Isotretinoin 10mg capsules

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Isotretinoin

Доступна с:

Sun Pharma UK Ltd

код АТС:

D10BA01

ИНН (Международная Имя):

Isotretinoin

дозировка:

10mg

Фармацевтическая форма:

Oral capsule

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 13060200; GTIN: 5015525090943

тонкая брошюра

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ISOTRETINOIN 10 MG CAPSULES
ISOTRETINOIN 20 MG CAPSULES
ISOTRETINOIN
WARNING
CAN SERIOUSLY HARM AN UNBORN BABY.
Women must use effective contraception.
Do not use if you are pregnant or you 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.
The name of your medicine is Isotretinoin 10 mg or 20 mg Capsules
(also referred to as Isotretinoin
Capsules or Isotretinoin throughout this leaflet).
WHAT IS IN THIS LEAFLET
:
1.
What Isotretinoin Capsules are and what they are used for
2.
What you need to know before you take Isotretinoin Capsules
3.
How to take Isotretinoin Capsules
4.
Possible side effects
5
How to store Isotretinoin Capsules
6.
Contents of the pack and other information
1.
WHAT ISOTRETINOIN CAPSULES ARE AND WHAT THEY ARE USED FOR
Isotretinoin Capsules contain the active ingredient isotretinoin. This
is a vitamin A derivative,
belonging to the retinoid class of medicines. Isotretinoin 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
treatments, including oral antibiotics.
Isotretinoin treatment must be supervised by a dermatologist (a doctor
specialised in the treatment of
skin problems). Isotretinoin capsules are not used to

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Isotretinoin 10mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains isotretinoin 10 mg.
Excipient(s) with known effect:
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsules, Soft
Oval shaped, light pink coloured, opaque soft gelatin capsules
imprinted with `RR` in
black edible ink containing orange-yellow coloured 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
antibacterials and topical therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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
treatment course. In the event of a definite relapse a further course
of isotretinoin
therapy may be considered using the same da