Aflaxen

1 What is Aflaxen?

Brand: Aflaxen, Aleve, Aleve Arthritis, Anaprox, Anaprox DS, EC Naprosyn, Naprelan, Naprelan 500, Naprelan Dose Card, Naprosyn ; Canada: Naxen.

Generic: Naproxen

Aflaxen is a non-steroidal, anti-inlflamatory drug (NSAID) that is used to relieve the symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis) such as inflammation, swelling, stiffness and joint pain. Naproxen also helps relieve the symptoms of ankylosing spondylitis, which is a type of arthritis that affects the spine.

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

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

This medication is only available through a doctor’s prescription.

This product is available in the following forms:

  • Tablet
  • Suspension
  • Enteric Coated Tablet
  • Extended Release Tablet
  • Liquid-Filled Capsule

2 What To Know Before Using

As with all medicines, the risks of using Aflaxen must be compared to how much it will help you. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

  • Allergies: Inform your doctor if you have ever had an allergic reaction to doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.
  • Pediatric: No appropriate studies have been performed on the relationship of age to the effects of Naproxen controlled-release tablets in children. Safety and efficacy have not been established.No appropriate studies have been performed on the relationship of age to the effects of Naproxen delayed release tablets, suspension and tablets in children younger than 2 years of age. Safety and efficacy have not been established.
  • Geriatric Usage: Up-to-date studies have not shown any problems specific to the elderly that would limit the use of this medication in the elderly population. However, elderly patients may be more sensitive to this medication than younger adults. They are more likely to have age-related kidney or stomach problems, which may require caution and an adjustment in the dose for elderly patients.
  • Pregnancy: This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.
  • Breastfeeding: Studies in women suggest that Naproxin poses minimal risk to the infant when used while breastfeeding. There are no up-to-date studies in women for determining infant risk when using Naproxin sodium while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.
  • Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below. The following interactions were selected on the basis of potential significance and are not all-inclusive. Using this medication with any of the following medication is not recommended, but may be unavoidable in some cases. Your doctor may make the decision not to treat you with this medication or change some of the other medications you take:
    • Abciximab
    • Amineptine
    • Amitriptyline
    • Amitriptylinoxide
    • Amoxapine
    • Anagrelide
    • Apixaban
    • Ardeparin
    • Argotroban
    • Aspirin
    • Beta Glucan
    • Bivalirudin
    • Ceritinib
    • Certoparin
    • Cilostazol
    • Citalopram
    • Clomipramine
    • Clopidogrel
    • Cyclosporine
    • Dabigatran Etexilate
    • Dabrafenib
    • Dalteparin
    • Danaparoid
    • Desipramine
    • Desirudin
    • Desvenlafaxine
    • Dibenzepin
    • Dipyridamole
    • Dothiepin
    • Doxepin
    • Duloxetine
    • Edoxaban
    • Enoxaparin
    • Eptifibatide
    • Erlotinib
    • Escitalopram
    • Feverfew
    • Fluoxetine
    • Fluvoxamine
    • Fondaparinux
    • Ginkgo
    • Gossypol
    • Heparin
    • Imipramine
    • Lepirudin
    • Levomilnacipran
    • Lofepramine
    • Meadowsweet
    • Melitracen
    • Methotrexate
    • Milnacipran
    • Nadroparin
    • Nefazodone
    • Nortriptyline
    • Opipramol
    • Parnaparin
    • Paroxetine
    • Pemetrexed
    • Pentosan Polysulfate Sodium
    • Pentoxifylline
    • Pixantrone
    • Pralatrexate
    • Prasugrel
    • Protein C
    • Protriptyline
    • Reboxetine
    • Reviparin
    • Rivaroxaban
    • Sertraline
    • Sibutramine
    • Tacrolimus
    • Tianeptine
    • Ticlopidine
    • Tinzaparin
    • Tirofiban
    • Trimipramine
    • Venlafaxine
    • Vilazodone
    • Vortioxetine
    • WarfarinUsing this medication with any of the following medication may increase your risk of certain side effects. However, using both drugs may be the best treatment for you. If your doctor prescribes both medications together, your doctor may change the dose or how often you use one or both medications:
    • Acebutolol
    • Alacepril
    • Alprenolol
    • Amiloride
    • Arotinolol
    • Atenolol
    • Azosemide
    • Befunolol
    • Bemetizide
    • Benazepril
    • Bendroflumethiazide
    • Benzthiazide
    • Betaxolol
    • Bevantolol
    • Bisoprolol
    • Bopindolol
    • Bucindolol
    • Bumetanide
    • Bupranolol
    • Buthiazide
    • Canrenoate
    • Captopril
    • Carteolol
    • Carvedilol
    • Celiprolol
    • Chlorothiazide
    • Chlorthalidone
    • Cilazapril
    • Clopamide
    • Cyclopenthiazide
    • Delapril
    • Dilevalol
    • Enalapril
    • Enalaprilat
    • Esmolol
    • Ethacrynic Acid
    • Fosinopril
    • Furosemide
    • Hydrochlorothiazide
    • Hydroflumethiazide
    • Imidapril
    • Indapamide
    • Labetalol
    • Landiolol
    • Levobunolol
    • Lisinopril
    • Lithium
    • Mepindolol
    • Methyclothiazide
    • Metipranolol
    • Metolazone
    • Metoprolol
    • Moexipril
    • Nadolol
    • Nebivolol
    • Nipradilol
    • Oxprenolol
    • Penbutolol
    • Pentopril
    • Perindopril
    • Pindolol
    • Piretanide
    • Polythiazide
    • Propranolol
    • Quinapril
    • Ramipril
    • Sotalol
    • Spirapril
    • Spironolactone
    • Talinolol
    • Temocapril
    • Tertatolol
    • Timolol
    • Torsemide
    • Trandolapril
    • Triamterene
    • Trichlormethiazide
    • Xipamide
    • Zofenopril
  • Other Interactions: Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.Using this medication with any of the following is not normally recommended, but may be unavoidable. If used together, your doctor may wish to change your dose or how often you take this medication, or give you instructions about your use of food, alcohol or tobacco:
    • Tobacco
  • Other Medical Problems: Pre-existing medical problems may affect the use of this medication. Be sure to tell your doctor if you have any other medical problems, especially:
    • Anemia
    • Bleeding problems
    • Blood clots
    • Fluid retention or swelling in the body (edema)
    • High blood pressure (hypertension)
    • History of stroke
    • Kidney disease
    • Liver disease (i.e. hepatitis)
    • Stomach or intestinal ulcers or bleeding - Use with caution. May make these conditions worse.
    • Aspirin-sensitive asthma
    • Aspirin sensitivity - Should not be used in patients with these conditions
    • Heart surgery (i.e. coronary artery bypass graft) - Should not be used to relieve pain right before or after the surgery.
Have a question aboutNaproxen?Ask a doctor now

3 Proper Usage

Only take Aflaxen as directed by your doctor. Do not take more, less or for a longer or shorter period of time than your doctor tells you.

This medication comes with a patient information brochure. It is very important that your read this information. Ask your doctor if you have any questions.

When using this medication for severe or chronic (continuous) arthritis, you must take it regularly in order to feel the full effects. The medication normally begins working within 1 week, but in severe cases, it may take 2 weeks or longer for the effects to begin.

Ask your doctor before changing dosage forms (i.e. 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, shake it gently before use. Use the marked measuring cup included in the package to measure your dose.

Dosing

Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.

The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

For Naproxen tablet and oral suspension forms:

  • For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis:
    • Adults - Start at 250 mg, 375 mg or 500 mg twice a day (morning and evening). Your doctor may increase your dose up to a maximum of 1500 mg per day as needed.
    • Children 2 years of age and older - Dose is based on body weight and must be determined by your doctor. The dose is normally 5 mg per kilogram of body weight, twice a day.
    • Children younger than 2 years of age - Use and dose must be determined by your doctor.
  • For bursitis, tendonitis, menstrual cramps and other kinds of pain:
    • Adults - 500 mg for the first dose, then 250mg every 6-8 hours as needed.
    • Children - Use and dose must be determined by your doctor.

For Naproxen controlled-release tablets:

  • For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis:
    • Adults - Start at 750 mg (One 700 mg or two 350 mg) or 1,000 mg (two 500 mg) once a day. Your doctor may increase your dose up to a maximum of 1,500 mg (two 750 mg or three 500 mg) per day.
    • Children - Use and dose must be determined by your doctor
  • For bursitis, tendonitis, menstrual cramps and other kinds of pain:
    • Adults - Start with 1,000 mg (two 500 mg) once a day. Some patients may need up to 1,500 mg (two 750 mg or three 500 mg) per day for a limited amount of time. However, the dose is not normally more than 1,000 mg per day.
    • Children - Use and dose must be determined by your doctor
  • For acute gout:
    • Adults - 1,000 mg to 1,500 mg (two to three 500 mg) once a day for the first dose, then 1,000 mg (two 500 mg) once a day until the symptoms are relieved.
    • Children - Use and dose must be determined by your doctor.

For Naproxen delayed-release tablet:

  • For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis:
    • Adults - Start with 375 mg to 500 mg twice a day (morning and evening). Your doctor may increase your dose up to a maximum of 1,500 mg per day as needed.
    • Children - Use and dose must be determined by your doctor.

For Naproxen sodium tablet:

  • For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis:
    • Adults - Start with 275 mg or 550 mg twice a day (morning and evening). Your doctor may increase your dose up to a maximum of 1500 mg per day as needed.
    • 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 12 hours or 275 mg every 6-8 hours as needed. Your doctor may increase your dose up to a maximum of 1,375 mg per day as needed.
    • Children - Use and dose must be determined by your doctor.
  • For acute gout:
    • Adults - 825 mg for the first dose, then 275 mg every 8 hours until symptoms are relieved.
    • Children - Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medication, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not double dose.

Storage

Store this medication in a closed container at room temperature. Keep it away form heat, moisture and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

4 Precautions To Take

It is very important that your doctor checks in with you often while you are receiving Aflaxen to make sure that it is working properly. Blood and urine tests may be needed to check for unwanted side effects.

This medication may raise your risk of having a heart attack or stroke. This is more likely in patients who already have heart disease, or use this medication for extended periods of time.

This medication may cause bleeding in the stomach or intestines. This can happen without warning signs. This is more likely if you have a history of stomach ulcers, if you smoke or drink regularly, if you are over 60 years of age, if you are in poor health, or if you are using certain other medications such as steroids or blood thinners.

This medication may cause serious skin reactions. Tell your doctor immediately if you experience any of the following side effects: Blistering, peeling or loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers or white spots in the mouth or lips, or unusual fatigue or weakness.

Possible warning signs of serious side effects that may occur while using this medication may include swelling of the face, fingers, feet or lower legs, severe stomach pain, black stool, vomiting blood or what looks like coffee grounds, unintentional weight gain, yellow skin or eyes (jaundice), decreased urination, unusual bleeding or bruising or skin rash.

Signs of serious heart problems may occur, such as chest pain, tightness in the chest, fast or irregular heartbeat (tachycardia, palpitations), unusual flushing or warmth of the skin, weakness or slurred speech. Stop taking this medication and inform your doctor immediately if you notice any of these warning signs.

This medication may cause a serious allergic reaction called anaphylaxis. This occurs more often in patients that are allergic to aspirin or any non-steroidal anti-inflammatory medications. Anaphylaxis is life-threatening and requires immediate medical attention. The most serious signs are very fast or irregular breathing, gasping for breath, wheezing or fainting (syncope). Other signs may include changes in facial color, fast and erratic heartbeat, hive-like swelling on the skin and puffiness or swelling around the eyes. If any of these symptoms occur, call emergency help immediately.

Using this medication during late pregnancy may harm your unborn child. If you think you have become pregnant while using this medication, inform your doctor immediately.

Inform your doctor immediately if you experience blurred vision, difficulty reading or any other changes in vision while taking this medication.

Inform your doctor that you are taking this medication before any kind of surgery or medical testing. You may need to stop taking this medication for a certain period of time, or change to a different non-steroidal anti-inflammatory medication before your procedure.

This medication may cause dizziness, lightheadedness, drowsiness or decreased alertness in some patients. Even if taken before sleep, you may feel drowsy or less alert upon awakening. Make sure you know how you react to this medication before driving, using machinery or any other activity that may be dangerous if you are not alert.

Do not take other prescription or over-the-counter medications without asking your doctor.

5 Potential Side Effects

Aflaxen may produce unwanted affects along with the intended 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 you experience any of the following side-effects:

More Common

  • Belching
  • Bruising
  • Difficulty breathing
  • Headache
  • Indigestion
  • 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 the chest
  • Wheezing

Less Common

  • Bloating
  • Bloody or black stool
  • Blurred or loss of vision
  • Burning upper abdominal or stomach pain
  • Cloudy urine
  • Constipation
  • Decreased urine output or decrease in urine-concentrating ability
  • Difficulty breathing with exertion
  • Disturbed color perception
  • Double vision
  • Fast, irregular, pounding, or racing heartbeat or pulse (tachycardia, palpitations)
  • Halos around lights
  • Indigestion
  • Loss of appetite
  • Nausea or vomiting
  • Night blindness
  • Over bright appearance of lights
  • Pale skin
  • 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
  • Tunnel vision
  • Unintentional weight loss
  • Unusual bleeding or bruising
  • Unusual fatigue or weakness
  • Vomiting of material that looks like coffee grounds

Rare

  • 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 (cyanosis)
  • 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 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 (syncope)
  • Fever with or without chills
  • Fluid-filled skin blisters
  • Flushed, dry skin
  • 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 (polydipsia)
  • Increased urination (polyuria)
  • 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
  • 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
  • Unintentional weight gain
  • Unintentional weight loss
  • Unpleasant breath odor (halitosis)
  • Watery or bloody diarrhea
  • Weakness or heaviness of the legs
  • Yellow eyes or skin (jaundice)

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

  • Bleeding under the skin
  • Confusion about identity, place, and time
  • Muscle tremors
  • Restlessness
  • Sleepiness

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

More Common

Less Common

  • Acid or sour stomach
  • Change in hearing
  • Feeling of constant movement of self or surroundings (vertigo)
  • Passing gas
  • Stomach soreness or discomfort

Rare

  • Appetite changes
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • Burning, dry, or itching eyes
  • Difficulty moving
  • Difficulty sleeping (insomnia)
  • Discharge, excessive tearing
  • General feeling of discomfort or illness (malaise)
  • Lack or loss of strength
  • Loss of concentration
  • Menstrual changes
  • Muscle aching, cramping, stiffness, or weakness
  • Redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • Seeing, hearing, or feeling things that are not there (visual, audial or tactile hallucinations)
  • Shakiness in the legs, arms, hands, or feet
  • Sleeplessness
  • 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

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

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

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