Neotigason 25 mg capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Acitretin

Available from:

Teva B.V.

ATC code:

D05BB; D05BB02

INN (International Name):

Acitretin

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Retinoids for treatment of psoriasis; acitretin

Authorization status:

Marketed

Authorization date:

1992-06-16

Patient Information leaflet

Package Leaflet:
Information for the user
NEOTIGASON® 10 MG CAPSULES
NEOTIGASON® 25 MG CAPSULES
Acitretin
WARNING
CAN SERIOUSLY HARM AN UNBORN
BABY
Women must use effective
contraception
Do not use if you are pregnant or
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
PLEASE 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 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 may be 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).
You must talk to a doctor if you do
not feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE NEOTIGASON
DO NOT TAKE NEOTIGASON IF YOU:
•
are pregnant or breast-feeding
•
there is any chance you could
become pregnant, you must
follow the pr

Summary of Product characteristics

Health Products Regulatory Authority
01 July 2022
CRN00CSX1
Page 1 of 11
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 4.8 for how to report adverse
reactions.
1 NAME OF THE MEDICINAL PRODUCT
Neotigason 25 mg capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Capsules containing 25 mg of acitretin.
Excipients: Glucose 41.00 mg.
For the full list of excipients, _see section 6.1._
3 PHARMACEUTICAL FORM
Capsule, hard.
Capsule with a brown cap and yellow body with ‘25’ printed in
black on the body; capsule size 1.
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).
Severe lichen planus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Neotigason 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
4.4 and 4.6. Neotigason capsules are for oral administration.
The capsules should be taken once daily with meals or with milk.
There is wide variation in the absorption and rate of metabolism of
Neotigason. 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 25 mg or 30 mg for two to four 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
increase the therapeutic effect. In general, a daily
dosage of 25-50 mg taken for a further six to eight weeks achieves
optimal therapeutic results