Leaflet: information for the user

Naproxeno sódico Aurovitas 550 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

1. What isNaproxeno sódico Aurovitasand what it is used for

2. What you need to know before you start takingNaproxeno sódico Aurovitas

3. How to takeNaproxeno sódico Aurovitas

4. Possible side effects

5. Storage ofNaproxeno sódico Aurovitas

6. Contents of the pack and additional information

NaproxenosódicoAurovitas contains naproxeno sódico as its active ingredient, a substance that belongs to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). This medication is used to reduce inflammation and pain in joints and muscles.

NaproxenosódicoAurovitas is indicated for the symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis (pain and stiffness in the neck and back), acute gout attacks, acute musculoskeletal disorders (such as sprains and strains), and dysmenorrhea (painful menstrual periods).

Do not take Naproxeno sódico Aurovitas

• if you are allergic to naproxen, naproxen sodium, or any of the other ingredients in 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 a stomach ulcer or duodenal ulcer, gastritis, or stomach pain.
• if you have had an allergic reaction, such as asthma, runny nose, or itching after taking acetylsalicylic acid, ibuprofen, or other pain-relieving 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.
• Naproxeno sódico Aurovitas may be associated with a moderate increase in the risk of suffering heart attacks (myocardial infarction) or strokes (cerebrovascular accident). This risk is more likely to occur when high doses are used and prolonged treatment is given. Do not exceed the recommended prescribed dose. If you have heart problems, a history of strokes, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), 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 previous 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 previous gastrointestinal symptoms, in combination with other medications that may cause ulcers or increase bleeding, such as anticoagulants, oral corticosteroids, and SSRIs, and in elderly patients. Your doctor may prescribe another medication in combination with naproxen to protect you from gastrointestinal symptoms.

At the beginning of treatment, elderly people often experience adverse effects and should report any unusual gastrointestinal symptoms (hemorrhage especially).

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 associated with the use of naproxen sodium. Stop taking naproxen sodium and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Medications like Naproxeno sódico Aurovitas may contribute to the worsening of infections during chickenpox. Do not use naproxen if you have chickenpox.

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

You must 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 ankles and feet) after using this medication.

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

Other medications and Naproxeno sódico Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, 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:

• blood-thinning medications (anticoagulants).
• SSRIs (Selective Serotonin Reuptake Inhibitors, antidepressants).
• diabetes medications.

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

• blood pressure medications (beta-blockers and diuretics).

• The risk of experiencing adverse effects from these medications may be increased when using naproxeno sódico:

• ACE inhibitors (for example, for high blood pressure).
• lithium (for nervous disorders).
• methotrexate (for rheumatism).
• ciclosporin (for autoimmune disorders).
• other pain-relieving and anti-inflammatory medications (NSAIDs, ibuprofen).
• acetylsalicylic acid for preventing blood clots.

The use of probenecid (for treating gout) may increase the risk of experiencing adverse effects from naproxen sodium.

Pregnancy, breastfeeding, 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.

Pregnancy

Do not take Naproxeno sódico 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 trimesters of pregnancy unless absolutely necessary and advised by your doctor. When naproxen is used in women 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 taken for more than a few days from week 20 of pregnancy, Naproxeno sódico Aurovitas may cause kidney problems in the 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.

Breastfeeding

Naproxen sodium is excreted in breast milk (in the form of naproxen). Therefore, do not use this medication during the breastfeeding period.

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

Driving and operating machinery

Before driving or operating machinery, 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.

Naproxeno sódico Aurovitas contains sodium

This medication contains50mg of sodium (main component of table salt/for cooking) in eachfilm-coated tablet. This is equivalent to2.5% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication 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 taken all at once, or divided into two 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.

Patients over 65 years old and patients with liver and kidney insufficiency

Your doctor will decide the dose, which will usually be lower than that of other adults.

Use in children

Naproxeno Sódico Aurovitas is not recommended for use in children under 16 years old.

Administration form:

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 Naproxeno Sódico Aurovitas than you should

If you have taken more naproxeno sódico than you should, consult your doctor or pharmacist immediately. Preferably bring the packaging or leaflet with you.

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.

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

If you forgot to take Naproxeno Sódico Aurovitas

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

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

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

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

A characteristic skin allergy known as fixed drug eruption, which generally reappears in the same location when exposed to the drug again and may appear as red, round or oval patches and skin swelling, blisters (urticaria) and itching.

Frequency not known: cannot be estimated from available data

Generalized skin rash, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and organ damage (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 common: may affect more than 1 in 10 people

Common: 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 available data

Blood and lymphatic system disorders

Common:bruising after a blow (ecchymosis), decreased blood coagulation.

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

Frequency not known:high blood pressure.

Immune system disorders

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

Nervous system disorders

Common:headache, dizziness, somnolence, vertigo.

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

Eye disorders

Uncommon:blurred vision.

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

Ear and labyrinth disorders

Common: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 the blood vessels (vasculitis).

Frequency not known:high blood pressure (hypertension).

Respiratory, thoracic and mediastinal disorders

Common:shortness of breath.

• Rare:fluid accumulation in the lungs, pneumonia, paroxysmal anxietydue to muscle spasm and inflammation of the respiratory tract mucosa, often accompanied by cough and coughing up mucus (asthma).

Gastrointestinal disorders

Common:heartburn and/or reflux, nausea, stomach discomfort, constipation.

Uncommon:vomiting, gastrointestinal bleeding, peptic ulcers,inflammation of the oral mucosa, thirst, indigestion with a feelingof fullness in the abdomen, stomach pain, belching, nausea,vomiting, burning sensation (dyspepsia) and diarrhea.

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

Frequency not known:stomach ulcer, flatulence, abdominal pain, blood in the stool,stomatitis ulcerosa, exacerbation of colitis and Crohn's diseasehave been reported after administration. Gastritis was observed withlower frequency.

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.

Skin and subcutaneous tissue disorders

Common:skin rash, itching.

Uncommon:hemorrhages.

• Rare:alopecia, skin redness (erythema multiforme), red, blue nodules on the skin (erythema nodosum), pink, blue nodules, small, shiny, and intensely itchy, which appear especially on the neck, armpits, and mouth (lichen planus), pustules, drug hypersensitivity reaction.

Very rare:eruption with blisters (including Stevens-Johnson syndrome andtoxic 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 (glomerulonephritis 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, high potassium levels in the blood that sometimes manifests with muscle cramps, diarrhea, nausea, dizziness, headache (hyperkalemia). Increased concentration of creatinine in the blood.

General disorders and administration site conditions

Common:peripheral edema.

Uncommon:sweating.

Rare:fatigue, decreased body temperature, fever.

Metabolism and nutrition disorders

Rare:decreased appetite.

Psychiatric disorders

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

Medicines like Naproxeno sódico Aurovitas may be associated with a small increase in the risk of suffering a heart attack (myocardial infarction) or stroke (cerebrovascular accident).

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:https://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 after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofNaproxeno sódico Aurovitas

• The active ingredient is naproxeno sódico. Each coated tablet contains 550 mg of naproxeno sódico (equivalent to 500 mg of naproxeno).
• 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, indigotin/aluminium lake indigotin (E 132).

Appearance of the product and contents of the package

Coated tablet.

Dark blue coated tablets in capsule shape, engraved with ‘T’ and ‘22’ on either side of the notch on one face and with a notch on the other face. The tablet can be divided into equal doses.

Naproxeno sódico Aurovitas is available in PVC/Aclar – aluminium blisters and HDPE bottles.

Package sizes:

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

Bottles: 30 and 500 coated tablets.

Only some package sizes may be marketed.

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

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: September 2024

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es).