"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
Flector Patch Consumer (continued)
Itching, burning, irritation, redness, or dry skin may occur at the application site. Nausea or change in taste may also occur. If any of these effects persist or worsen, 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.
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 rare. However, seek immediate medical attention 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 Flector Patch (diclofenac epolamine topical patch) 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 to other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain 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), recent heart bypass surgery (CABG).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestine problems (e.g., bleeding, ulcers), kidney disease, liver disease, poorly controlled diabetes, heart disease (e.g., heart failure, history of heart attack), high blood pressure, stroke, swelling (edema, water retention), a severe loss of body water (dehydration), blood disorders (e.g., anemia, bleeding/clotting problems), asthma, growths in the nose (nasal polyps).
Before having surgery, tell your doctor or dentist that you are using this medication.
If you are going to have an MRI test, notify testing personnel that you are using this patch. Serious burns may occur during MRI tests because of the aluminum contained in these patches. It should be removed just before the MRI test or consult your doctor for specific instructions.
This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop 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.
Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal 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. While 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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