IBUTHEK 400 MG ORAL POWDER

Introduction

Package Leaflet: Information for the User

Ibuthek 400 mg Oral Powder

ibuprofen

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 side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days.

Contents of the Package Leaflet:

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

1. What Ibuthek is and what it is used for

Ibuprofen belongs to a 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 your symptoms worsen or do not improve after 3 days.

2. What you need to know before taking Ibuthek

It is important to use the smallest dose that relieves-controls the 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).
• 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.
• severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

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 Ibuthek immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

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 higher when using high doses and prolonged treatments, 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-protecting 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 present 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 must 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 aseptic 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, you should not take higher doses of the medication.
• 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.
• If you have an infection; see the "Infections" heading below.

Skin Reactions

Severe skin reactions have been reported in association with ibuprofen treatment. Stop taking ibuprofen and consult your doctor immediately if you present any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these can be the first signs of a very 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 syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue ibuprofen treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular Precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased 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 Ibuprofeno Codramol 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.

Infections

Ibuprofeno Codramol may mask the signs of an infection, such as fever and pain. Consequently, Ibuthek 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.

Interference with Laboratory Tests:

Taking ibuprofen may 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: increase in 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 Ibuprofeno Codramol.

Using Ibuthek with Other Medications

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

Ibuprofeno Codramol may 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 it 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 may also affect or be affected by treatment with Ibuprofeno Codramol. Therefore, you should always consult your doctor or pharmacist before using Ibuthek 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 (SSRIs) may also increase the risk of gastrointestinal bleeding.

Taking Ibuthek with Food, Beverages, and Alcohol

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

Taking alcohol may 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.

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 and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as directed 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, Ibuprofeno Codramol may cause kidney problems in your fetus if taken for more than a few days, which can cause 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 during a period longer than a few days, your doctor may recommend additional checks.

Precautions during Pregnancy and in Women of Childbearing Age

Because the administration of this medication has been associated with an increased risk of congenital anomalies/abortions, its administration is not recommended during the first and second trimester 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 female patients of childbearing age, it should be noted that medications of this type have been associated with a decrease in fertility.

Breastfeeding

Although the levels of the medication in breast milk are negligible, it is recommended to consult a 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, you do not need to take special precautions.

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

Ibuthek contains isomalt.

This medication contains isomalt. 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 Ibuthek

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

The effective lowest dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

Dosage

Adults and adolescents (over 12 years old and weighing more than 40 kg): The recommended dose is 1 sachet (400 mg of ibuprofen) every 6-8 hours, 3 times a day.

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

The interval between doses should be chosen according to the symptoms and the maximum daily dose and may be 6 or 8 hours. Do not exceed 3 sachets (1200 mg of ibuprofen) in 24 hours.

The appearance of adverse reactions can be minimized if the lowest effective doses are used for the shortest time possible to control symptoms (see section 4.4).

This medication is used for short-term treatments.

Administration of this medication is subject to the appearance of pain or fever. As these symptoms disappear, the medication should be discontinued.

Special Patient Groups

Renal Insufficiency:

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

Hepatic Insufficiency:

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

Pediatric Population:

This medication should not be administered to children or adolescents with a body weight of less than 40 kg, as the dose is not adapted for use in these patients.

Method of Administration

For oral use.

Empty the contents of the sachet directly into the mouth. In patients with stomach upset, 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 or pharmacist immediately or the Toxicology Information Service, phone: 915620420, indicating the medication and the amount ingested. It is recommended to take the package and the package leaflet of the medication 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 find out about the risk and ask for advice on the measures to be taken.

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 such as drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing problems have been reported.

If you forget to take Ibuthek

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 for the next dose is near, 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 medicines, this medicine can cause adverse effects, although not all people suffer from them.

Frequencies have been defined as follows:

Very frequent:may affect more than 1 in 10 patients

Frequent: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 available data

The following adverse effects have been observed:

Gastrointestinal disorders

The most frequent adverse effects that occur with medicines containing this active ingredient are gastrointestinal: peptic ulcers, digestive 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.

Frequent: 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.

Disorders of the skin and subcutaneous tissue

Frequent: skin rash.

Uncommon: skin redness, itching or swelling of the skin, swelling of the lips, face, or tongue, increased nasal secretion, and difficulty breathing.

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. Medicines 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 may manifest with nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension, or shock.

Frequency not known: 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). Generalized red scaly rash, with bumps under the skin and localized blisters, mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno Codramol if you experience these symptoms and seek medical attention immediately. See also section 2. The skin becomes sensitive to light.

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

• Reddish, non-elevated, target-like or circular patches 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 hypertrophic lymph nodes (DRESS syndrome).
• Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Disorders of the nervous system

Frequent: 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

Frequent: feeling of instability and nervousness.

Uncommon: anxiety.

Rare: disorientation or confusion, depression.

Disorders of the ear and labyrinth

Uncommon: ringing or buzzing in the ears.

Rare: hearing difficulty.

Eye disorders

Uncommon: vision alteration.

Rare: abnormal or blurred vision.

Disorders of the blood and lymphatic system

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 medicines 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 medicines of this type.

Renal and urinary disorders

Kidney disease.

Hepatobiliary disorders

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

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 does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ibuthek

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

No special storage conditions are required

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. 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, anhydrous citric acid, potassium acesulfame (E-950), glycerol distearate (type I), and lemon flavor.

Appearance of the Product and Package Contents

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Farmalider S.A.

La Granja, 1

28108 Alcobendas - Madrid

Spain

Manufacturer

EDEFARM, S.L

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante

Valencia

or

FARMALIDER, S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Date of the Last Revision of this Leaflet:April 2025

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