Espididol 400 mg granules for oral solution, peppermint flavour

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Espididol 400 mg granules for oral solution, peppermint flavour

Ibuprofen (arginine)

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Always follow exactly the instructions for administration of this medicine as described in this leaflet or as given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read 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 effects not listed in this leaflet. See section 4.
• You should consult a doctor if symptoms worsen, or if fever persists for more than 3 days or pain for more than 5 days.

Contents of the leaflet

1. What Espididol is and what it is used for
2. What you need to know before taking Espididol
3. How to take Espididol
4. Possible side effects
5. How to store Espididol
6. Contents of the pack and other information

1. What Espididol is and what it is used for

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

This medicine is used in adults and adolescents from 12 years of age (weighing 40 kg or more) for the symptomatic relief of mild to moderate occasional pain, such as headaches, dental pain, menstrual pain, muscle pain (strains), or back pain (lumbago), as well as for feverish conditions.

2. What you need to know before taking Espididol

Do not take Espididol if:

• You are allergic to ibuprofen or to any of the other ingredients of the medicine (listed in section 6). Signs of allergy may include skin rash with itching, swelling of the face, lips or tongue, runny nose, breathing difficulties, bronchospasm or asthma.
• You have severe liver or kidney disease.
• You have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract.
• You are vomiting blood.
• You have black stools or bloody diarrhoea.
• You have active cerebrovascular bleeding or any other active bleeding.
• You have bleeding disorders or blood coagulation problems, or you are taking anticoagulants (medicines used to "thin" the blood). If concomitant use of anticoagulant medicines is necessary, your doctor will perform blood coagulation tests.
• You have severe heart failure.
• You have severe dehydration caused by vomiting, diarrhoea, or insufficient fluid intake.
• 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. Do not take more than 3 sachets of granules (1200 mg of ibuprofen) per day to avoid possible circulatory or heart problems.

Consult your doctor before starting to take Espididol:

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

Espididol may mask signs of infection such as fever and pain. Therefore, Espididol may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be performed.
• If you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to renal failure as a consequence of dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher when high doses are used, during long-term treatment, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.
• If you are taking concomitant medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as medicines like Espididol may worsen these conditions.
• If you are being treated with diuretics (medicines to increase urine production), because your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur.
• If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.
• If you suffer from headaches after prolonged treatment, do 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. Discontinue treatment if you develop redness, swelling, or skin lesions.
• Skin reactions: Serious skin reactions have been reported with Espididol treatment. Stop taking Espididol and see a doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.
• Your doctor will perform closer monitoring if you receive ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.

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

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

Take special care with Espididol:

Serious skin reactions have been reported with ibuprofen treatment, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). Discontinue treatment with Espididol and seek immediate medical attention if you notice any 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 (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

Cardiovascular precautions

Anti-inflammatory/pain-relieving 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 discuss your treatment with your doctor or pharmacist before taking Espididol if:

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

In addition, this type of medicine may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

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

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 such patients.

Children and adolescents

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

The use of this medicinal product is not recommended in children and adolescents weighing less than 40 kg or under 12 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dosing regimen in this patient group.

Precautions during pregnancy and in women of childbearing age

Since the administration of drugs of the ibuprofen type has been associated with an increased risk of congenital malformations and miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless considered strictly necessary and advised by your doctor.

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

If taken for several days starting from 20 weeks of gestation onward, Espididol may cause renal problems in your baby, which can 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 treatment for a few additional days is needed, your doctor may recommend further monitoring.

During the third trimester, administration of ibuprofen is contraindicated.

For patients of childbearing age, it should be noted that drugs of the ibuprofen type have been associated with a reversible reduction in fertility.

Interferences with diagnostic tests

• Bleeding time (may be prolonged for 1 day after discontinuation of treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase values.

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

Use of Espididol with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

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

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

The following medicines may interfere and therefore must not be taken together 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 lead to hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (which prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulants (medicines used to "thin" the blood and prevent the formation of 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 medicine (which slows the growth of certain cells produced by the body).
• Mifepristone (used to induce abortion).
• Digoxin and 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 together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide or insulin (for diabetes); dose adjustment may be necessary.
• Certain antidepressants (serotonin reuptake inhibitors).
• Tacrolimus (used in organ transplantation to prevent rejection).
• Zidovudine (a medicine for HIV virus).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: from Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous 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 together with other medicines.

Taking Espididol with food, drinks, and alcohol

Take this medicine with meals or with milk.

Ibuprofen should not be taken with alcohol to avoid stomach damage. Consuming alcohol during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Espididol should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing age). It may cause kidney and heart problems in your baby. It may affect your tendency and your baby's tendency to bleed, and may result in delayed or prolonged labour.

Minimal amounts of ibuprofen and its degradation products are excreted in breast milk. As no adverse effects in infants are known, breastfeeding does not usually need to be interrupted during short-term use at recommended doses.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and Use of Machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, you should not drive or operate dangerous machinery. If you take only a single dose of Espididol or use it for a short period, it is not necessary to take special precautions.

Espididol contains aspartame, sucrose, and sodium

This medicine contains 25 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Espididol

Follow exactly the administration instructions for this medicine provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay 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 ibuprofen) every 6 or 8 hours, if necessary. Do not take more than 3 sachets (1,200 mg ibuprofen) in 24 hours.
• Elderly patients: The dose should be determined by the doctor, as a reduction from the usual dose may be required.
• Patients with kidney, liver, or heart disease: Dose reduction is necessary; consult your doctor.

Always use the lowest dose that is effective.

This medicine should only be administered when pain or fever occurs. As these symptoms subside, treatment should be discontinued.

Consult a doctor if your condition worsens or does not improve, if fever persists for more than 3 days in adolescents or 5 days in adults, or if pain lasts longer 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 suitable for the recommended posology in this patient group.

Administration route:

This medicine is administered orally.

Completely dissolve the contents of one sachet in a glass of water and take immediately. Take this medicine with food or milk, especially if gastrointestinal discomfort occurs.

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 Toxicology Information Service (telephone: 91.5620420), indicating the medication and the amount ingested, to obtain information about the risks and advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, tinnitus, confusion, and involuntary eye movements. Agitation, somnolence, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, somnolence, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, sensation of cold body, and respiratory problems have been reported. Additionally, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may worsen in patients with asthma. Low blood pressure and difficulty breathing may also occur.

In cases of ingestion of large amounts, activated charcoal should be administered. Gastric emptying should be considered if large amounts have been ingested and within 60 minutes following ingestion.

If you forget to take Espididol

Do not take a double dose to make up for missed doses.

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

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

4. Possible adverse effects

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

Adverse effects of drugs such as Espididol are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatments and when the daily dose is below the recommended maximum dose.

Frequencies are defined according to the following classification: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); 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); frequency not known (cannot be estimated from available data).

The following adverse effects have been observed:

Infections and infestations

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

Note: If signs of infection appear or worsen during treatment with ibuprofen, medical advice should be sought immediately, as anti-infective/antibiotic therapy may be necessary.

Blood and lymphatic system disorders

Rare: Aplastic anemia (bone marrow failure to produce various types of blood 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 shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may increase susceptibility to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe reduction in granulocytes), hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding. Prolonged bleeding time.

Immune system disorders

Uncommon: Allergic reaction, hypersensitivity reactions with skin rash and pruritus, as well as asthma attacks (possibly along with 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, which may include potentially fatal shock).

Note: The appearance of these symptoms, which may occur with the first use, requires immediate medical attention.

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 sensation of instability.

Uncommon: Insomnia, excitement, irritability.

Rare: Paresthesia (numbness, tingling, pins and needles sensations, more commonly in hands, feet, arms, or legs).

Very rare: Aseptic meningitis. In most reported cases of aseptic meningitis with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which represented a risk factor. Symptoms observed included neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Eye disorders

Uncommon: Vision disturbances.

Rare: Abnormal or blurred vision.

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

Ear and labyrinth disorders

Common: Vertigo.

Uncommon: Tinnitus (ringing or buzzing in the ears).

Rare: Hearing difficulty.

Cardiac disorders

Medicines like Espididol may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Very rare: Palpitations, cardiac failure.

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

Vascular disorders

Edema (fluid retention), hypertension, and cardiac failure have also been observed in association with treatment using ibuprofen-type medicines (arginine).

Very rare: 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 with medicines such as Espididol are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients.

Common: Gastrointestinal discomfort such as pyrosis (acid reflux, heartburn), abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and minor gastrointestinal bleeding which may exceptionally lead to anemia.

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 (liver inflammation), abnormalities in liver function tests, and jaundice (yellowing of the skin and eyes).

Skin and subcutaneous tissue disorders

Common: Skin rash.

Uncommon: Skin redness, itching or swelling of the skin (angioedema, urticaria), purpura (purple spots on the skin).

Rare: Anaphylactic reaction.

Very rare: Medicines such as Espididol may, in very rare cases, be associated with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, mainly 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 lesions). Exceptionally, severe skin infections and complications in soft tissue may occur during chickenpox.

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

Generalized red, scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Espididol if you experience these symptoms and seek immediate medical attention. See also section 2.

Renal and urinary disorders

Rare: Hematuria (presence of blood in urine).

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

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

General disorders

Very rare: Worsening of inflammation during infectious processes.

Frequency not known: Edema.

Investigations

Rare: Abnormal liver function tests.

Frequency not known: Abnormal kidney function tests.

To date, no severe allergic reactions have been reported with Espididol, although they cannot be ruled out. Manifestations of such effects could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, angioedema, swelling of the face, tongue, and throat, breathing difficulty, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects occur, stop treatment and consult your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or diarrhea with blood.
• Severe stomach pain.
• Blisters or extensive skin peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Vision disturbances.

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Espididol

Keep out of sight and reach of children.

No special storage conditions required.

Do not use this medicine after the expiry date stated on the container, following the abbreviation EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or in household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Espididol

The active substance 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 flavor (contains modified corn starch (E1450)), and anise flavor (contains modified corn starch (E1450)) (see section 2 "Espididol contains aspartame, sucrose and sodium").

Appearance of the product and contents of the pack

White oral solution granules.

Supplied in containers containing 12 or 20 sachets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

Zambon, S.A.U.

Maresme, 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda (Barcelona)

Spain

Manufacturer

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 was approved in: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.