"Jan. 12, 2011 -- A new study weighs in on the debate over the relative safety of nonsteroidal anti-inflammatory medications (NSAIDs), commonly used to treat joint and muscle aches and pain.
The study, published online in the BMJ,"...
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
- Increased risk of a heart attack or stroke that can
lead to death. This risk may happen early in treatment and may increase:
- with increasing doses of NSAIDs
- with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”
Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
- Increased risk of bleeding, ulcers, and tears
(perforation) of the esophagus (tube leading from the mouth to the stomach),
stomach and intestines:
- anytime during use
- without warning symptoms
- that may cause death
The risk of getting an ulcer or bleeding increases with:
- past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
- taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
- increasing doses of NSAIDs
- longer use of NSAIDs
- drinking alcohol
- older age
- poor health
- advanced liver disease
- bleeding problems
NSAIDs should only be used:
- exactly as prescribed
- at the lowest dose possible for your treatment
- for the shortest time needed
What are NSAIDs?
Who should not take NSAIDs?
Do not take NSAIDS:
- if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
- right before or after heart bypass surgery.
Before taking NSAIDs, tell your health care provider about all of your medical conditions, including if you:
- have liver or kidney problems
- have high blood pressure
- have asthma
- are pregnant or plan to become pregnant. Talk to your health care provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy.
- are breastfeeding or plan to breast feed.
Tell your health care provider about all of the medicines you take, including prescription or overthe-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking new medicine without talking to your health care provider first.
What are the possible side effects of NSAIDs?
NSAIDs can cause serious side effects, including:
See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”
- new or worse high blood pressure
- heart failure
- liver problems including liver failure
- kidney problems including kidney failure
- low red blood cells (anemia)
- life-threatening skin reactions
- life-threatening allergic reactions
Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting and dizziness.
Get emergency help right away if you get 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 taking your NSAID and call your health care provider right away if you get any of the following symptoms:
- more tired or weaker than usual
- your skin or eyes look yellow
- indigestion or 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, legs, hands, and feet
If you take too much of your NSAID, call your health care provider or get medical help right away. These are not all the possible side effects of NSAIDs. For more information, ask your health care provider or pharmacist about NSAIDs.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.
Other information about NSAIDs
- Aspirin is an NSAID 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 NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your health care provider before using over-the-counter NSAIDs for more than 10 days.
General information about the safe and effective use of NSAIDs
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information about NSAIDs, talk with your health care provider. You can ask your pharmacist or health care provider for information about NSAIDs that is written for health professionals.
Manufactured by: Novartis Pharma Produktions GmbH, Wehr, Germany for Sandoz Inc., Princeton, NJ 08540For more information, go to www.XXXXXX.com or call 1-800-398-5876. Revised May2016
Instructions for Use
Important: Use the dosing card that is inside the VOLTAREN® GEL carton to correctly measure each dose. The dosing card is re-usable. Do not throw the dosing card away. Before you use VOLTAREN® GEL for the first time, your healthcare provider orpharmacist should show you how to correctly measure your dose using the dosing card.
Read this Instructions for Use before you start using VOLTAREN® GEL and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
Your healthcare provider 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) and in the legs (feet, ankles, and knees). It is not known if VOLTAREN® GEL is safe and effective if used on your spine, hips, or shoulders.
- Use VOLTAREN® GEL exactly how your healthcare provider prescribes it for you. Do not apply VOLTAREN® GEL anywhere other than where your healthcare provider tells you to.
- Do not use more than a total of 32 grams of VOLTAREN® GEL each day. If you add up the amount of VOLTAREN® GEL as directed by your healthcare provider, it should not be more than 32 grams in one day.
The dose for your hands, wrists, or elbows 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 feet, ankles, or knees 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 feet, ankles, or knees.
Some examples of VOLTAREN® GEL application 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 to measure your dose (see Figure A).
- Apply VOLTAREN® GEL to clean, dry skin that does not have any cuts, open wounds, infections, or rashes.
- Do not use heating pads or apply bandages to 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 healthcare provider if eye irritation lasts for more than one hour.
What if I miss a dose?
- If you miss a dose of VOLTAREN® GEL, continue with your next scheduled dose using theprescribed amount of VOLTAREN® GEL. Do not double the dose.
Applying 2 grams (2 g) of VOLTAREN® GEL to hands, wrists, or elbows:
Step 1. Remove the dosing card that is attached inside the VOLTAREN® GEL carton. Use the dosing card to correctly measure each dose of VOLTAREN® GEL. To measure the correct 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 Figure A). If you lose or misplace your dosing card, you can ask your pharmacist for a new one or call 1-800-452-0051. Ask yourhealthcare provider or pharmacist to show you how to correctly measure your dose of VOLTAREN® GEL while you are waiting to receive your new dosing card.
Figure B, C and Figure D
Step 2. Squeeze VOLTAREN® GEL onto the dosing card evenly, up to the 2 g line (a 2.25 inch length of gel). Make sure that the gel covers the 2 g area of the dosing card (see Figure B). Put the cap back on the tube of VOLTAREN® GEL. Ask your healthcare provider or pharmacist if you are not sure how to correctly measure your dose of VOLTAREN® GEL.
Step 3. Apply the gel to your hand, wrist, or elbow. You can use the dosing card to apply the gel (see Figure C). Then, use your hands to gently rub the gel into the skin (see Figure D). Do not share your dosing card with another person. Make sure to cover the entire affected hand, wrist, or elbow with the gel. Remember that the hand includes the palm of your hand, the top of yourhand, and your fingers.
Step 4. After using the dosing card, hold end with fingertips, rinse and dry. Store the dosing card until next use. Do not shower or bathe for at least 1 hour after applying VOLTAREN® GEL. Do not wash your treated hands for at least 1 hour after applying the VOLTAREN® GEL.
Step 5. After applying VOLTAREN® GEL, wait 10 minutes before covering the treated skin with gloves or clothing.
Applying 4 grams (4 g) of VOLTAREN® GEL to feet, ankles, or knees:
Step 1. Refer to Step 1 above.
Step 2. Squeeze VOLTAREN® GEL onto the dosing card evenly up to the 4 g line (a 4.5 inchlength of gel), making sure the gel covers the 4 g area of the dosing card (see Figure E). Put thecap back on the tube of VOLTAREN® GEL. Ask your healthcare provider or pharmacist if you are not sure how to correctly measure your dose of VOLTAREN® GEL.
Step 3. Apply VOLTAREN® GEL to your foot, ankle, or knee. You can use the dosing card toapply the gel (see Figure F). Then, use your hands to gently rub the gel into the skin (see Figure G). Do not share your dosing card with another person. Make sure to cover your entire foot, ankle, or knee area with the gel. For example, cover the skin above, below, inside and outside theknee cap. Remember that the foot includes the sole of your foot, the top of your foot, and your toes.
Figure E, F and Figure G
Refer to Steps 4 and 5 above. Wash your hands after applying VOLTAREN® GEL to your foot,ankle, or knee.
What are the ingredients in VOLTAREN® GEL?
Active ingredient: diclofenac sodium
Inactive ingredients: carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution.
How should I store VOLTAREN® GEL? Store at 20°C to 25°C (68°F to 77°F). Do not freezeVOLTAREN® GEL. Store the dosing card with your VOLTAREN® GEL.
Keep VOLTAREN® GEL, the dosing card, and all medicines out of the reach of children.
This Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 6/7/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Voltaren Gel Information
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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