Isotretinoin 5mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isotretinoin

Available from:

A A H Pharmaceuticals Ltd

ATC code:

D10BA01

INN (International Name):

Isotretinoin

Dosage:

5mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060200; GTIN: 5025903007128

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 5mg Capsules
Rizuderm 5mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5mg 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 gelatin capsules marked ‘P5’.
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 shown