CEPTON MEDICATED CLEAR GEL 0.5 %w/w Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CHLORHEXIDINE GLUCONATE

Available from:

Eastern Pharmaceuticals Limited

INN (International Name):

CHLORHEXIDINE GLUCONATE

Dosage:

0.5 %w/w

Pharmaceutical form:

Gel

Prescription type:

Product not subject to medical prescription

Authorization status:

Authorised

Authorization date:

0000-00-00

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cepton Medicated Clear Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Chlorhexidine Gluconate 0.5 % w/w (incorporated as Chlorhexidine Gluconate Solution BP 2.5 %
v/w)
_For excipients, see Section 6.1_
3 PHARMACEUTICAL FORM
Gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
An aid in the treatment of spots and acne.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical use only
Apply morning and night as follows:
Wash hands and face, apply a thin coating of the gel to the affected area and work in thoroughly.
4.3 CONTRAINDICATIONS
None known.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only
Keep all medicines away from children
If no improvement occurs or skins irritation follows, stop using and talk to your doctor
Keep out of the eyes.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None known.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/05/2010_
_CRN 2083457_
_page number: 1_
4.6 PREGNANCY AND LACTATION
No use in pregnancy warning is required.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
The ability to drive or use machines is not affected.
4.8 UNDESIRABLE EFFECTS
None known.
4.9 OVERDOSE
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Chlorhexidine is an effective antiseptic with a wide range of activity against micro-organisms, including gram positive
and gram negative bacteria, fungi and viruses.
5.2 PHARMACOKINETIC PROPERTIES
Not applicable.
5.3 PRECLINICAL SAFETY DATA
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Ethanol
Polyoxyethylated castor oil hydrogenated
Hydroxyethyl cellulose
Sodium acetate
Perf