ENSIGN LABORATORIES PTY LTD (AUSTRALIA)🇸🇬 Health Sciences Authority
Approval Date
Aug 28, 1998
Approval ID
924dee73275aa5fb
Company
ENSIGN LABORATORIES PTY LTD (AUSTRALIA)
Type
Therapeutic
Approval Details
Approval Id
924dee73275aa5fb
Drug Name
DIFFLAM MOUTH GEL
Product Name
DIFFLAM MOUTH GEL
Approval Number
SIN09963P
Approval Date
1998-08-28
Registrant
INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
Licence Holder
INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
Drug Type
Therapeutic
Forensic Classification
PHARMACY ONLY MEDICINES
Dosage Form
GEL
Dosage
<p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<ol>
<li><p>Apply approximately 1 cm of gel with finger.</p></li>
<li><p>Gently massage into sore area.</p></li>
<li><p>Do not eat or drink for 15 minutes.</p></li>
<li><p>Apply every 2–3 hours up to a maximum of 12 times/day.</p></li>
</ol>
<p><strong>With Impaired Renal Function</strong><br>
Since absorbed benzydamine and its metabolites are excreted in the urine, the possibility of systemic effects should be considered in patients with renal impairment.</p>
<p><strong>With Impaired Liver Function</strong><br>
Since absorbed benzydamine is highly metabolised in the liver, the possibility of systemic effects should be considered in patients with severe hepatic impairment.</p>
Route Of Administration
SUBMUCOSAL
Indication Info
<p><strong>INDICATIONS</strong><br >
Temporarily relieves painful inflamed conditions of the mouth, including mouth and denture ulcers and sore gums.</p>
Contraindications
<p><strong>CONTRAINDICATIONS</strong><br>
Difflam Mouth Gel is contraindicated in patients with known hypersensitivity to benzydamine or cetylpyridinium chloride or to any of the components of the vehicle.</p>
