NAPROXEN AUROVITAS 500 mg TABLETS

Introduction

Package Leaflet: Information for theuser

Naproxen Aurovitas 500 mg tablets EFG

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

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

Contents of the package leaflet

1. What is Naproxen Aurovitas and what is it used for
2. What you need to know before taking Naproxen Aurovitas
3. How to take Naproxen Aurovitas
4. Possible side effects
5. Storage of Naproxen Aurovitas
6. Package contents and additional information

1. What is Naproxen Aurovitas and what is it used for

Naproxen Aurovitas contains the active substance naproxen, which belongs to the group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs).

Naproxen is indicated for the treatment of:

• Mild or moderate pain, treatment of symptoms of rheumatoid arthritis (inflammation of the joints, including hands and feet, leading to swelling and pain), osteoarthritis (a chronic condition that causes cartilage damage), acute episodes of gout, and ankylosing spondylitis (inflammation affecting the joints of the spine).
• Menstrual pain.
• Relief of pain from acute migraine attacks.
• Pain secondary to bleeding associated with intrauterine devices (IUDs).

2. What you need to know before taking Naproxen Aurovitas

It is essential to use the smallest dose that relieves-controls the pain and not to take naproxen for longer than necessary to control your symptoms.

Do not take Naproxen Aurovitas

• If you are allergic (hypersensitive) to naproxen, naproxen sodium, or any of the other components of this medication (listed in section 6), to acetylsalicylic acid (aspirin), other NSAIDs, or any other pain-relieving medication (such as ibuprofen or diclofenac) and/or if you experience severe allergic reactions such as: asthma, rhinitis, or nasal polyps.
• If you are taking other medications of this type (non-steroidal anti-inflammatory drugs).
• If you currently have or have had stomach or intestinal problems, such as an ulcer or bleeding.
• If you have had a stomach bleed or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory medication.
• If you have ulcerative colitis (a bowel disease).
• If you have severe liver problems.
• If you have severe kidney problems.
• Severe heart problems (insufficient heart strength to pump blood).
• If you are in the third trimester of pregnancy.

Do not take naproxen if you are affected by any of the above points. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take naproxen.

Severe skin reactions have been reported with the use of non-steroidal anti-inflammatory drugs, appearing as red spots, generalized redness of the skin, ulcers, or widespread rash accompanied by symptoms similar to those of the flu, including fever (see section 4). The rash can 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 medication (see section 4). If you have developed any of these severe skin reactions with the use of naproxen, you should not restart treatment with naproxen at any time. If you develop a skin rash or these symptoms, stop taking naproxen and contact your doctor or seek immediate medical attention.

If you have heart problems, severe stroke, or think you may be at risk of these (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should consult your doctor or pharmacist about treatment.

Consult your doctor or pharmacist before starting to take this medication if:

• It is essential to use the smallest dose that relieves-controls the pain and not to take this medication 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-colored stools, or even without previous warning symptoms.
• If you have had a stomach bleed or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory medication.
• 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 medication.
• If you have or have had stomach problems, as naproxen can cause stomach irritation, bleeding, or ulcers. Your doctor will recommend the most suitable dose.
• If you are an elderly person.
• You have severe liver, kidney, or heart problems.
• You have blood coagulation problems.
• You have colitis or Crohn's disease (diseases that cause bowel inflammation, pain, diarrhea, vomiting, and weight loss), as medications like naproxen can worsen these conditions.
• If you have asthma or allergies (such as allergic rhinitis) or have had facial swelling, lip swelling, eye swelling, or tongue swelling in the past, as naproxen can cause breathing difficulties (bronchospasm).
• Nasal polyps or if you sneeze frequently or have nasal discharge, or a nose with itching or congestion (rhinitis).
• If you are taking medications that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also discuss the use of other medications that could 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 naproxen can mask the usual signs and symptoms of infectious processes.
• If you experience stomach pain and/or observe that your stools appear black when taking naproxen, you should interrupt treatment with naproxen.
• If you experience vision disorders during treatment.
• If you wish to become pregnant, as naproxen can affect fertility.

Cardiovascular precautions

Medications like naproxen can 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, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should consult your doctor or pharmacist about treatment.

In patients with heart failure, the use of this medication can cause fluid retention (swollen ankles, swollen fingers, mild peripheral edema).

It is preferable not to use this medication if you have chickenpox.

Prolonged treatment with any pain medication can worsen the pain itself. If you think this is your case, please contact your doctor.

Children

Naproxen is not recommended for children under 5 years of age.

Other medications and Naproxen Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This includes any medication purchased without a prescription or herbal remedies.

In particular, inform your doctor if you are taking:

• Other pain medications, such as ibuprofen, diclofenac, or paracetamol.
• Acetylsalicylic acid to prevent blood clots.
• Medications that affect blood coagulation, such as warfarin, heparin, ticlopidine, or clopidogrel.
• A hydantoin (for epilepsy), such as phenytoin.
• Medications of the sulfonamide type (a type of diuretic), such as hydrochlorothiazide, acetazolamide, indapamide, and sulfonamide antibiotics (for infections).
• A sulfonylurea (for diabetes), such as glimepiride or glipizide.
• An ACE inhibitor or any other medication for high blood pressure, such as cilazapril, enalapril, or propranolol.
• An angiotensin-II receptor antagonist, such as candesartan, eprosartan, or losartan.
• A diuretic (a water pill) (for blood pressure), such as furosemide.
• A cardiac glycoside (for heart problems), such as digoxin.
• A steroid (for swelling and inflammation), such as hydrocortisone, prednisolone, and dexamethasone.
• An antibiotic of the quinolone type (for infections), such as ciprofloxacin or moxifloxacin.
• Certain medications for mental health problems, such as lithium or 'IRSs', such as fluoxetine or citalopram.
• Probenecid (for gout).
• Methotrexate (used to treat skin problems, arthritis, or cancer).
• Cyclosporine or tacrolimus (for skin problems or after organ transplantation).
• Zidovudine (used to treat AIDS and HIV infections).
• Mifepristone (used to interrupt pregnancy or to induce labor if the baby has died).
• Antacids or cholestyramine, as they can delay the action of naproxen, but do not affect the overall effect.
• Steroids, as naproxen can interfere with adrenal function tests.

If any of the above points affect you, or if you are unsure, consult your doctor or pharmacist before taking this medication.

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.

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

Do not take this medication during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It can cause kidney and heart problems in the fetus. It can affect your tendency to bleed and that of your baby and may cause labor to be delayed or prolonged more than expected. You should not take this medication during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises you to do so. If you need treatment during this period or while trying to become pregnant, you should use the smallest dose for the shortest possible time. If you take it for more than a few days from the 20th week of pregnancy, Naproxen can cause kidney problems in your unborn baby, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Naproxen is excreted in breast milk; therefore, it should not be used during breastfeeding.

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.

For female patients of childbearing age, it should be noted that medications like naproxen have been associated with a decrease in fertility.

Driving and using machines

Naproxen can cause dizziness and drowsiness as side effects. If you are affected, do not drive or operate hazardous machinery.

Naproxen Aurovitas contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Naproxen Aurovitas

Follow the administration instructions for this medication exactly as 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 naproxen.

The recommended dose is:

Adults

The daily dose is usually 1 or 2 tablets (500 mg or 1,000 mg of naproxen). The initial dose is recommended to be 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 (1,000 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 is relieved. 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 migraine attacks

• 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 during the first day of menstruation is between 1 and a half and 2 and a half tablets (750 mg of naproxen and 1,250 mg of naproxen) divided into two daily doses. Continue with a dose of 1 or 2 tablets per day (500 mg or 1,000 mg of naproxen) divided into two daily doses for a maximum of 4 days.

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

In patients over 65 years of age or if you suffer from kidney or liver disease, 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 medication is not recommended in children under 16 years of age.

Method of administration:

This medication is taken orally.

The tablet can be divided into equal doses. The Naproxen Aurovitas 500 mg tablets are scored, the transverse notch on one face of the tablet allows it to be broken into two equal halves for those cases where a dose of 250 mg or 750 mg needs to be administered.

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 Naproxen Aurovitas than you should

If you have taken more naproxen 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 g of activated charcoal in the form of an aqueous suspension reduces the absorption of the medication.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Naproxen Aurovitas

Do not take a double dose to make up for forgotten doses; take the dose as soon as 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.

Important Adverse Effects to Identify:

Stop taking this medicine and inform your doctor immediately if any of the following adverse effects occur. You may need urgent medical treatment:

Gastrointestinal Disorders

Very Rare (may affect up to 1 in 10,000 people)

• Inflammation, bleeding (in some cases fatal, especially in the elderly), peptic ulcers, perforation, and obstruction of the upper or lower gastrointestinal tract (digestive system).
• 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.
• Acid reflux, dyspepsia (digestive disorders), abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood), and melena (black stools).

Blood and Lymphatic System Disorders

Frequent (may affect up to 1 in 10 people)

• Ecchymosis, reduced platelet aggregation, prolonged bleeding time.

Rare (may affect up to 1 in 1,000 people)

• Reduced hemoglobin and/or hematocrit levels.

Very Rare (may affect up to 1 in 10,000 people)

• 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).

Immune System Disorders

Very Rare (may affect up to 1 in 10,000 people)

• Anaphylactoid reactions (acute allergic reaction)

Frequency Not Known (frequency cannot be estimated from available data)

• Angioedema (inflammation of the skin, mucous membranes, and viscera).

Metabolic and Nutritional Disorders

Rare (may affect up to 1 in 1,000 people)

• Decreased appetite.

Very Rare (may affect up to 1 in 10,000 people)

• Hypercalcemia (increased calcium concentration in the blood).

Psychiatric Disorders

Rare (may affect up to 1 in 1,000 people)

• Nervousness, euphoria, nightmares, difficulty concentrating, cognitive dysfunction, hallucinations.

Very Rare (may affect up to 1 in 10,000 people)

• Depression, sleep disturbances.

Nervous System Disorders

Rare (may affect up to 1 in 1,000 people)

• Aseptic meningitis, angioedema.

Very Rare (may affect up to 1 in 10,000 people)

• Dizziness, somnolence, headaches, feeling of dizziness, vertigo, cognitive dysfunction, aseptic meningitis (inflammation of the meninges), convulsions, insomnia, optic neuritis (inflammation of the optic nerve), concentration difficulties.

Eye Disorders

Uncommon (may affect up to 1 in 100 people)

• Blurred vision.

Rare (may affect up to 1 in 1,000 people)

• Optic neuritis.

Very Rare (may affect up to 1 in 10,000 people)

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

Ear and Labyrinth Disorders

Very Rare (may affect up to 1 in 10,000 people)

• Hearing disturbances, tinnitus (ringing in the ears), hypoacusis (decreased hearing).

Cardiac Disorders

Rare (may affect up to 1 in 1,000 people)

• Hypertension, heart failure.

Very Rare (may affect up to 1 in 10,000 people)

• Palpitations, congestive heart failure (inability of the heart to perform its pumping function), hypertension (high blood pressure). Medications like naproxen may be associated with a moderate increased risk of suffering a heart attack ("myocardial infarction") or stroke.

Vascular Disorders

Very Rare (may affect up to 1 in 10,000 people)

• Vasculitis (inflammation of blood vessels), edema.

Infections and Infestations

Very Rare (may affect up to 1 in 10,000 people)

• Aseptic meningitis.

Respiratory, Thoracic, and Mediastinal Disorders

Very Rare (may affect up to 1 in 10,000 people)

• Asthma, eosinophilic pneumonitis, dyspnea (shortness of breath), pulmonary edema.

Infections and Infestations

Very Rare (may affect up to 1 in 10,000 people)

• Aseptic meningitis.

Hepatobiliary Disorders

Rare (may affect up to 1 in 1,000 people)

• Increased transaminases or alkaline phosphatase, increased bilirubin levels, jaundice, liver damage.

Very Rare (may affect up to 1 in 10,000 people)

• Hepatitis (inflammation of the liver), jaundice (yellowing of the skin). Medications like naproxen may be associated with rare cases of liver damage.

Skin and Subcutaneous Tissue Disorders

Very Rare (may affect up to 1 in 10,000 people)

• Cutaneous hemorrhage, pruritus, capillary hemorrhage, skin rash, sweating, alopecia, skin desquamation, lichen planus (skin disease with small, flat nodules), pus vesicle reaction, skin redness, systemic lupus erythematosus (autoimmune disease with characteristic skin signs, rash, and redness), severe blistering reactions such as Stevens-Johnson syndrome (skin rash with a map-like appearance), drug reaction with eosinophilia and systemic symptoms (DRESS), 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, blistering, or other symptoms indicative of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Frequency Not Known (frequency cannot be estimated from available data)

• Characteristic cutaneous allergic reaction known as fixed drug eruption, which usually reappears in the same location when re-exposed to the medication and may appear as reddish round or oval patches and swelling of the skin, hives (urticaria), and pruritus.

Musculoskeletal, Connective Tissue, and Bone Disorders

Very Rare (may affect up to 1 in 10,000 people)

• Muscle pain, muscle asthenia.

Frequency Not Known (frequency cannot be estimated from available data)

• Systemic lupus erythematosus (SLE).

Renal and Urinary Disorders

Rare (may affect up to 1 in 1,000 people)

• Polyuria, proteinuria, glomerulonephritis, increased serum creatinine, hyperpotasemia.

Very Rare (may affect up to 1 in 10,000 people)

• Hematuria, interstitial nephritis (renal inflammation with yellow-brown discoloration), nephrotic syndrome, kidney disease, renal failure, renal papillary necrosis (death of cells that form the renal papillae due to metabolic disorders).

Reproductive System and Breast Disorders

Very Rare (may affect up to 1 in 10,000 people)

• Infertility.

General Disorders and Administration Site Conditions

Uncommon (may affect up to 1 in 100 people)

• Perspiration

Rare (may affect up to 1 in 1,000 people)

• Fatigue, reduced temperature.

Very Rare (may affect up to 1 in 10,000 people)

• Edema, general malaise, pyrexia (chills and fever), thirst.

Frequency Not Known (frequency cannot be estimated from available data)

• Malaise

Investigations

Very Rare (may affect up to 1 in 10,000 people)

• Abnormal liver function test values, elevated serum creatinine, hyperpotasemia.

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 is not listed in this prospectus. 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 Naproxen Aurovitas

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

Do not use this medicine after the expiration date stated on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofNaproxen Aurovitas

• The active ingredient is naproxen. Each tablet contains 500 mg of naproxen.
• The other ingredients are: lactose monohydrate, cornstarch, sodium carboxymethyl starch (potato), povidone (E1201), yellow iron oxide (E172), and magnesium stearate (E470b).

Appearance of the Product and Package Contents

Yellow speckled, uncoated, biconvex tablets in capsule shape, engraved with 'T' and '20' on either side of the dividing line on one face, and smooth on the other face of the tablet. The size is 18.5 mm x 8 mm.

The tablet can be divided into equal doses.

This medicine is available in PVC/PE/PVdC-aluminum blisters containing 40 tablets.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000

Malta

Date of Last Revision of this Prospectus:June 2024

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