Naproxen

IMPORTANT WARNING:

People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as naproxen may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. These problems may develop at any time during treatment, but the risk may be higher for people who take NSAIDs for a long time or at higher doses. Do not take an NSAID such as naproxen if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take naproxen right before or right after the surgery.

NSAIDs such as naproxen may cause ulcers, bleeding, or holes in the esophagus (tube between the mouth and stomach), stomach, or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time or at higher doses, are older in age, have poor health, who smoke, or who drink large amounts of alcohol while taking naproxen. Tell your doctor if you take any of the following medications: anticoagulants (''blood thinners'') such as warfarin (Coumadin, Jantoven); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) and ketoprofen; oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); salicylate pain relievers such as diflunisal, magnesium salicylate (Doan's, others), and salsalate; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). Also tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, other bleeding disorders, or liver disease. If you experience any of the following symptoms, stop taking naproxen and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to naproxen. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with prescription naproxen and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Naproxen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Are there OTHER USES for this medicine?

Naproxen is also sometimes used to treat Paget's disease of bone (a condition in which the bones become abnormally thick, fragile, and misshapen) and Bartter syndrome (a condition in which the body does not absorb enough potassium, causing muscle cramping and weakness and other symptoms). Talk to your doctor about the risks of using this medication for your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Prescription naproxen comes as a regular tablet, a delayed-release (a tablet that releases the medication in the intestine to prevent damage to the stomach) tablet, an extended-release (long-acting) tablet, and a suspension (liquid) to take by mouth. The extended-release tablets are usually taken once a day. The tablets, delayed-release tablets, and suspension are usually taken twice a day for arthritis. The tablets and suspension are usually taken every 8 hours for gout, and every 6 to 8 hours as needed for pain. If you are taking naproxen on a regular basis, you should take it at the same time(s) every day.

Nonprescription naproxen comes as tablet, a capsule, and a gel capsule to take by mouth. It is usually taken with a full glass of water every 8 to 12 hours as needed. Nonprescription naproxen may be taken with food or milk to prevent nausea.

Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take naproxen exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or written on the package.

If you are taking the suspension, gently shake the suspension well before each use to mix the medication evenly. Use an oral syringe or measuring cup provided by your pharmacist to measure the correct amount of liquid needed for your dose.

Swallow the delayed-release tablets and extended release tablets whole; do not split, chew, or crush them.

If you are taking naproxen to relieve the symptoms of arthritis, your symptoms may begin to improve within 1 week. It may take 2 weeks or longer for you to feel the full benefit of the medication.

Stop taking nonprescription naproxen and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, the part of your body that was painful becomes red or swollen, your pain lasts for more than 10 days, or your fever lasts for more than 3 days.

What SPECIAL PRECAUTIONS should I follow?

Before taking naproxen,

• tell your doctor and pharmacist if you are allergic to naproxen, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and ketoprofen, any medications for pain or fever, other medications, or any of the ingredients in naproxen products. Ask your doctor or pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (Zestril, in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, InnoPran); cholestyramine (Prevalite); cyclosporine (Gengraf, Neoral, Sandimimune); digoxin (Lanoxin); diuretics ('water pills'); lithium (Lithobid), medications for diabetes; methotrexate (Otrexup, Rasuvo, Trexall); pemetrexed (Alimta, Pemfexy); phenytoin (Dilantin, Phenytek); probenecid (Probalan; in Col-Probenecid); and sulfa medications such as sulfamethoxazole (in Bactrim, in Septra). Also tell your doctor if you are taking antacids or sucralfate (Carafate). Your doctor may need to change the doses of your medication or monitor you more carefully for side effects.

• do not take nonprescription naproxen with any other medication for pain unless your doctor tells you that you should.

• tell your doctor if you have been told to follow a low sodium diet and if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the inside of the nose); heart failure; swelling of the hands, arms, feet, ankles, or lower legs; anemia (red blood cells do not bring enough oxygen to all parts of the body); or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant; or are breast-feeding. Naproxen may harm the fetus and cause problems with delivery if it is taken around 20 weeks or later during pregnancy. Do not take naproxen around or after 20 weeks of pregnancy, unless you are told to do so by your doctor. If you become pregnant while taking naproxen, call your doctor.

• you should know that this medication may temporarily decrease fertility in women. Talk to your doctor about the risks of taking naproxen if you have concerns about fertility.

• talk to your doctor about the risks and benefits of taking naproxen if you are 65 years of age or older. Older adults should usually take lower doses of naproxen for short periods of time because higher doses used regularly may not be more effective and are more likely to cause serious side effects.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Naproxen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• gas
• excessive thirst
• headache
• dizziness
• lightheadedness
• drowsiness
• difficulty falling asleep or staying asleep
• burning or tingling in the arms or legs
• cold symptoms
• ringing in the ears
• hearing problems

Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more naproxen until you speak to your doctor:

• changes in vision
• feeling that the tablet is stuck in your throat
• unexplained weight gain
• shortness of breath or difficulty breathing
• swelling in the abdomen, ankles, feet, or legs
• sore throat, fever, chills, and other signs of infection
• blisters
• rash
• skin reddening
• itching
• hives
• swelling of the eyes, face, lips, tongue, throat, arms, or hands
• difficulty breathing or swallowing
• hoarseness
• excessive tiredness
• pain in the upper right part of the stomach
• nausea
• diarrhea
• yellowing of the skin or eyes
• flu-like symptoms
• bruises or purple blotches under the skin
• fast heartbeat
• cloudy, discolored, or bloody urine
• back pain
• difficult or painful urination
• decreased urination
• loss of appetite
• confusion

Naproxen may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• extreme tiredness
• drowsiness
• stomach pain
• heartburn
• nausea
• vomiting
• slow or difficult breathing

What OTHER INFORMATION should I know?

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking naproxen.

If you are taking prescription naproxen, do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.