Naprelan

The recommended adult starting dose of naproxen sodium is 550 mg (two 275 mg tablets) followed by one 275 mg tablet every 6 to 8 hours as needed.

Alternatively, one of the 550 mg tablets may be taken twice daily. Do not take more than 1,375 mg per day. The lowest dose for the shortest period of time should be used to reduce the risk of side effects.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Naprelan (Naproxen-sodium) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Naprelan (Naproxen-sodium) at room temperature, protect it from light, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

375 mg
Each white, capsule-shaped, film-coated tablet debossed with "N" on one side and "375" on the other contains 412.5 mg of naproxen sodium, equivalent to 375 mg of naproxen. Nonmedicinal ingredients: ammonio methacrylate copolymer Type A, ammonio methacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.

500 mg
Each white, capsule-shaped, film-coated tablet debossed with "N" on one side and "500" on the other contains 550 mg of naproxen sodium, equivalent to 500 mg of naproxen. Nonmedicinal ingredients: ammonio methacrylate copolymer Type A, ammonio methacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.

Do not take Naprelan (Naproxen-sodium) if you:

• are allergic to naproxen sodium or any ingredients of Naprelan (Naproxen-sodium)
• are allergic to Asa or other NSAIDs (e.g., Ibuprofen, Ketorolac, Diclofenac) or have had allergic symptoms (e.g., runny nose, Asthma, itchy skin rash, nasal polyps, swelling of the face, throat, or tongue) caused by these medications
• are 18 years of age or younger
• are breast-feeding
• are currently taking other NSAIDs (e.g., ibuprofen, ketorolac, Indomethacin)
• are going to have or have just had heart bypass surgery
• are in your third trimester (last 3 months) of pregnancy
• have a bleeding disorder
• have a bleeding ulcer in the stomach or intestines
• have bleeding in the brain
• have high levels of blood potassium (hyperkalemia)
• have inflammatory bowel disease (e.g., Ulcerative Colitis, Crohn's Disease)
• have severely reduced liver function or liver disease
• have severely reduced or worsening kidney function
• have severe, uncontrolled heart failure
• have recently had Coronary Artery Bypass Surgery

There may be an interaction between naproxen sodium and any of the following:

• 5-ASA medications (e.g., Mesalamine, olsalzine, Sulfasalazine)
• acetylsalicylic acid (ASA)
• alcohol
• Aliskiren
• aminoglycoside antibiotics (e.g., Amikacin, gentamicin, tobramycin)
• angiotensin converting enzyme (ACE) inhibitors (e.g., ramipril, enalapril)
• angiotensin receptor blockers (e.g., valsartan, candesartan, Losartan)
• antacids
• Apixaban
• beta blockers (e.g., metoprolol, atenolol)
• bisphosphonates (e.g., Alendronate, etidronate)
• Celecoxib
• Cholestyramine
• clopidogrel
• Colestipol
• corticosteroids (e.g., prednisone)
• dabigatran
• Dasatinib
• Deferasirox
• deoxycholic acid
• Desmopressin
• cyclosporine
• Digoxin
• diuretics (water pills; e.g., Spironolactone, triamterene, Furosemide, hydrochlorothiazide)
• heparin
• herbal products that affect blood clotting (e.g., cat's claw, chamomile, fenugreek, evening primrose, feverfew, garlic, ginger, ginseng, turmeric)
• Hydralazine
• lithium
• low-molecular-weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• Methotrexate
• other non-steroidal anti-inflammatory drugs (NSAIDs e.g., diclofenac, ibuprofen, ketorolac)
• Obinutuzumab
• omega-3 fatty acids
• oral hypoglycemics (e.g., Glyburide, Gliclazide)
• other NSAIDs (e.g., ketorolac, ibuprofen, diclofenac)
• Pemetrexed
• Phenytoin
• potassium supplements
• prostaglandin eye drops (e.g., Latanoprost, Bimatoprost)
• Rivaroxaban
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• serotonin-norepinephrine reuptake inhibitors (SNRIs; Desvenlafaxine, Duloxetine, Venlafaxine)
• sodium phosphates
• sulfonamides (e.g., sulfamethoxazole)
• Tacrolimus
• Ticagrelor
• Ticlopidine
• tenofovir
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• vitamin E
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Naprelan (Naproxen-sodium). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Naprelan (Naproxen-sodium).

HEALTH CANADA ADVISORY

June 8, 2021

Health Canada has issued new information concerning the use of non-steroidal anti-inflammatory drugs (NSAIDs). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Allergic reactions: If you have had a reaction to acetylsalicylic acid (ASA) or other NSAIDs (e.g., ibuprofen, Ketoprofen, ketorolac) that included a runny nose, itchy skin rash, nasal polyps, or shortness of breath and wheezing, you should not take Naprelan (Naproxen-sodium). If you experience symptoms of a Anaphylaxis (severe allergic reaction) (e.g., Hives; difficulty breathing; wheezing; swelling of the face, tongue, or throat), get immediate medical attention.

Aseptic meningitis: Naprelan (Naproxen-sodium) can rarely cause symptoms of aseptic meningitis (inflammation or swelling of the membranes around the brain and spinal cord that is not caused by bacteria). If you have an autoimmune condition (e.g., systemic Lupus erythematosus, mixed connective tissue disease), you are more at risk for developing this. If you experience symptoms such as stiff neck, severe headache, nausea, vomiting, fever, or changes in consciousness, stop taking Naprelan (Naproxen-sodium) can get immediate medical attention.

Bladder problems: Naprelan (Naproxen-sodium) may cause bladder pain, painful or difficult urination, or increased frequency of urination. If these symptoms occur without an explanation (e.g., infection), stop taking Naprelan (Naproxen-sodium) and contact your doctor.

Blood clotting: Naprelan (Naproxen-sodium) may reduce the ability of the blood to clot. If you are taking anticoagulants (e.g., Warfarin, Heparin) or have Hemophilia or other blood disorders (e.g., low platelets), discuss with your doctor how Naprelan (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naprelan (Naproxen-sodium), and whether any special monitoring is needed. If you have a bleeding disorder, do not take Naprelan (Naproxen-sodium).

Drowsiness/reduced alertness: As with other NSAIDs, naproxen sodium can cause drowsiness, dizziness, and blurred vision. Avoid driving and other activities that require alertness and concentration until you determine the effect Naprelan (Naproxen-sodium) has on you.

Fluid and electrolyte balance: NSAIDs such as naproxen sodium can cause fluid retention and edema (swelling). This can lead to high blood pressure or worsening of heart failure. If you have heart failure or high blood pressure, discuss with your doctor how Naprelan (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naprelan (Naproxen-sodium), and whether any special monitoring is needed. If you have severe, uncontrolled heart failure, you should not take Naprelan (Naproxen-sodium).

Naproxen sodium may also cause high blood potassium levels. If you are a senior; have Diabetes or kidney failure; or are taking beta-blockers (e.g., Metoprolol, Atenolol), angiotensin converting enzyme (ACE) inhibitors (e.g., Ramipril, Enalapril), or some diuretics (e.g., triamterene, Amiloride), you are more at risk of high blood potassium. If you have high blood potassium levels, you should not take Naprelan (Naproxen-sodium).

Heart Attack and Stroke: Naprelan (Naproxen-sodium) may be associated with an increased risk of heart attack and stroke. The risk is increased with higher total daily doses and taking the medication over long periods of time. If you have a history of heart disease (e.g., heart attack, stroke, heart failure) or have risk factors for heart disease (e.g., high blood pressure, High Cholesterol, diabetes, smoking, Kidney Disease) discuss with your doctor how Naprelan (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naprelan (Naproxen-sodium), and whether any special monitoring is needed.

Kidney function: Long-term use of naproxen sodium may lead to kidney problems. If you have kidney problems, liver disease, or heart failure; or are dehydrated, on a salt restricted diet, or are a senior, you have an increased risk for kidney problems while taking Naprelan (Naproxen-sodium). If you are taking medications such as diuretics (e.g., Hydrochlorothiazide, triamterene, Indapamide), ACE inhibitors (e.g., enalapril, ramipril), angiotensin receptor blockers (e.g., Valsartan, Candesartan), or Cyclosporine, you are also at an increased risk.

If you have these conditions or are taking these medications, discuss with your doctor how Naprelan (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naprelan (Naproxen-sodium), and whether any special monitoring is needed. If you have severe kidney problems, you should not take Naprelan (Naproxen-sodium).

Liver problems: Rarely, Naprelan (Naproxen-sodium) causes liver problems. If you have reduced liver function, discuss with your doctor how Naprelan (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naprelan (Naproxen-sodium), and whether any special monitoring is needed.

If you experience unexplained tiredness, loss of appetite, itchy skin, or yellowing of the skin or eyes while taking Naprelan (Naproxen-sodium), contact your doctor immediately. If you have liver disease or severely reduced liver function, you should not take Naprelan (Naproxen-sodium).

Skin reactions: Naprelan (Naproxen-sodium) can cause skin reactions, some of which may be severe. If you experience a skin rash, especially where the skin is blistering or peeling, stop taking Naprelan (Naproxen-sodium) and contact your doctor.

Naprelan (Naproxen-sodium) may make your skin more sensitive to sunlight (including sunlamps) and may cause sunburn, skin blisters, and skin redness, itching or discolouration. If you have a reaction from the sun while taking Naprelan (Naproxen-sodium), contact your doctor.

Ulcers or bleeding in the stomach or intestines: Naproxen sodium can cause stomach ulcers, perforation (holes), and bleeding from the stomach. These complications can occur at any time without warning and are sometimes severe enough to require immediate medical attention.

The risk of ulcers and bleeding are increased if you are taking higher doses of Naprelan (Naproxen-sodium) for longer periods of time. Other factors that increase the risk of these complications include drinking excessive amounts of alcohol, increased age, smoking, poor health, H pylori infection, and taking certain medications (e.g., warfarin, ASA, Clopidogrel, Prednisone, Citalopram, Fluoxetine, Paroxetine, Sertraline).

If you currently have ulcers in the stomach or intestines that are bleeding, or have an inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), you should not take Naprelan (Naproxen-sodium). If you have a history of these conditions, discuss with your doctor how Naprelan (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naprelan (Naproxen-sodium), and whether any special monitoring is needed.

Stop taking the medication and get immediate medical attention if you experience symptoms or signs of stomach ulcers or bleeding in the stomach (black and tarry stools, vomit that looks like coffee grounds, stomach pain). These reactions can occur at any time during treatment without warning.

Pregnancy: Naprelan (Naproxen-sodium) should not be used during the third trimester (last 3 months) of pregnancy. Naprelan (Naproxen-sodium) should not be used during the first and second trimester (first 6 months) of pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Naprelan (Naproxen-sodium), contact your doctor immediately.

Naprelan (Naproxen-sodium) may reduce your ability to become pregnant. Taking Naprelan (Naproxen-sodium) while trying to become pregnant is not recommended.

Breast-feeding: You should not use Naprelan (Naproxen-sodium) if you are breast-feeding.

Children: The safety and effectiveness of using Naprelan (Naproxen-sodium) have not been established for children.

Seniors: If you are a senior, you may have a higher risk of experiencing side effects from Naprelan (Naproxen-sodium). You should use the lowest effective dose for the shortest period of time under close medical supervision.