Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
CLINDAMYCIN PHOSPHATE, TRETINOIN
Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
D10AF51
CLINDAMYCIN PHOSPHATE 10 mg/g TRETINOIN 0.25 mg/g
GEL
CLINDAMYCIN PHOSPHATE 10 mg/g TRETINOIN 0.25 mg/g
POM
ANTI-ACNE PREPARATIONS
Authorised
2013-04-02
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER_ _ TRECLIN 1 % / 0.025 % W/W GEL clindamycin 10 mg/g and tretinoin 0.25 mg/g _ _ _ _ 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 pregnant • if you are planning a pregnancy • if you are allergic to clindamycin, tretinoin, or any of the other ingredients of this medicine (listed in section 6). • if you are allergic to lincomycin. • if you have a chronic inflammatory bowel disease (e.g. Crohn’s disease or ulcerative colitis). • if you have a history of colitis with past antibiotic use which Soma hati kamili
Page 1 of 11 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. Page 2 of 11 _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 Soma hati kamili