Naproxen Aurovitas 500 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Naproxen Aurovitas 500 mg tablets EFG

Read all of 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Naproxen Aurovitas is and what it is used for
2. What you need to know before taking Naproxen Aurovitas
3. How to take Naproxen Aurovitas
4. Possible side effects
5. How to store Naproxen Aurovitas
6. Contents of the pack and other information

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

Naproxeno Aurovitas contains the active substance naproxen, a compound belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

Naproxen is indicated for the treatment of:

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

2. What you need to know before taking Naproxeno Aurovitas

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

Do not take Naproxeno Aurovitas

• If you are allergic (hypersensitive) to naproxen or to any of the other components of this medicine (listed in section 6);
• If you know you are allergic (hypersensitive) to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs and/or they cause you severe allergic reactions such as: asthma, rhinitis, or nasal polyps;
• If you are currently taking other medicines of this type (non-steroidal anti-inflammatory drugs);
• If you currently have or have previously had on more than one occasion: a stomach or duodenal ulcer or bleeding;
• If you have previously experienced stomach or duodenal bleeding or a gastrointestinal perforation while taking a non-steroidal anti-inflammatory drug;
• If you have ulcerative colitis (a bowel disease);
• If you have severe liver (liver disorders) or kidney (kidney disorders) impairment;
• 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 naproxen.

Serious skin reactions, including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (Lyell's syndrome), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with naproxen. Stop taking this medicine and consult your doctor immediately if you notice any symptoms related to serious skin reactions described in section 4. The rash may progress to widespread blisters or skin peeling. The greatest risk of these serious skin reactions occurs during the first weeks of treatment, but they may begin to develop several months after starting the medicine (see section 4). If you have developed any of these serious skin reactions while using naproxen, you must never restart treatment with naproxen at any time. If you develop a skin rash or these skin symptoms, stop taking naproxen and contact your doctor or seek immediate medical attention.

Exercise caution in the following situations:

• It is important that you use the lowest dose that relieves/controls your pain and that you do not take this medicine longer than necessary to control your symptoms;
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms;
• If you have previously experienced stomach or duodenal bleeding or gastrointestinal perforation while taking a non-steroidal anti-inflammatory drug;
• This risk is higher when high doses and prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor may consider prescribing a stomach-protective medicine;
• If you have or have had stomach problems, as naproxen may cause stomach irritation, bleeding, or ulcers. Your doctor will recommend the most appropriate dose;
• If you have Crohn's disease or ulcerative colitis, as medicines like naproxen may worsen these conditions;
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as naproxen may cause breathing difficulties (bronchospasm);
• If you have severe kidney, liver, or heart problems;
• If you are taking concomitant medicines that affect blood clotting or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants;
• If you have or suspect you have an infection, as naproxen may mask the usual signs and symptoms of infectious processes;
• If you experience stomach pain and/or notice black stools while taking naproxen, you should discontinue treatment with naproxen;
• If you experience vision disturbances during treatment;
• If you are planning to become pregnant, as naproxen may affect fertility.

Cardiovascular precautions

Medicines like naproxen may be associated with a moderate increase in the risk of heart attacks ("myocardial infarction") or strokes. This risk is more likely when high doses and prolonged treatments are used. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of stroke, or think you may be at risk of 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.

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

Other medicines and Naproxeno Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine, as it is very important because naproxen may alter how other medicines work. It is important that you inform your doctor if you are taking any of the following medicines:

• Antacids or cholestyramine, as they may delay the action of naproxen, but do not affect the overall effect;
• Acetylsalicylic acid used to prevent blood clots;
• Hydantoins (medicines primarily used for epilepsy);
• Sulfonylureas (medicines for diabetes);
• Sulfonamides (a type of diuretic medicine);
• Methotrexate (an immunosuppressive medicine);
• Beta-blockers (antihypertensive medicine);
• Furosemide (a medicine with natriuretic effect);
• Lithium. Naproxen may cause an increase in plasma lithium concentration;
• Steroids, as naproxen may interfere with adrenal function tests;
• ACE inhibitors (Angiotensin-Converting Enzyme Inhibitors, antihypertensive medicine);
• Angiotensin receptor antagonists or blockers (antihypertensive medicines).

Your doctor may need to adjust the dose of one or both medicines. Consult your doctor if you have any doubts about these points.

Taking Naproxeno with food and drinks

It is recommended to take the tablets during or immediately after meals to reduce the possibility of stomach discomfort.

Pregnancy, breastfeeding, and fertility

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

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

Because administration of this medicine has been associated with an increased risk of congenital abnormalities or miscarriage, you should not take this medicine during the first and second trimesters unless strictly necessary and specifically prescribed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, naproxen may cause kidney problems in your fetus if taken for more than a few days, which may 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 treatment for longer than a few days is needed, 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

For women of childbearing age, it should be noted that medicines like naproxen have been associated with a reduced ability to conceive.

Driving and using machines

Naproxen should be used with caution in patients whose activities require alertness and who have experienced dizziness or visual disturbances during treatment with this medicine.

Naproxeno Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Naproxeno Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate how long your treatment with naproxen should last.

The recommended dose is:

Adults

The daily dose is usually 1 or 2 tablets (500 mg or 1,000 mg of naproxen). As initial dose, administration of 1 tablet (500 mg of naproxen) followed by half a tablet (250 mg of naproxen) every 6 or 8 hours is recommended, depending on the severity of the condition. These doses may be adjusted as directed by your doctor.

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

• The usual initial dose is 1 tablet (500 mg of naproxen) taken twice daily (in the morning and at night) or 2 tablets (1,000 mg of naproxen) taken once daily.

For the treatment of acute gout attacks

• The usual initial dose is one and a half tablets (750 mg of naproxen), followed by half a tablet (250 mg of naproxen) every 8 hours until pain subsides. Consult your doctor regarding the duration of treatment.

For the treatment of dysmenorrhea (menstrual pain)

• The usual initial dose is 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 one and a half tablets (750 mg of naproxen) at the onset of symptoms, followed by half a tablet (250 mg of naproxen) half an hour after the initial dose.

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

• The initial dose on the first day of menstruation is between one and a half and two and a half tablets (750 mg and 1,250 mg of naproxen), divided into two daily doses. Continue with a dose of 1 or 2 tablets daily (500 mg or 1,000 mg of naproxen), divided into two daily doses, for up to the following 4 days.

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

In patients over 65 years of age or if you have kidney disease or liver disease, it is recommended to reduce the dose and use the lowest effective dose for the shortest possible duration. Consult your doctor.

Use in children and adolescents

This medicine is not recommended for use in children under 16 years of age.

Method of administration

This medicine is taken orally.

The tablet may be divided into equal doses. Naproxeno Aurovitas 500 mg tablets are scored; the transverse groove on one side of the tablet allows the tablet to be split into two halves for cases where doses of 250 mg or 750 mg are required.

Swallow the tablets with a sufficient amount of liquid, such as a glass of water or another drink, preferably during or after meals.

Always take the lowest 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.

Symptoms of overdose include drowsiness, heartburn, indigestion, nausea, vomiting, and in some cases, seizures.

In the event of accidental or intentional overdose, gastric lavage should be performed and symptomatic treatment initiated. Rapid administration of 50–100 g of activated charcoal as an aqueous suspension reduces drug absorption.

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

If you forget to take Naproxeno Aurovitas

Do not take a double dose to make up for missed doses. Take the missed dose as soon as you remember, and then continue with your next scheduled dose.

4. Possible adverse effects

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

The adverse effects that may occur during treatment with this medicine, and which have been observed with very rare frequency (in less than 1 in 10,000 patients), are:

Gastrointestinal disorders; the most frequent adverse effects observed with naproxen are of a gastrointestinal nature (affecting the stomach and intestine):

• inflammation, bleeding (in some cases fatal, especially in elderly patients), peptic ulcers, perforation, and obstruction of the upper or lower gastrointestinal tract (digestive system) may occur;
• cases of 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 have been observed.
• cases of stomach acidity, dyspepsia (digestive disturbances), abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence, hematemesis (vomiting blood), and melena (blackish stools) have also been observed.

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 blood), eosinophilia (increase in certain white blood cells in blood), leucopenia (decrease in the number of white blood cells in blood), thrombocytopenia (decrease in the number of platelets), lymphadenopathy (enlargement of lymph nodes), and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.

Immune system disorders:

• anaphylactoid reactions (acute allergic reaction)
• angioneurotic edema (inflammation of the skin, mucosa, and viscera), elevated body temperature.

Metabolism and nutrition disorders: hypercalcemia (increased concentration of calcium in blood).

Psychiatric disorders:

• difficulty concentrating
• depression, sleep disturbances.

Nervous system disorders: dizziness, somnolence, headache, sensation of dizziness, vertigo, cognitive dysfunction, aseptic meningitis (inflammation of the meninges), seizures, insomnia.

Eye disorders: visual disturbances, corneal opacity, papillitis (inflammation of the optic disc), retrobulbar optic neuritis (inflammation of the optic nerve), and papilledema.

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

Cardiac disorders: palpitations, congestive heart failure (inability of the heart to perform its pumping function), hypertension (high blood pressure). Medicines such as naproxen may be associated with a moderately increased risk of having 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 such as naproxen may rarely be associated with liver damage.

Skin and subcutaneous tissue disorders

• Generalized skin rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), lymphadenopathy, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2. Skin hemorrhage, pruritus, capillary bleeding, sweating, alopecia, skin desquamation, lichen planus (a skin disease characterized by small flat nodules), pustular reactions, skin redness, systemic lupus erythematosus (an autoimmune disease with typical skin signs, rash, and skin redness), very severe blistering reactions such as Stevens-Johnson syndrome (skin rash with map-like appearance) and toxic epidermal necrolysis, allergic reactions, photosensitivity reactions including rare cases where the skin resembles porphyria cutanea tarda, pseudoporphyria (liver enzyme defect), or epidermolysis bullosa. If skin fragility, blister formation, or other symptoms indicative of pseudoporphyria occur, treatment must be discontinued and the patient monitored.

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

Renal and urinary disorders:

• blood in urine, interstitial nephritis (kidney inflammation with yellowish-brown discoloration), nephrotic syndrome, nephropathy (kidney disease), renal failure, renal papillary necrosis (death of cells forming the renal papillae due to metabolic disturbance).

Reproductive system and breast disorders: infertility.

General disorders and administration site conditions: malaise, pyrexia (chills and fever), thirst, sore throat, a characteristic skin allergic reaction known as fixed drug eruption, which typically reappears in the same location upon re-exposure to the drug and may appear as round or oval red spots and skin swelling, urticaria (hives), and pruritus.

Additional investigations: abnormal results in liver function tests, elevated serum creatinine, hyperkalemia.

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Naproxen Aurovitas

• The active substance is naproxen. Each tablet contains 500 mg of naproxen.
• The other components are: monohydrate lactose, maize starch, sodium carboxymethyl starch (type A, from potato), povidone (E1201), yellow iron oxide (E172) and magnesium stearate (E470b).

Appearance of the product and contents of the pack

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

The tablet can be divided into equal doses.

This medicine is available in PVC/PE/PVdC – aluminium 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 the most recent review of this leaflet: October 2025

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