ISOTRETINOIN AN isotretinoin 20mg capsule blister pack

Main information

  • Trade name:
  • ISOTRETINOIN AN isotretinoin 20mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ISOTRETINOIN AN isotretinoin 20mg capsule blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 186340
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

186340

ISOTRETINOIN AN isotretinoin 20mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

8/06/2012

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. ISOTRETINOIN AN isotretinoin 20mg capsule blister pack

Product Type

Single Medicine Product

Effective date

22/09/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ISOTRETINOIN AN is indicated for the treatment of severe cystic acne and a single course of therapy has been shown to result in complete and

prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least eight weeks after

completion of the first course, since experience has shown that patients may continue to improve while off the drug. Because of significant adverse

effects associated with its use. Isotretinoin should be reversed for patients with severe cystic acne who are unresponsive to conventional therapy,

including systemic antibiotics.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 30

degrees Celsius

Not recorded

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

15 capsules

(S4) Prescription Only Medicine

30 capsules

(S4) Prescription Only Medicine

90 capsules

(S4) Prescription Only Medicine

60 capsules

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Maroon coloured oblong soft gelatin capsules, containing a yellow-orange

opaque viscous liquid.

Active Ingredients

Isotretinoin

20 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 29.11.2017 at 02:58:03 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

Isotretinoin AN capsules – Consumer Medicine Information

Isotretinoin AN CMI v3.0

Page 1

Isotretinoin AN capsules

Isotretinoin

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

Isotretinoin AN capsules. It does

contain

available

information.

does

take

place

talking

your

doctor

pharmacist.

medicines

have

risks

benefits.

Your

doctor

weighed the risks of you taking

Isotretinoin AN capsules against

the benefits they expect it will

have for you.

If

you

have

any

concerns

about

taking

this

medicine,

talk

to

your

doctor

or

pharmacist.

Keep

this

leaflet

with

your

medicine.

You may need to read it again.

What Isotretinoin AN

is used for

Isotretinoin

capsules

contains

active

ingredient

isotretinoin.

Isotretinoin AN is used to treat

acne.

Isotretinoin

belongs

group

medicines

called

retinoids,

which

similar

vitamin A.

The retinoids work by reducing

the amount of the oily substance

(i.e. sebum) made by glands in

your

skin,

reducing

bacteria,

reducing

inflammation

opening clogged pores.

There are many different types

of medicines used to treat acne.

Isotretinoin AN is used for more

severe cases.

Your

doctor,

however,

may

have

prescribed

Isotretinoin

AN for another purpose.

Ask your doctor if you have

any

questions

about

why

isotretinoin

AN

has

been

prescribed for you.

This medicine is available only

with a doctor's prescription.

Isotretinoin AN is not addictive.

Before You Take

Isotretinoin AN

When you must not take

Isotretinoin AN

Do not take Isotretinoin AN if:

3. you

have

had

an

allergic

reaction

to

Isotretinoin

AN,

vitamin A, other retinoids or

any

other

ingredients

of

Isotretinoin AN (listed at the

end of this leaflet)

4.

you

are

taking

tetracycline

antibiotics (such as Akamin®,

Vibramycin®,

Doxycycline

hydrochloride,

Doryx®,

Frakas®, Minomycin®)

5. you have severe liver disease

6. you have very high fat levels

(cholesterol,

triglycerides)

in

your blood

7. you have hypervitaminosis A

This is a condition caused by an

excessive amount of vitamin A in

the diet.

8. the

packaging

is

torn

or

shows signs of tampering

9. the expiry date (EXP) printed

on the pack has passed.

If you take this medicine after

the expiry date has passed, it

may not work as well.

If

you

are

not

sure

if

you

should

start

taking

Isotretinoin AN contact your

doctor.

Do not give Isotretinoin AN to

children.

There is limited information on

Isotretinoin

children before puberty.

Before you start to take

Isotretinoin AN

Tell your doctor if:

1. you have any allergies to

any

other

medicines,

foods,

preservatives or dyes

Isotretinoin

capsules

contain

soya

oil,

which

contain

traces

arachidic

acid

component of peanut oil)

2. you have or have had any

other

health

problems

or

issues including:

diabetes,

history

diabetes in your family

1. you are pregnant, or for

at least one month before

you plan to fall pregnant

fall

pregnant

while

taking Isotretinoin AN there

is an extremely high risk of

having

baby

that

severely

deformed.

must

effective

contraception

month

before,

during

one month after treatment.

2. you are breastfeeding

Breastfeeding

must

stop

before

treatment

begins.

breastfeed

while

taking Isotretinoin AN.

Isotretinoin AN capsules – Consumer Medicine Information

Isotretinoin AN CMI v3.0

Page 2

depression

liver disease

kidney disease

lipid

(cholesterol

triglyceride) disorder

hormone disorder

stomach or bowel disease

3. you drink large amounts of

alcohol.

If

you

have

not

told

your

doctor about any of the above,

tell

them

before

you

start

taking Isotretinoin AN.

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

interfere

with

Isotretinoin

These

include:

tetracycline antibiotics (such

Akamin,

Doxycycline

hydrochloride,

Frakas,

Vibramycin,

Doryx,

Minomycin)

vitamin

preparations

containing

vitamin

(including

vitamin

supplements)

other

medicines

using to treat your acne

the "mini-pill", a progestogen-

only oral contraceptive pill.

These

medicines

affected

Isotretinoin

may affect how well it works.

You may need to take different

amounts

your

medicine,

you may need to take different

medicines.

Your

doctor

will

advise you.

Your

doctor

pharmacist

have

more

information

medicines to be careful with or

avoid

while

taking

Isotretinoin

Ask your doctor or pharmacist

if you are not sure about this

list of medicines.

How

to

take

Isotretinoin AN

How much to take

Follow all directions given to

you

by

your

doctor

or

pharmacist carefully.

They

differ

from

information

contained

this

leaflet.

Take

Isotretinoin

AN

exactly

as your doctor has prescribed.

Your

doctor

will

tell

many Isotretinoin AN capsules to

take each day.

This dose will be calculated to

suit

your

individual

needs

your body weight. This dose may

adjusted

during

treatment

when the doctor knows how you

respond to Isotretinoin AN.

How to take Isotretinoin

AN

Capsules should be swallowed

whole with a glass of water or

milk.

Do not open the capsules and

do not take any capsules that

are damaged.

When to take Isotretinoin

AN

Isotretinoin

taken

once or twice a day and must

always be taken with meals.

Female

patients

should

wait

until the 2nd or 3rd day of the

next normal menstrual period

before starting Isotretinoin AN

treatment.

This helps ensure that you aren't

pregnant before you start taking

Isotretinoin AN.

If you forget to take

Isotretinoin AN

Do

not

try

to

make

up

for

missed

doses

by

taking

an

extra dose.

This may increase the chance of

getting an unwanted side effect.

If it is almost

time for your

next dose, skip the dose you

missed and take the next dose

when you are meant to.

have

missed

several

doses, please inform your doctor

and follow the advice given to

you.

How long to take

Isotretinoin AN for

Continue

taking

Isotretinoin

AN for as long as your doctor

prescribes.

Acne treatment with Isotretinoin

will

usually

last

months. In the first few weeks of

treatment

your

acne

will

probably get a little worse before

it gets better.

Do not worry about this, it is a

sign

that

Isotretinoin

working.

At the end of this time your acne

should

have

cleared

significantly. Most patients notice

their skin condition continues to

improve

even

after

Isotretinoin

AN treatment is finished. Please

note that Isotretinoin AN cannot

improve

scars

pitting

that

were

present

before

treatment

started, but it will help prevent

such skin damage in the future.

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

Isotretinoin AN. Do this even if

there

are

no

signs

of

discomfort or poisoning.

You may need urgent medical

attention.

Signs

overdose

include

transient

headache;

vomiting;

facial

flushing;

reddened,

Isotretinoin AN capsules – Consumer Medicine Information

Isotretinoin AN CMI v3.0

Page 3

cracked

lips;

stomach

pain;

headache;

dizziness

unsteady walking.

Keep telephone numbers for

these places handy.

While you are taking

Isotretinoin AN

Things you must do

If you become pregnant while

taking

Isotretinoin

AN,

stop

taking it and tell your doctor

immediately.

Isotretinoin AN can cause birth

defects

(damage

unborn

babies). You must use strict birth

control, starting at least 1 month

before

begin

taking

Isotretinoin

whole

time you are taking Isotretinoin

AN and for 1 month after you

finish taking Isotretinoin AN.

There is no known risk to males

who wish to father children.

Tell all doctors, dentists and

pharmacists who are treating

you

that

you

are

taking

Isotretinoin AN.

Tell

your

doctor

if,

for

any

reason,

you

have

not

taken

your

medicine

exactly

as

prescribed.

Otherwise, your doctor may think

that

effective

change

your

treatment

unnecessarily.

Tell

your

doctor

if

you

feel

Isotretinoin

AN

capsules

are

not helping your condition.

Be sure to keep all of your

appointments

with

your

doctor so that your progress

can be checked.

Your doctor may ask you to have

regular

blood

tests

monitor

your liver function, blood sugar

levels

blood

cholesterol

levels.

If you are intending to do a lot

of heavy lifting or exercise, tell

your doctor.

Your muscles and joints may be

more

prone

tenderness

stiffness if you do a lot of heavy

exercise while taking Isotretinoin

Things you must not do

Do not stop taking Isotretinoin

AN

or

change

the

dose

without

first

checking

with

your doctor.

Do not let yourself run out of

medicine over the weekend or

on holidays.

Do not give Isotretinoin AN to

anyone

else

even

if

their

symptoms

seem

similar

to

yours.

Do not use Isotretinoin AN to

treat other complaints unless

your doctor says to.

Do

not

donate

blood

during

treatment with Isotretinoin AN

or for at least 1 month after

stopping treatment.

Things to be careful of

Be careful driving or operating

machinery until you know how

Isotretinoin AN affects you.

Normally Isotretinoin AN would

not affect your ability to drive a

operate

machinery.

However altered night vision and

other

visual

disturbances

occur

when

taking

Isotretinoin

AN. Make sure you know how

react

Isotretinoin

before you drive a car, operate

machinery or do anything else

that may be dangerous if your

vision is affected.

Wearing contact lenses during

treatment with Isotretinoin AN

may cause discomfort.

Isotretinoin AN may cause dry

eyes.

lubricant

artificial

tears,

available

from

your pharmacist, should relieve

this

problem.

Otherwise,

temporarily

need

wear

your lenses for shorter periods

or wear glasses instead.

Avoid excessive sun exposure

and

solariums

and

apply

a

sunscreen

while

taking

Isotretinoin AN.

Your skin may be more prone to

sunburn

while

Isotretinoin

Avoid

waxing

and

dermabrasion

while

taking

Isotretinoin AN and for 5 to 6

months

after

stopping

Isotretinoin AN treatment.

Your skin may be more sensitive

while on Isotretinoin AN. Waxing

cause

dermatitis

dermabrasion

cause

scarring during and for several

months

after

Isotretinoin

treatment.

Avoid

using

facial

peels,

electrolysis

and

some

hair

treatments.

Your skin and hair may be more

delicate during treatment and for

while

after

Isotretinoin

treatment.

Side Effects

Isotretinoin

helps

most

people with acne but it may have

unwanted side effects in a few

people.

medicines

have

side

effects.

Sometimes

they

serious, most of the time they

are not. You may need medical

treatment if you get some of the

side effects.

Do not be alarmed by this list of

possible side effects. You may

not experience any of them.

Ask your doctor or pharmacist

to answer any questions you

may have.

Tell your doctor if you notice

any of the following and they

worry you:

Do not be alarmed by this list

of possible side effects.

You may not experience any of

them.

Ask your doctor or pharmacist

to answer any questions you

may have.

Tell your doctor if you notice

Isotretinoin AN capsules – Consumer Medicine Information

Isotretinoin AN CMI v3.0

Page 4

any of the following and they

worry you:

dryness

lips,

mouth,

nose and skin.

moisturiser

petroleum

jelly can be used to soften

lining

nose,

lips

skin

areas

affected by the acne

fragile skin

change in colour of the skin

peeling palms of the hands

and soles of the feet

itchy skin rash

an increased susceptibility to

sunburn

sweating

changes to the nails

problems

such

dry,

sore, swollen or itchy eyes,

discharge or trouble seeing at

night

nosebleeds

tenderness

stiffness

your bones, joints or muscles

tiredness

headache

hair loss (sometimes occurs

and is usually temporary but

in rare cases, has persisted)

excessive hairiness

hoarseness

These side effects are usually

mild and dose related. Most of

them disappear completely in a

few days to a few weeks after

dose

Isotretinoin

lowered or stopped.

Tell your doctor immediately if

you

experience

any

of

the

following:

nausea

vomiting

persistent headache

blurred

vision

visual

disturbances

changes in your hearing or

ringing in your ears

severe upper stomach pain

blood

stools

severe

diarrhoea

severe bruising

sudden red, often itchy spots,

similar to the rash of measles

starting on the face, hands or

feet.

spots

blister

change to flat round raised,

red,

pale-centred

marks.

Also,

have

fever,

sore throat, headache and/or

diarrhoea

painful

areas,

that

change to large blisters and

end with peeling of layers of

skin, that may occur on lips,

mouth,

eyes,

nose

genitals. Those affected may

have fever and chills, aching

muscles

generally

feel

unwell.

thinking,

seeing

hearing

things that are not real

feeling

depressed,

with

without suicidal thoughts

Symptoms

depression

include;

feeling sad or having crying

spells

losing

interest

activities

you once enjoyed

sleeping too much or having

trouble sleeping

changes in your appetite or

body weight

having trouble concentrating

withdrawing from your friends

or family

feeling

like

have

energy

feelings of worthlessness or

inappropriate guilt

These

serious

side

effects.

need

urgent

medical attention. Serious side

effects are rare.

This is not a complete list of all

possible

side

effects.

Others

may occur in some people and

there may be some side effects

not yet known.

Tell

your

doctor

notice

anything else that is making you

feel unwell, even if it is not on

this list.

Ask your doctor or pharmacist if

you don't understand anything in

this list.

After taking

Isotretinoin AN

Storage

Keep

your

capsules

in

the

blister pack until it is time to

take them.

If you take the capsules out of

the packaging they will not keep

well.

Keep the blister pack in a cool

dry

place

where

the

temperature stays below 25°C.

Do not store Isotretinoin AN,

or

any

other

medicine,

in

a

bathroom or near a sink.

Do not leave it in the car or on

window sills.

Heat and dampness can destroy

some medicines.

Keep

Isotretinoin

AN

where

young children cannot reach

it.

A locked cupboard at least one

half

meters

above

ground is a good place to store

medicines,

Protect

Isotretinoin

AN

from

light.

Disposal

If your doctor tells you to stop

taking Isotretinoin AN, or your

capsules

have

passed

their

expiry

date,

ask

your

pharmacist

what

to

do

with

any that are left over.

Product description

What it looks like

Isotretinoin AN 10 mg & 20 mg

isotretinoin)

presented

pack sizes of 15, 30, 60 & 90

capsules in blister.

Isotretinoin AN 10 mg (AUST R

186339)

Light violet coloured oblong soft

gelatin

capsules,

containing

yellow-orange

opaque

viscous

liquid

Isotretinoin AN capsules – Consumer Medicine Information

Isotretinoin AN CMI v3.0

Page 5

Isotretinoin AN 20 mg (AUST R

186340)

Maroon

coloured

oblong

soft

gelatin

capsules,

containing

yellow-orange

opaque

viscous

liquid.

Ingredients

Active Ingredient:

Isotretinoin

Each caosule may contain either

10 mg & 20 mg of isotretinoin

Other Ingredients:

yellow beeswax

brilliant scarlet 4R

butylated hydroxyanisole

disodium edetate

di-alpha-Tocopherol

Gelatin

Glycerol

Sorbitol solution (70 per cent)

(non-crystallising)

Soya OIl

Partially hydrogenated soya oil

Titanium oxide

Hydrogenated vegetable oil

Purified water

Isotretinoin AN 10 mg contains

black iron oxide.

Isotretinoin AN 20 mg contains

indigo carmine

Please read this leaflet carefully

before

start

taking

Isotretinoin AN. You may wish to

keep it to read again.

Name

and

Address

of

the

Sponsor

Amneal

Pharma

Australia

12 River St

South Yarra, Vic - 3141

Australia

Date of Preparation

September 2016