Ibuthek 400 mg oral powder

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ibuthek 400 mg oral powder

ibuprofen

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

Follow exactly the instructions for use provided in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 3 days.

Leaflet Contents:

1. What Ibuthek is 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. How to store Ibuthek
6. Contents of the pack and other information

1. What Ibuthek is and what it is used for

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

This medicine is indicated in adolescents and adults:

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

You should consult a doctor if symptoms worsen or do not improve after 3 days.

2. What you need to know before taking Ibuthek

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

Do not take Ibuthek:

• if you are allergic to ibuprofen or to any of the other components of this medicine (listed in section 6).
• if after taking acetylsalicylic acid or other NSAIDs you have experienced itchy rash, swelling of the face,
• lips or tongue, nasal discharge, breathing difficulties or asthma.
• if you have had stomach or duodenal bleeding or have suffered a perforation of the gastrointestinal tract while taking an anti-inflammatory medicine.
• if you currently have or have had on more than one occasion: 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 severe liver or kidney disease.
• if you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood).
• if you have an exacerbation of ulcerative colitis or Crohn's disease.
• severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake).

Allergic reactions to this medicine, including respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Immediately stop using Ibuthek 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 medicine:

• If you have had or develop a stomach or duodenal ulcer, bleeding or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
• This risk is higher when high doses or prolonged treatment are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor may consider prescribing a stomach-protective medicine.
• If you have had kidney or liver disease.
• If you have edema (fluid retention).
• If you suffer from asthma or any other respiratory disorder.
• If you are taking this medicine, as ibuprofen may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have heart disease or high blood pressure.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to perform regular checks. Your doctor will advise you on how often these checks should be done.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this specific case could lead to renal failure as a consequence of dehydration.
• If you are taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medicines of this type may worsen these conditions.
• If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect vital organs, the nervous system, blood vessels, skin, and joints), as there is an increased risk of developing aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria).
• If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions may occur with this medicine.
• Your doctor will monitor you more closely if you are receiving ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection; see the section "Infections" below.

Skin reactions

Serious skin reactions have been reported with ibuprofen treatment. Stop taking ibuprofen and see your doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

Serious 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 immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

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), have had a heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked 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 if you are a smoker.

Infections

Ibuprofeno Codramol may mask signs of infection such as fever and pain. Therefore, Ibuthek may delay appropriate treatment of an infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the infection symptoms 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 up to 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen, serum creatinine and potassium concentrations (may increase)

Liver function tests: increased transaminase levels

Inform your doctor if you are undergoing clinical laboratory testing and are taking or have recently taken ibuprofen.

Consult your doctor or pharmacist before starting to take Ibuprofeno Codramol.

Taking Ibuthek with other medicines

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

Ibuprofeno Codramol may interact with or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs): as this may increase the risk of adverse effects.
• Anticoagulant medicines (e.g., to treat or prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Lithium (a medicine used to treat depression): as this may increase blood levels of lithium and the risk of adverse effects. If you need to take both lithium and ibuprofen, your doctor may need to adjust your lithium dose.
• Methotrexate: if methotrexate and ibuprofen are taken simultaneously (within a 24-hour interval), blood levels of methotrexate and the risk of toxicity may increase. Your doctor may advise against taking ibuprofen if you are receiving high-dose methotrexate therapy.
• Hydantoins such as phenytoin (for epilepsy treatment).
• Sulphonamides: as they may increase their toxic effects.
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan).
• Corticosteroids such as cortisone and prednisolone, as they may increase the risk of gastrointestinal ulcer or bleeding.
• Diuretics (medicines used to increase urine elimination), as they may increase the risk of renal toxicity.

Other medicines may also interact with or be affected by Ibuprofeno Codramol. Therefore, you should always consult your doctor or pharmacist before using Ibuthek with other medicines.

• 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 (a medicine used to treat high cholesterol).
• Selective serotonin reuptake inhibitor (SSRI) antidepressants may also increase the risk of gastrointestinal bleeding.

Taking Ibuthek with food, drinks, and alcohol

For patients with gastric discomfort, it is recommended to take the medicine during meals.

Alcohol consumption may increase the risk of adverse reactions.

Pregnancy, breastfeeding, and fertility

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

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 unborn baby. It may affect your and your baby's ability to bleed and may delay or prolong labor more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibuprofeno Codramol may cause kidney problems in your unborn baby if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Precautions during pregnancy and in women of childbearing potential

Because administration of this medicine has been associated with an increased risk of congenital abnormalities or miscarriage, its use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration is contraindicated during the third trimester.

For women of childbearing potential, it should be noted that medicines of this type have been associated with a reduced ability to conceive.

Breastfeeding

Although drug levels in breast milk are negligible, it is recommended to consult your doctor during long-term treatment or when using high doses while breastfeeding.

Driving and using machines

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, you should not drive or operate machinery. If you take only 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 engaging in activities requiring high alertness, such as driving or operating machinery.

Ibuthek contains isomalt.

This medicine contains isomalt. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Ibuthek

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

Dosage

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

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

The interval between doses should be chosen according to symptom severity 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 occurrence of adverse reactions can be minimized by using the lowest effective doses for the shortest time needed to control symptoms (see section 4.4).

This medicine is intended for short-term treatment.

This medicine should only be administered when pain or fever occurs. As symptoms subside, treatment should be discontinued.

Special patient groups

Renal impairment:

Dose reduction is not necessary in patients with mild or moderate renal impairment.

Hepatic impairment:

Dose reduction is not necessary in patients with mild or moderate hepatic impairment.

Paediatric population:

This medicine must not be given to children or adolescents weighing less than 40 kg, as the dosage cannot be appropriately adjusted for use in these patients.

Method of administration

For oral use.

Empty the contents of the sachet directly into the mouth. In patients experiencing gastric discomfort, it is recommended to take the medicine 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915620420, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you have taken more Ibuthek than recommended, or if a child has accidentally ingested the medicine, consult a doctor or go to the nearest hospital to assess the risk and receive advice on the necessary measures.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At higher doses, symptoms such as 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 make up for a missed dose.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The frequencies have been defined as follows:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: cannot be estimated from the available data

The following adverse effects have been observed:

Gastrointestinal disorders

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

Common: nausea, vomiting, abdominal pain, heartburn, flatulence, and constipation.
Uncommon: bleeding, stomach or duodenal ulcers.
Rare: gastric or intestinal perforation, inflammation of the oesophagus, and ulcers or inflammation of the intestine.

Skin and subcutaneous tissue disorders

Common: skin rash.
Uncommon: redness of the skin, itching or swelling of the skin, swelling of the lips, face or tongue, increased nasal discharge, and breathing difficulties.
Rare: severe allergic reactions (anaphylactic shock).
Very rare: sudden onset of intense itching or blisters on the skin, joint pain and fever (systemic lupus erythematosus), hair loss, skin reactions due to light exposure. Medicines containing this active substance may very rarely be associated with very serious blistering reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and allergic vasculitis.

Severe allergic reaction that may present with nausea, vomiting, swelling of the face, tongue and throat, breathing difficulties, asthma, palpitations, hypotension or shock.

Frequency not known: A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell). Widespread red, scaly rash with bumps under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen Codramol and seek immediate medical attention if you experience these symptoms. See also section 2. The skin becomes sensitive to light.

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

• Reddish, non-elevated spots, target-like or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

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 disorders 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 (ringing or buzzing in the ears).
Rare: hearing difficulty.

Eye disorders

Uncommon: visual disturbances.
Rare: abnormal or blurred vision.

Blood and lymphatic system disorders

Very rare: prolonged bleeding time, blood cell abnormalities (early symptoms may include: fever, sore throat, mouth ulcers, flu-like symptoms, excessive tiredness, nosebleeds, and skin bleeding).

Cardiovascular disorders

These medicines may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Oedema (fluid retention), hypertension, and heart failure have also been observed in association with treatment using this type of medicine.

Renal and urinary disorders

Kidney disease.

Hepatobiliary disorders

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition

• The active substance 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 medicinal product and contents of the pack

Ibuthek is presented as a white or almost white oral powder with a pronounced lemon odor, in monodose sachets made of polyester/aluminum/polyethylene.

Two pack sizes are available: packs containing 12 units and packs containing 24 units.

Only certain pack 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.

Aragoneses, 2

28108 Alcobendas (Madrid)

Date of the most recent revision of this leaflet: April 2025

"Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"