Leaflet: information for the user

Ibukern600 mg film-coated tablets

Ibuprofen

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

This medicine is indicated for the treatment of fever, the treatment of mild to moderate pain including migraine, the treatment of arthritis (inflammation of the joints, including those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

Do not take Ibukernkern

• If you are allergic (hypersensitive) to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other ingredients in this medicine. Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding or clotting disorders, or are taking anticoagulants (blood thinners). If you need to take anticoagulants, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medicine.

Signs of allergic reaction to ibuprofen have been reported, including respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop taking Ibukern immediately and contact your doctor or emergency medical services if you notice any of these signs.

Inform your doctor:

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• If you have an infection; see the "Infections" section below.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a long time (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• If you have symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluid and contact your doctor immediately, as ibuprofen in this case may cause kidney failure as a result of dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may be indicated by severe abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when taking high doses and long-term treatment, especially in patients with a history of peptic ulcer disease and in the elderly. In these cases, your doctor may consider adding a stomach protector.
• If you are taking anticoagulants (blood thinners), antiplatelet agents (such as aspirin), or other medications that affect blood clotting, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestines, causing inflammation that often leads to bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are taking diuretics (water pills), as your doctor will need to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as ibuprofen may cause meningitis (inflammation of the membranes that protect the brain and spinal cord) not caused by bacteria.
• If you have porphyria (a metabolic disorder that affects the blood and can cause symptoms such as red urine, bloody urine, or liver disease), as your doctor will need to assess the need for ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medicine.
• It is possible to have an allergic reaction to this medicine.
• Your doctor will perform a more stringent check if you receive ibuprofen after major surgery.
• It is not recommended to take this medicine if you have chickenpox.

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

Skin reactions

Be especially careful with Ibukern:

Severe skin reactions, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with ibuprofen treatment. Stop taking Ibukern immediately and seek medical attention if you notice any of these symptoms.

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 taken in high doses.

Do not exceed the recommended dose or treatment duration.

Inform your doctor or pharmacist before taking ibuprofen if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease, 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.

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

Precautions during pregnancy and in fertile women

Due to the association of ibuprofen with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medicine during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

In the third trimester, the administration of ibuprofen is contraindicated.

For fertile women, it is essential to consider that ibuprofen-type medications have been associated with a decrease in fertility.

Infections

Ibukern may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibukern 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 medicine while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Taking Ibukern with other medicines

Inform your doctor or pharmacist if you are using, or have recently used, any other medicine, including those purchased without a prescription.

Ibukern may affect or be affected by other medicines. For example:

• Anticoagulant medications (e.g., for treating blood clotting problems, such as aspirin, warfarin, ticlopidine).
• Medications that lower high blood pressure (e.g., ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Baclofen (used to treat involuntary muscle contractions).
• Lithium (used to treat depression). Your doctor may need to adjust the dose of this medication.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medication.
• Mifepristone (an abortion inducer).
• Digoxin and other cardiac glycosides (used to treat heart conditions).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Corticosteroids like prednisone and prednisolone.
• Diuretics (used to increase urine production).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Ion exchange resins like cholestyramine (used to lower cholesterol levels).
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas like tolbutamide (used to treat diabetes).
• Tacrine (used to treat Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Thrombolytics (used to dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Voriconazole or fluconazole, used to treat fungal infections.
• Herbal extracts: Ginkgo biloba.

Other medicines may also affect or be affected by Ibukern treatment. Therefore, always consult your doctor or pharmacist before using Ibukern with other medicines.

Interference with laboratory tests

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Clearance of creatinine (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Serum concentrations of urea nitrogen, creatinine, and potassium (may increase).
• Liver function tests: increased values of transaminases.

If you are to undergo any diagnostic test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may affect the results.

Use of Ibukern with food, drink, and alcohol

You can take it with or without food. It is generally recommended to take it with meals or with milk to reduce the risk of stomach upset. If you take alcohol while taking this medicine, you may be more prone to adverse effects.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Do not take ibuprofen during pregnancy, especially during the third trimester (see "Precautions during pregnancy and in fertile women"). It may cause kidney and heart problems in your fetus. It may affect your and your baby's predisposition to bleeding and may delay or prolong labor. Do 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 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 (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

Although only small amounts of the medicine pass into breast milk, it is recommended not to take ibuprofen for extended periods during breastfeeding.

Therefore, if you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor.

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, do not drive or operate hazardous machinery. If you only take a single dose of ibuprofen or for a short period, you do not need to take special precautions.

Follow exactly the administration instructions for Ibuprofen indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the duration of treatment with Ibuprofen. Do not discontinue treatment beforehand, as this will not yield the expected results. Similarly, do not use Ibuprofen for a longer period than indicated by your doctor.

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

This medication is administered orally.Patients with stomach discomfort should take the medication with milk and/or during meals.

Adults:

In adults and adolescents from 14 to 18 years, one tablet (600 mg) will be taken every 6 to 8 hours, depending on the severity of the condition and the response to treatment.

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2400 mg in adults and 1600 mg in adolescents from 12 to 18 years.

Children and adolescents:

This medication is not recommended for use in children or adolescents under 14 years, as the ibuprofen dose contained in the tablet is not suitable for the recommended dosage in these patients.

Senior citizens:

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, the dose can only be increased once your doctor has confirmed that you tolerate the medication well.

Patients with kidney and/or liver diseases:

If you have a kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose prescribed by your doctor.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibukern than you should:

If you have taken more Ibukern than you should, or if a child has accidentally ingested the contents of the package, consult your doctor or pharmacist immediately, the Toxicological Information Service, phone: 91 562 04 20, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken, 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: stomach pain, nausea, vomiting (which may contain blood-stained mucus), indifference, drowsiness, headache, involuntary eye movements, buzzing in the ears, confusion, and muscle coordination disorders.More severe symptoms may appear, such as intestinal hemorrhage, low blood pressure, low body temperature, metabolic acidosis, seizures, kidney function impairment, coma, adult respiratory distress, and transient cessation of breathing in children (after ingesting large quantities).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..

If a severe intoxication has occurred, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric lavage will be considered if significant amounts have been ingested and within 60 minutes of ingestion..

If you forget to take Ibukern:

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 your usual time.

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

The side effects of medicines like Ibukern are more common in people over 65 years old.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

Frequencies are established according to the following classification: very common (may affect more than 1 in 10 patients); common (may affect up to 1 in 10 patients); uncommon (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1000 patients); very rare (up to 1 in 10,000 patients); frequency unknown (cannot be estimated from available data).

The following side effects have been observed:

Gastrointestinal::

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

Other side effects are:

Uncommon: mucosal inflammation with ulcer formation in the mouth.

Rare: esophageal inflammation, esophageal stricture (esophageal stenosis), exacerbation of intestinal diverticulitis disease, non-specific hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

Medicines containing Ibuprofen may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with Ibuprofen-like medicines.

Cutaneous:

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

• Flat, red, circular, or target-shaped patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and similar symptoms to the flu (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 bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Medicines containing Ibuprofen may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and painful lesions with necrosis and epidermal detachment) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and epidermal detachment).

Drug reaction with eosinophilia and systemic symptoms: A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Other side effects are:

Common: skin rash.

Uncommon: skin redness, itching, or swelling, purpura (purple spots on the skin).

Very rare: hair loss, erythema multiforme (skin lesion), light-sensitive skin reactions, inflammation of skin blood vessels.

Exceptionally, severe skin infections and complications in soft tissue during chickenpox can occur.

Frequency unknown: generalized, 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 pustular psoriasis). Stop taking Ibukern if you experience these symptoms and seek immediate medical attention. See section 2.

Immune system:

Uncommon: transient edema in areas of the skin, mucous membranes, or sometimes in internal organs (angioedema), nasal mucosa inflammation, bronchospasm (bronchi constriction that prevents air from reaching the lungs).

Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, facial swelling, tongue, and laryngeal swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.

Very rare: joint pain and fever (lupus erythematosus).

Central nervous system:

Common: fatigue or drowsiness, headache, dizziness, or feeling unsteady.

Rare: paresthesia (numbness, tingling, burning, etc. more common in hands, feet, arms, or legs).

Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases) which was a risk factor.The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness.

Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

Common: vertigo. Uncommon: ringing or buzzing in the ears.

Rare: hearing difficulty.

Visual:

Uncommon: visual disturbances.

Rare: abnormal or blurred vision.

Haematological:

Rare: decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red and white blood cells and platelets in the blood), agranulocytosis (very large decrease in granulocytes), aplastic anemia (bone marrow insufficiency to produce different types of cells) or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nasal and cutaneous bleeding.

Very rare: prolonged bleeding time.

Renal:

Based on the experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (characterized by protein in the urine and body swelling), and renal insufficiency (sudden loss of kidney function) cannot be ruled out.

Hepatic:

Medicines containing Ibuprofen may be associated, in rare cases, with liver damage.

Other rare side effects are: hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes).

Frequency unknown: liver failure (severe deterioration of the liver).

General:

Worsening of inflammation during infectious processes.

Until now, no severe allergic reactions have been reported with Ibuprofen, although they cannot be ruled out. The manifestations of this type of reaction may be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, facial swelling, tongue, and throat swelling, difficulty breathing, asthma, palpitations, hypotension, or shock.

If any of the following side effects appear, stop treatment and seek immediate medical attention:

• Allergic reactions such as skin rash, facial swelling, chest tightness, or difficulty breathing.
• Vomiting blood or coffee-ground-like vomit.
• Blood in stools or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or peeling of the skin.
• Severe headache or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this same section).
• Swelling of the extremities or fluid accumulation in the arms or legs.

Reporting of side effects

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

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on 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 unused medications at your local pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Ibu kern

• The active ingredient is ibuprofen. Each tablet contains 600 mg of ibuprofen.
• The other components are: cornstarch, pregelatinized cornstarch, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate in the tablet core and macrogol 8000, a cellulose derivative, poloxyl 40 stearate, hypromellose, titanium dioxide, and propylene glycol in the coating.

Appearance of the product and contents of the packaging

Ibu kern 600 mg are white, elongated, smooth, unnotched tablets with the mark 600 on one face.They are presented in PVC/Aluminum blisters in packs of 40 tablets and clinical packs of 500 tablets.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

Farmalider, S.A.

C/ Aragoneses, 2, Alcobendas

28108 Madrid

Spain

or

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2, Alcobendas

28108 Madrid

Spain

or

SAG MANUFACTURING, S.L.

National Highway I, Km 36

San Agustín de Guadalix28750

Madrid, Spain

Last review date of this leaflet: January 2024

The 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/.