Leaflet: information for the user

Ibufén junior200 mg oral powder

ibuprofen

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it 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 used in children from 7 years old and in adolescents:

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

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 not to take this medication for longer than necessary to control your symptoms.

Do not takeIbufén junior

• 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 swelling; lips or tongue, nasal secretion, breathing difficulty 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 coagulation 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 insufficient liquid 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, such as severe diarrhea or vomiting, take abundant liquid and immediately contact your doctor, as ibuprofen in this case could lead to kidney insufficiency due to dehydration.
• If you are taking anticoagulants or other medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid, warfarin, ticlopidine. Also, inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as medications of this type may worsen these conditions.
• If you are taking diuretics (medications to increase urine production), as your doctor needs to 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 urine discoloration, blood in urine, or liver disease), so 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" heading below.
• 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 this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibufén junior 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 suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

Inform your doctor or pharmacist before taking this medication if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to artery narrowing or blockage), 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 is recommended withIbufén junior

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 ibuprofen treatment. Discontinue Ibufén junior 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 this medication and seek medical attention immediately if you present any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, it is possible that this medication 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.

Furthermore, 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 kidney damage in dehydrated children and adolescents.

Interferences with laboratory tests:

The use of ibuprofen may alter the following laboratory tests:

• Bleeding time (may prolong for 1 day after discontinuing 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 to undergo a clinical test and are taking or have recently taken ibuprofen.

Other Medications and Ibufén junior

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

This medication 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-dose metotrexate treatment.
• Hidantoins like phenytoin (for treating epilepsy).
• Sulfonamides: as they may increase their toxic effects.
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Corticosteroids like 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 junior 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).
• Selective serotonin reuptake inhibitors (SSRIs) may also increase the risk of gastrointestinal bleeding.

Taking Ibufén junior with food, drinks, and alcohol,andalcohol

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 kidney and heart 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 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 time possible. 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 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 is essential to consider that medications of this type have been associated with a decrease in the ability to conceive.

Lactation

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

Driving and using machines

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 increased vigilance, such as driving and operating machinery.

Ibufén junior contains isomalta (E-953).

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

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

Dosage

Adolescents (body weight above 40 kg):

The recommended doseis 1 or 2 sachets 3/4 times a day every 6-8 hours.

Do not exceed 6 sachets (1,200 mg of ibuprofen) in 24 hours.

Children (under 12years) (body weight below 40 kg):

The recommended doseof ibuprofen depends on the age and weight of the child. For children from 6 months to 12 years, the recommended daily dose is 7 to 10 mg/kg as an individual dose up to a maximumdailyof 30 mg per kg of body weight.

Approximatelythe following recommendations can be followed from the table below:

The interval between doses should be chosen according to the symptoms and the maximum daily doseand maybe 6 or 8hours. Do not exceed the maximum daily dose recommendedfromthelastcolumn.

Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor as soon as possible if symptoms (such as fever and pain) persist or worsen (see section 2).

This medicationisusedintreatmentsofshortduration.

If symptoms worsen, if fever or pain persists for more than 3 days, you must consult a doctor.

Theadministrationofthismedicationissubjecttotheappearanceofpainorfever.Assoon as these symptomsdisappear, discontinue the medication.

Special groups of patients

Patientswithkidneydisease,liverdiseaseorheartdisease:

Reduce the dose and consult a doctor. Do not use ibuprofen in patients with severe heart, renal, or hepatic failure.

Pediatric population:

Thismedicationmustnotbeadministeredtochildrenunder7yearsorwithbodyweightbelow21kg,becausethedosedoesnotadapttoitsposology.

Form of administration

Fororaluse.

Emptythecontentsofthesachetdirectlyintothemouth.
In patientswithgastrointestinaldiscomfort,itisrecommendedtotakethemedicationduringmeals.

If you take moreIbufén juniorthan you should

If you have taken more of the medication than you should or have accidentally ingested the contents of the package, consult your doctor orpharmacist 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.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (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, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported.

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.

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

If you forgot to takeIbufén junior

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

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 doubts 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, bloody 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-induced 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.

A 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 skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized pustular psoriasis). The skin becomes sensitive to light. Stop taking the medicine if you experience these symptoms and seek medical attention immediately. See section 2 of this leaflet.

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.

Vestibular 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 (the first symptoms may be: fever, sore throat, mouth ulcers, symptoms similar to the flu, excessive fatigue, nasal and skin bleeding).

CARDIOVASCULAR DISORDERS

These medicines may 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 (yellowing 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 patches 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 start 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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on 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 point at 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 ofIbufén junior

• The active ingredient is ibuprofen. Each sachet contains 200 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, and alpha-tocopherol (E-307)).

Appearance of the product and content of the packaging

White or almost white oral powder with a marked lemon odor, conditioned in single-dose sachets of starch-coated/polyethylene terephthalate/aluminum/polyethylene terephthalate.

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 medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/