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PENNSAID

PENNSAID Consumer (continued)

SIDE EFFECTS: See also Warning section.

Skin irritation (e.g., dryness, redness, stinging), drowsiness, or dizziness may occur. If any of these effects persist or worsen, notify 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.

This drug may rarely cause serious (possibly fatal) liver problems. 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 unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

Read the PENNSAID (diclofenac sodium topical solution) Side Effects Center for a complete guide to possible side effects

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or to dimethyl sulfoxide, or to propylene glycol; or if you have any other allergies. This product may contain other inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, stomach/intestinal problems (e.g., bleeding ulcers, ulcerative colitis, Crohn's disease), bleeding or clotting problems, asthma, growths in the nose (nasal polyps), poorly controlled diabetes, heart disease (e.g., congestive heart failure), high blood pressure, swelling (edema, fluid retention), certain blood/immune disorders (e.g., porphyria, lupus).

This medication may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

This medication may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medication, may increase your risk for stomach bleeding. Limit alcohol and quit 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.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially stomach bleeding and kidney effects.

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.

Based on information from related drugs, this medication may pass into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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