Treclin 1%/0.025% w/w Gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLINDAMYCIN PHOSPHATE; TRETINOIN

Available from:

Meda Pharmaceuticals Limited

ATC code:

D10AF51

INN (International Name):

CLINDAMYCIN PHOSPHATE; TRETINOIN

Pharmaceutical form:

GEL

Composition:

CLINDAMYCIN PHOSPHATE 10 mg/g; TRETINOIN 0.25 mg/g

Prescription type:

POM

Therapeutic area:

ANTI-ACNE PREPARATIONS

Authorization status:

Authorised

Authorization date:

2013-04-02

Patient Information leaflet

1 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

TRECLIN 10 MG/G + 0.25 MG/G 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, tretinoi

Summary of Product characteristics

1
_ _
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.
2
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 Tre