Espidifen 400 mg granules for oral solution, peppermint flavour: detailed information

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Espidifen 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.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

What Espidifen is and what it is used for
What you need to know before taking Espidifen
How to take Espidifen
Possible side effects
How to store Espidifen
Contents of the pack and other information

1. What Espidifen is and what it is used for

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

This medicine is used for the treatment of fever, and for the relief of mild to moderate pain including migraine. It is also used in the treatment of arthritis (inflammation of the joints, typically affecting the hands and feet, resulting in swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic condition causing damage to cartilage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before taking Espidifen

Do not take Espidifen:

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: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties, bronchospasm or asthma.
If you have severe liver or kidney disease.
If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
If you are vomiting blood.
If you have black stools or bloody diarrhoea.
If you have active cerebral haemorrhage or any other active bleeding.
If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant medicines must be used concomitantly, your doctor will perform blood coagulation tests.
If you have severe heart failure.
If you have severe dehydration caused by vomiting, diarrhoea, or insufficient 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 oedema (fluid retention).
If you have or have had heart disorders or high blood pressure.
If you have asthma or any other respiratory disorder.
If you have an infection.

Espidifen may mask signs of infection such as fever and pain. Therefore, Espidifen could 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 long-term (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 due to 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 or prolonged treatments are used, 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 medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about using 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 of the ibuprofen (arginine) type may worsen these conditions.
If you are being treated with diuretics (medicines to increase urination), because your doctor needs to monitor kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may involve 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 redness, swelling, or skin lesions appear.
Skin reactions: Serious skin reactions have been reported with Espidifen treatment. Stop taking Espidifen and contact your doctor immediately if you develop any skin rash, lesions of mucous membranes, 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 dose that relieves/controls your pain and not to take this medicine longer than necessary to control your symptoms.

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

Take special care with Espidifen:

Serious skin reactions 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) have been reported in association with ibuprofen treatment. Stop treatment with Espidifen 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/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly 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 Espidifen if:

You have heart problems, including heart failure, angina (chest pain), history of heart attack, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked 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, these types of medicines may cause fluid retention, especially 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 emergency medical services immediately if you notice any of these signs.

Respiratory disorders

Ibuprofen should be used with caution when administered to patients who suffer from 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 impairment in dehydrated children and adolescents.

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

Precautions during pregnancy and in women of childbearing potential

Because administration of ibuprofen-type medicines (arginine) has been associated with an increased risk of congenital malformations and miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary and advised by your doctor.

If treatment is required 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 onwards, Espidifen may cause renal problems in your baby, which could 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 longer-term treatment is needed, your doctor may recommend additional monitoring.

During the third trimester, administration of ibuprofen (arginine) is contraindicated.

For women of childbearing potential, it should be noted that ibuprofen-type medicines (arginine) have been associated with a reduced fertility capacity.

Interference with diagnostic tests

Bleeding time (may be prolonged for up to 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 levels

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 Espidifen with other medicines

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

Espidifen 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, and angiotensin-II receptor antagonists such as losartan).

The following medicines may interact and therefore should not be taken together with Espidifen without first consulting your doctor:

Acetylsalicylic acid or other anti-inflammatory/analgesic agents: increased risk of gastrointestinal ulcers and bleeding.
Antihypertensives (beta-blockers, ACE inhibitors, and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness 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 (which prevent thrombus or clot formation in blood vessels), such as ticlopidine.
Anticoagulants (medicines used to "thin" the blood and prevent clots), such as warfarine.
Lithium (a medicine used to treat depression). Your doctor may need to adjust the dose of this medicine.
Methotrexate. Your doctor may need to adjust the dose of this antimetabolite medicine (which slows the growth of certain body cells).
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 to treat certain bacterial infections).
Corticosteroids such as cortisone and prednisolone.
Diuretics (medicines used to increase urine elimination).
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 against the 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 Espidifen. Therefore, always consult your doctor or pharmacist before using Espidifen with other medicines.

Taking Espidifen with food, drinks, and alcohol

It is recommended to take the ibuprofen (arginine) granule sachets with water or another liquid. They may be taken alone or with food. In general, it is advisable to take them during or immediately after meals to reduce the possibility of gastrointestinal discomfort. Alcohol consumption during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy and breastfeeding

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.

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

Minimal amounts of ibuprofen and its metabolites are excreted in breast milk. As no adverse effects in infants have been reported, interruption of breastfeeding is usually not necessary during short-term use at recommended doses.

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

Driving and use of 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 take only a single dose of ibuprofen (arginine) or use it for a short period, special precautions are generally not required.

Espidifen contains aspartame, sucrose, and sodium

This medicine contains 25 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful in individuals with 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 him or her before taking this medicine.

This medicine contains 57 mg of sodium (a 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 Espidifen

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the duration of treatment with Espidifen. Do not stop treatment earlier, as otherwise the expected results will not be achieved. Likewise, do not use this medicine for longer than prescribed by your doctor.

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

This medicine is administered orally.

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

Adults and adolescents

In adults and adolescents aged 12 to 18 years, one sachet (400 mg) should be taken every 6 to 8 hours, depending on the severity of symptoms and response to treatment.

Higher doses may be required in some conditions; however, 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 12 to 18 years.

Use in elderly patients

If you are over 60 years of age, your doctor may prescribe a lower than usual dose. If so, the dose may only be increased once your doctor has confirmed that you tolerate the medicine well.

Use in patients with kidney and/or liver disease

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

If you feel that the effect of Espidifen is too strong or too weak, inform your doctor or pharmacist.

Use in children

The use of this medicine 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 in this patient group.

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 Toxicology Information Service (telephone: 91.5620420), indicating the medicine and amount ingested, to obtain information about the risk and advice on measures to take.

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 tremulous eye movements. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and respiratory problems may be reported. Additionally, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may be exacerbated in asthmatic patients. Hypotension and breathing difficulties 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 of ingestion.

If you forget to take Espidifen

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

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

4. Possible adverse effects

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

Adverse effects of medicines such as Espidifen 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 related to infection (e.g., development of necrotizing fasciitis), occurring in association 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 required.

Blood and lymphatic system disorders

Rare: Aplastic anemia (bone marrow failure to produce various types of blood cells).

Very rare: Decreased platelet count, decreased white blood cell count (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cell count (may manifest 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 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, which may include potentially fatal shock).

Note: If these symptoms occur, even with first use, immediate medical attention is required.

Psychiatric disorders

Uncommon: Insomnia, anxiety, restlessness.

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

Nervous system disorders

Common: Fatigue or drowsiness, headache, dizziness, or feeling unsteady.

Uncommon: Insomnia, excitation, irritability.

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

Very rare: Aseptic meningitis. In most reported cases of aseptic meningitis associated 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 impairment.

Cardiac disorders

Medicines such as Espidifen 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 heart failure have also been observed in association with treatments using ibuprofen (arginine)-type medicines.

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 Espidifen are gastrointestinal: peptic ulcers, gastrointestinal hemorrhage, perforations (in some cases fatal, especially in elderly patients).

Common: Gastrointestinal discomfort such as heartburn (acid reflux), abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild 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 skin spots).

Rare: Anaphylactic reaction.

Very rare: Medicines such as Espidifen 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, primarily 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). Rarely, severe skin infections and soft tissue complications 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, elevated eosinophils (a type of white blood cell), generalized red scaly rash with nodules under the skin and blisters, primarily in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Espidifen and seek immediate medical attention if you experience these symptoms. 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 may sometimes include renal failure); kidney 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 Espidifen, 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 difficulties, asthma, palpitations, hypotension, 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 bloody diarrhea.
Severe stomach pain.
Blisters or extensive skin peeling.
Severe or persistent headache.
Yellowing of the skin (jaundice).
Signs of severe hypersensitivity (see above in this section).
Swelling of the limbs or fluid accumulation in the arms or legs.
Vision disturbances.

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

Flat, non-elevated, target-shaped or circular red spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe 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 type of adverse effect, consult 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 Espidifen

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Espidifen

The active substance is ibuprofen. 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 flavour (contains modified maize starch (E1450)) and aniseed flavour (contains modified maize starch (E1450)). See section 2. “Espidifen contains aspartame, sucrose and sodium”.

Appearance of Espidifen and contents of the pack

White oral granules for solution.

Each pack contains 30 sachets of granules.

Marketing Authorisation 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

Date of the most recent review of this leaflet: November 2024

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