Patient Information Leaflet

Ibuprofen B.Braun 600 mg Concentrate for Solution for Infusion

ibuprofen

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, 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.

Contents of the pack and additional information

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

Ibuprofeno B. Braun is used for the symptomatic treatment of short-term moderate acute pain and fever, when oral administration is inappropriate.

It is essential to use the smallest dose that relieves or controls pain and for the shortest duration possible to manage symptoms.

Do not use Ibuprofeno B. Braun:

- If you are allergic to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other components of this medication (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 NSAIDs.

- If you suffer from bleeding disorders.

- If you have or have a history of 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 suffer from cerebral hemorrhage or other active bleeding.

- In case of severe liver or kidney failure.

- If you suffer from coronary artery disease or severe heart failure.

- If you suffer from severe dehydration (caused by vomiting, diarrhea, or inadequate 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.

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

Reactions to the skin:

Severe skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized acute pustular psoriasis (AGEP) have been reported associated with ibuprofen treatment. Stop taking Ibuprofeno B. Braun and consult your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Signs of an allergic reaction to this medication, including respiratory problems, swelling of the face and neck region (angioedema), and chest pain, have been reported with ibuprofen. 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, coronary artery bypass surgery, peripheral artery disease, 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.

- If you have edema (fluid retention).

- Your doctor will perform a more stringent control if you receive ibuprofen after major surgery.

- If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms. This risk is higher 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 may consider associating a stomach-protective medication.

- If you have had kidney or liver disease.

- If you suffer from 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, such as severe diarrhea or vomiting, take plenty of fluids and immediately contact your doctor, as ibuprofen in this case could cause renal insufficiency due to dehydration.

- If you have Crohn's disease or ulcerative colitis, as these medications can worsen these conditions.

- If you are taking medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid, corticosteroids, and selective serotonin reuptake inhibitors (SSRIs), which can increase the risk of gastrointestinal bleeding.

- If you are taking diuretics (medications for urination) because your doctor needs to monitor your kidney function.

- Some cases of meningitis have been reported with the use of this medication, and 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 difficulties (asphyxia), stop using the medication immediately and inform your doctor or nurse.

- If you have chickenpox, as complications may arise.

- If you have intermittent acute porphyria.

• Blurred or decreased vision, blind spots in the visual field, and changes in color vision have been reported with oral ibuprofen.

• Infections

Ibuprofeno B. Braun may mask signs of infections such as fever and pain. Consequently, ibuprofen B. Braun may delay the appropriate treatment of the infection, increasing 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 symptoms of the infection persist or worsen, consult a doctor without delay.

Cardiovascular precautions

Nonsteroidal anti-inflammatory/analgesic medications like Ibuprofeno B. Braun may be associated with a moderate increase in the risk of suffering heart attacks or strokes, especially when used in high doses and prolonged treatment. 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, suffer from diabetes, have high cholesterol, or are a smoker), you should consult this treatment with your doctor or pharmacist.

These types of medications can also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Use of Ibuprofeno B. Braun with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

- Other nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect.

- Anticoagulant medications (e.g., for treating coagulation problems or preventing coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).

- Digoxin, phenytoin, or lithium may increase your blood levels when taken with ibuprofen.

- A medication used to treat certain types of cancer or rheumatism (methotrexate) taken at the same time as ibuprofen (within a 24-hour interval) may increase your blood levels and the risk of toxicity from this medication. Your doctor may advise you not to take ibuprofen if you receive high doses of methotrexate.

- Mifepristone (abortion inducer).

- Selective serotonin reuptake inhibitors (SSRIs) and antiplatelet agents may also increase the risk of gastrointestinal bleeding.

- Blood pressure-lowering medications (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan) and diuretics, as they may reduce the effect of ibuprofen.

- Sulfonamides like sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).

- Corticosteroids, which may increase the risk of gastrointestinal ulcers or bleeding.

- Diuretics (medications for urination), which may increase the risk of renal toxicity.

- Probenecid and sulfinpyrazone, which may delay the excretion of ibuprofen.

- Cyclosporine and tacrolimus, which may increase the risk of renal damage.

- Sulfonilureas, which may increase the risk of hypoglycemia.

- Quinolone antibiotics, which may increase the risk of seizures.

- Fungal infection medications (CYP2C9 inhibitors like voriconazole and fluconazole) may increase ibuprofen blood levels.

- HIV medications (zidovudine), which may increase the risk of joint accumulation 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 medications may also affect or be affected by the treatment with Ibuprofeno B. Braun. Therefore, you should always consult your doctor or pharmacist before using Ibuprofeno B. Braun with other medications.

Pregnancy, lactation, and fertility

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

Pregnancy

If you are pregnant, you will receive ibuprofen only if your doctor considers it absolutely necessary. Ibuprofen is contraindicated during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery.

Ibuprofen may cause renal and cardiac problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong delivery.

You should not receive ibuprofen during the first six 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 duration possible.

Intravenous ibuprofen treatment should not exceed three days. 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 surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

Lactation

It is not recommended to interrupt breastfeeding during short-term treatments at the recommended doses, although ibuprofen and its metabolites pass into breast milk.

Fertility

For patients of childbearing age, it should be noted that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Driving and operating machinery

In short-term or punctual treatments, no special precautions are necessary. However, the appearance of adverse effects, such as fatigue and dizziness, may impair your ability to drive vehicles and/or operate machinery. This is especially important when combined with alcohol.

Ibuprofeno B. Braun contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per 100 mg/ml, making it essentially "sodium-free."

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

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

Dosage

Adults

The recommended dose is 600 mg of ibuprofen 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 lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor as soon as possible if symptoms (such as fever and pain) persist or worsen (see section 2).

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

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

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

Administration Form

For intravenous administration.

The contents of a vial (6 ml, 600 mg of ibuprofen) should always be diluted in a volume of 100 ml of sodium chloride solution 9 mg/ml (0.9%), glucose saline solution 33 mg/ml glucose (3.3%), 3 mg/ml NaCl (0.3%), or lactate Ringer 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 particles in suspension 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 medication 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 administered an excessive amount of this solution.

If you consider that you have received more ibuprofen than you should, inform your doctor or nurse immediately.

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

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

.

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

The frequencies have been defined as follows: 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), and unknown frequency (cannot be estimated from available data).

Cardiovascular and vascular disorders

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

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

Blood and lymphatic system disorders

Rare: alterations in blood formation (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis). May appear frequent infections with fever, sore throat, superficial mouth ulcers, pseudo-gripal state, nasal hemorrhages, and skin bleeding.

Nervous system disorders

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

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

Eye disorders

Uncommon: visual disturbances. In this case, the patient must immediately inform the doctor and discontinue treatment.

Ear and labyrinth disorders

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

Gastrointestinal disorders

Common: heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and blood in stool.

Uncommon: 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 must immediately go to the doctor if they report severe upper abdominal pain or present blood in stool 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 with long-term treatment, increasing blood uric acid levels.

Very rare: reduced urine excretion and edema formation, especially in patients with hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis that may be accompanied by acute renal failure. Therefore, renal function must be regularly monitored.

Skin and subcutaneous tissue disorders

Common: 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 (Drug Reaction with Eosinophilia and Systemic Symptoms) may occur. DRESS symptoms include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

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

Generalized scaly rash, with subcutaneous nodules and localized blisters mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking Ibuprofeno B. Braun if you experience these symptoms and seek medical attention immediately. See section 2.

Stop taking ibuprofen and seek medical attention immediately if you notice any of the following symptoms:

• Circular or target-shaped, red, 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 reactions may be preceded by fever and pseudo-gripal 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 red rash with subcutaneous nodules and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Immune system disorders

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

Rare: severe hypersensitivity reactions. May appear edema, inflammation in the tongue, inflammation of the inner larynx with airway constriction, difficulty breathing, palpitations, and decreased blood pressure that may put the patient's life at risk. If any of these symptoms occur, even after the first administration, immediate medical assistance is required.

Psychiatric disorders

Rare: psychotic reactions and depression.

Hepatobiliary disorders

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

Unknown frequency: liver insufficiency.

Infections and infestations

Very rare: exacerbations of inflammatory conditions related to infections coinciding with the use of nonsteroidal anti-inflammatory drugs.

During ibuprofen treatment, symptoms of aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever, or confusion) have been observed in patients with autoimmune diseases (SLE, connective tissue diseases). Patients with autoimmune diseases appear to be predisposed.

Musculoskeletal and connective tissue disorders

Rare: neck stiffness.

General disorders and administration site conditions

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

Other

Very rare: aggravation of inflammation during infectious processes.

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 that does not appear in this leaflet. You can also report them directly throughSistema Español de Farmacovigilancia de Medicamentos de Uso Humano, Website: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.

Do not store at a temperature above 86°F (30°C). Do not refrigerate or freeze.

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.

For single use only. This product must be used immediately after opening. Dispose of any unused solution.

After dilution, the solution is chemically stable for 24 hours at 77°F (25°C).

From a microbiological standpoint, the product must be administered immediately. The medication should not be stored between 36-46°F (2-8°C). Otherwise, the time elapsed and usage conditions are the responsibility of the person preparing/administering it.

Do not use this medication if you observe particles in suspension or changes in color.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and medications that you no longer need. This will help protect the environment.

Composition of Ibuprofeno B.Braun

- The active ingredient is ibuprofen. Each vial of 6 ml 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 injection.

Aspect of the product and contents of the packaging

The solution is transparent and colorless.

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

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

B. BRAUN MEDICAL, S.A.

Ctra. De Terrassa, 121

08191 Rubí

Spain

Responsible for manufacturing:

B.Braun Medical, S.A.

Ronda de los Olivares, parcela 11

Polígono Industrial Los Olivares

23009 Jaén – Spain

Last review of this leaflet: April 2024

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