Isotrexin gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Erythromycin; Isotretinoin

Available from:

Stiefel Laboratories (UK) Ltd

ATC code:

D10AF52

INN (International Name):

Erythromycin; Isotretinoin

Dosage:

20mg/1gram ; 500microgram/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060100; GTIN: 5011091102127

Patient Information leaflet

ISOTREXIN
® GEL
(isotretinoin/erythromycin)
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 this medicine is Isotrexin Gel (called Isotrexin in this
leaflet),
which is used to treat moderate acne. Isotrexin contains two different
medicines called erythromycin and isotretinoin.
-
Erythromycin is an antibiotic. It works by fighting bacteria that can
cause
acne (spots).
-
Isotretinoin belongs to a family of medicines called retinoids, like
vitamin
A. It works by helping the skin so that blocked pores are less likely.
This
helps prevent spots.
Isotrexin helps to:
-
make your skin less oily
-
loosen blackheads and whiteheads so that they come out more easily
-
stop new blackheads, whiteheads and spots from forming
-
lower the number of bacteria which can cause acne
-
lower the number of red, inflamed acne spots.
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 Isotrexin (listed in Section 6)
-
you are pregnant, if you think you could be pregnant, or if you are
planning to become pregnant
-
you are breast-feeding.
➔
Don’t use Isotrexin if the above applies to you. If you are not
sure, ask
your doctor or pharmacist before using

Summary of Product characteristics

OBJECT 1
ISOTREXIN GEL
Summary of Product Characteristics Updated 07-Sep-2018 | Stiefel
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Isotrexin Gel
2. Qualitative and quantitative composition
Active Ingredient
Isotretinoin
0.05% w/w
Erythromycin
2.00% w/w
1g Gel contains:
Isotretinoin
0.5 mg
Erythromycin
20 mg
Also contains butylated hydroxytoluene (E321).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Gel
A pale yellow soft gel.
4. Clinical particulars
4.1 Therapeutic indications
Isotrexin is indicated for the topical treatment of moderate acne.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Isotrexin is for topical use only.
_Adults and Adolescents (aged 12 years and above)_
Apply Isotrexin in a thin film over the entire affected area once or
twice daily, preferably after cleaning
the skin gently with a mild cleanser and drying fully. Avoid close
prox