Package Insert: Information for the Patient

Naproxeno Sódico Kern Pharma 550 mg Film-Coated Tablets

Naproxeno Sódico

Read this entire 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 refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given 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.

This medication 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 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 disorder 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 should not take naproxen sodium for longer than necessary to control your symptoms.

Do not take Naproxeno sódico Kern Pharma

• If you are allergic (hypersensitive) to naproxen or naproxen sodium, or to any of the other components of this medication (listed in section 6),
• If you know that you are allergic (hypersensitive) to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs and/or cause 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 once: a stomach ulcer or bleeding in the stomach or duodenum,
• If you have had a previous stomach or duodenal bleeding 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 severe liver (hepatic) or kidney (renal) 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 this medication.

Be cautious in the following situations:

• It is essential to use the smallest dose that relieves or controls pain and should not take this medication for longer than necessary to control your symptoms,
• If you have had or develop a stomach ulcer, bleeding, or perforation in the stomach or duodenum, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms,
• If you have had a previous stomach or duodenal bleeding or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug,
• This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcers and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector medication,
• If you have or have had stomach problems, as this medication may cause irritation, bleeding, or stomach ulcers. Your doctor will recommend the most suitable dose,
• If you have Crohn's disease or ulcerative colitis, as naproxen sodium may worsen these conditions,
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as naproxen sodium may cause breathing difficulties (bronchospasm),
• If you have severe kidney, liver, or heart problems,
• If you are taking medications that alter blood clotting or increase the risk of ulcers, such as oral anticoagulants, or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors,
• If you have or suspect you have an infection, as this medication may mask the usual signs and symptoms of infectious processes,
• If you experience stomach pain and/or observe black stools while taking this medication, you should discontinue treatment with naproxen sodium,
• If you experience visual disturbances during treatment,
• This medication should be used with caution in patients with a low-sodium diet and a history of digestive problems,
• If you want to become pregnant, as this medication may affect fertility.

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (Lyell syndrome), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with naproxen sodium. Stop taking this medication and consult your doctor immediately if you observe any symptoms related to severe skin reactions described in section 4.

Cardiovascular precautions

Medications like naproxen sodium may be associated with a moderate increase in the risk of suffering heart attacks ("myocardial infarctions") or strokes. This risk is more likely to occur when using high doses and prolonged treatment. Do not exceed the recommended dose or treatment duration.

If you have heart problems, a history of strokes, or think you may be at risk for these conditions (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should consult this treatment with your doctor or pharmacist.

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

Taking Naproxeno sódico Kern Pharma with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

This is very important, as naproxen sodium may alter the way other medications work. It is essential to inform your doctor or pharmacist if you are taking any of the following medications:

• Antacids or cholestyramine, as they may delay the action of naproxen sodium, but do not affect the overall effect,
• Acetylsalicylic acid to prevent blood clots,
• Hydantoins (medications used primarily for epilepsy),
• Sulfonilureas (diabetes medications),
• Sulfonamides (a type of diuretic medication),
• Methotrexate (an immunosuppressive medication),
• Beta-blockers (anti-hypertensive medication),
• Furosemide (a medication with natriuretic effect),
• Lithium. It may cause an increase in lithium plasma concentration,
• Glucocorticoids, naproxen sodium may interfere with adrenal function tests,
• ACE inhibitors (anti-hypertensive medication),
• Angiotensin receptor blockers (anti-hypertensive medication).

You may need your doctor to adjust the dose of one of the two medications. Consult your doctor if you have any doubts about these points..

Taking Naproxeno sódico Kern Pharma with food and beverages

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

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. Oral forms (e.g., tablets) of this medication may cause severe adverse effects in the fetus.

This medication should not be administered during pregnancy, childbirth, or breastfeeding.

Do not take naproxen sodium if you are in 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 your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected. Do not take naproxeno sódico during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, naproxen sodium may cause kidney problems in your fetus if taken for more than a few days, which may cause 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 a period longer than a few days, your doctor may recommend additional monitoring.

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

Driving and operating machinery

This medication should be used with caution in patients whose activity requires attention and who have observed dizziness or visual disturbances during treatment with this medication.

Naproxeno sódico Kern Pharma contains sodium

This medication contains 52.68 mg of sodium (main component of table salt/for cooking) in each tablet. This corresponds to 2.63% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of this medication 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 Naproxeno sódico.

The recommended dose is:

Adults

The daily dose is usually 1 or 2 tablets (550 mg or 1100 mg of naproxeno sódico). As an initial dose, it is recommended to administer 1 tablet (550 mg of naproxeno sódico) followed by half a tablet (275 mg of naproxeno sódico) every 6 or 8 hours, depending on the intensity of the process. These doses may be modified by your doctor's indication.

For the treatment ofarthritis rheumatoid, osteoarthritis, and ankylosing spondylitis: the initial dose is usually 1 tablet (550 mg of naproxeno sódico) taken twice a day (in the morning and at night) or 2 tablets (1100 mg of naproxeno sódico) taken once a day.

For the treatment ofacute gout attacks: the initial dose is usually 1 and a half tablets (825 mg of naproxeno sódico) followed by half a tablet (275 mg of naproxeno sódico) every 8 hours until you no longer feel pain. Consult your doctor about the duration of treatment.

For the treatment ofmenstrual cramps (dysmenorrhea): the initial dose is usually 1 tablet (550 mg of naproxeno sódico) followed by half a tablet (275 mg of naproxeno sódico) every 6 or 8 hours.

For the treatment ofmigraine attacks: the initial dose is 1 and a half tablets (825 mg of naproxeno sódico) when you first experience symptoms, followed by half a tablet (275 mg of naproxeno sódico) when 30 minutes have passed since the initial dose.

For the treatment ofmenorrhagia (pain associated with excessive menstrual bleeding): the initial dose on the first day of menstruation is between 1 and a half and 2 and a half tablets (825 mg and 1375 mg of naproxeno sódico) divided into two doses per day. Continue with a dose of 1 or 2 tablets per day (550 mg or 1.100 mg of naproxeno sódico) divided into two doses per 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 disease 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.

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

Always take the lowest effective dose

If you take more Naproxeno sódico Kern Pharma than you should

If you have taken more Naproxeno sódico 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, Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Naproxeno sódico Kern Pharma

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 medications, this medication may cause side effects, although not everyone will experience them.

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

Gastrointestinal disorders:The most frequent side effects observed with naproxen sodium are of a gastrointestinal nature (affecting the stomach and intestines).

It may cause inflammation, bleeding(in some cases fatal, especially in the elderly), peptic ulcers, perforation, and obstruction of the upper or lower gastrointestinal tract (digestive system). 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 diseasehave been observed. Also, cases of stomach acid, dyspepsia (digestive disorders),abdominal pain, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood), and melena (black, tarry stools) have been observed.

Blood and lymphatic system disorders:agranulocytosis (increase/decrease of certain white blood cells), aplastic and hemolytic anemia (reduction of red blood cells, white blood cells, and platelets in the blood), eosinophilia (increase of certain white blood cells in the blood), leucopenia (decrease of white blood cells in the blood), thrombocytopenia (decrease of platelets).

Immune system disorders:anaphylactoid reactions (acute allergic reaction), angioneurotic edema (inflammation of the skin, mucosa, and viscera).

Metabolism and nutrition disorders:hyperkalemia (increase of potassium concentration in the blood).

Psychiatric disorders:difficulty concentrating, depression, sleep disturbances.

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

Eye disorders:vision disorders, corneal opacity, papillitis (inflammation of the papilla), retrobulbar optic neuritis (inflammation of the optic nerve), and papillary edema.

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

Cardiac disorders:palpitations, congestive heart failure (heart's inability to pump blood), hypertension (high blood pressure). Medications like naproxen sodium may be associated with a moderate increase in the risk of suffering a myocardial infarction (heart attack) or cerebral.

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). Medications like naproxen sodium may be associated with rare cases of liver damage.

Skin and subcutaneous tissue disorders:cutaneous hemorrhage, pruritus, capillary hemorrhage, skin rash, sweating, alopecia, skin desquamation, lichen planus (cutaneous disease of small flat nodules), vesicular rash, skin redness, systemic lupus erythematosus (autoimmune disease with typical skin symptoms, rash, and skin redness), severe bullous reactions such as Stevens-Johnson syndrome (cutaneous rash with map-like appearance) and toxic epidermal necrolysis, allergy, photosensitivity reactions including rare cases where the skin takes on a porphyria cutanea tarda appearance, pseudoporphyria (defect of liver enzymes) or epidermolysis bullosa. If cutaneous fragility, blister formation, or other symptoms indicative of pseudoporphyria occur, treatment should be suspended and the patient monitored.

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

Renal and urinary disorders:hematuria, interstitial nephritis (renal inflammation with yellow-brown discoloration), nephrotic syndrome, renal disease, renal insufficiency, papillary necrosis (death of cells forming the renal papillae due to metabolic alteration).

Reproductive and breast disorders:infertility.

General disorders and administration site conditions:general malaise, pyrexia (chills and fever), thirst, sore throat.

Complementary examinations:abnormal values of liver function tests, elevated serum creatinine, hyperkalemia.

The side effects that may occur during treatment with this medication, and that have been observed at an unknown frequency (cannot be estimated from available data) are:

Skin and subcutaneous tissue disorders:Generalized skin rash, elevated body temperature, high levels of liver enzymes, abnormal blood counts (eosinophilia), lymph node enlargement, and effects on other organs of the body (drug reaction with eosinophilia and systemic symptoms known as DRESS). See also section 2. 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 skin swelling, blisters (urticaria), and pruritus.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Communication of side effects:

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

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 storage conditions.

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. By doing so, you will help protect the environment.

Composition of Naproxeno sódico Kern Pharma

Tablet:

• Microcrystalline cellulose,
• Povidone,
• Sodium lauryl sulfate,
• Sodium carboxymethylcellulose type A (from potato),
• Talc,
• Magnesium stearate,
• Purified water

Coating:

• Hydroxypropyl methylcellulose,
• Macrogol,
• Titanium dioxide (E-171),
• Indigo carmine (E-132)

Appearance of the product and contents of the packaging

Naproxeno sódico Kern Pharma are film-coated tablets, oblong in shape, blue in color, and have a notch on one face of the tablet. The tablet can be divided into equal doses.

They are presented in packaging of 10 and 40 film-coated tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: July 2024

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