Voltaren (Page 6 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

VOLTAREN® GEL is available in tubes containing 100 g of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%).

100 g tube……………………………………NDC 63187-582-00

Storage
Store at 20°C to 25°C (68°F to 77°F). Keep from freezing. Store the dosing card with your VOLTAREN® GEL.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (NSAIDs Medication Guide and Instructions for Use) prior to using VOLTAREN® GEL.

Inform patients of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy

Cardiovascular Effects

VOLTAREN® GEL, like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Advise patients of the importance of this follow-up [see Warnings and Precautions (5.1)].

Gastrointestinal Effects

VOLTAREN® GEL, like other NSAIDs, can cause GI discomfort and, rarely, more serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding. Instruct patients to ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up [see Warnings and Precautions (5.2)].

Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “flulike” symptoms). If these occur, patients should be instructed to stop therapy with VOLTAREN® GEL and seek immediate medical therapy [see Warnings and Precautions (5.3)].

Adverse Skin Reactions

VOLTAREN® GEL, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalization and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching. Instruct patients to ask for medical advice when observing any indicative signs or symptoms [see Warnings and Precautions (5.8)].
Advise patients to stop VOLTAREN® GEL immediately if they develop any type of rash and contact their physicians as soon as possible.
Instruct patients not to apply VOLTAREN® GEL to open skin wounds, infections, inflammations, or exfoliative dermatitis, as it may affect absorption and tolerability of the drug.
Instruct patients to avoid concomitant use of VOLTAREN® GEL with other topical products, including sunscreens, cosmetics, lotions, moisturizers, and insect repellants. Concomitant use may result in skin reactions or change the absorption of VOLTAREN® GEL.
Instruct patients to minimize or avoid exposure of treated areas to natural or artificial sunlight.

Weight Gain and Edema

Instruct patients to report to their physicians signs or symptoms of unexplained weight gain or edema following treatment with VOLTAREN® GEL [see Warnings and Precautions (5.5)].

Anaphylactoid Reactions

Inform patients of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help [see Warnings and Precautions (5.7)].

Effects During Pregnancy

In late pregnancy, as with other NSAIDs, VOLTAREN® GEL should be avoided because it will cause premature closure of the ductus arteriosus [see Warnings and Precautions (5.9)].

Eye Exposure

Instruct patients to avoid contact of VOLTAREN® GEL with the eyes and mucosa, although not studied, should be avoided. Patients should be advised that if eye contact occurs, they should immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour.

Proper Application

Instruct patients how to use the dosing card to measure the proper dose of VOLTAREN® GEL to apply.
If the patient loses their dosing card, instruct them that they can call 1-800-398-5876to request a replacement dosing card or ask their pharmacist for a new dosing card. Instruct patients how to correctly measure the 2.25 inches (2 g) dose or 4.5 inches (4 g) dose while waiting for a replacement dosing card.

Comments or Questions?
Call toll-free 1-800-398-5876

Marketed by: Endo Pharmaceuticals Inc.
Malvern, PA 19355

Manufactured by: Novartis Pharma Produktions GmbHWehr, Germany for

Sandoz Inc., Princeton, NJ 08540

Revised: November 2014

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:

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 healthcare provider.

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.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):

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

Flector® , Cataflam® , Cambia® , Voltaren® , Voltaren® Gel, Arthrotec® (combined with misoprostol), Pennsaid® , Zipsor® , Zorvolex™

Diflunisal

Dolobid®

Etodolac

Lodine® , Lodine® XL

Fenoprofen

Nalfon® , Nalfon® 200

Flurbirofen

Ansaid®

Ibuprofen

Motrin® , Tab-Profen® , Vicoprofen®* (combined with hydrocodone), Combunox™ (combined with oxycodone), Duexis® (combined with famotidine)

Indomethacin

Indocin® , Indocin® SR, Indo-Lemmon™, Indomethagan™

Ketoprofen

Oruvail® , Nexcede™

Ketorolac

Toradol® , Sprix®

Mefenamic Acid

Ponstel®

Meloxicam

Mobic®

Nabumetone

Relafen®

Naproxen

Naprosyn® , Anaprox® , Anaprox® DS, EC-Naprosyn® , Naprelan® , Naprapac® (co-packaged with lansoprazole), Treximet® (combined with sumatriptan succinate), Vimovo® (combined with esomeprazole magnesium)

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.

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