Package Insert: Information for the User

Ibuprofen Kern Pharma 600 mg Effervescent Granules

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Ibuprofeno Kern Pharma is indicated for the treatment of symptoms of:

• Rheumatoid arthritis (inflammation of the joints, including those in the hands and feet, leading to swelling and pain) and juvenile rheumatoid arthritis, ankylosing spondylitis (inflammation affecting the joints of the spine), osteoarthritis and other acute or chronic rheumatic processes.
• Muscle and soft tissue injuries such as sprains and strains.
• Mild to moderate pain processes such as dental pain, postoperative pain, headache and menstrual pain.
• Fever of various causes.

It is essential to use the smallest effective dose to alleviate or control pain and not to take Ibuprofeno Kern Pharma for longer than necessary to control your symptoms.

Do not take Ibuprofeno Kern Pharma

• If you are allergic (hypersensitive) to ibuprofen, other nonsteroidal anti-inflammatory drugs, or any of the other components of Ibuprofeno Kern Pharma.
• If you have had a previous gastrointestinal bleeding or perforation while taking a nonsteroidal anti-inflammatory drug.
• If you currently have or have had more than one episode of stomach or duodenal ulcer or bleeding.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy (see the section "Pregnancy and breastfeeding").
• If you have a severe liver or kidney disease.
• If you are vomiting blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding or coagulation disorders, or are taking anticoagulants (blood thinners). If necessary, your doctor will perform coagulation tests.
• If you have a worsening of ulcerative colitis or Crohn's disease.
• If you are allergic to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs. These reactions may include skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you are pregnant (see the section "Pregnancy and breastfeeding").

Warnings and precautions

Signs of an allergic reaction to this medication, such as respiratory problems, facial swelling, and neck region swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibuprofeno Kern Pharma 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 develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms.
• This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector medication.
• If you have kidney or liver disease.
• If you have edema (fluid retention).
• If you have heart disease or hypertension.
• 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 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.

Inform your doctor

• If you are taking anticoagulant medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid, or corticosteroids and selective serotonin reuptake inhibitors (SSRIs) antidepressants, which may increase the risk of bleeding.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.

Skin reactions

Be especially cautious with Ibuprofeno Kern Pharma:

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno Kern Pharma and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

Nonsteroidal anti-inflammatory drugs 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.

Inform your doctor or pharmacist before taking Ibuprofeno Kern Pharma if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowed or blocked 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.

This type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Pregnancy and breastfeeding precautions

Due to the association of ibuprofen administration with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except when strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, ibuprofen administration is contraindicated.

For women of childbearing age, consider that ibuprofen-type medications have been associated with a decreased ability to conceive.

Inform your doctor if you have started treatment with ibuprofen before attending the consultation, as ibuprofen may mask the symptoms of a possible infection, making its diagnosis more difficult.

Infections

Ibuprofeno may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibuprofeno may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to varicella. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Use of Ibuprofeno Kern Pharma with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one or more of them.

Ibuprofeno Kern Pharma may affect or be affected by other medications. For example:

• Other nonsteroidal anti-inflammatory drugs (NSAIDs).
• Anticoagulant medications (e.g., for treating coagulation problems/preventing coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Metotrexato. Your doctor may adjust the dose of this medication.
• Mifepristona.
• Digoxin and cardiac glycosides (used to treat heart failure).
• Hidantoínas like phenytoin (used to treat epilepsy).
• Sulfamidas like sulfamethoxazole and cotrimoxazol (used to treat certain bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Diuréticos.
• Fluconazol.
• Pentoxifilina.
• Probenecid.
• Antibiotics of the quinolone group like norfloxacin.
• Sulfinpirazona.
• Sulfonilureas like tolbutamide.
• Tacrolimus.
• Zidovudina.

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

Taking Ibuprofeno Kern Pharma with food and beverages

It is recommended to take ibuprofen with meals or immediately after eating to reduce the possibility of stomach discomfort.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Ibuprofen should not be taken during pregnancy, especially during the third trimester. It may cause kidney and heart 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 six 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 possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for a period longer 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 extended periods during breastfeeding.

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

Driving and operating machinery

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

Ibuprofeno Kern Pharma contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains 162.5 mg (7 mmol) of sodium (main component of table salt/for cooking) in each packet.This is equivalent to 8.2% of the recommended daily maximum sodium intake for an adult.

Consult your doctor or pharmacist if you need 2 or more packets per day for an extended period, especially if you have been recommended a low-sodium diet.

Follow exactly the administration instructions for Ibuprofeno Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with ibuprofen. Do not discontinue treatment beforehand, as this will not yield the expected results. Similarly, do not take ibuprofen for a longer period than indicated by your doctor.

The effective dose should be used for the shortest time 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).

If you estimate that the action of ibuprofen is too strong or too weak, inform your doctor or pharmacist.

Dosage

Adults:

The dosage should be adjusted according to the severity of the disorder and the patient's discomfort.

Generally, the recommended daily dose is 1,200 mg of ibuprofen (2 packets), taken in 2 doses.

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg of ibuprofen (4 packets).

Pediatric population:

This medication is not recommended for children under 14 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in these children.

Geriatric population:

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If this is the case, the dose can only be increased once your doctor has confirmed that you tolerate the medication well.

Patients with kidney and/or liver disease:

If you have kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If this is the case, take the exact dose prescribed by your doctor.

Administration form

Ibuprofeno Kern Pharma is administered orally. Swallow after dissolving the contents of the packet in approximately half a glass of water.

If you take more Ibuprofeno Kern Pharma than you should

If you have taken more Ibuprofeno Kern Pharma 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, sleepiness, headache, involuntary eye movements, buzzing in the ears, confusion, and muscle coordination problems. More severe symptoms such as gastrointestinal bleeding, low blood pressure, seizures, and respiratory problems may occur.

At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported.

If you forgot to take Ibuprofeno Kern Pharma

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, Ibuprofeno Kern Pharma can cause side effects, although not everyone will experience them.

Side effects of medicines like ibuprofen are more common in people over 65 years old.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

Side effects are classified by frequency of occurrence:

Very common(affect more than 1 in 10 patients)

Common(affect between 1 and 10 in 100 patients)

Uncommon(affect between 1 and 10 in 1,000 patients)

Rare(affect between 1 and 10 in 10,000 patients)

Very rare(affect less than 1 in 10,000 patients)

The following side effects have been observed:

Gastrointestinal disorders:

The most common side effects that occur with medicines like ibuprofen are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Skin and subcutaneous tissue disorders:

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

• Flat, red, non-elevated spots, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and 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 skin protuberances and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Common: skin eruption.

Uncommon: urticaria, itching, bruising.

Very rare: intense itching in the skin, sudden blisters in the skin, joint pain, and fever (lupus erythematosus), hair loss, light-sensitive skin reactions.

Medicines like ibuprofen may be associated with very rare, severe blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Drug reaction with eosinophilia and systemic symptoms: A severe skin reaction known as DRESS syndrome may occur. 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 skin protuberances 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 Ibuprofeno Kern Pharma if you experience these symptoms and seek immediate medical attention. See section 2.

Immune system disorders:

Uncommon: skin redness, itching, or swelling, lip, face, or tongue swelling, increased nasal secretion, and difficulty breathing.

Rare: severe allergic reactions (anaphylactic shock).

Very rare: joint pain and fever (lupus erythematosus), aseptic meningitis (inflammation of the membranes covering the brain and spinal cord caused by certain viruses, more common in patients with autoimmune diseases).

Central nervous system disorders:

Common: fatigue or drowsiness, headache, dizziness, or feeling unsteady.

Rare: tingling sensation.

Very rare: aseptic meningitis (inflammation of the membranes covering the brain and spinal cord caused by certain viruses, see immune system disorders).

Psychiatric disorders:

Uncommon: difficulty sleeping, anxiety.

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

Vestibular disorders:

Common: vertigo.

Uncommon: hearing or ringing in the ears.

Rare: ear disorders.

Eye disorders:

Uncommon: vision disturbances.

Rare: reversible visual acuity decrease.

Blood and lymphatic system disorders:

Very rare: prolonged bleeding time, 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).

Cardiovascular and vascular disorders:

Swelling of the extremities or accumulation of fluid in the arms or legs (more likely in individuals with high blood pressure or kidney disorders). Heart failure (the heart pumps insufficient blood to meet the body's needs) or high blood pressure (hypertension), especially in elderly patients.

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

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

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatments with ibuprofen-like medications.

Renal and urinary disorders:

Kidney disorders.

Hepatobiliary disorders:

Medicines like ibuprofen may be associated, in rare cases, with liver damage.

Hepatitis (liver inflammation) and jaundice (yellow skin discoloration).

General disorders:

Worsening of inflammation during infectious processes.

Until now, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. Manifestations of this type of effect may include fever, skin eruption, severe abdominal pain, intense headache, persistent nausea, vomiting, facial swelling, tongue, and throat swelling, difficulty breathing, asthma, palpitations, hypotension (low blood pressure), or shock.

If any of the following side effects appear, stop taking the medication and seek immediate medical attention:

• Allergic reactions such as skin eruptions, facial swelling, chest tightness, or difficulty breathing.
• Vomiting blood or coffee-ground-like material.
• Blood in stool or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or skin peeling.
• Intense headache or persistent headache.
• Yellow skin discoloration (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the extremities or fluid accumulation in the arms or legs.

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 prospectus. 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 out of sight and reach of children.

Do not store at a temperature above25ºC.

Do not use Ibuprofeno Kern Pharma after the expiration date indicated on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ibuprofeno Kern Pharma 600 mg effervescent granule EFG

• The active ingredient is ibuprofen. Each sachet contains 600 mg of ibuprofen.
• The other components (excipients) are: anhydrous citric acid, sodium lauryl sulfate, povidone, sodium saccharin, anhydrous sodium carbonate, sodium hydrogen carbonate, anhydrous colloidal silica, anhydrous lactose, and orange flavor.

Appearance of the product and content of the packaging

Ibuprofeno Kern Pharma 600 mg is presented in the form of an effervescent granule of white color. Each package contains 20 or 40 sachets.

Holder of the marketing authorization and 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

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.