Prospecto: information for the user

Naproxeno sódico Normon 550 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

5.Storage of Naproxeno sódico Normon

6.Contents of the package and additional information

Naproxeno sódico Normon contains naproxeno sódico as its active ingredient, a substance that belongs to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).

Naproxeno 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 gout episodes, and ankylosing spondylitis (inflammation affecting the spine's joints),
• Menstrual pain.
• Relief of pain during acute migraine attacks.
• Pain secondary to bleeding associated with intrauterine devices (IUDs).

It is essential to use the smallest effective dose to alleviate/control pain and not to take Naproxeno sódico Normon for longer than necessary to control your symptoms.

Do not take Naproxeno sódico Normon

• If you are allergic to naproxen or naproxen sodium, or to any of the other components of this medication (listed in section 6).
• If you know you are allergic to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs and experience 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 one occasion: a stomach or duodenal ulcer or bleeding.
• If you have had a stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• If you have ulcerative colitis (a gastrointestinal 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 naproxen:

Severe skin reactions have been reported with the use of nonsteroidal anti-inflammatory drugs, appearing as red patches, generalized skin redness, ulcers, or widespread rash accompanied by symptoms similar to the flu, including fever (see section 4). The rash may progress to generalized blisters or skin peeling. The highest risk of these severe skin reactions is during the first weeks of treatment, but they may start to develop several months after administration of the medication (see section 4). If you have developed any of these severe skin reactions with the use of Naproxeno, do not restart treatment with this medication at any time. If you develop a skin rash or these symptoms, stop taking Naproxeno and contact your doctor or seek immediate medical attention.

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. Stop taking this medication and consult your doctor immediately if you observe any symptoms related to severe skin reactions described in section 4.

During treatment with naproxen, kidney inflammation may occur. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Inform your doctor of these signs.

Be cautious in the following situations:

• It is essential to use the smallest effective dose to alleviate/control pain and not to take this medication for longer than necessary to control your symptoms.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• If you have had a stomach or duodenal hemorrhage 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 elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector medication.
• If you have or have had gastrointestinal problems, as naproxen 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-type medications 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 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 Naproxeno may mask the usual signs and symptoms of infectious processes.
• If you experience stomach pain and/or observe black stools while taking naproxeno, you should discontinue treatment with naproxeno.
• If you experience vision disturbances during treatment.
• This medication should be used with caution in patients with low-sodium diets and a history of gastrointestinal problems.
• If you wish to become pregnant, as naproxen may affect fertility.

Cardiovascular precautions

Medications like naproxen 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 (e.g., you have high blood pressure, diabetes, high cholesterol, or are a smoker), 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).

Other medications and Naproxeno sódico Normon

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

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

• Antacids or cholestyramine, as they may delay the action of Naproxeno, but do not affect the total effect.
• Acetylsalicylic acid to prevent blood clots.
• Hydantoins (medications used primarily for epilepsy).
• Sulfonilureas (diabetes medications).
• Sulfonamides (a type of diuretic medication).
• Metotrexate (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, Naproxeno may interfere with adrenal function tests.
• ACE inhibitors (anti-hypertensive medication).
• Angiotensin receptor antagonists (anti-hypertensive medication).

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

Taking Naproxeno sódico Normon with food and drinks

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

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.

Naproxeno sódico Normon should not be administered during pregnancy, childbirth, or breastfeeding.

Do not take Naproxeno 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.

Due to the association of naproxen-type medications with an increased risk of congenital anomalies/abortions, do not take naproxen during the first and second trimesters of pregnancy unless strictly necessary and your doctor indicates it. 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 may cause kidney problems in your fetus if taken for more than a few days, which may lead to low amniotic fluid levels surrounding the baby. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

For fertile women, it is essential to consider that naproxen-type medications have been associated with a decrease in the ability to conceive.

Driving and operating machinery

Naproxeno sódico Normon 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 Normon contains sodium

This medication contains 51.87 mg of sodium (the main component of table salt/for cooking) in each tablet. This corresponds to 2.59% of the recommended daily maximum sodium intake for an adult.

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

Your doctor will inform you of the duration of your treatment with naproxen.

The recommended dose is:

Adults

The usual daily dose is 1 or 2 tablets (550 mg or 1.100 mg of naproxen sodium). As an initial dose, it is recommended to administer 1 tablet (550 mg of naproxen sodium) followed by half a tablet (275 mg of naproxen sodium) every 6 or 8 hours, depending on the intensity of the process. These doses may be modified at the discretion of your doctor.

For the treatment ofarthritis rheumatoid,osteoarthritisandankylosing spondylitis:The initial dose is usually 1 tablet (550 mg of naproxen sodium) taken twice a day (in the morning and at night) or 2 tablets (1.100 mg of naproxen sodium) taken once a day.

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

For the treatment of dysmenorrhea (menstrual pain): The initial dose is usually 1 tablet (550 mg of naproxen sodium) followed by half a tablet (275 mg of naproxen sodium) every 6 or 8 hours.

For the treatment of migraine crises:The initial dose is 1 and a half tablets (825 mg of naproxen sodium) when the first symptoms appear, followed by half a tablet (275 mg of naproxen sodium) when 30 minutes have passed since the initial dose.

For the treatment of menorragia (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 1.375 mg of naproxen sodium) divided into two doses per day. Continue with a dose of 1 or 2 tablets per day (550 mg or 1.100 mg of naproxen sodium) 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 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 Naproxen sodium Normon than you should

If you have taken more Naproxen 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 grams 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, phone 91 562 04 20, indicating the medication and the amount ingested. Do not go to the hospital alone, ask someone to accompany you. Bring this leaflet with you and any remaining tablets to show to your doctor.

If you forgot to take Naproxen sodium Normon

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 medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

Inflammation, bleeding (in some cases fatal, especially in the elderly), 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. Also, cases of stomach acid, indigestion, abdominal discomfort, 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), angioneuritic edema (inflammation of the skin, mucosa, and viscera).

Metabolism and nutrition disorders:Hypercalcemia (increase of calcium 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 disturbances, 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). Medicines like naproxen may be associated with a moderate increase in the risk of suffering a myocardial infarction (heart attack) or cerebral event.

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:Heptatitis (inflammation of the liver), icterus (yellow discoloration of the skin). Medicines like naproxen may be associated with rare liver damage.

Skin and subcutaneous tissue disorders:Cutaneous hemorrhage, pruritus, capillary hemorrhage, skin eruptions, 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.

Generalized cutaneous eruption, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and organ involvement (pharmacovigilance reaction with eosinophilia and systemic symptoms known as DRESS). See section 2.

A characteristic cutaneous allergic reaction known as fixed drug eruption, which generally reappears in the same location upon re-exposure to the drug and may appear as red, rounded, or oval patches and skin swelling, blisters (urticaria), and pruritus. (unknown frequency)

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

Renal and urinary disorders:Blood in the urine, 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, hyperpotasemia.

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

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 not listed in this prospectus. You can also report them directly through the Spanish System for 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 blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

1. Composition of Naproxeno sódico Normon

• The active ingredient is naproxeno sódico. Each tablet contains 550 mg of naproxeno sódico (equivalent to 500 mg of naproxeno)
• The other components (excipients) are:

Tablet core:Microcrystalline cellulose, sodium lauryl sulfate, povidone, talc, carboxymethylstarch sodium (type A) (from potato), magnesium stearate.

Coating of the tablets with a film:Hydroxypropyl methylcellulose, macrogol, talc, indigo carmine (E132).

Appearance of the product and contents of the packaging

Naproxeno sódico Normon are film-coated tablets, blue, elliptical, biconvex with a groove on one side and flat on the other, with a diameter of 19.7 mm x 8.7 mm ± 10%.

The tablet can be divided into two equal doses.

Naproxeno sódico Normon is available in packaging containing 10 and 40 tablets in a PVDC-PE/AL blister.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Last review date of this leaflet: July 2024

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