PENNSAID- diclofenac sodium liquid
Mallinckrodt, Inc
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Medication Guide For
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID medicines.)
What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.
This chance increases:
NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:
The chance of a person getting an ulcer or bleeding increases with:
NSAID medicines should only be used:
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
Tell your healthcare provider:
What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
Serious side effects include:
|
Other side effects include:
|
Get emergency help right away if you have any of the following symptoms:
Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:
These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.
Call your doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):
NSAID medicines that need a prescription
Generic Name |
Tradename |
Celecoxib |
Celebrex® |
Diclofenac |
Flector, Cataflam®, Voltaren®, Arthrotec™ (combined with misoprostol), PENNSAID® |
Diflunisal |
Dolobid® |
Etodolac |
Lodine®, Lodine® XL |
Fenoprofen |
Nalfon®, Nalfon® 200 |
Flurbirofen |
Ansaid® |
Ibuprofen |
Motrin®, Tab-Profen®, Vicoprofen®* (combined with hydrocodone), Combunox™ (combined with oxycodone) |
Indomethacin |
Indocin®, Indocin® SR, Indo-Lemmon™, Indomethagan™ |
Ketoprofen |
Oruvail® |
Ketorolac |
Toradol® |
Mefenamic Acid |
Ponstel® |
Meloxicam |
Mobic® |
Nabumetone |
Relafen® |
Naproxen |
Naprosyn®, Anaprox®, Anaprox® DS, EC-Naproxyn®, Naprelan®, Naprapac® (copackaged with lansoprazole) |
Oxaprozin |
Daypro® |
Piroxicam |
Feldene® |
Sulindac |
Clinoril® |
Tolmetin |
Tolectin®, Tolectin DS®, Tolectin® 600 |
*Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Instructions for Use
PENNSAID® (pen/sed)
(diclofenac sodium topical solution)
Read the Medication Guide that comes with PENNSAID® first. Be sure that you read, understand and follow these Instructions for Use before you use PENNSAID® for the first time.
Important: For use on the skin only (topical). Do not get PENNSAID® in your eyes, nose or mouth.
Before you use PENNSAID®:
Steps for using PENNSAID®:
Step 1. Wash your hands with soap and water before applying PENNSAID®.
Step 2. Put 10 drops of PENNSAID® either on your hand or directly on your knee (see Figure A).
Figure A
or
Step 3. Spread PENNSAID® evenly on the front, back and sides of your knee (see Figures B
and C). Repeat steps 2 and 3, three times so that your knee is completely covered with a total of 40 drops of PENNSAID®.
Figure B
Figure C
Step 4. If your healthcare provider has prescribed PENNSAID® for both knees, repeat steps 2 and 3 for the other knee.
After you use PENNSAID®:
Do not:
How should I store PENNSAID®?
Keep PENNSAID® and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Distributed by:
Mallinckrodt Brand Pharmaceuticals, Inc.
Hazelwood, MO 63042 USA
Manufactured by:
Nuvo Manufacturing
Varennes, Quebec, J3X 1P7 Canada
Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. PENNSAID is a trademark of Nuvo Research Inc. Other brands are trademarks of their respective owners. © 2013 Mallinckrodt.
Issued October 2013
Mallinckrodt™
Pharmaceuticals