ROACCUTANE isotretinoin 20mg capsule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

isotretinoin, Quantity: 20 mg

Available from:

Roche Products Pty Ltd

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: yellow beeswax; hydrogenated soya oil; Soya Oil; Gelatin; glycerol; titanium dioxide; partially hydrogenated soya oil; iron oxide red; maize starch; sorbitol; mannitol; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

60 capsules, 30 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ROACCUTANE 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 drug. Because of significant adverse effects associated with its use, ROACCUTANE should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

Product summary:

Visual Identification: one half brown-red, opaque, one half white, opaque, oval shaped, imprinted with 'ROA 20'.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-12-13

Patient Information leaflet

ROACCUTANE
®
_contains the active ingredient isotretinoin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Roaccutane. 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
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.
Retinoids work by reducing the
amount of the oily substance (i.e.
sebum) made by glands in your skin,
reducing bacteria and 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 YOU MUST STOP BREASTFEEDING
BEFORE TREATMENT BEGINS. DO NOT
BREASTFEED WHILE TAKING
ROACCUTANE.
3.
YOU HAVE HAD AN ALLERGIC
REACTION TO ROACCUTANE, VITAMIN
A, OTHER RETINOIDS OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
4.
YOU ARE TAKING TETRACYCLINE
ANTIBIOTICS
5.
YOU HAVE SEVERE LIVER DIS

Summary of Product characteristics

Roaccutane
®
PI 190415
1
AUSTRALIAN PRODUCT INFORMATION ROACCUTANE (ISOTRETINOIN)
1.
NAME OF THE MEDICINE
Isotretinoin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Roaccutane 20 mg capsule contains isotretinoin 20mg
Excipients with known effect
Contains soya bean oil (refined, hydrogenated and partially
hydrogenated).
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Roaccutane 20 mg - half brown-red soft capsule half opaque white,
imprinted with ROA 20
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Roaccutane 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 drug. Because of significant
adverse effects associated with its use, Roaccutane should be reserved
for patients with severe cystic acne
who are unresponsive to conventional therapy, including systemic
antibiotics.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The therapeutic response to Roaccutane is dose related and varies
between patients. This necessitates individual
adjustment of dosage according to the response of the condition and
the patient's tolerance of the drug. In most
cases complete or near-complete suppression of acne is achieved with a
16 week course of treatment.
All patients initially should receive Roaccutane at doses up to 0.5
mg/kg/day bodyweight daily for a period of
two to four weeks, when their responsiveness to the drug will usually
be apparent. It should be noted that
transient exacerbation of acne is occasionally seen during this
initial period. Satisfactory initial responses have
been reported from 0.05 mg/kg/day. Relapse rates on the lower doses
are higher (a second course may be
required in about two-thirds of patients on 0.1 mg/kg/day for 16
weeks), but