Leaflet: information for the user

Ibuthek 400 mg oral powder

ibuprofen

Read this leaflet carefully before you start to take 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 medication is indicatedinadolescentsandinadults:

• for symptomatic relief of occasional mild to moderate pain
• for the treatmentof fever

Consult a doctor if symptoms worsen or do 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 take Ibuthek:

• if you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• ifaftertakingaspirinorotherNSAIDsyouhaveexperiencedskineruptionwithitching,swellingoftheface,
• lipsortongue,nasalsecretion,breathingdifficultyorasthma.
• if you have had a stomach or duodenal ulcer bleeding or have suffered a digestive tract perforation while taking an anti-inflammatory medication.
• if you currently have or have had more than once: a stomach or duodenal ulcer or bleeding.
• 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.
• severe dehydration(causedbyvomiting,diarrheaorinsufficientliquidintake).

liquid intake).

Signs of an allergic reaction to ibuprofen, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibuthek immediately and contact your doctor or emergency medical services if you observe any of these signs.

Warnings and precautions

Consultyourdoctororpharmacistbeforestartingthismedication:

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent 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 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.
• Ifyouhaveorhavehadanyheartdisorderorhavetensionarterialhigh.
• 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.
• Ifyoupresentsymptomsofdroughte.g.severediarrheaorvomitingtakeabundantliquidandcontactyourdoctorimmediately,asibuprofeninthiscasecouldcauserenalinsufficiencyduetodrought.
• If you are takingsimultaneouslymedicationsthatalterbloodcoagulationsuchasoralanticoagulantsaspirinandantiplateletagentssuchasaspirinalsocommentontheuseofothermedicationsthatcouldincreasetheriskofthesebleedingssuchascorticosteroidsandSSRIs(selectiveserotoninreuptakeinhibitors).
• If you have Crohn's disease or ulcerative colitis, as these medications can worsen these conditions.
• If you are takingdiuretics(medicationsusedtoincreaseurineproduction),asyourdoctormustmonitoryourkidneyfunction.
• If you have systemic lupus erythematosus(a chronic disease that affects the immune system and can affectdifferentvitalorgansthenervoussystembloodvesselsskinandjoints),asitismorelikelytocauseasepticmeningitis(inflammationofthemeningesthatarethemembranesthatprotectthebrainandspinalcord,notcausedbybacteria).
• 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), for your doctor to evaluate the advisability or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform a morestrictcontrolifyoureceiveibuprofenafterbeingsubjectedtomajorsurgery.
• It is recommended not to take thismedicationifyouhavechickenpox.
• If you have an infection; see the "Infections" section below.

Skin reactions

Severe skin reactions associated with ibuprofen treatment have been reported. Stop taking Ibuprofen and immediately consult your doctor 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.

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. Interrupt the treatment with ibuprofen and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of 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 Ibuprofen Codramol if:

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

Infections

Ibuprofen Codramol may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibuprofen 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 symptoms of the infection persist or worsen, consult a doctor as soon as possible.

Interference with laboratory tests:

The use of ibuprofenmayalterthefollowinglaboratorytests:

• Bleeding time (maybeprolongedfor1dayaftersuspendingthetreatment)
• Blood glucose concentration (maydecrease)
• Creatinine clearance (maydecrease)
• Hematocrit or hemoglobin (maydecrease)
• Blood concentrations of urea nitrogen and serum concentrations of creatinine and potassium (mayincrease)

With liver function tests: increased values of transaminases

Informyourdoctorifyouareabouttoundergoaclinicaltestandaretakingorhaverecentlytakenibuprofen.

Consultyourdoctororpharmacistbeforestartingthismedication.

Use of Ibuthek with other medications

Informyourdoctororpharmacistifyouaretakinghavetakenrecentlyormayhavetotakeanyothermedication.

Ibuprofen Codramol 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.
• Anticoagulant medications (e.g., to treat bleeding/clotting problems, e.g., aspirin, warfarin, ticlopidine).
• Lithium (medication used to treat depression): as it may increase blood lithium levels and the risk of adverse effects. If you must 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 blood metotrexate levels and the risk of toxicity. Your doctor may advise you not to take ibuprofen if you receive high-dose metotrexate treatment.
• Hidantoins such as phenytoin (for epilepsy treatment).
• Sulfamides: 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 gastrointestinal 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 Codramol treatment. Therefore, always consult your doctor or pharmacist before using Ibuthek with other medications.

• Fluconazoleandvoriconazole(usedtotreatfungusinfections),pentoxifylline,probencid,andsulfinpyrazone(forgout),quinolones(suchasnorfloxacin),mifepristone,sulfonilureas(suchastolbutamide),tacrolimusandciclosporin(usedtopreventtransplantrejection),zidovudine(renalrisk),colestiramine(medicationusedtotreathighcholesterol).
• SSRIs may also increase the risk of gastrointestinal bleeding.

Taking Ibuthek 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.

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 predisposition 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 clearly 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 week 20 of pregnancy, Ibuprofen Codramol may cause kidney 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.

Pregnancy and fertility precautions

Due to the administration of this medication being associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimesters of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, administration is contraindicated.

For women of childbearing age, it should be noted that medications of this type have 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 cases of prolonged treatment or 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 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.

Ibuthek contains isomalta.

This medication contains isomalta. 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.

You should use the most effective dose for the shortest time 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).

Dosage

Adults and adolescents (over 12 years and weight over 40 kg):The recommended doseis 1 tablet (400 mg of ibuprofen) every 6-8 hours, 3 times a day.

The maximum daily dose is 3 tablets(1200 mg of ibuprofen).

The interval between doses should be chosenaccording to the symptomatology and the maximum daily doseand maybe 6 or 8hours. Do not exceed 3 tablets (1200 mg of ibuprofen) in 24 hours.

You can minimizethe appearance of adverse reactions if you use the lowest effective dosesfor the shortest time possible to control symptoms (see section 4.4).

This medicationisusedintreatmentsofshortduration.

Theadministrationofthismedicationissubject totheappearanceofpainorfever.Assoon as these disappear, you should discontinue the medication.

Special patient groups

Renal insufficiency:

No dose reduction is necessary in patients with mild or moderate renal insufficiency.

Liver insufficiency:

No dose reduction is necessary in patients with mild or moderate liver insufficiency.

Pediatric population:

Thismedicationshould notbe administeredtochildrenoradolescents withbody weightless than40kg,becausethe dose does notadapt to use in these patients.

Form of administration

Fororaluse.

Emptythecontentsofthetabletdirectlyintothemouth.
In patientswith gastrointestinal discomfort, it is recommended to take the medication during meals.

If you take more Ibuthek than you should

If you have taken more Ibuthek than you should or have accidentally ingested the contents of the package, consult your doctor orpharmacist immediately or the Toxicological Information Service, phone: 915620420, 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 Ibuthek 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), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing difficulties have been reported.

If you forget to take Ibuthek

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 almost due, skip the missed dose and take the next dose at your 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, 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 skin blisters, joint pain, and fever (systemic lupus erythematosus), hair loss, light-sensitive skin reactions, In rare cases, severe blistering reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and allergic vasculitis can occur.

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

Frequency not known:A severe skin reaction known as DRESS syndrome can occur. DRESS syndrome symptoms include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell). A generalized red, scaly rash with localized blisters, primarily on the skin folds, trunk, and upper limbs, accompanied by fever at the onset of treatment (acute generalized pustular exanthema). If you experience these symptoms, stop taking Ibuprofeno Codramol and seek immediate medical attention. See section 2. The skin becomes sensitive to light.

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

• flat, red spots, often with blisters in the center, on the trunk, often with skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin reactions can 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 localized blisters, accompanied by fever. Symptoms usually appear at the onset of treatment (acute generalized pustular exanthema).

Nervous system disorders

Common:headache.

Uncommon:fatigue or somnolence.

Very rare:aseptic meningitis(inflammation of the membranes covering the brain and spinal cord), in most cases in patients with an 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: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, 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

Also, edema (fluid retention), hypertension, and heart failure have been observed in association with treatments with medicines of this type.

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.

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 Vigilance 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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat 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, anhydrous citric acid, potassium acesulfame (E-950), glycerol diestearate (type I) and lemon aroma.

Appearance of the product and content of the packaging

Ibuthek is presented in the form of a white or almost white oral powder, with a marked lemon odor and in monodose polyester/aluminum/polyethylene blisters.

There are two presentations: blister packs of 12 units and 24 units.

Only some sizes of packaging may be commercially available.

Marketing authorization holder

Farmalider S.A.

The Granja, 1

28108 Alcobendas - Madrid

Spain

Responsible for manufacturing

EDEFARM, S.L

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante

Valencia

or

FARMALIDER, S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Dateofthelastreviewofthisleaflet:April 2025

“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/”