Package Insert: Information for the User

Ibufen400 mg Oral Powder

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

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

• Keep this package insert, as you may need to refer to 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 not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days.

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

This medicine is indicatedinadolescentsandinadults:

• 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.

It is essential to use the smallest dose that relieves or controls pain and should not take this medication for longer than necessary to control your symptoms.

Do not takeIbufén

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you have experienced skin rash with itching, facial, lip, or tongue swelling, nasal discharge, difficulty breathing, or asthma after taking acetylsalicylic acid or other NSAIDs.
• 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: stomach or duodenal ulcer or hemorrhage.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.
• If you have a severe liver or kidney disease.
• If you have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood).
• If you have ulcerative colitis or Crohn's disease.
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).

Warnings and precautions

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

• If you have had or develop a stomach or duodenal ulcer, hemorrhage, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector 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 may 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 present symptoms of dehydration, e.g., severe diarrhea or vomiting, take abundant fluid and immediately contact your doctor, as ibuprofen in this case could cause renal insufficiency as a consequence of dehydration.
• If you are taking anticoagulants (medications used to "thin" the blood), such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease or ulcerative colitis, as these medications may worsen these conditions.
• If you are taking diuretics (medications used 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 to cause aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have intermittent acute porphyria (a metabolic disease that affects your blood and can cause symptoms such as red urine, blood in urine, or liver disease), so your doctor can evaluate 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" heading later.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform a more strict control if you receive ibuprofen after undergoing major surgery.
• It is recommended not to take this medication if you have chickenpox.
• Signs of severe allergic reactions to ibuprofen, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibufén immediately and contact your doctor or emergency medical services if you observe any of these signs.

Cardiovascular precautions

Nonsteroidal anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increase in the risk of having 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 Ibufén if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation 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, a family history of heart disease or stroke, or are a smoker.

Special caution with Ibufén is recommended

Severe 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), generalized acute pustular psoriasis (PEGA), have been reported in association with Ibufén treatment.Stop Ibufén treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Stop taking Ibufén and see a doctor immediately if you present any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Ibufén may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibufén may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

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

Children and adolescents

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

Interferences with laboratory tests:

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may prolong for 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Creatinine clearance (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Serum concentrations of urea nitrogen, creatinine, and potassium (may increase).

With liver function tests: increased values of transaminases.

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

Consult your doctor or pharmacist before starting to take Ibufén.

Use of Ibufén with other medications

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

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

• Other nonsteroidal anti-inflammatory drugs (NSAIDs): as it may increase the risk of adverse effects.
• Anticoagulants (e.g., for treating coagulation problems/preventing coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).Lithium (medication used to treat depression): as it may increase lithium blood levels and the risk of adverse effects. If you need to take lithium and ibuprofen, your doctor may need to adjust your lithium dose.
• Metotrexate: if you take metotrexate and ibuprofen at the same time (within a 24-hour interval), they may increase metotrexate blood levels and the risk of toxicity. Your doctor may advise you not to take ibuprofen if you receive high doses of metotrexate.
• Hidantoins such as phenytoin (for treating 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 or intestinal ulcers or bleeding.
• Diuretics (medications used to increase urine production), as they may increase the risk of renal toxicity.

Other medications may also affect or be affected by ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using Ibufén 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 cyclosporine (used to prevent transplant rejection), zidovudine (renal risk), cholestyramine (medication used to treat high cholesterol).
• SSRIs (selective serotonin reuptake inhibitors) may also increase the risk of gastrointestinal bleeding.

Taking Ibufén with food, drinks, and alcohol

For patients with gastrointestinal discomfort, it is recommended to take the medication during meals.

Theconsumptionofalcoholmayincreasetheriskofadversereactions.

Pregnancy, lactation, 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 fertile women

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause renal and cardiac problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless it is strictly necessary and as your doctor indicates. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible. From week 20 of pregnancy, ibuprofen may cause renal problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

For fertile women, it should be noted that this type of medication has been associated with a decrease in the ability to conceive.

Lactation

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

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, you should not drive or operate machinery. If you only take a single dose of ibuprofen or for a short period, no special precautions are necessary.

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

Ibufén contains isomalt (E-953)

Ifyourdoctorhasindicatedthatyouhaveatolerancetocertainsugars,consultwithhimbeforetakingthismedication.

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

Dosage

Adults and adolescents (over 12 years and >40 kg)

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

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

Use the most effective dose for the shortest time necessary to relieve symptoms.If you have an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

This medicationisusedintreatmentsofshortduration.

If symptomsworsen, if fever persists for more than 3 days or pain for more than 5days(3 days in adolescents), you must consult your doctor.

Theadministrationofthismedicationisdependentontheappearanceofpainorfever.Assoonasthesesymptomsdisappear, discontinue the medication.

Pediatric population

Do not administer to children, or to adolescents with a weight of less than40 kg due to the dose not being adjusted to their dosage.

Geriatric population (over 65 years)

The dosage should be established by the doctor, as there is a possibility that a reduction in the usual dose may be needed.

Patientswithrenaldiseases,liverdiseasesorheartdiseases

Reducethe dose and consult your doctor. Do not use ibuprofen in patients with severe renal or hepatic insufficiency.

Administration form

Fororaluse.

Emptythecontentsofthetabletdirectlyintothemouth.
In patientswithgastrointestinaldisturbances, it is recommended to take the medication during meals.

If you take moreIbuprofenthan you should

If you have taken more Ibuprofen than you should or have accidentally ingested the contents of the package, consult your doctor orpharmacist immediately or the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and the medication leaflet to the healthcare professional.

If you have taken more Ibuprofen than you should, or if a child has accidentally ingested the medication, consult a doctor or go to the nearest hospital to inform yourself 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 blood),gastrointestinal hemorrhage (see section 4), diarrhea,headache, ringing in the ears, confusion, and involuntary eye movement.It may also cause agitation, disorientation, or coma.At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported.Blood in the urine,low potassium levels in the blood,chills, and breathing difficulties.

Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors.

Acute renal failure and liver damage may occur.

The exacerbation of asthma is possible in asthmatics. Additionally, low blood pressure and reduced breathing may occur.

If you forget to takeIbuprofen

Do not take a double dose to compensate for the missed dose.

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

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

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

Frequencies have been defined as follows:

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

Common:can affect up to 1 in 10 patients.

Uncommon:can affect up to 1 in 100 patients.

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

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

Frequency not known:cannot be estimated from available data.

The following side effects have been observed:

Gastrointestinal disorders

The most common side effects that occur with medicines containing this active ingredient are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach pain, blood in stools, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

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

Uncommon:bleeding, stomach or duodenal ulcers.

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

Skin and subcutaneous tissue disorders

Common:skin rash.

Uncommon:skin redness, itching, or swelling, lip, face, or tongue swelling, increased nasal secretion, and respiratory difficulty.

Rare:severe allergic reactions (anaphylactic shock).

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

Severe allergic reaction that may manifest with nausea, vomiting, facial, tongue, and throat swelling, respiratory difficulty, asthma, palpitations, hypotension, or shock.

Frequency not known:Generalized red scaly rash, with subcutaneous nodules and localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). The skin becomes sensitive to light. Stop taking Ibufen if you experience these symptoms and seek medical attention immediately. See section 2.

A severe skin reaction known as DRESS syndrome may occur. DRESS syndrome symptoms 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), mostly in patients with autoimmune diseases 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:tinnitus or ringing in the ears.

Rare:hearing difficulty.

Eye disorders

Uncommon:visual disturbance.

Rare:abnormal or blurred vision.

Blood and lymphatic system disorders

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

Cardiovascular disorders

These medicinesmay be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke. Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with medicines 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 (yellow discoloration of the skin). These medicines may be associated, in rare cases, with liver damage.

If any of the following side effects occur, discontinue treatment and seek immediate medical attention:

• Flat, red, non-elevated spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly rash, with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appearson the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition

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

Appearance of the product and content of the packaging

Ibufén is presented in the form of a white or almost white oral powder, with a marked lemon odor, and in blister packs of paper-coated/polyethylene/polypropylene/aluminum/polyethylene.

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

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

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

Industrial Estate Enchilagar del Rullo, 117

46191 Villamarchante

(Valencia)- Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: November 2024

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