Varophen (diclofenac) 1.5 %-15 %-10 % kit, cream and solution

Generic name:
Diclofenac solution - topical

Pronunciation
(dye-KLOE-fen-ak)

Brand name(s)
Pennsaid

Nonsteroidal anti-inflammatory drugs (including diclofenac) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while using this drug but is more likely if you use it for a long time. The risk may be greater in older adults or 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). Do not use this drug right before or after heart bypass surgery (CABG).

Also, this drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This side effect can occur without warning symptoms at any time while using diclofenac. Older adults may be at higher risk for this effect. (See also Precautions and Drug Interactions sections.)

Stop using diclofenac and get medical help right away if you notice any of the following rare but very serious side effects: stomach/abdominal pain that doesn't go away, black/bloody stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, sudden vision changes, trouble speaking.

Talk with your doctor or pharmacist about the benefits and risks of using this medication.

See also Warning section.

This medication is used to treat arthritis of the knee(s). It reduces pain, swelling, and joint stiffness and helps to improve your ability to move and flex the joint. 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.

Read the Medication Guide if available, and the Patient Information Leaflet provided by your pharmacist before you start using diclofenac and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is for use on the skin only. Apply this medication to clean, dry skin, as directed by your doctor, usually 2 or 4 times daily. The dosage is based on your medical condition and response to treatment.

If you are using the pump, read the Instructions for Use to learn how to correctly prime the pump before using it for the first time.

Place this medication first into the hand or directly onto the affected knee. Then spread the medication evenly around the front, back, and sides of the knee. Repeat these steps until you have applied the prescribed dose to cover all surfaces of the knee. Repeat on the other knee if directed to do so by your doctor. Let the medication dry for several minutes. Do not touch the treated knee, allow other people to touch it, or wear clothing over it until the treated knee is completely dry. Consult your doctor or pharmacist if you have any questions on how to use this medication.

Be sure to wash your hands before and after applying the medication. Avoid getting this medication in the eyes, nose, or mouth. Do not apply this medication to open wounds, or to infected or damaged skin. Do not bandage or tightly cover the treated area unless you are instructed to do so by your doctor. Wait at least 30 minutes after applying this medication before showering.

It is important to use this medication regularly at evenly spaced intervals to get the most benefit from it. Use the exact dose prescribed by your doctor. Do not use it more often or for longer than prescribed. Do not use this medication for more than 3 months at a time unless directed by your doctor. Discuss the risks and benefits with your doctor or pharmacist.

For certain conditions (such as arthritis), it may take up to 2 weeks of using this drug regularly until you get the full benefit.

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 medication may not work as well.

Tell your doctor if your condition gets worse.

See also Warning section.

Skin irritation (such as dryness, redness, stinging), drowsiness, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist right away.

Remember that this medication has been prescribed because your doctor 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.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• signs of kidney problems (such as change in the amount of urine)
• symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including:

• nausea/vomiting that doesn't stop
• loss of appetite
• stomach/abdominal pain
• yellowing eyes/skin
• dark urine

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:

• fever
• swollen lymph nodes
• 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 or at www.fda.gov/medwatch.

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

See also Warning section.

Before using this medication, 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 other inactive ingredients (such as dimethyl sulfoxide, propylene glycol), 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:

• asthma
• aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs)
• liver disease
• stomach/intestine problems (such as bleeding, ulcers, Crohn's disease)
• heart disease (such as previous heart attack)
• high blood pressure
• stroke
• swelling (edema, fluid retention)
• blood disorders (such as anemia)
• bleeding/clotting problems
• growths in the nose (nasal polyps)

Kidney problems can sometimes occur with the use of NSAID medications, including diclofenac. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis).

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco while using this medicine may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink.

This medication may make the treated area more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Wear protective clothing when outdoors. Ask your doctor whether you should use sunscreen along with this medication. Tell your doctor right away if you get sunburned or have skin blisters/redness.

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

Older adults may be at greater risk for stomach/intestinal bleeding, kidney problems, heart attack, and stroke while using this drug.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.

It is unknown if this form of diclofenac passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• aliskiren
• ACE inhibitors (such as captopril, lisinopril)
• angiotensin II receptor blockers (such as losartan, valsartan)
• cidofovir
• corticosteroids (such as dexamethasone, prednisone)
• lithium
• methotrexate
• "water pills" (diuretics such as furosemide)

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, ketorolac, or naproxen). These drugs are similar to diclofenac and may increase your risk of side effects if taken together. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe stomach pain, change in the amount of urine, slow/shallow breathing.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, complete blood count, liver/kidney function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Lifestyle changes (such as weight loss if needed, strengthening/conditioning exercises) may help improve your flexibility and joint function. Consult your doctor for specific instructions.

If 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. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Keep all medications 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.

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.