IBUPROFEN (ARGININE) KERN PHARMA 600 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

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

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet:

1. What is Ibuprofen (arginine) Kern Pharma and what is it used for
2. What you need to know before taking Ibuprofen (arginine) Kern Pharma
3. How to take Ibuprofen (arginine) Kern Pharma
4. Possible side effects
5. Storage of Ibuprofen (arginine) Kern Pharma
6. Package contents and additional information

1. What is Ibuprofen (arginine) Kern Pharma and what is it used for

Ibuprofen (arginine) belongs to the group of medications called non-steroidal anti-inflammatory drugs (NSAIDs).

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

2. What you need to know before taking Ibuprofen (arginine) Kern Pharma

Do not take this medication

• If you are allergic (hypersensitive) to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other components of Ibuprofen (arginine) Kern Pharma. 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 have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation 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.

With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop using Ibuprofeno (arginina) Kern Pharma immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Tell your doctor:

• If you have edema (fluid retention).
• If you have or have had heart problems or high blood pressure.
• If you have asthma or any other respiratory disorder.
• 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 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 experience symptoms of dehydration, e.g., 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 developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by severe abdominal pain or persistent 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 the elderly. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.

• If you take medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents like aspirin. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as medications like ibuprofeno (arginina) may worsen these conditions.
• If you are being treated with diuretics (medications to increase urine production), as your doctor should 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 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 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, do 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.

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

Skin reactions

Be particularly 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with 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

Anti-inflammatory/analgesic medications like ibuprofen (arginine) 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.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofeno (arginina) Kern Pharma 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, a family history of heart disease or stroke, or if you are a smoker.

Similarly, 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

Since the administration of medications like ibuprofeno (arginina) has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to take this medication 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, the administration of ibuprofeno (arginina) is contraindicated.

For women of childbearing age, it should be noted that medications like ibuprofeno (arginina) have been associated with a decreased ability to conceive.

Infections

Ibuprofen (Arginine) may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofen (Arginine) may delay the appropriate treatment of the infection, which may 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 stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase values

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

Use of Ibuprofeno (arginina) Kern Pharma with other medications

Tell 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 non-steroidal anti-inflammatory drugs.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medications (e.g., to treat coagulation problems/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 (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used to treat heart disorders).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medications used to increase urine production).
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.

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

Taking Ibuprofeno (arginina) Kern Pharma with food and beverages

You can take it alone or with food. In general, it is recommended to take it before meals to reduce the possibility 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 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 ability to bleed 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 the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may 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 for a period longer than a few days, your doctor may recommend additional monitoring.

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 using machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take one dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Ibuprofeno (arginina) Kern Pharma contains aspartame and sucrose

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 sucrose. 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 Ibuprofeno (arginina) Kern Pharma

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

Your doctor will indicate the duration of treatment with Ibuprofeno (arginina). Do not suspend treatment beforehand, as the expected results will not be obtained. Similarly, do not use Ibuprofeno (arginina) for longer than indicated by your doctor.

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay 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 sachet (600 mg) will be taken every 6 to 8 hours, depending on the intensity of the condition and the response to treatment.

In some processes, 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:

The use of this medication is not recommended in children and adolescents under 14 years, as the dose of ibuprofen it contains is not suitable for the recommended dosage in this group of patients.

Elderly patients:

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 checked that you tolerate the medication well.

Patients with kidney and/or liver disease:

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

If you think 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 Pharmathan 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 Toxicology Information Service, phone: 91 562 04 20, or go to the nearest hospital to find out 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 prospectus of the medication to the healthcare professional.

The symptoms of overdose may include: stomach pain, nausea, vomiting (which may contain bloody sputum), indifference, sleep, headache, involuntary eye movements, ringing in the ears, confusion, and lack of muscle coordination.

More serious symptoms may appear, such as intestinal bleeding, low blood pressure, low body temperature, metabolic acidosis, convulsions, kidney function impairment, coma, adult respiratory distress, and transient respiratory arrest in children (after ingesting large amounts).

At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (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 poisoning 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 after ingestion.

If you forgot to take Ibuprofeno (arginina) Kern Pharma

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 of the next dose is very close, skip the forgotten dose and take the next dose at the usual time.

4. Possible adverse effects

Like all medications, Ibuprofeno (arginina) can have adverse effects, although not all people suffer from them.

The adverse effects of medications like ibuprofeno (arginina) are more common in people over 65 years old.

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

Frequencies are established according to the following classification: very frequent (in more than 1 in 10 patients); frequent (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 (in less than 1 in 10,000 patients); frequency unknown (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal:

The most frequent adverse effects that occur with medications like ibuprofeno (arginina) are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stool, oral ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Other adverse effects are:

Uncommon: inflammation of the oral mucosa with ulcer formation.

Rare: esophageal inflammation, esophageal stricture (esophageal stenosis), exacerbation of diverticular disease, hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

Medications like ibuprofeno (arginina) 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 serious allergic reaction called Kounis syndrome.

Edema (fluid retention), arterial hypertension, and heart failure have also been observed in association with treatments with medications of the ibuprofeno (arginina) type.

Skin:

Stop treatment with Ibuprofeno (arginina) and seek immediate medical attention if you notice any of the following symptoms:

• Reddish patches, not elevated, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nose ulcers, genital ulcers, 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 swollen lymph nodes (DRESS syndrome).
• Generalized rash, red and scaly, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Medications like ibuprofeno (arginina) may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis).

Other adverse effects are:

Frequent: skin rash.

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

Very rare: hair loss, erythema multiforme (skin lesion), skin reactions due to light influence, inflammation of skin blood vessels. Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox.

Generalized red scaly rash, with bumps under the skin and blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno (arginina) Kern Pharma if you experience these symptoms and seek immediate medical attention. See also section 2.

Drug reaction with eosinophilia and systemic symptoms: A severe skin reaction known as DRESS syndrome can occur. The 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 viscera (angioedema), nasal mucosa inflammation, bronchospasm (bronchial spasm that prevents air from passing into the lungs).

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

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

Central nervous system:

Frequent: fatigue or drowsiness, headache, and dizziness or instability.

Rare: paresthesia (sensation of numbness, tingling, prickling, etc., more frequent 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:

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

Rare: hearing difficulty.

Ocular:

Uncommon: vision changes.

Rare: abnormal or blurred vision.

Blood:

Rare: decreased platelets, decreased white blood cells (which may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (which may manifest as difficulty breathing and pale skin), decreased granulocytes (a type of white blood cell that can predispose to infections), pancytopenia (deficiency of red, white, and platelet blood cells), agranulocytosis (very significant decrease in granulocytes), aplastic anemia (bone marrow failure 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, nosebleeds, and skin bleeding.

Very rare: prolonged bleeding time.

Renal:

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

Hepatic:

Medications like ibuprofeno (arginina) may be associated, in rare cases, with liver damage.

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

Frequency unknown: liver failure (severe liver deterioration).

General:

Worsening of inflammation during infectious processes.

To date, no serious allergic reactions have been reported with ibuprofeno (arginina), although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, facial swelling, tongue and throat swelling, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects appear, stop treatment and go immediately to your doctor:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Blood vomiting or coffee grounds-like vomiting.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blistering.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 not listed in this prospectus. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofeno (arginina) Kern Pharma

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Keep in the original package to protect from light and moisture.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewers or in the trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

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

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

• The other components are: arginine, aspartame (E-951), sucrose, sodium bicarbonate, sodium saccharin, sodium lauryl sulfate, anhydrous colloidal silica, menthol flavor, and peppermint flavor (contains cornstarch).

Appearance of the product and package contents

White granules with a characteristic mint flavor.

It is presented in packages with 20 or 40 sachets with granules for oral solution.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Date of the last revision of this prospectus: November 2024

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