Espidifen 600 mg granules for oral solution flavor cola-lemon

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Espidifen 600 mg effervescent granules for oral solution, cola-lemon flavour

Ibuprofen (arginine)

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the adverse effects are not listed in this leaflet. See section 4.

Package leaflet contents:

1. What Espidifen is and what it is used for

2. What you need to know before taking Espidifen

3. How to take Espidifen

4. Possible side effects

5. How to store Espidifen

6. Contents of the pack and other information

1. What Espidifen is and what it is used for

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

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

2. What you need to know before starting to take Espidifen

Do not take Espidifen:

• If you are allergic to ibuprofen or to any of the other ingredients of the medicine (listed in section 6). Reactions indicating allergy may include: itchy rash, swelling of the face, lips or tongue, runny nose, difficulty breathing, bronchospasm, or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
• If you are vomiting blood.
• If you have black stools or bloody diarrhoea.
• If you have active cerebral haemorrhage or any other active bleeding.
• If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant medicines must be used at the same time, your doctor will carry out blood coagulation tests.
• If you have severe heart failure.
• If you have severe dehydration caused by vomiting, diarrhoea, or insufficient 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 oedema (fluid retention).
• If you have or have had any heart disorder or high blood pressure.
• If you suffer from asthma or any other respiratory disorder.
• If you have an infection;

Espidifen may mask signs of infection, such as fever and pain. Therefore, Espidifen could delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and in bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and 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 require prolonged treatment (more than 1 to 2 weeks), your doctor may need to carry out regular monitoring. Your doctor will indicate how often these checks should be performed.
• If you experience symptoms of dehydration, e.g., severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this particular case could lead, as a consequence of dehydration, to renal failure.
• 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. This risk is higher when high doses are used and with prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor will consider the possibility of adding a stomach-protective medicine.
• If you are taking concomitantly medications that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about 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 suffer from Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in diarrhoea with blood) or ulcerative colitis, as medicines of the Espidifen type may worsen these conditions.
• If you are taking diuretics (medicines to increase urination), because your doctor must monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur.
• If you suffer from acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so that your doctor can assess whether treatment with ibuprofen is appropriate.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• If you experience visual disturbances during treatment with ibuprofen, stop treatment and consult your doctor for an ophthalmological examination.
• Allergic reactions may occur with this medicine. Treatment must be discontinued if redness, inflammation, or skin lesions appear.
• Skin reactions: Serious skin reactions have been reported with Espidifen treatment. Stop taking Espidifen and contact your doctor immediately if you develop any skin rash, mucosal lesions, 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 closer monitoring if you are receiving ibuprofen following major surgery.
• It is advisable not to take this medicine if you have chickenpox.

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

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

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

Exercise special caution with Espidifen:

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

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses.

Do not exceed the recommended dose or duration of treatment.

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

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in the legs or feet due to narrowing or blockage of 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.

In addition, this type of medicine may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Signs of allergic reaction to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop using this medicine immediately and contact your doctor or emergency medical services immediately if you experience any of these symptoms.

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 cases of bronchospasm, urticaria, or angioedema have been reported in such patients following ibuprofen administration.

Children and adolescents

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

The use of this medicinal product is not recommended in children or adolescents under 14 years of age, as the ibuprofen dose it contains is not suitable for the recommended dosage regimen in these patients.

Precautions during pregnancy and in women of childbearing potential

Since the administration of drugs of the ibuprofen type has been associated with an increased risk of congenital malformations/miscarriages, their use is not recommended during the first and second trimesters of pregnancy unless considered strictly necessary and advised by your doctor.

If you require treatment during this period or while trying to become pregnant, the lowest effective dose should be used for the shortest possible duration.

If taken for several days starting from 20 weeks of gestation onwards, Espidifen may cause renal 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 require treatment for a few additional days, your doctor may recommend additional monitoring.

During the third trimester, administration of ibuprofen is contraindicated.

For patients of childbearing potential, it should be noted that medications of the ibuprofen type have been associated with a reduced ability to conceive.

Interference with diagnostic tests

• Bleeding time (may be prolonged for up to 1 day after discontinuing treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase levels.

If you are scheduled for any diagnostic tests (including blood and urine analyses, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Use of espidifen with other medicines

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

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

• Anticoagulant medicines (e.g., used to treat clotting disorders/prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine),
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan).

The following medicines may interfere and therefore must not be taken together with Espidifen without first consulting your doctor:

• Acetylsalicylic acid 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 agents. Concomitant administration of ibuprofen and potassium-sparing diuretics may lead to hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (prevent formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulants (medicines used to "thin" the blood and prevent formation of clots) such as warfarin.
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate. Your doctor may adjust the dose of this antimetabolite medicine (which slows down the growth of certain cells produced by the body).
• Mifepristone (abortion-inducing agent).
• 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 (used to treat intermittent claudication).
• Probenecid (used in patients with gout or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide or insulin (for diabetes); dose adjustment may be necessary.
• Certain antidepressants (serotonin reuptake inhibitors).
• Tacrolimus (used in organ transplantation to prevent organ rejection).
• Zidovudine (a medicine against the AIDS virus).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• Inhibitors of CYP2C9 (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking espidifen with food, drinks, and alcohol

It is recommended to take the Ibuprofen (arginine) granule sachets together with water or another liquid. You may take them alone or with food. In general, it is advisable to take them during meals or immediately after eating, in order 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, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Espidifen should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing age). It may cause kidney and heart problems in your baby. It may affect your tendency and that of your baby to bleed, and may cause labour to start later or last longer than expected.

Minimal amounts of ibuprofen and its degradation products are excreted in breast milk. As no adverse effects on the infant are known, interruption of breastfeeding is usually not necessary 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, visual disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take only a single dose of Espidifen or use it for a short period, it is not necessary to take special precautions.

Espidifen contains aspartame, sucrose, and sodium

This medicine contains 80 mg of aspartame per sachet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains 87 mg of sodium (the main component of table/cooking salt) per sachet. This corresponds to 4.35% of the maximum daily sodium intake recommended for an adult.

3. How to take Espidifen

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate how long you should take Espidifen. Do not stop treatment earlier, as otherwise the expected results may not be achieved. Likewise, do not use this medicine for longer than prescribed by your doctor.

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

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

Adults and adolescents over 14 years of age

Dosage should be adjusted according to the severity of the condition 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.

Higher doses may be required in certain conditions; however, 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, bearing in mind that the lowest effective dose should be administered.

In rheumatoid arthritis, higher doses may be required; however, it is recommended not to exceed the maximum daily dose of 2,400 mg (4 sachets of granules) of ibuprofen.

For 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 granules).

Use in children and adolescents

The use of this medicine is not recommended in children or adolescents under 14 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dosing in these patients.

Use in elderly patients

In these patients, dosage should be determined by the doctor, as a reduction from the usual dose may be necessary.

Use in patients with kidney and/or liver disease

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

If you take more espidifen 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), stating the name of the medicine and the amount ingested, to assess the risk and receive advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, tinnitus (ringing in the ears), confusion, and involuntary eye movements. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and respiratory problems may be reported. In addition, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute kidney failure and liver damage may occur. Asthma exacerbation is possible in asthmatic patients. Low blood pressure and difficulty breathing may also occur.

In cases of ingestion of large amounts, activated charcoal should be administered. Gastric lavage should be considered if large amounts have been ingested and within 60 minutes of ingestion.

If you forget to take Espidifen

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

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

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

4. Possible adverse effects

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

Adverse effects of medicines such as Espidifen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the maximum recommended dose.

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

The following adverse effects have been observed:

Infections and infestations

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

Note: If signs of infection appear or worsen during treatment with ibuprofen, it is recommended to see a doctor immediately to determine whether anti-infective/antibiotic therapy is necessary.

Blood and lymphatic system disorders

Rare: Aplastic anemia (bone marrow failure to produce various types of blood cells).

Very rare: Decreased platelet count, decreased white blood cells (may present as frequent infections with fever, chills, or sore throat), decreased red blood cells (may present as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may increase susceptibility to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe reduction in granulocytes), hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin 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, bronchospasm, dyspnea, tachycardia, and hypotension, which may include potentially life-threatening shock).

Note: If these symptoms occur, even after the first dose, immediate medical attention is required.

Psychiatric disorders

Uncommon: Insomnia, anxiety, restlessness.

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

Nervous system disorders

Common: Fatigue or drowsiness, headache, dizziness, or feeling unsteady.

Uncommon: Insomnia, excitement, irritability.

Rare: Paresthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms, or legs).

Very rare: Aseptic meningitis. In most reported cases of aseptic meningitis associated with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which represented a risk factor. Symptoms observed included neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Eye disorders

Uncommon: Vision disturbances.

Rare: Abnormal or blurred vision.

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

Ear and labyrinth disorders

Common: Vertigo.

Uncommon: Tinnitus (ringing or buzzing in the ears).

Rare: Hearing difficulty.

Cardiac disorders

Medicines such as Espidifen may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Very rare: Palpitations, cardiac failure.

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

Vascular disorders

Edema (fluid retention), hypertension, and heart failure have also been observed with treatments using ibuprofen (arginine)-type medicines.

Very rare: 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 common adverse effects with medicines such as Espidifen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients.

Common: Gastrointestinal discomfort such as heartburn (acid reflux), abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and minor gastrointestinal bleeding, which may exceptionally lead to anemia.

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: Inflammation of the esophagus, pancreatitis, intestinal stenosis.

Frequency not known: Anorexia.

Hepatobiliary disorders

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

Skin and subcutaneous tissue disorders

Common: Skin rash.

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

Rare: Anaphylactic reaction.

Very rare: Medicines such as Espidifen may, in very rare cases, be associated with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, with purplish lesions, primarily on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis).

Hair loss, erythema multiforme (skin lesions). Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox.

Frequency not known: Skin reactions due to light exposure (photosensitivity), worsening of skin reactions. A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

Generalized red, scaly rash with bumps under the skin and blisters, primarily located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Discontinue Espidifen immediately if you experience these symptoms and seek immediate medical attention. See also section 2.

Renal and urinary disorders

Rare: Hematuria (presence of blood in urine).

Very rare: Edema (signs that may indicate kidney disease, which may sometimes include renal 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 renal failure cannot be excluded.

General disorders

Very rare: Worsening of inflammation during infectious processes.

Frequency not known: Edema.

Investigations

Rare: Abnormalities in liver function tests.

Frequency not known: Abnormalities in kidney function tests.

To date, no severe allergic reactions have been reported with Espidifen, although they cannot be ruled out. Manifestations of such effects could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulties, asthma, palpitations, hypotension (lower than normal blood pressure), or shock.

If any of the following adverse effects occur, stop taking the medicine and consult your doctor immediately:

• Allergic reactions such as skin rash, facial swelling, wheezing, or breathing difficulties.
• Vomiting blood or material resembling coffee grounds.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Blisters or extensive 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.
• Vision disturbances.

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

• Flat, non-elevated, target-shaped or circular red spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Reporting of adverse effects

If you experience any adverse effect, talk to 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. Storage of Espidifen

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Espidifen

The active substance is ibuprofen. Each sachet contains 600 mg of ibuprofen (as 1.155 mg of ibuprofen (arginine)).

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

Appearance of espidifen and contents of the pack

Yellowish-white granules for oral solution. Each pack contains 20 or 40 sachets with granules.

Only certain pack sizes may be marketed.

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

or

Zambon, S.A.U.

Maresme, 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda (Barcelona)

Spain

Date of the most recent review of this leaflet: November 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) http://www.aemps.gob.es/