Nonsteroidal anti-inflammatory drugs (including diclofenac) may rarely increase the risk for a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be used right before or after heart bypass surgery (CABG).
Also, this drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning symptoms at any time while using this drug. Older adults may be at higher risk for this effect. (See also Precautions and Drug Interactions sections.)
Stop using diclofenac and get medical help right away if you notice any of the following rare but very serious side effects: black/bloody stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, sudden vision changes, slurred speech.
Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.Who should not take diclofenac sodium topical?
This medication is used to treat arthritis of the knee(s). It reduces pain and swelling, and helps improve your ability to move and flex the joint. Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID).
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using diclofenac and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Before using the pump for the first time, remove the cap and prime the pump as directed by the manufacturer.
Apply this medication to clean, dry skin as directed by your doctor, usually 2 times a day to the affected knee(s). Press down firmly on the pump head 2 times and place the medication on the palm of your hand. Apply the medication evenly around the front, back, and sides of the knee. Repeat for the other knee if directed to do so by your doctor. Let the medication dry for several minutes. Do not wear clothing over it until the treated knee is completely dry. Also, do not apply sunscreen, insect repellant, lotion, or other topical products on your knee until it is completely dry.
Be sure to wash your hands before and after applying the medication. Avoid getting this medication in the eyes, nose, or mouth. Avoid showering/bathing for at least 30 minutes after application. Do not apply to open wounds or to infected or damaged skin. Do not wrap, bandage, or apply heat (such as a heating pad) on the treated area unless you are instructed to do so by your doctor.
Use this medication regularly to get the most benefit from it. Do not use more, apply it more often, or use it for a longer time than prescribed.
Tell your doctor if your condition does not improve or if it worsens.
See also Warning section.
Skin irritation such as dryness, flaking, redness, or itching may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because 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.
Tell your doctor right away if you have any serious side effects, including: swelling of the ankles/feet/hands (edema), sudden/unexplained weight gain, unusual tiredness, change in the amount of urine.
This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.
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.
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 this medication, 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), blood disorders (such as anemia, bleeding/clotting problems), growths in the nose (nasal polyps), heart disease (such as previous heart attack), high blood pressure, liver disease, stomach/intestinal problems (such as bleeding, ulcers), stroke.
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 any unusual 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 medication may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding and kidney problems.
Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). 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. Although there have been no reports of harm to nursing infants, 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 prednisone), cyclosporine, 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, ketorolac, or naproxen). 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 swallowing or overdose is suspected, contact a poison control center or emergency room immediately. 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 may include: severe stomach pain, vomit that looks like coffee grounds.
Do not share this medication with others.
Laboratory and/or medical tests (such as complete blood count, kidney/liver function tests) should be performed periodically to check for side effects. Consult your doctor for more details.
Non-drug treatment for arthritis that is approved by your doctor (such as weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility and joint function. Consult your doctor for specific instructions.
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. 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.
Information last revised May 2014. Copyright(c) 2014 First Databank, Inc.
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