Package Insert: Information for the User

Ibuprofen Kern Pharma 400 mg Film-Coated Tablets

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

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone 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.

Ibuprofenbelongs 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 Ibuprofeno Kern Pharma 400 mg

• 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 necessary, 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 allergic reaction to ibuprofen have been reported, including respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using Ibuprofeno Kern Pharma 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 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 in this case may cause kidney failure due to dehydration.

-If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as 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 treatment, especially in patients with a history of peptic ulcer disease and in elderly patients. In these cases, your doctor may consider adding a stomach protector medication.

-If you take anticoagulant medications, such as oral anticoagulants, antiplatelet agents like aspirin, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs). Inform your doctor about the use of these medications.

-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 Ibuprofeno Kern Pharma 400 mg tablets may worsen these conditions.

-If you are taking diuretics (medications to increase urine production), as your doctor should 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 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 your blood and can cause symptoms such as red urine, blood in urine, or liver disease), so your doctor can 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 a more stringent check if you receive ibuprofen after major surgery.

-It is not recommended to take this medication if you have chickenpox.

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

Skin reactions

Be especially careful with Ibuprofeno 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 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) like Ibuprofeno may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking Ibuprofeno 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 (problems with circulation 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 are a smoker.

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

PREGNANCY AND BREASTFEEDING PRECAUTIONS

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 when strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

In the third trimester, administration of Ibuprofeno is contraindicated.

For women of childbearing age, it is essential to consider that ibuprofen has been associated with a decrease in fertility.

INFECTIONS

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

USE OF IBUPROFENO KERN PHARMA WITH OTHER MEDICATIONS

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

The following medications may interact with Ibuprofeno and should not be taken together without consulting your doctor:

• Other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin.
• Antiplatelet agents (prevent blood clots) like ticlodipine.
• Anticoagulant medications (e.g., for blood clotting problems, e.g., aspirin, warfarin, ticlopidine).
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and other cardiac glycosides (used to treat heart problems).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and trimethoprim (used to treat 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.
• Sulfinpyrazone (used for gout).
• Sulfonylureas like tolbutamide (used to treat diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Trombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba.

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

Ibuprofeno may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose levels (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Serum urea nitrogen and creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase values

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

USE OF IBUPROFENO KERN PHARMA WITH FOOD AND BEVERAGES

You can take it alone or with food. Generally, it is recommended to take it before meals or with milk to reduce the possibility of stomach discomfort.

PREGNANCY AND BREASTFEEDING

Consult your doctor or pharmacist before using any medication.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see Pregnancy and Breastfeeding Precautions section). 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 time possible. After 20 weeks 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 monitoring.

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

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

DRIVING AND MACHINE OPERATION

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.

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 aged 12 to 18 years, one tablet (400 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 aged 12 to 18 years.

Use in children:

This medication is not recommended for use in children weighing less than 40 kg or under 12 years, as the ibuprofen dose contained is not suitable for the recommended dosage in these children.

Use in elderly individuals:

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 Ibuprofen Kern Pharma 400 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more doses of Ibuprofen Kern Pharma 400 mg than you should:

If you have taken more Ibuprofen Kern Pharma 400 mg 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, ringing in the ears, confusion, and muscle coordination problems.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 problems 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 Ibuprofen Kern Pharma 400 mg:

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, this medication may cause side effects, although not everyone will experience them.

The side effects of medications such as Ibuprofeno 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 Ibuprofeno are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, vomiting blood, 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 diverticulum disease, non-specific hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

Medications such as Ibuprofeno may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Chest pain, which may 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 Ibuprofeno Kern Pharma 400 mg.

Cutaneous:

Stop treatment with Ibuprofeno Kern Pharma 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 flu-like symptoms (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 subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Medications such as Ibuprofeno 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 purpuric lesions, preferably on the trunk) 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 may 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 patches on the skin).

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

Exceedingly rare cases of severe skin infections and soft tissue complications during chickenpox may occur.

Unknown frequency: generalized, red, scaly rash with subcutaneous nodules and blisters, primarily located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking Ibuprofeno Kern Pharma 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 (bronchial 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, 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.

Ocular:

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), 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 Ibuprofeno 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:

Exacerbation of inflammatory processes during infectious processes.

Until now, severe allergic reactions have not been reported with Ibuprofeno, although they cannot be ruled out. Manifestations of this type of reaction may include 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 occur, stop treatment and seek immediate medical attention:

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this prospectus. 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 adverse reactions, 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.

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 the packaging and medications you no longer need at your local SIGRE collection point.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of ibuprofen Kern Pharma 400 mg tablets

Appearance of the product and content of the packaging

Ibuprofen Kern Pharma 400 mg are round white tablets. They are presented in blisters in boxes of 30 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

SAG MANUFACTURING, S.L.

Carretera Nacional I, Km 36

San Agustín de Guadalix 28750

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/ .