LUNDIRAN 250 mg HARD CAPSULES

2. What you need to know before you take Lundiran

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 take Lundiran:

• If you are allergic (hypersensitive) to naproxen, naproxen sodium, or any of the other ingredients of this medicine (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 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 of stomach or duodenal ulcers or bleeding.
• If you have had a previous 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 (an intestinal disease).
• If you have severe liver (hepatic) or kidney (renal) impairment.
• 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 that you use the smallest dose that relieves your pain and do 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 prior warning symptoms.
• If you have had a previous 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 using high doses and prolonged treatments, 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 protective medication.
• If you have or have had stomach problems, as naproxen 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 Lundiran can worsen these conditions.
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as naproxen 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 could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have or suspect an infection, as naproxen can mask the usual signs and symptoms of infectious processes.
• If you experience stomach pain and/or observe black stools while taking naproxen, you should interrupt treatment with naproxen.
• 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 naproxen can affect fertility.

Cardiovascular precautions

Medicines like Lundiran can be associated with a moderate increase in the risk of suffering heart attacks ("myocardial infarctions") 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 (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).

There have been reports of severe 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. Stop taking this medication and consult your doctor immediately if you observe any symptoms related to severe skin reactions described in section 4.

Other medicines and Lundiran

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, homeopathic medicines, as well as herbal remedies and other health-related products.

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

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

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

Taking Lundiran with food and drinks

It is recommended to take the capsules 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 medication.

Naproxen should not be administered during pregnancy, childbirth, or during breastfeeding. It can cause kidney and heart problems in your fetus. It can affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take naproxen during the first six 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 can 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 checks.

For patients of childbearing age, it should be noted that medications like Lundiran have been associated with a decrease in fertility.

Driving and using machines

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

3. How to take Lundiran

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

The recommended dose is:

Adults

The daily dose is usually 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 by your doctor.

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

For the treatment of acute 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 of dysmenorrhea(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 of migraineattacks: the initial dose is 3 capsules (750 mg of naproxen) when the first symptoms appear, followed by 1 capsule (250 mg of naproxen) after half an hour of the initial intake.

For the treatment of menorrhagia(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) divided into two daily doses. Continue with a dose of 2 or 4 capsules per day (500 mg or 1000 mg of naproxen) 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 kidneyor liverdisease, 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 medication is not recommended in children under 16 years of age.

Method of administration:

This medication is taken orally.

Swallow the capsules with a sufficient amount of liquid, a glass of water, or another liquid, preferably during or after meals.

Always take the smallest 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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, 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 medication.

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 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).

Metabolic and Nutritional 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 papillary edema.

Ear and Labyrinth Disorders:hearing disturbances, 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 Lundiran may be associated with a moderate increased 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 Lundiran may be associated, in rare cases, with liver damage.

Skin and Subcutaneous Tissue Disorders:cutaneous hemorrhage, itching, 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 bullous 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.

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

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

Frequency not known: cannot be estimated from the available data.

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 red, round, or oval spots and skin swelling, blisters (urticaria), and itching.

Musculoskeletal, Connective Tissue, and Bone Disorders:muscle pain, muscle 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, hyperkalemia.

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 is not listed in this prospectus. 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 Lundiran

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

Do not use this medicine after the expiration date stated 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 disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Lundiran Composition

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

The other ingredients are magnesium stearate, indigo carmine (E-132), titanium dioxide (E-171), and gelatin.

Product Appearance and Packaging:

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

Marketing Authorization Holder and Manufacturer

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

Date of the Last Revision of this Prospectus: August 2024

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