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EC-Naprosyn (Generic Naproxen)

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WARNING

Nonsteroidal anti-inflammatory drug (NSAID) users may be more likely to get a heart attack or stroke than nonusers of these drugs, including those who take naproxen. These occurrences have the potential to be fatal and come about suddenly. The risk may be increased for those who take NSAIDs for a long period or at higher doses. These issues may arise at any point during the course of treatment. If you’ve just had a heart attack, avoid taking an NSAID like naproxen unless your doctor specifically instructs you to. Inform your doctor if you smoke, have high cholesterol, high blood pressure, or diabetes, or if you or anyone in your family has ever suffered from heart disease, a heart attack, or a stroke. If you suffer any of the following symptoms, seek emergency medical attention right away: chest pain, shortness of breath, weakness on one side or area of the body, or slurred speech.

You shouldn’t take naproxen shortly before or right after having coronary artery bypass graft surgery (CABG; a form of cardiac surgery).

In the oesophagus (tube connecting the mouth and stomach), stomach, or intestine, NSAIDs like naproxen may result in ulcers, bleeding, or perforations. These issues could arise at any point during therapy, without any prior symptoms, and could be fatal. The risk may be increased in those who take NSAIDs frequently or in greater dosages, are older, have poorer health, smoke, or consume substantial amounts of alcohol when using naproxen. If you use any of the following medications, let your doctor know: Aspirin, other NSAIDs including ibuprofen (Advil, Motrin), and ketoprofen, as well as anticoagulants (sometimes known as “blood thinners”) such as warfarin (Coumadin, Jantoven); salicylate painkillers such as diflunisal, magnesium salicylate (Doan’s, others), and salsalate; oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); citalopram (Celexa), fluoxetine (Prozac, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft) are examples of selective serotonin reuptake inhibitors (SSRIs); or SNRIs, which include desvenlafaxine (Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). Additionally, let your doctor know if you suffer from liver illness, stomach or intestinal bleeding, other bleeding problems, or ulcers. Stop taking naproxen and make an appointment with your doctor if you suffer any of the following symptoms: stomach pain, heartburn, bloody or resembling coffee grounds vomit, blood in the stool, or tarry or black faeces.

Keep all of your appointments with your physician and the lab. Your doctor will keep a close eye on your symptoms and possibly recommend a few tests to see how your body is responding to naproxen. Inform your physician about your feelings so that they can prescribe the ideal dosage of medication to cure your problem with the least chance of negative side effects.

When you start therapy with prescription naproxen and each time you refill your prescription, your doctor or chemist will give you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, thoroughly read the information, then consult your physician or chemist. The Medication Guide is also available on the Food and Drug Administration (FDA) website or the manufacturer’s website.

Why is this medication prescribed?

In order to treat the symptoms of juvenile arthritis (a form of joint disease in children), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused by a breakdown of the lining of the joints), and ankylosing spondylitis (arthritis that primarily affects the spine), prescription naproxen is used. In addition, bursitis, which is an inflammation of the fluid-filled sac in the shoulder joint, tendinitis, which is an inflammation of the tissue connecting muscle to bone, gouty arthritis, which is an attack of joint pain brought on by an accumulation of specific substances in the joints, as well as pain from various other conditions, such as menstrual pain, can all be treated with prescription-only naproxen tablets, extended-release tablets, and suspension. Non-prescription naproxen is used to treat minor discomfort from toothaches, backaches, menstrual cramps, arthritis, headaches, muscular pains, and the common cold. Naproxen belongs to the group of drugs known as NSAIDs. It functions by halting the body’s production of a chemical responsible for inflammation, fever, and discomfort.

How should this medicine be used?

Regular tablets, delayed-release tablets (which release the medication in the intestine rather than the stomach to prevent stomach injury), extended-release (long-acting) tablets, and oral suspensions are all available as forms of prescription naproxen. Typically, one daily dose of the extended-release tablets is required. For arthritis, the tablets, delayed-release tablets, and suspension are typically taken twice day. For gout, the tablets and suspension are often taken every eight hours, and for pain, every six to eight hours as needed. If you regularly take naproxen, you should do so at the same time(s) each day.

To be taken orally, non-prescription naproxen is available as a tablet, a capsule, and a gel capsule. It is typically taken as needed, every 8 to 12 hours, with a full glass of water. To prevent motion sickness, non-prescription naproxen can be given with food or milk.

Ask your doctor or chemist to explain any instructions on the packaging or prescription label that you do not understand, and carefully follow them. Take naproxen as instructed by your doctor. Never take it in larger or less amounts or more frequently than recommended by your doctor or the label on the medication.

If you’re taking a suspension, give it a good gentle shake well before each dose to mix the drug. For the precise amount of liquid required for your dose, use an oral syringe or measuring cup that your pharmacist will give.

Do not split, chew, or crush the extended-release or delayed-release pills; instead, swallow them whole.

Your arthritis symptoms may start to get better within a week if you are taking naproxen to treat them. You might not get all of the medication’s benefits for two weeks or longer.

If your symptoms worsen, you have new or unexpected symptoms, the area of your body that was hurting turns red or swollen, your pain lasts longer than 10 days, or your fever lasts longer than three days, stop using nonprescription naproxen and contact your doctor.

Other uses for this medicine

Naproxen is also occasionally used to treat Bartter syndrome, a condition in which the body does not absorb enough potassium, which results in symptoms including weakness and cramping in the muscles, as well as Paget’s disease of the bones, in which the bones grow unusually thick, fragile, and deformed. The dangers of using this drug for your illness should be discussed with your doctor.

Ask your doctor or chemist for more details if you’re interested in using this medication for any other conditions.

What special precautions should I follow?

Before taking naproxen,

  • Inform your doctor and chemist if you have any drug allergies, including those to naproxen, aspirin, other NSAIDs including ibuprofen (Advil, Motrin), ketoprofen, or any of the components in naproxen products. For a list of the ingredients, ask your doctor or chemist.
  • Inform your doctor and chemist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Mention the drugs in the IMPORTANT WARNING section as well as any of the following: Drugs that inhibit the angiotensin-converting enzyme (ACE), such as benazepril (Lotensin, in Lotrel), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, and lisinopril (Zestril, in Zestoretic), moexipril (Univasc), Angiotensin receptor blockers (ARBs) include candesartan (Atacand, in Atacand HCT), ramipril (Altace), and trandolapril (Mavik, in Tarka); ramipril (Altace), and trandolapril (Mavik, in Tarka); losartan (Cozaar, Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); eprosartan (Teveten), irbesartan (Avapro, in Avalide); beta blockers like nadolol (Corgard, in Corzide), propranolol (Hemangeol, Inderal, InnoPran), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), and atenolol (Tenormin, in Tenoretic); digoxin (Lanoxin), cholestyramine (Prevalite), cyclosporine (Gengraf, Neoral, Sandimimune), diuretics (‘water pills’), lithium (Lithobid), and diabetes medicines; phenytoin (Dilantin, Phenytek), methotrexate (Otrexup, Rasuvo, Trexall), pemetrexed (Alimta, Pemfexy); sulfa drugs like sulfamethoxazole (in Septra, Bactrim) and probenecid (Probalan; in Col-Probenecid) are examples of these. Additionally, let your physician know if you use antacids or sucralfate (Carafate). Your physician might need to adjust the dosage of your medication or keep a closer eye on you for adverse effects.
  • Non-prescription naproxen should not be taken with any other painkillers unless your doctor specifically instructs you to.
  • In particular, if you also have frequent stuffy or runny nose, nasal polyps (swelling of the inside of the nose), heart failure, swelling of the hands, arms, feet, ankles, or lower legs, anaemia (red blood cells do not bring enough oxygen to all parts of the body), or kidney disease, inform your doctor if you have been advised to follow a low sodium diet and if you have any of the conditions listed in the IMPORTANT WARNING section.
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. If naproxen is consumed beyond 20 weeks of pregnancy, it may harm the foetus and complicate delivery. When you are 20 weeks pregnant or afterward, avoid taking naproxen unless your doctor specifically instructs you to. Call your doctor if you become pregnant while taking naproxen.
  • You should be aware that this medicine may momentarily lower female fertility. If you are worried about your fertility, discuss the dangers of taking naproxen with your doctor.
  • If you are 65 years of age or older, discuss the advantages and disadvantages of taking naproxen with your doctor. Since bigger dosages taken frequently may not be more beneficial and are more likely to have major side effects, older persons should typically only take lower doses of naproxen for brief periods of time.
  • Inform your doctor or dentist that you are taking naproxen if you are having surgery, including dental surgery.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Naproxen could have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Constipation
  • Gas
  • Extreme thirst
  • Headache
  • Dizziness
  • Lightheadedness
  • Drowsiness
  • Having trouble falling or staying asleep
  • Tingling or burning in the legs or arms
  • Cold signs
  • Hearing ringing
  • Hearing issues

Some adverse effects can be very harmful. Call your doctor right away if you have any of the following symptoms or those listed in the IMPORTANT WARNING section. As soon as you have spoken with your doctor, stop using naproxen:

  • Alterations to vision
  • Experiencing throat pain from the tablet
  • Rise in weight without cause
  • Respiratory issues or lack of breath
  • Abdomen, ankles, foot, or leg swelling
  • Infection symptoms such as a sore throat, fever, chills, and others
  • Blisters
  • Rash
  • Skin turning crimson
  • Itching
  • Hives
  • Swelling of the hands, arms, hands, cheeks, lips, tongue, throat, or eyes
  • Breathing or swallowing challenges
  • Hoarseness
  • Extreme fatigue
  • Stomach ache in the top right corner
  • Nausea
  • Diarrhea
  • Eyes or skin that have a yellow tint
  • Flu-like signs
  • Purple spots or bruises under the skin
  • Rapid heart rate
  • Urine that is hazy, discoloured, or bloody
  • Back ache
  • Uncomfortable or challenging urinating
  • Less urinations
  • Reduced appetite
  • Confusion

Other negative effects of naproxen may occur. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you suffer a serious side event.

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it at room temperature and out of the bathroom and other places with excessive heat and moisture.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the ideal approach to get rid of your medicines. To find out about take-back programmes in your area, speak with your chemist or the garbage/recycling department in your city. If you do not have access to a take-back programme, visit the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Extreme fatigue
  • Drowsiness
  • Abdominal pain
  • Heartburn
  • Nausea
  • Vomiting
  • Sluggish or challenging breathing

What other information should I know?

Inform the lab staff and your doctor that you are taking naproxen prior to any laboratory test.

Do not give anyone else your prescription naproxen if you are using it. Any queries you may have regarding prescription refills should be directed to your chemist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Aleve®
  • Anaprox®
  • Anaprox® DS
  • EC-Naprosyn®
  • Flanax®
  • Naprelan®
  • Naprosyn®
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