Naproxen Gels

The recommended dose of naproxen/naproxen sodium for people 12 to 65 years of age is 200 mg taken by mouth every 8 to 12 hours. People over 65 years of age should take 200 mg by mouth every 12 hours. No more than 400 mg (2 doses) should be taken in any 24-hour period.

Naproxen/naproxen sodium may be taken with food or on an empty stomach, although it may take longer to notice an effect if it is taken with food or antacids.

When taken for fever, naproxen/naproxen sodium should not be used for more than 3 days. If used for pain, the medication should not be taken longer than 5 days. Contact your doctor after this time if you are still experiencing pain or fever.

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 Naproxen Gels exactly as recommended by your doctor or pharmacist.

Store Naproxen Gels 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.

Each clear, orange, oval, gelatin shell printed with “NX” in white ink and containing a clear, colourless-to-light-orange solution contains a total of 200 mg of naproxen as naproxen and naproxen sodium. Nonmedicinal ingredients: FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, povidone, sorbitan, sorbitol, and water.

Do not take Naproxen Gels if you:

• are allergic to naproxen, naproxen sodium, or any ingredients of Naproxen Gels
• 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 in your third trimester (last 3 months) of pregnancy
• have an active or bleeding ulcer in the stomach or intestines
• 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

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

• 5-ASA medications (e.g., Mesalamine, Olsalazine, Sulfasalazine)
• acetylsalicylic acid (ASA)
• alcohol
• Aliskiren
• 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., Dexamethasone, Prednisone)
• dabigatran
• Dasatinib
• Deferasirox
• deoxycholic acid
• Desmopressin
• Dipyridamole
• Cyclosporine
• Digoxin
• diuretics (water pills; e.g., Spironolactone, triamterene, Furosemide, Hydrochlorothiazide)
• drospirenone
• Edoxaban
• Eplerenone
• Haloperidol
• heparin
• herbal products that affect blood clotting (e.g., cat's claw, chamomile, fenugreek, evening primrose, feverfew, garlic, ginger, ginseng, turmeric)
• Hydralazine
• Ibrutinib
• lithium
• low-molecular-weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• medications to break down Blood Clots (e.g., alteplase, defibrotide, streptokinase, urokinase)
• Methotrexate
• multiple vitamin supplements with minerals
• other non-steroidal anti-inflammatory drugs (NSAIDs e.g., diclofenac, ibuprofen, ketorolac)
• Obinutuzumab
• omega-3 fatty acids
• Pemetrexed
• Pentoxifylline
• Porfimer
• Prasugrel
• prostaglandin eye drops (e.g., Latanoprost, Bimatoprost)
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• Rivaroxaban
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin-norepinephrine reuptake inhibitors (SNRIs; Desvenlafaxine, Duloxetine, Venlafaxine)
• sodium phosphates
• Tacrolimus
• tenofovir
• Ticagrelor
• Ticlopidine
• tipranavir
• 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 this medication. 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 Naproxen Gels.

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 this medication. If you experience symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; wheezing; or swelling of the face, tongue, or throat), get immediate medical attention.

Blood clotting: Naproxen Gels 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 Naproxen Gels may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naproxen Gels, and whether any special monitoring is needed. If you have a bleeding disorder, do not take Naproxen Gels.

Blood pressure: Naproxen Gels can cause fluid to build up in the body, increasing the amount of effort it takes for the heart to pump blood through the body. As a result, blood pressure can increase when taking naproxen/naproxen sodium. If you have high blood pressure, discuss with your doctor how Naproxen Gels may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naproxen Gels, and whether any special monitoring is needed.

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 Naproxen Gels has on you.

Heart function: Naproxen Gels can cause fluid to build up in the body. This may decrease the effectiveness of the heart and contribute to heart failure. If you have heart disease, discuss with your doctor how Naproxen Gels may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart Attack and Stroke: Naproxen Gels 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 Naproxen Gels may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naproxen Gels, and whether any special monitoring is needed.

Skin reactions: Naproxen Gels 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 this medication and contact your doctor.

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

Ulcers or bleeding in the stomach or intestines: Naproxen Gels can cause stomach ulcers, perforation (holes), and bleeding from the stomach, or can make these conditions worse.

The risk of ulcers and bleeding is increased if you are taking higher doses of Naproxen Gels for longer periods of time.

If you currently have bleeding ulcers in the stomach or intestines, or have an inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), you should not take this medication. If you have a history of these conditions, discuss with your doctor how Naproxen Gels may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naproxen Gels, 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 without warning at any time during treatment.

Pregnancy: Naproxen Gels should not be used during the third trimester (last 3 months) of pregnancy. Naproxen Gels 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 Naproxen Gels, contact your doctor immediately.

Naproxen Gels may reduce your ability to become pregnant. Taking Naproxen Gels while trying to become pregnant is not recommended.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking naproxen/naproxen sodium, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Naproxen Gels have not been established for children less than 12 years of age.

Seniors: If you are a senior, you may have a higher risk of experiencing side effects from Naproxen Gels. You should use the lowest effective dose under close medical supervision.