Roaccutane

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Isotretinoin

Tilgjengelig fra:

Roche Products Pty Ltd

Klasse:

Medicine Registered

Informasjon til brukeren

ROACCUTANE
®

_contains the active ingredient isotretinoin_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ROACCUTANE
capsules. 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
ROACCUTANE capsules against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ROACCUTANE
IS USED FOR
ROACCUTANE contains the active
ingredient isotretinoin.
ROACCUTANE is used to treat
acne.
ROACCUTANE belongs to a group
of medicines called retinoids, which
are similar to 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 and opening clogged
pores.
There are many different types of
medicines used to treat acne.
ROACCUTANE is used for more
severe cases.
YOUR DOCTOR, HOWEVER, MAY HAVE
PRESCRIBED ROACCUTANE FOR
ANOTHER PURPOSE.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
ROACCUTANE HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
ROACCUTANE is not addictive.
BEFORE YOU TAKE
ROACCUTANE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ROACCUTANE IF:
1. YOU ARE PREGNANT, OR FOR AT LEAST
ONE MONTH BEFORE YOU PLAN TO
FALL PREGNANT
 IF YOU FALL PREGNANT WHILE
TAKING ROACCUTANE THERE IS
AN EXTREMELY HIGH RISK OF
HAVING A BABY THAT IS SEVERELY
DEFORMED. YOU MUST USE
EFFECTIVE CONTRACEPTION FOR ONE
MONTH BEFORE, DURING AND ONE
MONTH AFTER TREATMENT.
2. YOU ARE BREASTFEEDING
 BREASTFEEDING MUST STOP BEFORE
TREATMENT BEGINS. DO NOT
BREASTFEED WHILE TAKING
ROACCUTANE.
3. YOU HAVE HAD AN ALLERGIC
REACTION TO ROACCUTANE,
VITAMIN A, OTHER RETINOIDS OR
ANY OTHER INGREDIENTS OF
ROACCUTANE (LISTED AT THE
END OF THIS LEAFLET)
4. YOU A

Preparatomtale

Roaccutane

 PI 130415   
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_ _
1 of 12 
CDS 5.0 
NAME OF THE MEDICINE 

ROACCUTANE® 
_(isotretinoin) _
CAS 4759-48-2 

Chemically, isotretinoin is (2_Z_, 4_E_, 6_E_,
8_E_)-3,7-dimethyl-9-
(2,6,6-trimethylcyclohex-1-enyl)nona-2,4,6,8-tetraenoic acid and is also known as 
13-cis-retinoic acid.  Isotretinoin is related to both retinoic acid and retinol (vitamin A).  The 
molecular formula is C
20
H
28
O
2
.  Isotretinoin has a molecular weight of 300.44. 

DESCRIPTION 

Isotretinoin is a yellow orange to orange crystalline powder, practically insoluble in water, 
soluble in methylene chloride, sparingly soluble in ether and slightly soluble in alcohol.  It is 
sensitive to air, heat and light, especially in solution. 

ROACCUTANE is available in 10 and 20 mg soft gelatin capsules for oral administration. In 
addition to isotretinoin, the capsules contain soya oil, yellow beeswax, partially hydrogenated 
soya oil and hydrogenated soya oil. 

The capsule shell contains gelatin, glycerol, titanium dioxide (CI77891), iron oxide red 
(CI77491) and proprietary ingredient Karion 83 (by R.P. Scherer GmbH, ARTG No. 2072). 

The printing ink, black ink edible S-1-27794 (ARTG No. 12104), contains shellac and iron 
oxide black CI77499.  

PHARMACOLOGY 

PHARMACODYNAMICS 

Isotretinoin is a retinoid that inhibits sebaceous gland function and keratinisation.  The exact 
mechanism of action of ROACCUTANE is unknown. 

Clinical improvement in cystic acne patients occurs in association with a reduction in sebum 
secretion. The decrease in sebum secretion is reversible and the extent is related to the dose and 
duration of treatment with ROACCUTANE and reflects a reduction in sebaceous gland size and 
an inhibition of sebaceous gland