Voltaren Gel - Consumer Medicine Information
|Manufacture:||Endo Pharmaceuticals Inc.|
|Class:||Topical non-steroidal anti-inflammatories|
|Form:||Cream, gel, liniment or balm, lotion, ointment, etc|
|Ingredients:||diclofenac sodium,carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution.|
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
- 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 healthcareprovider and pharmacist.
- if you are pregnant. NSAID medicines should not be used by pregnant women late intheir pregnancy.
- if you are breast-feeding. Talk to your healthcare provider.
What are the Possible Side Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Serious side effects include:
- heart attack
- 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
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:
- more tired or weaker than usual
- 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.
|Diclofenac||Flector, Cataflam,Cambia,Voltaren, VOLTAREN® GEL,Arthrotec(combined with misoprostol),Pennsaid, Zipsor,Zorvolex™|
|Etodolac||Lodine, Lodine XL|
|Fenoprofen||Nalfon, Nalfon 200|
|Ibuprofen||Motrin, Tab-Profen, Vicoprofen⚹ (combined with hydrocodone),Combunox™ (combined with oxycodone), Duexis (combined with famotidine)|
|Indomethacin||Indocin, Indocin SR, Indo-Lemmon™,Indomethagan™|
|Naproxen||Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan,Naprapac (co-packaged with lansoprazole), Treximet (combined with sumatriptan succinate), Vimovo (combined with esomeprazole magnesium)|
|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.
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 freeze VOLTAREN 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.
Endo Pharmaceuticals Inc., Malvern, PA 19355
Novartis Pharma Produktions GmbH Wehr, Germany