NAPROXEN NORMON 500 mg TABLETS

Introduction

Package Leaflet: Information for the User

Naproxen Normon 500 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Naproxen Normon and what is it used for
2. Before taking Naproxen Normon
3. How to take Naproxen Normon
4. Possible side effects
5. Storage of Naproxen Normon
6. Further information

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

Naproxen belongs to a group of medicines called non-steroidal anti-inflammatory drugs, with anti-inflammatory, analgesic, and antipyretic properties.

Naproxen Normon is indicated for the treatment of inflammatory and painful processes of the joints, muscles, tendons, and ligaments such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. Naproxen Normon is also indicated for the treatment of acute attacks of gout, rheumatoid syndromes, and menstrual pain.

2. Before taking Naproxen Normon

It is important that you use the smallest dose that relieves your pain and do not take this medicine for longer than necessary to control your symptoms.

Do not takeNaproxenNormon:

• If you are allergic (hypersensitive) to naproxen, naproxen sodium, or any of the other components of Naproxen Normon.
• If you have an allergy to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs and/or they cause you severe allergic reactions.
• If you have had a stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• If you have any intestinal disease.
• If you have severe liver or kidney disease.
• Naproxen Normon should not be administered to children under 2 years of age.
• You have severe heart failure

• You are in the third trimester of pregnancy.

Be careful with Naproxen Normon:

• If you have had or develop an ulcer, hemorrhage, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcer and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protective medication.

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

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

• Medicines like Naproxen Normon can be associated with a moderate increase in the risk of suffering heart attacks ('myocardial infarction') or strokes. This risk is more likely to occur when high doses and prolonged treatments are used. 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 your doctor or pharmacist about this treatment.

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

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

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

Tell your doctor:

• If you are taking medications that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents of the acetylsalicylic acid type. You should also discuss the use of other medications that may increase the risk of such hemorrhages, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medications of the Naproxen Normon type may worsen these conditions.
• There have been reports of serious skin reactions, including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (Lyell's syndrome), and drug reaction with eosinophilia and systemic symptoms (DRESS), in association with Naproxen Normon. Stop taking Naproxen Normon and consult your doctor immediately if you observe any of the symptoms related to serious skin reactions described in section 4.

Use of other medications:

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

• The concomitant administration of Naproxen Normon with the following medications is not recommended:
• antacids or cholestyramine, as they may delay the action of Naproxen Normon,
• hydantoins (medications used preferably for epilepsy),
• sulfonylureas (medications for diabetes),
• sulfonamides (a type of medication used to increase urine elimination),
• methotrexate (an immunosuppressive medication),
• probenecid (a medication used in patients with gout),
• furosemide (a type of medication used to increase urine elimination),

• lithium (antipsychotic, for treating depression),
• angiotensin-converting enzyme inhibitors (to lower blood pressure),
• β-blockers (to lower blood pressure).

Taking Naproxen Normon with food and drinks

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

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

Because the administration of medications of the Naproxen Normon type has been associated with an increased risk of suffering congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless 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 Naproxen Normon is contraindicated.

Do not take Naproxen Normon 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 and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take Naproxen 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 the 20th week of pregnancy, Naproxen Normon may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (arterial duct) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

For patients of childbearing age, it should be noted that medications of the Naproxen Normon type have been associated with a decrease in fertility.

Driving and using machines. Naproxen 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.

3. How to take Naproxen Normon

Follow exactly the administration instructions of this medication 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 stiffness, patients who switch from another anti-rheumatic treatment to Naproxen 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) daily for several weeks. As maintenance therapy, a single daily dose of one to two tablets (500-1000 mg) can be administered in the morning or at night.

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

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

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

In acute crisesand always when there is no history of gastrointestinal disease, the dose can 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 is recommended, divided into two doses, 12 hours apart.

Special populations:

In people over 65 years of age or in patients with heart, liver, or kidney disorders, the dose should be reduced.

Method of administration:

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

If you take more Naproxen Normon than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the package and the package leaflet of the medication to the healthcare professional.

If you forget to take Naproxen Normon

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 the number of red blood cells, white blood cells, and platelets in the blood), eosinophilia (increase of certain white blood cells in the blood),

leukopenia (decrease of the number of white blood cells in the blood), thrombocytopenia (decrease of the number of platelets).

Immune system disorders:anaphylactoid reactions (acute allergic reaction), angioedema (inflammation of the skin, mucous membranes, 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, drowsiness, headaches (headache), feeling of dizziness, vertigo, cognitive dysfunction (alteration in knowledge), aseptic meningitis (inflammation of the meninges), convulsions, insomnia, sleep disorders.

Eye disorders:vision disorders, corneal opacity (alteration in 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 disorders:hearing disturbances, tinnitus (ringing in the ears), hypoacusis (decrease in hearing).

Cardiovascular disorders: palpitations, vasculitis (inflammation of blood vessels). Medications like Naproxen Normon may be associated with a moderate increase in the risk of suffering a heart attack ('myocardial infarction') or stroke. Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatments with medications of the Naproxen Normon type.

Respiratory disorders:asthma, eosinophilic pneumonitis (inflammation of the lungs), dyspnea (shortness of breath), pulmonary edema (swelling due to fluid retention in the lungs).

Gastrointestinal disorders:The most frequent side effects that occur with medications like Naproxen Normon are gastrointestinal: peptic ulcers, gastrointestinal hemorrhages, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, oral aphthae, worsening of ulcerative colitis, and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Hepatobiliary disorders:hepatitis (inflammation of the liver), jaundice (yellowing of the skin). Medications like Naproxen Normon may be associated, in rare cases, with liver damage.

Skin and subcutaneous tissue disorders:edema, ecchymosis (extravasation of blood into tissues), pruritus (itching), purpura (blood spots on the skin), skin rashes, 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 reaction, skin rashes, systemic lupus erythematosus, urticaria, photosensitivity reactions (allergy to the sun). If skin fragility or blister formation occurs, consult your doctor immediately. Medications like Naproxen Normon may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson Syndrome and toxic epidermal necrolysis.

Frequency not known: cannot be estimated from the available data

-Generalized skin rash, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2.

-A characteristic skin allergic reaction known as fixed drug eruption, which usually recurs in the same location when re-exposed to the medication and may appear as red, round, or oval patches and skin swelling, blisters (urticaria), and itching.

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

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

Reproductive system and breast disorders:infertility.

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

Investigations:abnormal values of liver function tests, elevated serum creatinine, hyperpotasemia.

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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Naproxen Normon

Keep Naproxen Normon out of the sight and reach of children.

Store in the original packaging to protect it from light.

Do not use Naproxen Normon after the expiration date shown on the packaging after EXP.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

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6. ADDITIONAL INFORMATION

Naproxeno Normon Composition:

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

The other components are: sodium croscarmellose, povidone, magnesium stearate, and iron oxide (E-172).

Product Appearance and Packaging Size:

This medication is presented in pink, elongated, biconvex, scored, and serigraphed tablets. The tablet can be divided into equal doses. Each package contains 40 tablets.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.

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

Date of Last Revision of this Leaflet: July 2024

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