Ibufén Xpress 400 mg granules for oral solution: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibufén Xpress 400 mg granules for oral solution

Ibuprofen (arginine)

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

Follow exactly the instructions for use of this medicine provided in this leaflet or those given by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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

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

1. What Ibufén Xpress 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 aged 12 years and older (weighing 40 kg or more) for the symptomatic relief of mild to moderate occasional pain, such as headaches, toothaches, menstrual pain, muscle pain (contractures), or back pain (lumbago), as well as febrile conditions.

2. What you need to know before taking Ibufén Xpress

Do not take Ibufén Xpress

If you are allergic to ibuprofen or to any of the other ingredients of this 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 gastrointestinal tract perforation.
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 or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulants 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

Talk to your doctor or pharmacist before taking Ibufén Xpress.

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.

Inform your doctor

If you have oedema (fluid retention).
If you have or have had any heart disorder or have high blood pressure.
If you have asthma or any other respiratory disorder.
If you have an infection.
Ibuprofen may mask signs of infection such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin infections associated with chickenpox. If you take this medicine while having an infection and 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 perform regular monitoring. Your doctor will advise you on how often these checks should be done.
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 and prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing 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 mention the use of other medicines that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
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 ibuprofen-type medicines may worsen these conditions.
If you are taking diuretics (medicines to increase urine output), because your doctor needs to monitor your 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—without bacterial cause) 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 ibuprofen treatment 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 taking the medicine 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 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 with ibuprofen treatment. Stop taking Ibufén Xpress and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
Stop taking this medicine 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 severe 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.
Signs of allergic reaction to ibuprofen, such as breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop using Ibufén Xpress immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

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

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

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, 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 ibuprofen if:

you have heart problems, including heart failure, angina (chest pain), or have had a 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 smoke.

These medicines may also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

Ibuprofen should be used with caution in 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.

This medicine is not recommended for use 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 in this patient group.

Precautions during pregnancy and in women of childbearing age

Do not take ibuprofen during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and your baby's tendency to bleed, and may delay or prolong labour beyond the expected time. Do not take ibuprofen during the first 6 months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time.

From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, 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 treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that medicines like ibuprofen have been associated with a reduced ability to conceive.

Interference with diagnostic tests

Bleeding time (may be prolonged for up to 1 day after stopping treatment).
Blood glucose concentration (may decrease).
Creatinine clearance (may decrease).
Haematocrit or haemoglobin (may decrease).
Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase).
Liver function tests: increased transaminase values.

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

Other medicines and Ibufén Xpress

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

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

Anticoagulant medicines (e.g. to treat or prevent blood clotting, e.g. 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 ibuprofen (arginine) without first consulting your doctor:

Acetylsalicylic acid or other anti-inflammatory/analgesic medicines increase the risk of gastrointestinal ulcers and bleeding.
Antihypertensives (beta-blockers, ACE inhibitors and angiotensin-II receptor antagonists) and diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive agents. Concomitant administration of ibuprofen and potassium-sparing diuretics may cause hyperkalaemia and increase the risk of renal toxicity.
Antiplatelet agents (prevent blood clots in blood vessels) such as ticlopidine.
Anticoagulants (medicines used to "thin" the blood and prevent clots) such as warfarin.
Lithium (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 body cells).
Mifepristone (abortion-inducing agent).
Digoxin and cardiac glycosides (used to treat heart disorders).
Hydantoins such as phenytoin (used to treat epilepsy).
Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
Corticosteroids such as cortisone and prednisolone.
Pentoxifylline (used to treat intermittent claudication).
Probenecid (used in gout patients or with penicillin for infections).
Quinolone antibiotics such as norfloxacin.
Sulfinpyrazone (for gout).
Sulfonylureas such as tolbutamide or insulin (for diabetes); dose adjustment may be needed.
Certain antidepressants (serotonin reuptake inhibitors).
Tacrolimus (used in organ transplants to prevent rejection).
Zidovudine (an anti-HIV medicine).
Thrombolytics (medicines that dissolve blood clots).
Aminoglycoside antibiotics such as neomycin.
Herbal extracts: Ginkgo biloba.
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 ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using ibuprofen with other medicines.

Taking Ibufén Xpress with food, drinks and alcohol

Take this medicine with food or milk.

Do not take ibuprofen with alcohol, to avoid stomach damage. 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.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section "Precautions during pregnancy and in women of childbearing age").

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

Therefore, if you become pregnant or are breastfeeding, 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 take only a single dose of ibuprofen (arginine) or use it for a short period, no special precautions are usually necessary.

Ibufén Xpress contains aspartame, sucrose and sodium.

This medicine contains 25 mg of aspartame per sachet.

Aspartame contains 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 eliminate it properly.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 57.5 mg of sodium (the main component of table/cooking salt) per sachet. This corresponds to 2.9% of the maximum daily sodium intake recommended for an adult.

3. How to take Ibufén Xpress

Follow exactly the dosing instructions provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult 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 your 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 of ibuprofen) every 6 or 8 hours, if necessary. Do not exceed 3 sachets (1,200 mg of 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: Reduce the dose and consult your doctor.

Always use the lowest dose that is effective.

This medicine should only be administered when pain or fever occurs. As 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 persists beyond these periods.

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 ibuprofen dose contained is not suitable for the recommended dosing in this patient group.

Method of administration

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 Ibufén Xpress than you should

If you have taken more Ibufén Xpress than you should, or if a child has accidentally ingested the medicine, contact a doctor or the nearest hospital immediately to assess the risk and obtain advice on necessary measures.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested, to assess the risk and obtain advice on appropriate measures.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), diarrhoea, dizziness, spasms, hypotension, or signs of central nervous system depression (reduced consciousness), headache, tinnitus, confusion, and involuntary eye movements. Agitation, disorientation, or coma may also occur. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties may be reported.

Rarely, more severe symptoms such as gastrointestinal bleeding, low blood pressure, seizures, and respiratory disturbances may occur. Asthma exacerbation is possible in asthmatic patients. In cases of significant overdose, renal failure and hepatic damage may occur.

Additionally, the prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors.

In cases of ingestion of large quantities, 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 Ibufén Xpress

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

If you forget to take your 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 ibuprofen (arginine) are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the maximum recommended 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), and 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, it is recommended to seek medical advice immediately, in case anti-infective/antibiotic therapy becomes necessary.

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 predispose 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 life-threatening 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 of instability.

Uncommon: Insomnia, excitement, irritability.

Rare: Paresthesia (numbness, tingling, "pins and needles" sensation, more frequent 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: Visual 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 such as ibuprofen (arginine) may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Very rare: Palpitations, heart failure.

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

Vascular disorders

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatment with medicines of the type ibuprofen (arginine).

Very rare: Hypertension.

Frequency not known: Arterial thrombosis.

Respiratory, thoracic and mediastinal disorders

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

Frequency not known: Throat irritation.

Gastrointestinal disorders

The most frequent adverse effects occurring with medicines such as ibuprofen (arginine) 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 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 stools), gastritis.

Rare: Vomiting blood.

Very rare: Esophagitis, 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, purpura (purple skin spots).

Rare: Anaphylactic reaction.

Very rare: Medicines such as ibuprofen (arginine) 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 lesion). Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox.

Frequency not known: Skin becomes sensitive to light (photosensitivity), worsening of skin reactions.

A severe 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).

Widespread 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 ibuprofen (arginine) 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 renal 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.

Additional investigations

Rare: Abnormalities in liver function tests.

Frequency not known: Abnormalities in kidney function tests.

To date, severe allergic reactions with ibuprofen (arginine) have not been reported, 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 rash, swelling of the face, wheezing, or breathing difficulty.
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 (allergy) (see above in this section).
Swelling of the limbs or fluid accumulation in the arms or legs.
Visual disturbances.
Flat, non-elevated red spots, target-shaped or circular rashes 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).
Widespread, 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Ibufén Xpress

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after 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 pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibufén Xpress

The active substance is ibuprofen. Each sachet contains 400 mg of ibuprofen as ibuprofen (arginine).
The other components (excipients) are: L-Arginine, aspartame (E-951), sucrose, sodium saccharin (E-954), sodium hydrogen carbonate (E-500), peppermint flavour, anhydrous colloidal silica and sodium lauryl sulfate.

Appearance of Ibufén Xpress and contents of the pack

White granules with a characteristic peppermint odour.

Presented in printed metallic complex sachets composed of coated paper on one side + extruded polyethylene + aluminium + thermofusible resin.

Each pack contains 12 or 20 sachets.

Marketing Authorisation Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

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

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