Isotrexin 20 mg/g + 0.5 mg/g Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Isotretinoin; Erythromycin

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

D10AD54

INN (International Name):

Isotretinoin; Erythromycin

Dosage:

20+0.5 milligram(s)/gram

Pharmaceutical form:

Gel

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

isotretinoin, combinations

Authorization status:

Not marketed

Authorization date:

1998-10-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ISOTREXIN 20 MG/G + 0.5 MG/G GEL
ERYTHROMYCIN + ISOTRETINOIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Isotrexin is and what it is used for
2. What you need to know before you use Isotrexin
3. How to use Isotrexin
4. Possible side effects
5. How to store Isotrexin
6. Contents of the pack and other information
1.
WHAT ISOTREXIN IS AND WHAT IT IS USED FOR
The name of your medicine is Isotrexin Gel (called Isotrexin in this
leaflet). Isotrexin contains
two active ingredients; erythromycin (an antibiotic) that works by
fighting the bacteria that
cause acne, and isotretinoin (which belongs to a family of medicines
called retinoids, like
vitamin A), which works by helping the skin so that blocked pores are
less likely. This helps
prevent spots.
Isotrexin is used to treat mild to moderate acne (spots). It helps to:

fight the bacteria that can cause acne

treat existing blackheads, whiteheads, and spots

stop new blackheads, whiteheads, and spots from forming

lower the number of red, inflamed acne spots

make your skin less oily
Isotrexin is for use by adults and adolescents with acne. IT IS NOT
FOR USE BY CHILDREN UNDER
12 YEARS, as the safety and effectiveness are not known in this age
group.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ISOTREXIN
DO NOT USE ISOTREXIN IF:

you are ALLERGIC to erythromycin, isotretinoin, or any of the other
ingredients of this
medicine Isotrexin (listed in Section 6).

you are pregnant

you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isotrexin 20 mg/g + 0.5 mg/g Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients with known effect:
butylated hydroxytoluene (E321) 0.1mg/g.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
Pale yellow soft gel with an odour of ethanol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Isotrexin is indicated for the topical treatment of mild to moderate
acne vulgaris in adults and children over 12 years of
age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Isotrexin is for topical use only.
Adults & children over 12 years
Wash the skin gently with a mild cleanser and dry fully. Apply
Isotrexin in a thin film over the entire affected area once
or twice daily.
Avoid close proximity to eyes,
lips,
and other mucous membranes.
Hands should be washed after
application.
8 weeks of treatment may be required before a therapeutic effect is
observed. The efficacy and safety of Isotrexin has
not
been studied beyond 12 weeks in acne vulgaris clinical
trials.
The prescriber
should evaluate the benefit
of
continuing treatment
beyond 12 weeks of
uninterrupted use,
taking account
of
an increased risk of
antimicrobial
resistance.
Patients should be advised that
excessive application will
not
improve efficacy,
but
may increase the risk of skin
irritation.
If undue irritation (redness, peeling, or discomfort) occurs, patients
may use a moisturizer as needed and should reduce
frequency of application or temporarily interrupt
treatment.
The normal
frequency of application should be resumed
once the irritation subsides. Treatment should be discontinued if the
irritation persists. Efficacy has not been established
for less than once daily dosing frequencies.
Due to the flammable nature of Isotrexin gel,
patients should avoid smoking or being near an open flame during
application and immediately after use.
Paediatric population
The safety and efficacy of Isotrexin has not been established in
children less than 12 years of age, therefore Isotr