Isotretinoin SUN 20 mg soft capsules

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Isotretinoin

可用日期:

Sun Pharmaceutical Industries Europe B.V.

ATC代码:

D10BA01

INN（国际名称）:

Isotretinoin

剂量:

20 milligram(s)

药物剂型:

Capsule, soft

治疗领域:

isotretinoin

授权状态:

Not marketed

授权日期:

2021-11-26

资料单张

1
PACKAGE LEAFLET
V012
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ISOTRETINOIN SUN 10 MG SOFT CAPSULES
ISOTRETINOIN SUN 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.
This medicine 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.
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.
WHAT IS IN THIS LEAFLET
1.
What Isotretinoin SUN is and what it is used for
2.
What you need to know before you take Isotretinoin SUN
3.
How to take Isotretinoin SUN
4.
Possible side effects
5.
How to store Isotretinoin SUN
6.
Contents of the pack and other information
1.
WHAT ISOTRETINOIN SUN IS AND WHAT IT IS USED FOR
Isotretinoin SUN contains
_isotretinoin _
– a substance related to vitamin A, and one of a group of
medicines called
_retinoids_
(for treatment of acne)
_._
ISOTRETINOIN SUN 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. You will use Isotretinoin SUN
when your acne has not got better with anti-acne treatments, including
antibiotics and skin treatments.
Isotretinoin SUN should not be used to treat pubertal acne and not in
children aged less than 12 years
of age.
ISOTRETINOIN SUN TREATMENT MUST BE SUPERVISED BY A DERMATOLOGIST
(a doctor

产品特点

Health Products Regulatory Authority
15 August 2022
CRN00CV5W
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isotretinoin SUN 20 mg soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 20 mg of isotretinoin.
Excipients with known effect
Contains soya bean oil (refined, hydrogenated).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft
Isotretinoin SUN 20 mg soft capsules comprise of oval shaped, orange
to reddish orange colored, opaque soft gelatin capsules
imprinted with `RR' in black edible ink, of approximately 13.20±0.5
mm length and 7.80±0.5 mm width, containing
orange-yellow colored oily suspension.
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.
_Paediatric population_
Isotretinoin SUN 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 expecte