Package Insert: Information for the Patient

Espididol 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.

Follow exactly the administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if symptoms worsen, or fever persists for more than 3 days or pain for more than 5 days.

1. What is Espididol and for what it is used

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

3. How to take Espididol

4. Possible adverse effects

5. Storage of Espididol

6. Contents of the package and additional information

Ibuprofen, the active ingredient of this medication, acts by reducing pain and fever.

This medication is used in adults and adolescents 12 years of age or older (weight equal to or greater than 40 kg), for symptomatic relief of occasional mild to moderate pains, such as headaches, toothaches, menstrual cramps, muscle spasms, or back pain (lumbago), as well as febrile states.

Do not take Espididol if:

• 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 or other bleeding.
• If you have bleeding disorders or coagulation problems 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

Nonsteroidal anti-inflammatory drugs (NSAIDs) like 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. Do not take more than 3 packets of granules (1200 mg of ibuprofen) per day to avoid possible cardiovascular or heart problems.

Consult your doctor before starting to take Espididol:

• 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 problems.
• If you have an infection;

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

• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluid and immediately contact your doctor, as ibuprofen in this case may cause kidney insufficiency due to dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and in elderly patients. In these cases, your doctor may consider associating a stomach protector medication.
• If you take 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 Espididol-type medications may worsen these conditions.
• If you are taking diuretics (medications to urinate), as your doctor should 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, 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 your doctor for an eye examination.
• It is possible to experience allergic reactions with this medication. Discontinue treatment if you develop redness, inflammation, or skin lesions.
• Cutaneous reactions: Severe cutaneous reactions associated with Espididol treatment have been reported. Stop taking Espididol and consult your 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 cutaneous reaction. See section 4.
• Your doctor will perform a more stringent control 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.

Be especially careful with Espididol:

Severe cutaneous 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 Espididol treatment and seek immediate medical attention if you notice any of the symptoms related to these severe cutaneous reactions described in section 4.

Precautions in elderly patients

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

Cardiovascular precautions

NSAIDs like 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 Espididol 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.

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 problems

Ibuprofen should be used with caution in 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 insufficiency 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 administration with an increased risk of congenital anomalies/abortions, its administration is not recommended during the first and second trimesters of pregnancy, except when 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 taken for a few days from 20 weeks of gestation onwards, Espididol may cause kidney problems in your baby, which 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, ibuprofen administration is contraindicated.

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

Interference with laboratory tests

• Prothrombin 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 Espididol with other medications

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

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

• Anticoagulants (e.g., for treating coagulation problems or preventing coagulation, e.g., aspirin, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).

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

• Aspirin or other NSAIDs: increase the risk of gastrointestinal ulcers and bleeding.
• Anti-hypertensive medications (beta-blockers, ACE inhibitors, and angiotensin II receptor antagonists) and diuretics: NSAIDs may reduce the effect of diuretics and other anti-hypertensive medications. Concurrent administration of ibuprofen and potassium-sparing diuretics may cause hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (prevent blood clot formation) like ticlopidine.
• Anticoagulants (medications that "thin" the blood) like 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 (abortion inducer).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas like 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 against HIV/AIDS).
• Trombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba.
• Inhibitors of CYP2C9 (responsible for metabolizing numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking Espididol with food, drinks, and alcohol

Take this medication with meals or with milk.

Do not administer ibuprofen with alcohol to avoid damaging the stomach. 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 or are trying to become pregnant, consult your doctor or pharmacist before using this medication.

Espididol should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in fertile women).Espididol 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.

In breast milk, ibuprofen and its metabolites are excreted in minimal amounts. 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 Espididol or take it for a short period, no special precautions are necessary.

Espididol 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, 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 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 (the main component of table salt/for cooking) in each packet, which is equivalent to 2.85% of the recommended daily maximum sodium intake for an adult.

This medication may cause local reactions or mucous membrane irritation due to the presence of butylated hydroxyanisole (E 320).

Follow exactly the administration instructions of this medication as contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor promptly if symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended dose is:

• Adults and adolescents over 12 years of age and weighing 40 kg or more: Take one packet (400 mg of ibuprofen) every 6 or 8 hours as needed. Do not take more than 3 packets (1,200 mg of ibuprofen) in 24 hours.
• Elderly patients: The dose should be established by the doctor, as it may be necessary to reduce the usual dose.
• Patients with kidney, liver, or heart disease: Reduce the dose and consult a doctor.

Always use the lowest dose that is effective.

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

Consult a doctor if symptoms worsen or do not improve, if fever persists for more than 3 days or pain for more than 3 days in adolescents or 5 days in adults.

Use in children

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

Administration form:

This medication is administered orally.

Dissolve the entire contents of a packet in a glass of water and drink immediately. Take this medication with meals or with milk, especially if digestive discomfort is noted.

If you take more Espididol than you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately, go to the nearest hospital, or call the 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. Hematuria, low potassium levels in the blood, feeling cold, and respiratory problems may also occur. 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. Furthermore, low blood pressure and breathing difficulties may also 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 Espididol

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 dose is due 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 product, 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 Espididol 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 hemorrhage. 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 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 feeling 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 Espididol may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Very rare: Palpitations, heart failure.

Frequency not known: Cardiac arrest,chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Vascular disorders

Also, edema (fluid retention), high blood pressure, and heart failure have 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 Espididol are gastrointestinal: Peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients.

Common: Gastrointestinal discomfort such as heartburn, 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 Espididol may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions 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 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).

A generalized red, scaly rash, with bumps under the skin and blisters, located mainly on skin folds, the trunk, and upper limbs, accompanied by fever. The symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema). Stop taking Espididol 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 inflammation during infectious processes.

Frequency not known: Edema.

Investigations

Rare: Alteration of liver function tests.

Frequency not known: Alteration of renal function tests.

Until the present time, severe allergic reactions have not been reported with Espididol, 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 (lower than usual blood pressure) or shock.

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

• 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 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.

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

• Red, non-elevated spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and symptoms similar to the flu [exfoliative dermatitis, 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. The 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 medication.

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.Deposit empty packaging and unused medicines at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of empty packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Espididol

The active principle is ibuprofen-arginine. 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 “Espididol contains aspartame, sucrose, butyl hydroxyanisole (E 320) and sodium”).

Appearance of the product and contents of the packaging

White oral granule solution.

It is presented in packaging that contains 12 or 20 sachets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Zambon, S.A.U.

Maresme, 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda (Barcelona)

Spain

Manufacturer responsible

Zambon, S.p.A.

Via della Chimica, 9

36100 Vicenza

Italy

Zambon, S.A.U.

Maresme, 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda (Barcelona)

Spain

This leaflet has been approved in:November2024

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