Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLINDAMYCIN PHOSPHATE
Orient Europharma (M) Sdn Bhd
CLINDAMYCIN PHOSPHATE
30 gm
DR. AUGUST WOLFF GMBH & CO. ARZNEIMITTEL
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ______________________________________________________________________________ 1 ZINDACLIN GEL Clindamycin Phosphate (1% w/w) ________________________________________________________________________________________________________ WHAT IS IN THIS LEAFLET 1. What _Zindaclin Gel_ is used for 2. How _Zindaclin Gel_ works _3._ _ _ Before you use _Zindaclin Gel _ 4. How to use _Zindaclin Gel_ 5. While you are using it 6. Side effects _7._ _ _ Storage and Disposal of _Zindaclin Gel _ 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _ZINDACLIN GEL_ IS USED FOR Zindaclin Gel is used to treat mild to moderate acne (spots). 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 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. HOW _ZINDACLIN GEL_ WORKS Zindaclin Gel contains an antibiotic clindamycin that reduces the number of bacteria and stops the skin pores becoming blocked and new spots forming. Zindaclin Gel may also help to reduce the redness of the spots you already have. It will take some time once you have started using Zindaclin Gel before you see your acne improving. BEFORE YOU USE _ZINDACLIN GEL_ _When you must not use it _ ➢ If you are allergic (hypersensitive) to the active substance clindamycin phosphate or any of the other ingredients (see section _inactive ingredients_ ). ➢ 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 Gel should not be used by children under the age of 12 years. _ _ _Before you start to use it _ ➢ Before y Pročitajte cijeli dokument
Mock-up 06_22 ZINDACLIN 1% GEL, MY ❶ • 148 x 270 mm • BLACK • Zindaclin ® 1% Gel (Clindamycin Phosphate) Package Insert 1. Name of the Medicinal Product ZINDACLIN 1% GEL 2. Qualitative and quantitative composition The gel contains clindamycin phosphate equivalent clindamycin 1% w/w. Can also be expressed as 1 g of gel contains 10 mg clindamycin (1% w/w) equivalent to 11.88 mg clindamycin phosphate For 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 periodically. Children ZINDACLIN is not indicated for use in children below the age of 12 years. Cutaneous use. Patient response should be reviewed after 6-8 weeks of treatment and the duration of treatment should be limited to 12 weeks. _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-sensitization 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 characterized by severe persistent diarrhoea and abdominal cramps. Should antibiotic-associated colitis occur, appropriate diagnostic and therapeutic measures (such as vancomycin treatment) Pročitajte cijeli dokument