Consumer Information

Zipsor

Generic Name: diclofenac (dye KLOE fen ak)
Brand Names: Cataflam, Voltaren, Voltaren-XR, Zipsor

What is Zipsor?

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Zipsor liquid-filled capsules contain the nonsteroidal anti-inflammatory (NSAIDs) medicine diclofenac. This medicine works by reducing hormones that cause inflammation and pain in the body.

Zipsor liquid-filled capsules are used to treat mild to moderate acute pain.

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

Important information about Zipsor

Zipsor 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 Zipsor 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.

Zipsor 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 Zipsor. 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 Zipsor (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 Zipsor. Alcohol can increase the risk of stomach bleeding caused by diclofenac. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Zipsor can make your skin more sensitive to sunlight and sunburn may result.

Before taking Zipsor

Do not use Zipsor if you are allergic to diclofenac, or if you have a history of allergic reaction to aspirin or other NSAIDs.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Zipsor:

  • a history of heart attack, stroke, or blood clot;

  • heart disease, congestive heart failure, high blood pressure;

  • a history of stomach ulcers or bleeding;

  • liver or kidney disease,
  • asthma;

  • polyps in your nose;

  • a bleeding or blood clotting disorder; or

  • if you smoke.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking Zipsor during the last 3 months of pregnancy may harm the unborn baby. Do not take Zipsor during pregnancy unless your doctor has told you to. Diclofenac can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give Zipsor to a child without the advice of a doctor.

How should I take Zipsor?

Take Zipsor exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

If you switch brands of diclofenac, your dose needs may change. Follow your doctor's instructions about how much medicine to take.

If you take Zipsor for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

Store Zipsor at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, and fainting.

What should I avoid while taking Zipsor?

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 Zipsor. Alcohol can increase the risk of stomach bleeding caused by diclofenac. Avoid prolonged exposure to sunlight. Zipsor may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Zipsor side effects

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

  • fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious Zipsor 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Zipsor?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with Zipsor may cause you to bruise or bleed easily.

Before taking Zipsor, tell your doctor if you are taking any of the following drugs:

  • a blood thinner such as warfarin (Coumadin);

  • cyclosporine (Neoral, Sandimmune);

  • lithium (Eskalith, Lithobid);

  • methotrexate (Rheumatrex, Trexall);

  • diuretics (water pills) such as furosemide (Lasix).

  • steroids (prednisone and others);

  • aspirin or other NSAIDs such as etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or

  • an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others.

This list is not complete and there may be other drugs that can interact with Zipsor. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Zipsor.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2009 Cerner Multum, Inc. Version: 9.01. Revision Date: 08/31/2009 4:10:39 PM.

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