Naproxen sodium Kern Pharma 550 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Naproxeno sódico Kern Pharma 550 mg film-coated tablets EFG

Naproxen sodium

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Naproxeno sódico Kern Pharma is and what it is used for
2. What you need to know before taking Naproxeno sódico Kern Pharma
3. How to take Naproxeno sódico Kern Pharma
4. Possible side effects
5. How to store Naproxeno sódico Kern Pharma
6. Contents of the pack and other information

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

This medicine contains naproxen sodium as the active substance, a component belonging to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for the treatment of:

• Mild to moderate pain, and symptoms of rheumatoid arthritis (inflammation of the joints, usually affecting those of the hands and feet, causing swelling and pain), osteoarthritis (a chronic condition causing damage to cartilage), acute gout attacks, and ankylosing spondylitis (inflammation affecting 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 starting to take Naproxen Sodium Kern Pharma

It is important that you use the lowest dose that relieves/controls your pain and you should not 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 ingredients of this medicine (listed in section 6),
• If you know you are allergic (hypersensitive) to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs) and/or they cause you severe allergic reactions such as: asthma, rhinitis, or nasal polyps,
• If you are currently taking other medicines of this type (non-steroidal anti-inflammatory drugs),
• If you currently have or have had on more than one occasion: a stomach or duodenal ulcer or bleeding,
• If you have previously experienced stomach or duodenal bleeding or a perforation of the gastrointestinal tract while taking a non-steroidal anti-inflammatory drug,
• If you have ulcerative colitis (an intestinal disease),
• If you have severe liver (liver disorders) or severe kidney (kidney disorders) impairment,
• If you are in the third trimester of pregnancy,
• If you have severe heart failure.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

Be cautious in the following situations:

• It is important that you use the lowest dose that relieves/controls your pain and you should not take this medicine for longer than necessary to control your symptoms,
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, even without prior warning symptoms,
• If you have previously experienced stomach or duodenal bleeding or gastrointestinal perforation 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 ulcer, and in elderly patients. In these cases, your doctor may consider prescribing a stomach-protective medicine,
• If you have or have had stomach problems, as this medicine may cause stomach irritation, bleeding, or ulcers. Your doctor will recommend the most appropriate dose,
• If you have Crohn's disease or ulcerative colitis, as medicines like naproxen sodium may worsen these conditions,
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as naproxen sodium may cause breathing difficulties (bronchospasm),
• If you have severe kidney, liver, or heart problems,
• If you are taking medications that affect 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 medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants,
• If you have or suspect you have an infection, as this medicine may mask the usual signs and symptoms of infectious processes,
• If you experience stomach pain and/or notice black stools while taking this medicine, you should stop treatment with naproxen sodium,
• If you experience visual disturbances during treatment,
• This medicine should be used with caution in patients on a low-salt diet and those with a history of gastrointestinal problems,
• If you are planning to become pregnant, as this medicine may affect fertility.

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

Cardiovascular precautions

Medicines such as naproxen sodium may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke. This risk is more likely 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 stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist.

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

Taking Naproxen Sodium Kern Pharma with other medicines

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

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

• Antacids or cholestyramine, as they may delay the action of naproxen sodium, but do not affect its overall effect,
• Acetylsalicylic acid used to prevent blood clots,
• Hydantoins (drugs primarily used for epilepsy),
• Sulfonylureas (diabetes medicines),
• Sulfonamides (a type of diuretic medicine),
• Methotrexate (an immunosuppressive medicine),
• Beta-blockers (antihypertensive medicine),
• Furosemide (a medicine with natriuretic effect),
• Lithium. It may cause an increase in plasma lithium concentration,
• Steroids; naproxen sodium may interfere with adrenal function tests,
• ACE inhibitors (Angiotensin-Converting Enzyme Inhibitors, antihypertensive medicine),
• Angiotensin receptor antagonists or blockers (antihypertensive medicines).

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

Taking Naproxen Sodium Kern Pharma 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. Oral forms (e.g., tablets) of this medicine may cause serious adverse effects in the fetus.

This medicine 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 could 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 may delay or prolong labor more than expected. Do not take naproxen sodium during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, naproxen sodium may cause kidney problems in your fetus if taken for more than a few days, which could 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 treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that medicines like naproxen sodium have been associated with a reduced ability to conceive.

Driving and using machines

This medicine should be used with caution in patients whose activities require alertness and who have experienced dizziness or visual disturbances during treatment with this medicine.

Naproxen Sodium Kern Pharma contains sodium

This medicine contains 52.68 mg of sodium (main component of table/cooking salt) in each tablet. This corresponds to 2.63% of the maximum daily sodium intake recommended for an adult.

3. How to take Naproxen Sodium Kern Pharma

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the duration of your treatment with Naproxen Sodium.

The recommended dose is:

Adults

The usual daily dose is 1 or 2 tablets (550 mg or 1100 mg of naproxen sodium). As an initial dose, administration of 1 tablet (550 mg of naproxen sodium) followed by half a tablet (275 mg of naproxen sodium) every 6 or 8 hours is recommended, depending on the severity of the condition. These doses may be adjusted at your doctor's discretion.

For the treatment of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: the usual initial dose is 1 tablet (550 mg of naproxen sodium) taken twice daily (in the morning and at night), or 2 tablets (1100 mg of naproxen sodium) taken once daily.

For the treatment of acute gout attacks: the usual initial dose is one and a half tablets (825 mg of naproxen sodium), followed by half a tablet (275 mg of naproxen sodium) every 8 hours until pain subsides. Consult your doctor regarding the duration of treatment.

For the treatment of dysmenorrhea (menstrual pain): the usual initial dose is 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 attacks: the initial dose is one and a half tablets (825 mg of naproxen sodium) at the onset of symptoms, followed by half a tablet (275 mg of naproxen sodium) 30 minutes after 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 one and a half and two and a half tablets (825 mg and 1375 mg of naproxen sodium), divided into two daily doses. Continue with a daily dose of 1 or 2 tablets (550 mg or 1100 mg of naproxen sodium), divided into two daily doses, for up to the following 4 days.

Use in patients aged 65 years or older or in patients with kidney and/or liver disease

In patients aged 65 years or older, or if you have any kidney or liver disease, it is recommended to reduce the dose and use the lowest effective dose for the shortest possible duration. Consult your doctor.

Use in children and adolescents

This medicine is not recommended for use in children under 16 years of age.

Method of administration:

This medicine is taken orally.

The tablet may be divided into equal doses.

Swallow the tablets with a sufficient amount of liquid, such as a glass of water or another drink, 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.

Symptoms of overdose include drowsiness, stomach burning, indigestion, nausea, vomiting, and in some cases, seizures.

In the event of accidental or intentional overdose, gastric lavage should be performed and symptomatic treatment initiated. Rapid administration of 50–100 g of activated charcoal as an aqueous suspension reduces drug absorption.

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

If you forget to take Naproxen Sodium Kern Pharma

Do not take a double dose to make up for missed doses. Take the missed dose as soon as you remember, then continue with your next scheduled dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects that may occur during treatment with this medicine, observed with very rare frequency (in less than 1 in 10,000 patients), are:

Gastrointestinal disorders: The most frequently observed adverse effects with sodium naproxen are gastrointestinal in nature (affecting the stomach and intestine).

Inflammation, bleeding (in some cases fatal, especially in elderly patients), 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. Other reported effects include stomach acidity, dyspepsia (digestive disturbances), abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood), and melena (black, tarry stools).

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

Immune system disorders: anaphylactoid reactions (acute allergic reaction), angioneurotic edema (inflammation of the skin, mucosa, and viscera).

Metabolism and nutrition disorders: hyperkalemia (increased concentration of potassium in the blood).

Psychiatric disorders: difficulty concentrating, depression, sleep disturbances.

Nervous system disorders: dizziness, somnolence, headache, lightheadedness, vertigo, cognitive dysfunction, aseptic meningitis (inflammation of the meninges), seizures, insomnia.

Eye disorders: visual disturbances, corneal opacity, papillitis (inflammation of the optic disc), retrobulbar optic neuritis (inflammation of the optic nerve), and papilledema.

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

Cardiac disorders: palpitations, congestive heart failure (inability of the heart to perform its pumping function), hypertension (high blood pressure). Medicines such as sodium naproxen may be associated with a moderate increase in the risk of 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 (liver inflammation), jaundice (yellowing of the skin). Medicines such as sodium naproxen may rarely be associated with liver injury.

Skin and subcutaneous tissue disorders: skin hemorrhage, pruritus (itching), capillary hemorrhage, skin rashes, sweating, alopecia, skin desquamation, lichen planus (a skin disease characterized by small, flat papules), pustular reactions, skin redness, systemic lupus erythematosus (an autoimmune disease with characteristic skin signs such as rash and skin redness), and severe blistering reactions such as Stevens-Johnson syndrome (a map-like skin rash) and toxic epidermal necrolysis, allergic reactions, photosensitivity reactions including rare cases where the skin resembles porphyria cutanea tarda, pseudoporphyria (defect in liver enzymes), or epidermolysis bullosa. If skin fragility, blister formation, or other symptoms suggestive of pseudoporphyria occur, treatment must be discontinued and the patient closely monitored.

Musculoskeletal, connective tissue, and bone disorders: muscle pain, muscular asthenia.

Renal and urinary disorders: blood in urine, interstitial nephritis (kidney inflammation with yellowish-brown discoloration), nephrotic syndrome, nephropathy (kidney disease), renal failure, renal papillary necrosis (death of cells forming the renal papillae due to metabolic disturbances).

Reproductive system and breast disorders: infertility.

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

Additional investigations: abnormal liver function test results, elevated serum creatinine, hyperkalemia.

Adverse effects that may occur during treatment with this medicine, observed with unknown frequency (cannot be estimated from available data), are:

Skin and subcutaneous tissue disorders: generalized skin rash, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), lymphadenopathy (enlargement of lymph nodes), and involvement of other 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 typically recurs at the same site upon re-exposure to the drug and may appear as round or oval reddish patches, swelling of the skin, blisters (urticaria), and itching.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Naproxen Sodium Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or with household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Naproxen Sodium Kern Pharma

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

Tablet core:

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

Coating:

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

Appearance of the medicinal product and contents of the pack

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

Available in packs containing 10 and 40 film-coated tablets.

Only certain pack 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 most recent revision of this leaflet: July 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es