Isotretinoin 20mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isotretinoin

Available from:

Alliance Pharmaceuticals Ltd

ATC code:

D10BA01

INN (International Name):

Isotretinoin

Dosage:

20mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060200; GTIN: 5060061160032 5036631004211

Patient Information leaflet

TEXT FREE AREA
TEXT FREE AREA
PACKAGE LEAFLET: INFORMATION FOR THE USER
ISOTRETINOIN 5MG AND 20MG CAPSULES
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 the 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 is and what it is 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 IS AND WHAT IT IS USED
FOR
Isotretinoin belongs to a group of medicines known as
retinoids that are normally used to treat skin problems.
Isotretinoin Capsules are used to treat severe 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.
Isotretinoin Capsules are for patients whose acne has
not responded to other treatments.
Their use must be supervised by a dermatologist (a
doctor who specialises in the treatment of skin
problems).
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ISOTRETINOIN CAPSULES
DO NOT TAKE ISOTRETINOIN CAPSULES IF:
•
you are pregnant, think you may be pregnant or
breast-feed

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
Isotretinoin 20mg Capsules
Rizuderm 20mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20mg isotretinoin.
Excipients with known effect:
Contains soya bean oil (refined, hydrogenated and partially
hydrogenated) maltitol
and sorbitol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
_ _
Capsules, soft.
Red/orange soft capsules marked ‘P20’.
_ _
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
Isotretinoin is not indicated for the treatment of prepubertal acne
and is not
recommended in patients 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 s