Klofensaid II (Topical application)

Diclofenac treats pain and other symptoms of arthritis in the joints (like osteoarthritis), including inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure osteoarthritis and will help you only as long as you keep using it. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID).

Diclofenac topical 3% gel is also used to treat actinic keratosis, a skin condition that can become cancerous if not treated. The exact way that topical diclofenac helps this condition is not known.

Diclofenac topical solution treats pain and swelling from osteoarthritis of the knees.

Diclofenac topical patch and topical system are used to treat acute pain from minor strains, sprains, and contusions (bruises).

This medicine is available only with your doctor's prescription.

This medicine is available without a prescription.

It is very important for your doctor to check your or your child's progress during regular visits. This will help your doctor ensure this medicine is working properly and decide if you should keep using it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This risk is higher for people who already have heart disease or for those who use this medicine for a long time.

This medicine may cause bleeding in your stomach or bowels. These issues can happen without warning signs. You are at greater risk if you have had a stomach ulcer before, if you smoke or drink alcohol regularly, are over 60 years old, are in poor health, or are taking certain other medicines (for example, other NSAIDs, steroid medicine, blood thinners).

Contact your doctor immediately if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of your eyes or skin. These could be signs of a serious liver issue.

Serious skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can happen while using this medicine. Contact your doctor immediately if you experience black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or extreme tiredness or weakness.

Some warning signs of serious side effects that can occur while using this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting blood or material that looks like coffee grounds, or yellowing of the skin or eyes. Additionally, signs of serious heart problems could occur, including chest pain or tightness, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurred speech. Contact your doctor immediately if you notice any of these warning signs.

Contact your doctor immediately if you have bloody urine, a decrease in how often or how much you urinate, high blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, extreme tiredness or weakness, vomiting, or weight gain. These could be signs of a serious kidney problem.

Hyperkalemia (high potassium in the blood) may occur while using this medicine. Contact your doctor immediately if you have stomach pain, confusion, difficulty breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness in the legs.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and needs urgent medical attention. It may happen more often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Call your doctor immediately if you have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Using this medicine during the later stages of pregnancy can be harmful to your unborn baby. If you think you might be pregnant while using this medicine, tell your doctor immediately.

If your symptoms worsen, contact your doctor.

Diclofenac may cause redness, soreness, scaling, and peeling of the skin that is affected. Do not stop using this medicine without first checking with your doctor. If the reaction is very uncomfortable, consult your doctor.

While using this medicine, your skin may become more sensitive to sunlight than usual, and too much sunlight may increase its effects. During this time:

• Stay out of direct sunlight, especially between 10 AM and 3 PM, if you can.
• Wear protective clothing, including a hat and sunglasses.
• Do not use a sunlamp or tanning bed or booth.
• Be sure to discuss the use of a sunblock product with your doctor.

If you have a severe reaction to the sun, contact your doctor.

This medicine may delay ovulation for women and affect their ability to have children. If you plan to have children, speak with your doctor before using this medicine.

Before any type of surgery or medical tests, inform your doctor that you are using this medicine. You may need to stop treatment for a while or switch to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the chances of using the medicine must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medication, the following should be considered:

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this medication or any other medicines. Also inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diclofenac topical gel, patch, or solution in children and diclofenac topical system in children younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diclofenac topical in the elderly. Nevertheless, elderly patients are more likely to have age-related kidney, heart, or stomach issues, which may require caution and an adjustment in the dose for patients receiving diclofenac topical.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks before using this drug while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different drugs may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are taking this medication, it is especially important that your healthcare professional know if you are using any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac

Using this medication with any of the following medications is usually not recommended, but may be required in some cases. If both drugs are prescribed together, your clinician may change the dose or how frequently you use one or both of the medicines.

• Abciximab
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bivalirudin
• Budesonide
• Bumetanide
• Cangrelor
• Capecitabine
• Ceritinib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Cilostazol
• Citalopram
• Clomipramine
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deferiprone
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Inotersen
• Ketoprofen
• Lepirudin
• Levoketoconazole
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Mavacamten
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melphalan
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piretanide
• Piroxicam
• Polythiazide
• Potassium Citrate
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quinethazone
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Selexipag
• Sertraline
• Sibutramine
• Sodium Salicylate
• Sparsentan
• Spironolactone
• Sulfasalazine
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Tacrolimus
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Trazodone
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using this drug with any of the following drugs may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both drugs are prescribed together, your clinician may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Ciprofloxacin
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Perindopril
• Pindolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Timolol
• Trandolapril
• Valsartan

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may additionally cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Bleeding issues or
• Blood clots or
• Congestive heart failure or
• Edema (fluid retention or body swelling) or
• Heart attack, recent or history of or
• Heart disease or
• Hyperkalemia (high potassium in the blood) or
• Hypertension (high blood pressure) or
• Kidney disease, slight to moderate or
• Stomach ulcers or bleeding, history of or
• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or
• Aspirin (or other NSAIDs) sensitivity, history of or
• Kidney disease, serious—Should not be used in patients with these conditions.

• Damaged or non-intact skin caused by skin diseases (eg, exudative dermatitis, eczema, infection lesions), burns, or wounds (for skin patch and topical system only)—Should not be used in patients with this condition.

• Dehydration or
• Hypovolemia—Must be corrected first prior to using this medicine.

• Heart surgery (eg, coronary artery bypass graft [CABG] surgery)—Should not be used to ease pain right prior to or after the surgery.

• Liver disease—Use with caution. The effects may be increased since of slower removal of the drug from the body.

Along with its intended effects, a medicine may cause some unwanted effects. While not all of these side effects may occur, if they do, they might require medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Burning, itching, redness, skin rash, swelling, or soreness at the application site
• Itching skin

Less common

• Blood in the urine
• Chest pain or tightness
• Cough
• Dry, itching, or burning eyes
• Eye pain
• Headaches, including migraines
• Increased sensitivity of the skin to sunlight
• Pain or tenderness around the eyes and cheekbones
• Redness of the skin
• Redness or swelling of the eyes
• Runny or stuffy nose
• Skin rash other than at the application site
• Sore throat
• Trouble breathing
• Ulcers or sores on the skin, other than at the application site

Incidence not known

• Black, tarry stools
• Chills
• Fever
• Painful or difficult urination
• Sores, ulcers, or white spots on lips or in mouth
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Diarrhea
• General feeling of discomfort or illness
• Joint pain
• Loss of appetite
• Muscle aches and pains
• Nausea
• Scaly, thick, or tingling skin
• Shivering
• Sweating
• Trouble sleeping
• Vomiting

Less common

• Acne
• Back pain
• Belching
• Bleeding skin
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Dizziness
• Heartburn
• Increase in body movements
• Indigestion
• Lack or loss of strength
• Loss of or change in taste
• Loss or thinning of the hair
• Neck pain
• Sleepiness or unusual drowsiness
• Stomach upset or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Flector
• Klofensaid II
• Licart
• Pennsaid
• Rexaphenac
• Solaraze
• Voltaren

Available Dosage Forms:

• Patch, Extended Release
• Solution
• Gel/Jelly
• Spray
• Cream

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Keep using this medicine for the full time of treatment. However, do not use this medicine more often or for a longer time than your doctor ordered. This medicine is not for long-term use.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Follow the instructions on the medicine label if you are using this medicine without a prescription.

To use the skin patch or topical system:

• Use this medicine exactly as directed by your doctor. It will work only if applied correctly.
• Wash your hands with soap and water before and after applying a patch or topical system. Do not touch your eyes until after you have washed your hands. If it gets into your eyes, wash the eyes right away with water or saline. If eye irritation persists for more than one hour, call your doctor.
• Apply the patch or topical system right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch or topical system.
• Apply the patch or topical system to a clean, dry, intact skin area. Choose an area with little or no hair and free of scars, cuts, or irritation. Avoid putting the patch or topical system on areas where it could be rubbed off by tight clothing.
• Press the patch or topical system firmly in place with your fingertips to make sure that the edges stick well. If the patch or topical system begins to peel off, the edges may be taped down.
• If the patch or topical system still peels off, it may be used with a mesh netting sleeve (eg, Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) to hold the patch or topical system applied to the ankles, knees, or elbows. The mesh netting sleeve must not be occlusive and must allow air to pass through.
• Do not use the patch or topical system when you take a bath or shower.
• To help you remember to use your medicine, try to get into the habit of using it at regular times. If you are using the skin patch, try to change it at the same time and day of the week.

To use the topical gel:

• Wash your hands before and after using this medicine.
• For Voltaren® 1% topical gel: Use the enclosed dosing card to measure the correct dose. The gel should be applied within the oblong area of the dosing card up to the 2 or 4 gram line (2 grams for each elbow, wrist, or hand, and 4 grams for each knee, ankle, or foot).
• Apply the medicine very carefully to clean, dry skin, and avoid getting any in your eyes, nose, or mouth.
• Do not apply this medicine to areas with broken skin or open wounds, infection, or severely peeling skin.
• Apply enough medicine each time to cover the entire affected area.
• Do not use heating pads or cover the treated area with a bandage unless your doctor has told you to.
• Do not use cosmetics (eg, makeup or sunscreens) or other skin care products on the same skin areas where you have applied this medicine.
• For Voltaren® 1% topical gel: After applying this medicine, do not shower, bathe, or wash the affected area for at least 1 hour. Wait for at least 10 minutes before covering the treated skin with gloves or clothing.

To use the topical solution:

• Use this medicine exactly as directed by your doctor. It will work only if applied correctly. Do not apply this medicine anywhere on your body other than where your doctor tells you.
• Wash your hands with soap and water before and after applying the solution. If you get this medicine into your eyes, wash the eyes right away with water or saline. If eye irritation persists for more than 1 hour, call your doctor.
• Apply the solution to a clean, dry, intact skin area. Choose an area free of open wounds scars, cuts, or irritation.
• Put 10 drops of the solution at a time on your hand or directly to your knee. Apply the solution evenly on the front, back, and sides of your knee.
• After using the Pennsaid® solution, wait for at least 30 minutes before showering or bathing.
• Do not use external heat or dressings to the treated knee. Avoid wearing clothing or applying skin care products, such as sunscreen, insect repellant, lotion, moisturizer, or cosmetics, over the treated knee until the skin is completely dry.
• Avoid skin-to-skin contact between other people and the treated knee until the skin is completely dry.
• Protect the treated knee from sunlight.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (gel): For actinic keratosis using Solaraze® 3% gel: Adults—Apply to affected skin area 2 times a day. Children—Use and dose must be determined by your doctor. For osteoarthritis of the hands, elbows, or wrists using Voltaren® 1% gel: Adults—Apply 2 grams (g) to the affected skin areas four times a day (a total of 8 g each day). However, the total dose should not exceed 32 g per day over all affected joints. Use the enclosed dosing card to measure the appropriate dose. Children—Use and dose must be determined by your doctor. For osteoarthritis of the knees, ankles, or feet using Voltaren® 1% gel: Adults—Apply 4 grams (g) to the affected skin areas four times a day (a total of 16 g each day). However, the total dose should not exceed 32 g per day over all affected joints. Use the enclosed dosing card to measure the appropriate dose. Children—Use and dose must be determined by your doctor.
• For topical dosage form (solution):For osteoarthritis of the knee: Adults—40 drops (10 drops at a time) on each affected knee 4 times a day. Children—Use and dose must be determined by your doctor.
• For transdermal dosage form (skin patch):For acute pain: Adults—One patch applied to the painful area 2 times a day. Children—Use and dose must be determined by your doctor.
• For transdermal dosage form (topical system):For acute pain: Adults and children 6 years of age and older—One topical system applied to the most painful area 2 times a day. Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.