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  
Statistically significant improvement also seen at Week 610
Improvement in Knee Pain at Week 12
  • 46% improvement from baseline in hand pain intensity at Week 6 vs 36% with placebo (P=0.023); primary endpoint11
§In an 8-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of patients with osteoarthritis of the hand (N=385: Voltaren Gel, n =198; placebo, n=187). Weeks 4 and 6 were primary endpoints. 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 and 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, randomized, double-blind, multicenter, placebo-controlled, parallel-group
trial of patients with osteoarthritis of the knee (N=246: Voltaren Gel, n=127; placebo, n=119).
Primary outcome at Week 12 in modified efficacy subpopulation. 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.9

WOMAC (Western Ontario 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.

Indication
Voltaren® Gel is 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 has not been evaluated for use on the spine, hip, or shoulder.
Important Safety Information
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 [see Warnings and Precautions].
  • Voltaren Gel is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications].
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 [see Warnings and Precautions].
The most common adverse reactions reported in Voltaren Gel clinical trials were application site reactions in 7% of treated patients. With all NSAIDs there may be an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.
NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.
The use of Voltaren Gel is contraindicated in patients with a known hypersensitivity to diclofenac.
Voltaren Gel should not be administered in patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
Voltaren Gel should not be used in combination with other oral NSAIDs or aspirin because of the potential for increased adverse effects. Similarly, combined use of Voltaren Gel with other topical products, such as sunscreens and cosmetics, on the same skin area has not been tested and should be avoided because of the potential to alter local tolerability and absorption.
NSAIDs, including Voltaren Gel, can lead to high blood pressure or worsening of high blood pressure, which may add to the increased risk of heart attack and stroke.
There is a potential for elevation in liver function tests during treatment with diclofenac containing products.
Safety and effectiveness in pediatric patients have not been established.
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
Indication
Voltaren® Gel is 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 has not been evaluated for use on the spine, hip, or shoulder.
IMPORTANT SAFETY INFORMATION
for Voltaren Gel
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 [see Warnings and Precautions].
  • Voltaren Gel is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications].
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 [see Warnings and Precautions].
The most common adverse reactions reported in Voltaren Gel clinical trials were application site reactions in 7% of treated patients. With all NSAIDs there may be an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.
NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.
The use of Voltaren Gel is contraindicated in patients with a known hypersensitivity to diclofenac.
Voltaren Gel should not be administered in patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
Voltaren Gel should not be used in combination with other oral NSAIDs or aspirin because of the potential for increased adverse effects. Similarly, combined use of Voltaren Gel with other topical products, such as sunscreens and cosmetics, on the same skin area has not been tested and should be avoided because of the potential to alter local tolerability and absorption.
NSAIDs, including Voltaren Gel, can lead to high blood pressure or worsening of high blood pressure, which may add to the increased risk of heart attack and stroke.
There is a potential for elevation in liver function tests during treatment with diclofenac containing products.
Safety and effectiveness in pediatric patients have not been established.
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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