Lundiran 250 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lundiran 250 mg hard capsules

naproxen

Package leaflet:

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

1. What Lundiran is and what it is used for

Lundiran contains naproxen as the active ingredient, a substance belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Lundiran is indicated for the treatment of:

• Mild to moderate pain, and symptoms of rheumatoid arthritis (inflammation of the joints, usually affecting the hands and feet, causing swelling and pain), osteoarthritis (a chronic condition causing damage to the cartilage), acute gout attacks, and ankylosing spondylitis (inflammation affecting the spinal joints).
• 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 Lundiran

It is important that you use the lowest dose that relieves/controls your pain and that you do not take this medicine longer than necessary to control your symptoms.

Do not take Lundiran:

• If you are allergic (hypersensitive) to naproxen, sodium naproxen, 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 more than once 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 Lundiran.

Use caution in the following situations:

• It is important that you use the lowest dose that relieves/controls your pain and that you do not take this medicine 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, or even without prior warning symptoms.
• If you have previously experienced gastrointestinal bleeding or perforation while taking a non-steroidal anti-inflammatory drug, the risk is higher when high doses or long-term treatment 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 naproxen 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 Lundiran 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 affect blood clotting or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention 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 naproxen may mask the usual signs and symptoms of infectious processes.
• If you experience stomach pain and/or notice black-colored stools while taking naproxen, you should stop treatment with naproxen.
• If you experience vision disturbances during treatment.
• This medicine should be used with caution in patients on a low-salt diet or with a history of gastrointestinal problems.
• If you are planning to become pregnant, as naproxen may affect fertility.

Cardiovascular precautions

Medicines like Lundiran may be associated with a moderate increase in the risk of heart attacks ("myocardial infarction") or strokes. This risk is more likely when high doses and long-term 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 for 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.

In addition, these types of medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

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

Other medicines and Lundiran

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines, homeopathic remedies, herbal medicines, and other health-related products.

This is very important because naproxen may alter how 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 its overall effect.
• Acetylsalicylic acid used to prevent blood clots.
• Hydantoins (medicines mainly used for epilepsy).
• Sulfonylureas (medicines for diabetes).
• Sulfonamides (a type of diuretic medicine).
• Methotrexate (an immunosuppressive medicine).
• Beta-blockers (antihypertensive medicine).
• Furosemide (a natriuretic medicine).
• Lithium. Naproxen may increase plasma lithium concentrations.
• Steroids; naproxen may interfere with adrenal function tests.
• ACE inhibitors (Angiotensin-Converting Enzyme inhibitors, antihypertensive medicines).
• Angiotensin receptor antagonists or blockers (antihypertensive medicines).

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

Taking Lundiran with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Naproxen should not be administered during pregnancy, childbirth, or breastfeeding. 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 beyond expected. You should not take naproxen 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 effective 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 levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment beyond a few days is needed, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that medicines like Lundiran have been associated with reduced fertility.

Driving and using machines

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

3. How to take Lundiran

Follow exactly the instructions for use of 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 Lundiran.

Recommended dose:

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 take 2 capsules (500 mg of naproxen), followed by 1 capsule (250 mg of naproxen) every 6 or 8 hours, depending on the severity of the condition. Your doctor may adjust these doses as necessary.

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

For the treatment of acute gout attacks: the usual initial dose is 3 capsules (750 mg of naproxen), followed by 1 capsule (250 mg of naproxen) 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 2 capsules (500 mg of naproxen), followed by 1 capsule (250 mg of naproxen) every 6 or 8 hours.

For the treatment of migraine attacks: the initial dose is 3 capsules (750 mg of naproxen) at the onset of symptoms, followed by 1 capsule (250 mg of naproxen) half an hour 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 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 daily (500 mg or 1000 mg of naproxen), 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 over 65 years of age or in those with kidney disease or liver disease, the dose should be reduced. 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 for oral use.

Swallow the capsules 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 Lundiran than you should

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.

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 in aqueous suspension reduces the absorption of the medicine.

4. Possible adverse effects

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

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

Gastrointestinal disorders: The most frequent adverse effects observed with naproxen are of gastrointestinal nature (affecting the stomach and intestines).

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 mucosa), pancreatitis (inflammation of the pancreas), stomatitis (inflammation of the oral mucosa), and worsening of ulcerative colitis and Crohn's disease have also 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 blood), eosinophilia (increase in certain white blood cells in blood), leucopenia (decrease in the number of white blood cells in blood), leucopenia (decrease in the number of white blood cells in blood), thrombocytopenia (decrease in the number of platelets).

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

Metabolism and nutrition disorders: hypercalcemia (increased calcium concentration in blood).

Psychiatric disorders: difficulty concentrating, depression, sleep disturbances.

Nervous system disorders: dizziness, drowsiness, headache, sensation of dizziness, vertigo, cognitive dysfunction, aseptic meningitis (inflammation of the meninges), convulsions, insomnia.

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

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 pump effectively), hypertension (high blood pressure). Medicines like Lundiran 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 (inflammation of the liver), jaundice (yellowing of the skin). Medicines like Lundiran may rarely be associated with liver damage.

Skin and subcutaneous tissue disorders: skin hemorrhage, itching, capillary bleeding, skin rashes, sweating, alopecia, skin peeling, lichen planus (a skin disease characterized by small, flat nodules), pustular reactions, skin redness, systemic lupus erythematosus (an autoimmune disease with typical skin signs such as rash and redness), very 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 (liver enzyme defect), or epidermolysis bullosa. If skin fragility, blister formation, or other symptoms suggestive of pseudoporphyria occur, treatment must be discontinued and the patient closely monitored.

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

Generalized skin rash, high body temperature, elevated liver enzyme levels, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other 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 skin allergic reaction known as fixed drug eruption, which usually reappears in the same location upon re-exposure to the medicine and may appear as round or oval red patches, skin swelling, blisters (urticaria), and itching.

Musculoskeletal, connective tissue and bone disorders: muscle pain, muscle 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 disturbance).

Reproductive system and breast disorders: infertility.

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

Additional investigations: abnormal 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Lundiran Storage

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

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

This medicine requires no special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, 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 Lundiran

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

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

Appearance of the product and contents of the pack:

Hard gelatin capsules with a white body and blue cap, packed 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 most recent revision of this leaflet: August 2024

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