Package Insert: Information for thePatient

Naprosyn 500 mg Tablets

Naproxen

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

1. What is Naprosyn and how is it used

2. What you need to know before starting to take Naprosyn

3. How to take Naprosyn

4. Possible adverse effects

5. Storage of Naprosyn

6. Contents of the package and additional information

Naprosyn contains as itsactiveingredientnaproxen, a substance that belongs to the group of medications known as nonsteroidal anti-inflammatory drugs(NSAIDs).

Naprosyn is indicated for the treatment of:

• Mild to moderate pain, treatment of the symptoms of rheumatoid arthritis,(inflammation of the joints, including those in the hands and feet, leading to swelling and pain), osteoarthritis(a chronic disorder that causes cartilage damage), acute gout attacks, and ankylosing spondylitis(inflammation affecting the joints of the spine).

• Menstrual pain.

• Relief of pain from acute migraine attacks.

• Pain secondary todegrees associated with intrauterine devices(IUDs).

It is essential to use the smallest effective dose to alleviate or control pain and not to take Naprosyn for longer than necessary to manage your symptoms.

Do not take Naprosyn

• If you are allergic (hypersensitive) to naproxen or any of the other components of this medication (listed in section 6)

• If you know you are allergic (hypersensitive) to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs and experience severe allergic reactions such as asthma, rhinitis, or nasal polyps,
• If you are taking other medications of this type (nonsteroidal anti-inflammatory drugs),

• If you currently have or have had more than once: a stomach ulcer or bleeding, or a duodenal ulcer or bleeding,
• If you have had a previous stomach or duodenal bleeding or have experienced a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug,
• If you have ulcerative colitis (a gastrointestinal disease),

• If you have severe liver (hepatic) or kidney (renal) impairment,
• If you are in the third trimester of pregnancy.
• If you have severe heart failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Naprosyn.

Severe skin reactions have been reported with the use of nonsteroidal anti-inflammatory drugs, appearing as red patches, generalized skin redness, ulcers, or widespread rashes accompanied by symptoms similar to the flu, including fever (see section 4). The rash may progress to generalized blisters or skin peeling. The highest risk of these severe skin reactions is during the first weeks of treatment, but they may start to develop several months after medication administration (see section 4). If you have developed any of these severe skin reactions with Naprosyn, do not restart treatment with Naprosyn at any time. If you develop a skin rash or these symptoms, stop taking Naprosyn and contact your doctor or seek immediate medical attention.

Be cautious in the following situations:

• It is essential to use the smallest effective dose to alleviate or control pain and not to take this medication for longer than necessary to manage your symptoms.
• If you have had or develop a stomach ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• If you have had a previous stomach or duodenal bleeding or have experienced a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug,
• This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcers, and in the elderly. In these cases, your doctor may consider associating a stomach protector.

• If you have or have had gastrointestinal problems, as Naprosyn may cause stomach irritation, bleeding, or ulcers. Your doctor will recommend the most suitable dose,
• If you have Crohn's disease or ulcerative colitis, as Naprosyn-type medications may worsen these conditions,
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as Naprosyn may cause breathing difficulties (bronchospasm),
• If you have severe kidney, liver, or heart problems,
• If you are taking medications that alter blood clotting or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors,
• If you have or suspect you have an infection, as Naprosyn may mask the usual signs and symptoms of infectious processes,
• If you experience stomach pain and/or observe black stools while taking Naprosyn, you should discontinue treatment,
• If you experience visual disturbances during treatment.
• If you wish to become pregnant, as Naprosyn may affect fertility.

Cardiovascular precautions

Medications like Naprosyn may be associated with a moderate increase in the risk of suffering heart attacks ("myocardial infarctions") or strokes. This risk is more likely to occur when using high doses and prolonged treatment. Do not exceed the recommended dose or treatment duration.

If you have heart problems, a history of strokes, or think you may be at risk for these conditions (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker), consult this treatment with your doctor or pharmacist.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Other medications and Naprosyn

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is crucial because Naprosyn may alter the way other medications work. It is essential to inform your doctor if you take any of the following medications:

• Antacids or cholestyramine, as they may slow down the action of Naprosyn, but do not affect the overall effect,
• Acetylsalicylic acid to prevent blood clots,

• Hydantoins (medications used primarily for epilepsy),
• Sulfonilureas (diabetes medications),
• Sulfonamides (a type of diuretic medication),

• Metotrexate (an immunosuppressive medication).
• Beta-blockers (anti-hypertensive medication),
• Furosemide (a medication with natriuretic effect),
• Lithium. It may cause an increase in lithium plasma concentration,
• Glucocorticoids, Naprosyn may interfere with adrenal function tests,
• ACE inhibitors (anti-hypertensive medication).
• Angiotensin receptor blockers (anti-hypertensive medication)

You may need your doctor to adjust the dose of one of the two medications. Consult your doctor if you have any doubts about these points.

Taking Naprosyn with food and drinks

It is recommended to take the tablets during meals or immediately after eating to reduce the likelihood of stomach discomfort.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Naprosyn should not be administered during pregnancy, childbirth, or breastfeeding.

Do not take Naprosyn if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your bleeding tendency and that of your baby, delaying or prolonging delivery more than expected.

Due to the association of Naprosyn-type medications with an increased risk of congenital anomalies/abortions, do not take Naprosyn during the first and second trimesters of pregnancy unless strictly necessary and your doctor indicates it. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible. From week 20 of pregnancy, Naprosyn may cause kidney problems in your fetus if taken for more than a few days, which may lead to low amniotic fluid levels (oligohydramnios). If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

For fertile women, it is essential to consider that Naprosyn-type medications have been associated with a decrease in the ability to conceive.

Driving and operating machinery:

Naprosyn should be used with caution in patients whose activity requires attention and who have observed dizziness or visual disturbances during treatment with this medication.

Naprosyn contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free."

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again..

Your doctor will inform you of the duration of your treatment with Naprosyn.

The recommended dose is:

Adults

The daily dose is usually 1 or 2 tablets (500 mg or 1000 mg of naproxen). As an initial dose, it is recommended to administer 1 tablet (500 mg of naproxen) followed by half a tablet (250 mg of naproxen) every 6 or 8 hours, depending on the intensity of the process.These doses may be modified by your doctor's indication.

For the treatment ofrheumatoid arthritis,osteoarthritisandankylosing spondylitis: the initial dose is usually 1 tablet (500 mg of naproxen) taken twice a day (in the morning and at night) or 2 tablets (1000 mg of naproxen) taken once a day.

For the treatment of acute episodes of gout:the initial dose is usually 1 and a half tablets (750 mg of naproxen) followed by half a tablet (250 mg of naproxen) every 8 hours until you no longer feel pain. Consult your doctor about the duration of treatment.

Por the treatment of dysmenorrhea (menstrual pain): the initial dose is usually 1 tablet (500 mg of naproxen) followed by half a tablet (250 mg of naproxen) every 6 or 8 hours.

Por the treatment of migraine crises:the initial dose is 1 and a half tablets (750 mg of naproxen) when the first symptoms appear, followed by half a tablet (250 mg of naproxen) when 30 minutes have passed since the initial dose.

Por the treatment of menorrhagia (pain associated with excessive menstrual bleeding): the initial dose during the first day of menstruation is between 1 and a half and 2 and a half tablets (750 mg and 1 250 mg of naproxen) divided into two doses per day. Continue with a dose of 1 or 2 tablets per day (500 mg or 1,000 mg of naproxen) divided into two doses per day, for a maximum of 4 days.

Use in patients over 65 years or with kidney and/or liver disease

In patients over 65 years or with kidney or liver disease, it is recommended to reduce the dose and use the lowest effective dose for the shortest possible time. Consult your doctor.

Use in children and adolescents

This medication is not recommended for use in children under 16 years old.

Administration form:

This medication is taken orally.

The tablet can be divided into equal doses. Naprosyn 500 mg tablets are scored, the transverse score on one of the faces of the tablet allows the tablet to be divided into two halves for cases where a dose of 250 mg or 750 mg is required.

Swallow the tablets with a sufficient amount of liquid, a glass of water or another liquid, preferably during or after meals.

Always take the lowest effective dose.

If you take more Naprosyn than you should

If you have taken more Naprosyn than you should, consult your doctor or pharmacist immediately.

The symptoms of overdose are characterized by drowsiness, stomach burning, indigestion, nausea, vomiting, and in some cases, convulsions.

In case of accidental or intentional overdose, proceed with gastric lavage and initiate symptomatic treatment. The rapid administration of 50-100 grams of activated charcoal in the form of a water suspension reduces the absorption of the medication.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, Telephone (91) 562.04.20.

If you forgot to take Naprosyn

Do not take a double dose to compensate for the missed doses, take the dose when you remember and continue with the next dose.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects that may occur during treatment with this medicine, and which have been observed with a very rare frequency (in less than 1 in 10,000 patients) are:

Gastrointestinal disorders:The most frequent side effects observed with Naprosyn are of a gastrointestinal nature (affecting the stomach and intestines)

It may cause inflammation, bleeding(in some cases fatal, especially in the elderly), peptic ulcers, perforation, and obstruction of the upper or lower gastrointestinal tract (digestive system). Cases of esophagitis (inflammation of the esophagus), gastritis (inflammation of the stomach lining), pancreatitis (inflammation of the pancreas), stomatitis (inflammation of the oral mucosa), and worsening of ulcerative colitis and Crohn's diseasehave also been observed. Additionally, cases of stomach acidreflux, dyspepsia (digestive disorders),abdominal pain, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood) and melena (black, tarry stools)

Blood and lymphatic system disorders:agranulocytosis (increase/decrease of certain white blood cells), aplastic and hemolytic anemia (reduction of red blood cells, white blood cells, and platelets in the blood), eosinophilia (increase of certain white blood cells in the blood), leucopenia (decrease of white blood cells in the blood), thrombocytopenia (decrease of platelets), lymph node enlargement, and affection of other organs of the body (drug reaction with eosinophilia and systemic symptoms known as DRESS). See also section 2.

Immune system disorders:anaphylactoid reactions (acute allergic reaction), angioneurotic edema (inflammation of the skin, mucosa, and viscera), elevated body temperature.

Metabolism and nutrition disorders:hypercalcemia (elevated calcium levels in the blood).

Mental disorders:difficulty concentrating, depression, sleep disturbances.

Nervous system disorders:dizziness, somnolence, headaches, sensation of dizziness, vertigo, cognitive dysfunction, aseptic meningitis (inflammation of the meninges), convulsions, insomnia.

Eye disorders:vision disturbances, corneal opacity, papillitis (inflammation of the papilla), retrobulbar optic neuritis (inflammation of the optic nerve) and papillary edema.

Ear and labyrinth disorders:hearing disturbances, tinnitus (ringing in the ears), hearing loss.

Cardiac disorders:palpitations, congestive heart failure (heart's inability to pump blood), hypertension (high blood pressure). Medicines like Naprosyn may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Vascular disorders:vasculitis (inflammation of blood vessels), edema.

Respiratory, thoracic, and mediastinal disorders:asthma, eosinophilic pneumonitis, dyspnea (shortness of breath), pulmonary edema.

Infections and infestations:aseptic meningitis.

Hepatobiliary disorders:hepatitis (inflammation of the liver), jaundice (yellowing of the skin), and elevated liver enzymes. Medicines like Naprosyn may be associated with rare cases of liver damage.

Skin and subcutaneous tissue disorders:cutaneous hemorrhage, pruritus, capillary hemorrhage, generalized skin eruptions, sweating, alopecia, skin peeling, lichen planus (skin disease with small, flat nodules), vesicular rash, skin redness, systemic lupus erythematosus (autoimmune disease with typical skin symptoms, rash, and redness), severe bullous reactions such as Stevens-Johnson syndrome (skin rash resembling a map) and toxic epidermal necrolysis, allergy, photosensitivity reactions, including rare cases where the skin takes on the appearance of porphyria cutanea tarda, pseudoporphyria (liver enzyme defect), or epidermolysis bullosa. If cutaneous fragility, blister formation, or other symptoms indicative of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Musculoskeletal, connective tissue, and bone disorders:muscle pain, asthenia.

Renal and urinary disorders:hematuria, interstitial nephritis (renal inflammation with yellow-brown discoloration), nephrotic syndrome, renal disease, renal insufficiency, papillary necrosis (death of cells forming the renal papillae due to metabolic alteration).

Reproductive and breast disorders:infertility.

General disorders and administration site conditions:general malaise, pyrexia (chills and fever), thirst, sore throat, a characteristic cutaneous allergic reaction known as fixed drug eruption, which usually reappears at the same site upon re-exposure to the drug and may appear as red, rounded, or oval patches and skin swelling, blisters (urticaria), and pruritus.

Complementary examinations:abnormal liver function test values, elevated serum creatinine, hyperkalemia.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es/. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reachof children.

Do not use Naprosyn after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unusedmedicines at the SIGREPoint of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Naprosyn 500 mg tablets

-The active ingredient is naproxen. Each tablet contains 500 mg of naproxen.

-The other components are: povidone K-90, croscarmellose sodium, iron oxide (E-172), and magnesium stearate.

Appearance of the product and content of the container

They are oval-shaped tablets with a yellow color. One of their faces has NPR LE 500 engraved, while the other face of the tablet has a groove that allows the tablet to be divided (it can be divided into two equal doses)

They are presented in containers of 40 tablets.

Holder of the marketing authorization

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Responsible for manufacturing

Recipharm Leganés S.L.U.

C/ Severo Ochoa, 13. Pol. Ind. Leganés

28914 Madrid

Atnahs Pharma Denmark ApS

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Misom Labs Ltd

Malta Life Sciences Park

LS2.01.06

Industrial Estate

San Gwann, SGN 3000

Malta

Local representative

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Last review date of this leaflet in February 2025

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”