Diclofenac Sodium

IMPORTANT: 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.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, complete blood count, liver/kidney function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

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. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Do not freeze. 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.

See also Warning section.

Rash, scaling, dry skin, swelling, or itching may occur at the application site. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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: 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. If you notice any of the following rare but very serious side effects, stop using this medication and get medical help right away: stomach/abdominal pain that doesn't go away, black/bloody stools, vomit that looks like coffee grounds.

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, 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: fever, swollen lymph nodes, 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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Nonsteroidal anti-inflammatory drugs (including diclofenac) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while using this drug but is more likely if you use it for a long time. The risk may be greater in older adults or 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). Do not use this drug right before or after heart bypass surgery (CABG).

Stop using diclofenac and get medical help right away if you notice any of these rare but serious side effects: chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, trouble speaking, sudden vision changes.

Talk to your doctor or pharmacist about the benefits and risks of using this drug.

See also Warning section.

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 (such as benzyl alcohol), 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, 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 previous heart attack), high blood pressure, stroke, 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.

Your condition may get worse when exposed to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Wear protective clothing when outdoors. Ask your doctor if you should use sunscreen along with this medication.

Older adults may be at greater risk for stomach/intestinal bleeding, kidney problems, heart attack, and stroke while using this drug.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.

It is unknown if this form of diclofenac passes into breast milk. Consult your doctor before breastfeeding.

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 valsartan, losartan), 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 told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used for gout, bursitis, or tendonitis.

Read the Medication Guide 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.

This medication is for use on the skin only. Wash and dry your hands before applying the medication. Gently apply enough medication to cover the affected skin well as directed by your doctor, usually 2 times daily. This medication is usually applied for 60 to 90 days. Wash your hands after using, unless you are using this medication to treat the hands.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, use this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or use this drug more often or for longer than prescribed. Discuss the risks and benefits with your doctor or pharmacist.

Do not apply the medication in or around the eyes, open skin wounds, or infected/scraped/burned skin. If you do get the medication in those areas, flush with plenty of water.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Tell your doctor if your condition lasts or gets worse. It may take up to 30 days after finishing the medication for the skin to completely heal.