Voltaren Gel

DRUG DESCRIPTION

Voltaren® Gel (diclofenac sodium topical gel) is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. It contains the active ingredient, diclofenac sodium, in an opaque, white gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. Diclofenac sodium is a benzene–acetic acid derivative. The chemical name is 2-[ (2,6-dichlorophenyl)amino]benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2. It has the following structural formula:

Voltaren&reg Gel (diclofenac sodium) Structural Formula Illustration

Voltaren® Gel (diclofenac sodium gel) also contains carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution.

What are the possible side effects of diclofenac topical (Flector Patch, Solaraze, Voltaren Topical)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness,...

Read All Potential Side Effects and See Pictures of Voltaren Gel »

What are the precautions when taking diclofenac sodium gel (Voltaren Gel)?

Before taking diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal/esophagus problems (such as bleeding, ulcers, recurring heartburn), kidney disease, liver disease, asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), stroke, dehydration, bleeding or clotting problems, growths in the nose (nasal polyps).

Before having surgery, tell your doctor or dentist...

Read All Potential Precautions of Voltaren Gel »


Voltaren Gel Consumer (continued)

SIDE EFFECTS: See also Warning section.

Upset stomach, nausea, heartburn, diarrhea, constipation, gas, headache, tiredness, drowsiness, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: swelling of the hands or feet (edema), sudden or unexplained weight gain, hearing changes (such as ringing in the ears), mental/mood changes, difficult/painful swallowing.

Get medical help right away if any of these rare but very serious side effects occur: change in the amount of urine, unexplained stiff neck.

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes or skin, unusual/extreme tiredness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal/esophagus problems (such as bleeding, ulcers, recurring heartburn), kidney disease, liver disease, asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), stroke, dehydration, bleeding or clotting problems, growths in the nose (nasal polyps).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Older adults may be at greater risk for stomach/intestinal bleeding and kidney effects while using this drug.

This medication should be used only when clearly needed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to possible harm to an unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.


Voltaren Gel Patient Information Including Side Effects

Brand Names: Flector Patch, Solaraze, Voltaren Topical

Generic Name: diclofenac topical (Pronunciation: dye KLOE fen ak)

  • What is diclofenac topical (Voltaren Gel)?
  • What are the possible side effects of diclofenac topical (Voltaren Gel)?
  • What is the most important information I should know about diclofenac topical (Voltaren Gel)?
  • What should I discuss with my healthcare provider before using diclofenac topical (Voltaren Gel)?
  • How should I use diclofenac topical (Voltaren Gel)?
  • What happens if I miss a dose (Voltaren Gel)?
  • What happens if I overdose (Voltaren Gel)?
  • What should I avoid while using diclofenac topical (Voltaren Gel)?
  • What other drugs will affect diclofenac topical (Voltaren Gel)?
  • Where can I get more information?

What is diclofenac topical (Voltaren Gel)?

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.

Diclofenac topical skin patch (Flector Patch) is used to treat pain caused by minor sprains, strains, or bruising.

Diclofenac topical 1% gel (Voltaren Topical) is used to treat joint pain in the hands, wrists, elbows, knees, ankles, or feet caused by osteoarthritis. This medication may not be effective in treating arthritis pain elsewhere in the body.

Diclofenac topical 3% (Solaraze) gel is used to treat warty overgrowths of skin (actinic keratoses) on sun-exposed areas of the body.

Diclofenac topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of diclofenac topical (Voltaren Gel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain;
  • urinating less than usual or not at all;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

  • dryness, itching, peeling, or scaling of treated skin; or
  • fever, chills, sore throat, body aches or other flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about diclofenac topical (Voltaren Gel)?

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have a history of stomach ulcer or bleeding, liver or kidney disease, high blood pressure, or congestive heart failure.

While the risk of absorbing diclofenac topical into your bloodstream is low, all non-steroidal anti-inflammatory drugs (NSAIDs) can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use diclofenac topical just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are using an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

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