SPL MEDGUIDE SECTION

Medication GuideforNon-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:

• with longer use of NSAID medicines
• in people who have heart disease

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:

• can happen without warning symptoms
• may cause death

     The chance of a person getting an ulcer or bleeding increases with:

• taking medicines called “corticosteroids” and “anticoagulants”
• longer use
• smoking
• drinking alcohol
• older age
• having poor health

NSAID medicines should only be used:

• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed

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:

• different types of arthritis
• menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
• for pain right before or after heart bypass surgery

Tell your healthcare provider:

• about all of your medical conditions.
• about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.

• if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
• if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include: heart attack stroke high blood pressure heart failure from body swelling (fluid retention) kidney problems including kidney failure bleeding and ulcers in the stomach and intestine low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions liver problems including liver failure asthma attacks in people who have asthma

Other side effects include: stomach pain constipation diarrhea gas heartburn nausea vomiting dizziness

Get emergency help right away if you have any of the following symptoms:

shortness of breath or trouble breathing chest pain weakness in one part or side of your body

slurred speech swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

nausea more tired or weaker than usual itching your skin or eyes look yellow stomach pain flu-like symptoms vomit blood

there is blood in your bowel movement or it is black and sticky like tar unusual weight gain skin rash or blisters with fever swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

• Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Generic Name	Tradename
Celecoxib	Celebrex®
Diclofenac	Cataflam®, Voltaren®, Arthrotec™ (combined with misoprostol)
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-Naprosyn®, 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. 

Revised: June 2008

19 Patient Package Insert

Patient Instructions for Use

Your doctor has prescribed Voltaren® Gel to help relieve arthritis pain in some of your joints. Voltaren® Gel may be used to treat arthritis pain:

• In the arms: hands, wrists and elbows.
• In the legs: feet, ankles and knees.
• Use Voltaren® Gel exactly how your doctor prescribes it for you. Do not apply Voltaren® Gel anywhere other than where your doctor tells you to.
• Do not use more than a total of 32 grams of Voltaren® Gel each day. This means that if you add up the amount of Voltaren® Gel as directed by your doctor, it should not be more than 32 grams in one day.

The dose for your hands, elbows or wrists is 2 grams of Voltaren® Gel each time you apply it.

• Apply Voltaren® Gel 4 times a day (a total of 8 grams each day).
• Do not apply more than 8 grams each day to any one of your affected hands, wrists or elbows

The dose for your knees, ankles or feet is 4 grams of Voltaren® Gel each time you apply it.

• Apply Voltaren® Gel 4 times a day (a total of 16 grams each day)
• Do not apply more than 16 grams each day to any one of your affected knees, ankles or feet.

Some examples include:

• If you use 2 grams of Voltaren® Gel on one hand, 4 times a day, your total dose for one day is 8 grams
• If you use 4 grams of Voltaren® Gel on one knee, 4 times a day, your total dose for one day is 16 grams.
• Your total dose for one day, treating one hand and one knee, is 8 grams plus 16 grams, which equals 24 grams of Voltaren® Gel.
• Before you use a new tube of Voltaren® Gel for the first time, open the foil seal that covers the tube opening by using the spiked top of the cap. Remember to remove the dosing card from the carton.
• Apply Voltaren®  Gel to clean, dry skin that does not have any cuts, infections or rashes. 
• Do not use heating pads or apply bandages where you have applied Voltaren® Gel.
• Avoid exposing skin where you apply Voltaren® Gel to sunlight and artificial light, such as tanning booths.
• Do not use sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medicines on the same skin areas where you have applied Voltaren® Gel.  
• Do not get Voltaren® Gel in your eyes, nose or mouth. Voltaren® Gel is only to be used on your skin (topical use). If you get Voltaren® Gel in your eyes, rinse your eyes right away with water or saline. Talk with your doctor if eye irritation lasts for more than one hour.

What to do if you miss a dose:

• If you miss a dose of Voltaren® Gel, continue with your next scheduled dose using the proper amount of Voltaren® Gel.
• Do not double the dose.     

Applying Voltaren® Gel to hands, elbows or wrists:

1. The dose for each hand, elbow or wrist is 2 grams of Voltaren® Gel.
Apply Voltaren® Gel  4 times a day (a total of 8 grams each day). Do not apply more than 8 grams each day to any one of your affected hands, wrists or elbows.
2. To measure the right amount of Voltaren® Gel, remove one dosing card from the package and place the card on a flat surface so that you can read the print. If the print is backwards, flip dosing card over.  See the picture below.
3. Squeeze Voltaren® Gel onto the dosing card evenly, up to the 2 gram line. Make sure the gel covers the entire 2 gram area of the dosing card as shown in the picture below. Put the cap back on the tube of Voltaren® Gel.
4. Apply the gel to your elbow, wrist, or hand. You can use the dosing card to apply the gel.. The hands should be used to gently rub the gel into the skin. Do not share the dosing card with another person.
Make sure to cover the entire affected elbow, wrist or hand with the gel. Remember that the hand includes the palm of your hand, the top of your hand and your fingers.
5. After using the dosing card, hold end with fingertips, rinse and dry. Store dosing card until next use. Store out of reach of children.
6.      Do not shower or bathe for at least 1 hour after applying Voltaren® Gel. Do not wash your treated hand for at least 1 hour after applying Voltaren® Gel.
7.      Wait 10 minutes before covering the treated skin with gloves or clothing..

Applying Voltaren® Gel to knees, ankles, or feet:

1. The dose for each knee, ankle or foot is 4 grams of Voltaren® Gel.
Apply Voltaren® Gel 4 times a day (a total 16 grams each day). Do not apply more than 16 grams each day to any one of your affected knees, ankles or feet.
2. To measure the right amount of Voltaren® Gel, place the dosing card on a flat surface so that you can read the print. If the print is backwards, flip dosing card over. See the picture below.
3. Squeeze Voltaren® Gel onto the dosing card evenly up to the 4 gram line, making sure the gel covers the entire 4 gram area of the dosing card, as shown in the picture below. Put the cap back on the tube of Voltaren® Gel.
4. Apply Voltaren® Gel to foot, ankle or knee and gently rub the gel into the skin.
You can use the dosing card to apply the gel. Make sure to cover the entire foot, ankle or knee area with the gel.
For example, cover the skin above, below, inside and outside the knee cap. Remember that the foot includes the sole of your foot, the top of your foot and your toes.
5. After using the dosing card, fold the used dosing card in half (application side inside) and throw it away in a safe place out of the reach of children and pets.
6. Do not shower or bathe for 1 hour after application. 7. Wait 10 minutes before covering the treated skin with clothing.
8. Wash your hands after applying Voltaren® Gel to your foot, ankle or knee.

Store Voltaren® Gel at room temperature, 59° F to 86°F (15°C to 30°C).

All registered trademarks in this document are the property of their respective owners.

Comments or Questions?

Call toll-free 1-800-452-0051

Marketed by: Endo Pharmaceuticals Inc. Chadds Ford, PA 19317
Manufactured for: Novartis Consumer Health, Inc. Parsippany, NJ 07054
Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany

©2009 Novartis Consumer Health, Inc., Parsippany, NJ 07054. All Trademarks owned and licensed by Novartis AG

42035D/ October 2009