Naproxen sodium Aurovitas 550 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Naproxen sodium Aurovitas 550 mg film-coated tablets EFG

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

• Keep this leaflet. 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, because it may harm them.
• If you experience any adverse effects, talk to 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 sodium Aurovitas is and what it is used for
2. What you need to know before taking Naproxen sodium Aurovitas
3. How to take Naproxen sodium Aurovitas
4. Possible side effects
5. How to store Naproxen sodium Aurovitas
6. Contents of the pack and other information

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

Naproxeno sódico Aurovitas contains the active substance naproxeno sódico, a compound belonging to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). This medicine is used to reduce inflammation and pain in the joints and muscles.

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

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 ingredients of this medicine (listed in section 6).
• if you are over 65 years of age.
• if you have severe renal impairment.
• if you have severe hepatic impairment.
• if you have internal bleeding (such as gastric bleeding, intestinal bleeding, or stroke).
• if you have gastric or duodenal ulcer, gastritis, or stomach pain.
• if you have previously had an allergic reaction, such as asthma, runny nose, or itching, after taking acetylsalicylic acid, ibuprofen, or other painkillers or anti-inflammatory medicines (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 taking naproxen:

• If you have hepatic dysfunction.
• If you have an infection.
• Medicines such as Naproxen Sodium Aurovitas may be associated with a moderately increased risk of heart attack (myocardial infarction) or stroke (cerebrovascular accident). This risk is more likely when high doses are used or treatment is prolonged. Do not exceed the recommended prescribed dose. If you have heart problems, a history of stroke (cerebrovascular accident), 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), you should consult your doctor or pharmacist before taking this medicine.

Gastrointestinal ulcers or bleeding, which may be life-threatening, can occur at any time during treatment with NSAIDs, even without prior warning symptoms.

If you experience gastrointestinal ulcers or bleeding, stop using this medicine immediately and consult your doctor. The risk is higher at higher doses, with previous gastrointestinal symptoms, when used in combination with other medicines that may cause ulcers or increase bleeding, such as anticoagulants, orally administered corticosteroids, and SSRIs, and in elderly patients. See also “Other medicines and Naproxen Sodium Aurovitas”. Your doctor may prescribe another medicine to be taken in combination with naproxen to protect you from gastrointestinal symptoms.

At the beginning of treatment, elderly patients frequently experience adverse effects and should report any unusual gastrointestinal symptoms (especially bleeding).

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

Medicines such as Naproxen Sodium Aurovitas may contribute to worsening 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 previously applied.

You should consult your doctor or pharmacist:

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

This medicine belongs to a group of medicines (NSAIDs) that may negatively affect female fertility during use. This effect is reversible upon discontinuation of the medicine.

Other medicines and Naproxen Sodium Aurovitas

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

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

• medicines used to prevent blood clotting (anticoagulants).

• SSRIs (Selective Serotonin Reuptake Inhibitors, antidepressants).

• medicines for diabetes.

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

• medicines for high blood pressure (beta-blockers and diuretics).

• The risk of adverse effects from these medicines may increase when using naproxen sodium:

• angiotensin-converting enzyme inhibitors (ACE inhibitors) (e.g., for high blood pressure).

• lithium (for nervous disorders).

• methotrexate (for rheumatoid arthritis).

• cyclosporine (for autoimmune disorders).

• other painkillers and anti-inflammatory medicines (NSAIDs, ibuprofen).

• acetylsalicylic acid for preventing blood clots.

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

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.

Pregnancy

Do not take Naproxen Sodium Aurovitas during the last 3 months of pregnancy, as it could harm the fetus or cause problems during delivery. It may affect your bleeding tendency and that of your baby, and may delay or prolong labor. 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 who are trying to conceive or during the first or second trimester of pregnancy, the dose should be kept as low as possible and treatment should be as short as possible. If taken for more than a few days starting from week 20 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 require 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 medicine should not be used during breastfeeding.

This medicine belongs to a group of medicines (NSAIDs) that may negatively affect female fertility during use. This effect is reversible upon discontinuation of the medicine.

Driving and using machines

Before driving or operating machinery, wait to see how you react to naproxen sodium. Naproxen sodium may cause drowsiness and dizziness. Therefore, it may affect your ability to drive and/or operate machinery.

Naproxen Sodium Aurovitas contains sodium

This medicine contains 50 mg of sodium (a main component of table/cooking salt) in each film-coated tablet. This corresponds to 2.5% of the maximum daily sodium intake recommended for an adult.

3. How to take Naproxen Sodium Aurovitas

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

The recommended dose is:

Acute musculoskeletal disorders and dysmenorrhea (menstrual pain)

The recommended initial 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 may be administered as a single dose or divided into two doses taken twice daily.

Gout

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

Patients over 65 years of age and patients with hepatic or renal impairment

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

Use in children

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

Method of administration

This medicine is taken orally. Tablets should preferably be taken during or after a meal, with a sufficient amount of water or milk. The tablet may 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, contact your doctor or pharmacist immediately. Take the packaging or leaflet with you if possible.

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

The following symptoms may occur in overdose: nausea, vomiting, gastric pain, somnolence, dizziness, and diarrhea.

If you forget to take Naproxen Sodium Aurovitas

In this case, take the next dose at the scheduled time. 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 everyone experiences them.

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

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

A characteristic skin allergic reaction known as fixed drug eruption, which usually reappears at the same site upon re-exposure to the medicine and may appear as red, round or oval skin patches, swelling of the skin, 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 involvement 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 sodium naproxen.

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 injury (ecchymosis), reduced blood clotting.
Rare: changes in blood composition, anaemia, 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), a very serious 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 (leucopenia), excessive occurrence of certain types of white blood cells (eosinophilia).
Frequency not known: elevated blood pressure.

Immune system disorders

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

Nervous system disorders

Common: headache, dizziness, drowsiness, vertigo.
Rare: infectious disease characterized by inflammation of the meninges and/or spinal cord (aseptic meningitis), swelling (edema) of mucous membranes (angioneurotic edema), seizures.

Eye disorders

Uncommon: blurred vision.
Rare: corneal opacity, inflammation in the eye (papillitis), nerve inflammation associated with pain, numbness, and sometimes impaired optic nerve function (retrobulbar optic neuritis), accumulation of fluid in or around the eye (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 blood vessels (vasculitis).
Frequency not known: increased blood pressure (hypertension).

Respiratory, thoracic and mediastinal disorders

Common: dyspnea.
Rare: accumulation of fluid in the lungs, pneumonia, paroxysmal anxiety due to spasm of muscles and inflammation of the mucous membranes of the airways, often accompanied by cough and productive cough (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 feeling of fullness in the abdomen, stomach pain, belching, nausea, vomiting, burning sensation (dyspepsia), and diarrhoea.
Rare: gastrointestinal perforation, ulcers, recurrent (severe) inflammation of the colon (colitis), inflammation of the oesophageal wall, vomiting with blood, inflammation of the pancreas accompanied by severe upper abdominal pain radiating to the back and vomiting (pancreatitis), dry mouth, throat irritation.
Frequency not known: gastric ulcer, flatulence, abdominal pain, blood in stools, 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), inflammation of the liver (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: haemorrhages.
Rare: alopecia, redness of the skin (erythema multiforme), blue-red lumps on the skin (erythema nodosum), small, shiny, pink-blue nodules, intensely itchy, appearing especially on the neck, armpits, and 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 urine (proteinuria), inflammation of the kidneys (glomerular and interstitial nephritis), death of part of the kidney (papillary renal necrosis), condition characterized by the presence of protein in urine (nephrotic syndrome), renal failure, blood in urine, excess potassium in blood which may sometimes manifest as muscle cramps, diarrhoea, nausea, dizziness, headache (hyperkalaemia). Increased blood creatinine concentration.

General disorders and administration site conditions

Common: fluid retention in arms and legs (peripheral oedema).
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, poor concentration, forgetfulness, and loss of consciousness (cognitive dysfunction), mild depression.

Medicines such as Sodium Naproxen Aurovitas may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (cerebrovascular accident).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Naproxen Sodium 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 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 point at your pharmacy. If you have any doubts, 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 Sodium Aurovitas

• The active substance 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, indigo carmine/aluminum indigo carmine lake (E132).

Appearance of the product and contents of the pack

Film-coated tablet.

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

Naproxen Sodium Aurovitas is available in PVC/Aclar – aluminum blisters and HDPE bottles.

Pack sizes:

Blister: 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.

Only certain pack 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 medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: September 2024

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