IBUPROFEN KERN PHARMA 200 mg EFFERVSCENT GRANULES

Introduction

Package Leaflet: Information for the User

Ibuprofeno Kern Pharma 200 mg Effervescent Granules

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

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

Contents of the Package Leaflet:

1. What is Ibuprofeno Kern Pharma and what is it used for
2. What you need to know before taking Ibuprofeno Kern Pharma
3. How to take Ibuprofeno Kern Pharma
4. Possible side effects
5. Storage of Ibuprofeno Kern Pharma
6. Package Contents and Additional Information

1. What is Ibuprofeno Kern Pharma and what is it used for

Ibuprofeno Kern Pharma belongs to a group of medications 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 hands and feet, leading to swelling and pain that appears at an early age).
• Mild or moderate painful processes.
• Fever of various causes.

2. What you need to know before taking Ibuprofeno Kern Pharma

It is essential to use the smallest dose that relieves-controls the 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 non-steroidal anti-inflammatory drugs, or any of the other components of Ibuprofeno Kern Pharma.
• If you have had a stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• If you currently have or have had an ulcer or stomach or duodenal hemorrhage on more than one occasion.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy (see section "Pregnancy and Breastfeeding").
• If you have severe liver or kidney disease.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform coagulation tests.
• If you have worsening ulcerative colitis or Crohn's disease.
• If you are allergic to acetylsalicylic acid or other NSAIDs. Such reactions could be: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you are pregnant (see section "Pregnancy and Breastfeeding").

Warnings and Precautions

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

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

• 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 higher when using high doses and prolonged treatments, 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 protective medication.
• If you have had 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" section below.
• 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 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.

Tell your Doctor

• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid. 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 like Ibuprofeno may worsen these conditions.

Skin Reactions

Be particularly 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Ibuprofeno Kern Pharma and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Cardiovascular Precautions

Anti-inflammatory/analgesic medications 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.

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, a family history of heart disease or stroke, or if you are a smoker.

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

Precautions during Pregnancy and in Women of Childbearing Age

Because the administration of ibuprofen has been associated with an increased risk of congenital anomalies/abortions, it is not recommended during the first and second trimester of pregnancy unless 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 should be noted that ibuprofen has been associated with a decrease in fertility.

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

Infections

Ibuprofen may hide the signs of an infection, such as fever and pain. Consequently, Ibuprofeno 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 medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Use of Ibuprofeno Kern Pharma with other Medications

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

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

• Other non-steroidal anti-inflammatory drugs (NSAIDs).
• Anticoagulant medications (e.g., to treat coagulation problems/prevent 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 in the treatment of heart failure).
• Hydantoins like phenytoin (used in the treatment of epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used in the treatment of 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 treatment with Ibuprofeno Kern Pharma. Therefore, you should always consult your doctor or pharmacist before using Ibuprofeno Kern Pharma with other medications.

Taking Ibuprofeno Kern Pharma with Food and Drinks

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.

Do not take ibuprofen during pregnancy, especially during the third trimester. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected. Do not take ibuprofen during the first six months of pregnancy unless 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 the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which can lead to 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 a longer period, your doctor may recommend additional checks.

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofeno for prolonged periods during breastfeeding.

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

Driving and Using Machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or use hazardous machinery.

If you only take one dose of ibuprofen or take it for a short period, you do not need to take special precautions.

Ibuprofeno Kern Pharma contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

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

Consult your doctor or pharmacist if you need to take this medication for an extended period, especially if you have been recommended a low-salt diet (sodium).

3. How to take Ibuprofeno Kern Pharma

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with ibuprofen. Do not stop treatment before, as the expected results will not be achieved. Similarly, do not take Ibuprofeno Kern Pharma for longer than indicated by your doctor.

The effective lowest dose should be used for the shortest necessary duration to relieve 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).

If you think the effect of ibuprofen is too strong or too weak, tell 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 sachet 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 1200 mg - 1600 mg of ibuprofen per day, divided into 3 or 4 doses (2 sachets 3 or 4 times a day), with a maximum recommended daily dose of 1600 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 1200 mg - 1800 mg of ibuprofen per day, divided into 3 or 4 doses (2 or 3 sachets 3 or 4 times a day), with a maximum recommended dose of 2400 mg.

Elderly 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 checked that you tolerate the medication well.

Patient 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.

Method of Administration

Ibuprofeno Kern Pharma is administered orally. Dissolve the contents of the sachet in approximately half a glass of water before ingestion.

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, or contact 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 medication and the amount ingested. It is recommended to take the package and the package leaflet of the medication to the healthcare professional.

Symptoms of overdose may include: stomach pain, nausea, vomiting (which may contain blood), indifference, drowsiness, headache, involuntary eye movements, ringing in the ears, confusion, and lack of muscle coordination.

More severe symptoms can occur, such as gastrointestinal hemorrhage, low blood pressure, seizures, and respiratory changes. At high doses, symptoms such as 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 make up for forgotten doses.

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

4. Possible Adverse Effects

Like all medicines, Ibuprofeno Kern Pharma can cause adverse effects, although not all people suffer from them.

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

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

Possible adverse effects are classified by frequency of occurrence:

Very Frequent(affect more than 1 in 10 patients)

Frequent(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 adverse effects have been observed:

Gastrointestinal Disorders:

The most frequent adverse 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, heartburn, abdominal pain, blood in stool, oral ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Disorders of the Skin and Subcutaneous Tissue:

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

• Reddish, non-elevated patches, target-like or circular on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and hypertrophied lymph nodes (DRESS syndrome).
• Generalized, red, and scaly rash, 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.

Uncommon: urticaria, itching, bruising.

Very Rare: intense itching of the skin with sudden onset or blisters on the skin, joint pain, and fever (lupus erythematosus), hair loss, skin reactions due to light influence.

Medicines like ibuprofen may be associated, in very rare cases, with 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. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Frequency not known: generalized red scaly rash, 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 Ibuprofeno Kern Pharma if you experience these symptoms and seek immediate medical attention. See also section 2.

Disorders of the Immune System:

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

Disorders of the Central Nervous System:

Frequent: fatigue or drowsiness, headache, and dizziness or feeling of instability.

Rare: tingling sensation.

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

Psychiatric Disorders:

Uncommon: difficulty sleeping, anxiety.

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

Disorders of the Ear and Labyrinth:

Frequent: vertigo.

Uncommon: noticing beats or ringing in the ear.

Rare: ear disorders.

Eye Disorders:

Uncommon: vision changes.

Rare: reversible decrease in visual acuity.

Disorders of the Blood and Lymphatic System:

Very Rare: prolonged bleeding time, decrease in white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decrease in red blood cells (may manifest as difficulty breathing and pale skin).

Cardiac and Vascular Disorders:

Swelling of the limbs or fluid accumulation in the arms or legs (more likely in subjects with high blood pressure or kidney disorders). Heart failure (the amount of blood pumped by the heart is insufficient to meet the body's needs) or high blood pressure (hypertension), especially in elderly patients.

Chest pain, which can 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), hypertension, and heart failure have also been observed in association with treatments with ibuprofen-like medicines.

Renal and Urinary Disorders:

Kidney changes.

Hepatobiliary Disorders:

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

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

General Disorders:

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. The manifestations of this type of effect could be fever, skin rash, abdominal pain, intense and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension (decrease in blood pressure), or shock.

If any of the following adverse effects appear, stop treatment and consult your doctor immediately:

• Allergic reactions such as skin rashes, swelling of the face, wheezing, or difficulty breathing.
• Vomiting blood or coffee-ground-like vomit.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Blisters or significant skin peeling.
• Intense or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (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 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 medicine.

5. Storage of Ibuprofeno Kern Pharma

Keep out of sight and reach of children.

Do not store at a temperature above 25°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 thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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 Package Contents

Ibuprofeno Kern Pharma 200 mg is presented in the form of a white effervescent granule. Each package contains 20 sachets.

Marketing Authorization Holder and 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.