Package Leaflet: Information for the User

IbuprofenKernPharma40 mg/ml Oral Suspension EFG

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

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

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

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

3. How to take Ibuprofen Kern Pharma

4. Possible side effects

5. Storage of Ibuprofen Kern Pharma

6. Contents of the pack and additional information

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

This medicine is indicated for the symptomatic treatment of fever and mild to moderate pain in adults and children from 3 months of age.

Do not take IbuprofenoKernPharma:

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you have had a stomach or duodenal ulcer or bleeding in the past, or if you have had a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• If you currently have or have had more than one stomach or duodenal ulcer or bleeding.
• If you have had allergic reactions such as asthma, rhinitis, or urticaria when taking aspirin or other nonsteroidal 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.
• If you are in the third trimester of pregnancy.

Warnings and precautions

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

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

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• If this risk is greater when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector medication.
• If you are taking medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of these bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as Ibuprofeno Kern Pharma 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 impaired renal or hepatic function.
• If you have asthma or allergic disease.
• If you are an elderly patient, as it may be more frequent for adverse effects to occur.
• If you have an infection; see the "Infections" heading later.

It is essential to use the smallest dose that relieves or controls pain and not to take this medication Ibuprofeno Kern Pharma 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 syndrome), generalized acute pustular exanthema (PEGA), have been reported in association with ibuprofen treatment. Discontinue treatment with 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

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform 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, coronary artery bypass surgery, peripheral artery disease (problems with circulation 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.

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

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibuprofeno may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Children

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

Use of Ibuprofeno Kern Pharma with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• Other nonsteroidal anti-inflammatory drugs.
• Anticoagulant medications (e.g., for treating coagulation problems/preventing coagulation, such as acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Metotrexate. Your doctor may adjust the dose of this antimetabolite (slows down the growth of certain cells produced by the body).
• Mifepristone (inducer of abortion).
• Digoxin and 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).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medications used to increase urine elimination).
• Fluconazole (used in the treatment of fungal infections).
• Pentoxifylline (used in the treatment of intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used in gout).
• Sulfonylureas such as tolbutamide (used in diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (medication against HIV).
• Baclofen (antispasmodic medication).
• Ion exchange resins (colestiramine).

Other medications may also affect or be affected by the 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, 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 discomfort.

The consumption of alcohol during treatment may increase the risk of adverse effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Due to the association of ibuprofen medication with an increased risk of congenital anomalies/abortions, the administration of Ibuprofeno Kern Pharma is not recommended during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of Ibuprofeno Kern Pharma is contraindicated.

It may cause renal and cardiac problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong labor more than expected. Do not take ibuprofen during the first 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 week 20 of pregnancy, ibuprofen may cause renal problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Fertility

For fertile women, it should be noted that ibuprofen medications have been associated with a decrease in the ability to conceive.

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 using any medication.

Driving and operating machinery

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

Ibuprofeno Kern Pharma contains maltitol liquid and sodium

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

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

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Ibuprofeno Kern Pharma. Do not discontinue treatment beforehand, as this will not yield the expected effects.

The most effective dose should be used for the shortest duration necessary to alleviate symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Ibuprofeno Kern Pharma is an oral suspension. It can be administered directly or diluted in water.

For an exact dosage, the containers contain an oral syringe graduated to 5 ml. The syringe is inserted into the perforated cap, the bottle is inverted, the plunger is pulled until the liquid reaches the ml mark, 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 medication with meals.

Use in children

The dose of ibuprofen administered 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 body 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.

Geriatric patients

No special dose adjustments are required.

If you estimate that the action of Ibuprofeno Kern Pharma is too strong or too weak, inform your doctor or pharmacist.

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 container, consult your doctor or pharmacist immediately, the Toxicological Information Service, phone: 91 562 04 20, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken, indicating the medication and the amount ingested. It is recommended to bring the container and the medication package to the healthcare professional.

The symptoms of overdose may include: stomach pain, nausea, vomiting (which may contain blood-stained mucus), indifference, sleepiness, headache, involuntary eye movements, buzzing in the ears, confusion, and muscle coordination problems.

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

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

If a severe intoxication 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 significant amounts have been ingested and within 60 minutes of ingestion.

If you forgot to take Ibuprofeno Kern Pharma

Do not take a double dose to compensate for the missed doses.If you forget to take your scheduled dose, take it as soon as you remember. However, if the time for the next dose is near, skip the missed dose and take the next dose at its usual time.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Frequencies are established according to the following classification: very common (can affect more than 1 in 10 people); common (can affect up to 1 in 10 people); uncommon (can affect up to 1 in 100 people); rare (can affect up to 1 in 1000 people); very rare (can affect up to 1 in 10,000 people); unknown frequency (cannot be estimated from available data).

The following side effects have been observed:

Gastrointestinal

The most common side effects that occur with Ibuprofeno Kern Pharma medicines are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, bloody stools, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Uncommon: 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 upper stomach pain, vomit blood, have bloody stools, or dark stools, stop taking Ibuprofeno Kern Pharma and immediately inform your doctor.

Skin and allergic reactions

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

• Flat, red, circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions can be preceded by fever and flu-like symptoms [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly eruption with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Common: skin eruption.

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

Rare: severe allergic reactions (anaphylactic shock).

Very rare: intense itching on the skin, sudden appearance of blisters on the skin, joint pain, and fever (systemic lupus erythematosus), intense itching on the skin, sudden appearance of blisters on the skin, joint pain, and fever (systemic lupus erythematosus), hair loss, skin reactions caused by light exposure.

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

Exceptionally, severe skin infections and complications may occur during chickenpox.

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

Severe allergic reaction that can manifest with nausea, vomiting, facial swelling, tongue swelling, respiratory difficulty, asthma, palpitations, hypotension, or shock.

Unknown frequency: generalized, red, scaly eruption with bumps under the skin and blisters, located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking Ibuprofeno Kern Pharma if you experience these symptoms and seek immediate medical attention. See section 2.

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

Central nervous system

Common: headache, dizziness, and fatigue.

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

Psychiatric

Uncommon: insomnia, restlessness, and anxiety.

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

Auditory

Common: vertigo.

Uncommon: ringing or buzzing in the ears.

Rare: auditory disorders.

Ocular

Uncommon: visual disturbances.

Rare: nystagmus.

Blood

Very rare: prolonged bleeding time, blood cell alterations (initial 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), hypertension, and heart failure have also been observed in association with treatments with Ibuprofeno Kern Pharma medicines.

Renal

Ibuprofeno Kern Pharma should be used with caution in patients with kidney disease, especially when used with diuretics. It may cause fluid retention and renal function deterioration. In these patients, the lowest possible dose of ibuprofen should be used.

Caution should be exercised not to administer it to dehydrated individuals, as it may develop renal insufficiency.

Liver

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

Unknown frequency: liver insufficiency.

Musculoskeletal

Rare: neck stiffness.

Others

Common: fatigue.

Use with caution in patients with asthma.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of IbuprofenKernPharma

• 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, taumatine, purified water, c.s.

Appearance of the product and contents of the packaging

IbuprofenKernPharmais an oral, viscous suspension, white or almost white in color, and with a strawberry odor.

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

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

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible for Manufacturing

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

Last review date of this leaflet: October 2024

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