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Solaraze Consumer (continued)
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, sudden/unexplained weight gain, unusual tiredness, signs of kidney problems (such as change in the amount of urine).
Other medications similar to this medication may rarely cause serious bleeding from the stomach or intestines. Also, related drugs have rarely caused blood clots to form, causing heart attacks and strokes. If you notice any of the following rare but very serious side effects, stop using this medication and get medical help right away: black/bloody stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain, chest/jaw/left arm pain, shortness of breath, unusual sweating, sudden vision changes, weakness on one side of the body, trouble speaking, confusion.
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.
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 Solaraze (diclofenac sodium) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: 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, recent heart bypass surgery (CABG), 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 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 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. Avoid prolonged sun exposure, 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 more sensitive to the side effects of this drug, especially stomach/intestinal bleeding, kidney problems and worsening heart problems.
Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). 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. 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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