LOETTE

Main information

  • Trade name:
  • LOETTE ethinylestradiol / levonorgestrel tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LOETTE ethinylestradiol / levonorgestrel tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215494
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215494

LOETTE ethinylestradiol / levonorgestrel tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

6/11/2013

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. LOETTE ethinylestradiol / levonorgestrel tablet blister pack

Product Type

Composite Pack

Effective date

11/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

1. The prevention of pregnancy. 2. The treatment of moderate acne vulgaris not controlled with topical preparations in post-menarchal, pre-menopausal

women who accept contraception.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

3 x 21 active & 7 placebo

(S4) Prescription Only Medicine

1 x 21 active & 7 placebo

(S4) Prescription Only Medicine

4 x 21 active & 7 placebo

(S4) Prescription Only Medicine

2 x 21 active & 7 placebo

(S4) Prescription Only Medicine

Components

1. Placebo

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White film-coated round tablet with convex faces

2. Levonorgestrel and Ethinyloestradiol tablet

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Round, pink, biconvex tablets with "W" debossed on one side and "912"

debossed on the other side.

Active Ingredients

ethinylestradiol

20 microgram

Levonorgestrel

100 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 26.11.2017 at 08:39:29 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

LOETTE

®

Levonorgestrel and Ethinyloestradiol Tablets

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Loette.

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

Loette against the benefits this

medicine is expected to have for you.

If you have any questions about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Loette is used

for

Loette is an oral contraceptive,

commonly known as a "birth control

pill" or "the Pill". Loette tablets

contain two hormones

(levonorgestrel and

ethinyloestradiol), which prevent you

from becoming pregnant if taken

correctly. They are similar to the

hormones that your body normally

produces.

Loette prevents pregnancy in several

ways:

It inhibits the egg release by

stopping it maturing

It changes the cervical mucus

consistency making it difficult for

the sperm to reach the egg

It changes the lining of the uterus

making it less suitable for

implantation.

Loette is also used to treat moderate

acne in women when this has not

improved with acne treatments

applied to the skin and who are also

willing to be on a contraceptive.

Ask your doctor if you have any

questions about why Loette has

been prescribed for you.

Your doctor may have prescribed

Loette for another reason.

This medicine is available only with

a doctor's prescription.

Loette is not habit-forming.

This medicine is not expected to

affect your ability to drive a car or

operate machinery.

Before you take Loette

When you must not take

Loette

Do not take Loette if you have an

allergy to:

Any medicine containing

ethinyloestradiol or

levonorgestrel

Any of the ingredients listed at

the end of this leaflet

Any other similar medicines

(such as other oral

contraceptives).

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 Loette if you have or

have had any of the following

medical conditions:

Venous thromboembolism (VTE)

and are on medicines called

anticoagulants which are used to

"thin the blood"

Blood clots or a history of blood

clots in the:

Legs (thrombophlebitis or

deep vein thrombosis (DVT)),

Lungs (pulmonary embolism)

Eyes.

Hereditary or an acquired

disposition for venous

thromboembolism

Multiple risk factors VTE

including obesity, age above 35

years, smoking

Major surgery and have been

confined to bed for long periods

of time

Arterial thromboembolism (ATE)

or a past history of these that

include:

Stroke

Angina

Transient ischaemic attack or

"mini stroke".

Hereditary or an acquired

disposition for ATE

History of migraine, accompanied

by blurred vision, difficulty in

speaking, muscle weakness, or

increased sensitivity to light,

sound, or noise

Multiple risk factors for ATE or a

serious risk factor for ATE that

include:

High blood pressure

LOETTE

Diabetes with blood vessel

damage

Severe lipid disease

Sickle cell anaemia.

Disease in any blood vessel(s)

Inflammation of the pancreas

which is associated with very

high blood levels of triglycerides

(fatty substances)

Breast cancer or cancer of the

lining of the womb, cervix or

vagina, or you think you have

these conditions

Unexplained vaginal bleeding

Liver tumour or liver disease

Yellowing of the whites of the

eyes or of the skin (jaundice)

during pregnancy or during

previous use of an oral

contraceptive.

If you are not certain whether

these may apply to you, or you are

worried by anything in this list, tell

your doctor.

Do not take this medicine if you

are pregnant or you think you are

pregnant.

Pregnancy must be excluded before

you start taking Loette.

Do not give this medicine to a

child.

Do not take this medicine if you

have already experienced

menopause.

Do not take this medicine after the

expiry date (EXP) printed on the

pack or if the packaging is torn or

shows signs of tampering.

If it is expired or is damaged, return

it to your pharmacist for disposal.

Before you start to take

Loette

You must have a thorough medical

check-up, including a Pap smear,

breast check, blood pressure check

and urine test.

You must tell your doctor if you or

anyone in your immediate family

has, or has had blood clots in the

legs or lungs.

Blood clots are a rare occurrence

when taking an oral contraceptive.

The risk of a blood clot is highest

during the first year of taking an oral

contraceptive for the first time or if

you are re-starting the "pill" after a

break of 4 weeks or more.

The risk of having a blood clot is

higher in oral contraceptive users

than in non-users, but is not as high

as during pregnancy.

Tell your doctor about any of the

following conditions as these are

risk factors for developing blood

clots:

Cancer

Systemic lupus erythematosus

(SLE)

Haemolytic uraemic syndrome

(HUS) - a disorder of blood

coagulation causing failure of the

kidneys)

Crohn's disease or ulcerative

colitis (chronic inflammatory

bowel disease)

Sickle cell disease

Smoking particularly if you are

heavy smoker (15 or more

cigarettes per day) and are aged

over 35 years

Have had any recent surgery or

trauma

Recently had a baby

Lost a baby in the second

trimester

Are pregnant

Had major surgery and have been

confined to bed for long periods

of time

Also tell your doctor if you are

planning a long haul plane flight

(greater than 4 hours).

You must tell your doctor if you or

anyone in your immediate family

has, or has had a stroke or heart

attack.

Taking oral contraceptives is linked

with an increased risk of having a

heart attack, angina, stroke or a "mini

stroke".

Tell your doctor if you have any of

the following conditions:

Heart disease including heart

valve disorders or certain heart

rhythm disorders

High blood pressure, a history of

high blood pressure or high blood

pressure during pregnancy

High cholesterol

Diabetes

Migraine or other headaches

Hyperhomocysteinemia.

Tell your doctor if over 35 years of

age or are overweight.

If you are not certain whether any of

the above may apply to you, check

with your doctor.

Tell your doctor if you the

following conditions:

Breast lumps, abnormal breast X-

ray or mammogram

Epilepsy

Depression

Gallbladder disease

Kidney disease

Asthma

Fibroids

Yellowing of the whites of the

eyes or skin (jaundice) during

pregnancy or during previous oral

contraceptive use

The hearing problem known as

otosclerosis

A history of a skin condition

called herpes gestationis found in

pregnant women and not caused

by the herpes virus

Multiple sclerosis

Hereditary angioedema.

If you have any of these conditions

you should have regular check-ups

with your doctor to make sure that

taking Loette is not making the

conditions worse.

Tell your doctor if you plan to

become pregnant or are

breastfeeding.

Your doctor can discuss the risks and

benefits involved with you.

LOETTE

If you have not told your doctor

about any of the above, tell him/

her before you start taking Loette.

Loette contains lactose.

If you know that you are intolerant to

some sugars, or your doctor has told

you so, speak to your doctor before

taking it.

Tell your doctor if you are allergic

to any foods, dyes, preservatives or

any other medicines.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including:

All prescription medicines

All medicines, vitamins, herbal

supplements or natural therapies

you buy without a prescription

from a pharmacy, supermarket,

naturopath or health food shop.

Some medicines may be affected by

Loette or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Your doctor will advise you.

Tell your doctor or pharmacist if

you are taking any of the

following:

Rifampicin and rifabutin for the

treatment of tuberculosis

Antibiotics such as ampicillin,

other penicillins and tetracyclines

Anti-fungal medicines such as

griseofulvin

Barbiturates (certain types of

medicines prescribed for

epilepsy, such as phenobarbitone)

Medicines for epilepsy (such as

phenytoin, primidone,

carbamazepine and topiramate)

Ritonavir for the treatment of

HIV infection

Modafinil used to treat excessive

daytime sleepiness

St. John's Wort, an ingredient in

many medicines you can buy

without a prescription from a

pharmacy, health food shop or

supermarket

Corticosteroids such as

dexamethasone.

While you are taking any of these

medicines, and for the next 7 days

after stopping them, you must also

use an additional non-hormonal

method of contraception (such as

condoms or a diaphragm, but not

the rhythm or temperature

methods). If you come to the end of

the pink tablets during these 7

days, start the next pack straight

away. Skip the 7 white tablets.

If you take rifampicin and some other

medicines, you may need to use

additional non-hormonal

contraception for four weeks after

finishing the course of treatment.

Ask your doctor or pharmacist

about how long you need to use

additional non-hormonal

contraception.

Tell your doctor or pharmacist if

you are taking any of the

following:

Atorvastatin used to treat high

cholesterol

Indinavir for the treatment of HIV

infection

Anti-fungal medicines such as

itraconazole and fluconazole

Paracetamol and ascorbic acid

(Vitamin C).

Cyclosporin used to prevent

organ rejection

Theophyllines used for asthma

and other breathing difficulties

Corticosteroids

Lamotrigine for seizures.

If you have not told your doctor or

pharmacist about any of the above,

tell them before you start taking

Loette.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while you are

taking this medicine.

How to take it

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How to take it

Swallow tablets whole with a full

glass of water.

When to take Loette

You must take Loette every day,

regardless of how often you have

sex.

Loette will work best if you do not

miss any tablets and take it at the

same time each day. Taking Loette at

the same time each day will also help

you remember when to take your

tablets.

It does not matter if you take Loette

before or after food.

If you are concerned about this,

please speak to your doctor or

pharmacist.

Starting a hormonal

contraceptive for the first

time

To start taking Loette follow these

steps:

On the first day of your menstrual

period, take a pink tablet that

matches the day of the week from

the pink shaded section of the

blister pack. For example if your

period commences on a Friday,

then take a pink tablet marked

Friday.

Then take one pink tablet each

day, following the arrows so that

you are taking the correct tablet

for the day of the week until all

21 pink tablets have gone.

Then take one white tablet each

day for the next 7 days.

LOETTE

You will have a 'withdrawal'

bleed, similar to having a period,

during the week of white tablets.

Loette is effective from the first day

of use if begun as instructed.

If you do not have a period while

you are taking the white tablets,

and there is any chance that you

have not followed all the

instructions in this leaflet, contact

your doctor to check if you are

pregnant.

Going on to further blister

packs

On the day after your last white

tablet, begin the next pack with a

pink tablet from the pink shaded

section of the blister pack that

matches the day of the week. Do this

even if you are still bleeding.

If you start taking your new pack

late, you must also use an

additional non-hormonal method

of contraception (such as condoms

or a diaphragm, but not the

rhythm or temperature methods)

until a pink tablet has been taken

daily for 7 days without a break.

Switching from a different

combined oral contraceptive

When changing from a different

combined oral contraceptive to

Loette, it is important to follow the

instructions below carefully.

Loette works best if you do not miss

any tablets and take it at the same

time each day.

Follow these steps if your current

oral contraceptive contains an

oestrogen and a progestogen:

Stop taking your current oral

contraceptive after you have

taken the last active tablet. If your

current oral contraceptive pack

also contains inactive or reminder

tablets, do not take them.

The next day, take the first pink

Loette tablet from the pink

shaded section that matches the

day of the week.

You must also use an additional

non-hormonal method of

contraception (such as condoms

or a diaphragm, but not the

rhythm or temperature

methods) until a pink tablet has

been taken daily for 7 days

without a break.

Then take one pink tablet each

day following the direction of the

arrows until all 21 pink tablets

have gone.

Then take one white tablet each

day for the next 7 days.

You will have a 'withdrawal'

bleed, similar to having a period,

during the week of white tablets.

If you do not have a period while

you are taking the white tablets,

and there is any chance that you

have not followed all the

instructions in this leaflet, contact

your doctor to check if you are

pregnant.

Switching from a

progestogen-only

contraceptive

You can stop taking a progestogen-

only contraceptive tablet any day

and start taking Loette the next

day, at the same time.

If you have been using a

progestogen implant, start taking

Loette on the day the implant is

removed.

If you have been using a

progestogen injection, start taking

Loette when your next injection

would be due.

In all cases start Loette by taking a

pink tablet from the pink shaded

section that matches the day of the

week.

You must also use an additional

non-hormonal method of

contraception (such as condoms or

a diaphragm, but not the rhythm

or temperature methods) until a

pink tablet has been taken daily for

7 days without a break.

After having a baby

If you have just had a baby, talk to

your doctor before you start taking

Loette.

After a miscarriage or

abortion

Your doctor will advise you how to

take Loette after a miscarriage or

abortion.

How long to take it

Continue taking your medicine for

as long as your doctor tells you.

For contraception:

Your doctor may prescribe Loette for

long periods, until you no longer

need or want contraception.

For the treatment of acne:

Your doctor will advise how long to

take Loette for the treatment of acne.

If you forget to take your

tablets

If you forget to take Loette every day

it may not work as well in protecting

you from becoming pregnant.

Do not try to make up for missed

doses by taking more than one

tablet at a time.

Forgetting one pink tablet

If you forget one pink tablet but it

is less than 12 hours late, take the

missed tablet immediately. Take

the next tablet at your usual time,

even if this means taking two

tablets in one day.

If you do not take the missed

tablet within 12 hours, Loette

may not work as well in

protecting you from becoming

pregnant.

If one pink tablet is missed and it

is more than 12 hours late, take

the missed tablet as soon as you

remember and the next pink tablet

at the usual time, even if this

means taking two tablets in one

day.

Continue to take tablets at your

usual time but you must also use

an additional non-hormonal

LOETTE

method of contraception (such as

condoms or a diaphragm but not

the rhythm or temperature

methods) until a pink tablet has

been taken daily for 7 days

without a break. If you come to

the end of the pink tablets during

the 7 days after a missed tablet,

start the next pack straight away.

Skip the 7 white tablets.

Forgetting more than one pink

tablet

Contact your doctor for advice on

what to do.

Forgetting a white tablet

If you miss one or more white

tablets, leave them in the pack

and do not worry.

However, if you miss white

tablets and then forget to start the

next pack on time, start as soon as

you remember by taking a pink

tablet that matches the day of the

week from the pink shaded

section. You must also use an

additional non-hormonal method

of contraception (such as

condoms or a diaphragm but not

the rhythm or temperature

methods) until a pink tablet has

been taken daily for 7 days

without a break.

If you are not sure what to do, ask

your doctor or pharmacist.

If you are having trouble

remembering to take Loette, ask your

pharmacist for some hints.

If you wish to delay a period

After you have finished the last

pink tablet in your pack, skip the

7 white tablets.

Start the next pack the following

day by taking a pink tablet from

the pink shaded section, which

matches the day of the week.

Then take one pink tablet each

day, following the arrows so that

you are taking the correct tablet

for the day of the week until all

21 pink tablets have been taken.

Then take one white tablet each

day for the next 7 days.

Whilst taking the second pack you

may have some breakthrough

bleeding or spotting. You will not

have a 'withdrawal bleed' or period

until the end of the second pack

when the white tablets are taken.

If you vomit or have

diarrhoea after taking Loette

If you have vomiting or diarrhoea

within 3 to 4 hours after taking a

pink tablet, you must use an

additional non-hormonal method

of contraception (such as condoms

or a diaphragm, but not the

rhythm or temperature methods)

until a pink tablet has been taken

daily for 7 days without a break. If

you come to the end of the pink

tablets during these 7 days, start

the next pack straight away. Skip

the 7 white tablets.

The tablet may not have time to be

absorbed properly and may not

protect you from becoming pregnant.

If you have vomiting or diarrhoea

after taking a white tablet, do not

worry.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital if you think

you or anyone else may have taken

too much Loette.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

Symptoms of an overdose may

include:

Feeling sick or vomiting,

Dizziness

Feeling sleepy or tired

Women may also experience

menstrual bleeding.

While you are taking

Loette

Things you must do

Tell any other doctors, dentists and

pharmacists who are treating you

that you are taking Loette.

If you are about to start taking any

new medicines, tell the doctor or

pharmacist that you are taking

Loette.

If you become pregnant while

taking Loette, see your doctor

immediately.

If you are about to have any blood

tests, tell your doctor you are

taking Loette.

It may interfere with the results of

some tests.

If you miss a period and you have

taken your tablets correctly,

continue taking your tablets as you

would normally.

Sometimes you might not have a

menstrual period while taking Loette.

If you miss a period and you have

not taken your tablets correctly,

keep taking your tablets and see

your doctor immediately.

Not taking your tablets correctly

includes missing one or more tablets

or starting a new pack later than you

should have.

If you miss two menstrual periods,

stop taking your tablets and see

your doctor, even if you have taken

the tablets correctly. You must use

a non-hormonal method of

contraception, (such as condoms or

a diaphragm) during this time.

Your doctor should make sure you

are not pregnant before you start

taking Loette again.

Have regular checkups from your

doctor, including a Pap smear.

Oral contraceptives should not be

prescribed for longer than one year

without your doctor carrying out a

check-up. Your doctor will advise

you how often you need a Pap smear.

A Pap smear can detect abnormal

cells lining the cervix. Sometimes

LOETTE

abnormal cells can progress to

cervical cancer. The most important

risk factor for cervical cancer is

persistent human papillomavirus

(HPV) infection. However, cervical

cancer has been reported to occur

more often in women using an oral

contraceptive for a long time. This

finding may not be caused by the oral

contraceptive, but may be related to

sexual behaviour and other reasons.

Perform regular breast self-

examination.

Risk factors for the development of

breast cancer include increasing age,

family history, obesity, never having

had a baby, and late age for first full-

term pregnancy. Breast cancer has

also been found slightly more often

in women who use oral

contraceptives than in women of the

same age who do not use them. This

slight increase in the number of

breast cancer cases gradually

disappears during the course of 10

years after stopping use of oral

contraceptives. It is not known

whether the oral contraceptive causes

the difference. It may be that the

women were examined more often,

so that the breast cancer was noticed

earlier.

If you are concerned about

contracting a sexually transmitted

disease (STD), ask your partner to

wear a condom when having sexual

intercourse with you.

Loette 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 help protect yourself from STDs,

you need to use a barrier

contraceptive such as a condom.

Tell your doctor you are taking

Loette at least 4 weeks before any

planned hospitalisation or surgery.

Your doctor may tell you to stop

taking Loette several weeks before

surgery or at the time of

immobilisation. Your doctor will tell

you when you can start taking Loette

after you are back on your feet.

To avoid pregnancy during this

time you must use a non-hormonal

method of contraception such as

condoms or a diaphragm.

Things you must not do

Do not take Loette to treat any

other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else even if they have the

same condition as you.

Do not stop taking Loette, or

change the dosage, without

checking with your doctor.

If you stop taking Loette or do not

take a tablet every day, without using

another form of contraception, you

may become pregnant.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while taking Loette.

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.

It can be difficult to tell whether side

effects are the result of taking Loette

or are side effects of another

medicine you are taking.

Do not be alarmed by the list of

side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you have.

Tell your doctor if...

Tell your doctor if you notice any

of the following and they worry

you:

Changes in bleeding patterns,

including breakthrough bleeding/

spotting

Painful periods

Missed periods, but if you have

not taken Loette as directed you

should check whether you are

pregnant

Changes in mucus from the

vagina

Vaginal thrush (Candida)

Breast pain, tenderness,

enlargement, possible milk

secretion

Changes in sex drive

Nausea or vomiting

Abdominal pain, cramps or

bloating

Mood changes, including

depression

Headache, including migraines

Nervousness

Dizziness

Contact lenses becoming

uncomfortable to wear

Weight change (increase or

decrease)

Changes in appetite

Swelling of the hands, ankles or

feet

Acne

Rash

Darkening of the skin, which may

persist after stopping your

medicine

Loss of scalp hair

Increase in body hair.

The above list includes the more

common side effects of your

medicine.

Tell your doctor as soon as

possible if...

Tell your doctor as soon as possible

if you notice any worsening of

conditions that you may already have

such as:

Chorea (involuntary muscle

spasm)

Porphyria

Systemic lupus erythematosus

(Lupus)

Varicose veins

Gallbladder disease

LOETTE

Hereditary angioedema (swelling

of the face lips, mouth tongue or

throat).

Go to hospital if...

Tell your doctor immediately, or

go to Accident and Emergency at

your nearest hospital if you notice

any of the following:

Unexplained or persistent pains in

the head, chest, arm or below the

breastbone

Severe pain, swelling or

discolouration in either of your

legs

Shortness of breath

Rapid or irregular heartbeat

Blurred or double vision

Partial or complete loss of sight

Eye protrusion, swelling of the

eye or eye lesions

Dizziness or fainting, sometimes

with loss of balance

Sweating, nausea or vomiting

An unusual cough

Weakness or numbness in any

part of your body

Discomfort radiating to the back,

jaw, throat or stomach

Confusion, trouble speaking or

understanding

Bloody diarrhoea

Abdominal pain

Fever

Feeling of indigestion or choking

Rectal bleeding

Feeling tired

Lose your appetite or lose weight

Breast lumps

Jaundice or a yellowing of the

skin or eyeballs, often with fever,

fatigue, loss of appetite, dark

coloured urine or light coloured

bowel movements. Taking oral

contraceptives has been

associated with an increased risk

of having a benign liver tumour,

and in very rare cases, liver

cancer. The risk appears to

increase the longer oral

contraceptives are taken

Migraine headaches for the first

time

More frequent migraines if you

already suffer from them

Itchy rash

You are an epileptic and your fits

become more frequent

Rise in blood pressure. You may

experience headache, blurred

vision or palpitations. Sometimes

your blood pressure may rise

without you experiencing any of

these symptoms. It is important to

keep your routine doctor's

appointments so that your blood

pressure can be checked

Swelling around eyes or mouth.

Whilst these side effects are rare,

they are serious. You may need

urgent medical attention or

hospitalisation.

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice

anything else that is making you

feel unwell, even if it is not on this

list.

After stopping Loette

If your periods do not return

within 2 to 3 months of stopping

Loette tell your doctor.

Some women have short-term

problems getting pregnant after

stopping Loette, especially if they

had irregular menstrual cycles before

starting to use an oral contraceptive.

If you are planning to become

pregnant after stopping Loette, use

a non-hormonal method of

contraception such as condoms or

a diaphragm for 3 months before

trying to get pregnant.

Ask your doctor or pharmacist for

advice about taking folate if you

plan to become pregnant.

After taking Loette

Storage

Keep your tablets in the blister

pack until it is time to take them.

If you take the tablets out of the

blister pack, they may not keep well.

Keep your tablets in a cool, dry

place where the temperature stays

below 25°C and is away from light.

Do not store Loette or any other

medicine, in a bathroom or near a

sink. Do not leave Loette in the car

on hot days or on window sills.

Heat and dampness can destroy some

medicines.

Keep it 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 Loette, or the expiry date

has passed, ask your pharmacist

what to do with any medicine that

is left over.

Product description

What it looks like

Loette comes in a 4-week sample

pack containing one blister and a 12-

week box containing 3 blister packs.

Each blister pack contains 21 pink

hormone tablets and 7 white non-

hormonal tablets. The blister pack is

marked with days of the week next to

each tablet.

Ingredients

Each pink tablet contains 100

micrograms of levonorgestrel and 20

micrograms of ethinyloestradiol as

the active ingredients.

White tablets do not contain active

ingredients.

The pink tablets contain the

following inactive ingredients:

LOETTE

Microcrystalline cellulose

Lactose

Polacrilin potassium

Magnesium stearate

Macrogol

Hypromellose

Titanium dioxide

Iron Oxide Red CI 77491.

The white tablets contain:

Lactose

Maize starch

Magnesium stearate

Macrogol

Hypromellose

Hydroxypropylcellulose

Titanium dioxide.

Loette does not contain gluten,

tartrazine or any other azo dyes.

Supplier

Loette is supplied in Australia by:

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

West Ryde NSW 2114

Toll Free number 1800 675 229.

Australian Registration

Number

AUST R 215494

Date of preparation

This leaflet was prepared in

December 2016

= Registered Trademark

© Pfizer Australia Pty Ltd 2016

LOETTE

There are no safety alerts related to this product.