Isotretinoin Capsules, Soft 5mg

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

ISOTRETINOIN

Verfügbar ab:

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

ATC-Code:

D10BA01

INN (Internationale Bezeichnung):

ISOTRETINOIN 5 mg

Darreichungsform:

SOFT CAPSULE

Zusammensetzung:

ISOTRETINOIN 5 mg

Verschreibungstyp:

POM

Therapiebereich:

ANTI-ACNE PREPARATIONS

Produktbesonderheiten:

Licence number in the source country: United Kingdom - PL40739/0002

Berechtigungsstatus:

Invalid

Berechtigungsdatum:

2018-10-03

Gebrauchsinformation

1. WHAT ISOTRETINOIN 5
MG IS AND WHAT IT IS
USED FOR
Isotretinoin 5 mg capsules contain
the active ingredient isotretinoin. This
a vitamin A derivative, belonging to
the retinoid class of medicines.
Isotretinoin 5 mg is used to treat
severe forms of acne (such as
nodular or conglobate acne, or acne
at risk of permanent scarring) in
adults and adolescents from 12
years of age only after puberty. You
will use Isotretinoin 5 mg when your
acne has not got better after other
anti-acne treatments, including oral
antibiotics and skin treatments.
ISOTRETINOIN 5 MG TREATMENT MUST
BE SUPERVISED BY A DERMATOLOGIST
(a doctor specialised in the treatment
of skin problems).
2. WHAT YOU NEED TO
KNOW BEFORE YOU
TAKE ISOTRETINOIN 5
MG
DO NOT TAKE ISOTRETINOIN 5 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
ISOTRETINOIN 5MG PREGNANCY
PREVENTION PROGRAMME
!
IF YOU ARE ALLERGIC TO
_isotretinoin_, PEANUT OR SOYA OR
ANY OTHER INGREDIENTS of this
medicine (listed in section 6)
!
IF YOU HAVE LIVER DISEASE
!
IF YOU HAVE VERY HIGH LEVELS OF
BLOOD FATS (e.g. high cholesterol
or triglycerides)
!
IF YOU HAVE VERY HIGH LEVELS OF
VITAMIN A in your body
(hypervitaminosis A)
!
IF YOU ARE RECEIVING TREATMENT
WITH TETRACYCLINES (a type of
ISOTRETINOIN
5 MG 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
har

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Isotretinoin 5 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 5 mg of isotretinoin.
Excipients with known effect:
Soya-bean oil, refined 66,40 mg
Soya-bean oil, partly hydrogenated 3,850 mg
Sorbitol, liquid (non-crystallising) (E420) 4,995 mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, soft
Faint pinkish/cream to cream coloured oval, soft-gelatin capsules,
containing a
yellow/orange, opaque, viscous liquid.
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.
Paediatric Population
Isotretinoin should not be used for the treatment of prepubertal acne
and is not
recommended in children less than 12 years of age due to a lack of
data on efficacy and
safety.
_ _
_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
indivi