A-cnotren capsules soft

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv ingrediens:

isotretinoin

Tilgjengelig fra:

Pharmathen International S.A.

ATC-kode:

D10BA01

INN (International Name):

isotretinoin

Dosering :

10mg

Legemiddelform:

capsules soft

Enheter i pakken:

(30/3x10/) in blister

Resept typen:

Prescription

Autorisasjon status:

Registered

Autorisasjon dato:

2021-02-25

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
A-CNOTREN 10 MG AND 20 MG, CAPSULES SOFT
Isotretinoin
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.
WHAT IS IN THIS LEAFLET:
1.
What A-cnotren is and what it is used for
2.
What you need to know before you take A-cnotren
3.
How to take A-cnotren
4.
Possible side effects
5.
How to store A-cnotren
6.
Contents of the pack and other information
1.
WHAT A-CNOTREN IS AND WHAT IT IS USED FOR
A-cnotren 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 anti-acne
treatments including oral antibiotics.
A-cnotren contains the active ingredient isotretinoin belonging to the
retinoid class of
medicines.
The doctor might have prescribed other treatment. Please follow
doctors orders.
The A-cnotren treatment must be supervised by doctors specialised in
the treatment of
severe acne and fully understands the risk of congenital malformations
in children. A-
cnotren is not used to treat acne occuring before puberty, or in
children younger than
12 years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE A-CNOTREN
DO NOT TAKE A-CNOTREN:
-
if you are pregnant or think you may be pregnant
-
if you are breastfeeding
-
if you have liver disease
-
if you have very high levels of lipids (cholesterol, trigl

Preparatomtale

A-CNOTREN, SOFT CAPSULES
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
A-cnotren 10 mg and 20 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 10 mg or 20 mg of isotretinoin
Excipients: refined soya-bean oil, hydrogenated soya bean oil,
partially hydrogenated soya
bean oil.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsules, soft.
10 mg capsules are oval, red/orange (size 3).
20 mg capsules are oval, red/orange (size 6).
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 treatme