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:

2015-10-20

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
A-CNOTREN 10 MG AND 20 MG, CAPSULES SOFT
Isotretinoin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAK-
ING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT IN-
FORMATION 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 phar-
macist. 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 belong-
ing to the retinoid class of medicines.
The doctor might have prescribed other treatment. Please
follow doctors orders.
The isotretinoin treatment must be supervised by doctors
specialised in the treatment of severe acne and fully un-
derstands the risk of congenital malformations in children.
Isotretinoin is not used to treat acne occuring before pu-
berty, 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, triglyc-
erides) in your blood
- if you have very high levels of vitamin A in your body (hy-
pervitaminosis A)
- if you are allergic to isotretinoin or any of the other in-
gredients of this medicine (listed in sect

Preparatomtale

A-CNOTREN, SOFT CAPSULES
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 treatment
course of 16-24 weeks is normally sufficient to achieve remission.
In the majority of patients, complete clearing of the acne is obtained
with a single
treatment course. In the event of a definite relapse a further course
of isotretinoin therapy
may be