IBUKERN 600 MG ORAL SUSPENSION

2. What you need to know before you take Ibukern

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

Do not take Ibukern if:

• You are allergic to ibuprofen or any of the other components of this medicine (listed in section 6).
• You have had a stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory medicine.
• You currently have or have had more than one occasion: a stomach or duodenal ulcer or hemorrhage.
• You have severe heart failure.
• You are in the third trimester of pregnancy.
• You have severe liver or kidney disease.
• You have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood).
• You have worsening ulcerative colitis or Crohn's disease.
• After taking acetylsalicylic acid or other NSAIDs, you have experienced skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.

Warnings and Precautions

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

Consult your doctor, pharmacist, or nurse before starting to take this medicine if:

• You have had or developed an ulcer, hemorrhage, 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 greater when high doses and prolonged treatments are used, 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-protecting medicine.
• If you take medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the acetylsalicylic acid type. You should also discuss the use of other medications that may increase the risk of such hemorrhages, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medications of this type can worsen these conditions.
• If you have had kidney or liver disease.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you have an infection; see the "Infections" heading later.
• If you have heart, kidney, or liver disease, are over 60 years old, or need to take the medicine 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.

Skin Reactions

Be especially 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 syndrome), 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 medicines like ibuprofen may be associated with a small increased risk of suffering a 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 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, have a family history of heart disease or stroke, or are a smoker.

Similarly, this type of medicine can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Consult your doctor or pharmacist before starting to take Ibukern.

Infections

Ibukern may hide the signs of an infection, such as fever and pain. Consequently, this medicine may delay the appropriate treatment of the infection, which can increase 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 the symptoms of the infection persist or worsen, consult a doctor without delay.

Children:

Do not administer to children under 12 years old without consulting a doctor.

Use of Ibukern with other medicines:

Tell your doctor that you are taking, have recently taken, or may need to take any other medicine.

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

• Other non-steroidal anti-inflammatory drugs (NSAIDs): as they may increase the risk of adverse effects.
• Anticoagulant medicines (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Lithium (medicine used to treat depression): as it may increase lithium levels in the blood and the risk of adverse effects. If you need to take lithium and ibuprofen, your doctor may need to adjust your lithium dose.
• Methotrexate: if you take methotrexate and ibuprofen at the same time (within a 24-hour interval), they may increase methotrexate levels in the blood and the risk of toxicity from this medicine. Your doctor may advise you not to take ibuprofen if you are receiving high-dose methotrexate treatment.
• Hydantoins such as phenytoin (for the treatment of epilepsy).
• Sulfonamides: as they may increase their toxic effects.

Other interactions that require caution:

• Corticosteroids such as cortisone and prednisolone, diuretics, fluconazole, pentoxifylline, probenecid, quinolones (such as norfloxacin), sulfinpyrazone, sulfonylureas (such as tolbutamide), tacrolimus, cyclosporine, zidovudine, as they may increase the risk of gastrointestinal ulcer or bleeding.
• Selective serotonin reuptake inhibitor antidepressants may also increase the risk of gastrointestinal bleeding.

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

Taking Ibukern with food and drinks:

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

Precautions during pregnancy and in women of childbearing age

Because the administration of medicines of this type has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it 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 this medicine is contraindicated.

It can cause kidney and heart problems in your fetus. It can affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is 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 in your fetus if taken for more than a few days, which can 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 more than a few days, your doctor may recommend additional checks.

For women of childbearing age, it should be taken into account that medicines of this type have been associated with a decrease in fertility.

Breastfeeding:

Although the levels of the medicine in breast milk are negligible, it is recommended to consult a doctor in cases of long-term treatment or high doses during breastfeeding.

Driving and using machines

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

Ibukern contains sodium, sodium benzoate (E-211), and liquid maltitol (E-965)

This medicine contains 87 mg of sodium (main component of table salt/cooking salt) per sachet. This is equivalent to 4.35% of the maximum recommended daily sodium intake for an adult.

This medicine contains 15 mg of sodium benzoate (E-211) per sachet.

This medicine contains liquid maltitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It can produce a mild laxative effect because it contains 7.5 g of liquid maltitol per sachet.

Caloric value: 2.3 kcal/g of maltitol/isomalt.

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3. How to take Ibukern

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The effective lowest dose should be used during the shortest time necessary to alleviate the symptoms. If you have an infection, consult a doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

Adults:

The recommended doses in adults and adolescents are one sachet (600 mg) every 6 to 8 hours, depending on the intensity of the condition and response to treatment. In adults, the maximum recommended daily dose is 2400 mg, while in adolescents it is 1600 mg.

Do not administer this medicine to children under 12 years old without consulting a doctor.

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

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 medicine well.

Always take the lowest effective dose. The treatment duration will be decided by your doctor and should not be stopped before.

This medicine is administered orally.

This product is a suspension. It should be homogenized before taking by pressing the top and bottom of the sachet with your fingers several times. It can be taken directly from the sachet or diluted in water.

In case of gastrointestinal upset, it is recommended to take the medicine with meals.

Remember to take your medicine, and if you think the action of this medicine is too strong or 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, 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 medicine and the amount ingested. It is recommended to take the package and the package leaflet of the medicine 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. 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 problems have been reported.

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

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Ibukern can cause adverse effects, although not all people suffer from them.

Frequencies have been defined as follows: very frequent (may affect more than 1 in 10 patients), frequent (may affect up to 1 in 10 patients), infrequent (may affect up to 1 in 100 patients), rare (may affect up to 1 in 1,000 patients), very rare (may affect up to 1 in 10,000 patients), and unknown frequency (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal:

The most frequent adverse effects that occur with medications containing this active ingredient are gastrointestinal: peptic ulcers, digestive hemorrhages, 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. Gastritis has been observed less frequently.

Frequent:nausea, vomiting, abdominal pain, heartburn, flatulence, and constipation.

Infrequent:hemorrhage, stomach or duodenal ulcers.

Rare:gastric or intestinal perforation, esophageal inflammation, and ulcers or inflammation of the intestine.

Cutaneous:

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

• Reddish, non-elevated, target-like or circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe cutaneous eruptions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread cutaneous eruption, elevated body temperature, and hypertrophic lymph nodes (DRESS syndrome).
• Widespread, red, scaly eruption, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Frequent:skin rash.

Infrequent:skin redness, itching or swelling of the skin, swelling of the lips, face, or tongue, increased nasal secretion, and difficulty breathing.

Rare:severe allergic reactions (anaphylactic shock).

Very rare:intense itching of the skin with sudden onset or blisters on the skin, joint pain, and fever (systemic lupus erythematosus), hair loss, skin reactions due to light influence. Medications containing this active ingredient may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and allergic vasculitis.

Aseptic meningitis (inflammation of the membranes covering the brain and spinal cord), in most cases in patients with some autoimmune disease such as systemic lupus erythematosus.

Severe allergic reaction that can manifest with nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension, or shock.

Drug reaction with eosinophilia and systemic symptoms: A severe cutaneous 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).

Unknown frequency: Widespread, red, scaly eruption, with bumps under the skin and blisters, mainly located in 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 immediate medical attention. See also section 2.

Central Nervous System:

Frequent:headache.

Infrequent:fatigue or drowsiness.

Very rare:aseptic meningitis.

Psychiatric:

Frequent:feeling of instability and nervousness.

Infrequent:anxiety.

Rare:disorientation or confusion, depression.

Auditory:

Infrequent:ringing or buzzing in the ears.

Rare:hearing difficulty.

Ocular

Infrequent:vision alteration.

Rare:abnormal or blurred vision.

Haematological:

Very rare:prolonged bleeding time, alterations in blood cells (the first symptoms may be: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nasal and skin bleeding).

Cardiovascular:

These medications may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

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

Renal:

Kidney disease.

Hepatic:

Rare:hepatitis (liver inflammation) and jaundice (yellowing of the skin). These medications may be associated, in rare cases, with liver damage.

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibukern

Keep this medication out of sight and reach of children.

Store in the original packaging.

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 thrown away through the sewers or in the trash. Deposit the packaging 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 packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibukern

• The active ingredient is ibuprofen. Each sachet contains 600 mg of ibuprofen.
• The other components (excipients) are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol, thaumatin (E-957), strawberry flavor, glycerol, and purified water.

Appearance of the Product and Package Contents

Ibukern 600 mg is presented in the form of an oral suspension. Heat-sealed sachets formed by an aluminum complex (polyester, aluminum, polyethylene, polyester, and polyethylene). Each package contains 20 or 40 sachets.

Marketing Authorization Holder and Manufacturer

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

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 Health Products (AEMPS) http://www.aemps.gob.es/