Novatretin 25mg Capsules

国: マレーシア

言語: 英語

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

有効成分:

ACITRETIN

から入手可能:

SCHMIDT BIOMEDTECH SDN BHD

INN（国際名）:

ACITRETIN

パッケージ内のユニット:

60capsule Capsules

製:

Micro-sphere SA

情報リーフレット

DESCRIPTION
: Novatretin Caps PIL MY 310083
SIZE
: 510 x 210 mm
PRINTED
: Black
DATE
: Wednesday 02 August 2023
Novatretin Capsules
®
Acitretin (10 mg and 25)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What
NOVATRETIN CAPSULES
is used for
2.
How
NOVATRETIN CAPSULES
works
3.
Before you use
NOVATRETIN CAPSULES
4.
How to use
NOVATRETIN CAPSULES
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
NOVATRETIN CAPSULES
8.
Product Description
9.
Manufacturer and Product Registration Holder
10.
Date of revision
WHAT NOVATRETIN CAPSULES IS USED FOR
NOVATRETIN is used to treat severe forms of psoriasis and severe
disorders of keratinization
HOW NOVATRETIN CAPSULES WORKS
The active ingredient in NOVATRETIN capsules is acitretin, which
belongs to a group of medicines called retinoids. It is very similar
to
Vitamin A which is obtained from our diet and is vital for the normal
growth and development of the body, especially the skin.
NOVATRETIN works to return skin to normal when problems with the
normal development of the skin are present, as in the case of severe
psoriasis and some other skin disorders.
There are various types of medicines used to treat skin conditions.
You may have been prescribed NOVATRETIN by your doctor for
another reason. If you have any questions about why NOVATRETIN
has been prescribed for you, ask your doctor.
NOVATRETIN is only accessible with a doctor’s prescription
BEFORE YOU USE NOVATRETIN CAPSULES
_-_
_ _
_When you must not use it_
_ _
Do not take NOVATRETIN capsules if:
•
you are pregnant or you intend to become pregnant in the next 36
months. Any possibility that you may be pregnant must be ruled out
by both yourself and your doctor before you start taking
NOVATRETIN capsules. The result of a pregnancy test must be
negative when performed within one week before beginning of
NOVATRETIN treatment.
NOVATRETIN is highly teratogenic i.e. there is an extremely high risk
of having a baby that is severely deformed. This means you must u

製品の特徴

Novatretin
TM
Package Insert
Acitretin 10 mg and 25 mg Capsules
DESCRIPTION: Novatretin Caps MY 310082
SIZE: 510 x 210 mm
PRINTED: Black (50% - 100%)
DATE: Wednesday 22 February 2023
PRESENTATION
Novatretin 10 mg Capsules are hard gelatin capsules containing a
yellow powder with a
white to off-white body and a brown cap printed in black with
“A10” on the capsule body.
Novatretin 25 Capsules are hard gelatin capsules containing a yellow
powder with a
yellow to light yellow body and a brown cap printed in black with
“A25” on the capsule
body.
ACTIONS
Acitretin, the active ingredient of NOVATRETIN, is a synthetic
aromatic analogue of
retinoic acid. In preclinical investigations of the tolerability of
acitretin, no relevant
mutagenic or carcinogenic effects were found, nor was there any
evidence of direct liver
toxicity. Acitretin was found to be highly teratogenic in animals.
Clinical trials confirmed that, in psoriasis and disorders of
keratinization, acitretin brought
about normalization of epidermal cell proliferation, differentiation
and cornification, while
the side effects were, in general, tolerable. The effect of acitretin
is purely symptomatic;
the mechanism of action is as yet largely unknown.
PHARMACOKINETICS
Absorption
Acitretin reaches peak plasma concentration 1-4 hours after ingestion
of the medicine.
Bioavailability of orally administered acitretin is best when the
medicine is taken together
with food. Bioavailability of a single dose is approximately 60%, but
this may vary
considerably (36-95%).
Distribution
Acitretin is highly lipophilic and penetrates readily into body
tissues. Protein binding
of acitretin exceeds 99%. In animal studies, acitretin passed the
placental barrier in
quantities sufficient to produce foetal malformations. Due to its
lipophilic nature, it can
be assumed that acitretin passes into breast milk in considerable
quantities.
Metabolism
Acitretin is metabolized by isomerization into its 13-cis isomer (cis
acitretin), by
glucuronidation and cleavage of the side chain.
El