Voltaren XR

DRUG DESCRIPTION

Voltaren®-XR (diclofenac sodium extended-release) tablets, USP is a benzeneacetic acid derivative. Voltaren-XR is available as extended-release tablets of 100 mg (light pink) for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula

Voltaren®-XR (diclofenac sodium ) Structural Formula Illustration

The inactive ingredients in Voltaren-XR include: cetyl alcohol, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, polyethylene glycol, polysorbate, povidone, silicon dioxide, sucrose, talc, titanium dioxide.

What are the possible side effects of diclofenac (Cambia, Cataflam, Voltaren, Voltaren-XR, Zipsor)?

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.

Stop taking diclofenac and seek medical attention or 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;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee...

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

What are the precautions when taking diclofenac sodium extended-release tablets (Voltaren XR)?

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 XR »


Voltaren XR 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 XR Patient Information Including Side Effects

Brand Names: Cambia, Cataflam, Voltaren, Voltaren-XR, Zipsor

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

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

What is diclofenac (Voltaren XR)?

Diclofenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Diclofenac works by reducing hormones that cause inflammation and pain in the body.

Diclofenac is used to treat pain or inflammation caused by arthritis or ankylosing spondylitis.

Diclofenac powder (Cambia) is used to treat a migraine headache attack. Do not use this medication to treat a cluster headache.

Cambia will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

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

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

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.

Stop taking diclofenac and seek medical attention or 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;
  • black, 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;
  • bruising, severe tingling, numbness, pain, muscle weakness; or
  • neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious side effects may include:

  • upset stomach, mild heartburn or stomach pain, diarrhea, constipation bloating, gas;
  • dizziness, headache, nervousness;
  • skin itching or rash;
  • blurred vision; or
  • ringing in your ears.

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 (Voltaren XR)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use diclofenac. Do not use this medicine 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 taking diclofenac. 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.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

Do not drink alcohol while taking diclofenac. Alcohol can increase the risk of stomach bleeding caused by diclofenac.

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