Neotigason

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ACITRETIN

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

D05BB02

INN (International Name):

ACITRETIN 10 mg

Pharmaceutical form:

CAPSULE

Composition:

ACITRETIN 10 mg

Prescription type:

POM

Therapeutic area:

ANTIPSORIATICS

Authorization status:

Withdrawn

Authorization date:

2005-12-23

Patient Information leaflet

Patient Information Leaflet UK
(Actavis Logo)
NEOTIGASON 10MG AND 25MG CAPSULES
Acitretin
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
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4 for
how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
because it contains important
information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them even if their
signs of illness
are the same as yours.
•
If
you get
any side effects,talk your doctor or pharmacist.
This includes any possible side effects not
listed in this leaflet. See section 4.
IN THIS LEAFLET:
1. WHAT NEOTIGASON IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE NEOTIGASON
3 HOW TO TAKE NEOTIGASON
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE NEOTIGASON
6.
CONTENTS OF THE PACK AND OTHER
INFORMATION
1. WHAT NEOTIGASON IS AND WHAT IT IS USED FOR
Neotigason contains a medicine called acitretin. This belongs to a
group of medicines called ‘retinoids’.
Neotigason is used to treat severe skin problems where the skin has
become thick and maybe scaly. These
skin problems include psoriasis, ichthyosis and keratosis follicularis
(Darier’s disease). It works by making
your skin grow more normally.
Neotigason is normally used while under the care of a specialist
dermatologist (skin doctor).
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE NEOTIGASON
DO NOT TAKE NEOTIGASON IF YOU ARE ALLERGIC () TO:
•
Acitretin or any of the other ingredients of Neotigason (listed in
Section 7:).
•
Other ‘retinoid’ medicines. These include isotretinoin and
tazarotene.
Do not take Neotigason if any

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Neotigason10 mg hard capsules
▼This medicinal product is subject to additional monitoring. This
will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse reactions. See section “Undesirable effects” for
how to report adverse
reactions.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg
Excipient with known effect
Glucose (see section 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
10 mg: Capsules with brown cap and white body with “Actavis”
printed in black on the cap and
“10” printed in black on the body; capsule size 4.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe forms of psoriasis including:
-
erythrodermic psoriasis;
-
local or generalized pustular psoriasis.
Severe disorders of keratinisation such as:
-
congenital ichthyosis;
-
pityriasis rubra pilaris;
-
Darier’s disease;
-
other disorders of keratinisation which may be resistant to other
therapies.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Acitretin should only be prescribed by physicians who are experienced
in the use of systemic
retinoids and understand the risk of teratogenicity associated with
acitretin therapy. See section
4.6.
The capsules should be taken once daily with meals or with milk.
There is a wide variation in the absorption and rate of metabolism of
Acitretin. This necessitates
individual adjustment of dosage. For this reason the following dosage
recommendations can serve
only as a guide.
_Adults _
Initial daily dose should be 25mg or 30mg for 2 to 4 weeks. After this
initial treatment period the
involved areas of the skin should show a marked response and/or
side-effects should be apparent.
Following assessment of the initial treatment period, titration of the
dose upwards or downwards
may be necessary to achieve the desired therapeutic response with the
minimum of side-effects.
The maintenance dose must b