missing your tablets,

there is a possibility of becoming

pregnant.

If you forget to take a green

inactive tablet, take it as soon as

you remember and take the next

tablet at the usual time.

You are still protected against

pregnancy because the green tablets

do not contain any active ingredients.

Summary of advice if you

missed a pink active tablet

more than 12 hours ago:

Before missing your tablet, did you

take pink active tablets for the

previous 7 days?

NO - Did you have sex in the 7

days before missing the tablet?

NO - Take the tablet missed

AND use extra barrier

precaution for 7 days. If there

are fewer than 7 pink active

tablets left in the pack, finish

the pink active tablets and go

straight to the pink active

tablets of the next pack. This

means you skip the green

inactive tablets.

YES - See your doctor or

pharmacist for advice

YES - Does your pack still have 7

active pink tablets in a row to

follow?

NO - Take the tablet you

missed AND complete taking

the pink active tablets. Skip the

green inactive tablets. Start

your next pack with pink active

tablets.

YES - Take the tablet you

missed AND complete the pack

as normal

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, or New

Zealand: 0800 poison or 0800 764

766) for advice, or go to the

Accident and Emergency

Department at your nearest

hospital, if you think that you or

anyone else may have taken too

much LENEST 20 ED. Do this

even if there are no signs of

discomfort or poisoning.

LENEST 20 ED

You may need urgent medical

attention.

While you are taking

LENEST 20 ED

What you must do

Tell any other 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.

It 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 pap smear test. Your doctor will

advise how often you need a pap

smear test. A pap smear 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

LENEST 20 ED.

Stop taking LENEST 20 ED and

see your doctor immediately if you

notice possible signs of thrombosis.

These include:

an unusual cough

severe pain or heaviness in the

chest

breathlessness

any unusual, severe, or prolonged

headache or migraine attack

partial or complete loss of vision,

or double vision

slurring or speech disability

sudden changes to your hearing,

sense of smell, or taste

dizziness or fainting

weakness or numbness in any part

of your body

severe pain in your abdomen

severe pain, swelling or

discolouration in either of your

legs.

If you are going to have surgery,

tell the surgeon or anaesthetist

beforehand that you are taking

LENEST 20 ED.

The risk of having deep venous

thrombosis (DVT) is temporarily

increased as a result of an operation

or immobilisation (for example,

when you have your leg or legs in

plaster or splints). In women who

take the Pill, the risk may be higher.

Your doctor may tell you to stop

taking the Pill several weeks before

surgery, or at the time of

immobilisation, and when you can

start taking the Pill again. If you

notice possible signs of a thrombosis,

stop taking the Pill and consult your

doctor immediately.

Consult your doctor if you develop

high blood pressure while taking

LENEST 20 ED - 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 pink active tablet, the active

ingredients may not have been

completely absorbed. This is like

missing a tablet. Follow the advice

for missed tablets.

If you have unexpected bleeding

and it continues, becomes heavy, or

occurs again, tell you doctor.

When taking this pill for the first few

months, you can have irregular

vaginal bleeding (spotting or

breakthrough bleeding) between your

periods. You may need to use

sanitary protection, 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 pink active

tablets at the right time

you have not been taking a

medicine(s) that may interfere

with your pill

you have not vomited or had

severe diarrhoea during this cycle

If this is so, continue to take

LENEST 20 ED 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 LENEST 20 ED 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.

LENEST 20 ED will not protect you

from HIV-AIDS or any other

sexually transmitted diseases (STDs),

such as chlamydia, genital herpes,

genital warts, gonorrhoea, hepatitis

B, human papilloma virus and

syphilis.

To protect yourself from STDs,

you will need to use additional

barrier contraceptives (e.g.

condoms).

Things you must not do

Do not take LENEST 20 ED to

treat any other complaints 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 LENEST 20 ED, 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 LENEST

20 ED.

LENEST 20 ED

This medicine helps most women,

although a few may have unwanted

side effects.

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 worry you, tell

your doctor or pharmacist:

acne

nausea

stomach pain

changes in weight

headache, including migraines

mood changes, including

depression

breast tenderness or pain

hair loss or hair growth

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

discomfort radiating to the 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 fainting attack or you collapse

unusual headaches or migraines

that are worse than usual

sudden problems with speech,

understanding or eyesight

The side effects listed above are

possible signs of a 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 may also

occur in some people.

Thrombosis and the Pill

Thrombosis is the formation of a

blood clot that may block a blood

vessel.

Thrombosis sometimes occurs in the

deep veins of the legs (deep venous

thrombosis - DVT). If a blood clot

breaks away from the veins where it

has formed, it may reach and block

the arteries 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 after having a

break from the Pill for 4 weeks or

more.

If you notice possible signs of a

blood clot, stop taking LENEST 20

ED and consult your doctor

immediately.

If you are concerned about an

increased risk of blood clots while on

LENEST 20 ED, 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 lump.

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 LENEST

20 ED

Storage

Keep your tablets in the blister

pack until it is time to take them.

If you take the tablets out of the pack

they may not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25°C.

LENEST 20 ED

Do not store it or any other

medicine in the bathroom or near a

sink, or on a window-sill. Do not

leave it in the car.

Heat and dampness can destroy some

medicines.

Keep LENEST 20 ED 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 LENEST 20 ED looks

like

LENEST 20 ED active tablets are

pink and round with '405' on one side

and other side plain.

LENEST 20 ED inactive tablets are

green and round with '471' debossed

on one side and other side plain.

LENEST 20 ED is available in a box

containing 1, 2, 3 or 4 blister packs.

However not all pack sizes may be

marketed.

Each blister pack contains 21 pink

active tablets and 7 green inactive

tablets.

Ingredients

Each pink active tablet contains:

Active ingredients:

20 micrograms of

ethinyloestradiol

100 micrograms of levonorgestrel

Inactive ingredients:

lactose

microcrystalline cellulose

croscarmellose sodium

povidone

sodium lauryl sulfate

iron oxide red

magnesium stearate

Each green inactive tablet

contains:

lactose

microcrystalline cellulose

croscarmellose sodium

povidone

iron oxide yellow

brilliant blue FCF aluminium lake

magnesium stearate

Supplier

LENEST 20 ED is supplied in

Australia by:

Alphapharm Pty Ltd

(Mylan Australia)

(ABN 93 002 359 739)

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

Phone: 1800 274 276

www.mylan.com.au

Australian Registration Number:

LENEST 20 ED - AUST R 219146

This leaflet was prepared on

18 May 2017.

Lenest20ED_cmi\May17/00

LENEST 20 ED

There are no safety alerts related to this product.