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

IMPORTANT SAFETY INFORMATION

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK

Heart Risk

• Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious heart clotting events, heart attack and stroke, which can kill you. This risk may increase with longer use. Patients with heart disease or risk factors for heart disease may be at greater risk.
• PENNSAID 2% should not be used if you are in the hospital for certain heart surgeries.

Stomach and Intestine Risk

• NSAIDs cause an increased risk of serious stomach and intestine events including bleeding, ulcers and holes in the stomach or intestines, which can kill you. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious stomach and intestine events.

CONTRAINDICATIONS

• DO NOT USE PENNSAID 2% if you:
  
  
  • are in the hospital for certain heart surgeries.
    
    
  • know you are allergic to diclofenac sodium or any other ingredient of PENNSAID 2%.
    
    
  • have experienced asthma, hives, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, allergic reactions, that will rarely kill you, to NSAIDs have been reported in such patients.
    
    

WARNINGS AND PRECAUTIONS

• To minimize the potential for increased risk of serious heart events while being treated with an NSAID, use the lowest effective dose for the shortest duration possible.
  
  
• Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID 2% should be discontinued immediately if abnormal liver tests persist or worsen.
  
  
• Use with caution in patients with fluid retention or heart failure.
  
  
• Hypertension can occur with NSAID treatment. Monitor blood pressure closely with PENNSAID 2% treatment.
  
  
• Long-term use of NSAIDs can result in severe kidney injury. Use PENNSAID 2% with caution in patients at greatest risk of this reaction, including the elderly, those with impaired kidney function, heart failure, liver dysfunction and those taking diuretics and ACE-inhibitors (certain blood pressure medicines).