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 25 mg

Pharmaceutical form:

CAPSULE

Composition:

ACITRETIN 25 mg

Prescription type:

POM

Therapeutic area:

ANTIPSORIATICS

Authorization status:

Withdrawn

Authorization date:

2005-12-23

Patient Information leaflet

Acitretine 10mg and 25mg capsules leaflet - Teva UK/Malta
item no:
print proof no:
origination date:
originated by:
revision date:
revised by:
dimensions:
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. pms 281
2.
3.
4.
5.
6.
1. Profile
2.
3.
date sent:
supplier:
technically app. date:
min pt size:
TECHNICAL APPROVAL
AAAJ6631
02
02-03-2017
NM
07-03-2017
NM
Cenexi Osny
125 x 210 4p
7.5 pts
02-03-2017
03-03-2017
PLEASE READ ALL OF THIS LEAFLET
CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
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. Do not pass it on to others.
It may harm them even if their
symptoms are the same as yours.
•
If any of the side effects become
serious or troublesome, or if you
notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. WHAT NEOTIGASON IS AND WHAT IT IS
USED FOR
2. BEFORE YOU TAKE NEOTIGASON
3. IMPORTANT INFORMATION FOR WOMEN
4. HOW TO TAKE NEOTIGASON
5. POSSIBLE SIDE EFFECTS
6. HOW TO STORE NEOTIGASON
7. FURTHER 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. BEFORE YOU TAKE NEOTIGASON
DO NOT TAKE NEOTIGASON IF YOU ARE ALLERGIC
(HYPERSENSITIVE) TO:
•
Acitretin or any of the other ingredients
of Neotigason (listed in Section 7: Further
Information).
•
Other ‘retinoid’ medicines. These include
isotretinoin and tazarotene.
Do not take Neotigason if any of the above
apply to you. If you are not sure, talk to
your doctor

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Neotigason10 mg hard capsules
Neotigason 25 mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg or 25 mg acitretin.
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.
25 mg: Capsules with brown cap and yellow body with “Actavis”
printed in black on
the cap and “25” printed in black on the body; capsule size 1.
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
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.
Posology
Because there are differences in the absorption and rate of metabolism
of acitretin, the
dosage must be individually adjusted. The following will serve as
guidelines.
Page 2 of 12
_Adults _
The _initial daily dosage_, 25 mg (i.e. 1 capsule 25 mg) or 30 mg
(i.e. 3 capsules 10 mg)
for about 2-4 weeks may give satisfactory therapeutic results.
The _maintenance dose_ must be based on clinical efficacy and
tolerability. In general, a
daily dosage of 25-50 mg taken for a further 6-8 weeks achieves
optimal therapeutic
results. It may be necessary in some cases to increase the dose up to
a maximum of 75
mg/day (i.e. 3 capsules 25 mg).
Therapy can be terminated in patients with _ psoriasis_ whose lesions
have resolved
sufficiently. Relapses should be treated as des