Feldene

This medicine does not cure arthritis and will help you only as long as you continue to take it.

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

This product is available in the following dosage forms:

• Capsule


• Tablet

Before Using

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell 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 piroxicam in the pediatric population. 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 piroxicam in the elderly. However, elderly patients may be more sensitive to the adverse stomach effects (e.g., ulcers, bleeding) of piroxicam than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving piroxicam.

Pregnancy

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

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 medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ardeparin


• Beta Glucan


• Certoparin


• Dalteparin


• Danaparoid


• Dicumarol


• Enoxaparin


• Ginkgo


• Methotrexate


• Nadroparin


• Parnaparin


• Pemetrexed


• Reviparin


• Tacrolimus


• Tinzaparin

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

• Acenocoumarol


• Acetohexamide


• Alacepril


• Amiloride


• Anisindione


• Azosemide


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Bumetanide


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Citalopram


• Clopamide


• Clopidogrel


• Clovoxamine


• Cyclopenthiazide


• Cyclosporine


• Cyclothiazide


• Delapril


• Desvenlafaxine


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Escitalopram


• Ethacrynic Acid


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Lisinopril


• Lithium


• Losartan


• Methyclothiazide


• Metolazone


• Milnacipran


• Moexipril


• Nefazodone


• Olmesartan Medoxomil


• Paroxetine


• Pentopril


• Perindopril


• Piretanide


• Polythiazide


• Quinapril


• Quinethazone


• Ramipril


• Sertraline


• Spirapril


• Spironolactone


• Tasosartan


• Telmisartan


• Temocapril


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Xipamide


• Zimeldine


• Zofenopril

Other Interactions

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 also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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 problems or


• Blood clots or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease (e.g., congestive heart failure) or


• Hepatitis, history of or


• Hypertension (high blood pressure) or


• Kidney disease or


• Stomach ulcers or bleeding, history of or


• Stroke, history ofa€”Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma, history of or


• Aspirin sensitivity, history ofa€”Should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)a€”Should not be used to relieve pain right before or after the surgery.

• Liver diseasea€”Use with caution. Effects may be increased because of slower removal of the medicine from the body .

Proper Use

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of this medicine may increase the chance of unwanted effects.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

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 oral dosage form (capsules):
  
  
  
  • For osteoarthritis and rheumatoid arthritis:
    
    
    
    • Adultsa€”20 milligrams (mg) once a day or 10 mg two times a day.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take 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. Do not double doses.

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.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take 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 is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs . This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or using certain other medicines (such as a steroid or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.

Some possible warning signs of serious side effects that can occur during treatment with 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 of blood or material that looks like coffee grounds; or yellow skin or eyes. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs .

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention . The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine in the last months of a pregnancy can harm your unborn baby . If you think you have become pregnant while using the medicine, tell your doctor right away. Do not use this medicine during the later part of a pregnancy unless your doctor tells you to.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment . Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor . This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

More common

• Bloating


• Bloody or black, tarry stools


• Burning upper abdominal or stomach pain


• Cloudy urine


• Constipation


• Decrease in urine output or decrease in urine-concentrating ability


• Headache


• Heartburn


• Indigestion


• Itching skin


• Loss of appetite


• Nausea or vomiting


• Pale skin


• Severe abdominal or stomach pain, cramping, or burning


• Severe and continuing nausea


• Skin rash


• Swelling


• Troubled breathing with exertion


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Vomiting of blood or material that looks like coffee grounds


• Weight loss

Less common

• Bleeding gums


• Blood in the urine


• Bloody nose


• Blurred vision


• Burning feeling in the chest or stomach


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Chest pain


• Clay-colored stools


• Confusion


• Cough or hoarseness


• Dark urine


• Difficult or labored breathing


• Difficult, burning, or painful urination


• Difficulty with swallowing


• Dilated neck veins


• Dizziness


• Extreme fatigue


• Fainting


• Fever or chills


• Flushing or redness of the skin


• Frequent urge to urinate


• Increased sensitivity of the skin to sunlight


• Increased thirst


• Increased volume of pale, dilute urine


• Large, flat, blue, or purplish patches in the skin


• Lightheadedness


• Lower back or side pain


• Nervousness


• Noisy breathing


• Numbness or tingling in the hands, feet, or lips


• Pain or burning in the throat


• Peeling of the skin


• Pinpoint red or purple spots on the skin


• Pounding in the ears


• Rapid, shallow breathing


• Redness or other discoloration of the skin


• Redness, swelling, or soreness of the tongue


• Severe sunburn


• Shortness of breath


• Slow, fast, pounding, or irregular heartbeat or pulse


• Sore throat


• Sores, ulcers, or white spots on the lips or tongue or inside the mouth


• Stomach upset


• Swelling of the face, fingers, feet, or lower legs


• Swelling or inflammation of the mouth


• Swollen glands


• Tenderness in the stomach area


• Tightness in the chest


• Unpleasant breath odor


• Unusually warm skin


• Weakness or heaviness of the legs


• Weight gain


• Wheezing


• Yellow eyes or skin

Rare

• Anxiety


• Back or leg pains


• Burning, dry, or itching eyes


• Cold sweats


• Coma


• Cracks in the skin


• Diarrhea


• Discharge, excessive tearing


• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position


• Dry mouth


• Flushed, dry skin


• Fruit-like breath odor


• General body swelling


• General feeling of discomfort or illness


• High fever


• Increased hunger


• Increased urination


• Inflammation of the joints


• Irregular, fast or slow, or shallow breathing


• Joint pain


• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• Light-colored stools


• Loss of heat from the body


• Muscle aches and pains


• Nightmares


• No blood pressure


• No breathing


• No pulse


• Pain or discomfort in the arms, jaw, back, or neck


• Pains in the stomach, side, or abdomen, possibly radiating to the back


• Pale or blue lips, fingernails, or skin


• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• Red skin lesions, often with a purple center


• Red, irritated eyes


• Redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• Runny nose


• Scaly skin


• Seeing, hearing, or feeling things that are not there


• Seizures


• Severe headache


• Shakiness


• Shivering


• Sleepiness


• Slurred speech


• Sneezing


• Sores, welting, or blisters


• Stiff neck or back


• Stomach pain, continuing


• Suddenly sweating


• Swollen, painful, or tender lymph glands in the neck, armpit, or groin


• Trouble sleeping

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation


• Depression


• Hives


• Hostility


• Irritability


• Muscle twitching


• Pain or discomfort in the chest, upper stomach, or throat


• Rapid weight gain


• Stupor


• Swelling of the ankles or hands


• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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. Also, your health care professional may be able to tell you about ways 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

• Acid or sour stomach


• Belching


• Continuing ringing or buzzing or other unexplained noise in the ears


• Excess air or gas in the stomach or intestines


• Hearing loss


• Passing gas


• Stomach discomfort or upset

Less common

• Feeling of constant movement of self or surroundings


• Hair loss or thinning of the hair


• Lack or loss of strength


• Sensation of spinning


• Shakiness in the legs, arms, hands, or feet


• Sleeplessness


• Trembling or shaking of the hands or feet


• Unable to sleep

Rare

• Change in hearing


• Changes in appetite


• Inability to sit still


• Mood alterations


• Need to keep moving


• Restlessness

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.