Espididol 400 mg comprimidos recubiertos

Package Insert: Information for the Patient

Espididol 400 mg Coated Tablets

Ibuprofen (arginine)

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

Follow exactly the administration instructions of the medicine 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 pains (spasms) or back pain (lumbago), as well as febrile states.

Do not take Espididol

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, bronchospasm, or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have an active cerebral hemorrhage or other active bleeding.
• If you have bleeding or clotting disorders or are taking anticoagulants (medications used to "thin" the blood). If anticoagulants are necessary, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you have severe dehydration caused by vomiting, diarrhea, or inadequate fluid intake.
• If you are in the third trimester of pregnancy.

Warnings and precautions

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 coated tablets (1200 mg of ibuprofen) per day to avoid potential 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 disorder or high blood pressure.
• If you have asthma or any other respiratory disorder.
• 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, such as 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 pain 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 anticoagulant medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents like 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 condition in which the immune system attacks the intestine, causing inflammation that typically results in bloody diarrhea) or ulcerative colitis, as Espididol 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 condition 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 disorder that affects your blood and may cause symptoms such as red urine, bloody urine, or liver disease), so your doctor can evaluate the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• If you experience vision disturbances during ibuprofen treatment, discontinue treatment and consult a doctor for an eye examination.
• It is possible to experience allergic reactions with this medication. Discontinue treatment if you notice redness, inflammation, or skin lesions.
• Severe skin reactions: Severe skin reactions associated with Espididol treatment have been reported. Discontinue Espididol and seek medical attention immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.
• Your doctor will perform a more stringent check if you receive ibuprofen after undergoing major surgery.
• It is recommended not to take this medication if you have chickenpox.

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

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

Be especially careful with Espididol:

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 Espididol treatment and seek medical attention immediately if you notice any 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 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 (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 ibuprofen, such as respiratory problems, facial swelling, and neck swelling (angioedema), and chest pain. Discontinue use immediately and contact your doctor or emergency medical services if you observe any of these signs.

Respiratory disorders

Ibuprofen should be used with caution 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 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 time possible.

If taken for a few days from 20 weeks of gestation onwards, Espididol 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.

In the third trimester, ibuprofen administration is contraindicated.

For fertile women, consider that ibuprofen has 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)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen concentrations, 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 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:

• Anticoagulant medications (e.g., for treating coagulation problems/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.
• Beta-blockers, ACE inhibitors, and angiotensin II receptor antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive substances. Concurrent administration of ibuprofen and potassium-sparing diuretics may cause hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (prevent blood clot formation in blood vessels) like ticlopidine.
• Oral anticoagulants (medications that "thin" the blood) like warfarin.
• Lithium (medication used to treat depression). Your doctor may adjust your lithium dose.
• Methotrexate. Your doctor may adjust your methotrexate dose.
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used to treat heart disorders).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids like prednisone 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.
• CYP2C9 inhibitors (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, breastfeeding, think you may be pregnant, or plan 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, minimal amounts of ibuprofen and its metabolites 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, 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 saccharose and sodium

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

This medication contains 83 mg of sodium (main component of table salt/for cooking) in each tablet. This corresponds to 4% of the recommended daily maximum sodium intake for an adult.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The 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).

The recommended dose is:

• Adults and adolescents over 12 years old (weight equal to or greater than 40 kg): Take one tablet (400 mg of ibuprofen) every 6 or 8 hours, if necessary. No more than 3 tablets (1,200 mg of ibuprofen) should be taken in 24 hours.
• Older adults: 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 effective dose.

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

You should 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 old, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

Administration form:

This medication is administered orally.

Take the tablet with half a glass of water. 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 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. Low blood pressure and difficulty breathing 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 forgot to take Espididol

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

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 its usual time.

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

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

The side effects of medications such as 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 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 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

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 Espididol are gastrointestinal: Peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients.

Common: Gastrointestinal disturbances 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, 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 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 cutaneous 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, mainly located in skin folds, 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 now, 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, discontinue 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.

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

• Flat, red spots not elevated, in the form 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 [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, 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 Vigilance of Medicinal Products for Human Use:https://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 appearing on the packaging,after the CAD abbreviation. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection pointof the pharmacy.Ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

Composition of Espididol

The active ingredient is ibuprofen-arginine. Each coated tablet contains 400 mg of ibuprofen (as 770 mg of ibuprofenarginine).

The other components are: sodium hydrogen carbonate, crospovidone and magnesium stearate. The coating contains hypromellose (E464), sucrose, titanium dioxide (E171) and macrogol 4000.

Appearance of the product and content of the container

They are white or almost white, oval-shaped, scored tablets.

They are presented in containers that contain 6, 12 and 18 coated tablets.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Zambon, S.A.U.

Maresme, 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda (Barcelona)

Spain

Responsible for manufacturing

Zambon, S.p.A.

Via Della Chimica, 9

36100 Vicenza

Italy

This leaflet has been reviewed in: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/.