IBUPROFEN KERN PHARMA 40 mg/ml ORAL SUSPENSION

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

Do not take IbuprofenKernPharma:

• If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If you have previously had a stomach or duodenal ulcer 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.
• If you have had allergic reactions of an asthmatic type, rhinitis or urticaria when taking aspirin or other non-steroidal anti-inflammatory drugs.
• If you have severe liver or kidney disease.
• If you have severe heart failure.
• If you have a worsening of ulcerative colitis or Crohn's disease.
• You are in the third trimester of pregnancy.

Warnings and precautions

Be careful with Ibuprofen Kern Pharma:

Allergic reactions to this medicine, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop using Ibuprofen 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 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.
• If this risk is higher 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 are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the aspirin type. 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 medications of the Ibuprofen Kern Pharma type may worsen these conditions.
• If you have systemic lupus erythematosus or mixed connective tissue disease.
• If you have high blood pressure or heart failure.
• If you have a kidney or liver function disorder.
• If you have asthma or an allergic disease.
• If you are an elderly patient, as the appearance of side effects may be more frequent.
• If you have an infection; see the "Infections" heading below.

It is important to use the smallest dose that relieves-controls the pain and do not take this medicine Ibuprofen Kern Pharma for longer than necessary to control your symptoms.

Skin Reactions

Be careful with Ibuprofen 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofen 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 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 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, 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).

Infections

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

Children

Ibuprofen Kern Pharma should not be administered to children under 3 months.

Use of IbuprofenKernPharmawith other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• Other non-steroidal anti-inflammatory drugs.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., aspirin, warfarin, ticlopidine).
• Medications that lower blood pressure (e.g., ACE inhibitors like captopril, beta-blockers like atenolol, 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 antimetabolite medication (slows down the growth of certain cells produced by the body).
• Mifepristone (an abortion inducer).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• 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 (medications used to increase urine elimination).
• Fluconazole (for the treatment of fungal infections).
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas like tolbutamide (for diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (a medication against the AIDS virus).
• Baclofen (an antispastic medication).
• Ion exchange resins (cholestyramine).

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

Taking IbuprofenKernPharmawith food, drinks, and alcohol

You can take it alone or with food. In general, it is recommended to take it before meals to reduce the possibility of stomach upset.

Consuming alcohol during treatment may increase the risk of adverse effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Because the administration of medications like Ibuprofen Kern Pharma 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 Kern Pharma is contraindicated.

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 more than a few days, your doctor may recommend additional checks.

Fertility

For patients of childbearing age, it should be noted that medications like Ibuprofen Kern Pharma have been associated with a decrease in fertility.

Breastfeeding

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 or pharmacist before taking any medication.

Driving and using machines

Although this effect is rare, this medicine should be used with caution in patients whose activity requires attention and who have observed symptoms of drowsiness, dizziness, or depression during treatment.

IbuprofenKernPharmacontains liquid maltitol and sodium

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

Patients on low-sodium diets should note that this medicine contains 5.79 mg (0.25 mmol) of sodium per milliliter.

3. How to take Ibuprofen Kern Pharma

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Ibuprofen Kern Pharma. Do not stop treatment before then, as the expected effects will not be achieved.

The effective lowest dose should be used during the shortest necessary time to alleviate the 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).

Ibuprofen Kern Pharma is an oral suspension for administration by mouth. It can be administered directly or diluted in water.

For exact dosing, the packages contain a 5 ml oral syringe. The syringe is inserted into the pierced cap, the bottle is inverted, the plunger is pulled until the liquid reaches the mark in ml, the bottle is returned to its initial position, and the syringe is removed.

The syringe must be removed from the bottle, disassembled, cleaned, and dried after each use.

If you have a sensitive stomach, take the medicine with meals.

Use in children

The administered dose of ibuprofen depends on the child's age and weight. For children from 3 months to 12 years, the recommended daily dose is 20 to 30 mg/kg of weight, divided into three or four doses (see the following table).

Adults

The recommended dose is 10 ml 3 times a day (equivalent to 1200 mg of ibuprofen) while symptoms persist.

Elderly patients

No special dose modifications are required.

If you think the effect of Ibuprofen Kern Pharma is too strong or too weak, tell your doctor or pharmacist.

If you take more IbuprofenKernPharmathan you should

If you have taken more Ibuprofen 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 leaflet of the medication to the healthcare professional.

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

More severe symptoms may appear, such as intestinal bleeding, low blood pressure, low body temperature, metabolic acidosis, convulsions, altered kidney function, coma, dyspnea/acute adult respiratory distress syndrome, and transient respiratory arrest in children (after ingesting large amounts).

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. Gastric lavage will be considered if large amounts have been ingested and within 60 minutes after ingestion.

If you forget to take IbuprofenKernPharma

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 very close, skip the forgotten dose and take the next dose at its usual time.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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 (may affect more than 1 in 10 people); frequent (may affect up to 1 in 10 people); infrequent (may affect up to 1 in 100 people); rare (may affect up to 1 in 1000 people); very rare (may affect up to 1 in 10,000 people); unknown frequency (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal

The most frequent adverse effects that occur with medicines like Ibuprofeno Kern Pharma 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.

Infrequent: gastrointestinal disorders, such as digestive alterations, abdominal pain, and nausea.

Rare: diarrhea, vomiting, flatulence, and constipation.

Very rare: gastrointestinal ulcers, sometimes with bleeding and perforation, pancreatitis. If you have severe pain in the upper abdomen, vomit blood, have blood in your stool, or dark-colored stool, you should stop taking Ibuprofeno Kern Pharma and inform your doctor immediately.

Skin and Allergic Reactions

Interrupt 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].
• 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.

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

Rare: severe allergic reactions (anaphylactic shock).

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

Medicines like Ibuprofeno Kern Pharma may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and allergic vasculitis.

Severe skin infections and complications during chickenpox may exceptionally appear.

Aseptic meningitis (inflammation of the membranes covering the brain and spinal cord), in most cases in patients with some autoimmune disease, such as systemic lupus erythematosus.

Severe allergic reaction that can manifest with nausea, vomiting, face, tongue, and throat swelling, difficulty breathing, asthma, palpitations, hypotension, or shock.

Unknown frequency: Widespread, red, scaly rash, with bumps under the skin and blisters, mainly on 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.

Drug reaction with eosinophilia and systemic symptoms: A severe skin reaction known as DRESS syndrome can occur. DRESS syndrome symptoms include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Central Nervous System

Frequent: headache, feeling of instability, and fatigue.

Very rare: aseptic meningitis (see skin and allergic reactions)

Psychiatric

Infrequent: insomnia, restlessness, and anxiety.

Rare: disorientation or confusion, depression, nervousness, and irritability.

Auditory

Frequent: vertigo.

Infrequent: ringing or buzzing in the ears.

Rare: hearing disorders.

Ocular

Infrequent: visual disturbances.

Rare: lazy eye.

Blood

Very rare: prolonged bleeding time, alterations in blood cells (the first symptoms may be: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nasal and skin bleeding)

Cardiovascular

Medicines like Ibuprofeno Kern Pharma 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 severe allergic reaction called Kounis syndrome.

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

Kidney

Ibuprofeno Kern Pharma should be used with caution in patients with kidney disease, especially if used in conjunction with diuretic medications. Fluid retention and renal function deterioration may occur. In these patients, the dose of ibuprofen should be as low as possible.

Caution should be exercised in not administering it to dehydrated individuals, as renal failure may develop.

Liver

Rare: hepatitis (liver inflammation) and jaundice (yellow skin discoloration) Medicines like Ibuprofeno Kern Pharma may be associated, in rare cases, with liver damage.

Unknown frequency: liver failure.

Musculoskeletal

Rare: neck stiffness.

Others

Frequent: fatigue.

It should be used with caution in asthmatic patients.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 this medicine out of sight and reach of children.

No special storage conditions are required.

Once the package is opened, store below 30°C for a maximum of 6 months.

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

Medicines should not be thrown away through the sewers or into the trash. Deposit the packages 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 packages 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

• The active ingredient is ibuprofen. Each ml of oral suspension contains 40 mg of ibuprofen.
• The other components are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol, glycerol (E-422), strawberry flavor, thaumatin, purified water, c.s.

Product Appearance and Package Contents

Ibuprofeno Kern Pharma is a viscous, white or almost white oral suspension with a strawberry odor.

It contains a 5 ml graduated syringe with a polypropylene cylinder and a polyethylene piston.

It is presented in packages of 100, 150, and 200 ml. Only some package sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

Edefarm, S.L.

Polígono Industrial Enchilagar del Rullo, 117

Villamarchante, Valencia, 46191,

Spain

or

Farmalider, S.A.

C/ Aragoneses 2,

28108 Alcobendas - Madrid

Spain

Date of the Last Revision of this Prospectus: October 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/