Felbinac topical

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Rheumatic pain, Mild arthritic pain, Sprains &amp; Strains, Sports injuries, Soft tissue injuries, Contusion, Minor musculoskeletal trauma </span></span></p>

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Topical/Cutaneous</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Pain and inflammation</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Adult:</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">For the symptomatic relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries (including strains, sprains, and contusions):</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">As 3% gel: Apply approx 1 inch (approx 1 g) into the affected area(s) 2-4 times daily.</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Max: 25 g daily (regardless of the size or number of affected areas). Reassess treatment after 14 days.</span></span></p>

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Safety and efficacy have not been established.</span></span></p>

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">No special dosage recommendations are made for elderly patients; however, NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed.</span></span></p>

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Hypersensitivity to the active substance or to any of the excipients, aspirin, or other NSAIDs.</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">History of NSAID-induced asthma, urticaria, or allergic rhinitis.</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Use on broken skin or denuded skin.</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Use with occlusive dressings.</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Use simultaneously at the same site with any other topical preparations.</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Use in the presence of local infection.</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Use in patients with active peptic ulceration.</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Pregnancy and breastfeeding.</span></span></p>

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Avoid application to open wounds, damaged skin, eyes, and mucous membranes.</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Use with caution in patients with asthma or sensitivity to NSAIDs.</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Avoid excessive sun exposure on treated areas.</span></span></p>

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Pregnancy&nbsp;</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Felbinac is suspected to cause serious birth defects when administered during pregnancy. Felbinac&nbsp;Gel is contraindicated in pregnancy. As with other non-steroidal anti-inflammatory agents, which inhibit prostaglandin synthesis, dystocia and delayed parturition were observed when felbinac was administered subcutaneously in animal studies.</span></span></p> <p>&nbsp;</p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Breastfeeding</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Felbinac&nbsp;Gel should not be used during breastfeeding.</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Felbinac&nbsp;Gel is contraindicated during breastfeeding.</span></span></p> <p>&nbsp;</p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Fertility</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">No human data available.</span></span></p>

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">May increase the incidence of adverse effects when used concomitantly with aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).</span></span></p>

<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Felbinac inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing the production of prostaglandins that contribute to pain and inflammation.</span></span></p>