IBUKERN 600 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibukern600 mg film-coated tablets EFG

Ibuprofen

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Ibukern and what is it used for.
2. What you need to know before you take Ibukern.
3. How to take Ibukern.
4. Possible side effects.
5. Storing Ibukern.
6. Contents of the pack and further information.

1. What is Ibukern and what is it used for

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

This medicine is indicated for the treatment of fever, treatment of pain of mild or moderate intensity including migraine, treatment of arthritis (inflammation of the joints, including usually 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 that affects the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before you take Ibukern

Do not take Ibukern

• If you are allergic (hypersensitive) to ibuprofen, to other medicines of the non-steroidal anti-inflammatory drug group (NSAIDs), to aspirin, or to any of the other ingredients of this medicine. Allergic reactions may be: skin rash with itching, swelling of the face, lips, or tongue, runny nose, 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 (medicines 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 medicine.

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

Tell your doctor:

• If you have edema (fluid retention).
• If you have or have had any heart disorder or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you have an infection; see the "Infections" heading later.
• 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 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 as a consequence of dehydration.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal 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 elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medication.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• 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 Ibuprofen may worsen these conditions.
• If you are being treated with diuretics (medicines 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 important that you use the smallest dose that relieves-controls the pain and do not take this medication for longer than necessary to control your symptoms.

Skin reactions

Be careful with Ibukern:

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Ibukern treatment 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 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.

Tell your doctor or pharmacist before taking ibuprofen 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 ibuprofen has been associated with an increased risk of congenital anomalies/abortions, it is not recommended during the first and second trimester of pregnancy unless strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

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

For women of childbearing age, it should be taken into account that ibuprofen has been associated with a decrease in fertility.

Infections

Ibukern may hide the signs of an infection, such as fever and pain. Consequently, Ibukern 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.

Taking Ibukern with other medications

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

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

• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, such as acetylsalicylic acid, 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).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Lithium (a 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 (an abortion inducer).
• Digoxin and other cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of 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).
• Antibiotics of the quinolone group such as norfloxacin.
• Ion exchange resins such as cholestyramine (used to decrease blood cholesterol levels).
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrine (used in the treatment of Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (a medication against the AIDS virus).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Voriconazole or fluconazole, used for fungal infections.
• Herbal extracts: Ginkgo biloba tree.

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

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.

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

Using Ibukern with food, drink, and alcohol

You can take it alone or with food. In general, it is recommended to take it with meals or with milk to reduce the possibility of stomach upset. If you drink alcohol while being treated with this medication, you may be more prone to side effects.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking 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 to your fetus. It may affect your and your baby's ability to clot and delay or prolong labor more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as indicated 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 the 20th week of pregnancy, ibuprofen may cause kidney problems to your fetus if taken for more than a few days, which may cause low levels of the fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the 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 are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice.

Driving and using machines

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

3. How to take Ibukern

Follow the administration instructions for Ibuprofen exactly as 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 suspend treatment beforehand, as this will not achieve the expected results. Similarly, do not use Ibuprofeno 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 with milk and/or during meals.

Adults:

In adults and adolescents from 14 to 18 years, take one tablet (600 mg) every 6 to 8 hours, depending on the intensity of the condition and 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:

The use of this medication is not recommended in children or adolescents under 14 years, as the dose of ibuprofen contained in the tablet is not suitable for the recommended dosage in these 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 prescribed by your doctor.

If you think 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, or contact 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 medication prospectus to the healthcare professional.

Symptoms of overdose may include: stomach pain, nausea, vomiting (which may contain bloody sputum), indifference, sleepiness, headache, involuntary eye movements, ringing in the ears, confusion, and lack of muscle coordination. More severe symptoms such as intestinal bleeding, low blood pressure, low body temperature, metabolic acidosis, convulsions, kidney function impairment, coma, adult respiratory distress, and temporary respiratory arrest in children (after ingesting large amounts) may occur. 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 large amounts have been ingested and within 60 minutes after ingestion.

If you forget to take Ibukern

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 for the next dose is near, skip the forgotten dose and take the next dose at the usual time.

4. Possible side effects

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

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

The incidence of side 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 (may affect more than 1 in 10 patients); frequent (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); unknown frequency (cannot be estimated from available data).

The following side effects have been observed:

Gastrointestinal:

The most frequent side effects that occur with ibuprofen medications are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. 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 side effects are:

Uncommon: inflammation of the oral mucosa with ulcer formation.

Rare: esophageal inflammation, esophageal narrowing (esophageal stenosis), exacerbation of intestinal diverticulitis, hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

Ibuprofen medications may be associated with a moderate increased 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), high blood pressure, and heart failure have also been observed in association with ibuprofen treatments.

Dermatological:

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

• Reddish patches, target-like or circular on the trunk, often with blisters in the center, skin peeling, oral ulcers, throat ulcers, nasal 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 rash, high 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).

Ibuprofen medications 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).

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).

Other side 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), photosensitive skin reactions, inflammation of skin blood vessels.

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

Unknown frequency: 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 Ibukern if you experience these symptoms and seek medical attention immediately. See also section 2.

Immune system:

Uncommon: transient edema in 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, 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:

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

Rare: paresthesia (sensation of numbness, tingling, burning, 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.

Hematological:

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 can predispose to infections), pancytopenia (deficiency of red, white, and platelet blood cells), agranulocytosis (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 renal failure (sudden loss of kidney function) cannot be excluded.

Hepatic:

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

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

Unknown frequency: liver failure (severe liver damage).

General:

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with Ibuprofen, 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 side effects occur, stop treatment and go to your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee grounds-like vomit.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blisters.
• 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.

Reporting side effects

If you experience any side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish Medication Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ibukern

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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 down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE Point of your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ibukern

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

Appearance of the product and package contents

Ibukern 600 mg are white, elongated, smooth tablets without scores and with the mark 600 on one face. They are presented in PVC/Aluminum blisters in packages with 40 tablets and a clinical package of 500 tablets.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

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.

Carretera Nacional I, Km 36

San Agustín de Guadalix 28750

Madrid, Spain

Date of the last revision of this prospectus: January 2024.

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