Package Insert: Information for the User

Ibuprofen (arginine) Kern Pharma 600 mg powder for oral solution EFG

Read this package insert carefully before starting to take this medication, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only and should not be given to others even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

This medicine is indicated for the treatmentof 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 this medication

• If you are allergic (hypersensitive) to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other ingredients in Ibuprofeno (arginina) Kern Pharma.The signs of an allergic reaction 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 have experienced bleeding in the digestive tract.
• If you are vomiting 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 medication.

Signs of a severe allergic reaction to ibuprofen have been reported, including respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop taking Ibuprofeno (arginina) Kern Pharma immediately and contact your doctor or emergency medical services if you experience any of these symptoms.

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 medication 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 experience symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure due to dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may be indicated by severe abdominal pain or black stools, or even without previous warning symptoms. This risk is higher with high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and the elderly. In these cases, your doctor may consider adding a stomach protector.

• If you are taking anticoagulants or antiplatelet agents, such as aspirin, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestines, causing inflammation that often results in bloody diarrhea) or ulcerative colitis, as ibuprofen may worsen these conditions.
• If you are taking diuretics (medications to increase urine production), 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 it may cause aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have porphyria (a metabolic disorder that affects the blood and can cause symptoms such as red urine, blood in the 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 medication.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform more frequent checks if you take ibuprofen after major surgery.
• It is not recommended to take this medication if you have chickenpox.

It is essential to use the smallest effective dose to alleviate or control pain and not take this medication for longer than necessary to control your symptoms.

Skin reactions

Be especially careful with Ibuprofeno (arginina) Kern Pharma: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.Stop taking Ibuprofeno (arginina) Kern Pharma 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), such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

Inform your doctor or pharmacist before taking Ibuprofeno (arginina) Kern Pharma 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.

This type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Precautions during pregnancy and in women of childbearing age

Due to the association of ibuprofen with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication 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 women of childbearing age, it is essential to consider that ibuprofen may decrease fertility.

Infections

Ibuprofeno (Arginina) may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibuprofeno (Arginina) may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Interference with laboratory tests

The use of ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Urea nitrogen and serum creatinine and potassium concentrations (may increase)
• With liver function tests: increased values of transaminases

Inform your doctor if you are to undergo a clinical analysis and are taking or have recently taken ibuprofen.

Use of Ibuprofeno (arginina) Kern Pharma with other medications

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

Ibuprofeno (arginina) Kern Pharma may affect or be affected by other medications. For example:

• Other nonsteroidal anti-inflammatory drugs (NSAIDs).
• Antiplatelet agents (prevent the formation of blood clots in blood vessels) such as ticlopidine.
• Anticoagulants (e.g., to treat blood clotting problems or prevent coagulation, e.g., aspirin, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Lithium (a medication 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 cardiac glycosides (used to treat heart problems).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Corticosteroids such as prednisone and prednisolone.
• Diuretics (medications used to increase urine production).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas such as tolbutamide (used to treat diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.

Other medications may also affect or be affected by the treatment with Ibuprofeno (arginina) Kern Pharma. Therefore, always consult your doctor or pharmacist before using Ibuprofeno (arginina) Kern Pharma with other medications.

Taking Ibuprofeno (arginina) Kern Pharma with food and drinks

You can take it alone or with food. In general, it is recommended to take it before meals to reduce the risk of stomach upset.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Do not take ibuprofen during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing age). It may cause kidney and heart problems in your fetus. It may affect your and your baby's predisposition to bleeding and delay or prolong labor more than expected. 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 possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may result in 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 medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take a single dose of ibuprofen or for a short period, no special precautions are necessary.

Ibuprofeno (arginina) Kern Pharma contains aspartame and saccharose

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.Each sachet contains 30 mg of aspartame, equivalent to 16.84 mg of phenylalanine.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the duration of treatment with Ibuprofeno (arginina). Do not discontinue treatment beforehand, as this will not yield the expected results. Similarly, do not use Ibuprofeno (arginina) 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 immediately 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 during meals.

Adults:

In adults and adolescents from 14 to 18 years, one packet (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:

This medication is not recommended for use in children and adolescents under 14 years, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

Senior patients:

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If this is the case, 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 this is the case, 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 doses of Ibuprofeno (arginina) Kern Pharma than you should

If you have taken more Ibuprofeno (arginina) Kern Pharma 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 forgot to take Ibuprofeno (arginina) Kern Pharma

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 medications,Ibuprofen (arginine)may have side effects, although not everyone will experience them.

Side effects of medications such as ibuprofen (arginine) 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 (in more than 1 in 10 patients); common (between 1 and 10 in 100 patients); uncommon (between 1 and 10 in 1,000 patients); rare (between 1 and 10 in 10,000 patients); very rare (less than 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 medications such as ibuprofen (arginine) are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, stomach pain, blood in stool, 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 of the mouth with the formation of ulcers.

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

Very rare: pancreatitis.

Cardiovascular:

Medications such as ibuprofen (arginine) 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 medications of the type ibuprofen (arginine).

Cutaneous:

Stop taking Ibuprofen (arginine) Kern Pharma immediately and seek medical attention if you notice any of the following symptoms:

• Flat, red, circular, or target-shaped spots 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 flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly, and blistered skin rash, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Medications such as ibuprofen (arginine) may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread skin and mucous membrane erosions) and toxic epidermal necrolysis (erosions in mucous membranes and painful, necrotic skin lesions).

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), photosensitivity reactions, inflammation of skin blood vessels. Exceptionally, severe skin infections and complications in soft tissue during chickenpox may occur.

Generalized, red, scaly skin rash, with blisters under the skin and localized primarily in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking Ibuprofen (arginine) Kern Pharma if you experience these symptoms and seek immediate medical attention. See section 2.

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

Immune system:

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

Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, swelling of the face, tongue, and larynx, 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, or prickling sensations, 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. 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: vision disturbances.

Rare: abnormal or blurred vision.

Blood:

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), pancitopenia (deficiency of red, white, and platelet cells 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:

Medications such as ibuprofen (arginine) 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).

Unknown frequency: 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 (arginine), although they cannot be ruled out. Manifestations of this type of reaction may include fever, skin rash, abdominal pain, severe headache, nausea, vomiting, facial, 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 material.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Significant blistering 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 limbs or accumulation of fluid in the arms or legs.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 not mentioned in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Keep in its original packaging to protect from light and moisture.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications.By doing so, you will help protect the environment.

Composition of Ibuprofeno (arginina) Kern Pharma 600 mg granulated for oral solution

• The active ingredient is Ibuprofeno. Each sachet contains 600 mg of Ibuprofeno.

• The other components are: arginina, aspartamo (E-951), sacarosa, bicarbonato de sodio, sacarina de sodio, lauril sulfato de sodio, sílice coloidal anhidra, aroma de mentol and aroma de menta (contains cornstarch).

Appearance of the product and contents of the packaging

White granulated product with a characteristic minty odor.

It is presented in packaging with 20 or 40 sachets of granulated oral solution.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Last review date of this leaflet: November 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.