NAPROXEN SODIUM NORMON 550 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Naproxen Sodium Normon 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 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 Package Leaflet

1. What is Naproxen Sodium Normon and what is it used for
2. What you need to know before you take Naproxen Sodium Normon
3. How to take Naproxen Sodium Normon
4. Possible side effects

1. Storage of Naproxen Sodium Normon
2. Contents of the pack and other information

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

Naproxen Sodium Normon contains the active substance naproxen sodium, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Naproxen is indicated for the treatment of:

• Mild or moderate pain, treatment of symptoms of rheumatoid arthritis (inflammation of the joints, including hands and feet, leading to swelling and pain), osteoarthritis (a chronic condition that causes cartilage damage), acute episodes of gout, and ankylosing spondylitis (inflammation that affects the joints of the spine),
• Menstrual pain.
• Relief of pain from acute migraine attacks.
• Pain secondary to bleeding associated with intrauterine devices (IUDs).

2. What you need to know before you take Naproxen Sodium Normon

It is important to use the smallest dose that relieves/control your pain and you should not take Naproxen Sodium Normon for longer than necessary to control your symptoms.

Do not take Naproxen Sodium Normon

• If you are allergic to naproxen or naproxen sodium, or to any of the other ingredients of this medicine (listed in section 6).
• If you know you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs and/or they cause you severe allergic reactions such as: asthma, rhinitis, or nasal polyps.
• If you are taking other medicines of this type (non-steroidal 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 bleeding or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• If you have ulcerative colitis (a bowel disease).
• If you have severe liver (liver disorders) or kidney (kidney disorders) failure.
• 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 non-steroidal anti-inflammatory drugs that appear as red spots, generalized redness of the skin, ulcers, or widespread rash accompanied by symptoms similar to those of the flu, including fever (see section 4). The rash can progress to generalized blisters or skin peeling. The greatest risk of these severe skin reactions is during the first few weeks of treatment, but they could start to develop up to several months after taking the medicine (see section 4). If you have developed any of these severe skin reactions with the use of Naproxen, you should not restart treatment with this medicine at any time. If you develop a skin rash or these symptoms, stop taking Naproxen and contact your doctor or seek medical attention immediately.

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

Kidney inflammation may occur during treatment with naproxen. The 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. You should inform your doctor of these signs.

Be cautious in the following situations:

• It is important to use the smallest dose that relieves/control your pain and you should not take this medicine for longer than necessary to control your symptoms.
• If you have had or developed an ulcer, bleeding, 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.
• If you have had a stomach or duodenal bleeding or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach-protecting medicine.
• If you have or have had stomach problems, as naproxen may cause stomach irritation, bleeding, or ulcers. Your doctor will recommend the most suitable dose.
• If you have Crohn's disease or ulcerative colitis, as medicines of the naproxen type 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 medicines that alter blood clotting 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 medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have or suspect you have an infection, as Naproxen may mask the usual signs and symptoms of infectious processes.
• If you experience stomach pain and/or observe that your stools appear black when taking naproxen, you should interrupt treatment with naproxen.
• If you experience vision disorders during treatment.
• This medicine should be used with caution in patients who have a low-salt diet and a history of digestive problems.
• If you wish to become pregnant, as naproxen may affect fertility.

Cardiovascular precautions

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

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.

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

Other medicines and Naproxen Sodium Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is very important because naproxen may alter the way other medicines work. It is important that you inform your doctor if you are taking any of the following medicines:

• Antacids or cholestyramine, as they may delay the action of Naproxen, but do not affect the total effect.
• Acetylsalicylic acid to prevent blood clots.
• Hydantoins (medicines used preferably for epilepsy).
• Sulfonylureas (medicines for diabetes).
• Sulfonamides (a type of diuretic medicine).
• Methotrexate (an immunosuppressive medicine).
• Beta-blockers (anti-hypertensive medicine).
• Furosemide (a medicine with a natriuretic effect).
• Lithium. It may cause an increase in lithium plasma concentration.
• Corticosteroids, Naproxen may interfere with adrenal function tests.
• ACE inhibitors (angiotensin-converting enzyme inhibitors, anti-hypertensive medicine).
• Angiotensin receptor blockers or antagonists (anti-hypertensive medicines).

It may be necessary for your doctor to modify the dose of one of the two medicines. Consult your doctor if you have any doubts about these points.

Taking Naproxen Sodium Normon with food and drinks

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

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 medicine.

Naproxen Sodium Normon should not be administered during pregnancy, childbirth, or during breastfeeding.

Do not take Naproxen 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.

Because the administration of naproxen-type medicines has been associated with an increased risk of congenital anomalies/abortions, you should not take naproxen during the first and second trimester of pregnancy unless it is strictly necessary and 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 may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of the fluid that surrounds the baby. If you need treatment for more than a few days, your doctor may recommend additional checks.

For women of childbearing age, it should be noted that naproxen-type medicines have been associated with a decrease in fertility.

Driving and using machines

Naproxen Sodium Normon should be used with caution in patients whose activity requires attention and who have observed dizziness or visual disturbances during treatment with this medicine.

Naproxen Sodium Normon contains sodium

This medicine contains 51.87 mg of sodium (the main component of table salt) per tablet. This is equivalent to 2.59% of the maximum recommended daily sodium intake for an adult.

3. How to take Naproxen Sodium Normon

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with naproxen.

The recommended dose is:

Adults

The daily dose is usually 1 or 2 tablets (550 mg or 1,100 mg of naproxen sodium). 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, depending on the intensity of the process. These doses may be modified by your doctor.

For the treatment of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: the initial dose is usually 1 tablet (550 mg of naproxen sodium) taken twice a day (morning and 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 the pain subsides. 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 migraineattacks: 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) after half an hour of the initial intake.

For the treatment of menorrhagia(pain associated with excessive menstrual bleeding): the initial dose during 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 daily doses. Continue with a dose of 1 or 2 tablets per day (550 mg or 1,100 mg of naproxen sodium) divided into two daily doses, 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 if you suffer from kidney or liver disease, it is recommended to reduce the dose and use the smallest effective dose for the shortest possible time. Consult your doctor.

Use in children and adolescents

The use of this medicine is not recommended in children under 16 years.

Method of administration:

This medicine 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 other liquid, preferably during or after meals.

Always take the smallest 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, gastric lavage should be performed and symptomatic treatment should be initiated. The rapid administration of 50-100 grams of activated charcoal in the form of an aqueous suspension reduces the absorption of the medicine.

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 medicine 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 the doctor.

If you forget to take Naproxen Sodium Normon

Do not take a double dose to make up for forgotten doses, take the dose at the moment you remember and continue with the next dose.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

Gastrointestinal Disorders:the most frequent adverse effects observed with naproxen are of a gastrointestinal nature (affecting the stomach and intestine).

Inflammation, bleeding (in some cases fatal, especially in the elderly), peptic ulcers, perforation, and obstruction of the upper or lower part of the gastrointestinal tract (digestive system) may occur. Cases of esophagitis (inflammation of the esophagus), gastritis (inflammation of the stomach mucosa), pancreatitis (inflammation of the pancreas), stomatitis (inflammation of the oral mucosa), and worsening of ulcerative colitis and Crohn's disease have been observed. Additionally, cases of stomach acidity, dyspepsia (digestive disorders), abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood), and melena (black-colored stools) have been reported.

Blood and Lymphatic System Disorders:agranulocytosis (increase/decrease in certain white blood cells), aplastic and hemolytic anemia (reduction in the number of red blood cells, white blood cells, and platelets in the blood), eosinophilia (increase in certain white blood cells in the blood), leucopenia (decrease in the number of leukocytes in the blood), thrombocytopenia (decrease in the number of platelets).

Immune System Disorders:anaphylactoid reactions (acute allergic reaction), angioneurotic edema (inflammation of the skin, mucous membranes, and viscera).

Metabolism and Nutrition Disorders:hypercalcemia (increased calcium concentration in the blood).

Psychiatric Disorders:difficulty concentrating, depression, sleep disturbances.

Nervous System Disorders:dizziness, somnolence, headaches, feeling 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 papilla edema.

Ear and Labyrinth Disorders:hearing alterations, tinnitus (ringing in the ears), hypoacusia (decreased hearing).

Cardiac Disorders:palpitations, congestive heart failure (inability of the heart to perform its pumping function), hypertension (high blood pressure). Medicines like naproxen may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

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). Medicines like naproxen may be associated with liver damage in rare cases.

Skin and Subcutaneous Tissue Disorders:cutaneous hemorrhage, pruritus, capillary hemorrhage, skin eruptions, sweating, alopecia, skin desquamation, lichen planus (skin disease with small flat nodules), pus vesicle reaction, skin redness, systemic lupus erythematosus (autoimmune disease with characteristic skin signs, eruption, and skin redness), severe blistering reactions such as Stevens-Johnson syndrome (skin eruption with a map-like appearance) and toxic epidermal necrolysis, allergy, photosensitivity reactions including rare cases where the skin takes on a appearance of porphyria cutanea tarda, pseudoporphyria (defect of liver enzymes), or epidermolysis bullosa. If cutaneous fragility, blister formation, or other symptoms indicative of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Generalized skin eruption, 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 allergic skin reaction known as fixed drug eruption, which usually reappears in the same location when re-exposed to the medicine and may appear as reddish round or oval spots and skin swelling, blisters (urticaria), and pruritus (frequency not known).

Musculoskeletal, Connective Tissue, and Bone Disorders:muscle pain, muscular asthenia.

Renal and Urinary Disorders:blood in the urine, interstitial nephritis (renal inflammation with yellowish-brown discoloration), nephrotic syndrome, kidney disease, renal failure, renal papillary necrosis (death of the cells that form the renal papillae due to metabolic alteration).

Reproductive System and Breast Disorders:infertility.

General Disorders and Administration Site Conditions:general malaise, pyrexia (chills and fever), thirst, sore throat.

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

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this leaflet.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Naproxen Sodium Normon

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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 medicine does not require special storage conditions.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

1. Composition of Naproxen Sodium Normon

• The active ingredient is naproxen sodium. Each tablet contains 550 mg of naproxen sodium (equivalent to 500 mg of naproxen)
• The other ingredients (excipients) are:

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

Tablet film coating:Hypromellose, macrogol, talc, indigo carmine (E132).

Appearance of the Product and Package Contents

Naproxen Sodium Normon are film-coated tablets, blue, elliptical, biconvex with a score line 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.

Naproxen Sodium Normon is available in packages containing 10 and 40 tablets in PVDC-PE/AL blisters.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Leaflet: July 2024

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