Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
HYDROCORTISONE ACEPONATE
PHARMAFORTE (MALAYSIA) SDN. BHD.
HYDROCORTISONE ACEPONATE
30gm mcg/mL; 5gm mcg/mL; 15gm mcg/mL
LICHTENHELDT GMBH, PHARMAZEUTISCHE FABRIK
_Consumer Medication Information Leaflet (RiMUP)_ EFFICORT ® LIPOCREAM Hydrocortisone aceponate 1 What is in this leaflet 1. What is Efficort ® Lipocream used for 2. How Efficort ® Lipocream works 3. Before you use Efficort ® Lipocream 4. How to take Efficort ® Lipocream 5. While you are using Efficort ® Lipocream 6. Side Effects 7. Storage and disposal of Efficort ® Lipocream 8. Product description 9. Manufacturer 10. Product registration holder 11. Date of revision WHAT IS EFFICORT ® LIPOCREAM USED FOR Efficort ® Lipocream is recommended for the treatment of dry squamous inflammatory lesions. HOW EFFICORT ® LIPOCREAM WORKS Efficort ® Lipocream contains hydrocortisone acepoanate which acts on certain inflammatory and allergic processes occurring in the course of atopic and/or contact dermatitis. BEFORE YOU USE EFFICORT ® LIPOCREAM WHEN YOU MUST NOT USE EFFICORT ® LIPOCREAM Efficort ® Lipocream must not be used on open wounds or damage skin. HOW TO USE EFFICORT ® LIPOCREAM Squeeze the tube gently at its base to place a quantity of cream on the fingertips sufficient to cover the area to be treated. Wash hands thoroughly and replace cap tightly after use. HOW MUCH TO USE ADULTS: Unless otherwise prescribed, Efficort ® Lipocream should be applied once to twice daily in a thin layer over the affected skin areas. For the application to be reasonable it is advisable to dab a small amount of product on to several sites at the affected areas and to gently massage in until has been completely absorbed. Application should be limited to twice a day. An increase in the number of daily applications would be likely to aggravate the side effects without improving the therapeutic efficacy of the preparation. INFANTS AND YOUNG CHILDREN Unless otherwise prescribed, one daily application is generally adequate. Continuous daily treatment should be limited to a short period (about 1 week). If used for a longer duration, periodical steroid-free breaks should be interposed. Occlusive dressings should be avoided in infan Perskaitykite visą dokumentą
INTERACTION WITH OTHER MEDICATIONS AND OTHER FORMS OF INTERACTION Hydrolysis by alkaline agents: do not use alkaline antiseptics prior to applying Efficort. Incompatibility with oxidative agents. The concomitant use of other adrenocorticosteroids in the form of tablets, drops or injections may intensify the side effects. DOSAGE AND METHOD OF ADMINISTRATION ADULTS: Unless otherwise prescribed, Efficort should be applied once to twice daily in a thin layer over the affected skin areas. For the application to be reasonable it is advisable to dab a small amount of product on to several sites at the affected areas and to gently massage in until it has been completely absorbed. Application should be limited to twice a day. An increase in the number of daily applications would be likely to aggravate the side effects without improving the therapeutic efficacy of the preparation. Treatment of large areas or long term therapy (3 weeks or more) require clinical monitoring. In any case the duration of treatment prescribed by the physician must be strictly obser- ved. If required, an occlusive dressing could be prescribed by the physician. In case of certain dermatological conditions (psoriasis, dermatitis, ...) a gradual withdrawal might be desirable. This may be achieved by reducing the frequency of application and / or the use of a more dilute or less potent corticosteroid. INFANTS AND YOUNG CHILDREN: Unless otherwise prescribed, one daily application is generally adequate. Continuous daily treatment should be limited to a short period (about 1 week). If used for a longer duration, period-ical steroid-free breaks should be interposed. Occlusive dressings should be avoided in infants and young children. INSTRUCTIONS FOR USE / HANDLING: Squeeze the tube gently at its base to place a quantity of cream on the fingertips sufficient to cover the area to be treated. Wash hands thoroughly and replace cap tightly after use. EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES Based on the pharmacodynamic profile and extensive clinical Perskaitykite visą dokumentą