NAPROXEN SODIUM AUROVITAS 550 mg FILM-COATED TABLETS

2. What you need to know before taking Naproxen Sodium Aurovitas

Do not take Naproxen Sodium Aurovitas

• if you are allergic to naproxen, naproxen sodium, or any of the other components of this medication (listed in section 6).
• if you are over 65 years old.
• if you have severe kidney failure.
• if you have severe liver failure.
• if you have internal bleeding (such as gastric bleeding, intestinal bleeding, or stroke).
• if you have stomach ulcers, duodenal ulcers, gastritis, or stomach pain.
• if you have ever had an allergic reaction, such as asthma, nasal discharge, or itching after taking acetylsalicylic acid, ibuprofen, or other analgesic or anti-inflammatory medications (NSAIDs).
• if you have increased bleeding or are being treated with anticoagulants.
• if you have severe heart failure.
• during the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take naproxen:

• If you have liver dysfunction.
• If you have an infection.
• Medications like Naproxen Sodium Aurovitas may be associated with a moderate increase in the risk of heart attacks (myocardial infarction) or strokes. This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended prescribed dose. If you have heart problems, a history of strokes, or think you may be at risk of suffering from these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or if you are a smoker), you should consult your doctor or pharmacist before taking this medication.

Gastrointestinal ulcers or bleeding, which can be fatal, may occur at any time during treatment with NSAIDs, without prior symptoms.

In case of gastrointestinal ulcers or bleeding, stop using this medication immediately and consult your doctor. The risk is higher at higher doses, with prior gastrointestinal symptoms, in combination with other medications that may cause ulcers or increase bleeding, such as anticoagulants, oral corticosteroids, and ISRSs, and in elderly patients. See also "Other medications and Naproxen Sodium Aurovitas". Your doctor may prescribe another medication in combination with naproxen to protect you from gastrointestinal symptoms.

At the start of treatment, elderly people often suffer from frequent side effects and should report any unusual gastrointestinal symptoms (especially bleeding).

Severe skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be fatal, have been reported with the use of naproxen sodium. Stop taking naproxen sodium and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Medications like Naproxen Sodium Aurovitas may contribute to the worsening of infections during chickenpox. The use of naproxen is not recommended if you have chickenpox.

Consult your doctor if any of the above warnings apply to you or have applied to you in the past.

You should consult your doctor or pharmacist:

• If you develop gastrointestinal symptoms (such as stomach pain, acidity, or bleeding) after using naproxen sodium.
• If you experience fluid retention (such as swelling of the ankles and feet) after using this medication.

This medication belongs to a group of medications (NSAIDs) that may negatively affect female fertility during use. This is reversible if the use of this medication is discontinued.

Other medications and Naproxen Sodium Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This also applies to medications obtained without a prescription.

• The effect of the following medications may be increased when using naproxen sodium:

• medications to prevent blood clotting (anticoagulants).
• ISRS (Selective Serotonin Reuptake Inhibitors, antidepressants).
• medications for diabetes.

• The effect of the following medications may be reduced when using naproxen sodium:

• medications for the treatment of high blood pressure (beta blockers and diuretics).

• The risk of side effects from these medications may increase when using naproxen sodium:

• angiotensin-converting enzyme inhibitors (ACEIs) (for example, for high blood pressure).
• lithium (for nervous system disorders).
• methotrexate (for rheumatism).
• cyclosporine (for autoimmune disorders).
• other analgesics and anti-inflammatory medications (NSAIDs, ibuprofen).
• acetylsalicylic acid to prevent blood clots.

The use of probenecid (for the treatment of gout) may increase the risk of side effects from naproxen sodium.

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.

Pregnancy

Do not take Naproxen Sodium Aurovitas if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may affect your tendency to bleed and that of your baby, and may cause the delivery to be delayed or prolonged. Naproxen should not be administered during the first and second trimester of pregnancy unless it is absolutely necessary and advised by your doctor. When naproxen is used in women who are trying to become pregnant or during the first or second trimester of pregnancy, the dose should be kept as low as possible and the treatment should be as short as possible. If you take it for more than a few days from the 20th week of pregnancy, Naproxen Sodium Aurovitas may 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.

Breastfeeding

Naproxen sodium is excreted in breast milk (as naproxen). Therefore, this medication should not be used during breastfeeding.

This medication belongs to a group of medications (NSAIDs) that may negatively affect female fertility during use. This is reversible if the use of this medication is discontinued.

Driving and using machines

Before driving or using machines, wait to see how you respond to naproxen sodium. Naproxen sodium may cause drowsiness and dizziness. Therefore, it affects your ability to drive and/or operate machinery.

Naproxen Sodium Aurovitas contains sodium

This medication contains 50 mg of sodium (main component of table salt/cooking salt) per film-coated tablet. This is equivalent to 2.5% of the maximum recommended daily sodium intake for an adult.

3. How to take Naproxen Sodium Aurovitas

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

The recommended dose is:

Acute musculoskeletal disorders and dysmenorrhea (menstrual pain)

The initial recommended dose is 550 mg, followed by half a tablet every 6 or 8 hours as needed, with a maximum daily dose of 1,375 mg after the first day.

Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis

The recommended dose is between 550 mg and 1,100 mg.

The dose can be administered all at once or divided into two doses and taken twice a day.

Gout

The initial dose is 825 mg, followed by 550 mg 8 hours later, and then 275 mg every 8 hours until the episode ends.

Patient over 65 years old and patients with liver and kidney failure

Your doctor will decide the dose, which is usually lower than that for other adults.

Use in children

The use of Naproxen Sodium Aurovitas is not recommended in children under 16 years old.

Method of administration:

This medication is taken orally. The tablets should be taken preferably during or after meals, with a sufficient amount of water or milk. The tablet can be divided into equal doses.

If you take more Naproxen Sodium Aurovitas than you should

If you have taken more naproxen sodium than you should, consult your doctor or pharmacist immediately. Preferably, take the package or package leaflet with you.

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

The following symptoms may occur due to overdose: nausea, vomiting, stomach pain, drowsiness, dizziness, and diarrhea.

If you forget to take Naproxen Sodium Aurovitas

In that case, take the next dose when it is due. Do not take a double dose to make up for forgotten doses.

4. Possible Adverse Effects

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

If you observe any of the following adverse effects, stop taking naproxen sodium and consult your doctor immediately:

Rare: may affect up to 1 in 1,000 people

A characteristic allergic skin reaction known as fixed drug eruption, which usually recurs in the same spot when re-exposed to the medicine and may appear as reddish round or oval spots and swelling of the skin, blisters (urticaria) and itching.

Frequency not known: cannot be estimated from the available data

Generalized skin rash, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), enlargement of the lymph nodes and affectation of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.

The following adverse reactions have been observed during the use of naproxen sodium.

Very frequent: may affect more than 1 in 10 people

Frequent: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

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

Frequency not known: cannot be estimated from the available data

Disorders of the Blood and Lymphatic System

Frequent: hematoma after a blow (ecchymosis), decreased blood coagulation.

Rare: alteration in blood composition, anemia, blood abnormalities (low platelet count) associated with bruising and bleeding (thrombocytopenia), blood disorder (lack of white blood cells) accompanied by increased susceptibility to infections (granulocytopenia), very severe blood disorder (lack of white blood cells) accompanied by sudden high fever, severe sore throat and mouth ulcers (agranulocytosis), blood disorder (lack of white blood cells) accompanied by increased susceptibility to infections (leukopenia), excessive incidence of certain types of white blood cells in the blood (eosinophilia).

Frequency not known: high blood pressure.

Disorders of the Immune System

Rare: adverse reactions (sudden and marked decrease in arterial function, paleness, restlessness, weakness, rapid pulse, cold skin, loss of consciousness) due to a sudden and severe vasodilation resulting from hypersensitivity to certain substances (anaphylactic reaction).

Disorders of the Nervous System

Frequent: headache, dizziness, drowsiness, nausea.

• Rare: infectious disease characterized by inflammation of the meninges and/or spinal cord (aseptic meningitis), swelling (edema) of the mucous membranes (angioneurotic edema), convulsions.

Eye Disorders

Uncommon: blurred vision.

Rare: corneal opacity, eye inflammation (papillitis), nerve inflammation associated with pain, numbness and sometimes impaired function of the optic nerve (retrobulbar optic neuritis), fluid accumulation in the eye or around it (papilledema).

Disorders of the Ear and Labyrinth

Frequent: tinnitus (ringing in the ears).

Uncommon: balance disorder, hearing impairment.

Cardiac Disorders

Uncommon: palpitations.

Frequency not known: heart failure (inability of the heart to perform its pumping function).

Vascular Disorders

Rare: inflammation of blood vessels (vasculitis).

Frequency not known: high blood pressure (hypertension).

Respiratory, Thoracic, and Mediastinal Disorders

Frequent: dyspnea.

• Rare: fluid accumulation in the lungs, pneumonia, paroxysmal appearance of anxiety due to spasm of the muscles and inflammation of the mucosa of the airways often accompanied by coughing and coughing with phlegm (asthma).

Gastrointestinal Disorders

Frequent: acidity and/or reflux, nausea, stomach discomfort, constipation.

Uncommon: vomiting, gastrointestinal bleeding, peptic ulcers, inflammation of the oral mucosa, dry mouth, indigestion with a feeling of fullness in the abdomen, stomach pain, belching, nausea, vomiting, heartburn (dyspepsia) and diarrhea.

Rare: gastrointestinal perforation, ulcers, recurrent (severe) inflammation of the colon (colitis), inflammation of the esophageal wall, vomiting blood, pancreatitis accompanied by intense pain in the upper abdomen that extends to the back and vomiting, dry mouth, throat irritation.

Frequency not known: stomach ulcer, flatulence, abdominal pain, blood in the stool, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration. Gastritis was observed less frequently.

Hepatobiliary Disorders

Rare: jaundice (yellowing of the skin and eyes), liver inflammation (hepatitis) accompanied by jaundice (yellowing of the skin and eyes), including some cases that may be fatal.

Disorders of the Skin and Subcutaneous Tissue

Frequent: skin rash, itching.

Uncommon: bleeding.

• Rare: alopecia, redness of the skin (erythema multiforme), bluish-red bumps on the skin (erythema nodosum), pinkish-blue, small, shiny and intensely itchy nodules that appear especially on the neck, in the armpits and in the mouth (lichen planus), pustules, hypersensitivity reaction due to medication use.

Very rare: blistering rash (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

Musculoskeletal and Connective Tissue Disorders

Rare: muscle weakness.

Renal and Urinary Disorders

Rare: increased need to urinate, protein in the urine (proteinuria), kidney inflammation (glomerular and interstitial nephritis), death of a part of the kidney (renal papillary necrosis), disease characterized by the appearance of protein in the urine (nephrotic syndrome), kidney failure, blood in the urine, excess potassium in the blood that sometimes manifests with muscle cramps, diarrhea, nausea, dizziness, headache (hyperkalemia). Increase in blood creatinine concentration.

General Disorders and Administration Site Conditions

Frequent: fluid retention in the arms and legs (peripheral edema).

Uncommon: sweating.

Rare: fatigue, decreased body temperature, fever.

Metabolism and Nutrition Disorders

Rare: decreased appetite.

Psychiatric Disorders

Rare: insomnia, nervousness, feeling of extreme happiness (euphoria), strange dreams, insufficient concentration, forgetfulness and loss of consciousness (cognitive dysfunction), mild depression.

Medicines like Naproxen Sodium Aurovitas may be associated with a small increased risk of suffering a heart attack (myocardial infarction) or stroke.

Reporting of Adverse Effects

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

5. Conservation of Naproxen Sodium Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging 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 thrown down the drain or into the trash. Deposit the containers and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Naproxen Sodium Aurovitas

• The active principle is naproxen sodium. Each film-coated tablet contains 550 mg of naproxen sodium (equivalent to 500 mg of naproxen).
• The other components are

Core:povidone (K-30) (E1201), microcrystalline cellulose (PH-200) (E460), anhydrous colloidal silica (E551), talc (E553b) and magnesium stearate (E572).

Coating:hypromellose 6cP (E464), titanium dioxide (E171), macrogol/PEG 8000, aluminum indigo lake (E 132).

Appearance of the Product and Package Contents

Film-coated tablet.

Dark blue film-coated tablets, capsule-shaped, engraved with 'T' and '22' on either side of the score line on one face and with a score line on the other face. The tablet can be divided into equal doses.

Naproxen Sodium Aurovitas is available in PVC/Aclar - aluminum blister packs and HDPE bottles.

Package sizes:

Blister pack: 7, 10, 12, 14, 20, 24, 25, 28, 30, 36, 40, 48, 50, 60, 90, 96, 98 and 100 film-coated tablets.

Bottles: 30 and 500 film-coated tablets.

Not all package sizes may be marketed.

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

This medicine is authorized in the Member States of the European Economic Area with the following names:

Date of the last revision of this prospectus: September 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).