Roaccutane 10 mg soft capsules

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Isotretinoin

Verfügbar ab:

Roche Products (Ireland) Ltd

ATC-Code:

D10BA; D10BA01

INN (Internationale Bezeichnung):

Isotretinoin

Dosierung:

10 milligram(s)

Darreichungsform:

Capsule, soft

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Retinoids for treatment of acne; isotretinoin

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2006-11-20

Gebrauchsinformation

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ROACCUTANE 10 MG AND 20 MG
SOFT CAPSULES
isotretinoin
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
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep the leaflet. You may need to read it again.
•
If you have more 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.
WHAT IS IN THIS LEAFLET
1.
What Roaccutane is and what it is used for
2.
What you need to know before you take Roaccutane
3.
How to take Roaccutane
4.
Possible side effects
5.
How to store Roaccutane
6.
Contents of the pack and other information
1.
WHAT ROACCUTANE IS AND WHAT IT IS USED FOR
Roaccutane contains
_isotretinoin_
– a substance related to vitamin A, and one of a group of medicines
called
_ retinoids_
(for treatment of acne)
_. _
_ _
ROACCUTANE IS USED TO TREAT SEVERE FORMS OF ACNE
(such as
_nodular _
or
_conglobate_
acne, or acne that is
at risk of causing permanent scarring) in adults and adolescents. You
will use Roaccutane when your
acne has not got better with anti-acne treatments, including
antibiotics and skin treatments.
Roaccutane should not be used to treat prepubertal acne and not in
children aged less than 12 years of
age.
ROACCUTANE 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 ROACCUTANE
DO NOT TAKE ROACCUTANE:
•
If you are pregnant or breast-feeding
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•
If there is any chance you could become pregn

Fachinformation

Health Products Regulatory Authority
11 March 2024
CRN00F2RV
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Roaccutane 10 mg soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 10 mg of isotretinoin.
Excipients with known effect:
Contains soya-bean oil (refined, hydrogenated and partially
hydrogenated) and sorbitol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, soft
10 mg capsules: Oval, opaque, brown-red capsules imprinted with ROA 10
in black ink.
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 anti-bacterials 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_
Roaccutane 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 i