Package Leaflet: Information for the User

Naproxeno Normon 500 mg Tablets EFG

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. Before taking Naproxeno Normon

3. How to take Naproxeno Normon

4. Possible side effects

5. Storage of Naproxeno Normon

6. Additional information

Naproxeno belongs to a group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), with anti-inflammatory (against inflammation), analgesic (against pain), and antipyretic/antithermic (fever reduction) properties.

NaproxenoNormonis indicated for the treatment of inflammatory and painful processes in joints, muscles, tendons, and ligaments such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. NaproxenoNormonis also indicated for the treatment of acute gout attacks, rheumatic syndromes, and menstrual cramps.

It is essential to use the smallest effective dose to alleviate or control pain and not to take this medication for longer than necessary to control your symptoms.

Do not takeNaproxeno Normon:

• If you are allergic (hypersensitive) to naproxen, naproxen sodium, or any of the other components of Naproxeno Normon.
• If you have an allergy to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs and/or experience severe allergic reactions.
• If you have had a previous gastrointestinal hemorrhage or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• If you have any intestinal disease.
• If you have severe liver or kidney disease.
• Naproxeno Normon should not be administered to children under 2 years old.
• If you have severe heart failure.

• During the third trimester of pregnancy.

Be especially careful with Naproxeno Normon:

• If you have had or develop a stomach or duodenal ulcer, hemorrhage, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatments, especially in patients with a history of peptic ulcers and the elderly. In these cases, your doctor may consider associating a stomach protector medication.

• If you have asthma or allergic disorders, as Naproxeno Normon may cause breathing difficulties (bronchospasm).

If you have severe kidney, liver, or heart problems, consult your doctor.

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

If you have heart problems, a history of brain attacks, or think you may be at risk for these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking), consult this treatment with your doctor or pharmacist.

This type of medication may also cause fluid retention, especially in patients with heart failure and/or high blood pressure.

• If you are taking other anti-inflammatory medications, consult your doctor.
• If you have, or suspect you have, an infection, as Naproxeno Normon may mask the usual signs and symptoms of infectious processes, consult your doctor.

• If you experience vision disturbances during treatment, consult your doctor or pharmacist.

Inform your doctor:

• If you are taking medications that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medications that may increase the risk of these hemorrhages, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as medications like Naproxeno Normon may worsen these conditions.
• 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 Naproxeno Normon. Stop taking Naproxeno Normon and consult your doctor immediately if you observe any symptoms related to severe skin reactions described in section 4.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

• Do not recommend the concurrent administration of Naproxeno Normon with the following medications:
• anti-acids or cholestyramine, as they may delay the action of Naproxeno Normon,
• hydantoins (medications used primarily for epilepsy),
• sulfonilureas (medications for diabetes),
• sulfonamides (a type of medication used to increase urine elimination),
• methotrexate (an immunosuppressive medication),
• probencid (a medication used in patients with gout),
• furosemide (a type of medication used to increase urine elimination),

• lithium (antipsychotic, for treating depression),
• ACE inhibitors (to reduce blood pressure),
• β-blockers (to reduce blood pressure).

Taking Naproxeno Normon with food and beverages

Swallow the tablets with a sufficient amount of liquid, a glass of water, or other liquid. It is recommended to take the product during meals.

Pregnancy and lactation:Consult your doctor or pharmacist before using any medication. Naproxeno Normon should not be administered during pregnancy, childbirth, or lactation.

Due to the association of medications like Naproxeno Normon with an increased risk of congenital anomalies/abortions, it is not recommended to administer the medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of Naproxeno Normon is contraindicated.

Do not take Naproxeno Normon if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause renal and cardiac problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong childbirth more than expected. Do not take Naproxeno Normon 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, Naproxeno Normon may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (arterial duct) 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 is essential to consider that medications like Naproxeno Normon have been associated with a decrease in the ability to conceive.

Driving and operating machinery. Naproxeno Normon should be used with caution in patients whose activity requires attention and who have observed vertigo or visual disturbances during treatment with this medication.

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

The recommended dose is:

Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:The usual initial dose is one to two tablets (500-1000 mg of naproxen) twice a day (morning and night). In patients with severe nocturnal pain and/or morning numbness, patients switching from another anti-rheumatic treatment to Naproxeno Normon, and in osteoarthritis with pain as the predominant symptom, it is recommended to start therapy with a dose of one and a half to two tablets (750-1000 mg) per day for several weeks. As maintenance therapy, a single daily dose of one to two tablets (500-1000 mg) in the morning or evening may be administered.

Acute gout:A dose of one and a half tablets (750 mg) is recommended, followed after 8 hours by one tablet (500 mg), and then continue with half a tablet (250 mg) every 8 hours until the attack subsides.

Menstrual cramps:The initial recommended dose is one tablet (500 mg) followed by half a tablet (250 mg) every 6 or 8 hours.

Acute musculoskeletal processes:The initial recommended dose is one tablet (500 mg) followed by half a tablet (250 mg) every 6 or 8 hours.

Inacute crisesand whenever there are no previous gastrointestinal disease, the dose may be increased to three tablets (1500 mg) for no more than 2 weeks.

Use in children:

In juvenile rheumatoid arthritis, a dose of 10 mg/kg/day, divided into two doses, 12 hours apart, is recommended.

Special populations:

In patients over 65 years old or with heart, liver, or kidney disease, the dose should be reduced.

Administration form:

This medication is administered orally. Swallow the tablets with a sufficient amount of liquid in a glass of water or other liquid. It is recommended to take the product during meals.

If you take more Naproxeno Normon than you should

The symptoms of an overdose are: dizziness, drowsiness, abdominal pain, indigestion, stomach acid, nausea. Transient liver disorders, blood clotting deficiency, renal disorders, excessive blood acidity, temporary suspension of breathing, disorientation, or vomiting.

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.It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to takeNaproxeno Normon

Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

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

The side effects, all of which are very rare (less than 1 in 10,000 people), that may occur during treatment are:

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).

Mental health disorders:difficulty concentrating, depression, sleep disturbances.

Nervous system disorders:dizziness, somnolence, headaches (headache), sensation of dizziness, vertigo, cognitive dysfunction (alteration in knowledge), aseptic meningitis (inflammation of the meninges), convulsions, insomnia, sleep anomalies.

Eye disorders:vision disturbances, corneal opacity (alteration of the cornea that ranges from a faint spot to a grayish-white spot visible to the naked eye), papillitis (inflammation of the papilla), retrobulbar optic neuritis (inflammation of the optic nerve) and papillary edema.

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

Cardiovascular disorders: palpitations, vasculitis (inflammation of blood vessels). Medicines likeNaproxenoNormon may be associated with a moderate increase in the risk of suffering a heart attack (‘myocardial infarction”) or cerebral stroke. Also, edema (fluid retention), hypertension, and heart failure have been observed in association with treatments with medicines of the typeNaproxenoNormon.

Respiratory, thoracic, and mediastinal disorders:asthma, eosinophilic pneumonitis (inflammatory lung disease), dyspnea (shortness of breath), pulmonary edema (swelling due to fluid retention in the lung).

Gastrointestinal disorders:The most frequent side effects that occur with medicines likeNaproxenoNormon are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in the elderly. Also, nausea, vomiting, diarrhea, flatulence, constipation, stomach pain, blood in stool, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have been observed. Less frequently, the appearance of gastritis

Hepatobiliary disorders:hepatitis (inflammation of the liver), jaundice (yellowing of the skin). Medicines likeNaproxenoNormon may be associated, in rare cases, to liver damage.

Skin and subcutaneous tissue disorders:edema, ecchymosis (extravasation of blood to tissues), pruritus (itching), purpura (blood clots in the skin), skin eruptions, sweating, alopecia (hair loss), erythema (redness of the skin), exanthema (rash), lichen planus (inflammation of the skin with red papules mainly on the neck, forearm, and abdomen), pustular reactions, skin eruptions, systemic lupus erythematosus, urticaria, photosensitivity reactions (allergy to the sun). If fragility of the skin or formation of blisters occurs, consult your doctor immediately. Medicines likeNaproxenoNormon may be associated, in very rare cases, to severe blistering reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.

Unknown frequency: cannot be estimated from available data

-Generalized skin eruption, elevated body temperature, high levels of liver enzymes, blood anomalies (eosinophilia), lymph node enlargement, and organ involvement (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS). See also section 2.

-A characteristic skin allergic reaction known as fixed drug eruption, which generally reappears in the same location when exposed to the drug again and can be seen as red, round or oval spots and skin swelling, blisters (urticaria) and itching.

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

Renal and urinary disorders:hematuria (blood in urine), interstitial nephritis (inflammation of the kidney), nephrotic syndrome (manifested by cloudy urine and facial swelling), renal disease, renal insufficiency, papillary necrosis.

Reproductive and breast disorders:infertility.

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

Laboratory investigations:abnormal liver function test values, elevated serum creatinine, hyperkalemia.

Reporting of suspected adverse reactions

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 to 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 Naproxeno Normon out of the sight and reach of children.

Store in the original packaging to protect it from light.

Do not use Naproxeno Normon after the expiration date that appears on the packaging after CAD.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

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Naproxeno Normon Composition:

The active ingredient is naproxeno. Each tablet contains 500 mg of naproxeno.

The other components are: croscarmelosa sódica, povidona, estearato de magnesio and óxido de hierro (E-172).

Product appearance and packaging size:

This medicationis presented in pinkish-colored, elongated, biconvex, scored and printed tablets. The tablet can be divided into equal doses. Each package contains 40 tablets.

Marketing authorization holder and responsible manufacturer:

LABORATORIOS NORMON, S.A.

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

Last review date of this leaflet: July 2024

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