EC Naprosyn

Generic Name: naproxen (Oral route)

na-PROX-en

Commonly used brand name(s):

In the U.S.

• Aflaxen
• Aleve
• Aleve Arthritis
• Anaprox
• Anaprox DS
• EC Naprosyn
• Naprelan
• Naprelan 500
• Naprosyn

In Canada

• Naxen

Available Dosage Forms:

• Tablet, Enteric Coated
• Tablet, Extended Release
• Tablet
• Suspension

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

User Reviews & Ratings As a treatment for... Avg User Ratings [?] Costochondritis 2 reviews Rate it! 10 Sciatica 3 reviews Rate it! 9.0 Ankylosing Spondylitis 1 reviews Rate it! 9.0 Showing 3 of 18 conditions - Show All... Compare with other drugs.

Uses For EC Naprosyn

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis) such as inflammation, swelling, stiffness, and joint pain. Naproxen also helps relieve symptoms of ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. However, this medicine does not cure arthritis and will help you only as long as you continue to take it .

This medicine may also be used to treat mild to moderate pain, including acute gout and other painful conditions such as bursitis, tendonitis, or menstrual cramps .

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

Before Using EC Naprosyn

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 naproxen in children below 2 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of naproxen in the elderly. However, elderly patients may be more sensitive to the effects of naproxen than younger adults, and are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving naproxen .

Pregnancy

Breast Feeding

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

Interactions with Medicines

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
• Enoxaparin
• Ginkgo
• Methotrexate
• Nadroparin
• Parnaparin
• Pemetrexed
• Reviparin
• Tacrolimus
• Tinzaparin
• Warfarin

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.

• Acetohexamide
• Alacepril
• Amiloride
• 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
• 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

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 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
• Asthma 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
• High blood pressure or
• Kidney disease or
• Liver disease (e.g., hepatitis) or
• Stomach or intestinal ulcers or bleeding or
• Stroke, history of—Use with caution. This medicine may make these conditions worse .

• Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition .

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine should NOT be used to relieve pain right before or after the surgery .

Proper Use of naproxen

This section provides information on the proper use of a number of products that contain naproxen. It may not be specific to EC Naprosyn. Please read with care.

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 ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

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.

Check with your doctor first before changing dosage forms (e.g., tablets, suspension). These forms are very different from each other.

Swallow the delayed-release tablet whole. Do not crush, break, or chew it .

If you are using the suspension form of this medicine, shake it gently before using. Use the marked measuring cup included in the package to measure the dose .

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 naproxen (e.g., Naprosyn) tablet and oral suspension dosage forms:
  • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
    • Adults—At first, 250 milligrams (mg) (10 milliliters (mL)/2 teaspoons), 375 mg (15 mL/3 teaspoons), or 500 mg (20 mL/4 teaspoons) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg a day. After your condition improves your doctor may direct you to take a lower dose.
    • Children—The dose is based on body weight. At first, 5 mg per kilogram (kg) (about 2.25 mg per pound) of body weight twice a day. After your condition improves your doctor may direct you to take a lower dose .
  • For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
    • Adults—500 mg for the first dose, then 250 mg every six to eight hours as needed.
    • Children—Use and dose must be determined by your doctor .
  • For acute gout:
    • Adults—750 mg for the first dose, then 250 mg every eight hours until the attack is relieved.
    • Children—Use and dose must be determined by your doctor .

• For naproxen delayed-release tablet (e.g., EC-Naprosyn) dosage form:
  • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
    • Adults—At first, 375 or 500 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg a day. After your condition improves your doctor may direct you to take a lower dose.
    • Children—Use and dose must be determined by your doctor .

• For naproxen sodium (e.g., Anaprox, Anaprox DS) tablet dosage form:
  • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
    • Adults—At first, 275 or 550 mg two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg a day. After your condition improves your doctor may direct you to take a lower dose.
    • Children—Use and dose must be determined by your doctor .
  • For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
    • Adults—550 mg for the first dose, then 550 mg every twelve hours or 275 mg every six to eight hours as needed. Your doctor may increase the dose, if necessary, up to a total of 1375 mg for the initial total daily dose and thereafter, 1100 mg total daily dose.
    • Children—Use and dose must be determined by your doctor .
  • For acute gout:
    • Adults—825 mg for the first dose, then 275 mg every eight hours until the attack is relieved.
    • Children—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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using EC Naprosyn

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, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (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 skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of 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. Anaphylaxis 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 while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away .

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 .

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

EC Naprosyn 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:

• Belching
• bruising
• difficult or labored breathing
• feeling of indigestion
• headache
• itching skin
• large, flat, blue or purplish patches in the skin
• pain in the chest below the breastbone
• shortness of breath
• skin eruptions
• stomach pain
• swelling
• tightness in chest
• wheezing

• Bloating
• bloody or black, tarry stools
• blurred or loss of vision
• burning upper abdominal pain
• cloudy urine
• constipation
• decrease in urine output or decrease in urine-concentrating ability
• disturbed color perception
• double vision
• fast, irregular, pounding, or racing heartbeat or pulse
• halos around lights
• indigestion
• loss of appetite
• nausea or vomiting
• night blindness
• overbright appearance of lights
• pale skin
• pinpoint red or purple spots on skin
• skin rash
• severe and continuing nausea
• severe stomach burning, cramping or pain
• swelling or inflammation of the mouth
• troubled breathing with exertion
• tunnel vision
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of material that looks like coffee grounds
• weight loss

• Anxiety
• back or leg pains
• bleeding gums
• blindness
• blistering, peeling, loosening of skin
• blood in urine or stools
• blue lips and fingernails
• canker sores
• change in ability to see colors, especially blue or yellow
• chest pain or discomfort
• clay-colored stools
• cold sweats
• coma
• confusion
• cool, pale skin
• cough or hoarseness
• coughing that sometimes produces a pink frothy sputum
• cracks in the skin
• darkened urine
• decreased vision
• depression
• diarrhea
• difficult, burning, or painful urination
• difficult, fast, noisy breathing
• difficulty swallowing
• dilated neck veins
• dizziness
• dry cough
• dry mouth
• early appearance of redness, or swelling of the skin
• excess air or gas in stomach
• extreme fatigue
• eye pain
• fainting
• fever with or without chills
• fluid-filled skin blisters
• flushed, dry skin
• frequent urination
• fruit-like breath odor
• greatly decreased frequency of urination or amount of urine
• hair loss
• high fever
• hives
• increased hunger
• increased sensitivity of skin to sunlight
• increased sweating
• increased thirst
• increased urination
• increased volume of pale, dilute urine
• irregular breathing
• joint or muscle pain
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• late appearance of rash with or without weeping blisters that become crusted, especially in sun-exposed areas of skin, may extend to unexposed areas
• light-colored stools
• lightheadedness
• loss of heat from the body
• lower back or side pain
• nervousness
• nightmares
• no blood pressure
• no breathing
• no pulse
• nosebleeds
• numbness or tingling in hands, feet, or lips
• pain in ankles or knees
• pain or burning in throat
• pain or discomfort in arms, jaw, back, or neck
• painful, red lumps under the skin, mostly on the legs
• pains in stomach, side, or abdomen, possibly radiating to the back
• pale or blue lips, fingernails, or skin
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• rapid, shallow breathing
• red irritated eyes
• red skin lesions, often with a purple center
• red-green color blindness
• redness or other discoloration of skin
• redness, swelling, or soreness of tongue
• scaly skin
• seizures
• severe sunburn
• shakiness
• skin thinness
• slurred speech
• sneezing
• sore throat
• sores, ulcers, or white spots on lips or tongue or inside the mouth
• sores, welting, or blisters
• spots on your skin resembling a blister or pimple
• stiff neck or back
• stomach cramps or tenderness
• stomach upset
• swelling in legs and ankles
• swelling of face, fingers, feet, or lower legs
• swollen, painful, or tender lymph glands in neck, armpit, or groin
• tiny bumps on the inner lining of eyelid
• unexplained weight loss
• unpleasant breath odor
• watery or bloody diarrhea
• weakness or heaviness of legs
• weight gain
• yellow eyes or skin

• Bleeding under the skin
• confusion about identity, place, and time
• muscle tremors
• restlessness
• sleepiness

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:

• Continuing ringing or buzzing or other unexplained noise in ears
• hearing loss

• Acid or sour stomach
• change in hearing
• feeling of constant movement of self or surroundings
• passing gas
• sensation of spinning
• stomach soreness or discomfort

• Appetite changes
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• difficulty in moving
• discharge, excessive tearing
• general feeling of discomfort or illness
• lack or loss of strength
• menstrual changes
• muscle aching, cramping, stiffness, or weakness
• not able to concentrate
• redness, pain, swelling of eye, eyelid, or inner lining of eyelid
• seeing, hearing, or feeling things that are not there
• shakiness in legs, arms, hands, or feet
• sleeplessness
• swollen joints
• trembling or shaking of hands or feet
• trouble getting pregnant
• trouble performing routine tasks
• trouble sleeping
• unable to sleep
• unusual drowsiness, dullness, or feeling of sluggishness

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

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