A-cnotren capsules soft

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

isotretinoin

Beschikbaar vanaf:

Pharmathen International S.A.

ATC-code:

D10BA01

INN (Algemene Internationale Benaming):

isotretinoin

Dosering:

20mg

farmaceutische vorm:

capsules soft

Eenheden in pakket:

(30/3x10/) in blister

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2021-10-08

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
A-CNOTREN 10 MG CAPSULES, SOFT
A-CNOTREN 20 MG CAPSULES, SOFT
Isotretinoin
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 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 for how
to
report adverse reactions
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. See section 4.
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 contains the active ingredient isotretinoin-a substance
related to vitamin A,
and one of a group of medicines called retinoids (for treatment of
acne).
A-CNOTREN IS USED TO TREAT SEVERE FORMS OF ACNE (such as nodular or
conglobate acne
or acne at risk of causing permanent scarring) in adults and
adolescents from 12 years
of age only after puberty. You will use A-cnotren when your acne has
not got better
with anti-acne treatments, including antibiotics and skin treatments.
THE A-CNOTREN 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 A-CNOTREN
DO NOT TAKE A-CNOTREN:

IF YOU ARE ALLE

Productkenmerken

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 for how to report adverse reactions
1.
NAME OF THE MEDICINAL PRODUCT
A-cnotren 10 mg capsules, soft
A-cnotren 20 mg capsules, soft
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg soft capsule contains 10 mg of isotretinoin.
Each 20 mg soft capsule contains 20 mg of isotretinoin.
Excipients with known effect:
Contains refined soya-bean oil, hydrogenated soya-bean oil, partially
hydrogenated soya-
bean oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, 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 anti-bacterials 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 _
A-cnotren 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 events are
dose-related and vary between
patients. This necessitates individual dose adjustment during therapy.
For most patients,
the dose ranges from 0.5-1.0 mg/kg per day.
Long-term remission and relapse rat