Package Insert: Information for the Patient

Espidifen 600 mg Granule for Oral Solution, Orange Flavor

Ibuprofen (arginine)

Read this entire package insert carefully before taking 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 you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Espidifen and how is it used

2. What you need to know before starting Espidifen

3. How to take Espidifen

4. Possible adverse effects

5. Storage of Espidifen

6. Contents of the package and additional information

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

This medicine is used for the treatment of fever, the treatment of moderate to severe pain including migraine, the treatment of arthritis (inflammation of the joints, including those in the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic condition 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, 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 system.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have an active cerebral hemorrhage or other active bleeding.
• If you have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood). If anticoagulants are necessary, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you have severe dehydration caused by vomiting, diarrhea, or inadequate fluid intake.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor before starting to take Espidifen:

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

Espidifen may mask the signs of an infection, such as fever and pain. Consequently, Espidifen may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medication while 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 present symptoms of dehydration, e.g. severe diarrhea or vomiting, take plenty of liquid and contact your doctor immediately, as ibuprofen in this case may cause kidney insufficiency as a consequence of dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest 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 treatments, in patients with a history of peptic ulcer and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector medication.

• If you take Espidifen 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 produces bloody diarrhea) or ulcerative colitis, as Espidifen-type medications may worsen these conditions.
• If you are being treated with diuretics (medications to urinate) because your doctor must monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges, 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 your doctor can evaluate 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 visual disturbances during ibuprofen treatment, discontinue treatment and consult your doctor for an eye examination.
• It is possible to experience allergic reactions with this medication. You should discontinue treatment if redness, inflammation, or skin lesions appear.
• Severe skin reactions: Severe skin reactions associated with Espidifen treatment have been reported. Discontinue Espidifen and seek medical attention immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.
• Your doctor will perform a more stringent 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 administration with other NSAIDs, including 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 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.

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

Respiratory disorders

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

Children and adolescents

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

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

Precautions during pregnancy and in fertile women

Due to the administration of ibuprofen (arginine) being associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it 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 taken for a few days from 20 weeks of gestation onwards, Espidifen may cause kidney problems in your baby, which may lead to low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a few more days, your doctor may recommend additional monitoring.In the third trimester, the administration of ibuprofen (arginine) is contraindicated.

This medication may affect your tendency and that of your baby to bleed and make labor longer or more difficult than expected.

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: increased transaminase values.

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

Use of Espidifen with other medications

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

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

• 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 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 diuretics that save potassium 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 other 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 with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonureas such as tolbutamide or insulin (for diabetes), may need to adjust the dose.
• Some antidepressants (selective serotonin reuptake inhibitors).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (medication against HIV/AIDS).
• Fibrinolytics (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 ibuprofen (arginine) granules with water or another liquid. You can take them alone or with food. In general, it is recommended to take it during meals or immediately after eating to reduce the possibility of stomach discomfort. Consuming alcohol during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or 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).This 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, very small amounts of ibuprofen and its degradation products are excreted. 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 Espidifen or take it for a short period, you do not need to take special precautions.

Espidifen contains aspartame, saccharose, and sodium

This medication contains 60 mg of aspartame in each packet.

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

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

This medication contains 84.35 mg of sodium (main component of table salt/for cooking) in each packet. This is equivalent to 4.22% of the recommended daily maximum sodium intake for an adult.

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

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

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

This medication is administered orally.

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

Adults and adolescents

The recommended dose for adults and adolescents aged 14 to 18 years is one packet (600 mg of ibuprofen) every 6 to 8 hours, depending on the intensity of symptoms 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 14 to 18 years.

Use in elderly patients

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

Use in patients with kidney and/or liver disease

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

Use in children and adolescents

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

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 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 difficulty breathing may occur.

In case of significant ingestion, 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 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 medication, ask your doctor or pharmacist.

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

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

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

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

The following side effects have been observed:

Infections and infestations

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

Nota: If signs of infection or worsening occur during treatment with ibuprofen, it is recommended to see a doctor immediately, if necessary to initiate anti-infective/antibiotic therapy.

Blood and lymphatic system disorders

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

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

Immune system disorders

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

Rare: Anaphylaxis (generalized allergic reaction).

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

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

Mental disorders

Uncommon:Insomnia, anxiety, restlessness.

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

Nervous system disorders

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

Uncommon:Insomnia, excitement, irritability.

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

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

Eye disorders

Uncommon: Vision disturbances.

Rare: Abnormal or blurred vision.

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

Ear and labyrinth disorders

Common: Dizziness.

Uncommon: Ringing or buzzing in the ears.

Rare: Hearing difficulty.

Cardiac disorders

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

Vascular disorders

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

Very rare: High blood pressure.

Frequency not known: Arterial thrombosis.

Respiratory, thoracic, and mediastinal disorders

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

Frequency not known: Irritation of the throat.

Gastrointestinal disorders

The most common side effects that occur with medications like Espidifen 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 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 soft tissue may occur during chickenpox.

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

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

Renal and urinary disorders

Rare:Hematuria (blood in urine).

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

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

General disorders and administration site conditions

Very rare:Worsening of inflammation during infectious processes.

Frequency not known: Edema.

Investigations

Rare: Alteration of liver function tests.

Frequency not known: Alteration of renal function tests.

Until now, no severe allergic reactions have 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 (lower than usual blood pressure) or shock.

If any of the following side effects appear, discontinue treatment and see a doctor 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 or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.
• Visual disturbances.

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

• Flat, red spots, in the shape of a target or circles on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and symptoms similar to the flu (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized 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 adverse reactions

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 Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date appearing 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 packaging and unused medicines at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Espidifen

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

The other components (excipients) are: aspartame (E951), sucrose, sodium hydrogen carbonate, sodium saccharin, apricot aroma.

Appearance of Espidifen and content of the packaging

Oral granule solution, white in color.

Each package contains 20 or 40 sachets with granules.

Only some package sizes may be marketed.

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

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