Voltarol

• Do not use diclofenac if you are allergic to diclofenac (the active ingredient), any inactive ingredient, or aspirin.
• Diclofenac is an NSAID medication. Although some forms of diclofenac can be applied to the skin, some of the medication is absorbed into the blood stream. NSAIDs have been linked to stomach and intestinal bleeding, ulcers, heart attack, stroke, congestive heart failure, allergic reactions, and worsening asthma.
• Tell your doctor right away if you experience symptoms of ulcers or bleeding including:
  • black, tarry stools
  • blood in stools
  • stomach pain
  • vomiting blood
• Call 911 if you experience heart attack symptoms:
  • chest discomfort (uncomfortable pressure, fullness, or pain in chest)
  • shortness of breath
• Diclofenac can also cause or worsen existing hypertension. Blood pressure should be monitored closely during treatment with diclofenac treatment.
• Fluid retention and swelling have been observed in those who have taken NSAIDs. Diclofenac should be used with caution in patients with fluid retention or heart failure.
• Kidney injury may occur with long-term use. Diclofenac should be used with caution in patients at greatest risk of this, including the elderly, those with impaired kidney function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors.
• Severe allergic reactions have occurred in patients with the aspirin triad or in patients without prior exposure to diclofenac. Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • rash
• Serious skin adverse events have occurred with diclofenac use. Discontinue diclofenac if rash or other signs of a skin reaction occur.
• Diclofenac can cause dizziness. Do not drive or operate heavy machinery until you know how diclofenac can affect you.

Cardiovascular Risk

• Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
• Diclofenac is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.