Flanax Pain Reliever

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Naproxen works by reducing hormones that cause inflammation and pain in the body.

Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

The delayed-release or extended-release tablets are slower-acting forms of naproxen that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms of naproxen will not work fast enough to treat acute pain.

Naproxen may also be used for purposes not listed in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Do not crush, chew, or break a naproxen tablet. Swallow it whole.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you change brands, strengths, or forms of naproxen, your dosage needs may change. Ask your pharmacist if you have any questions about the kind of naproxen you are using.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Naproxen doses are based on weight in children, and any changes may affect your child's dose.

If you use naproxen long-term, you may need frequent medical tests.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using naproxen.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin while you are taking naproxen.

Ask your doctor before taking any other medication for pain, arthritis, fever, or swelling. Many medicines available over the counter contain aspirin, salicylates, or other medicines similar to naproxen (such as ibuprofen or ketoprofen). Taking certain products together can cause you to get too much of this type of medication.

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb naproxen.

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using naproxen and call your doctor at once if you have:

• shortness of breath (even with mild exertion);

• swelling or rapid weight gain;

• the first sign of any skin rash, no matter how mild;

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;

• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• indigestion, heartburn, stomach pain, nausea;

• headache, dizziness, drowsiness;

• bruising, itching, rash;

• swelling; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using naproxen if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use naproxen if you are also using any of the following drugs:

• cholestyramine;

• cyclosporine;

• digoxin;

• lithium;

• methotrexate;

• pemetrexed;

• phenytoin or similar seizure medications;

• probenecid;

• warfarin (Coumadin, Jantoven) or similar blood thinners;

• a diuretic or "water pill";

• heart or blood pressure medication; or

• insulin or oral diabetes medicine.

This list is not complete. Other drugs may interact with naproxen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

You should not take Flanax Pain Reliever Tablets when you:

• Are age 60 or older
• Have had stomach ulcers or bleeding problems
• Take a blood thinning (anticoagulant) or steroid drug
• Take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
• Have three or more alcoholic drinks every day while using this product
• Take more or for a longer time than directed
• Have ever had an allergic reaction to any other pain reliever/fever reducer
• Are about to receive heart surgery or recently received one

Applies to naproxen: oral capsule liquid filled, oral suspension, oral tablet, oral tablet enteric coated, oral tablet extended release

Along with its needed effects, naproxen (the active ingredient contained in Flanax Pain Reliever) 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 while taking naproxen:

• 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
• skin eruptions
• stomach pain
• swelling
• tightness in the chest

• Bloating
• bloody or black, tarry stools
• blurred or loss of vision
• burning upper abdominal or stomach 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 the skin
• severe and continuing nausea
• severe stomach burning, cramping, or pain
• skin rash
• 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, or loosening of the skin
• blood in the urine or stools
• blue lips and fingernails
• canker sores
• change in the 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, or noisy breathing
• difficulty with swallowing
• dilated neck veins
• dizziness
• dry cough
• dry mouth
• early appearance of redness, or swelling of the skin
• excess air or gas in the 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 the 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 the 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 the hands, feet, or lips
• pain in the ankles or knees
• pain or burning in the throat
• pain or discomfort in the arms, jaw, back, or neck
• painful, red lumps under the skin, mostly on the legs
• pains in the 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 the skin
• redness, swelling, or soreness of the tongue
• scaly skin
• seizures
• severe sunburn
• shakiness
• skin thinness
• slurred speech
• sneezing
• sore throat
• sores, ulcers, or white spots on the 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 the legs and ankles
• swelling of the face, fingers, feet, or lower legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tiny bumps on the inner lining of the eyelid
• unexplained weight loss
• unpleasant breath odor
• watery or bloody diarrhea
• weakness or heaviness of the legs
• weight gain
• yellow eyes or skin

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

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

Some side effects of naproxen 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 the 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 with 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, or swelling of the eye, eyelid, or inner lining of the eyelid
• seeing, hearing, or feeling things that are not there
• shakiness in the legs, arms, hands, or feet
• swollen joints
• trembling or shaking of the hands or feet
• trouble getting pregnant
• trouble performing routine tasks
• trouble sleeping
• unusual drowsiness, dullness, or feeling of sluggishness

Applies to naproxen: compounding powder, oral capsule, oral delayed release tablet, oral suspension, oral tablet, oral tablet extended release, oral and topical kit

Gastrointestinal

Very common (10% or more): Dyspepsia (14%), heartburn, nausea, constipation
Common (1% to 10%): Diarrhea, abdominal pain
Very rare (less than 0.01%): Pancreatitis
Frequency not reported: Flatulence, gastritis, vomiting, dysphagia, stomatitis, abdomen enlarged, eructation, GI hemorrhage, rectal hemorrhage, aphthous, mouth ulcer, stomach ulcer, cardiospasm, colitis, esophagitis, gastroenteritis, GI disorder, rectal disorder, tooth disorder, melena esophageal ulcer, hematemesis, non-peptic GI ulceration, ulcerative stomatitis, sialadenitis, colitis
Postmarketing reports: Inflammation, bleeding, ulceration, perforation, obstruction, exacerbation of inflammatory bowel disease[Ref]

Hepatic

Rare (less than 0.1%): Hepatitis, jaundice
Frequency not reported: Cholecystitis, cholelithiasis, hepatosplenomegaly, liver function abnormality, SGOT increased, SGPT increased, elevated liver enzymes[Ref]

Nervous system

Very common (10% or more): Headache (15%)
Common (1% to 10%): Drowsiness, dizziness
Uncommon (0.1% to 1%): Cognitive dysfunction, poor concentration
Very rare (less than 0.01%): Convulsions, stroke
Frequency not reported: Paresthesia, lightheadedness, migraine, syncope, hypertonia, neuralgia, neuritis, amnesia, paralysis[Ref]

Renal

Very rare (less than 0.01%): Glomerular nephritis, interstitial nephritis, nephrotic syndrome, renal papillary necrosis
Frequency not reported: Kidney function abnormality, pyelonephritis, creatinine increased, glucosuria, albuminuria, BUN increased, renal failure, renal disease, kidney pain, nephrosclerosis, kidney failure, kidney calculus, nephropathy[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Palpitations
Rare (0.01% to 0.1%): Vasculitis
Very rare (less than 0.01%): Arterial thrombotic events, myocardial infarction
Frequency not reported: Hypertension, angina pectoris, coronary artery disease, deep thrombophlebitis, vasodilation, vascular anomaly, arrhythmia, bundle branch block, abnormal ECG, right heart failure, hemorrhage, aortic stenosis, tachycardia, congestive heart failure
Postmarketing reports: Cardiac failure[Ref]

Hematologic

Rare (0.01% to 0.1%): Hemolytic anemia
Very rare (less than 0.01%): Granulocytopenia, thrombocytopenia, agranulocytosis
Frequency not reported: Anemia, aplastic anemia, leukopenia, bleeding time increased, eosinophilia, abnormal RBC, abnormal WBC, neutropenia, pancytopenia[Ref]

Hypersensitivity

Rare (less than 0.1%): Allergic reaction, anaphylactoid/anaphylaxis reaction, hypersensitivity reaction[Ref]

Dermatologic

Common (1% to 10%): Ecchymosis, rash, skin eruptions, pruritus, purpura
Uncommon (0.1% to 1%): Urticaria, photosensitivity
Rare (0.01% to 0.1%): Alopecia, pseudo-porphyria
Very rare (less than 0.01%): Toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, epidermolysis bullosa
Frequency not reported: Angioneurotic edema/angioedema, angiodermatitis, dry skin, sweating, skin ulcer, acne, contact dermatitis, eczema, skin necrosis, subcutaneous nodule, photosensitive dermatitis, porphyria cutaneous tarda, nail disorder, epidermal necrosis, exfoliative dermatoses, bullous dermatoses, lichen planus
Postmarketing reports: Erythema nodosum, fixed drug eruption, pustular reaction, bullous reactions[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, rhinitis, dyspnea
Rare (less than 0.1%): Aggravated asthma, eosinophilic pneumonitis
Frequency not reported: Bronchitis, cough increased, asthma, pulmonary edema, laryngitis, lung disorder, epistaxis, pneumonia, respiratory distress, respiratory disorder, bronchospasm, sore throat[Ref]

Other

Very common (10% or more): Influenza-like syndrome (10%)
Common (1% to 10%): Infection, edema, tinnitus, fatigue
Rare (0.01% to 0.1%): Hearing impairment
Very rare (less than 0.01%): Aseptic meningitis
Frequency not reported: Fever, accidental injury, asthenia, chest pain, peripheral edema, hearing disturbances, thirst, abscess, cellulitis, malaise, mucous membrane disorder, periodontal abscess, necrosis, aseptic meningitis, chills, weight increased, otitis media, deafness, ear disorder, herpes simplex, herpes zoster, vertigo, subdural hematoma, exacerbation of Parkinson's disease[Ref]

Metabolic

Rare (less than 0.1%): Hyperkalemia
Frequency not reported: Hyperglycemia, anorexia, hypoglycemia, hypercholesteremia, alkalosis, dehydration, glucose tolerance increase, hyperuricemia, hypokalemia[Ref]

Endocrine

Postmarketing reports: Infertility[Ref]

General

The most frequently reported adverse events were headache, dyspepsia, nausea, constipation, heartburn, abdominal pain, and influenza-like syndrome.[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Very rare (less than 0.01%): Hematuria
Frequency not reported: Cystitis, monilia, pelvic pain, dysmenorrhea, dysuria, nocturia, prostate disorder, urinary incontinence, menorrhagia, menstrual disorders, vaginitis, uterine spasm, urinary retention, urinary frequency, abnormal urine, pyuria, metrorrhagia[Ref]

Musculoskeletal

Common (1% to 10%): Back pain
Rare (less than 0.1%): Myalgia, muscle weakness
Frequency not reported: Leg cramps, arthralgia, joint disorder, tendon disorder, neck rigid/pain, LE syndrome, myasthenia, bone disorder, spontaneous bone fracture, fibrotendinitis, bone pain, spasm, bursitis
Postmarketing reports: Systemic lupus erythematosus[Ref]

Ocular

Common (1% to 10%): Visual disturbances
Frequency not reported: Ptosis, amblyopia, scleritis, cataract, conjunctivitis, keratoconjunctivitis, lacrimation disorder, eye pain, diplopia, retrobulbar optic neuritis
Postmarketing reports: Corneal opacity, papillitis, papilledema[Ref]

Oncologic

Frequency not reported: Carcinoma, breast carcinoma, breast neoplasm, skin neoplasm[Ref]

Psychiatric

Common (1% to 10%): Confusion
Uncommon (0.1% to 1%): Depression, dream abnormalities, mood alterations
Frequency not reported: Insomnia, anxiety, nervousness, emotional lability, hallucinations[Ref]

Some side effects of Flanax Pain Reliever may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.