What is Voltaren Gel?
Voltaren Gel is a nonsteroidal anti-inflammatory drug (NSAID) that is for topical use only. NSAIDs are used to treat pain and redness, swelling, and heat (inflammation).
Voltaren Gel is used to relieve the pain of osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands.
Voltaren gel has not been evaluated for use on the spine, hip or shoulder.
The safety and efficacy of Voltaren Gel in pediatric patients has not been established.
What is the most important information I should know about Voltaren Gel?
Voltaren Gel and other 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 use Voltaren Gel or other NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)".
Avoid using Voltaren Gel and other 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
Voltaren Gel and other NSAIDs should only be used:
- exactly as prescribed
- at the lowest dose possible for your treatment
- for the shortest time needed
Who should not use Voltaren Gel?
Do not take Voltaren Gel:
- if you have a known hypersensitivity to diclofenac or any of the other ingredients in Voltaren Gel
- 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
- if you are more than 29 weeks pregnant
What should I tell my healthcare provider before using Voltaren Gel?
Before using Voltaren Gel and other NSAIDS, tell your healthcare 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 healthcare provider if you are considering using Voltaren Gel or other NSAIDs during pregnancy. You should not use Voltaren Gel or other NSAIDs after 29 weeks of pregnancy.
- are breast-feeding or plan to breast feed
Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. Voltaren Gel, other NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.
How should I use Voltaren Gel?
- Apply Voltaren Gel exactly as prescribed. Your healthcare provider may need to change your dose of Voltaren Gel until the dose is right for you
- Use the lowest possible dose for the shortest time needed
- Lower extremities: apply Voltaren Gel (4g) to the affected area 4 times per day. Do not apply more than 16g daily to any one affected joint of the lower extremities
- Upper extremities: apply Voltaren Gen (2g) to the affected area 4 time per day. Do not apply more than 8g daily to any one affected joint of the upper extremities
- Total dose should not exceed 32g per day, over all affected joints
- Voltaren Gel should be measured onto the dosing care to the appropriate 2g or 4g designation. See "Instructions for Use"
- Wash hands after application, unless using Voltaren Gel to treat joints on the hands
- Call your healthcare provider if the dose you are prescribed does not control your pain
What should I avoid while using Voltaren Gel?
- Do not use combination therapy with Voltaren Gel and an oral NSAID unless the benefit outweighs the risk. Talk with your healthcare provider before using Voltaren Gel and taking an oral NSAID
- You should talk with your healthcare provider before using Voltaren Gel and low dose aspirin
- Avoid showering/bathing for at least 1 hour after applying Voltaren Gel
- Do not apply Voltaren Gel to open wounds
- Avoid contact of Voltaren Gel with eyes and mucous membranes
- Do not apply external heat and/or occlusive dressings to treated joints
- Avoid exposure of the treated joint(s) to natural or artificial sunlight
- Avoid concomitant use of Voltaren Gel on the treated skin site with other topical products, including sunscreen, cosmetics, lotions, moisturizers, insect repellants, or other topical medications
- Avoid wearing clothing or gloves for at least 10 minutes after applying Voltaren Gel
What are the possible side effects of Voltaren Gel and other NSAIDs?
The most common side effect associated with Voltaren Gel is application site reactions, including dermatitis.
Voltaren Gel and other NSAIDs can also cause serious side effects, including:
- See “What is the most important information I should know about Voltaren Gel?"
- 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 Voltaren Gel and other NSAIDs include:
- stomach pain
Get emergency help right away if you get any of the following symptoms:
- shortness of breath or trouble breathing
- slurred speech
- chest pain
- swelling of the face or throat
- weakness in one part or side of your body
Stop using Voltaren Gel and call your healthcare 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 use too much Voltaren Gel, call your healthcare provider or get medical help right away.
These are not all the possible side effects of Voltaren Gel. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Voltaren Gel
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Voltaren Gel for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information about Voltaren Gel, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Voltaren Gel that is written for health professionals.
How should I store Voltaren Gel?
Store at room temperature 68°F to 77°F (20°C to 25°C). Do not freeze
Store the dosing card with your Voltaren Gel
- Keep Voltaren Gel and all medicines out of reach of children
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
Voltaren Gel (diclofenac sodium)
topical gel, 1%
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 or pharmacist 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 no apply Voltaren Gel anywhere other than where you 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:
Unscrew cap and press the indent on the top of the cap (see Figure A) onto the star-shaped seal on the tube. Firmly turn the cap to remove the safety seal (see Figure B).
- Remember to remove the dosing card from the carton to measure your dose (see Figure C).
- 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 or artificial light, such as tanning booths.
- Do not use sunscreen, 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 you 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 the prescribed 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 C). If you lose or misplace your dosing card, you can ask your pharmacist for a new one or call 1-855-297-3031. Ask your healthcare 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.
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 D). 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 E). Then, use your hands to gently rub the gel into the skin (see Figure F). 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 your hand, 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 inch length of gel), making sure the gel covers the 4 g area of the dosing card (see Figure G). 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 Voltaren Gel to your foot, ankle, or knee. You can use the dosing card to apply the gel (see Figure H). Then, use your hands to gently rub the gel into the skin (see Figure I). 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 the knee cap. Remember that the foot includes the sole of your foot, the top of your foot, and your toes.
Refer to Steps 4 and 5 above. Wash your hands after applying Voltaren Gel to your foot, ankle, or knee.