Prospect: information for the patient

Espidifen 600 mg granulated for oral solution, lemon-lime flavor

Ibuprofen (arginine)

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the prospect:

1. What Espidifen is and for what it is used
2. What you need to know before starting to take Espidifen
3. How to take Espidifen
4. Possible adverse effects
5. Storage of Espidifen

6. Contents of the package and additional information

Ibuprofen (arginine) belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medicine is used in adults and adolescents aged 14 years and above for the treatment of fever, the treatment of moderate to severe pain including migraine, the treatment of arthritis (inflammation of the joints, including those of hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder causing cartilage damage), ankylosing spondylitis (inflammation affecting the spine joints), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

No take Espidifen:

• If you are allergic to ibuprofen or any of the other components of the medication (listed in section 6). Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, 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 bleeding, 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 or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood). If anticoagulants are necessary, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you have severe dehydration caused by vomiting, diarrhea, or inadequate fluid intake.
• If you are in the third trimester of pregnancy.

Warnings and Precautions

Consult your doctor before starting to take Espidifen:

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

Espidifen may mask the signs of an infection, such as fever and pain. Consequently, Espidifen may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medication while you have 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 present symptoms of dehydration, e.g. severe diarrhea or vomiting, take plenty of fluid and contact your doctor immediately, as ibuprofen in this case may cause kidney insufficiency as a consequence of dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest 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 disease, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector medication.
• If you are taking anticoagulants or antiplatelet agents, such as aspirin, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as Espidifen-type medications may worsen these conditions.
• If you are taking diuretics (medications to urinate), as your doctor will need to 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, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have intermittent acute porphyria (a metabolic disease that affects your blood and may cause symptoms such as red urine, bloody urine, or liver disease), so your doctor can assess the advisability 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 disturbances during ibuprofen treatment, discontinue treatment and consult a doctor for an eye examination.
• It is possible to experience allergic reactions with this medication. Discontinue treatment if you notice redness, inflammation, or skin lesions.
• Severe skin reactions: Severe skin reactions associated with Espidifen treatment have been reported. Discontinue Espidifen and seek medical attention immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.
• Your doctor will perform a more stringent check if you receive ibuprofen after undergoing major surgery.
• It is recommended not to take this medication if you have chickenpox.

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

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

Precautions in elderly patients

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

Be especially careful with Espidifen:

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue Espidifen treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular Precautions

NSAIDs, such as ibuprofen, may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses.

Do not exceed the recommended dose or treatment duration.

Inform your doctor or pharmacist before taking Espidifen if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease, 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 are a smoker.

NSAIDs may also cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Ibuprofen has been reported to cause allergic reactions to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain. Discontinue use immediately and contact your doctor or emergency medical services if you observe any of these signs.

Respiratory Disorders

Ibuprofen should be used with caution in patients who have or have had asthma, bronchial asthma, 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 insufficiency in dehydrated children and adolescents.

This medication is not recommended for use in children or adolescents under 14 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in these patients.

Precautions during Pregnancy and in Women of Childbearing Age

Due to the association of ibuprofen administration with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary and advised by your doctor.

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

If you take this medication for a few days from 20 weeks of gestation onwards, Espidifen may cause kidney problems in your baby, which may lead to low amniotic fluid levels or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for a few more days, your doctor may recommend additional monitoring.

In the third trimester, ibuprofen administration is contraindicated.

For women of childbearing age, consider that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Interference with Laboratory Tests

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

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

Use of Espidifen with Other Medications

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

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

• Anticoagulants (e.g. for treating coagulation problems/preventing 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 Espidifen without consulting your doctor:

• Aspirin or other NSAIDs: increase the risk of gastrointestinal ulcers and bleeding.
• Beta-blockers, ACE inhibitors, and diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive substances. Concurrent administration of ibuprofen and potassium-sparing diuretics may cause hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (prevent blood clotting) such as ticlopidine.
• Anticoagulants (medications that "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 (slows down the growth of certain cells produced by the body).
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart disorders).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as prednisone and prednisolone.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas such as tolbutamide or insulin (used to treat diabetes), may require dose adjustment.
• Some antidepressants (selective serotonin reuptake inhibitors).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (medication used to treat HIV/AIDS).
• Trombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• 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 Espidifen treatment. Therefore, always consult your doctor or pharmacist before using Espidifen with other medications.

Taking Espidifen with Food, Drinks, and Alcohol

It is recommended to take the granulated ibuprofen (arginine) tablets with water or another liquid. You can take them alone or with food. In general, it is recommended to take it during meals or immediately after eating to reduce the possibility of stomach discomfort. Consuming alcohol during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Espidifen should not be taken during pregnancy, especially during the third trimester (see section Precautions during Pregnancy and in Women of Childbearing Age).Espidifen may cause kidney and heart problems in your baby. It may affect your tendency and that of your baby to bleed and make labor longer or more difficult than expected..

Minimal amounts of ibuprofen and its metabolites are excreted in breast milk. As no undesirable effects have been reported in the infant, it is usually not necessary to discontinue breastfeeding during short-term use at recommended doses.

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

Driving and Operating Machinery

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medication, you should not drive or operate hazardous machinery. If you only take a single dose of Espidifen or take it for a short period, no special precautions are necessary.

Espidifen contains aspartame, saccharose, and sodium

This medication contains 80 mg of aspartame in each packet.

Aspartame contains a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

This medication contains 87 mg of sodium (the main component of table salt/for cooking) in each packet. This represents 4.35% of the recommended daily maximum sodium intake for an adult.

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

Your doctor will indicate the duration of treatment with Espidifen. Do not discontinue treatment beforehand, as this would not yield the expected results. Similarly, do not use this medication for a longer period than indicated by your doctor.

The most effective dose should be used for the shortest duration necessary to alleviate symptoms. If you have an infection, consult a doctor promptly if symptoms (such as fever and pain) persist or worsen (see section 2).

The entire contents of the sachet should be taken after dissolving it in a sufficient amount of water.

Adults and adolescents over 14 years old

The dosage should be adjusted according to the severity of the disorder and the patient's response.

In adults and adolescents aged 14 to 18 years, the recommended dose is one sachet (600 mg of ibuprofen) every 6 to 8 hours.

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg in adults and 1,600 mg in adolescents aged 12 to 18 years, taking into account that the lower effective dose should be administered.

In rheumatoid arthritis, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg (4 sachets of granulate) of ibuprofen.

In primary dysmenorrhea, a daily dose of 600 mg of ibuprofen is recommended until pain relief is achieved, with a maximum daily dose of 1,200 mg (2 sachets of granulate).

Use in children and adolescents

This medication is not recommended for use in children or adolescents under 14 years old, as the dose of ibuprofen contained is not suitable for the recommended dosage in these patients.

Use in elderly patients

In these patients, the dosage should be established by the doctor, as it may be necessary to reduce the usual dose.

Use in patients with kidney and/or liver disease

If you have kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose prescribed by your doctor.

What if I take more Espidifen than I should?

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicological Information Service (phone: 91.5620420), indicating the medication and the amount ingested, to inform yourself 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 bloody), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, confusion, and eye tremors. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients develop seizures. At high doses, somnolence, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as blood in the urine, low potassium levels in the blood, feeling cold, and respiratory problems. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. It is possible that asthma may worsen in asthmatics. Additionally, there may be low blood pressure and difficulty breathing.

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

What if I forget to take Espidifen?

Do not take a double dose to compensate for the missed dose.

If you forget to take your dose, take it as soon as you remember. However, if the next scheduled dose is soon, skip the missed 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.

Like all medications, this medication may cause side effects, although not everyone will experience them.

The side effects of medications such as Espidifen are more common in people over 65 years old.

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

Frequencies are established according to the following classification: very common (may affect more than 1 in 10 patients); common (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 side effects have been observed:

Infections and infestations

Very rare: Exacerbation of infections-related inflammation (for example, the development of necrotizing fasciitis), coinciding with the use of nonsteroidal anti-inflammatory drugs.

Nota: If signs of infection or worsening occur during treatment with ibuprofen, it is recommended to see a doctor immediately, if necessary to initiate an anti-infective/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 pale skin), decreased granulocytes (a type of white blood cell that may 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, pseudogripal symptoms, extreme fatigue, nasal and cutaneous bleeding. Prolonged bleeding time.

Immune system disorders

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

Rare: Anaphylaxis (generalized allergic reaction).

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

Nota: In the appearance of these symptoms, which may occur with the first use, immediate assistance from a doctor is required.

Mental disorders

Uncommon: Insomnia, anxiety, restlessness.

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

Nervous system disorders

Common: Fatigue or drowsiness, headache, dizziness or sensation of instability.

Uncommon:Insomnia, excitement, irritability.

Rare: Paresthesia (numbness, tingling, burning, 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 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

Common: Dizziness.

Uncommon: Ringing or buzzing in the ears.

Rare: Hearing difficulty.

Cardiac disorders

Medications such as Espidifen 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: Cardiac arrest,chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Vascular disorders

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatments with ibuprofen (arginine) type medications.

Very rare: High blood pressure.

Frequency not known: Arterial thrombosis.

Respiratory, thoracic, and mediastinal disorders

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

Frequency not known: Irritation of the throat.

Gastrointestinal disorders

The most common side effects that occur with medications such as Espidifen are gastrointestinal: Peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients.

Common: Gastrointestinal disturbances such as pyrosis (heartburn, reflux), abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding that may cause anemia in exceptional cases.

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

Rare: Vomiting with blood.

Very rare: Inflammation of the esophagus, pancreatitis, intestinal stenosis.

Frequency not known: Anorexia.

Hepatobiliary disorders

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

Skin and subcutaneous tissue disorders

Common: 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 such as Espidifen 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 in mucous membranes and painful lesions with necrosis and detachment of the epidermis).

Loss of hair, erythema multiforme (skin lesion). Exceptionally, severe skin infections and complications in soft tissue may occur during chickenpox.

Frequency not known: Photosensitivity reactions, worsening of skin reactions. A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Generalized red and scaly rash, with bumps under the skin and blisters, located mainly on skin folds, trunk, and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).

Renal and urinary disorders

Rare: Hematuria (blood in urine).

Very rare: Edema (signs that may indicate kidney disease, which sometimes may include renal insufficiency); renal tissue damage (papillary necrosis), increased serum uric acid concentration.

Based on the experience with nonsteroidal anti-inflammatory drugs in general, cases of interstitial nephritis, nephrotic syndrome, and renal insufficiency cannot be ruled out.

General disorders and administration site conditions

Very rare: Exacerbation of inflammation during infectious processes.

Frequency not known: Edema.

Investigations

Rare: Alteration of liver function tests.

Frequency not known: Alteration of renal function tests.

Until now, severe allergic reactions have not been reported with Espidifen, although they cannot be ruled out. The manifestations of this type of effect may be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulty, asthma, palpitations, hypotension (lower than usual blood pressure) or shock.

If any of the following side effects appear, discontinue treatment and seek immediate medical attention:

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

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

• Flat, red, non-elevated spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and symptoms similar to the flu [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the 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 disposed of through drains or trash. Dispose of the packaging and medications you no longer need at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Espidifen

The active ingredient is Ibuprofen. Each blister pack contains 600 mg of ibuprofen (as 1.155 mg of ibuprofen (arginine)).

The other components (excipients) are: L-arginine, potassium acesulfame (E950), aspartame (E951), sucrose, anhydrous sodium carbonate, lemon-lime flavor

Aspect to Espidifen and content of the packaging

White-yellowish granulated powder for oral solution. Each package contains 20 or 40 blister packs with granulated powder.

Only some package sizes may be commercially available.

Title of the marketing authorization

Zambon, S.A.U.

Maresme, 5.Polígono Can Bernades-Subirà

08130 Sta.Perpètua de Mogoda (Barcelona)

Spain

Responsible for manufacturing

Zambon, S.p.A.

Via della Chimica, 9

36100 Vicenza

Italy

or

Zambon, S.A.U.

Maresme, 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda (Barcelona)

Spain

Fecha of the last review of this leaflet:November2024

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