País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
CLINDAMYCIN PHOSPHATE
Canute Pharma (Ireland) Limited
D10AF; D10AF01
CLINDAMYCIN PHOSPHATE
1 percent weight/weight
Gel
Antiinfectives for treatment of acne; clindamycin
Marketed
2002-11-22
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER ZINDACLIN® 1% GEL Clindamycin Phosphate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. ➢ 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. ➢ If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Zindaclin is and what it is used for. 2. Before you use Zindaclin. 3. How to use Zindaclin. 4. Possible side effects. 5. How to store Zindaclin. 6. Further information. 1. WHAT ZINDACLIN IS AND WHAT IT IS USED FOR Zindaclin is used to treat mild to moderate acne (spots). Zindaclin contains an antibiotic clindamycin that reduces the number of bacteria and stops the skin pores becoming blocked and new spots forming. Zindaclin may also help to reduce the redness of the spots you already have. It will take some time once you have started using Zindaclin before you see your acne improving. WHAT IS ACNE? Acne is an extremely common skin condition most common in adolescence, but not restricted to this stage of life. During adolescence, glands in the skin produce extra grease in response to normal amounts of sex hormones in the body, and this can cause blocked pores, resulting in blackheads. When this happens the pores are invaded by bacteria. The chemicals produced by these bacteria go into deeper layers of the skin and produce red spots filled with pus. 2. BEFORE YOU USE ZINDACLIN DO NOT USE ZINDACLIN ➢ If you are allergic (hypersensitive) to the active substance clindamycin phosphate or any of the other ingredients (See Section 6). ➢ If you are allergic (hypersensitive) to lincomycin another type of antibiotic. An allergic reaction may include a rash, red skin, itching, swelling or breathing difficulties. Zindaclin Llegiu el document complet
Health Products Regulatory Authority 20 July 2023 CRN00DFMZ Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zindaclin 1% Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1g of gel contains 10mg clindamycin (1% w/w) equivalent to 11.88mg of clindamycin phosphate. Excipients with known effect: This medicine contains propylene glycol (40% w/w) and ethanol (20% w/w). For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Gel. A white translucent gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zindaclin is indicated for the treatment of mild to moderate acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and adolescents Apply a thin film of Zindaclin once daily to the affected area. Patient response should be reviewed after 6-8 weeks of treatment and the duration of treatment should be limited to 12 weeks. Children Zindaclin is not indicated for use in children below the age of 12 years. Cutaneous use. 4.3 CONTRAINDICATIONS Zindaclin is contra-indicated in patients with a hypersensitivity to the active substance clindamycin or to any of the excipients in the medicinal product. Although cross-sensitisation to lincomycin has not been demonstrated, it is recommended that Zindaclin should not be used in patients who have demonstrated lincomycin sensitivity. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe pseudomembranous colitis. Topical clindamycin has very rarely been associated with pseudomembranous colitis; however if diarrhoea occurs the product should be discontinued immediately. Studies indicate a toxin(s) produced by _Clostridium difficile _is the major cause of antibiotic-associated colitis. Colitis is usually characterised by severe persistent diarrhoea and abdominal cramps. Should antibiotic associated colitis occur appropriate diagnostic and therapeutic measures (such as stopping Zindaclin and if necessary, antibiotic treatment such as metronidazole o Llegiu el document complet