Isotretinoin Capsules, Soft 20mg

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

ISOTRETINOIN

Tilgængelig fra:

Ennogen Healthcare Ltd Unit G4 Riverside, Industrial Estate, Riverside Way, DA15BSUI, Dartford, Kent , United Kingdom

ATC-kode:

D10BA01

INN (International Name):

ISOTRETINOIN 20 mg

Lægemiddelform:

SOFT CAPSULE

Sammensætning:

ISOTRETINOIN 20 mg

Recept type:

POM

Terapeutisk område:

ANTI-ACNE PREPARATIONS

Produkt oversigt:

Licence number in the source country: United Kingdom - PL40739/0001

Autorisation status:

Invalid

Autorisation dato:

2018-10-03

Indlægsseddel

1.
WHAT ISOTRETINOIN 20
MG IS AND WHAT IT IS
USED FOR
Isotretinoin 20 mg soft capsules
contains the active ingredient
isotretinoin. This is a vitamin A
derivative, belonging to the retinoid
class of medicines. Isotretinoin 20 mg
is used to treat severe forms of acne
(such as nodular or conglobate acne,
or acne at risk of permanent scarring)
which has not got better after other
anti-acne treatments, including oral
antibiotics.
2.
WHAT YOU NEED TO
KNOW BEFORE YOU
TAKE ISOTRETINOIN
20 MG
ISOTRETINOIN SHOULD ONLY BE
PRESCRIBED BY OR UNDER THE
SUPERVISION OF A DERMATOLOGIST (a
doctor specialised in the treatment of
skin problems) with understanding of
the risks of isotretinoin therapy and
monitoring requirements.
YOUR DOCTOR WILL INFORM YOU ABOUT
THE PRECAUTIONS YOU HAVE TO FULFIL
WHEN YOU TAKE ISOTRETINOIN 20 MG.
Additionally, you should receive
information materials from your
doctor. If not, ask your doctor for this
information. If your doctor has not
explained the precautionary
measures or you have not
understood them, please contact
your doctor before you start taking
Isotretinoin 20 mg.
DO NOT TAKE ISOTRETINOIN 20 MG
!
IF YOU ARE PREGNANT or think you
may be pregnant
!
IF YOU ARE BREAST-FEEDING
!
IF YOU ARE ABLE TO BECOME
PREGNANT BUT ARE UNABLE OR
UNWILLING TO FOLLOW THE
NECESSARY PREGNANCY
PREVENTION MEASURES THAT ARE
LISTED IN THE PREGNANCY
PREVENTION PROGRAMME
ISOTRETINOIN
20 MG SOFT
CAPSULES
Isotretinoin
PACKAGE LEAFLET:
INFORMATION FOR THE USER
THIS MEDICINAL
PRODUCT IS STRONGLY
TERATOGENIC
Please see the brochures on
the contraceptive programme
and the information you are
given in this patient leaflet in
section 2 under the heading
"Pregnancy Prevention
Programme".
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 i

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Isotretinoin 20 mg soft capsules
Reticutan 20mg soft capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg isotretinoin.
Excipients with known effect
Soya-bean oil 265.600 mg
Soya-bean oil, partly hydrogenated 15.400 mg
Sorbitol solution 70% (non crystallizing) 16.985 mg
Ponceau 4R 0.336 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Soft gelatin capsules.
Isotretinoin capsules are maroon coloured soft gelatin capsules with
the markings
Iso20.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe forms of acne (such as nodular or conglobate acne or acne at
risk of
permanent scarring) resistant to adequate courses of standard therapy
with systemic
antibacterials and topical therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Isotretinoin should only be prescribed by or under the supervision of
physicians with
expertise in the use of systemic retinoids for the treatment of severe
acne and a full
understanding of the risks of isotretinoin therapy and monitoring
requirements.
The capsules should be taken with food once or twice daily.
_Adults including adolescents and the elderly:_
Isotretinoin therapy should be started at a dose of 0.5 mg/kg daily.
The therapeutic
response to isotretinoin and some of the adverse effects are
dose-related and vary
between patients. This necessitates individual dosage adjustment
during therapy. For
most patients, the dose ranges from 0.5-1.0 mg/kg per day.
Long-term remission and relapse rates are more closely related to the
total dose
administered than to either duration of treatment or daily dose. It
has been shown that
no substantial additional benefit is to be expected beyond a
cumulative treatment dose
of 120-150 mg/kg. The duration of treatment will depend on the
individual daily
dose. A treatment course of 16-24 weeks is normally sufficient to
achieve remission.
In the majority of patients, complete clearing of the acne is obtained
with a single
tr