ROACCUTANE CAPSULE 20MG

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

ISOTRETINOIN

Tilgjengelig fra:

ROCHE (MALAYSIA) SDN. BHD.

INN (International Name):

ISOTRETINOIN

Enheter i pakken:

30Capsule Capsules

Produsert av:

Catalent Germany Eberbach GmbH

Informasjon til brukeren

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
ROACCUTANE CAPSULE
®
_ _Isotretinoin (10mg, 20mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Roaccutane is used for
2.
How Roaccutane works
3.
Before you use Roaccutane
4.
How to use Roaccutane
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Roaccutane
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ROACCUTANE IS USED FOR
ROACCUTANE IS USED TO TREAT SEVERE
TYPES OF ACNE (such as acne that is at
risk of causing permanent scarring).
You will use Roaccutane when your
acne has not got better with anti-acne
treatments, including antibiotics and
skin treatments.
ROACCUTANE TREATMENT MUST BE
SUPERVISED BY A SKIN SPECIALIST.
HOW ROACCUTANE WORKS
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.
BEFORE YOU USE ROACCUTANE
WARNING
CAN SERIOUSLY HARM AN
UNBORN BABY
Women must use effective
contraception.
Do not use if you are pregnant or
think you may be pregnant.
_ _
-
_When you must not use it _
DO NOT TAKE ROACCUTANE IF:
1.
YOU ARE PREGNANT, OR FOR AT
LEAST ONE MONTH BEFORE YOU
PLAN TO BECOME PREGNANT, or if
there is any chance you could
become pregnant.
WOMEN MUST USE EFFECTIVE
CONTRACEPTION BEFORE, DURING
AND AFTER TAKING ROACCUTANE:
- You must agree to use at least
one very reliable method of
contraception (for example an
intrauterine device or
contraceptive implant) or, two
effective methods that work in
different ways (for example a
hormonal contraceptive pill and
a condom). Discuss with your
doctor which methods would be
suitable for you.
- You must use contraception for
a month before taking
Roaccutane, during treatment
and for a month afterwards.
- You must use contraception
even if you do not have periods
or you are not sexually active
(unless your doctor decides this
is no

Preparatomtale

Roaccutane
®
Isotretinoin
1
1.
DESCRIPTION
1.1
Therapeutic / Pharmacologic Class of Drug
Retinoid for systemic treatment of acne.
ATC Code: D10BA01
1.2
Type of Dosage Form
Capsules: soft: 10 mg and 20 mg.
1.3
Route of Administration
Oral
.
1.4
Qualitative and Quantitative Composition
Active ingredient: isotretinoin; 13-cis retinoic acid.
Excipients:
Capsule filling:
Beeswax, yellow;
Soya-bean oil, refined;
Soya-bean oil, hydrogenated;
Soya-bean oil, partially hydrogenated.
Capsule shell:
Gelatin;
Glycerol 85%;
Karion 83 containing sorbitol, mannitol, hydrogenated hydrolysed
starch;
Titanium dioxide (E171);
Red iron oxide (E172).
Dry printing ink:
Shellac, modified;
Black iron oxide (E172).
2.
CLINICAL
PARTICULARS
2.1
Therapeutic Indication(s)
Roaccutane is indicated for the treatment of severe forms of acne
(nodular or conglobate acne, or acne at risk of
permanent scarring) and acne which has failed to respond to standard
therapies with systemic antibacterials and
topical therapy.
2.2
Dosage and Administration
Roaccutane should only be prescribed by physicians who are experienced
in the use of systemic retinoids and
understand the risk of teratogenicity associated with isotretinoin
therapy. Both female and male patients should be
given a copy of the Patient Reminder Card (see sections 2.4 Warnings
and Precautions and 2.5 Use in Special
Populations).
The therapeutic response to Roaccutane and its adverse events are
dose-related and vary between patients. This
necessitates individual dosage adjustment during therapy. Roaccutane
therapy should be started at a dose of 0.5
mg/kg daily. For most patients the dose ranges from 0.5 to1.0 mg/kg
per day. Patients with very severe disease or
with truncal acne may require higher daily doses up to 2.0 mg/kg.
The capsules should be taken with food once or twice daily.
A cumulative treatment dose of 120–150 mg/kg per treatment has been
documented to increase remission rates and
prevent relapse. The therapy duration in individual patients therefore
varies as a function of the