PENNSAID

DRUG DESCRIPTION

PENNSAID (diclofenac sodium topical solution) is a clear, colorless to faintly pink-orange solution for topical application.

PENNSAID contains 1.5% w/w diclofenac sodium, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2 and it has the following structural formula:

Pennsaid (diclofenac sodium) structural formula illustration

Each 1 mL of solution contains 16.05 mg of diclofenac sodium. In addition, PENNSAID (diclofenac sodium topical solution) contains the following inactive ingredients: dimethyl sulfoxide USP (DMSO, 45.5% w/w), propylene glycol, alcohol, glycerin and purified water.

What are the precautions when taking diclofenac sodium topical solution (PENNSAID)?

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...

Read All Potential Precautions of 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 immediately if any of these unlikely but serious side effects occur: easy bruising or bleeding, fast/pounding heartbeat, sudden or unexplained weight gain, swelling of the hands/feet, change in the amount of urine, signs of infection (e.g., fever, persistent sore throat), persistent/severe headache, mental/mood changes, unexplained stiff neck, vision changes.

This drug may rarely cause serious liver disease. If you notice any of the following rare but very serious side effects, stop using this medication and consult your doctor or pharmacist immediately: persistent nausea/vomiting, yellowing eyes/skin, dark urine, unusual/extreme tiredness.

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.

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.

This medication should be used only when clearly needed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to possible harm to an unborn baby. Discuss the risks and benefits with your doctor.

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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