NAPROXEN SODIUM KERN PHARMA 550 MG FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Naproxen Sodium Kern Pharma 550 mg Film-Coated Tablets EFG

Naproxen Sodium

Read the entire summary of product characteristics carefully before starting to take this medication, as it contains important information for you.

• Keep this summary of product characteristics, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this summary of product characteristics. See section 4.

Contents of the Summary of Product Characteristics

1. What is Naproxen Sodium Kern Pharma and what is it used for
2. What you need to know before taking Naproxen Sodium Kern Pharma
3. How to take Naproxen Sodium Kern Pharma
4. Possible side effects
5. Storage of Naproxen Sodium Kern Pharma
6. Package contents and additional information

1. What is Naproxen Sodium Kern Pharma and what is it used for

This medication contains the active ingredient naproxen sodium, which belongs to the group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs).

This medication 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 gout attacks, and ankylosing spondylitis (inflammation that affects the joints of the spine),
• menstrual pain.
• relief of pain during acute migraine attacks.
• pain secondary to bleeding associated with intrauterine devices (IUDs).

2. What you need to know before taking Naproxen Sodium Kern Pharma

It is essential to use the smallest dose that relieves-controls the pain and not to take naproxen sodium for longer than necessary to control your symptoms.

Do not take Naproxen Sodium 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 you are allergic (hypersensitive) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs and/or they cause severe allergic reactions such as: asthma, rhinitis, or nasal polyps,
• If you are taking other medications 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 (hepatic) or kidney (renal) 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 this medication.

Be cautious in the following situations:

• It is essential to use the smallest dose that relieves-controls the pain and not to take this medication 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 higher when high doses and prolonged treatments are used, 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-protecting medication,
• If you have or have had stomach problems, as this medication can cause stomach irritation, bleeding, or ulcers. Your doctor will recommend the most suitable dose,
• If you have Crohn's disease or ulcerative colitis, as medications like naproxen sodium can worsen these conditions,
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as naproxen sodium can cause breathing difficulties (bronchospasm),
• If you have severe kidney, liver, or heart problems,
• 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 discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors,
• If you have or suspect you have an infection, as this medication can 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 interrupt treatment with naproxen sodium,
• If you experience vision disorders during treatment,
• This medication 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 this medication can affect fertility.

There have been reports of severe skin reactions, including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), associated 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 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 medication can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Taking Naproxen Sodium Kern Pharma with other medications

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

This is very important, as naproxen sodium can alter the way other medications work. It is essential to inform your doctor or pharmacist if you are taking any of these 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),
• Sulfonylureas (medications for diabetes),
• Sulfonamides (a type of diuretic medication),
• Methotrexate (an immunosuppressive medication),
• Beta-blockers (antihypertensive medication),
• Furosemide (a medication with a natriuretic effect),
• Lithium. It may cause an increase in lithium plasma concentration,
• Corticosteroids, as naproxen sodium may interfere with adrenal function tests,
• Angiotensin-converting enzyme inhibitors (ACE inhibitors, antihypertensive medication),
• Angiotensin receptor blockers (antihypertensive medications).

It may be necessary for your doctor to adjust the dose of one of the two medications. Consult your doctor if you have any questions about these points.

Taking Naproxen Sodium Kern Pharma with food and beverages

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 plan to become pregnant, consult your doctor or pharmacist before using this medication. The oral forms (e.g., tablets) of this medication can cause serious side 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 and your baby's tendency to bleed and prolong or prolong delivery more than expected. You should not take naproxen sodium during the first 6 months of pregnancy unless it is clearly necessary and as directed 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 sodium may cause kidney problems in your fetus if taken for more than a few days, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that medications like naproxen sodium have been associated with decreased fertility.

Driving and using machines

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

Naproxen Sodium Kern Pharma contains sodium

This medication contains 52.68 mg of sodium (the main component of table salt) per tablet. This is equivalent to 2.63% of the maximum recommended daily sodium intake for an adult.

3. How to take Naproxen Sodium Kern Pharma

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Naproxen Sodium Kern Pharma.

The recommended dose is:

Adults

The daily dose is usually 1 or 2 tablets (550 mg or 1100 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 (in the morning and at night) or 2 tablets (1100 mg of naproxen sodium) taken once a day.

For the treatment of acute gout attacks: 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 is relieved. 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 30 minutes of the initial dose.

For the treatment of menorrhagia(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 naproxen sodium) divided into two doses per day. Continue with a dose of 1 or 2 tablets per day (550 mg or 1100 mg of naproxen sodium) divided into two doses per day for a maximum of 4 days.

Use in patients over 65 years of age or with kidney and/or liver disease

In patients over 65 years of age or if you have kidneyor liverdisease, 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

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

Method of administration:

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 other liquid, preferably during or after meals.

Always take the lowest effective dose

If you take more Naproxen Sodium Kern Pharma than you should

If you have taken more Naproxen Sodium 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 g of activated charcoal in the form of an aqueous suspension reduces the absorption of the medication.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Naproxen Sodium Kern Pharma

Do not take a double dose to make up for forgotten doses; take the dose as soon as 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 which 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 sodium 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), leukopenia (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 in the skin, mucosa, and viscera).

Metabolic and Nutritional Disorders:hyperkalemia (increase in potassium 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), hypoacusis (decreased hearing).

Cardiac Disorders:palpitations, congestive heart failure (inability of the heart to perform its pumping function), hypertension (high blood pressure). Medicines like naproxen sodium 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 sodium 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.

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 altered metabolism).

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, hyperkalemia.

The adverse effects that may occur during treatment with this medicine, and which have been observed with an unknown frequency (cannot be estimated from the available data), are:

Skin and Subcutaneous Tissue Disorders: 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. Characteristic cutaneous allergic reaction known as fixed drug eruption, which usually reappears in the same location upon re-exposure to the medicine and may appear as reddish round or oval patches and skin swelling, blisters (urticaria), and pruritus.

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

Adverse Effect Reporting

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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Naproxen Sodium Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Naproxen Sodium Kern Pharma

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

Tablet:

• Microcrystalline cellulose,
• povidone,
• sodium lauryl sulfate,
• sodium carboxymethyl starch type A (potato),
• talc,
• magnesium stearate,
• purified water

Coating:

• hypromellose,
• macrogol,
• titanium dioxide (E-171),
• indigo carmine lake (E-132)

Appearance of the Product and Package Contents

Naproxen Sodium Kern Pharma are film-coated tablets, oblong, blue in color, and with a score line on one face of the tablet. The tablet can be divided into equal doses.

They are available in packages of 10 and 40 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Prospectus: July 2024

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