Ibukern 600 mg film-coated tablets EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ibukern 600 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, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

What Ibukern is and what it is used for.
What you need to know before taking Ibukern.
How to take Ibukern.
Possible side effects.
How to store Ibukern.
Contents of the pack and other information.

1. What Ibukern is and what it is 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, and for the treatment of mild to moderate pain including migraine, arthritis (inflammation of the joints, usually affecting hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder causing damage to cartilage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before taking Ibukern

Do not take Ibukern

If you are allergic (hypersensitive) to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other ingredients of this medicine. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties, or asthma.
If you have severe liver or kidney disease.
If you have had a stomach or duodenal ulcer, gastrointestinal bleeding, or a perforation of the digestive tract.
If you are vomiting blood.
If you have black stools or bloody diarrhoea.
If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulants must be used 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

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

Allergic reactions to ibuprofen, such as breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop taking Ibukern immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

Inform 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 section "Infections" below.
If you have kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks should occur.
If you experience symptoms of dehydration, such as severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this case could lead to kidney failure due to dehydration.
If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. The risk is higher with high doses and prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.
If you are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
If you have Crohn's disease (a chronic condition where the immune system attacks the intestine, causing inflammation and usually bloody diarrhoea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
If you are taking diuretics (medicines to increase urine production), as your doctor needs to monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can involve vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—without bacterial infection) may occur.
If you have acute intermittent porphyria (a metabolic disorder affecting the blood, which may cause reddish urine, blood in urine, or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate.
If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
Allergic reactions may occur with this medicine.
Your doctor will monitor you more closely if you are receiving ibuprofen after major surgery.
It is advisable not to take this medicine if you have chickenpox.

It is important to use the lowest effective dose that relieves/controls your pain and not to take this medicine longer than necessary to control your symptoms.

Skin reactions

Take special care with Ibukern:

Serious skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Stop treatment with Ibukern and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses.

Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

You have heart problems, including heart failure, angina (chest pain), a history of heart attack, coronary artery bypass surgery, peripheral arterial disease (circulation problems in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA").
You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

In addition, these medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Pregnancy and fertility precautions

Because administration of medicines like ibuprofen has been associated with an increased risk of congenital malformations and miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of ibuprofen is contraindicated during the third trimester.

For women of childbearing age, it should be noted that medicines like ibuprofen have been associated with reduced fertility.

Infections

Ibukern may mask signs of infection, such as fever and pain. Therefore, Ibukern may delay appropriate treatment of an infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Taking Ibukern with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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

Anticoagulants (e.g. medicines to treat or prevent blood clotting, such as acetylsalicylic acid, warfarin, ticlopidine).
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).
Baclofen (used to treat involuntary and persistent muscle contractions).
Lithium (used to treat depression). Your doctor may adjust the dose of this medicine.
Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
Mifepristone (used to induce abortion).
Digoxin and other cardiac glycosides (used to treat heart disorders).
Hydantoins such as phenytoin (used to treat epilepsy).
Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
Corticosteroids such as cortisone and prednisolone.
Diuretics (medicines used to increase urine output).
Pentoxifylline (used to treat intermittent claudication).
Probenecid (used in gout patients or together with penicillin in infections).
Quinolone antibiotics such as norfloxacin.
Ion-exchange resins such as cholestyramine (used to lower blood cholesterol levels).
Sulfinpyrazone (used for gout).
Sulfonylureas such as tolbutamide (used for diabetes).
Tacrine (used in the treatment of Alzheimer's disease).
Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
Zidovudine (an anti-HIV medicine).
Thrombolytics (medicines that dissolve blood clots).
Aminoglycoside antibiotics such as neomycin.
Voriconazole or fluconazole (used for fungal infections).
Herbal extracts: Ginkgo biloba.

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

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

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

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

Use of Ibukern with food, drink, and alcohol

You may take it alone or with food. It is generally recommended to take it with meals or milk to reduce the possibility of stomach discomfort. If you consume alcohol while taking this medicine, you may be more likely to experience adverse effects.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section on pregnancy and fertility precautions). It may cause kidney and heart problems in your unborn baby. It may affect your and your baby's ability to clot blood and may delay or prolong labour. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your unborn baby if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

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

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take only a single dose of ibuprofen or use it for a short period, no special precautions are usually necessary.

3. How to take Ibukern

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

Your doctor will indicate how long your Ibuprofen treatment should last. Do not stop the treatment earlier, as otherwise the expected results would not be achieved. Likewise, do not use Ibuprofen for longer than indicated by your doctor.

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

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

Adults:

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

In some conditions, 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.

Children and adolescents:

This medicine is not recommended for use in children or adolescents under 14 years of age, as the ibuprofen dose 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 you a lower than usual dose. In such case, the dose may only be increased once your doctor has confirmed that you tolerate the medicine well.

Patients with kidney and/or liver disease:

If you suffer from kidney and/or liver disease, your doctor may prescribe you a lower than usual dose. In such case, take exactly the dose prescribed by your doctor.

If you think that the effect of this medicine 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, contact your doctor or pharmacist immediately, the Toxicology Information Service, telephone: 91 562 04 20, or go to the nearest hospital to find out about the risk and obtain advice on the measures to be taken, indicating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

Symptoms of overdose may include: stomach pain, nausea, vomiting (which may contain blood-stained sputum), indifference, drowsiness, headache, involuntary eye movements, tinnitus, confusion, and lack of muscle coordination. More severe symptoms may occur, such as gastrointestinal bleeding, low blood pressure, decreased body temperature, metabolic acidosis, seizures, impaired kidney function, coma, adult respiratory distress, and transient cessation of breathing in children (after ingestion of large amounts). At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, 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 large amounts, activated charcoal should be administered. Gastric emptying should be considered if large amounts have been ingested and within 60 minutes following ingestion.

If you forget to take Ibukern

Do not take a double dose to make up for missed doses.

If you forget to take your scheduled dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at your usual time.

4. Possible adverse effects

Like all medicines, Ibukern may produce adverse effects, although not everyone experiences them.

Adverse effects of medicines such as Ibukern are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatments and when the daily dose is below the recommended maximum dose.

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

The following adverse effects have been observed:

Gastrointestinal:

The most common adverse effects associated with ibuprofen-containing medicines are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, oral ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Other adverse effects include:

Uncommon: inflammation of the oral mucosa with ulcer formation.

Rare: inflammation of the esophagus, esophageal narrowing (esophageal stenosis), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

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

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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

Skin and subcutaneous tissue:

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

Red, non-elevated spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may 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, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Ibuprofen-containing medicines may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, mainly on the trunk) and toxic epidermal necrolysis (mucosal erosions and painful lesions with necrosis and detachment of the epidermis).

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

Other adverse effects include:

Common: skin rash.

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

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

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

Frequency not known: widespread red, scaly rash with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Discontinue Ibukern immediately if these symptoms occur and seek medical attention immediately. See also section 2.

Immune system disorders:

Uncommon: transient swelling in areas of the skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of the nasal mucosa, bronchospasm (spasm of the bronchi obstructing airflow to the lungs).

Rare: severe allergic reactions (anaphylactic shock). In cases 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, "pins and needles," more frequent in hands, feet, arms, or legs).

Very rare: aseptic meningitis. In most reported cases of aseptic meningitis associated 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 observed included neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness.

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

Auditory:

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

Rare: hearing difficulty.

Ocular:

Uncommon: visual disturbances.

Rare: abnormal or blurred vision.

Blood and lymphatic system:

Rare: decreased platelets, decreased white blood cells (may present as frequent infections with fever, chills, or sore throat), decreased red blood cells (may present as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may increase susceptibility to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe decrease in granulocytes), aplastic anemia (bone marrow failure to produce various blood cells), or hemolytic anemia (premature destruction of red blood cells). Early symptoms include: 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 urine and body swelling), and renal failure (sudden loss of kidney function) cannot be excluded.

Hepatic:

Ibuprofen-containing medicines may, on rare occasions, be associated with liver injury.

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

Frequency not known: liver failure (severe liver impairment).

General:

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. Manifestations of such reactions could include fever, skin rash, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulty, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulty.
Vomiting blood or material resembling coffee grounds.
Blood in stools or bloody diarrhea.
Severe stomach pain.
Blisters or significant skin peeling.
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 of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibukern

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibukern

The active substance is ibuprofen. Each tablet contains 600 mg of ibuprofen.
The other components are: corn starch, pregelatinized corn starch, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate in the tablet core; and polyethylene glycol 8000, cellulose derivative, polyoxyl 40 stearate, hypromellose, titanium dioxide and propylene glycol in the coating.

Appearance of the product and contents of the pack

Ibukern 600 mg are white, elongated, smooth tablets without score lines, marked "600" on one side. They are supplied in PVC/aluminum blisters, in packs of 40 tablets and in a hospital pack 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

Farmalider, S.A.

C/ Aragoneses, 2, Alcobendas

28108 Madrid

Spain

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2, Alcobendas

28108 Madrid

Spain

SAG MANUFACTURING, S.L.

Carretera Nacional I, Km 36

San Agustín de Guadalix 28750

Madrid, Spain

Date of the most recent revision of this leaflet: January 2024.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.