Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BENZYDAMINE HYDROCHLORIDE; CETYLPYRIDINIUM CHLORIDE
iNova Pharmaceuticals (Singapore) Pte Ltd (incorporated In Singapore) Malaysia Branch
BENZYDAMINE HYDROCHLORIDE; CETYLPYRIDINIUM CHLORIDE
10gm mcg/mL
ENSIGN LABS PTY LTD
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ DIFFLAM MOUTH GEL Benzydamine hydrochloride / Cetylpyridinium chloride (1%w/w / 0.1%w/w) WHAT IS IN THIS LEAFLET 1. What Difflam Mouth Gel is used for 2. How Difflam Mouth Gel works 3. Before you use Difflam Mouth Gel 4. How to use Difflam Mouth Gel 5. While you are using it 6. Side effects 7. Storage and disposal of Difflam Mouth Gel 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DIFFLAM MOUTH GEL IS USED FOR Difflam Mouth Gel is used to relieve inflammation and pain in the mouth, denture ulcers and sore gums. Cetylpyridinium chloride has antiseptic activities. HOW DIFFLAM MOUTH GEL WORKS Difflam Mouth Gel works by reducing the pain, redness and swelling. BEFORE YOU USE DIFFLAM MOUTH GEL _-When you must not use it _ Do not use this medicine if you have an allergy to: any medicine containing Benzydamine hydrochloride or Cetylpyridinium chloride any of the ingredients listed at the end of this leaflet. Do not use this medicine if you are pregnant or plan to become pregnant. It may affect your developing baby if you use it during pregnancy. Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy. Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If you are not sure whether you should start using this medicine, talk to your pharmacist or doctor. _-Before you start to use it _ Tell your pharmacist if you have allergies to any other medicines, foods, preservatives or dyes. Tell your pharmacist if you have or have had any of the following medical conditions: impaired kidney or liver function It is not known if Benzydamine hydrochloride or Cetylpyridinium chloride passes into the breast milk. Your pharmacist or doctor will discuss the potential benefits and risks of using the medicine if you are breastfeeding. If you have not told your pharmacist or doctor about any of the above, Baca dokumen lengkap
PRODUCT BRAND: Difflam PRODUCT VARIANT: PACK SIZE: 10g COUNTRY: SG, MY DATE: 02/03/2018 COMPONENT: Leaflet DIMENSIONS: 152mm w x 220mm h FILENAME: 81923_LT0045_DL_Mouth- Gel_10g_Leaflet_SG_MY_V0.ai DIELINE REF: XXX BLACK PRINTER: XXX ARTWORK SOFTWARE: Illustrator CC 2017 BARCODE %: SIGNED: ARTWORKER: DATE: 00/00/2018 EMO: Ensign SKU NO: 100037 PRINTER DETAILS FONTS USED: BODY COPY SIZE: 6.5pts MIN. FONT SIZE: 1.268mm FONTS CODES APPROVALS UIC: LT0045 02/03/18 : New Artwork Build - Elaine AMENDS ARTWORKER INFO COLOURS VERSION: 0 JOB NO: 81923 PLEASE NOTE: THIS IS A LOW RESOLUTION PDF & IS NOT TO BE USED FOR PRINTING Helvetica Regular Helvetica Bold Helvetica Neue 77 Bold Condensed Helvetica Neue 57 Condensed Bauhaus Heavy Mouth Gel PRODUCT INFORMATION PHARMACODYNAMICS The mechanism of anti-inflammatory action is not related to stimulation of the pituitary-adrenal axis. Like other non-steroidal anti-inflammatory agents, benzydamine inhibits the biosynthesis of prostaglandins under certain conditions but its properties in this respect have not been fully elucidated. The stabilising effect on cellular membranes may also be involved in the mechanism of action. PHARMACOKINETICS _ABSORPTION_ Benzydamine is well absorbed following oral administration. Following topical administration of benzydamine hydrochloride, benzydamine is well absorbed into the inflamed oral mucosa where it exerts anti-inflammatory and local anaesthetic action. Plasma benzydamine levels following use of benzydamine orally are low and paralled the amount actually ingested. _EXCRETION_ Benzydamine and its metabolites are excreted largely in the urine. Metabolism is largely by oxidative pathways although dealkylation can also be shown. Benzydamine has been detected in blood and urine following use of oral solutions of benzydamine. Most of the absorbed dose was eliminated in the first 24 hours. Repeated administration for 7 days did not result in accumulation of benzydamine in plasma. INDICATIONS Temporarily relieves painful inflamed conditions of the Baca dokumen lengkap