Package Insert: Information for the UserNaproxeno Aurovitas 500 mg Tablets EFG

Read this 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 read 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 even if they 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 Naproxeno Aurovitas and how is it used

2. What you need to know before starting to take Naproxeno Aurovitas

3. How to take Naproxeno Aurovitas

4. Possible adverse effects

5. Storage of Naproxeno Aurovitas

6. Contents of the package and additional information

Naproxeno Aurovitas contains naproxeno as its active ingredient, a substance that belongs to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).

Naproxeno is indicated for the treatment of:

• Mild to moderate pain, treatment of symptoms of rheumatoid arthritis (inflammation of the joints, including those in the 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).

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

Do not take Naproxeno Aurovitas

• If you are allergic (hypersensitive) to naproxen, naproxen sodium, or any of the other components of this medication (including those listed in section 6), to acetylsalicylic acid (aspirin), other nonsteroidal anti-inflammatory drugs (NSAIDs), or any other pain-relieving medication (such as ibuprofen or diclofenac) and/or 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 one occasion of a stomach or intestinal problem, such as an ulcer or bleeding.
• If you have had a previous stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• If you have ulcerative colitis (a bowel disease).
• If you have liver failure (severe liver problems).
• If you have kidney failure (severe kidney problems).
• Severe heart problems (insufficient heart force 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 nonsteroidal anti-inflammatory drugs, which appear as red patches, generalized redness of the skin, ulcers, or widespread rash accompanied by symptoms similar to 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 may start to develop several months after medication administration (see section 4). If you have developed any of these severe skin reactions with naproxen, do 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, a severe stroke, 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), consult this treatment with your doctor or pharmacist.

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

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

A prolonged treatment with any headache medication may worsen the same. If you think this is your case, please contact your doctor.

Children

Naproxen is not recommended for children under 5 years old.

Other medications and Naproxeno Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recentlyor 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.
• Blood thinners, 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 sulfonilurea (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 (urine pill) (for high 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.
• A quinolone antibiotic (for infections), such as ciprofloxacin or moxifloxacin.
• Some medications for mental health problems, such as lithium or SSRIs, such as fluoxetine or citalopram.
• Probencid (for gout).
• Methotrexate (used to treat skin problems, arthritis, or cancer).
• Ciclosporin or tacrolimus (for skin problems or after an organ transplant).
• Zidovudine (used to treat AIDS and HIV infections).
• Mifepristone (used to interrupt pregnancy or induce labor if the baby has died).
• Antacids or cholestyramine, as they may slow the action of naproxen, but do not affect the total effect.
• Glucocorticoids, naproxen may 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, lactation, and fertility

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

Naproxen should not be administered during pregnancy, childbirth, or 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 may cause kidney and heart problems in the fetus. It may affect your bleeding tendency and that of your baby and may cause the delivery to be delayed or prolonged. Do not take this medication during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises you to. If you need treatment during this period or while trying to become pregnant, use the smallest dose for the shortest time possible. If taken for more than a few days after week 20 of pregnancy, Naproxen may cause kidney problems in your unborn baby that may lead to low amniotic fluid levels 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, so it should not be used during breastfeeding.

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

For fertile women, it should be noted that medications of the type naproxen have been associated with a decrease in the ability to conceive.

Driving and operating machinery

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

Naproxeno Aurovitas contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this 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 indicate the duration of your treatment with naproxen.

The recommended dose is:

Adults

The usual daily dose is 1 or 2 tablets (500 mg or 1,000 mg of naproxen). As a starting 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 as indicated by your doctor.

For the treatment of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis

• The starting dose is usually 1 tablet (500 mg of naproxen) taken twice a day (in the morning and at night) or 2 tablets (1,000 mg of naproxen) taken once a day.

For the treatment of acute gout attacks

• The starting 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 pain is no longer felt. Consult your doctor about the duration of treatment.

For the treatment of dysmenorrhea (menstrual pain)

• The starting 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 starting 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.

For the treatment of menorrhagia (pain associated with excessive menstrual bleeding)

• The starting dose on 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) taken in two doses a day. Continue with a dose of 1 or 2 tablets a day (500 mg or 1,000 mg of naproxen) taken in two doses a 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. Naproxen Aurovitas 500 mg tablets are scored, the transverse score on one of the faces of the tablet allows it 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 other liquid, preferably during or after meals.

Always take the smallest effective dose.

If you take more Naproxeno Aurovitas than you should

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

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

If you forgot to take Naproxeno Aurovitas

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.

Important side effects to identify:

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

Gastrointestinal disorders

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 lining), pancreatitis (inflammation of the pancreas), stomatitis (inflammation of the oral mucosa), and worsening of ulcerative colitis and Crohn's disease.
• Heartburn, indigestion, abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood), and melena (black, tarry stools).

Blood and lymphatic system disorders

Common (may affect up to 1 in 10 people)

• Ecchymosis, reduction in platelet aggregation capacity, prolongation of bleeding time.

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

• Reduction in 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), leukopenia (reduction in the number of white blood cells in the blood), thrombocytopenia (reduction 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 unknown (frequency cannot be estimated from available data)

• Angioneurotic edema (inflammation in the skin, mucosa, and viscera).

Metabolism and nutrition 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 (elevated calcium levels 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)

• Asymptomatic meningitis, angioneurotic edema.

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

• Dizziness, somnolence, headaches, sensation of dizziness, vertigo, cognitive dysfunction, asymptomatic meningitis, convulsions, insomnia, retrobulbar optic neuritis, difficulty concentrating.

Eye disorders

Uncommon (may affect up to 1 in 100 people)

• Blurred vision.

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

• Retrobulbar optic neuritis.

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

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

Vestibular disorders

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

• Auditory disturbances, tinnitus (ringing in the ears), hearing loss.

Cardiac disorders

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

• High blood pressure, heart failure.

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

• Palpitations, congestive heart failure (heart's inability to pump blood), hypertension (high blood pressure). Medications like naproxen may be associated with a moderate increase in the 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)

• Asymptomatic 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)

• Asymptomatic meningitis.

Hepatobiliary disorders

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

• Increased transaminases or alkaline phosphatase, elevated 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 eruptions, sweating, alopecia, skin desquamation, lichen planus (skin disease with small, flat nodules), vesicular rash, skin redness, systemic lupus erythematosus (autoimmune disease with typical skin manifestations, rash, and skin redness), severe vesicular reactions such as Stevens-Johnson syndrome (skin rash with 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 porphyria cutanea tarda appearance, pseudoporphyria (defect in liver enzymes), or epidermolysis bullosa. If fragility, blistering, or other symptoms indicative of pseudoporphyria occur, discontinue treatment and monitor the patient.

Frequency unknown (frequency cannot be estimated from available data)

• Characteristic cutaneous allergic reaction known as fixed drug eruption, which generally reappears at the same site upon re-exposure to the medication and may appear as red, round, or oval patches with swelling on the skin, blisters (urticaria), and pruritus.

Musculoskeletal, connective tissue, and bone disorders

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

• Muscle pain, asthenia.

Frequency unknown (frequency cannot be estimated from available data)

• Lupus erythematosus.

Renal and urinary disorders

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

• Polyuria, proteinuria, glomerulonephritis, elevated serum creatinine, hyperkalemia.

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

• Blood in the urine, interstitial nephritis (renal inflammation with brown-yellow discoloration), nephrotic syndrome, renal disease, renal insufficiency, papillary necrosis (death of renal papilla cells due to metabolic alteration).

Reproductive 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)

• Sweating

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 unknown (frequency cannot be estimated from available data)

• Malaise

Laboratory tests

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

• Abnormal liver function test results, elevated serum creatinine, hyperkalemia.

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging andthe medication that you no longer need at the SIGREpoint of the pharmacy.Please ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition ofNaproxeno Aurovitas

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

- The other components are: lactose monohydrate, cornstarch, carboxymethylstarch sodium (from potato), povidone (E1201), iron oxide yellow (E172), and magnesium stearate (E470b).

Appearance of the product and contents of the packaging

Yellow, speckled, uncoated, biconvex, capsule-shaped tablets, engraved with ‘T’ and ‘20’ on either side of the dividing line on one face, and smooth on the other face of the tablet. Their size is 18.5 mm x 8 mm.

The tablet can be divided into equal doses.

This medication is available in a PVC/PE/PVdC – aluminum blister pack, containing 40 tablets.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for Manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000

Malta

Last review date of this leaflet:June 2024

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