Roaccutane 10mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isotretinoin

Available from:

Roche Products Ltd

ATC code:

D10BA01

INN (International Name):

Isotretinoin

Dosage:

10mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060200; GTIN: 5000471006971

Patient Information leaflet

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
▼
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 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 breast-feeding
● If th

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick
identification of new safety information. Healthcare professionals are
asked to report
any suspected adverse reactions. See section 4.8 for how to report
adverse reactions.
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 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