ESPIDIDOL 400 mg FILM-COATED TABLETS

2. What you need to know before taking Espididol

Do not take Espididol

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, bronchospasm, or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have an active cerebral hemorrhage or other active bleeding.
• If you have bleeding disorders or blood coagulation disorders or are taking anticoagulants (medications used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• If you have severe heart failure.
• If you have severe dehydration caused by vomiting, diarrhea, or insufficient fluid intake.
• If you are in the third trimester of pregnancy.

Warnings and Precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration. You should not take more than 3 coated tablets (1200 mg of ibuprofen) per day to avoid possible circulatory or heart problems.

Consult your doctor before starting to take Espididol:

• If you have edema (fluid retention).
• If you have or have had heart disorders or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you have an infection;

Espididol may mask the signs of an infection, such as fever and pain. Consequently, Espididol may delay the appropriate treatment of the infection, which can increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen in this case could cause kidney failure due to dehydration.
• 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. This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the aspirin type. 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 Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as medications like Espididol may worsen these conditions.
• If you are being treated with diuretics (medications to urinate) because your doctor must monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria).
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• If you experience vision changes during treatment with ibuprofen, interrupt treatment and consult your doctor for an ophthalmological examination.
• It is possible that allergic reactions may occur with this medication. Treatment should be discontinued if redness and inflammation or skin injury appear.
• Skin reactions: Serious skin reactions have been reported in association with Espididol treatment. Stop taking Espididol and consult your doctor immediately if you present any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.

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

Avoid concomitant administration with other NSAIDs, including COX-2 inhibitors.

Be careful with Espididol:

Serious skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Interrupt Espididol treatment and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Precautions in Elderly Patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Cardiovascular Precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses.

Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking Espididol if:

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

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

Ibuprofen has been associated with signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop using this medication immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

Respiratory Disorders

Ibuprofen should be used with caution when administered to patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in these patients.

Children and Adolescents

There is a risk of kidney failure in dehydrated children and adolescents.

The use of this medication is not recommended in children and adolescents weighing less than 40 kg or under 12 years old, as the dose of ibuprofen it contains is not suitable for the recommended dosage in this group of patients.

Precautions during Pregnancy and in Women of Childbearing Age

Because the administration of medications like ibuprofen has been associated with an increased risk of congenital anomalies/abortions, its administration is not recommended during the first and second trimester of pregnancy unless it is strictly necessary and advised by your doctor.

If you need treatment during this period or while trying to become pregnant, you should use the lowest dose for the shortest possible time.

If you take it for a few days from the 20th week of gestation onwards, Espididol may cause kidney problems in your baby, 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 a few more days, your doctor may recommend additional monitoring.

In the third trimester, the administration of ibuprofen is contraindicated.

For women of childbearing age, it should be taken into account that medications like ibuprofen have been associated with a decrease in fertility.

Interference with Analytical Tests

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood concentrations of urea nitrogen and serum creatinine and potassium (may increase)
• With liver function tests: increased transaminase values.

If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Use of Espididol with Other Medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Espididol may affect or be affected by other medications. For example:

• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., aspirin, warfarin, ticlopidine)
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).

The following medications may interfere and should not be taken with Espididol without consulting your doctor:

• Aspirin or other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding.
• Antihypertensives (beta-blockers, ACE inhibitors, and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive substances. Concomitant administration of ibuprofen and potassium-sparing diuretics may cause hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (prevent the formation of thrombi or clots in blood vessels) such as ticlopidine.
• Anticoagulants (medications used to "thin" the blood) such as warfarin.
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate. Your doctor may adjust the dose of this antimetabolite medication (slows down the growth of certain cells produced by the body).
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide or insulin (for diabetes), may need dose adjustment.
• Certain antidepressants (selective serotonin reuptake inhibitors).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).
• Thrombolytics (medications that dissolve clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medications may also affect or be affected by treatment with Espididol. Therefore, you should always consult your doctor or pharmacist before using Espididol with other medications.

Taking Espididol with Food, Drinks, and Alcohol

Take this medication with meals or with milk.

Do not administer ibuprofen with alcohol to avoid damaging the stomach. Alcohol consumption during treatment may increase the risk of gastrointestinal adverse reactions.

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 medication.

Espididol should not be taken during pregnancy, especially during the third trimester (see section precautions during pregnancy and in women of childbearing age). It may cause kidney and heart problems in your baby. It may affect your and your baby's tendency to bleed and make labor longer than expected.

Minimal amounts of ibuprofen and its degradation products are excreted in breast milk. As no adverse effects are known in the breastfed infant, it is not usually necessary to interrupt breastfeeding during short-term use at recommended doses.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and Use of Machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or use hazardous machinery. If you only take one dose of Espididol or take it for a short period, it is not necessary to take special precautions.

Espididol Contains Sucrose and Sodium

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 83 mg of sodium (the main component of table salt/cooking salt) per coated tablet. This is equivalent to 4% of the maximum recommended daily sodium intake for an adult.

3. How to take Espididol

Follow the administration instructions for this medication contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended dose is:

• Adults and adolescents over 12 years old (weight equal to or greater than 40 kg): Take one tablet (400 mg of ibuprofen) every 6 or 8 hours, if necessary. Do not take more than 3 tablets (1200 mg of ibuprofen) in 24 hours.
• Elderly people: the dose should be established by the doctor, as it may be necessary to reduce the usual dose.
• Patients with kidney, liver, or heart disease: reduce the dose and consult a doctor. Always use the lowest effective dose.

The administration of this medication is subject to the appearance of pain or fever. As these disappear, the medication should be suspended.

You should consult a doctor if it worsens or does not improve, if the fever persists for more than 3 days or the pain for more than 3 days in adolescents or 5 days in adults.

Use in children

The use of this medication is not recommended in children and adolescents with less than 40 kg of weight or under 12 years, since the dose of ibuprofen it contains is not suitable for the recommended dosage in this group of patients.

Method of administration:

This medication is administered orally.

Take the tablet with half a glass of water. Take this medication with meals or with milk, especially if digestive discomfort is noticed.

If you take more Espididol than you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately, go to the nearest hospital or call the Toxicology Information Service, (telephone: 91.5620420), indicating the medication and the amount ingested, to inform about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may be with blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, confusion, and tremulous movement of the eyes. Agitation, drowsiness, disorientation, or coma may also appear. Occasionally, patients develop convulsions. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling of cold body, and respiratory problems have been reported. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute renal failure and liver damage may occur. An exacerbation of asthma in asthmatics is possible. Additionally, there may be low blood pressure and difficulty breathing.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric lavage will be considered if significant amounts have been ingested and within 60 minutes following ingestion.

If you forget to take Espididol

Do not take a double dose to make up for forgotten doses.

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time of the next dose is very close, skip the forgotten dose and take the next dose at its usual time.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

Adverse effects of medications like Espididol are more common in people over 65 years old.

The incidence of adverse effects is lower in short treatments and if the daily dose is below the maximum recommended dose.

Frequencies are established according to the following classification: very frequent (may affect more than 1 in 10 patients); frequent (may affect up to 1 in 10 patients); uncommon (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); frequency not known (cannot be estimated from available data).

The following adverse effects have been observed:

Infections and infestations

Very rare: Exacerbation of inflammation-related infections (e.g., development of necrotizing fasciitis), coinciding with the use of non-steroidal anti-inflammatory drugs.

Note: If signs of infection or worsening are observed during treatment with ibuprofen, it is recommended to go to the doctor immediately, in case it is necessary to initiate anti-infectious/antibiotic therapy.

Blood and lymphatic system disorders

Rare: Aplastic anemia (insufficiency of the bone marrow to produce different types of cells).

Very rare: Decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and paleness of the skin), decreased granulocytes (a type of white blood cell that can predispose to infections), pancytopenia (deficiency of red, white, and platelet cells in the blood), agranulocytosis (very large decrease in granulocytes), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudo-flu symptoms, extreme fatigue, nasal and skin bleeding. Prolongation of bleeding time.

Immune system disorders

Uncommon: Allergic reaction, hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly along with a drop in blood pressure).

Rare: Anaphylaxis (generalized allergic reaction).

Very rare: Severe hypersensitivity reactions (these can be characterized by swelling of the face, tongue, and larynx with bronchospasm, dyspnea, tachycardia, and hypotension that can include potentially fatal shock).

Note: In the appearance of these symptoms, which can occur with the first use, immediate medical attention is required.

Psychiatric disorders

Uncommon: Insomnia, anxiety, restlessness.

Rare: Psychotic reaction, nervousness, irritability, depression, confusion, disorientation.

Nervous system disorders

Frequent: Fatigue or drowsiness, headache, and dizziness or feeling of instability.

Uncommon: Insomnia, excitement, irritability.

Rare: Paresthesia (sensation of numbness, tingling, prickling, etc., more frequent in hands, feet, arms, or legs).

Very rare: Aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Eye disorders

Uncommon: Vision disturbances.

Rare: Abnormal or blurred vision.

Frequency not known: Papilledema (inflammation of the optic nerve).

Ear and labyrinth disorders

Frequent: Vertigo.

Uncommon: Ringing or buzzing in the ears.

Rare: Hearing difficulty.

Cardiac disorders

Medications like Espididol may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Very rare: Palpitations, heart failure.

Frequency not known: Heart failure, chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Vascular disorders

Edema (fluid retention), arterial hypertension, and heart failure have also been observed in association with treatments with medications of the Ibuprofen (arginine) type.

Very rare: Arterial hypertension.

Frequency not known: Arterial thrombosis.

Respiratory disorders

Uncommon: Asthma, worsening of asthma, bronchospasm, dyspnea (difficulty breathing)

Frequency not known: Throat irritation.

Gastrointestinal disorders

The most frequent adverse effects that occur with medications like Espididol are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients.

Frequent: Gastrointestinal disorders such as heartburn (acidity, reflux), abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding that can cause anemia in exceptional cases.

Uncommon: Gastrointestinal ulcers, potentially with bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, melena (blood in stool), gastritis.

Rare: Vomiting blood.

Very rare: Esophageal inflammation, pancreatitis, intestinal stenosis.

Frequency not known: Anorexia.

Hepatobiliary disorders

Rare: Liver damage, hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes).

Skin and subcutaneous tissue disorders

Frequent: Skin rash.

Uncommon: Redness of the skin, itching or swelling of the skin (angioedema, urticaria), purpura (purple spots on the skin).

Rare: Anaphylactic reaction.

Very rare: Medications like Espididol may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis). Hair loss, erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox.

Frequency not known: Skin reactions due to light influence (photosensitivity), worsening of skin reactions. A severe skin reaction known as DRESS syndrome can occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Generalized red scaly rash, with bumps under the skin and blisters located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Espididol if you present these symptoms and seek immediate medical attention. See also section 2.

Renal and urinary disorders

Rare: Hematuria (presence of blood in the urine).

Very rare: Edema (signs that may be indicative of kidney disease, which can sometimes include kidney failure); kidney tissue damage (papillary necrosis), increased serum uric acid concentration.

Based on experience with non-steroidal anti-inflammatory drugs in general, cases of interstitial nephritis, nephrotic syndrome, and kidney failure cannot be excluded.

General disorders

Very rare: Worsening of inflammation during infectious processes.

Frequency not known: Edema.

Investigations

Rare: Alteration of liver function tests.

Frequency not known: Alteration of renal function tests.

To date, no serious allergic reactions have been reported with Espididol, although they cannot be ruled out. The manifestations of this type of effect could be fever, skin rash, abdominal pain, intense and persistent headache, nausea, vomiting, angioedema, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects appear, discontinue treatment and go immediately to your doctor:

• Allergic reactions such as skin rashes, swelling of the face, wheezing in the chest, or difficulty breathing.
• Vomiting blood or coffee grounds-like material.
• Blood in the stool or bloody diarrhea.
• Severe stomach pain.
• Blistering or significant peeling of the skin.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Visual disturbances.

Discontinue treatment with Espididol and seek immediate medical attention if you notice any of the following symptoms:

• red patches that are not raised, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

5. Conservation of Espididol

Keep out of sight and reach of children.

No special storage conditions are required.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications that are no longer needed in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications that are no longer needed. In this way, you will help protect the environment.

6. Package contents and additional information

Composition of Espididol

The active ingredient is ibuprofen-arginine. Each coated tablet contains 400 mg of ibuprofen (as 770 mg of ibuprofen arginine).

The other components are: sodium hydrogen carbonate, crospovidone, and magnesium stearate. The coating contains hypromellose (E464), sucrose, titanium dioxide (E171), and macrogol 4000.

Appearance of the product and package contents

They are white or almost white coated tablets, oval in shape and scored on one side.

They are presented in packages containing 6, 12, and 18 coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zambon, S.A.U.

Maresme, 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda (Barcelona)

Spain

Manufacturer

Zambon, S.p.A.

Via Della Chimica, 9

36100 Vicenza

Italy

This prospectus was revised in:November 2024

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