Leaflet: information for the user

Ibukern 600 mg oral suspension

Ibuprofen

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Ibukern and what it is used for

2. What you need to know before starting to take Ibukern

3. How to take Ibukern

4. Possible side effects

5. Storage of Ibukern

6. Contents of the pack and additional information

Ibuprofen belongs 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 in processes such as dental pain, postoperative pain, headache including migraine, symptomatic relief of pain, fever, and inflammation that accompanies processes such as pharyngitis (inflammation of the upper region of the throat), tonsillitis (inflammation of the tonsils), and otitis (inflammation of certain structures of the middle ear), among others, the treatment of arthritis or joint inflammation (rheumatoid, psoriatic, gouty, etc.), osteoarthritis (inflammation of the cartilage of the joints), ankylosing spondylitis (inflammation that affects the joints of the spine), non-rheumatic inflammation (bursitis, synovitis, capsulitis, or other types of traumatic or sports-related inflammatory injuries), and primary dysmenorrhea (painful menstruation).

It is essential to use the smallest effective dose to alleviate or control pain and not to take this medication 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 medication (listed in section 6).

-You have had a previous stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.

-You currently have or have had more than one occasion: stomach or duodenal ulcer or hemorrhage.

-You have severe heart failure.

-You are in the third trimester of pregnancy.

-You have a severe liver or kidney disease.

-You have bleeding or coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood).

-You have a worsening of ulcerative colitis or Crohn's disease.

-After taking aspirin or other NSAIDs, you have experienced skin rash with itching, facial swelling, lip or tongue swelling, nasal secretion, difficulty breathing, or asthma.

Warnings and precautions

Signs of an allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibukern immediately and contact your doctor or emergency medical services if you observe any of these signs.

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

• You have had or are developing a stomach or duodenal ulcer, hemorrhage, or perforation, which may manifest as 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, especially in patients with a history of peptic ulcer and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector medication.
• If you are taking medications that alter blood coagulation, 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).
• If you have Crohn's disease or ulcerative colitis, as these medications may worsen these conditions.
• If you have 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 below.
• If you have a heart, kidney, or liver disease, are over 60 years old, or need to take the medication for an extended period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.

Severe skin reactions

Be especially cautious 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), generalized acute pustular exanthema (PEGA), 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

NSAIDs like ibuprofen 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.

Consult your doctor or pharmacist before taking ibuprofen if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (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 are a smoker.

These medications may also cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Consult your doctor or pharmacist before starting to take Ibukern.

Infections

Ibukern may mask the signs of an infection, such as fever and pain. Therefore, it is possible that this medication 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.

Children:

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

Use of Ibukern with other medications:

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

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

-Other nonsteroidal anti-inflammatory drugs (NSAIDs): as it may increase the risk of adverse effects.

-Anticoagulant medications (e.g., for treating coagulation problems/preventing coagulation, e.g., aspirin, warfarin, ticlopidine).

-Blood pressure-lowering medications (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).

-Lithium (medication used to treat depression): as it may increase lithium blood levels and the risk of adverse effects. If you need to take lithium and ibuprofen, your doctor may need to adjust your lithium dose.

-Metotrexate: if you take metotrexate and ibuprofen at the same time (within a 24-hour interval), they may increase metotrexate blood levels and the risk of toxicity. Your doctor may advise you not to take ibuprofen if you receive high-dose metotrexate treatment.

-Hidantoínas like phenytoin (for epilepsy treatment).

-Sulfamidas: as they may increase their toxic effects.

Other interactions that require caution:

-Corticosteroids like cortisone and prednisolone, diuretics, fluconazole, pentoxifylline, probenecid, quinolones (like norfloxacin), sulfinpyrazone, sulfonylureas (like tolbutamide), tacrolimus, ciclosporina, zidovudine, as they may increase the risk of gastrointestinal ulcers or bleeding.

-SSRIs may also increase the risk of gastrointestinal bleeding.

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

Taking Ibukern with food and drinks:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

Precautions during pregnancy and in fertile women

Due to the association of administering medications of this type 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 in cases where 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 medication is contraindicated.

It may cause renal and cardiac problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong labor more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as 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 week 20 of pregnancy, ibuprofen may cause renal problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

For fertile women, it is essential to consider that medications of this type have been associated with a decrease in the ability to conceive.

Breastfeeding:

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

Driving and operating machinery

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

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

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

This medication contains 15 mg of sodium benzoate (E-211) in each sachet.

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

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

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

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

Adults:

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

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

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.

Older 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 confirmed that you tolerate the medication well.

Always take the lowest effective dose. The duration of treatment will be decided by your doctor and should not be discontinued prematurely.

This medication is administered orally.

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

For gastrointestinal discomfort, it is recommended to take the medication with meals.

Remember to take your medication and inform your doctor or pharmacist if you estimate that the effect of this medication is too strong or too weak.

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 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.At high doses, symptoms of somnolence, 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 difficulties have been reported.

If you forget to take Ibukern

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 its usual time.

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

Like all medicines, Ibukern may cause side effects, although not everyone will experience them.

The frequencies have been defined as follows: very common (may affect more than 1 in 10 patients), common (may affect up to 1 in 10 patients), uncommon (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 side effects have been observed:

Gastrointestinal:

The most common side effects that occur with medications containing this active ingredient are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach pain, bloody stools, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, the appearance of gastritis has been observed.

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

Uncommon:bleeding, stomach or duodenal ulcers.

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

Dermatological:

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

• Flat, red spots, often with blisters in the center, on the trunk, often with peeling of the skin, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and similar symptoms to the flu [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly eruption, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Common:skin eruption.

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

Rare:severe allergic reactions (anaphylactic shock).

Very rare:intense itching on the skin, sudden appearance of blisters on the skin, joint pain, and fever (systemic lupus erythematosus), hair loss, skin reactions caused by light exposure. 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.

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

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

Drug reaction with eosinophilia and systemic symptoms: A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin eruption, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Unknown frequency: Generalized, red, scaly eruption, with bumps under the skin and blisters, located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis).Stop taking Ibukern if you experience these symptoms and seek immediate medical attention. See section 2.

Central nervous system:

Common:headache.

Uncommon:fatigue or drowsiness.

Very rare:asymptomatic meningitis.

Psychiatric:

Common:feeling of instability and nervousness.

Uncommon:anxiety.

Rare:disorientation or confusion, depression.

Auditory:

Uncommon:tinnitus or buzzing in the ears.

Rare:hearing difficulty.

Ocular:

Uncommon:vision alteration.

Rare:abnormal or blurred vision.

Hematologic:

Very rare:prolonged bleeding time, alterations in blood cells (initial 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 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 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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the 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 disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

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, taumatine (E-957), strawberry flavor, glycerol, and purified water.

Appearance of the product and contents of the packaging

Ibukern 600 mg is presented in the form of an oral suspension. Thermosealed sachets made of a complex of aluminum (polyester, aluminum, polyethylene, polyester, and polyethylene). Each package contains 20 or 40 sachets.

Holder of the marketing authorization and responsible for manufacturing

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

Last review date of this leaflet: November 2024

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