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HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
This medication is used to relieve joint and muscle pain (such as a sprained ankle, muscle strain). Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID). Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
Read the Patient Information Leaflet if available from your pharmacist before you start using diclofenac. Read all directions on the product package before using this medication. If you have any questions, consult your pharmacist. This medication is for use on the skin only. Follow all directions for the proper use of this medication. Wash and dry your hands before applying the medication, then clean and dry the affected area.
Gently rub the medication into the affected joint or muscle as directed by your doctor. Wash your hands after using, unless you are using this medication to treat the hands. Follow the directions on the package label. To reduce your risk of stomach bleeding and other side effects, use the lowest effective dose for the shortest possible time. Do not increase your dose or use it for more than 7 days unless otherwise directed. Pain medications work best if they are used as the first signs of pain occur.
If you wait until the pain has worsened, the medication may not work as well. Do not apply the medication on open skin wounds, infected/scraped/burned skin, or irritated skin (such as eczema). Do not wrap or bandage the treated area unless directed by the doctor. Do not get the medication in the eyes, nose, mouth, or vaginal/anal area. If you do get the medication in these areas, flush with plenty of water. Contact your doctor right away if irritation persists. Tell your doctor if your pain does not improve within 7 days or if it worsens.
Rash, irritation, redness, or itching at the application site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor right away if you have any serious side effects, including: skin discoloration/peeling/blistering at the application site, signs of kidney problems (such as change in the amount of urine), symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). Other medications similar to this medication may rarely cause serious bleeding from the stomach or intestines. Rarely, related drugs have caused blood clots to form, resulting in heart attacks and strokes.
If you notice any of the following rare but very serious side effects, stop using this medication and get medical help right away: black/bloody stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain, chest/jaw/left arm pain, shortness of breath, unusual sweating, sudden vision changes, weakness on one side of the body, trouble speaking, confusion. This drug may rarely cause serious (possibly fatal) liver disease.
Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects.
If you notice other effects not listed above, contact your doctor or pharmacist.
In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
If you have any of the following health problems, consult your doctor or pharmacist before using this medication: asthma, aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), liver disease, stomach/intestine problems (such as bleeding, ulcers), heart disease (such as history of heart attack), high blood pressure, stroke, recent heart bypass surgery (CABG), swelling (edema, fluid retention), diabetes, blood disorders (such as anemia), bleeding/clotting problems, growths in the nose (nasal polyps).
Kidney problems can sometimes occur with the use of NSAID medications, including diclofenac. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medicine may rarely cause stomach bleeding. Daily use of alcohol and tobacco while using this medicine may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Wear protective clothing when outdoors.
Ask your doctor or pharmacist whether you should use sunscreen along with this medication. Tell your doctor right away if you get sunburned or have skin blisters/redness. Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding, kidney problems, and worsening heart problems. Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant.
During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. It is unknown if this form of diclofenac passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), cidofovir, corticosteroids (such as dexamethasone, prednisone), lithium, methotrexate, “water pills” (diuretics such as furosemide). This medication may increase the risk of bleeding when used with other drugs that also may cause bleeding.
Examples include anti-platelet drugs such as clopidogrel, “blood thinners” such as dabigatran/enoxaparin/warfarin, among others. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen, naproxen, or ketorolac).
These drugs are similar to diclofenac and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.
This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose/swallowing may include: severe stomach pain, change in the amount of urine, slow/shallow breathing.
Do not share this medication with others. Laboratory and/or medical tests (such as blood pressure, complete blood count, liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Keep all regular medical and laboratory appointments.
Store at room temperature away from light and moisture. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
DICLOFENAC GEL – TOPICAL