Diclofenac Sodium topical

Prototypical NSAIA; phenylacetic acid derivative.1 2 3 4 5

Actinic Keratoses

Treatment of actinic keratoses.1 2 3 4

NSAIAs

Potential pharmacologic interaction with oral NSAIAs including analgesic/anti-inflammatory dosages of aspirin.1

Storage

Topical

20–25°C (may be exposed to 15–30°C).a Protect from heat; do not freeze.a

See also Warning section.

Skin irritation/redness may occur at the application site. If this effect persists or worsens, 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.

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: swelling ankles/feet/hands, sudden/unexplained weight gain, unusual tiredness, signs of kidney problems (such as 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: 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.

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, other products applied to treated skin, "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 antiplatelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, erlotinib, 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.