Neotigason capsules 25mg

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

ACITRETIN

Διαθέσιμο από:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Διεθνής Όνομα):

ACITRETIN

Μονάδες σε πακέτο:

3 x 10 Capsules; 10 x 10 Capsules

Κατασκευάζεται από:

CENEXI

Φύλλο οδηγιών χρήσης

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NEOTIGASON CAPSULES
Acitretin (10mg, 25mg)
1
WHAT IS IN THIS LEAFLET
1.
What Neotigason is used for
2.
How Neotigason works
3.
Before you use Neotigason
4.
How to take Neotigason
5.
While
you
are
using
Neotigason
6.
Side Effects
7.
Storage
and
Disposal
of
Neotigason
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT NEOTIGASON IS USED FOR
Neotigason is used to treat:
• extensive and serious forms of
psoriasis.
• severe dry scales as a result of
marked
keratinization
such
as
ichthyosis
(a
group
of
skin
disorders characterized by dry,
scaly,
or
thickened
skin),
pityriasis (a temporary rash of
raised red scaly patches on the
body) or Darier’s disease (a skin
condition characterized by wart-
like blemishes on the body).
HOW NEOTIGASON WORKS
Acitretin belongs to a group of
medicines known as retinoids.
Retinoids
are
derived
from
vitamin A.
The way acitretin works is not
known.
BEFORE YOU USE NEOTIGASON
WARNING
CAN SERIOUSLY HARM AN
UNBORN BABY
Women
must
use
effective
contraception.
Do not use if you are pregnant or
you think you may be pregnant.
_-When you must not take it _
Do not take Neotigason if:-
•
you
are
pregnant
or
breast-
feeding
• there is any chance you could
become pregnant.
WOMEN
MUST
USE
EFFECTIVE
CONTRACEPTION
BEFORE,
DURING
AND AFTER TAKING NEOTIGASON:
• You must agree to use at least
one
very
reliable
method
of
contraception
(for
example
an
intra
uterine
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
Neotigason,
during
treatment
and for 3 years afterwards
• You must use contraception
even if you do not have periods
or you are not sexually active
(unless your doctor decides this
is not necessary).
WOMEN
MUST
AGREE
TO
PREGNANCY
TESTING
BEFORE,
DURING
AND
AFTER
TAKING
NEOTIGASO

Αρχείο Π.Χ.Π.

02
20.10.23
VV
25.10.23
VV
125x250 mm
Cenexi, France
9 pt
profile
black
129830_S2 - P: Acitretin (Neotigason) MY, Capsules, ALL, Cenexi
RETINOID FOR ORAL TREATMENT OF SEVERE CASES
OF PSORIASIS AND DISORDERS OF KERATINIZATION
PRODUCT NAME
Neotigason capsules 10mg
Neotigason capsules 25mg
COMPOSITION
Active ingredient: acitretin.
Capsules 10 mg and 25 mg.
Excipient: antioxidant, sodium ascorbate.
The 10mg capsules have a brown cap and a
white body with “10”, printed in black. Capsule
content: powder, eventually with lumps,
yellowish to yellow.
The 25mg capsules have a brown cap and a
yellow body with “25”, printed in black. Capsule
content: powder, eventually with lumps,
yellowish to yellow.
PROPERTIES AND EFFECTS
Acitretin, the active ingredient of Neotigason, 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 Neotigason 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 drug. Bioavailability
of orally administered acitretin is best when the
drug is taken together with food. Bioavailability
of a single dose is approximately 60%, but
this may vary considerably from one patient to
another (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 fetal malformations. Due
to its lipophilic nature, it can be assumed that
acitretin pas