IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
DICLOFENAC 1% - TOPICAL
COMMON BRAND NAME(S): Voltaren
WARNING: This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This side effect can occur without warning at any time during treatment with diclofenac. The elderly are at increased risk for serious stomach/intestinal bleeding. Nonsteroidal anti-inflammatory drugs (including diclofenac) may rarely increase the risk for a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG). Stop using diclofenac and seek immediate medical attention if you notice any of the following rare but very serious side effects: black/bloody stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest pain, shortness of breath, weakness on one side of the body, sudden vision changes, slurred speech. Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.
USES: This medication is used to relieve joint pain from arthritis. Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.
HOW TO USE: Read the Medication Guide and patient instructions for use provided by your pharmacist before you start using diclofenac and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Use this medication on the skin only. To measure the right dose, use the dosing card(s) provided with the medication. Place a dosing card on a flat surface so that you can read the print on the card. Squeeze an even line of the medication from the tube onto the dosing card, using the marks on the card to measure the prescribed dose. Gently rub the medication into the entire affected joint, usually 4 times daily or as directed by your doctor. You may use the dosing card to apply the medication. Do not apply the medication on skin that has cuts, infections, or rashes. If the package instructions direct you to reuse the dosing card, then after each use, hold the card with your fingertips, rinse, and dry. When you are ready to discard the dosing card, fold the card in half with the medication side inside and throw away out of the reach of children and pets. Wash your hands after using the medication unless you are using it to treat the hands. Do not shower, bathe, or wash your treated hands for at least an hour after applying the medication. Wait at least 10 minutes before covering the treated area with gloves or clothing. Do not wrap, bandage, or apply heat (e.g., heating pad) to the treated area. Dosage is based on your medical condition and response to treatment. Do not apply more than 16 grams of diclofenac per day to any single joint of the lower body (e.g., knee, ankle, foot). Do not apply more than 8 grams of diclofenac per day to any single joint of the upper body (e.g., hand, wrist, elbow). No matter how many joints you are treating, do not use more than a total of 32 grams of diclofenac per day. Discuss the risks and benefits of using this drug with your doctor or pharmacist. To reduce side effect risks (e.g., stomach bleeding), use this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, use it more often than prescribed, or apply the medication to any area not prescribed by your doctor. Do not get the medication in the eyes, nose, or mouth. If you do get the medication in those areas, flush with plenty of water. Contact your doctor immediately if irritation persists. If you are using this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medicine may not work as well. Tell your doctor if your pain persists or worsens.
SIDE EFFECTS: See also Warning section. Swelling may occur at the application site. If this effect persists or worsens, 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 you have any serious side effects, including: swelling of the ankles/feet/hands (edema), sudden/unexplained weight gain, unusual tiredness. This drug may rarely cause serious (possibly fatal) liver problems. 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/skin. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., 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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG). Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, stomach/intestine problems (e.g., bleeding, ulcers), heart disease (e.g., heart failure, history of heart attack), high blood pressure, stroke, swelling (edema, water retention), poorly controlled diabetes, a severe loss of body water (dehydration), blood disorders (e.g., anemia, bleeding/clotting problems), asthma, growths in the nose (nasal polyps). Before having surgery, tell your doctor or dentist that you are using this medication. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information. This medication may make the treated area more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Wear protective clothing when outdoors. Ask your doctor whether you should use sunscreen along with this medication. Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding and kidney effects. Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. Based on information from related drugs, this medication may pass into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), cidofovir, corticosteroids (e.g., prednisone), cyclosporine, desmopressin, digoxin, lithium, methotrexate, pemetrexed, probenecid, other products applied to treated skin, tenofovir. This medication may increase the risk of bleeding when used with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These drugs are similar to diclofenac and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: This medication may be harmful if swallowed. If overdose or swallowing is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose/swallowing may include: seizures, severe stomach pain, change in the amount of urine, slow/shallow breathing.
NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as complete blood count, liver and kidney function tests) should be performed periodically to check for side effects. Consult your doctor for more details. Keep all doctor appointments and lab visits so your therapy can be monitored closely.
MISSED DOSE: If you are prescribed this drug on a regular schedule (not just "as needed") and you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not freeze. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2012. Copyright(c) 2012 First Databank, Inc.