Clindamycin + Benzoyl Peroxide 10 mg/g + 50 mg/g gel

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

CLINDAMYCIN PHOSPHATE; Benzoyl Peroxide, Hydrous

זמין מ:

European Regulatory Affairs t/a Ivowen

קוד ATC:

D10AF51

INN (שם בינלאומי):

CLINDAMYCIN PHOSPHATE; Benzoyl Peroxide, Hydrous

כמות:

10 + 50 milligram(s)/gram

טופס פרצבטיות:

Gel

איזור תרפויטי:

clindamycin, combinations

מצב אישור:

Not marketed

תאריך אישור:

2021-09-24

עלון מידע

1 PACKAGE LEAFLET: INFORMATION FOR THE USER
CLINDAMYCIN + BENZOYL PEROXIDE 10 MG/G + 50 MG/G GEL
clindamycin + anhydrous benzoyl peroxide
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 this medicine is and what it is used for
2.
What you need to know before you use this medicine
3.
How to use this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
Clindamycin + Benzoyl Peroxide Gel contains two medicines: clindamycin
and benzoyl peroxide.
Clindamycin + Benzoyl Peroxide Gel belongs to a group of medicines
known as ‘anti-acne
preparations’.
This medicine is used for treating mild to moderate acne on your skin.
•
Clindamycin is an antibiotic which stops the bacteria involved in acne
from reproducing
•
Benzoyl peroxide reduces blackheads and whiteheads. It also kills the
bacteria involved in
acne.
Used together in Clindamycin + Benzoyl Peroxide Gel, these work by:
•
fighting the bacteria that can cause acne
•
treating existing blackheads, whiteheads, and spots
•
lowering the number of red, inflamed acne spots
This medicine is for use by adults and adolescents aged 12 years or
over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE THIS MEDICINE
DO NOT USE
Clindamycin + Benzoyl Peroxide Gel
:
-
if you are allergic to clindamycin, lincomycin, benzoyl peroxide or
any of the other ingredients
of this medicine (listed in Section 6)
Do not use this medicine if any of the above apply to you. If y

מאפייני מוצר

Health Products Regulatory Authority
01 October 2021
CRN009Q12
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clindamycin + Benzoyl Peroxide 10 mg/g + 50 mg/g gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains:
10 mg clindamycin as clindamycin phosphate
50 mg anhydrous benzoyl peroxide as hydrous benzoyl peroxide
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
White to slightly yellow homogenous gel with visible fine particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clindamycin + Benzoyl Peroxide Gel is indicated for the topical
treatment of mild to moderate acne vulgaris, particularly
inflammatory lesions, in adults and adolescents aged 12 years and
above (see sections 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only.
Posology
_Adults and Adolescents (aged 12 years and above)_
Clindamycin + Benzoyl Peroxide Gel should be applied once daily in the
evening, to the entire affected area.
Patients should be advised that excessive application will not improve
efficacy, but may increase the risk of skin irritation.
If excessive dryness or peeling occurs, frequency of application
should be reduced or application temporarily interrupted (see
section 4.4).
An effect on inflammatory and non-inflammatory lesions may be seen as
early as week 2-5 of treatment (see section 5.1).
The safety and efficacy of clindamycin 10 mg/g + anhydrous benzoyl
peroxide 50 mg/g gel has not been studied beyond 12
weeks in acne vulgaris clinical trials.
Treatment with this medicine should not exceed more than 12 weeks of
continuous use.
_Paediatric population_
The safety and efficacy of clindamycin 10 mg/g + anhydrous benzoyl
peroxide 50 mg/g gel in children under 12 years of age
has not been established, therefore this medicine is not recommended
for use in this population.
_Elderly _
No specific recommendations.
_ _
Method of admi