IBUPROFEN KERN PHARMA 600 mg EFFERVSCENT GRANULES

Introduction

Package Leaflet: Information for the User

Ibuprofeno Kern Pharma 600 mg Effervescent Granules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Ibuprofeno Kern Pharma and what is it used for.
2. What you need to know before you take Ibuprofeno Kern Pharma.
3. How to take Ibuprofeno Kern Pharma.
4. Possible side effects.
5. Storing Ibuprofeno Kern Pharma.
6. Contents of the pack and other information.

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

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 usually those of 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.
• Soft tissue injuries such as sprains and strains.
• Painful processes of mild or moderate intensity such as dental pain, post-operative pain, headache, and menstrual pain.
• Fever of various causes.

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

It is important to use the smallest dose that relieves/pain and you should not 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, to other non-steroidal anti-inflammatory drugs, or to any of the other ingredients of Ibuprofeno Kern Pharma.
• If you have had a stomach or duodenal bleeding or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• If you currently have or have had more than one occasion a stomach or duodenal ulcer or bleeding.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy (see section "Pregnancy and lactation").
• 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 (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood 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 lactation").

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 area (angioedema), and chest pain. Stop using Ibuprofeno Kern Pharma 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, bleeding, 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 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" 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 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 of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen-type medications can worsen these conditions.

Skin reactions

Be especially careful with Ibuprofeno Kern Pharma:

Severe skin reactions have been reported, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), 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

Anti-inflammatory/analgesic medications 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 Ibuprofeno Kern Pharma 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 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-type medications 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 ibuprofen is contraindicated.

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

Tell your doctor if you started treatment with ibuprofen before going to the consultation, as ibuprofen can mask the symptoms of a possible infection, making its diagnosis difficult.

Infections

Ibuprofen may hide the signs of an infection, such as fever and pain. Consequently, Ibuprofeno Kern Pharma 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.

Using 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 such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Lithium (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 such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics.
• Fluconazole.
• Pentoxifylline.
• Probenecid.
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone.
• Sulfonylureas such as 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 upset.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Ibuprofen should not be taken during pregnancy, especially during the third trimester. 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 possible time. From the 20th week of pregnancy, ibuprofen can 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 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 using machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or operate 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 162.5 mg (7 mmol) of sodium (main component of table/cooking salt) in each sachet. This is equivalent to 8.2% of the maximum daily recommended sodium intake for an adult.

Consult your doctor or pharmacist if you need to take 2 or more sachets per day for a prolonged period, especially if you have been recommended a low-sodium diet.

3. How to take Ibuprofeno Kern Pharma

Follow exactly the administration instructions of 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 obtained. Similarly, do not take ibuprofeno 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

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 sachets), divided into 2 doses.

In some processes, 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 sachets).

Pediatric population:

The use of this medication is not recommended in children under 14 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dosage in these children.

Elderly population:

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, the dose will only be increased once your doctor has checked 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 that your doctor has prescribed.

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, 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 bloody stools), indifference, sleepiness, headache, involuntary eye movements, ringing in the ears, confusion, and lack of muscle coordination. More severe symptoms can occur, such as gastrointestinal bleeding, 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 of 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 ibuprofeno are more common in people over 65 years of age.

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 ibuprofeno are gastrointestinal: peptic ulcers, gastrointestinal 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 patches, not elevated, in a target or circular shape 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].
• Widespread skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, 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, appearance of bruises.

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 ibuprofeno may be associated, in very rare cases, with very 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: Widespread, 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 paleness of the 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 serious allergic reaction called Kounis syndrome.

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

Edema (fluid retention), arterial hypertension, and heart failure have also been observed in association with treatments with medicines of the ibuprofeno type.

Renal and urinary disorders:

Kidney changes.

Hepatobiliary disorders:

Medicines like ibuprofeno 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 serious allergic reactions have been reported with ibuprofeno, 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 go immediately to your doctor:

• Allergic reactions such as skin rashes, swelling of the face, wheezing in the chest, or difficulty breathing.
• Vomiting blood or coffee grounds-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. Conservation 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 in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno Kern Pharma 600 mg effervescent granule EFG

• The active ingredient is ibuprofeno. Each sachet contains 600 mg of ibuprofeno.
• 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 package contents

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