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Teva Naproxen Sodium DS

Teva Naproxen Sodium DS

(naproxen-sodium)

Naproxen sodium belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It reduces swelling, inflammation and pain, and is used for the relief of mild to moderately severe pain accompanied by inflammation.

Available form

Dosage

Tablet

220MG, 275MG, 550MG

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Teva Naproxen Sodium DS information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

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 Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (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.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Teva Naproxen Sodium DS (Naproxen-sodium). If you are concerned about side effects, discuss the risks and benefits of Teva Naproxen Sodium DS (Naproxen-sodium) with your doctor.

The following side effects have been reported by at least 1% of people taking Teva Naproxen Sodium DS (Naproxen-sodium). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

abdominal pain
drowsiness
heartburn
indigestion
nausea
vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

confusion
decreased hearing, any other change in hearing, or ringing or buzzing in ears
difficult or painful urination
dizziness or lightheadedness
feeling of being unwell
increased sensitivity of the skin to sunlight (Sunburn, skin blisters, skin rash, redness, itching, discoloration)
persistent heartburn, stomach pain, Diarrhea, or nausea
rapid weight gain
signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
swelling of the feet or ankles
symptoms of Depression (difficulty concentrating, trouble sleeping or sleeping too much, increase or decrease in appetite, loss of energy, feeling of guilt or hopelessness, loss of interest in activities)
symptoms of liver problems (e.g., yellowing of the skin or eyes with or without itchy skin)
vomiting

Stop taking the medication and seek immediate medical attention if any of the following occur:

blurred vision or any visual disturbance
change in the amount or colour of urine
signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
signs of Meningitis not caused by infection (e.g., headache [severe], throbbing, or with stiff neck or back)
signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
signs of a severe skin reaction (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with Fever or discomfort)
shortness of breath, wheezing, and chest tightness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Teva Naproxen Sodium DS (Naproxen-sodium).

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 Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (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: Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (Naproxen-sodium) can get immediate medical attention.

Bladder problems: Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (Naproxen-sodium) and contact your doctor.

Blood clotting: Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Naproxen Sodium DS (Naproxen-sodium), and whether any special monitoring is needed. If you have a bleeding disorder, do not take Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Naproxen Sodium DS (Naproxen-sodium), and whether any special monitoring is needed. If you have severe, uncontrolled heart failure, you should not take Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (Naproxen-sodium).

Heart Attack and Stroke: Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Naproxen Sodium DS (Naproxen-sodium), and whether any special monitoring is needed. If you have severe kidney problems, you should not take Teva Naproxen Sodium DS (Naproxen-sodium).

Liver problems: Rarely, Teva Naproxen Sodium DS (Naproxen-sodium) causes liver problems. If you have reduced liver function, discuss with your doctor how Teva Naproxen Sodium DS (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (Naproxen-sodium), contact your doctor immediately. If you have liver disease or severely reduced liver function, you should not take Teva Naproxen Sodium DS (Naproxen-sodium).

Skin reactions: Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (Naproxen-sodium) and contact your doctor.

Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (Naproxen-sodium). If you have a history of these conditions, discuss with your doctor how Teva Naproxen Sodium DS (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Naproxen Sodium DS (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: Teva Naproxen Sodium DS (Naproxen-sodium) should not be used during the third trimester (last 3 months) of pregnancy. Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (Naproxen-sodium), contact your doctor immediately.

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

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

Children: The safety and effectiveness of using Teva Naproxen Sodium DS (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 Teva Naproxen Sodium DS (Naproxen-sodium). You should use the lowest effective dose for the shortest period of time under close medical supervision.

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