IBUFEN 400 mg ORAL POWDER

Introduction

Package Leaflet: Information for the User

Ibufen400 mg Oral Powder

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Package Leaflet Contents

1. What Ibufen is and what it is used for
2. What you need to know before taking Ibufen
3. How to take Ibufen
4. Possible side effects
5. Storage of Ibufen
6. Package Contents and Additional Information

1. What Ibufen is and what it is used for

Ibuprofen belongs to the group of medications called non-steroidal anti-inflammatory drugs (NSAIDs).

This medication is indicated in adolescents and adults:

• for the symptomatic relief of occasional mild to moderate pain;
• for the treatment of fever.

You should consult a doctor if it worsens or does not improve after 3 days.

2. What you need to know before taking Ibufen

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

Do not takeIbufen

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If, after taking acetylsalicylic acid or other NSAIDs, you have experienced a skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have had a stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking an anti-inflammatory medication.
• If you currently have or have had more than one occasion: a stomach or duodenal ulcer or hemorrhage.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.
• If you have severe liver or kidney disease.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood).
• If you have worsening ulcerative colitis or Crohn's disease.
• If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication.

• If you have had or developed an ulcer, hemorrhage, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• This risk is greater when high doses and prolonged treatments 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 protective medication.
• If you have had kidney or liver disease.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you are taking this medication, as ibuprofen can mask fever, which is an important sign of infection, making its diagnosis more difficult.
• If you have or have had any heart disorder or have high blood pressure.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen could cause kidney failure as a consequence of dehydration.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid, you should also discuss the use of other medications that could increase the risk of such hemorrhages, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medications of this type can worsen these conditions.
• If you are being treated with diuretics (medications to increase urine production), as your doctor should monitor your kidney function.
• If you have 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), as it is more likely that meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria) may occur.
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• If you have an infection; see the "Infections" section below.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibufen immediately and contact your doctor or the medical emergency service immediately if you observe any of these signs.

Cardiovascular precautions

Anti-inflammatory/analgesic medications like ibuprofen can be associated with a small increase in the risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

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

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

Special caution is recommended with Ibufen

Skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with Ibufen treatment. Discontinue Ibufen treatment and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Stop taking Ibufen and consult your doctor immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these can be the first signs of a severe skin reaction. See section 4.

Ibufen can mask the signs of an infection, such as fever and pain. Consequently, Ibufen may delay the appropriate treatment of the infection, which can increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Similarly, this type of medication can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Children and Adolescents

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

Interference with Laboratory Tests:

Taking ibuprofen can alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after discontinuing treatment).
• Blood glucose concentration (may decrease).
• Creatinine clearance (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Blood levels of urea nitrogen and serum creatinine and potassium (may increase).

With liver function tests: increased transaminase values.

Inform your doctor if you are going to undergo a clinical analysis and are taking or have recently taken ibuprofen.

Consult your doctor or pharmacist before starting to take Ibufen.

Use of Ibufen with Other Medications

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

Ibufen can affect or be affected by other medications. For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs): as they may increase the risk of adverse effects.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine). Lithium (medication used to treat depression): as they may increase blood levels of lithium and the risk of adverse effects. If you need to take lithium and ibuprofen, your doctor may need to adjust your lithium dose.
• Methotrexate: if you take methotrexate and ibuprofen at the same time (within a 24-hour interval), they may increase blood levels of methotrexate and the risk of toxicity from this medication. Your doctor may advise you not to take ibuprofen if you are receiving high-dose methotrexate treatment.
• Hydantoins such as phenytoin (for the treatment of epilepsy).
• Sulfonamides: as they may increase their toxic effects.
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).
• Corticosteroids such as cortisone and prednisolone, as they may increase the risk of stomach ulcers or gastrointestinal bleeding.
• Diuretics (medications used to increase urine production), as they may increase the risk of kidney toxicity.

Other medications can also affect or be affected by Ibufen treatment. Therefore, you should always consult your doctor or pharmacist before using Ibufen with other medications.

• Fluconazole and voriconazole (used to treat fungal infections), pentoxifylline, probenecid, and sulfinpyrazone (for gout), quinolones (such as norfloxacin), mifepristone, sulfonylureas (such as tolbutamide), tacrolimus and cyclosporin (used to prevent rejection in transplants), zidovudine (kidney risk), and cholestyramine (medication used to treat high cholesterol).
• Selective serotonin reuptake inhibitor antidepressants can also increase the risk of gastrointestinal bleeding.

Taking Ibufen with Food, Beverages, and Alcohol

For patients with stomach upset, it is recommended to take the medication during meals.

Consuming alcohol can increase the risk of adverse reactions.

Pregnancy, Breastfeeding, and Fertility

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

Precautions during pregnancy and in women of childbearing age

Do not take Ibufen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It can cause kidney and heart problems in your fetus. It can affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is strictly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, ibuprofen can cause kidney problems in your fetus if taken for more than a few days, 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 you need treatment for more than a few days, your doctor may recommend additional checks.

For women of childbearing age, it should be noted that medications of this type have been associated with a decrease in fertility.

Breastfeeding

Although the medication levels in breast milk are negligible, it is recommended to consult your doctor in cases of long-term treatment or high doses during breastfeeding.

Driving and Using Machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or operate machinery. If you only take one dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Ibuprofen can delay your reaction time, which should be taken into account before performing activities that require greater vigilance, such as driving and using machinery.

Ibufen Contains Isomalt (E-953)

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

3. How to Take Ibufén

Follow the administration instructions of the medication contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Dosage

Adults andadolescents (over 12 years and >40 kg)

The recommended dose is 1 sachet (400 mg of ibuprofen) 3 times a day every 6-8 hours.

The dosage interval should be chosen according to the symptoms. Do not exceed 1,200 mg of ibuprofen (3 sachets) within 24 hours.

The lowest effective dose should be used for the shortest time 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).

This medication is used for short-term treatments.

If symptoms worsen, if the fever persists for more than 3 days or the pain for more than 5 days (3 days in adolescents), you should consult a doctor.

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

Pediatric population

Do not administer to children or adolescents with a weight of less than 40 kg, as the dose does not adjust to their posology.

Elderly population (over 65 years)

The dosage should be established by the doctor, as it may be necessary to reduce the usual dose.

Patientswithkidney,liverorheartdiseases

Reduce the dose and consult your doctor. Ibuprofen should not be used in patients with severe renal or hepatic insufficiency.

Method of administration

For oral use.

Empty the contents of the sachet directly into the mouth. In patients with gastric discomfort, it is recommended to take the medication during meals.

If you take moreIbufénthan you should

If you have taken more Ibufén than you should, or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately, or the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the package and the prospectus of the medication to the healthcare professional.

If you have taken more Ibufén than you should, or if a child has accidentally ingested the medication, consult a doctor or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), gastrointestinal bleeding (see section 4), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement. Agitation, disorientation, or coma may also occur. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported.

Acute kidney failure and liver damage may also occur.

Asthma exacerbation is possible in asthmatics. Additionally, there may be low blood pressure and reduced breathing.

If you forget to takeIbufén

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

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time of the next dose is very close, skip the forgotten dose and take the next dose at the usual time.

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

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

The frequencies have been defined as follows:

Very common:may affect more than 1 in 10 patients.

Common:may affect up to 1 in 10 patients.

Uncommon:may affect up to 1 in 100 patients.

Rare:may affect up to 1 in 1,000 patients.

Very rare:may affect up to 1 in 10,000 patients.

Frequency not known:cannot be estimated from the available data.

The following adverse effects have been observed:

Gastrointestinal disorders

The most frequent adverse effects that occur with medications containing this active ingredient are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, oral ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Common:nausea, vomiting, abdominal pain, heartburn, flatulence, and constipation.

Uncommon:bleeding, stomach or duodenal ulcers.

Rare:gastric or intestinal perforation, esophageal inflammation, and ulcers or inflammation of the intestine.

Skin and subcutaneous tissue disorders

Common:skin rash.

Uncommon:skin redness, itching or skin swelling, lip swelling, facial or tongue swelling, increased nasal secretion, and breathing difficulties.

Rare:severe allergic reactions (anaphylactic shock).

Very rare:intense itching of the skin with sudden onset or blisters on the skin, joint pain, and fever (systemic lupus erythematosus), hair loss, skin reactions due to light influence. Medications containing this active ingredient may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and allergic vasculitis.

Severe allergic reaction that can manifest with nausea, vomiting, facial, tongue, and throat swelling, breathing difficulties, asthma, palpitations, hypotension, or shock.

Frequency not known: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 start of treatment (acute generalized exanthematous pustulosis). The skin becomes sensitive to light. Stop taking Ibufén if you experience these symptoms and seek medical attention immediately. See also section 2.

A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Nervous system disorders

Common:headache.

Uncommon:fatigue or drowsiness.

Very rare:aseptic meningitis (inflammation of the membranes covering the brain and spinal cord), in most cases in patients with some autoimmune disease such as systemic lupus erythematosus.

Psychiatric disorders

Common:feeling of instability and nervousness.

Uncommon:anxiety.

Rare:disorientation or confusion, depression.

Ear and labyrinth disorders

Uncommon:ringing or buzzing in the ears.

Rare:hearing difficulty.

Eye disorders

Uncommon:vision alteration.

Rare:abnormal or blurred vision.

Blood and lymphatic system disorders

Very rare:prolonged bleeding time, alterations in blood cells (the first symptoms may be: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nasal and skin bleeding).

Cardiovascular disorders

These medications may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke. Edema (fluid retention), arterial hypertension, and heart failure have also been observed in association with treatments with medications of this type.

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

Renal and urinary disorders

Kidney disease.

Hepatobiliary disorders

Rare:hepatitis (liver inflammation) and jaundice (yellowing of the skin). These medications may be associated, in rare cases, with liver damage.

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

• Red, non-raised spots, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can 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 swollen lymph nodes (DRESS syndrome).
• Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start 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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibufén

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications that are no longer needed at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications that are no longer needed. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition

• The active ingredient is Ibuprofen. Each sachet contains 400 mg of ibuprofen.
• The other components (excipients) are: Isomalt (E-953), anhydrous citric acid, acesulfame potassium (E-950), glycerol distearate (type I), and lemon flavor (natural flavorings, maltodextrin, alpha-tocopherol (E-307)).

Appearance of the product and package contents

Ibufén is presented in the form of a white or almost white oral powder with a marked lemon odor and in monodose sachets of coated paper/polyethylene coextruded/aluminum/polyethylene coextruded.

There are two presentations: packages of 12 units and 24 units.

Only some package sizes may be marketed.

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

ZINEREO PHARMA, S.L.U.

A Relva, s/n, O Porriño

36410 Pontevedra - Spain

or

FARMALIDER, S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid) - Spain

or

EDEFARM S.L

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante

(Valencia) - Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this prospectus: November 2024

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