NAPROSYN 500 mg TABLETS

2. What you need to know before you take Naprosyn

It is important that you use the smallest dose that relieves/control your pain and do not take Naprosyn for longer than necessary to control your symptoms.

Do not take Naprosyn

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

• If you know you are allergic (hypersensitive) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs and/or they cause you severe allergic reactions such as: asthma, rhinitis, or nasal polyps,
• If you are taking other medicines of this type (non-steroidal anti-inflammatory drugs),

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

• If you have severe liver (hepatic) or kidney (renal) failure,
• 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 non-steroidal anti-inflammatory drugs, appearing as red patches, generalized skin redness, ulcers, or widespread rash accompanied by symptoms similar to those of the flu, including fever (see section 4). The rash may progress to generalized blisters or skin peeling. The greatest risk of these severe skin reactions is during the first weeks of treatment, but they could start to develop up to several months after taking the medicine (see section 4). If you have developed any of these severe skin reactions with the use of Naprosyn, you should 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 medical attention immediately.

Be cautious in the following situations:

• It is essential that you use the smallest dose that relieves/control your pain and do not take this medicine for longer than necessary to control your symptoms.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• If you have had a stomach or duodenal bleeding or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug,
• This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcers, and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach-protecting medicine.

• If you have or have had stomach 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 medicines of the Naprosyn type 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 medicines that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents of the acetylsalicylic acid type. You should also discuss the use of other medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants,
• 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 that your stools appear black when taking Naprosyn, you should interrupt treatment with Naprosyn,
• If you experience vision disorders during treatment.
• If you wish to become pregnant, as Naprosyn may affect fertility.

Cardiovascular precautions

Medicines 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 high doses and prolonged treatments are used. 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), you should discuss this treatment with your doctor or pharmacist.

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

Other medicines and Naprosyn

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is very important because Naprosyn may alter the way other medicines work. It is essential that you inform your doctor if you are taking any of the following medicines:

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

• Hydantoins (medicines used preferably for epilepsy),
• Sulfonylureas (medicines for diabetes),
• Sulfonamides (a type of diuretic medicine),

• Methotrexate (an immunosuppressive medicine).
• Beta-blockers (antihypertensive medicine),
• Furosemide (a medicine with a natriuretic effect),
• Lithium. It may cause an increase in lithium plasma concentration,
• Corticosteroids, Naprosyn may interfere with adrenal function tests,
• ACE inhibitors (angiotensin-converting enzyme inhibitors, antihypertensive medicine).
• Angiotensin receptor antagonists or blockers (antihypertensive medicines)

It may be necessary for your doctor to modify the dose of one of the two medicines. 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 possibility 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 medicine.

Naprosyn should not be administered during pregnancy, childbirth, or during 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 and your baby's tendency to bleed and delay or prolong delivery more than expected.

Because the administration of medicines of the Naprosyn type has been associated with an increased risk of congenital anomalies/abortions, you should not take Naprosyn during the first and second trimester of pregnancy unless it is strictly necessary and indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, Naprosyn may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of the amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

For women of childbearing age, it should be noted that medicines of the Naprosyn type have been associated with a decrease in fertility.

Driving and using machines

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

Naprosyn contains sodium

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

3. How to take Naprosyn

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate 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.

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

For the treatment of acute gout episodes: 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 the pain subsides. Consult your doctor about the duration of treatment.

For 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.

For the treatment of migraineattacks: 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) after half an hour of the initial intake.

For the treatment of menorrhagia(pain associated with excessive menstrual bleeding): the initial dose on the first day of menstruation is between 1 and a half and 2 and a half tablets (750 mg and 1250 mg of naproxen) divided into two daily doses. Continue with a dose of 1 or 2 tablets per day (500 mg or 1000 mg of naproxen) divided into two daily doses for a maximum of 4 days.

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

In patients over 65 years old or if you suffer from kidneyor liverdisease, it is recommended to reduce the dose and use the smallest effective dose for the shortest possible time. Consult your doctor.

Use in children and adolescents

The use of this medicine is not recommended in children under 16 years old.

Method of administration:

This medicine is taken orally.

The tablet can be divided into equal doses. The 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 those cases where it is necessary to administer doses of 250 mg or 750 mg.

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

Always take the smallest 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.

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

In case of accidental or intentional overdose, gastric lavage should be performed and symptomatic treatment should be initiated. The rapid administration of 50-100 grams of activated charcoal in the form of an aqueous suspension reduces the absorption of the medicine.

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

If you forget to take Naprosyn

Do not take a double dose to make up for forgotten doses, take the dose at the moment you remember and continue with the next dose.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The adverse 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 adverse effects observed with Naprosyn are of a gastrointestinal nature (affecting the stomach and intestine)

Inflammation, bleeding (in some cases fatal, especially in the elderly), peptic ulcers, perforation, and obstruction of the upper or lower part of the gastrointestinal tract (digestive system) may occur. Cases of esophagitis (inflammation of the esophagus), gastritis (inflammation of the stomach mucosa), pancreatitis (inflammation of the pancreas), stomatitis (inflammation of the oral mucosa), and worsening of ulcerative colitis and Crohn's disease have been observed. Additionally, cases of stomach acidity, dyspepsia (digestive disorders), abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood), and melena (black-colored stools) have been reported.

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

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

Metabolic and nutritional disorders:hypercalcemia (increased calcium concentration in the blood).

Psychiatric 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 disorders, corneal opacity, papillitis (inflammation of the papilla), retrobulbar optic neuritis (inflammation of the optic nerve), and papilla edema.

Ear and labyrinth disorders:hearing alterations, tinnitus (ringing in the ears), hypoacusis (decreased hearing).

Cardiac disorders:palpitations, congestive heart failure (inability of the heart to perform its pumping function), 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 enzyme levels. Medicines like Naprosyn may be associated with rare cases of liver damage.

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

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

Renal and urinary disorders:blood in the urine, interstitial nephritis (renal inflammation with yellow-brown discoloration), nephrotic syndrome, kidney disease, renal failure, renal papillary necrosis (death of the cells that form the renal papillae due to metabolic alteration).

Reproductive system 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 in the same location upon re-exposure to the medicine and may appear as red, round, or oval patches and skin swelling, hives (urticaria), and pruritus.

Investigations:abnormal values of liver function tests, elevated serum creatinine, hyperpotassemia.

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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es/. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

5. Storage of Naprosyn

Keep this medicine out of the sight and reach of children.

Do not use Naprosyn after the expiration date stated 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 via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Naprosyn 500 mg tablets

• The active ingredient is naproxen. Each tablet contains 500 mg of naproxen.
• The other ingredients are: povidone K-90, sodium croscarmellose, iron oxide (E-172), and magnesium stearate.

Appearance of the product and package contents

They are oval-shaped tablets with a yellow color. On one side, they have the inscription NPR LE 500, while on the other side of the tablet, there is a score line that allows the tablet to be divided into two equal doses.

They are available in packages of 40 tablets.

Marketing authorization holder

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturer

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

Date of the last revision of this leaflet in February 2025

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/"