Acitretin 25mg capsules

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Acitretin

Доступно од:

Phoenix Healthcare Distribution Ltd

АТЦ код:

D05BB02

INN (Међународно име):

Acitretin

Дозирање:

25mg

Фармацеутски облик:

Oral capsule

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 13050200

Информативни летак

Patient Information Leaflet UK
(Actavis Logo)
ACITRETIN 10MG AND 25MG CAPSULES
▼
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 to your doctor or pharmacist.
This includes any possible side effects not
listed in this leaflet. See section 4.
IN THIS LEAFLET:
1. WHAT ACITRETIN IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACITRETIN
3. HOW TO TAKE ACITRETIN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ACITRETIN
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ACITRETIN IS AND WHAT IT IS USED FOR
Acitretin contains a medicine called acitretin. This belongs to a
group of medicines called ‘retinoids’.
Acitretin 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.
Acitretin is normally used while under the care of a specialist
dermatologist (skin doctor).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACITRETIN
DO NOT TAKE ACITRETIN IF YOU ARE ALLERGIC TO:

Acitretin or any of the other ingredients of Acitretin (listed in
Section 7).

Other ‘retinoid’ medicines. These include isotretinoin and
tazarotene.
Do not take Acitretin if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist
before taking Acitretin.
WARNING
CAN SERIOUSLY HARM AN UNBORN BABY
Women must us

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
▼
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.
1
NAME OF THE MEDICINAL PRODUCT
Neotigason 25mg Capsules
Acitretin 25mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capsules with brown cap and yellow body with “25” printed in black
on the
body, containing 25mg acitretin.
Excipient with known affect: Glucose (see section 4.3).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules for oral administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe extensive psoriasis which is resistant to other forms of
therapy.
Palmo-plantar pustular psoriasis.
Severe congenital ichthyosis.
Severe Darier's disease (keratosis follicularis).
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 be based on clinical efficacy
and
tolerability. In general, a daily dosage of 25 - 50mg taken for a
further 6 to 8
weeks achieves optimal therapeu