Zipsor

Diclofenac



(dye kloe' fen ak)

Cambia®
Cataflam®¶
Voltaren XR®¶
Zipsor®
Zorvolex®

People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as diclofenac may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take an NSAID such as diclofenac if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.
If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take diclofenac right before or right after the surgery.
NSAIDs such as diclofenac may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or drink large amounts of alcohol while taking diclofenac. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). Also tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking diclofenac and call your doctor: stomach pain, heartburn, vomiting a substance that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.
Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to diclofenac. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with diclofenac and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Transdermal diclofenac is used to treat short-term pain due to minor strains, sprains, and bruises. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain.

Transdermal diclofenac comes as a patch to apply to the skin. Diclofenac patches are usually applied two times a day, once every 12 hours. Apply diclofenac patches at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Do not apply more or fewer patches or apply patches more often than prescribed by your doctor.
Do not apply diclofenac patches to skin that is broken, damaged, cut, infected, or covered by a rash.
Do not let the patches come in contact with your eyes, nose, or mouth. If the patch does touch your eye, wash the eye out immediately with water or saline. Call a doctor if there is eye irritation that lasts for more than one hour.
Do not wear a patch while bathing or showering. Plan to bathe or shower after you remove a patch and before you apply the next patch.
To apply diclofenac patches, follow these steps:



Wash the skin area where you will apply the patch with soap and water. Do not use any moisturizing soaps, lotions, astringents, or other skin care products on the chosen skin area.

Completely dry the skin area where you will be applying the patch.

Cut open the envelope containing the patches, cutting on the dotted line and making sure not to cut the zipper seal just below it.

Pull apart the zipper seal on the envelope and remove one patch. Reseal the envelope by squeezing the zipper seal together. Make sure the envelope is closed tightly to keep the patches inside from drying out.

Fold over one corner of the patch and gently rub the folded corner between your finger and thumb to separate the patch from the clear liner that is attached to the sticky side. Peel off the entire liner.

Firmly press the patch into place on the chosen skin area. Press down around all four edges to secure the patch.

The patch may begin to peel off while you are wearing it. If this happens, tape down the edges of the patch with first aid tape.

When you remove a patch, fold it in half so that it sticks to itself and throw it away in a garbage can that is out of the reach of children and pets.

Wash your hands when you are finished applying or handling the patch.

Before taking diclofenac,

tell your doctor and pharmacist if you are allergic to diclofenac (also available as Solaraze and Pennsaid, in Arthrotec), aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in the diclofenac product you plan to take. Ask your pharmacist or check the medication guide for a list of the inactive ingredients. If you will be taking diclofenac capsules (Zipsor), tell your doctor if you are allergic to bovine (cow) proteins such as those found in milk, beef, or gelatin.

tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: acetaminophen (Tylenol, in other products), angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran); cyclosporine (Gengraf, Neoral, Sandimmune); digoxin (Lanoxin); diuretics ('water pills'); insulin and oral medication for diabetes; lithium (Lithobid); medications for seizures; methotrexate (Otrexup, Rasuvo, Trexall), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), and voriconazole (Vfend). Many other medications may also interact with diclofenac, so be sure to tell your doctor about all the medications you are taking even if they do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); porphyria (an abnormal increase in the amount of certain natural substances made by the liver); heart failure ; swelling of the hands, feet, ankles, or lower legs; or liver or kidney disease.

tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while taking diclofenac, call your doctor.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking diclofenac.

if you have phenylketonuria (PKU; an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the powder for solution contains aspartame, a source of phenylalanine.

Unless your doctor tells you otherwise, continue your normal diet.

Apply a new patch as soon as you remember it. However, if it is almost time for the next scheduled application, skip the missed dose and continue your regular schedule. Do not apply an extra diclofenac patch to make up for a missed dose.

Diclofenac may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:



diarrhea

constipation

gas or bloating

headache

dizziness

ringing in the ears

Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical help. Do not take any more diclofenac until you speak to your doctor.



unexplained weight gain

shortness of breath or difficulty breathing

swelling of the abdomen, feet, ankles, or lower legs

excessive tiredness

lack of energy

nausea

loss of appetite

itching

pain in the upper right part of the stomach

yellowing of the skin or eyes

flu-like symptoms

fever

blisters

rash

hives

swelling of the eyes, face, tongue, lips, throat, arms, or hands

difficulty breathing or swallowing

hoarseness

pale skin

fast heartbeat

cloudy, discolored, or bloody urine

back pain

difficult or painful urination
Diclofenac may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them.  However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community.  See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
¶ This branded product is no longer on the market. Generic alternatives may be available.