Acitretin 25mg capsules

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Acitretin

Доступна з:

Genus Pharmaceuticals Ltd

Код атс:

D05BB02

ІПН (Міжнародна Ім'я):

Acitretin

Дозування:

25mg

Фармацевтична форма:

Oral capsule

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 13050200; GTIN: 5030451004468

інформаційний буклет

PACKAGE LEAFLET:
INFORMATION FOR THE USER
ACITRETIN 10 MG
CAPSULES
ACITRETIN 25 MG
CAPSULES
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.
-
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 get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
WHAT IS 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
The name of your medicine is “Acitretin 10 mg
Capsules” or “Acitretin 25 mg Capsules” but
will be referred to as “Acitretin” throughout the
leaflet.
Acitretin belongs to a group of medicines
known as retinoids. Retinoids are derived from
vitamin A.
The medicine is used to treat severe skin
problems where the skin has become thick
and may be scaly and which does not respond
to other conventional treatments satisfactorily.
ACITRETIN IS USED TO TREAT
•
EXTENSIVE AND SERIOUS FORMS OF VARIOUS
SKIN DISORDERS resulting from disturbances
of the outer layer of skin (the epidermis),
such as psoriasis, together with a dry,
scaling, waxy rash
•
SPECIFIC SKIN DISORDERS CHARACTERIZED
BY DRY SCALES as a result of marked
keratinization (ichthyosis, an organic
process by which keratin is deposited in
cells an

Характеристики продукта

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
Acitretin 25 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard of Acitretin 25 mg contains 25 mg acitretin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
Acitretin 25 mg consists of a yellow to light yellow body and a brown
cap, printed in
black with “A25” on the capsule body and filled with a yellow
powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Extensive and severe refractory forms of psoriasis;
•
Pustulous psoriasis of the hands and feet;
•
Severe congenital ichthyosis and ichthyosiform dermatitis;
•
Lichen ruber planus of skin and mucous membranes;
•
Other severe and refractory forms of dermatitis characterised by
dyskeratosis
and/or hyperkeratosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Acitretin should only be prescribed by doctors, who have experience in
treatment
with systemic retinoids and who are aware of the teratogenic risk
associated with
acitretin (see sections 4.4 and 4.6).
The dosage is based on the clinical appearance of the disorder and the
tolerability of
the product. The treating physician must determine the dosage
individually for each
patient. The following information can serve as a guide.
This product is available in two strengths:
Acitretin 10 mg capsules
Acitretin 25 mg capsules
Adults
An initial daily dose of 25 or 30 mg acitretin (i.e. 1 capsule of
Acitretin 25 mg or 3
capsules of Acitretin 10 mg) for 2 to 4 weeks is recommended. After
this initial
phase, it may be necessary in some cases to increase the dose up to a
maximum of 75
mg acitretin per day (i.e. 3 capsules of Acitretin 25 mg). This
maximum dose should
not be exceeded.
In patients with Dari