611 0 Kommentare Horizon Pharma plc Announces Settlement of PENNSAID(R) 2% Patent Litigation With Perrigo Company plc - Seite 3

Severe allergic reactions may occur without prior use of PENNSAID 2%. NSAIDs can cause serious skin reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), which can kill you.

Wash and dry hands before and after use. Avoid contact of PENNSAID 2% with the eyes, nose and mouth.

PENNSAID 2% was not studied under the conditions of heat application, complete covering bandages or exercise; therefore, concurrent use of PENNSAID under these conditions is not recommended.

Do not:

Apply PENNSAID 2% to open wounds.
Shower for at least 30 minutes after applying PENNSAID 2%.
Wear clothing over the PENNSAID 2% treated knee until the treated knee is dry.

Protect treated knee(s) from natural or artificial sunlight.

Protect treated knee(s) from sunlight (real and tanning booths).

Topicals, such as sunscreen and bug repellent, should not be used until after PENNSAID treated knee(s) are completely dry.

Do not use with oral NSAIDs unless your doctor says it is OK and you have lab tests to check your progress.

There is no consistent evidence that regular use of aspirin lessens the increased risk of serious heart events, such as heart clotting, heart attack and stroke associated with NSAID use. As with all NSAIDs, regular administration of PENNSAID 2% and aspirin is not generally recommended because of the potential of increased risks.

ADVERSE REACTIONS

The most common adverse events in a phase 2 clinical trial of PENNSAID 2% were application site reactions, such as dryness (22%), peeling (7%), redness (4%), itching (2%), pain (2%), skin hardening (2%), rash (2%) and scabbing ( < 1%). Other adverse reactions occurring in > 1% of patients receiving PENNSAID 2% included bladder infection (3%), bruising (2%), sinus congestion (2%) and nausea (2%).