Ibuprofen Kern Pharma 40 mg/ml oral suspension EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofen KernPharma 40 mg/ml oral suspension EFG

Read all of 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Ibuprofen 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.

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

Do not take Ibuprofen Kern Pharma:

• If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract while taking a non-steroidal anti-inflammatory drug (NSAID).
• If you currently have or have had more than one episode of stomach or duodenal ulcer or bleeding.
• If you have previously experienced allergic reactions such as asthma, rhinitis, or urticaria when taking aspirin or other drugs in the NSAID group.
• 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

Allergic reactions to ibuprofen have been reported, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibuprofen Kern Pharma immediately and contact your doctor or emergency medical services right away if you experience any of these signs.

Consult your doctor, pharmacist, or nurse before starting this medicine:

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, even without prior warning symptoms.
• If your risk is higher when using high doses or prolonged treatment, especially in patients with a history of peptic ulcer or in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medication.
• If you are taking medications that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about using other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medicines like Ibuprofen Kern Pharma may worsen these conditions.
• If you have systemic lupus erythematosus or mixed connective tissue disease.
• If you have hypertension 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 adverse effects may be more common.
• If you have an infection; see the "Infections" section below.

It is important to use the lowest effective dose that relieves/controls your pain and not to take Ibuprofen Kern Pharma for longer than necessary to control your symptoms.

Skin reactions

Take special care with Ibuprofen Kern Pharma:

Severe skin reactions have been reported with ibuprofen, including 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). Discontinue treatment with Ibuprofen Kern Pharma and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Cardiovascular precautions

Non-steroidal anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

• You have heart problems, including heart failure, angina (chest pain), a previous heart attack, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked 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.

In addition, these medicines may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Infections

Ibuprofen may mask signs of infection, such as fever and pain. Therefore, Ibuprofen may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

Children

Ibuprofen Kern Pharma must not be given to children under 3 months of age.

Using Ibuprofen Kern Pharmawith other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

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

• Other non-steroidal anti-inflammatory drugs (NSAIDs).
• Anticoagulant medicines (e.g., to treat or prevent clotting, such as acetylsalicylic acid, warfarin, ticlopidine).
• Medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).
• Lithium (used to treat depression). Your doctor may adjust your dose.
• Methotrexate. Your doctor may adjust the dose of this antimetabolite (which slows the growth of certain body cells).
• Mifepristone (used to induce abortion).
• Digoxin and cardiac glycosides (used to treat heart disorders).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine output).
• Fluconazole (used to treat fungal infections).
• Pentoxifylline (used for intermittent claudication).
• Probenecid (used in gout patients or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (an anti-HIV medicine).
• Baclofen (an antispasmodic medicine).
• Ion-exchange resins (cholestyramine).

Other medicines may also interact with or be affected by Ibuprofen Kern Pharma. Therefore, always consult your doctor or pharmacist before using Ibuprofen Kern Pharma with other medicines.

Taking Ibuprofen Kern Pharmawith food, drinks, and alcohol

You may take it with or without food. It is generally recommended to take it before meals to reduce the possibility of stomach discomfort.

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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Because administration of medicines like Ibuprofen Kern Pharma has been associated with an increased risk of congenital abnormalities or miscarriage, it is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of Ibuprofen Kern Pharma is contraindicated during the third trimester.

It may cause kidney and heart problems in your fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labor. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Fertility

For women of childbearing age, it should be noted that medicines like Ibuprofen Kern Pharma have been associated with reduced fertility.

Breastfeeding

Although only small amounts of the medicine 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 medicine.

Driving and using machines

Although this effect is rare, this medicine should be used with caution in patients whose activities require alertness, especially if symptoms such as drowsiness, dizziness, or depression occur during treatment.

Ibuprofen Kern Pharmaccontains maltitol liquid and sodium

This medicine contains maltitol liquid. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Ibuprofen Kern Pharma

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in 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 prematurely, as otherwise the expected effects will not be achieved.

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

Ibuprofen Kern Pharma is an oral suspension. It may be administered directly or diluted in water.

For accurate dosing, the packaging contains a 5 ml graduated oral syringe. Insert the syringe into the pierced cap, invert the bottle, pull the plunger until the liquid reaches the mark in ml, return the bottle to its upright position, and remove the syringe.

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 food.

Use in children

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

Age	Body weight	Dosage
Children 3 to 6 months	Approx. 5 to 7.6 kg	1.25 ml three times daily (equivalent to 150 mg of ibuprofen/day)
Children 6 to 12 months	Approx. 7.7 to 9 kg	1.25 ml three to four times daily (equivalent to 150–200 mg of ibuprofen/day)
Children 1 to 3 years	Approx. 10 to 15 kg	2.5 ml three times daily (equivalent to 300 mg of ibuprofen/day)
Children 4 to 6 years	Approx. 16 to 20 kg	3.75 ml three times daily (equivalent to 450 mg of ibuprofen/day)
Children 7 to 9 years	Approx. 21 to 29 kg	5 ml three times daily (equivalent to 600 mg of ibuprofen/day)
Children 10 to 12 years	Approx. 30 to 40 kg	7.5 ml three times daily (equivalent to 900 mg of ibuprofen/day)

Adults

The recommended dose is 10 ml three times daily (equivalent to 1200 mg of ibuprofen) for as long as symptoms persist.

Elderly patients

No special dose adjustments are required.

If you feel that the effect 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, contact your doctor or pharmacist immediately, call the Toxicology Information Service at 91 562 04 20, or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken, indicating the medication and the amount ingested. It is recommended to bring the medication container and package leaflet to the healthcare professional.

Symptoms of overdose may include: stomach pain, nausea, vomiting (which may contain blood-stained sputum), indifference, drowsiness, headache, involuntary eye movements, tinnitus, confusion, and lack of muscle coordination.

More severe symptoms may occur, such as gastrointestinal bleeding, low blood pressure, decreased body temperature, metabolic acidosis, seizures, impaired kidney function, coma, dyspnea / acute respiratory distress syndrome in adults, and transient respiratory arrest in children (after ingestion of large amounts).

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

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

In case of ingestion of large amounts, activated charcoal should be administered. Gastric lavage should be considered if large amounts have been ingested and within 60 minutes following ingestion.

If you forget to take Ibuprofeno Kern Pharma

Do not take a double dose to make up for a missed dose. If you forget to take your scheduled dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the regular time.

If you have any further 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 everyone experiences them.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

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

The following adverse effects have been observed:

Gastrointestinal

The most common adverse effects associated with medicines such as Ibuprofen Kern Pharma 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 stools, mouth ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Uncommon: gastrointestinal disorders such as indigestion, abdominal pain, and nausea.

Rare: diarrhea, vomiting, flatulence, and constipation.

Very rare: gastrointestinal ulcers, sometimes with bleeding and perforation, pancreatitis. If you experience severe pain in the upper part of your stomach, vomit blood, have blood in your stools, or pass dark-colored stools, you must stop taking Ibuprofen Kern Pharma and inform your doctor immediately.

Skin and allergic reactions

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

• Red, non-elevated spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• Generalized red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Common: skin rash.

Uncommon: skin redness, itching or swelling of the skin, swelling of the lips, face, or tongue, increased nasal discharge, and breathing difficulties.

Rare: severe allergic reactions (anaphylactic shock).

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

Medicines such as Ibuprofen Kern Pharma may, very rarely, be associated with very serious blistering reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and allergic vasculitis.

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

Aseptic 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 may manifest as nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulties, asthma, palpitations, hypotension, or shock.

Frequency not known: Generalized red, scaly rash with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen Kern Pharma if you experience 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 may occur. Symptoms of DRESS syndrome include: skin rash, lymph node swelling, and elevated eosinophils (a type of white blood cell).

Central nervous system

Common: headache, dizziness, and fatigue.

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

Psychiatric

Uncommon: insomnia, restlessness, and anxiety.

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

Auditory

Common: dizziness.

Uncommon: tinnitus (ringing or buzzing in the ears).

Rare: hearing disorders.

Ocular

Uncommon: visual disturbances.

Rare: lazy eye.

Blood

Very rare: prolonged bleeding time, blood cell abnormalities (early symptoms may include: fever, sore throat, mouth ulcers, flu-like symptoms, excessive tiredness, nosebleeds, and skin bleeding)

Cardiovascular

Medicines such as Ibuprofen Kern Pharma may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Chest pain, which may 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 treatment using medicines like Ibuprofen Kern Pharma.

Kidney

Ibuprofen Kern Pharma should be used with caution in patients with kidney disease, especially if used together with diuretic medicines. Fluid retention and worsening of kidney function may occur. In these patients, the dose of ibuprofen should be as low as possible.

Caution should be taken not to administer it to dehydrated individuals, as kidney failure may develop.

Liver

Rare: hepatitis (inflammation of the liver) and jaundice (yellowing of the skin). Medicines such as Ibuprofen Kern Pharma may, in rare cases, be associated with liver damage.

Frequency not known: liver failure.

Musculoskeletal

Rare: neck stiffness.

Other

Common: tiredness.

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen Kern Pharma

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

No special storage conditions are required.

After opening the container, store below 30°C and use within a maximum of 6 months.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of IbuprofenoKernPharma

• The active substance 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, q.s.

Appearance of the product and contents of the pack

Ibuprofeno Kern Pharma is a viscous oral suspension, white or almost white in colour, with a strawberry odour.

It includes a 5 ml graduated oral syringe with a polypropylene barrel and a polyethylene plunger.

Pack sizes of 100 ml, 150 ml and 200 ml are available. Only certain pack 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 most recent revision of this leaflet: October 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/