The #1 prescribed topical NSAID1
Voltaren® Gel Is Proven Effective in Patients With Moderate
to Severe Osteoarthritis (OA) Joint Pain2,9,10,*,
Voltaren® Gel can help relieve OA pain in joints amenable to topical treatment including2:
  • Knees
  • Ankles
  • Feet
  • Elbows
  • Wrists
  • Hands
Voltaren® Gel has not been evaluated for use on the spine, hip, or shoulder.
Statistically significant reduction in osteoarthritis (OA) hand pain by Week 4
Improvement in Knee Pain at Week 12
  • 42% improvement from baseline in hand pain intensity at Week 4 vs 32% with placebo (P=0.018); primary endpoint10
*In an 8-week, prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of patients with OA of the hand (N=385: Voltaren® Gel, n=198; placebo, n=187). Primary end points were assessed at Weeks 4 and 6. OA pain intensity was measured on a 100-mm visual analog scale (VAS) of pain intensity in which 0=no pain and 100=unbearable pain. Administered dose: 2 g per hand, 4 times daily, on both hands (16 g per day).10

Statistically significant vs placebo.

Proven effective in patients with moderate or severe OA knee pain9
Mean Reduction in Hand Pain
  • 51% improvement from baseline in knee pain vs 39% with placebo
    (P=0.023); primary endpoint9,†,‡
In a 12-week, prospective, randomized, double-blind, multicenter, placebo-controlled, parallel-group trial of patients with OA of the knee (N=246: Voltaren® Gel, n=127; placebo, n=119). Primary end point WOMAC Pain Subindex was measured at Week 12. Target study population consisted of ambulatory patients with OA of 1 or both knees and a history of clinically symptomatic OA with moderate-to-severe pain in 1 knee only diagnosed 6 months previously and verified by X-ray.9

§WOMAC (Western Ontario and McMaster Universities Osteoarthritis Pain index), a validated instrument to assess OA pain. Pain index scale: 0 to 20. Administered dose: 4 g, 4 times daily, on 1 knee (16 g per day)9

Statistically significant vs placebo.

INDICATIONS AND USAGE
Voltaren® Gel is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Voltaren® Gel was not evaluated for use on joints of the spine, hip, or shoulder.
Important Safety Information

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
See full prescribing information for complete boxed warning.

Cardiovascular Risk
  • Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.
  • Voltaren® Gel is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
  • Non-steroidal anti-inflammatory drugs (NSAIDs), including Voltaren® Gel, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Elderly patients are at greater risk for serious gastrointestinal events.
  • Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke can occur with NSAID treatment. The lowest possible dose of Voltaren® Gel should be used in patients with known CV disease or risk factors for CV disease.
  • NSAIDs, including diclofenac, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation. Voltaren® Gel should be prescribed with caution in those with a prior history of ulcer disease or gastrointestinal bleeding.
  • Elevation of one or more liver tests may occur during therapy with diclofenac. Voltaren® Gel should be discontinued immediately if abnormal liver tests persist or worsen.
  • Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. Voltaren® Gel should be used with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE-inhibitors.
  • Hypertension can occur with NSAID treatment. Blood pressure should be monitored closely during treatment with Voltaren® Gel.
  • Fluid retention and edema have been observed in some patients taking NSAIDs. Voltaren® Gel should be used with caution in patients with fluid retention or heart failure.
  • Anaphylactoid reactions may occur in patients with the aspirin triad or in patients without prior exposure to Voltaren® Gel and should be discontinued immediately if an anaphylactoid reaction occurs.
  • NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Voltaren® Gel should be discontinued if rash or other signs of local skin reaction occur.

Contraindications:

  • Known hypersensitivity to diclofenac, aspirin, or other NSAIDs.
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
  • Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery.
To report SUSPECTED ADVERSE EVENTS, contact Novartis Consumer Health, Inc. at
1-800-452-0051 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Indication and IMPORTANT SAFETY INFORMATION for Voltaren® Gel
INDICATIONS AND USAGE
Voltaren® Gel is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Voltaren® Gel was not evaluated for use on joints of the spine, hip, or shoulder.
Important Safety Information

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
See full prescribing information for complete boxed warning.

Cardiovascular Risk
  • Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.
  • Voltaren® Gel is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
  • Non-steroidal anti-inflammatory drugs (NSAIDs), including Voltaren® Gel, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Elderly patients are at greater risk for serious gastrointestinal events.
  • Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke can occur with NSAID treatment. The lowest possible dose of Voltaren® Gel should be used in patients with known CV disease or risk factors for CV disease.
  • NSAIDs, including diclofenac, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation. Voltaren® Gel should be prescribed with caution in those with a prior history of ulcer disease or gastrointestinal bleeding.
  • Elevation of one or more liver tests may occur during therapy with diclofenac. Voltaren® Gel should be discontinued immediately if abnormal liver tests persist or worsen.
  • Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. Voltaren® Gel should be used with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE-inhibitors.
  • Hypertension can occur with NSAID treatment. Blood pressure should be monitored closely during treatment with Voltaren® Gel.
  • Fluid retention and edema have been observed in some patients taking NSAIDs. Voltaren® Gel should be used with caution in patients with fluid retention or heart failure.
  • Anaphylactoid reactions may occur in patients with the aspirin triad or in patients without prior exposure to Voltaren® Gel and should be discontinued immediately if an anaphylactoid reaction occurs.
  • NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Voltaren® Gel should be discontinued if rash or other signs of local skin reaction occur.

Contraindications:

  • Known hypersensitivity to diclofenac, aspirin, or other NSAIDs.
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
  • Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery.
To report SUSPECTED ADVERSE EVENTS, contact Novartis Consumer Health, Inc. at 1-800-452-0051 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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