Espididol 400 mg 20 Sachets Granules for Oral Solution (Mint Flavor)

Ibuprofen, the active ingredient in this medicine, acts by reducing pain and fever.

This medicine is used in adults and adolescents aged 12 years and older (weight equal to or greater than 40 kg) for the symptomatic relief of occasional mild to moderate pain, such as headaches, dental pain, menstrual pain, muscle pain (contractures) or back pain (lumbago), as well as feverish states.

Do not take Espididol if:

• If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6). Reactions indicating allergy may include: itchy rash, swelling of the face, lips or tongue, runny nose, difficulty breathing, bronchospasm or asthma.
• If you have severe liver or kidney disease.
• If you have had an ulcer or bleeding in the stomach or duodenum 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 stroke or other active bleeding.
• If you have bleeding or blood clotting disorders or are taking anticoagulants (medicines used to “thin” the blood). If anticoagulant medications need to be used at the same time, your doctor will perform blood clotting tests.
• If you suffer from severe heart failure.
• If you suffer from severe dehydration caused by vomiting, diarrhea or insufficient fluid intake.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment. You should not take more than 3 sachets of granules (1200 mg ibuprofen) per day, to avoid possible heart or circulatory problems.

Consult your doctor before taking Espididol:

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

Espididol may hide the signs of an infection, such as fever and pain. Therefore, Espididol may delay proper treatment of the infection, which may increase the risk of complications. This has been seen in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection 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 of age, or need to take the medicine for a long time (more than 1 to 2 weeks), your doctor may need to check you regularly. Your doctor will tell you how often these checks should be carried out.
• If you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this particular case could cause kidney failure as a result of dehydration.
• If you have had or develop an ulcer, bleeding or perforation in the stomach or duodenum, which may manifest as severe or persistent abdominal pain and/or black stools, or even without any warning symptoms. This risk is greater when high doses and prolonged treatment are used, 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-protecting medication.
• If you are taking medicines that alter blood clotting, such as oral anticoagulants and antiplatelet agents such as acetylsalicylic acid. You should also tell your doctor about the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you suffer from Crohn's disease (a chronic disease in which the immune system attacks the intestine causing inflammation that generally produces bloody diarrhea) or ulcerative colitis, then medications such as Espididol can worsen these conditions.
• If you are being treated with diuretics (medicines to make you urinate) because your doctor must monitor your kidney function.
• If you suffer from 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), since aseptic meningitis may occur (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you suffer from acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine, blood in your urine or liver disease), to assess whether or not treatment with ibuprofen is appropriate.
• If you experience headaches after prolonged treatment, you should not take higher doses of the medicine.
• If you experience visual disturbances during treatment with ibuprofen, stop treatment and consult your doctor for an ophthalmological examination.
• Allergic reactions may occur with this medicine. Treatment should be discontinued if redness, swelling or skin lesions appear.
• Skin reactions: Serious skin reactions have been reported in association with treatment with Espididol. Stop taking Espididol and see a doctor immediately if you develop any skin rash, lesions on mucous membranes, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.
• Your doctor will monitor you more closely if you receive ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.

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

Avoid co-administration with other NSAIDs including so-called COX-2 inhibitors.

Take special care with Espididol:

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

Precautions in elderly patients

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

Cardiovascular precautions

Anti-inflammatory/pain-relieving medications such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses.

Do not exceed the recommended dose or duration of treatment.

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

• have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including a “mini-stroke” or transient ischemic attack “TIA”).
• have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker.

These types of medications can also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

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

Respiratory disorders

Ibuprofen should be used with caution when administered to patients suffering from or with a history of bronchial asthma, chronic rhinitis or allergic diseases since ibuprofen has been reported to cause bronchospasm, urticaria or angioedema in such patients.

Children and adolescents

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

This medicine is not recommended for use in children and adolescents weighing less than 40 kg or under 12 years of age, as the dose of ibuprofen it contains is not adequate for the recommended dosage in this group of patients.

Precautions during pregnancy and in women of childbearing age

Because the administration of ibuprofen-type medications has been associated with an increased risk of congenital abnormalities/miscarriages, its administration is not recommended during the first and second trimester of pregnancy unless considered strictly necessary and advised by your doctor.

If you need treatment during this period or while you are trying to become pregnant, the lowest dose should be used for the shortest possible time.

If taken for a few days from 20 weeks gestation onwards, Espididol may cause kidney problems in your baby which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a few more days, your doctor may recommend additional monitoring.

In the third trimester, the administration of ibuprofen is contraindicated.

For patients of childbearing age, it should be noted that ibuprofen-type medications have been associated with a decreased ability to conceive.

Interference with analytical tests

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (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 going to have any diagnostic tests (including blood tests, urine tests, skin tests using allergens, etc.) tell your doctor that you are taking this medicine, as it may alter the results.

Using Espididol with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

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

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

• Acetylsalicylic acid or other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding.
• Antihypertensives (beta-blockers, ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive agents. Concomitant administration of ibuprofen and potassium-sparing diuretics may cause hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (prevent the formation of thrombi or clots in blood vessels) such as ticlopidine.
• Anticoagulants (medicines used to “thin” the blood and prevent clots) such as warfarin.
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate. Your doctor may adjust the dose of this antimetabolite medication (it slows the growth of certain cells made by the body).
• Mifepristone (abortion inducer).
• Digoxin and cardiotonic 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 to treat some bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Pentoxifylline (to treat intermittent claudication).
• Probenecid (used in patients with gout or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide or insulin (for diabetes), dosage adjustment may be necessary.
• Some antidepressants (serotonin reuptake inhibitors).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (drug against the AIDS virus).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: from the Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking Espididol with food, drink and alcohol

Take this medicine with food or milk.

Ibuprofen should not be administered with alcohol to avoid stomach upset. Alcohol consumption during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Espididol should not be taken during pregnancy, especially during the third trimester (see section Precautions during pregnancy and in women of childbearing potential). It may cause kidney and heart problems in your baby. It may affect your and your baby's tendency to bleed and make your labour take longer or later than expected.

Small amounts of ibuprofen and its degradation products are excreted in breast milk. Since there are no known adverse effects on the breastfed infant, it is not usually necessary to discontinue breastfeeding during short-term use at recommended doses.

Therefore, if you become pregnant or are breast-feeding, consult your doctor.

Driving and using machines

If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you only take one dose of Espididol or take it for a short period, you do not need to take any special precautions.

Espididol contains aspartame, sucrose, butyl hydroxyanisole (E 320) and sodium

This medicine contains 25 mg of aspartame in each sachet. Aspartame contains a source of phenylalanine which may be harmful if you suffer from phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body is unable to remove it properly.

This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains 57 mg of sodium (main component of table/cooking salt) in each sachet. This is equivalent to 2.85% of the maximum recommended daily sodium intake for an adult.

This medicine may cause local reactions or irritation of mucous membranes because it contains butyl hydroxyanisole (E 320).

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are not sure.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, tell 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 weighing 40 kg or more: Take one sachet (400 mg of ibuprofen) every 6 to 8 hours, if necessary. Do not take more than 3 sachets (1,200 mg of ibuprofen) in 24 hours.
• Elderly patients: the dose should be established by the doctor, since there is a possibility that a reduction in the usual dose may be necessary.
• Patients with kidney, liver or heart disease: reduce the dose and consult a doctor.

Always use the lowest effective dose.

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

You should consult a doctor if your condition gets worse or does not improve, if your fever persists for more than 3 days or if your pain persists for more than 3 days in adolescents or 5 days in adults.

Use in children

This medicine is not recommended for use in children and adolescents weighing less than 40 kg or under 12 years of age, as the dose of ibuprofen it contains is not adequate for the recommended dosage in this group of patients.

Method of administration:

This medicine is administered orally.

Dissolve the contents of one sachet completely in a glass of water and then swallow. Take this medicine with food or milk, especially if you experience digestive discomfort.

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 Poison Information Service (telephone: 91.5620420), indicating the medicine and the amount ingested, to find out about the risk and ask for advice on the measures to be taken.

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain bloody sputum), dizziness, spasms, low blood pressure or depression of the nervous system (reduced consciousness), headache, ringing in the ears, confusion and involuntary eye movements. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in the urine, chills and breathing problems have been reported.

Rarely, more serious symptoms such as gastrointestinal bleeding, low blood pressure, convulsions and respiratory disorders may occur. In cases of severe overdose, kidney failure and liver damage may occur.

If large quantities are ingested, activated charcoal should be administered. Stomach emptying should be considered if large quantities have been ingested and within 60 minutes of ingestion.

If you forget to take Espididol

Do not take a double dose to make up for a forgotten dose.

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

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects of drugs like Espididol are more common in people over 65 years of age.

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

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

The following adverse effects have been observed:

Infections and infestations

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

Note : If signs of infection are observed or worsen during treatment with ibuprofen, it is recommended to see a doctor immediately, in case anti-infectious/antibiotic therapy is necessary.

Blood and lymphatic system disorders

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

Very rare : Decreased platelets, decreased white blood cells (may present as frequent infections with fever, chills or sore throat), decreased red blood cells (may present as difficulty breathing and pale skin), decreased granulocytes (a type of white blood cell which may predispose you to infections), pancytopenia (deficiency of red blood cells, white blood cells and platelets), agranulocytosis (very large decrease in granulocytes), haemolytic anaemia (premature destruction of red blood cells). Early symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme tiredness, nose bleeds and skin bleeds. Prolonged bleeding time.

Immune system disorders

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

Rare : Anaphylaxis (generalized allergic reaction).

Very rare : Severe hypersensitivity reactions (these may be characterised by swelling of the face, tongue and larynx with bronchospasm, dyspnoea, tachycardia and hypotension which may include life-threatening shock).

Note : If these symptoms appear, which may occur upon first use, immediate medical assistance is required.

Psychiatric disorders

Uncommon : Insomnia, anxiety, restlessness.

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

Nervous system disorders

Common : Fatigue or drowsiness, headache and dizziness or feeling of unsteadiness.

Uncommon : Insomnia, excitation, irritability.

Rare : Paresthesia (sensation of numbness, tingling, numbness, etc. more frequently in hands, feet, arms or legs).

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

Eye disorders

Uncommon : Visual disturbances.

Rare : Abnormal or blurred vision.

Not known frequency : 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 Espididol may be associated with a modest increased risk of heart attack (“myocardial infarction”) or stroke.

Very rare : Palpitations, heart failure.

Not known frequency : Heart failure, chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Vascular disorders

Edema (fluid retention), high blood pressure, and heart failure in association with treatments with drugs such as Ibuprofen (arginine).

Very rare : Arterial hypertension.

Frequency not known : Arterial thrombosis.

Respiratory disorders

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

Frequency not known : Throat irritation.

Gastrointestinal disorders

The most common adverse effects that occur with medications such as Espididol are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients.

Common : Gastrointestinal complaints such as heartburn (acidity, reflux), abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation and mild gastrointestinal bleeding which may cause anaemia in exceptional cases.

Uncommon : Gastrointestinal ulcers, potentially with bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, melena (blood in stool), gastritis.

Rare : Vomiting blood.

Very rare : Inflammation of the esophagus, pancreatitis, intestinal stenosis.

Frequency not known : Anorexia.

Hepatobiliary disorders

Rare : Liver injury, hepatitis (inflammation of the liver), liver function abnormalities 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 Espididol may very rarely be associated with very serious blistering reactions such as Stevens-Johnson Syndrome (widespread erosions affecting the skin and two or more mucous membranes and purple lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis). Hair loss, erythema multiforme (skin lesion). In exceptional cases, serious skin infections and soft tissue complications may occur during chickenpox.

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

A widespread red, scaly rash with lumps under the skin and blisters, mainly located in skin folds, on the trunk and upper limbs, accompanied by fever at the start of treatment (acute generalised exanthematous pustulosis). Stop taking Espididol if you experience these symptoms and seek medical attention immediately. See also section 2.

Kidney and urinary disorders

Rare : Hematuria (presence of blood in the urine).

Very rare : Edema (signs which may be indicative of kidney disease, which may sometimes include kidney failure); renal tissue damage (papillary necrosis), increased serum uric acid concentration.

Based on experience with nonsteroidal anti-inflammatory drugs in general, cases of interstitial nephritis, nephrotic syndrome and renal failure cannot be excluded.

General disorders

Very rare : Aggravation of inflammation during infectious processes.

Frequency not known : Oedema.

Additional explorations

Rare : Abnormal liver function tests.

Not known frequency : Abnormal renal function tests.

To date, no serious allergic reactions have been reported with Espididol, although they cannot be ruled out. Manifestations of such effects may include fever, skin rash, abdominal pain, severe and persistent 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 occur, stop treatment and contact your doctor immediately:

• Allergic reactions such as skin rash, swelling of the face, wheezing, or difficulty breathing.
• Vomiting blood or vomiting that looks like coffee grounds.
• Blood in the stool or bloody diarrhea.
• Severe stomach pain.
• Blisters or significant peeling of the skin.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the extremities or fluid buildup in the arms or legs.
• Vision disturbances.

Stop taking Espididol and seek medical attention immediately if you notice any of the following symptoms:

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

Communication of adverse effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es . By reporting side effects you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

It does not require special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after the abbreviation EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Please dispose of any packaging and any medicines you no longer need at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of packaging and any medicines you no longer need. This will help protect the environment.

Espididol composition

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

The other ingredients (excipients) are: aspartame (E951), sucrose, sodium hydrogen carbonate, sodium saccharin, mint flavouring and aniseed flavouring (contains butyl hydroxyanisole (E-320)) (see section 2 “Espididol contains aspartame, sucrose, butyl hydroxyanisole (E 320) and sodium”).

Product appearance and contents of the package

White granules for oral solution.

It comes in packages containing 12 or 20 sachets.

Only certain package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zambon, SAU

Maresme, 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda (Barcelona)

Spain

Manufacturing Manager

Zambon, SpA

Via della Chimica, 9

36100 Vicenza

Italy

Zambon, SAU

Maresme, 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda (Barcelona)

Spain

This prospectus was approved in: May 2024

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