Package Leaflet: Information for the user

Ibuprofen Kern Pharma 200 mg effervescent granules EFG

Read 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. Do not give it to others, even if they have the same symptoms, 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.

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:

• Juvenile rheumatoid arthritis (inflammation of the joints, including those of the hands and feet, resulting in swelling and pain that appears at early ages).
• Mild to moderate painful processes.
• Fever of various causes.

It is essential to use the smallest dose that relieves or controls 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 stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• If you currently have or have had more than one occasion of stomach or duodenal ulcer or hemorrhage.
• 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 vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or coagulation problems, 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 and neck 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, 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 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 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 heart, kidney, or liver disease, are over 60 years old, or need to take the medication for a prolonged 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, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.

Skin reactions

Be especially careful 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 syndrome), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue Ibuprofeno Kern Pharma 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

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 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 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-type medications 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 ibuprofen is contraindicated.

For women of childbearing age, it is essential to 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

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, 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.
• Methotrexate. Your doctor may adjust the dose of this medication.
• Mifepristone.
• Digoxin and cardiac glycosides (used to treat heart failure).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Diuretics.
• Fluconazole.
• Pentoxifylline.
• Probenecid.
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone.
• Sulfonylureas like tolbutamide.
• Tacrolimus.
• Zidovudine.

Other medications may also affect or be affected by Ibuprofeno Kern Pharma treatment. 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 during 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 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.

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 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 lactose intolerance, consult with them before taking this medication.

This medication contains saccharose. If your doctor has indicated that you have a saccharose intolerance, consult with them before taking this medication. It may cause tooth decay.

This medication contains 53.8 mg of sodium (main component of table salt/for cooking) in each packet. This is equivalent to 2.7% of the recommended daily maximum sodium intake for an adult.

Consult your doctor or pharmacist if you need to take this medication for a prolonged 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 necessary period 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

Pediatric population:

• Children and adolescents weighing 25 to 40 kg: The recommended daily dose is 600 mg – 800 mg of ibuprofen, divided into 3 or 4 doses (1 packet 3 or 4 times a day), with a maximum recommended daily dose of 800 mg.
• Children and adolescents weighing more than 40 kg: The recommended daily dose is 1,200 mg – 1,600 mg of ibuprofen per day, divided into 3 or 4 doses (2 packets 3 or 4 times a day), with a maximum recommended daily dose of 1,600 mg.

For the treatment of juvenile rheumatoid arthritis, higher doses may be necessary, although it is recommended not to exceed 40 mg/kg/day of ibuprofen.

The interval between doses will depend on the evolution of symptoms, but never less than 4 hours. It is not recommended to use this medication in children under six months.

Adults:

The recommended daily dose is 1,200 mg – 1,800 mg of ibuprofen per day, divided into 3 or 4 doses (2 or 3 packets 3 or 4 times a day), with a maximum recommended dose of 2,400 mg.

Geriatric population:

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.

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.

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, drowsiness, headache, involuntary eye movements, ringing in the ears, confusion, and muscle coordination problems.

More severe symptoms such as gastrointestinal bleeding, low blood pressure, seizures, and respiratory disturbances 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 forget 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 ibuprofeno are more common in people over 65 years old.

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

Side effects are classified by their 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 ibuprofeno are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach 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 can 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 appearance of blisters in the skin, joint pain, and fever (lupus erythematosus), hair loss, light-sensitive skin reactions.

Medicines like ibuprofeno can 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 can 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: numbness.

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: feeling like you're hitting or ringing in your ear.

Rare: ear disorders.

Eye disorders:

Uncommon: vision disturbances.

Rare: reversible decrease in visual acuity.

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 people with high blood pressure or kidney disorders). Heart failure (the heart pumps insufficient blood to meet the body's needs) or high blood pressure, especially in elderly patients.

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

Medicines like ibuprofeno can 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 ibuprofeno-like medicines.

Renal and urinary disorders:

Kidney disorders.

Hepatobiliary disorders:

Medicines like ibuprofeno can be associated, in rare cases, with liver damage.

Hepatitis (liver inflammation) and jaundice (yellowing of the skin).

General disorders:

Worsening of inflammation during infectious processes.

Until now, no severe allergic reactions have been reported with ibuprofeno, although they cannot be ruled out. Manifestations of this type of effect could be 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.
• Yellowing of the skin (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 Medicines 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 above25°C.

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 pointat 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 200 mg effervescent granule EFG

• The active ingredient is ibuprofen. Each sachet contains 200 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, orange flavor, and sucrose.

Appearance of the product and contents of the packaging

Ibuprofeno Kern Pharma 200 mg is presented in the form of an effervescent granule, white in color. Each package contains 20 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 on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .