IBUPROFEN KERN PHARMA 20 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Ibuprofen Kern Pharma20 mg/mloral suspension EFG

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

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

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

This medicine is indicated for the treatment of fever and pain of mild to moderate intensity.

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

Do not take Ibuprofen Kern Pharma

• If you are allergic (hypersensitive) to ibuprofen, to other medicines of the NSAID group (e.g. acetylsalicylic acid, naproxen, etc.) or to any of the other ingredients of this medicine. Allergic reactions may be: skin rash with itching, swelling of the face, lips or tongue, nasal discharge, difficulty breathing or asthma.
• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or diarrhea with blood.
• If you have a severe liver or kidney disease.
• 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 severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medicine.

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 emergency medical services immediately if you notice any of these signs.

Tell your doctor:

• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by severe 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 edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you have or have had any heart disorder or have high blood pressure.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine 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.
• If you experience symptoms of dehydration, e.g. severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure as a consequence of dehydration.
• 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 inhibitors.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen-like medications can worsen these conditions.
• If you are being treated with diuretics (medicines to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it can cause aseptic meningitis.
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you have an infection; see the "Infections" section below.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• It is important to use the smallest dose that relieves-controls the pain and not to take this medication for longer than necessary to control your symptoms.

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), 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 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 heart attack or stroke, especially when used in high doses. Do not exceed the dose or duration of treatment.

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

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

Precautions during pregnancy and in women of childbearing age:

Ibuprofen should not be taken during the first and second trimester of pregnancy unless strictly necessary, as the administration of ibuprofen-like medications has been associated with an increased risk of congenital anomalies (birth defects) or miscarriages. If it is considered essential to use it, 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-like medications have been associated with a decrease in fertility.

Infections

Ibuprofen may hide the signs of an infection, such as fever and pain. Consequently, it is possible that Ibuprofen may delay the appropriate treatment of the infection, which may 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.

Interference with laboratory tests:

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase values.

Tell your doctor if you are going to have a clinical analysis and are taking or have recently taken ibuprofen.

Using Ibuprofeno Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

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

• Anticoagulant medications (e.g. to treat coagulation problems/prevent coagulation, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Antiplatelet agents (prevent the formation of blood clots in blood vessels) such as ticlopidine.
• Corticosteroids such as cortisone and prednisolone.
• Selective serotonin reuptake inhibitors (used in depression).
• Other NSAIDs such as aspirin.
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and other cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Diuretics (medicines used to increase urine production).
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Medications that lower high blood pressure (such as ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin-II receptor antagonists like losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Zidovudine (medication against the AIDS virus).
• Aminoglycoside antibiotics such as neomycin.
• Ginkgo biloba herb extracts.

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.

Using Ibuprofeno Kern Pharma with food and drinks

It is recommended to take Ibuprofeno Kern Pharma with food or immediately after eating, to reduce the possibility of stomach upset.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medication.

Ibuprofen should not be taken during pregnancy, especially during the third trimester, as it may be dangerous for the fetus (see section precautions during pregnancy and in women of childbearing age). It may cause kidney and heart problems for your fetus. It may affect your and your baby's ability to clot 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 time possible. From the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may 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 more 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. It is not necessary to interrupt breastfeeding during short-term treatment with the recommended dose for pain and fever.

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

Driving and using machines

If a single dose of ibuprofen is administered or during a short period, no special precautions are necessary.

In the case of prolonged treatment, caution is recommended due to the possibility of appearance of adverse effects related to the central nervous system, such as dizziness, vertigo, visual disturbances, or others. If you experience these symptoms, you should not drive or use machinery.

Important information about some of the ingredients of Ibuprofeno Kern Pharma

This medication may cause headache, stomach upset, and diarrhea because it contains glycerol.

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

Patients on low-sodium diets should note that this medication contains 1.84 mg (0.08 mmol) of sodium per ml of oral suspension.

3. How to take Ibuprofeno Kern Pharma

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

Remember to take your medication.

Your doctor will indicate the duration of treatment with Ibuprofeno Kern Pharma. Do not suspend treatment beforehand, as the expected results will not be obtained. Similarly, do not use Ibuprofeno for longer than indicated by your doctor.

The lowest effective dose should be used for the shortest necessary time to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

This medication is an oral suspension for administration.

For exact dosing, the packages contain a 5 ml oral syringe. The syringe should be cleaned and dried after each use.

Patients with stomach discomfort should take the medication during meals.

Children:

The dose of ibuprofen to be administered depends on the child's age and weight. As a general rule, the recommended daily dose is 20 to 30 mg per kg of weight, divided into three or four individual doses. It is recommended not to exceed the maximum daily dose of 40 mg per kg of weight of ibuprofeno.

The use of this medication is not recommended in children under 3 months.

The interval between doses will depend on the evolution of symptoms, but will never be less than 4 hours.

However, as a guideline, the following dosing schedule is recommended:

Adults and adolescents:

The recommended dose is 20 ml 3 to 4 times a day (equivalent to 1200-1600 mg of ibuprofen/day), while symptoms persist.

Due to the amount of ibuprofen contained in this medication, it is recommended to use other presentations more suitable for ibuprofen treatment in adults and adolescents (over 12 years).

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.

Elderly patients:

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, you can only increase the dose once your doctor has checked that you tolerate the medication well.

It is essential to use the smallest dose that relieves/controls pain and should not take this medication for longer than necessary to control symptoms.

Consult your doctor if symptoms persist or worsen during the treatment period.

If you think the action of this medication is too strong or weak, inform your doctor or pharmacist.

If you take more Ibuprofeno Kern Pharma than you should

If you have taken more medication 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 bring the package and the medication prospectus to the healthcare professional.

The symptoms of an overdose may include: stomach pain, nausea, vomiting (which may contain bloody sputum), indifference, sleepiness, headache, involuntary eye movements, ringing in the ears, confusion, and lack of muscle coordination. More severe symptoms such as intestinal bleeding, low blood pressure, low body temperature, metabolic acidosis, convulsions, altered kidney function, coma, adult respiratory distress, and transient respiratory arrest in children (after ingesting large amounts) may appear.

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

If a severe poisoning has occurred, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered. Stomach emptying will be considered if significant amounts have been ingested and within 60 minutes following ingestion.

If you forgot to take Ibuprofeno Kern Pharma

Do not take a double dose to make up for the forgotten dose.

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

4. Possible adverse effects

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

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

The adverse effects of medications 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.

Frequencies are established according to the following classification: very frequent (in more than 1 in 10 patients); frequent (between 1 and 10 in 100 patients); uncommon (between 1 and 10 in 1,000 patients); rare (between 1 and 10 in 10,000 patients); very rare (in less than 1 in 10,000 patients); frequency unknown (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal:

The most frequent adverse effects that occur with medications like Ibuprofeno 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 stools, vomiting blood, oral aphthae, worsening of ulcerative colitis, and Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces diarrhea with blood) have also been observed. Less frequently, gastritis has been observed.

Other adverse effects are: Uncommon: inflammation of the oral mucosa with ulcer formation. Rare: esophageal inflammation, esophageal stricture, exacerbation of diverticular disease, nonspecific hemorrhagic colitis. Very rare: pancreatitis.

Cardiovascular:

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

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

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

Skin:

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

• Reddish patches, not elevated, in the shape of a target or circular on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, polymorphic erythema, 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).

Medications like Ibuprofeno may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and detachment of the epidermis).

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).

Other adverse effects are: Frequent: skin rash. Uncommon: skin redness, itching or skin swelling, purpura (purple spots on the skin). Very rare: hair loss, polymorphic erythema (skin lesion), skin reactions due to light influence, inflammation of skin blood vessels. Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox.

Unknown frequency: Widespread, red, scaly rash, with bumps under the skin and blisters, mainly 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 present these symptoms and seek immediate medical attention. See also section 2.

Immune system:

Uncommon: transient edema in areas of the skin, mucous membranes, or sometimes in viscera (angioedema), nasal mucosa inflammation, bronchospasm (bronchial spasm that prevents air from passing to the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, facial swelling, tongue and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may appear. Very rare: joint pain and fever (lupus erythematosus).

Central nervous system:

Frequent: fatigue or drowsiness, headache, and dizziness or instability. Rare: paresthesia (sensation of numbness, tingling, prickling, etc., more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

Frequent: vertigo. Uncommon: ringing or buzzing in the ears. Rare: hearing difficulty.

Ocular:

Uncommon: vision changes. Rare: abnormal or blurred vision.

Blood:

Rare: decreased platelets, 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), decreased granulocytes (a type of white blood cell that can predispose to infections), pancytopenia (deficiency of red, white, and platelet blood cells), agranulocytosis (very significant decrease in granulocytes), aplastic anemia (bone marrow failure to produce different types of cells), or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding. Very rare: prolonged bleeding time.

Kidney:

Based on experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder) and nephrotic syndrome (disorder characterized by protein in the urine and body swelling) and kidney failure (sudden loss of kidney function) cannot be excluded.

Liver:

Medications like Ibuprofeno may be associated, in rare cases, with liver damage. Other rare adverse effects are: hepatitis (liver inflammation), liver function abnormalities, and jaundice (yellowing of the skin and eyes). Unknown frequency: liver failure (severe liver deterioration).

General:

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 reaction could be fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, facial swelling, tongue and throat swelling, difficulty breathing, asthma, palpitations, hypotension (lower than usual 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, facial swelling, wheezing in the chest, or difficulty breathing.
• Vomiting blood or coffee grounds-like vomit.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blistering or significant skin peeling.
• Severe 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 Medication Surveillance System for human use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofeno Kern Pharma

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the package after "CAD". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno Kern Pharma

• The active ingredient is ibuprofen. Each ml of oral suspension contains 20 mg of ibuprofen.
• The other components (excipients) are: glycerol (E-422), maltitol syrup (E-965), microcrystalline cellulose (E-460i), xanthan gum (E-415), anhydrous citric acid (E-330), sodium citrate (E-331), sodium benzoate (E-211), polysorbate 80 (E-433), sodium saccharin (E-954), orange essence, and purified water.

Appearance of Ibuprofeno Kern Pharma and package contents

White oral suspension with orange odor and flavor.

It is presented in a plastic bottle containing 200 ml of oral suspension. It includes a 5 ml graduated dosing syringe.

It is also available in 400 mg and 600 mg tablets and 200 mg and 600 mg effervescent granule 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:July 2024

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