EllaOne

Main information

  • Trade name:
  • EllaOne ulipristal acetate 30 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EllaOne ulipristal acetate 30 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219535
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219535

EllaOne ulipristal acetate 30 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

MS Health Pty Ltd

Postal Address

PO Box 1635,MELBOURNE, VIC, 3001

Australia

ARTG Start Date

6/03/2015

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

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. EllaOne ulipristal acetate 30 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

15/08/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

EllaOne is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

36 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Store in Original

Container

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S3) Pharmacist Only Medicine

Components

1.

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Tablet is a white to off white round tablet engraved on both faces with the

code "ella"

Active Ingredients

ulipristal acetate

30 mg

© 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 03:38:03 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

EllaOne

Version–24 March 2017

Page 1 of 3

EllaOne

®

ulipristal acetate 30 mg tablet

Consumer Medicine Information

What is in this leaflet

This leaflet answers some

common

questions about EllaOne

. 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 being given EllaOne

against the

expected benefits it will have for you.

If

you

have

any

concerns

about

being given this medicine, ask your

doctor.

Keep this leaflet.

You may need to

read it again.

What EllaOne

®

is used

for

EllaOne

is an oral emergency

contraceptive intended to prevent

pregnancy after unprotected sex or if

your contraceptive method has failed,

for example:

- if you had sex without protection;

- if your or your partner’s condom

tore, slipped or came off, or if you

forgot to use one;

- if you did not take your birth control

pill as recommended.

You should take EllaOne

as soon as

possible after sex, and within a

maximum of 5 days (120 hours).

This is because the sperm can survive

up to 5 days in your body after

intercourse.

EllaOne

is suitable for any woman

of child bearing age, including

adolescents.

You can take EllaOne

at any time in

the menstrual cycle.

EllaOne

contains the substance

ulipristal acetate, which acts by

modifying the activity of the natural

hormone progesterone which is

necessary for ovulation to occur. As

a result, EllaOne

works by

postponing ovulation.

Emergency contraception is not

effective in every case: of 100 women

who take EllaOne

, approximately 2

will become pregnant.

EllaOne

does not work if you are

already pregnant.

EllaOne

is not suitable as a regular

method of contraception.

After using EllaOne

, if you want to

have sex, you should use a reliable

barrier contraceptive method such as

condom. This is because EllaOne

will not work if you have unprotected

sex again.

EllaOne

does not protect against

HIV infection (AIDS) or any other

sexually transmitted diseases (such as

chlamydia, genital herpes, genital

warts, gonorrhoea, hepatitis B and

syphilis). Only condoms can protect

you from these diseases.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Before you take

EllaOne

®

When you must not take it

- if you know or suspect that you are

pregnant.

- if you are allergic to ulipristal

acetate, or to any of the other

ingredients listed under “Product

description”.

You should not use this medicine

after the expiry date printed on the

EllaOne

pack or if the packaging is

torn or shows signs of tampering.

After using EllaOne

, if you want to

have sex, you should use a reliable

barrier contraceptive method such as

condom. This is because EllaOne

will not work if you have unprotected

sex again.

Emergency contraception is a backup

method for preventing pregnancy and

should only be used occasionally.

Your doctor or healthcare provider

can tell you about long-term methods

of contraception that may be

appropriate for you.

Before you start to take

EllaOne

®

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

EllaOne

contains lactose. Tell your

doctor, healthcare provider or

pharmacist if you have intolerance to

some sugars.

Tell your doctor, healthcare provider

or pharmacist:

- if your period is late or you have

symptoms of pregnancy (heavy

breasts, morning sickness), as you

may already be pregnant

- if you suffer from severe asthma.

- if you suffer from severe liver

disease.

If you have not told your doctor

about any of the above, tell him/her

before you take EllaOne

®

.

Pregnancy

EllaOne

is a contraceptive used to

prevent a pregnancy from starting. If

you are already pregnant it will not

interrupt an existing pregnancy.

EllaOne

Version–24 March 2017

Page 2 of 3

If you are breast-feeding

Do not breast-feed your baby for one

week after taking EllaOne

. During

this time, it is recommended to use a

breast pump in order to maintain milk

production but throw away your

breast milk. The effect of

breastfeeding your baby in the week

after taking EllaOne

is not known.

Fertility

EllaOne

will not affect your future

fertility. If you have unprotected sex

after taking EllaOne

, it will not stop

you from becoming pregnant.

Therefore it is important you use

condoms until your next period.

After using EllaOne

, if you wish to

use regular hormonal contraception

such as birth control pills, you should

do so no sooner than 5 days after the

intake of EllaOne

. Be sure to also

use a reliable barrier contraceptive

method such as condoms until your

next period.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other medicines,

including any that you buy without

a prescription from your

pharmacy, supermarket, health

food shop, naturopath, herbalist or

internet.

Some medicines and EllaOne

interfere with each other. These

include:

- Phenytoin, fosphenytoine,

phenobarbital, primidone,

carbamazepine, oxcarbazepine (used

to treat epilepsy)

-Ritonavir,efavirenz, nevirapine (used

to treat HIV infection)

- Rifampicin, rifabutin (used to treat

certain bacterial infections)

- Herbal remedies containing St

John's wort (Hypericum perforatum)

(used for depression or anxiety)

Using EllaOne

with regular

hormonal contraceptives could reduce

contraceptive action of both drugs.

After using EllaOne

, if you wish to

use regular hormonal contraception

such as birth control pills, you should

do so no sooner than 5 days after the

intake of EllaOne

. Be sure to also

use a reliable barrier contraceptive

method such as condoms until your

next period.

EllaOne

should not be

used together with emergency

contraceptives containing

levonorgestrel. By taking them both

together, you might make EllaOne

less effective.

Your doctor and pharmacist may have

more information on medicines to be

careful with or avoid while being

treated with EllaOne

How to take EllaOne

®

How much to take

Your doctor will tell you how and

when to take EllaOne

The recommended dose of EllaOne

is one tablet.

EllaOne

is for occasional use only

and should not be used to as regular

contraceptive method.

How to take EllaOne

®

The EllaOne

tablet should be taken

orally.

When to take EllaOne

®

- Take one tablet by mouth as soon as

possible and no later than 120 hours

(5 days) after you have had

unprotected sex or contraceptive

failure. Take the tablet without

delay.

- You can take EllaOne

at any time

in your cycle.

- You can take EllaOne

either

before, during or after a meal.

- If you vomit within 3 hours of

taking an EllaOne

tablet, you

should consult your doctor or

healthcare provider in order to take

another tablet.

If you forget to take it

If you miss taking EllaOne

within 5

days (120 hours) after sex, it cannot

be relied upon to work as a

contraceptive. It is important to

contact your doctor.

If you take too much

(overdose)

There has been no report of harmful

effects from taking higher dose than

recommended of this medicine.

However, telephone your doctor, or

the Poisons Information Centre (13 11

26) if you take too many EllaOne

tablets.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking EllaOne

®

.

Do not be alarmed by the following

list of side effects, you may not

experience any of them.

Tell your doctor if you notice any of

the following common side effects

and they worry you:

- nausea, abdominal pain, abdominal

discomfort, vomiting

- headache, dizziness

- painful menses, pelvic pain, breast

tenderness

- tiredness

- mood swings

- muscle pain, back pain

Other uncommon side effects

include:

- diarrhoea, dry mouth, heartburn,

intestinal gases

- abnormal vaginal bleeding and

menstrual disorder (heavy/prolonged

periods, premenstrual syndrome)

- vaginal inflammation, vaginal

discharge

- hot flushes

- influenza, fever, chills

- feeling sick

- appetite changes, emotional

disorders, anxiety, agitation, trouble

sleeping, sleepiness, decreased /

increased libido

- acne, skin lesion, itching

- migraine

- visual disturbances

Tell your doctor if you notice

anything that is making you feel

generally unwell.

Other side effects not listed above are

rare and may also occur in some

people.

After taking EllaOne

, some women

experience dizziness, drowsiness,

blurred vision and/or loss of

concentration. If you experience such

symptoms, do not drive or use

machines.

After taking EllaOne

®

After using EllaOne

®

, if you want

to have sex, you should use a

reliable barrier contraceptive

method such as condom. This is

because EllaOne

®

will not work if

you have unprotected sex again.

EllaOne

Version–24 March 2017

Page 3 of 3

After using EllaOne

, if you wish to

start hormonal contraception such as

birth control pills in the same cycle,

you can do so but you should still use

a reliable barrier contraceptive

method such as condoms until your

next period.

After taking EllaOne

, most women

have a normal period at the expected

time. But some may have their period

later or earlier than normal (see “Side

effects”). If your period is more than

7 days late or is unusually light or

unusually heavy or if you experience

symptoms such as abdominal pain,

nausea, vomiting or breast pain or if

you have any doubt about being

pregnant, you should perform a

pregnancy test to make sure you are

not pregnant.

If you do become pregnant after

taking EllaOne

, it is important to

contact your doctor. As for any

pregnancy, your doctor may want to

check that the pregnancy is not

outside the womb. This is especially

important if you have severe

abdominal (stomach) pain or bleeding

or if you have previously had a

pregnancy outside the womb, tubal

surgery or long term (chronic) genital

infection.

Storage

Store below 25°C. Store in the

original packaging to protect from

moisture. Keep the blister in the

outer carton to protect from light.

Keep EllaOne

where children cannot

reach it.

Disposal

Dispose of EllaOne

in a secure place

such that children and others cannot

access the disposed product.

Product description

What it looks like

The EllaOne

tablet is a white to off-

white, round curved tablet engraved

on both faces with the code “еllа”.

Each tablet contains 30 mg of

ulipristal acetate.

EllaOne

is available in the following

pack size: carton containing one

blister of 1 tablet.

Ingredients

The EllaOne

tablet contains the

active ingredient ulipristal acetate,

plus the inactive ingredients lactose,

povidone, croscarmellose sodium and

magnesium stearate.

Supplier

EllaOne

is supplied in Australia by:

MS Health Pty Ltd,

Suite 60, 278 Church Street,

Richmond, VIC, 3121, Australia.

EllaOne

is a registered trademark

and product of:

Laboratoire HRA Pharma,

15 rue Béranger,

75003 Paris

France

Australian registration number:

AUST R 219535

This leaflet was approved in January

2016. This leaflet was updated in

March 2017.

Copyright 2016. All rights reserved.

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