Package Insert: Information for the Patient

Lundiran 250 mg Hard Capsules

naproxeno

Lundiran contains naproxen as its active ingredient, a substance that belongs to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).that belongs to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).

Lundiran is indicated for the treatment of:

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

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 take Lundiran:

• If you are allergic (hypersensitive) to naproxen, naproxen sodium, or any of the other components of this medication (listed in section 6).
• If you know you are allergic (hypersensitive) to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs and/or cause severe allergic reactions such as asthma, rhinitis, or nasal polyps.
• If you are taking other medications of this type (nonsteroidal anti-inflammatory drugs).
• If you currently have or have had more than one occasion of stomach ulcers or bleeding.
• If you have had a stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• If you have Crohn's disease or ulcerative colitis (a gastrointestinal disease).
• If you have severe liver or kidney disease.
• 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 Lundiran.

Be cautious in the following situations:

• 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.
• If you have had or develop a stomach ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
• If you have had a stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug, 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 will consider the possibility of associating a stomach protector medication.
• If you have or have had gastrointestinal 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 Lundiran-type medications 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 medications that alter blood coagulation 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 medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have or suspect you have an infection, as naproxen may mask the typical signs and symptoms of infectious processes.
• If you experience stomach pain and/or observe black stools while taking naproxen, you should discontinue treatment.
• If you experience vision disturbances during treatment.
• This medication should be used with caution in patients with low-sodium diets and a history of gastrointestinal problems.
• If you plan to become pregnant, as naproxen may affect fertility.

Cardiovascular precautions:

Medications like Lundiran may be associated with a moderate increase in the risk of heart attacks or strokes. 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 strokes, 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.

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

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

Other medications and Lundiran:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications, homeopathic products, herbal supplements, and other health-related products.

This is crucial as naproxen may alter the way other medications work. It is essential to inform your doctor if you are taking any of the following medications:

• Antacids or cholestyramine, as they may delay the action of naproxen, but do not affect the overall effect.
• Acetylsalicylic acid to prevent blood clots.
• Hydantoins (medications used primarily for epilepsy).
• Sulfonilureas (diabetes medications).
• Sulfonamides (a type of diuretic medication).
• Metotrexate (an immunosuppressant medication).
• Beta-blockers (anti-hypertensive medications).
• Furosemide (a medication with natriuretic effects).
• Lithium. It may cause an increase in lithium plasma concentration.
• Glucocorticoids, as naproxen may interfere with adrenal function tests.
• IECAS (Inhibitors of the Angiotensin-Converting Enzyme, anti-hypertensive medications).
• Angiotensin receptor antagonists or blockers (anti-hypertensive medications).

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

Taking Lundiran with food and beverages:

It is recommended to take the capsules during meals or immediately after eating to reduce the likelihood of stomach discomfort.

Pregnancy, lactation, 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.

Naproxen should not be administered during pregnancy, childbirth, or breastfeeding. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected. Do not take naproxen during the first six 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, naproxen may cause kidney problems in your fetus if taken for more than a few days, which may lead to low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) 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 patients, it is essential to consider that Lundiran-type medications have been associated with a decrease in the ability to conceive.

Driving and operating machinery:

This medication should be used with caution in patients whose activity requires attention and who have noticed dizziness, visual disturbances, or somnolence during treatment with this medication.

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

Your doctor will inform you of the duration of your treatment with Lundiran.

The recommended dose is:

Adults

The usual daily dose is 2 or 4 capsules (500 mg or 1000 mg of naproxen). As an initial dose, it is recommended to administer 2 capsules (500 mg of naproxen) followed by 1 capsule (250 mg of naproxen) every 6 or 8 hours, depending on the intensity of the process. These doses may be modified as indicated by your doctor.

For the treatment ofarthritis rheumatoid,osteoarthritisandankylosing spondylitis: the initial dose is usually 2 capsules (500 mg of naproxen) taken twice a day (in the morning and at night) or 4 capsules (1000 mg of naproxen) taken once a day.

For the treatment ofacute gout attacks: the initial dose is usually 3 capsules (750 mg of naproxen) followed by 1 capsule (250 mg of naproxen) every 8 hours until the pain subsides. Consult your doctor about the duration of treatment.

For the treatment ofmenstrual cramps(menstrual pain): the initial dose is usually 2 capsules (500 mg of naproxen) followed by 1 capsule (250 mg of naproxen) every 6 or 8 hours.

For the treatment ofmigraine attacks: the initial dose is 3 capsules (750 mg of naproxen) when the first symptoms appear, followed by 1 capsule (250 mg of naproxen) 30 minutes after the initial dose.

For the treatment ofmenorrhagia(pain associated with excessive menstrual bleeding): the initial dose on the first day of menstruation is between 3 and 5 capsules (750 mg and 1250 mg of naproxen) taken in two doses. Continue with a dose of 2 or 4 capsules per day (500 mg or 1000 mg of naproxen) taken in two doses per day 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 with kidney or liver disease, 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

This medication is not recommended for use in children under 16 years.

Administration form:

This medication is taken orally.

Swallow the capsules 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 Lundiran than you should

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

The symptoms of overdose are characterized by drowsiness, stomach burning, indigestion, nausea, vomiting, and in some cases, convulsions.

In the event of an accidental or intentional overdose, proceed with gastric lavage and initiate symptomatic treatment. The rapid administration of 50-100 grams of activated charcoal in the form of a water suspension reduces the absorption of the medication.

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

The side 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 side effects observed with naproxen are of a gastrointestinal nature (affecting the stomach and intestines).

It may cause inflammation, bleeding (in some cases fatal, especially in the elderly), peptic ulcers, perforation, and obstruction of the upper or lower gastrointestinal tract (digestive system). 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. Also, cases of stomach acid, dyspepsia (digestive disorders), abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood), and melena (black, tarry stools) have been observed.

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), leukopenia (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).

Psychiatric disorders:difficulty concentrating, depression, sleep disturbances.

Nervous system disorders:dizziness, somnolence, headaches, sensation 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 papillary edema.

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

Cardiac disorders:palpitations, congestive heart failure (heart's inability to pump blood), hypertension (high blood pressure). Medicines like Lundiran may be associated with a moderate increase in the risk of suffering a myocardial infarction (heart attack) or cerebral.

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 (yellow discoloration of the skin).

Medicines like Lundiran may be associated, in rare cases, with liver damage.

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

If you notice the appearance of the following side effects, stop taking this medicine and consult your doctor immediately:

Generalized skin rash, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and organ involvement (pharmacovigilance reaction with eosinophilia and systemic symptoms, also known as DRESS). See section 2.

Unknown frequency: cannot be estimated from available data.

A characteristic cutaneous allergic reaction known as fixed drug eruption, which generally reappears in the same location upon re-exposure to the drug and may be seen as red, round, or oval patches and skin swelling, blisters (urticaria), and pruritus.

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

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

Reproductive and breast disorders:infertility

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

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

Reporting of 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 through 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 this medication out of the sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Lundiran Composition

The active ingredient is naproxen. Each capsule contains 250 mg of naproxen.

The other components are magnesium stearate, indigotin (E-132), titanium dioxide (E-171), and gelatin.

Product appearance and packaging content:

Hard gelatin capsules with a white body and blue cap, packaged in aluminum/PVC blister packs containing 30 hard capsules.

Marketing authorization holder and responsible manufacturer

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-70. Polígono Industrial Urtinsa II.

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet: August 2024

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