ROACCUTANE 20 Milligram Capsules, Soft

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

ISOTRETINOIN

Disponível em:

Roche Products Limited

Código ATC:

D10BA01

DCI (Denominação Comum Internacional):

ISOTRETINOIN

Dosagem:

20 Milligram

Forma farmacêutica:

Capsules, Soft

Tipo de prescrição:

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

Área terapêutica:

Retinoids for treatment of acne

Status de autorização:

Authorised

Data de autorização:

1983-04-19

Folheto informativo - Bula

1
ie-pl-clean-171030-10-20mg-caps
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROACCUTANE 10 MG AND 20 MG
SOFT CAPSULES
Isotretinoin
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 TYPES OF ACNE
(such as
_nodular _
or
_conglobate_
acne, or acne
that is at risk of causing permanent scarring) in adults and
adolescents from 12 years of age only
after puberty. You will use Roaccutane when your acne has not got
better with anti-acne
treatments, including antibiotics and skin treatments.
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 think you may be
•
IF YOU ARE BREASTFEEDING
•
IF YOU ARE ABLE TO BECOME PREGNANT BUT ARE UNABLE OR UNWILLING TO
FOLLOW
the
necessary pregnancy prevention measures that are listed in the
ROACCUTANE
PREGNANCY PREVENTION PROGRAMME
•
IF YOU ARE ALLERGIC TO _isotretinoin_
,
PEANUT OR SOYA OR ANY OTHER INGREDIENTS
of
this medicine (listed in section 6)
•
IF Y

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Roaccutane 20 mg soft capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 20 mg 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
20 mg capsules: Oval, opaque, brown-red and white capsules imprinted
with ROA 20 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 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_
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 individual daily dose. A treatment
course of 16
-
24 weeks is normally