NAPROXEN SUSTAINED-RELEASE - ORAL

NAPROXEN SUSTAINED-RELEASE - ORAL

PHONETIC PRONUNCIATION: (nah-PROX-en)

COMMON BRAND NAME(S): Naprelan

GENERIC NAME(S): naproxen sodium

Uses

USES: Naproxen is used to relieve pain from various conditions. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. Some brands of sustained-release naproxen take longer to be absorbed and are not recommended for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist if you have questions about your particular brand.


How to use NAPROXEN SUSTAINED-RELEASE - ORAL

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using naproxen and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily with a full glass of water (8 ounces/240 milliliters). Do not lie down for at least 10 minutes after taking this drug. To prevent stomach upset, take this medication with food, milk, or an antacid. Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. The dosage is based on your medical condition and response to treatment. Your doctor will usually start you on the short-acting form of this medication and switch you over to this form if it provides the proper dose and if your pain/condition lasts for a long time. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or take this drug more often than directed. For ongoing conditions such as arthritis, continue taking this medication as directed by your doctor. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. For certain conditions (such as arthritis), it may take up to two weeks of taking this drug regularly until you get the full benefit. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

SIDE EFFECTS: See also Warning section. Upset stomach, nausea, heartburn, headache, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, difficult/painful swallowing, hearing changes (such as ringing in the ears), mental/mood changes, signs of kidney problems (such as change in the amount of urine), unexplained stiff neck, vision changes, symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking naproxen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), blood disorders (such as anemia, bleeding/clotting problems), growths in the nose (nasal polyps), heart disease (such as previous heart attack), high blood pressure, liver disease, stroke, throat/stomach/intestinal problems (such as bleeding, heartburn, ulcers). Kidney problems can sometimes occur with the use of NSAID medications, including naproxen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine. This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Some naproxen products contain salt (sodium). Tell your doctor if you are on a salt-restricted diet. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding and kidney problems. Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), cidofovir, corticosteroids (such as prednisone), lithium, "water pills" (diuretics such as furosemide). This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or ketorolac). These drugs are similar to naproxen and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Daily use of naproxen may decrease aspirin's ability to prevent heart attack/stroke. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain/fever. If you must take naproxen, talk to your doctor about possibly taking immediate-release aspirin (not enteric-coated/EC) and then taking your naproxen at a different time after your aspirin. Do not increase your daily dose of aspirin or change the way you take aspirin/other medications without your doctor's approval. This medication can affect the results of certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, extreme drowsiness, seizures.

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Faq for NAPROXEN SUSTAINED-RELEASE - ORAL

Naproxen Sustained-Release is a medication used to relieve pain, inflammation, and swelling caused by conditions like arthritis, gout, and menstrual cramps.

Take Naproxen Sustained-Release tablets orally, with a full glass of water. It is usually taken once daily, preferably with food to reduce stomach upset. Do not crush or chew the tablet, as it is designed to release the medication slowly.

Common side effects of Naproxen Sustained-Release may include stomach upset, nausea, heartburn, headache, drowsiness, and dizziness. If these persist or worsen, consult your doctor.

Naproxen Sustained-Release is generally not recommended during pregnancy, especially during the third trimester, as it may harm the unborn baby and may affect labor and delivery. Consult your doctor before using this medication if you are pregnant or planning to become pregnant.

It is important to inform your doctor about all the medications you are currently taking, including prescription, over-the-counter, and herbal products. Naproxen may interact with certain medications, so your doctor can determine if any adjustments or precautions are necessary.

Naproxen Sustained-Release is not typically recommended for children under 12 years of age. It is advisable to consult a pediatrician to discuss alternative options for pain relief in children.

If you miss a dose, take it as soon as you remember. However, if it is close to the next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.

The onset of action for Naproxen Sustained-Release can vary, but it typically starts relieving pain and inflammation within 1 to 2 hours after taking the medication.

No, Naproxen Sustained-Release is not addictive. It is a nonsteroidal anti-inflammatory drug (NSAID) and does not have addictive properties.


Warning

WARNING: Nonsteroidal anti-inflammatory drugs (including naproxen) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while taking this drug but is more likely if you take it for a long time. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). Do not take this drug right before or after heart bypass surgery (CABG). This drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning at any time while taking this drug. Older adults may be at higher risk for this effect. Stop taking naproxen and get medical help right away if you notice any of these rare but serious side effects: black/tarry stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, slurred speech, sudden vision changes. Talk to your doctor or pharmacist about the benefits and risks of taking this drug.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.