IBUPROFEN B. BRAUN 600 MG CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Ibuprofeno B.Braun 600 mg Concentrate for Solution for Infusion

ibuprofeno

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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Ibuprofeno B.Braun and what is it used for
2. What you need to know before you use Ibuprofeno B.Braun
3. How to use Ibuprofeno B.Braun
4. Possible side effects
5. Storage of Ibuprofeno B.Braun

Contents of the pack and further information

1. What is Ibuprofeno B.Braun and what is it used for

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

Ibuprofeno B. Braun is used for the short-term symptomatic treatment of moderate acute pain and fever, when oral administration is not appropriate.

2. What you need to know before you use Ibuprofeno B. Braun

It is important that you use the smallest dose that relieves your pain and for the shortest time possible to control your symptoms.

Do not use Ibuprofeno B. Braun:

• If you are allergic to ibuprofeno, other NSAIDs, or any of the other ingredients of this medicine (listed in section 6).
• If you have had a history of bronchospasm, asthma, rhinitis, angioedema, or urticaria associated with the consumption of acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you have coagulation disorders.
• If you have or have had stomach/intestinal ulcers and/or active or recurrent gastrointestinal bleeding (two or more episodes of ulceration or bleeding).
• If you have had a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
• If you have active cerebral hemorrhage or other active bleeding.
• In case of severe liver or kidney failure.
• If you have coronary artery disease or severe heart failure.
• If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• If you are in the last three months of pregnancy.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Ibuprofeno B. Braun.

Anti-inflammatory/analgesic medicines like ibuprofeno may be associated with a small increased risk of having a heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or treatment duration.

Skin reactions:

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 with ibuprofeno treatment. Stop taking Ibuprofeno B.Braun and consult your doctor immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Signs of an allergic reaction to this medicine, including respiratory problems, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofeno. Stop taking Ibuprofeno B.Braun immediately and contact your doctor or emergency medical services if you notice any of these signs.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofeno B. Braun 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.
• You have edema (fluid retention).
• Your doctor will monitor you more closely if you receive ibuprofeno after major surgery.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by severe abdominal pain or persistent abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcer and in elderly patients. In these cases, your doctor may consider the possibility of associating a stomach protective medication.
• If you have had kidney or liver disease.
• If you have asthma or any other respiratory disorder.
• If you have an infection, see the "Infections" heading below.
• If you have kidney or liver disease or are over 60 years old, 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 ibuprofeno may cause kidney failure in this case due to dehydration.
• If you have Crohn's disease or ulcerative colitis, as medications of this type may worsen these conditions.
• If you are taking medications that affect blood clotting, 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 bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you are being treated with diuretics (medications to increase urine production), as your doctor needs to monitor your kidney function.
• There have been reports of aseptic meningitis with the use of this medicine, the risk is higher if you have a systemic autoimmune disease called systemic lupus erythematosus and other collagen diseases.
• If you notice skin lesions, swelling, or redness, breathing problems (asphyxia), stop using the medicine immediately and inform your doctor or nurse.
• If you have chickenpox, as complications may arise.
• If you have acute intermittent porphyria.

• There have been reports of blurred or decreased vision, blind spots in the visual field, and changes in color vision with oral ibuprofeno.

• Infections

Ibuprofeno B. Braun may mask signs of infection, such as fever and pain. Therefore, Ibuprofeno B. Braun may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and in bacterial skin infections related to chickenpox. If you are taking this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Cardiovascular precautions

Medicines like Ibuprofeno B. Braun may be associated with a moderate increase in the risk of heart attacks ("myocardial infarctions") or strokes. This risk is more likely to occur when using high doses and prolonged treatments. Do not exceed the recommended dose or treatment duration.

If you have heart problems, a history of strokes, or think you may be at risk for these conditions (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist.

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

Using Ibuprofeno B. Braun with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Ibuprofeno B. Braun may affect or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs), as they may increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect.
• Anticoagulant medicines (e.g., to treat blood clotting problems/prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Digoxin, phenytoin, or lithium may increase their blood levels when taken with ibuprofeno.
• A medicine used to treat certain types of cancer or rheumatism (methotrexate) taken at the same time as ibuprofeno (within a 24-hour interval) may increase its blood levels and the risk of toxicity from this medicine. Your doctor may advise you not to take ibuprofeno if you are receiving high-dose methotrexate treatment.
• Mifepristone (abortion inducer).
• Selective serotonin reuptake inhibitor antidepressants (SSRIs) and antiplatelet agents may also increase the risk of gastrointestinal bleeding.
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan) and diuretics, as they may decrease their effect.
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids, as they increase the risk of gastrointestinal ulcers or bleeding.
• Diuretics (medicines used to increase urine production), as they may increase the risk of kidney toxicity.
• Medicines containing probenecid and sulfinpyrazone may delay the excretion of ibuprofeno.
• Cyclosporin and tacrolimus, which may increase the risk of kidney damage.
• Medicines used to treat diabetes (sulfonylureas). It is recommended to monitor blood glucose levels when used together.
• Quinolone antibiotics, due to an increased risk of developing seizures.
• Medicines used to treat fungal infections (CYP2C9 inhibitors such as voriconazole, fluconazole) may increase ibuprofeno blood levels.
• Medicines for HIV (zidovudine), due to an increased risk of blood accumulation in joints and bruising in HIV-positive hemophiliacs.
• Chronic alcohol consumption may increase the risk of significant side effects in the stomach and intestines, including bleeding.

Other medicines may also affect or be affected by treatment with Ibuprofeno B. Braun. Therefore, you should always consult your doctor or pharmacist before using Ibuprofeno B. Braun with other medicines.

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

If you are pregnant, you will receive ibuprofeno only if your doctor considers it absolutely necessary. Ibuprofeno is contraindicated during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected.

You should not receive ibuprofeno during the first six months of pregnancy unless it is clearly necessary and as directed 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.

Treatment with ibuprofeno by intravenous route should not exceed 3 days. From the 20th week of pregnancy, ibuprofeno 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.

Breastfeeding

It is not recommended to interrupt breastfeeding in short treatments at the recommended doses, although ibuprofeno and its metabolites pass into breast milk.

Fertility

For patients of childbearing age, it should be noted that medicines of the ibuprofeno type have been associated with a decrease in fertility.

Driving and using machines

In short or occasional treatments, no special precautions are necessary. However, the appearance of side effects, such as fatigue and dizziness, may impair the ability to drive vehicles and/or use machines. This is especially important when combined with alcohol.

Ibuprofeno B. Braun contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 100 mg/ml, so it is considered essentially "sodium-free".

3. How to use Ibuprofeno B. Braun

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

This medicine is prescribed to you by a doctor and will be administered to you only by a doctor or nurse in an environment with the appropriate equipment.

Dosage

Adults

The recommended dose is 600 mg of ibuprofeno every 6-8 hours.

The recommended daily dose is 1200-1600 mg in multiple doses. Do not exceed the maximum daily dose of 2400 mg in multiple doses.

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

After observing the initial response to treatment, the dose and frequency of administration should be adjusted according to the needs of each patient.

Adequate patient hydration should be maintained to minimize the risk of possible adverse reactions at the renal level.

This medicine is indicated for short-term use, and the duration of treatment should be limited to the acute symptomatic period while the oral route is not available. Patients should adopt oral analgesic treatment when possible.

Method of administration

For intravenous administration.

The contents of a vial (6 ml, 600 mg of ibuprofeno) should always be diluted in a volume of 100 ml of sodium chloride 9 mg/ml (0.9%) solution, glucose saline 33 mg/ml glucose (3.3%), 3 mg/ml NaCl (0.3%) solution, or Ringer's lactate solution. The solution should be diluted aseptically (for storage conditions of the diluted solution, see section 5).

The diluted solution is transparent. Before administration, the solution should be visually inspected to ensure it is transparent and colorless. It should not be used if it contains suspended particles or changes in color are observed.

The diluted solution is administered as an intravenous infusion over 30 minutes.

A vial is intended for single use, and any unused amount should be discarded.

The contents of the vial should not be administered directly, undiluted. Direct infusion of this medicine without dilution may cause hemolysis.

If you use more Ibuprofeno B. Braun than you should

Since your dose is controlled by a doctor or nurse, it is unlikely that you will be given too much of this solution.

If you think you have received more ibuprofeno than you should, inform your doctor or nurse immediately.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and ataxia (alterations in movement coordination). At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. You may also experience hypotension, bluish discoloration of the skin or mucous membranes (cyanosis), gastrointestinal or intestinal bleeding, as well as liver and kidney problems.

In case of overdose or accidental ingestion, go to a Medical Center or consult the Toxicology Information Service, phone 915620420, indicating the medicine and the amount ingested. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

4. Possible Adverse Effects

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

The frequencies have been defined as follows: 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 1,000 people), very rare (may affect up to 1 in 10,000 people), and unknown frequency (cannot be estimated from available data).

Cardiac and Vascular Disorders

Very rare: palpitations, arterial hypertension, heart failure, and myocardial infarction.

Unknown frequency: chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Disorders of the Blood and Lymphatic System

Rare: alterations in blood formation (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Frequent infections with fever, sore throat, superficial mouth ulcers, pseudo-flu-like state, nasal bleeding, and skin bleeding may occur.

Disorders of the Nervous System

Frequent: headache, dizziness, insomnia, agitation, irritability, and fatigue.

Very rare: some cases of aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever, or confusion) have been observed during treatment with ibuprofen in patients with systemic lupus erythematosus. Patients with autoimmune diseases (SLE, connective tissue diseases) seem to be predisposed.

Ocular Disorders

Infrequent: visual disturbances. In this case, the patient should inform the doctor immediately and interrupt treatment.

Disorders of the Ear and Labyrinth

Infrequent: tinnitus (sensation of hearing sounds that do not come from an external source)

Gastrointestinal Disorders

Frequent: heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and blood in stools.

Infrequent: gastrointestinal ulcers, potentially with bleeding and perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis.

Rare: esophagitis, intestinal stenosis, and diaphragmatic stenosis.

Very rare: pancreatitis.

The patient should go to the doctor immediately if they report severe pain in the upper abdomen or present blood in stools or vomit.

Respiratory, Thoracic, and Mediastinal Disorders

Very rare: asthma, bronchospasm, difficulty breathing, and wheezing.

Renal and Urinary Disorders

Rare: renal tissue damage (papillary necrosis), especially in long-term treatments, increasing uric acid concentration in blood.

Very rare: reduction of urinary excretion and edema formation, especially in patients with arterial hypertension or renal failure, nephrotic syndrome, interstitial nephritis that may be accompanied by acute renal failure. Therefore, renal function should be regularly monitored.

Disorders of the Skin and Subcutaneous Tissue

Frequent: skin rash.

Rare: vesicular reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome). Alopecia.

Unknown frequency: a severe skin reaction known as DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

In exceptional cases, severe skin infections and minor tissue complications may occur during a varicella infection.

Generalized scaly eruption, with bumps under the skin and localized blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno B. Braun if you experience these symptoms and seek medical attention immediately. See also section 2.

Stop taking ibuprofen and go to the doctor immediately if you notice any of the following symptoms:

• Circular or target-like, reddish, and non-elevated patches on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and pseudo-flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• Generalized scaly and reddened skin rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Disorders of the Immune System

Frequent: hypersensitivity reactions with skin rash and urticaria, as well as asthma attacks (possibly with decreased blood pressure).

Rare: severe hypersensitivity reactions. Edema, tongue inflammation, inflammation of the inner larynx with constriction of the airways, difficulty breathing, palpitations, and decreased blood pressure that can put the patient's life at risk may occur. If any of these symptoms occur, which can happen even with the first administration, immediate medical attention is required.

Psychiatric Disorders

Rare: psychotic reactions and depression.

Hepatobiliary Disorders

Rare: liver dysfunction, liver damage, and acute hepatitis.

Unknown frequency: liver failure.

Infections and Infestations

Very rare: exacerbations of inflammation-related infections coinciding with the use of non-steroidal anti-inflammatory drugs.

Symptoms of aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever, or confusion) have been observed during treatment with ibuprofen. Patients with autoimmune diseases (SLE, connective tissue diseases) seem to be predisposed.

Musculoskeletal and Connective Tissue Disorders

Rare: neck stiffness.

General Disorders and Administration Site Conditions

Frequent: pain and burning sensation at the injection site, mild in character. Fatigue.

Others

Very rare: worsening of inflammation during infectious processes.

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, Website: www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ibuprofeno B.Braun

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30°C. Do not refrigerate or freeze.

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

For single use. This product must be used immediately after opening. Any unused solution must be discarded.

After dilution, the solution is chemically stable for 24 hours at 25°C.

From a microbiological point of view, the product must be administered immediately. The medicine should not be stored between 2-8°C. Otherwise, the time elapsed and the conditions of use are the responsibility of the person who prepares/administers it.

Do not use this medicine if you observe particles in suspension or changes in coloration.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibuprofeno B.Braun

• The active principle is ibuprofen. Each 6 ml vial contains 600 mg of ibuprofen.
• The other components (excipients) are L-arginine, sodium chloride, hydrochloric acid (pH adjustment), sodium hydroxide (pH adjustment), and water for injectables.

Appearance of the Product and Package Contents

The solution is transparent and colorless.

Ibuprofeno B.Braun 600 mg concentrated solution for infusion is presented in packs of 1 and 100 glass vials type I of 6 ml with a rubber stopper.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

• BRAUN MEDICAL, S.A.

Ctra. De Terrassa, 121

08191 Rubí

Spain

Manufacturer:

B.Braun Medical, S.A.

Ronda de los Olivares, parcela 11

Polígono Industrial Los Olivares

23009 Jaén – Spain

Last Revision of this Prospectus:January 2025

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