Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLINDAMYCIN PHOSPHATE; Benzoyl Peroxide, Hydrous
Morningside Healthcare (Malta) Limited
D10AF51
CLINDAMYCIN PHOSPHATE; Benzoyl Peroxide, Hydrous
Gel
clindamycin, combinations
Not marketed
2021-09-24
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 Read the complete document
Health Products Regulatory Authority 05 January 2024 CRN00DYH0 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 Read the complete document