1. Diclofenac epolamine topical system 1.3% [package insert]. Parsippany, NJ: YARAL Pharma Inc; 2020. 2. J.-M. Coudreuse et al.; Curr Med Research Opin.; 2010; 26(9):2221-8. 3. K.D. Rainsford et al., Curr Med Research Opin.; 2018; 35(6): 989-1002
Simply stated, an Authorized Generic (AG) is an approved brand name drug marketed without the brand on its label.
Diclofenac epolamine topical system 1.3% is manufactured by IBSA Group, our parent company and makers of the original Flector® topical patch system. Patients are prescribed a product identical to the brand, at an affordable price.
Diclofenac epolamine topical system 1.3% vs. Other NSAID Pain Relievers
Diclofenac epolomine topical system 1.3%
Voltaren Gel® (diclofenac 1%)
Pennsaid® (diclofenac sodium topical solution 2%)
Oral pain relievers (Ibuprofen, etc.) †,††
Localized absorption of active ingredient
† Nonprescription †† Includes acetaminophen, ibuprofen, naproxen, etc
General Information About Diclofenac epolamine topical system 1.3%
What is Diclofenac?
Diclofenac epolamine topical system 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.
How should I use Diclofenac?
When you apply diclofenac epolamine topical system 1.3% to the site of your acute pain due to minor strains, sprains, and contusions, keep the following in mind: • Do not cut the patch • Apply as prescribed by your doctor • Apply directly to the site of injury • Only apply to unbroken or undamaged skin • Do not use while bathing or showering • If it peels off, tape down the edges or use a mesh netting sleeve • Remove before applying a new diclofenac epolamine topical system 1.3% topical system • Safely discard used topical system where children and pets cannot get to them • Wash hands after applying, handling, or removing topical system • Avoid eye contact • Do not use combination therapy with diclofenac epolamine topical system 1.3% and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations
Who should not use Diclofenac?
Do not take NSAIDs including diclofenac epolamine topical system 1.3%:
• If you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs • Right before or after heart bypass surgery • Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
How should I store my Diclofenac?
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
What are the possible side effects of Diclofenac?
Diclofenac epolamine topical system 1.3% is a topical nonsteroidal anti-inflammatory drug (NSAID). NSAIDs like diclofenac epolamine topical system 1.3% can cause serious side effects, such as:
• New or worse high blood pressure • Heart disease (including heart attack and heart failure) • Liver problems including liver failure • Kidney problems including kidney failure • Low red blood cells (anemia) • Life-threatening skin reactions • Life-threatening allergic reactions
Talk with your doctor about all of your medical conditions and about any prescription or nonprescription medication that you are taking before starting diclofenac epolamine topical system 1.3% or any other NSAID therapy.
Click hereto see Important Safety Information for Diclofenac epolamine topical system 1.3%.
About Acute Pain
What is acute pain?
Acute pain is short-term pain that’s often described as a physical sensation such as stabbing, burning, twisting, tearing, or squeezing. And it may result from minor injuries, including strains, sprains, and contusions. Acute (short-term) pain may be a signal that your body is experiencing—or has experienced—some type of tissue damage.
What is a strain?
Strains occur when a tendon or muscle is stretched too far. Tendons connect muscles to bones.
What is a sprain?
Sprains occur when a ligament is stretched too far and are most common in ankles and wrists. Ligaments connect bones and support joints.
What is a contusion?
Contusions are the result of blunt impact against the skin.
What are NSAIDs?
NSAIDs or nonsteroidal anti-inflammatory drugs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of pain.
Who should not take NSAIDs?
Do not take NSAIDs:
• If you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs • Right before or after heart bypass surgery
What should I tell my doctor before taking NSAIDs?
Before taking NSAIDs, tell your healthcare provider about all of your medical conditions and all of the medicines you are taking, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.