TRECLIN 1/0.025 %w/w Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLINDAMYCIN, TRETINOIN

Available from:

Meda Health Sales Ireland Limited

ATC code:

D10AF01

INN (International Name):

CLINDAMYCIN, TRETINOIN

Dosage:

1/0.025 %w/w

Pharmaceutical form:

Gel

Prescription type:

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

Therapeutic area:

Antiinfectives for treatment of acne

Authorization status:

Authorised

Authorization date:

2013-03-22

Patient Information leaflet

Package leaflet: Information for the user 
TRECLIN 1%  / 0.025% W/W GEL 
Clindamycin and tretinoin 

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 Treclin is and what it is used for 
2.  What you need to know before you use Treclin  
3.  How to use Treclin 
4.  Possible side effects 
5.  How to store Treclin 
6.  Contents of the pack and other information 

1.  WHAT TRECLIN IS AND WHAT IT IS USED FOR 
Treclin contains the
active substances clindamycin and tretinoin. 
Clindamycin is an antibiotic. It limits the growth of
bacteria associated with acne and the 
inflammation caused by these bacteria. 
Tretinoin normalizes the growth of superficial skin cells
and causes normal shedding of the cells that 
clog the hair follicles in areas
with acne. This prevents the build-up of
sebum and the formation of 
early acne lesions (blackheads and whiteheads). 
These active substances are more effective when combined
than when used separately. 
Treclin is used on the skin to treat acne
in patients 12 years and older.  

2.  WHAT YOU NEED TO KNOW BEFORE YOU USE TRECLIN 
DO NOT USE TRECLIN: 


If you are allergic to clindamycin, tretinoin, or any of
the other ingredients of this medicine 
(listed in section 6).  


If you are al

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Treclin 1 % / 0.025 % w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of gel contains 10 mg (1%) clindamycin (as clindamycin
phosphate) and 0.25 mg (0.025%) tretinoin.
Excipients with known effect:
Methyl parahydroxybenzoate (E 218): 1.5 mg/g (0.15%)
Propyl parahydroxybenzoate (E216): 0.3 mg/g (0.03%)
Butylhydroxytoluene (E321): 0.2 mg/g (0.02%)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
Translucent yellow gel
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treclin is indicated for the topical
treatment
of acne vulgaris when comedones,
papules and pustules are present
in
patients 12 years or older (see section 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents and acne treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents (_
_12 years)_
Once daily at bedtime the entire face should be washed with mild soap
and dried.
A pea-sized amount of medication
should be squeezed onto one fingertip,
dot onto the chin; cheeks,
nose,
and forehead,
then gently rub over the entire
face.
Treatment with Treclin should not exceed 12 weeks of continuous use
without careful evaluation.
It should be noted
that therapeutic improvement may not be observed for several weeks
after starting treatment.
In case of a missed dose of Treclin,
the patient
should wait
for the next
dose at
the usual
time.
Patients should not
double the dose to make up for the forgotten dose.
_Use in Children below 12 years of age_
Treclin is not recommended for use in children below 12 years of age,
since safety and efficacy of Treclin in children
have not been established.
_Use in the Elderly (>65 years of age)_
Safety and efficacy of Treclin in patients above the age of 65 years
have not been established.
_Renal and hepatic impairment_
In view of
the low systemic exposure to clindamycin and tretinoin following
topical
administration of
Treclin,
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