Isotretinoin 5mg capsules

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Isotretinoin

Dostupné z:

Mawdsley-Brooks & Company Ltd

ATC kód:

D10BA01

INN (Medzinárodný Name):

Isotretinoin

Dávkovanie:

5mg

Forma lieku:

Oral capsule

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 13060200

Príbalový leták

Rizuderm 5 & 20mg PIL UK 008
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIZUDERM
® 5MG AND 20MG CAPSULES
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 Rizuderm is and what it is used for
2. What you need to know before you take Rizuderm Capsules
3. How to take Rizuderm Capsules
4. Possible side effects
5. How to store Rizuderm Capsules
6. Contents of the pack and other information
1. WHAT ISOTRETINOIN IS AND WHAT IT IS USED FOR
Rizuderm Capsules contain Isotretinoin which belongs to a group of
medicines
known as retinoids that are normally used to treat skin problems.
Rizuderm 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. Rizuderm 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).
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
Rizuderm 5 & 20mg PIL UK 008
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIZUDERM
CAPSULES
DO NOT TAKE RIZUDERM CAPSULES IF:
•
you are pregnant, think you may

Súhrn charakteristických

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