Package Insert: Information for the Patient

Espidifen 400 mg Granule for Oral Solution, Peppermint Flavor

Ibuprofen (Arginine)

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

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

1. What isEspidifenand for what it is used

2. What you need to know before starting to takeEspidifen

3. How to takeEspidifen

4. Possible adverse effects

5. Storage ofEspidifen

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 for the treatment of fever, the treatment of mild to moderate pain including migraine, the treatment of arthritis (inflammation of the joints, including those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

Do not 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 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 problems or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you have an infection;

Espidifenmay mask the signs of an infection, such as fever and pain. Consequently, it ispossible thatEspidifenmay delay the appropriate treatment of the infection, which may increasethe 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 aninfection 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 failure as a result of dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as 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 treatment, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor may consider associating a stomach-protective medication.

• If you take ibuprofen simultaneously with medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also inform your doctor about the use of 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 ibuprofen (arginine) type medications may worsen these conditions.
• If you are being treated with diuretics (medications to urinate) because your doctor needs 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 can cause symptoms such as red urine, blood in urine, or liver disease), so that 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.

• Ifyouexperience visual disturbances during ibuprofen treatment, discontinue treatment and consult a doctor for an eye examination.

• It is possible to experience allergic reactions with this medication. You should discontinue treatment if you develop skin redness and inflammation or skin lesions.
• Severe skin reactions: Severe skin reactions associated with Espidifen treatment have been reported. Stop taking Espidifen and see a doctor 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 control if you receive ibuprofen after undergoing major surgery.
• It is advisable 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 administrationwith other NSAIDs, including those referred to as COX-2 inhibitors.

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.

Precautions in elderly patients

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

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.

You should 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 (problems with circulation 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 are a smoker.

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

Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using this medication immediately and contact your doctor or emergency medical services if you observe any of these signs.

Respiratory disorders

Ibuprofen should be used with caution when administered to patients who have or have had asthma, 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.

This medication is not recommended for children and adolescents weighing less than 40 kg or under 12 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

Precautions during pregnancy and in fertile women

Due to the association of ibuprofen (arginine) type medications 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, you should use the lowest dose for the shortest possible time.

If you take it for a few days from 20 weeks of gestation onwards, Espidifen may cause kidney problems in your baby that may lead to low amniotic fluid levels 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.

During the third trimester, the administration of ibuprofen (arginine) is contraindicated.

For fertile women, it should be noted that ibuprofen (arginine) type medications have been associated with a decrease in the ability to conceive.

Interference with analytical tests

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

If you are to undergo any diagnostic test (includingblood, urine, skin tests that use allergens, etc...) inform your doctor thatyou are takingthis 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:

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

The following medications may interfere and, therefore, should not be taken together with Espidifen without consulting your doctor:

• Acetylsalicylic acid or other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding.
• Antihypertensive medications (beta-blockers, ACE inhibitors, and angiotensin II receptor antagonists) 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 the formation of blood 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 (slows down the growth of certain cells produced by the body).
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medications used to increase urine production).
• 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 need to adjust the dose.
• Some antidepressants (selective serotonin reuptake inhibitors).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (medication against HIV/AIDS).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: from the Ginkgo biloba tree.
• Inhibitors of CYP2C9 (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, you should 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. Drinking alcohol during treatment may increase the risk of gastrointestinal side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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 on precautions during pregnancy and in fertile women). It 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..

Small 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, visual disturbances, or other symptoms while taking this medication, you should not drive or operate hazardous machinery. If you only take a single dose of ibuprofen (arginine) or take it for a short period, you do not need to take special precautions.

Espidifen contains aspartame, sucrose, butylated hydroxyanisole (E 320), and sodium

This medication contains 25 mg of aspartame in each packet. Aspartame contains a source of phenylalanine that 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 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 57 mg of sodium (main component of table salt/for cooking) in each packet. This corresponds to 2.85% of the recommended daily maximum sodium intake for an adult.

This medication may cause local reactions or irritation of mucous membranes because it contains butylated hydroxyanisole (E320).

Follow exactly the administration instructions of this medication 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 immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

This medication is administered orally.

Patients with stomach discomfort should take the medication with milk or during/after meals.

Adults and adolescents

In adults and adolescents aged 12 to 18 years, one packet (400 mg) will be taken every 6 to 8 hours, depending on the severity of the condition and response to treatment.

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.

Use in elderly patients

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, the dose can only be increased once your doctor has confirmed that you tolerate the medication well.

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.

If you estimate that the action of Espidifen is too strong or too weak, inform your doctor or pharmacist.

Use in children

This medication is not recommended for use in children and adolescents weighing less than 40 kg or under 12 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

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 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 tremors of the eyes. 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, blood in the urine, low potassium levels in the blood, feeling cold, and respiratory problems have been reported. 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, low blood pressure and difficulty breathing may occur.

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

If you 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 time for the next dose is near, skip the missed dose and take the next dose at your usual time.

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

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

The side effects of medicines like 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 (can affect more than 1 in 10 patients); common (can affect up to 1 in 10 patients); uncommon (can affect up to 1 in 100 patients); rare (can affect up to 1 in 1,000 patients); very rare (can affect up to 1 in 10,000 patients); frequency unknown (cannot be estimated from available data).

The following side effects have been observed:

Infections and infestations

Very rare: Exacerbation of inflammatory conditions related to infection (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 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 fall 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 potentially fatal shock).

Nota: In the event 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: Visual disturbances.

Rare: Abnormal or blurred vision.

Frequency unknown: Papilledema (inflammation of the optic nerve).

Ear and labyrinth disorders

Common: Vertigo.

Uncommon: Ringing or buzzing in the ears.

Rare: Hearing difficulty.

Cardiac disorders

Medicines like 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 unknown: Cardiac failure,chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Vascular disorders

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

Very rare: Hypertension.

Frequency unknown: Arterial thrombosis.

Respiratory, thoracic and mediastinal disorders

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

Frequency unknown: Irritation of the throat.

Gastrointestinal disorders

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

Common: Gastrointestinal disorders 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, 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 unknown: 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: Medicines like 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). Hair loss, erythema multiforme (skin lesion),. Exceptionally, severe skin infections and complications in the soft tissue may occur during chickenpox.

Frequency unknown:Phototoxicity, aggravation of skin reactions.Severe skin reactions known as DRESS syndrome may occur. 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 beginning of treatment (generalized acute pustular exanthema). Stop taking Espidifen if you experience these symptoms and seek medical attention immediately. See section 2.

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 inflammatory conditions during infectious processes.

Frequency unknown: Edema.

Investigations

Rare: Alteration of liver function tests.

Frequency unknown: 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 side effect could be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, angioedema, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension, or shock.

If any of the following side effects occur, discontinue treatment and seek medical attention immediately:

• Allergic reactions such as skin rash, swelling of the face, chest tightness, or difficulty breathing.
• Vomiting blood or coffee ground-like material.
• Blood in stool or diarrhea with blood.
• Severe abdominal pain.
• Significant blisters or peeling of the skin.
• Severe headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (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 medical attention immediately if you notice any of the following symptoms:

• spots or patches of red, non-elevated, in the shape of a target or circular on the trunk, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. 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 red scaly 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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Espidifen

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

The other components (excipients) are: aspartame (E951), sucrose, sodium hydrogen carbonate, sodium saccharin, peppermint aroma and anise aroma (contains butyl hydroxyanisole (E 320)). See section 2. “Espidifen contains aspartame, sucrose, butyl hydroxyanisole (E 320) and sodium”

Appearance of Espidifen and contents of the packaging

Oral granule solution, white in color.

Each package contains 30 sachets with granules.

Marketing Authorization Holder

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

Last review date of this leaflet:November 2024

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