Label: information for the patient

Ibuprofen B. Braun 600 mg solution for infusion

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

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

2.What you need to know before starting to use Ibuprofen B. Braun

3.How to use Ibuprofen B. Braun

4.Possible adverse effects

5.Storage of Ibuprofen B. Braun

6.Contents of the package and additional information

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

This medicine is used in adults for the short-term symptomatic treatment of moderate acute pain and fever, whenoral administration is inappropriate.

Do not use Ibuprofeno B. Braun:

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you have ever had any respiratory problems, asthma, rhinitis, angioedema, or urticaria associated with the consumption of acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• If you have bleeding disorders.
• If you have active or recurrent peptic ulcers and/or 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.
• If you have severe kidney, liver, or heart disease.
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• If you are in the last trimester of pregnancy.

Warnings and precautions

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

Analgesics and anti-inflammatory drugs like ibuprofen may be associated with a slight increase in the risk of 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 with Ibuprofeno B. Braun. Stop taking Ibuprofeno B. Braun and see 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 medication, including respiratory problems, swelling of the face and neck (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.

Inform your doctor:

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• Your doctor will perform a more stringent control if you receive ibuprofen after undergoing 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, especially in patients with a history of peptic ulcers and in the elderly. In these cases, your doctor may consider associating a stomach protector medication.
• If you have kidney or liver disease.
• If you have asthma or any other respiratory disorder.
• If you have kidney or liver disease or are over 60, your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• If you experience symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluid and contact your doctor immediately, as ibuprofen in this case may cause kidney insufficiency due to dehydration.
• If you have Crohn's disease or ulcerative colitis, as these medications may worsen these conditions.
• If you are taking anticoagulant medications, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you are taking diuretics (medications to promote urination), as your doctor should monitor your kidney function.
• If you have an infection, see the "Infections" section below.
• Some cases of aseptic meningitis have been reported with the use of this medication, and the risk is higher if you have systemic lupus erythematosus and other collagen diseases.
• If you notice skin lesions, swelling, or redness, difficulty breathing (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.
• It is essential to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

• Infections

Ibuprofeno B. Braun may mask signs of infections such as fever and pain. Therefore, it is possible that ibuprofeno B. Braun 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.

Ibuprofeno may affect the results of the following laboratory tests:

• Bleeding time (may be prolonged 1 day after the end of treatment)
• Blood glucose levels (may decrease)
• Acreaminuria (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Urea nitrogen in blood, serum creatinine, and potassium (may increase)
• Liver function tests; increased concentrations of transaminases

If you are undergoing laboratory tests, inform your doctor if you are taking ibuprofeno or have taken it recently.

In general, the use of (different types of) analgesics can cause severe and permanent kidney damage.

With prolonged use of analgesics, headache may occur, which should not be treated by increasing the medication dose.

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

Simultaneous use with NSAIDs, among others, cyclooxygenase-2 inhibitors, should be avoided.

During treatment with this medication, allergic reactions may occur, mainly at the beginning of treatment. In this case, treatment should be suspended.

Use of Ibuprofeno B. Braun with other medications

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

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

• Other nonsteroidal anti-inflammatory drugs (NSAIDs), as it 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 their blood levels when taken with ibuprofeno.
• Medications used to treat heart failure (cardiac glycosides like digoxin), epilepsy (phenytoin), or depression (lithium) may increase their blood levels when taken simultaneously with ibuprofeno.
• Methotrexate taken at the same time as ibuprofeno (within a 24-hour interval) may increase their blood levels and the risk of toxicity from this medication. Your doctor may advise you not to take ibuprofeno if you receive high doses of methotrexate.
• Mifepristone (inducer of abortion).
• Antidepressants that inhibit serotonin reuptake (SSRIs) and antiplatelet agents may also increase the risk of gastrointestinal bleeding.
• Medications used to lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan)
• Diuretics (medications used to promote urination, such as bendroflumethiazide), as NSAIDs may reduce the effect of these medications, increasing the risk of kidney problems (the use of potassium-sparing diuretics with ibuprofeno may cause an increase in blood potassium levels).
• Sulfonamides like sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Medications used to treat inflammation (corticosteroids like hydrocortisone), as they increase the risk of gastrointestinal ulcers or bleeding.
• Diuretics (medications used to promote urination), as it may increase the risk of renal toxicity.
• Medications containing probenecid and sulfinpyrazone may delay the excretion of ibuprofeno.
• Medications used to prevent organ transplant rejection (cyclosporine and tacrolimus) may increase the risk of renal damage.
• Sulfonylureas, medications used to treat diabetes. It is recommended to monitor blood glucose levels when used together.
• Quinolone antibiotics, as they may increase the risk of seizures.
• Voriconazole, fluconazole (CYP2C9 inhibitors) may increase ibuprofeno blood levels.
• Medications for HIV (zidovudine), as they may increase the risk of blood accumulation in joints and bruising in HIV-positive hemophiliacs.
• Chronic alcohol consumption may increase the risk of significant gastrointestinal side effects, including bleeding.
• A type of antibiotic (aminoglycosides). NSAIDs may decrease the excretion of aminoglycosides and increase toxicity.
• Ginkgo biloba(a medicinal plant commonly used to treat dementia) may increase the risk of bleeding

Other medications may also affect or be affected by ibuprofeno treatment. Therefore, always consult your doctor before using Ibuprofeno B. Braun with other medications.

Pregnancy, lactation, and fertility

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

Pregnancy

If you are pregnant, you will receive ibuprofeno only if your doctor considers it absolutely necessary.

Ibuprofeno is contraindicated during the last 3 months of pregnancy. 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 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.

Intravenous ibuprofeno treatment should not exceed 3 days. From week 20 of pregnancy, ibuprofeno may cause kidney 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 more than a few days, your doctor may recommend additional checks.

Lactation

This medication is excreted in breast milk, but it can be used during breastfeeding, provided the recommended dose is used for the shortest possible time.However, if higher doses or prolonged treatment are used, your doctor may recommend interrupting breastfeeding.

Fertility

Ibuprofeno may make it difficult to conceive. If you plan to become pregnant or have difficulty becoming pregnant, inform your doctor.

Driving and operating machinery

In short or punctual treatments, no special precautions are necessary. However, in longer treatments, the occurrence 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 360 mg of sodium (main component of table salt/for cooking) per vial. This is equivalent to 18% of the recommended daily maximum sodium intake for an adult.

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

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

Your doctor will administer the most effective dose at the shortest possible time necessary to avoid adverse effects. Your doctor will also check that you have ingested a sufficient amount of liquids to minimize the risk of adverse effects on the kidneys.

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 most effective dose should be used and for the shortest possible time according to the needs of each patient. 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 adverse reactions at the renal level.

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

Intravenous route

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

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

If you use more Ibuprofeno B. Braun than you should

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

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Also, blood in the urine, chills, and breathing difficulties may occur.

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 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may cause side effects, although not everyone will experience them.

The side effects that have been observed with a higher frequency affect the stomach and intestines. They may cause peptic ulcers (digestive or intestinal ulcers), holes in the stomach or intestinal wall (perforation) or gastrointestinal bleeding, sometimes fatal. Indigestion, black stools, vomiting blood, inflammation of the oral mucosa accompanied by ulceration (ulcerative stomatitis), exacerbation of inflammatory bowel disease (colitis) and Crohn's disease have been reported. Gastritis has been observed less frequently. It is worth noting that the risk of gastrointestinal bleeding depends on the interval between doses and the duration of treatment.

Cases of edema (accumulation of fluid in tissues), hypertension and heart failure related to AINE treatment have been reported. Medications such as ibuprofen may be associated with a slight increase in the risk of suffering a heart attack (myocardial infarction) or stroke.

Cases of very rare allergic reactions (including reactions at the injection site and anaphylactic shock) and severe skin side effects, alopecia (hair loss), photosensitivity reactions and allergic vasculitis (inflammation of a blood vessel) have been reported.

Stop taking ibuprofen and seek medical attention immediately if you notice any of the following symptoms:note 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 eruptions may be preceded by fever and pseudogripal symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin eruption, high body temperature and enlarged lymph nodes (DRESS syndrome).
• Generalized, scaly, red skin eruption with subcutaneous nodules and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Very rare cases of exacerbation of inflammatory conditions related to infections (e.g., development of necrotizing fasciitis) concurrent with AINE use have been reported.

Exceptionally rare cases of severe skin infections and soft tissue complications during a varicella virus infection have been reported.

Very common side effects (may affect more than 1 in 10 people):

• Fatigue or insomnia, headache and dizziness.
• Stomach burning, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation and mild gastrointestinal bleeding that may cause anemia in exceptional cases.

Common (may affect up to 1 in 10 people):

• Dizziness.
• Skin eruption.
• Pain and burning sensation at the injection site.
• Gastroduodenal ulcer that may be accompanied by bleeding and perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease.

Uncommon (may affect up to 1 in 100 people):

• Difficulty falling asleep (insomnia), agitation, irritability or fatigue, anxiety and restlessness.
• Visual disturbances.
• Tinnitus (ringing in the ears).
• Reduced urine production and fluid accumulation in tissues (edema), especially in patients with hypertension or renal insufficiency, symptoms due to renal damage (nephrotic syndrome) and interstitial nephritis, which may be accompanied by acute renal failure.
• Urticaria, pruritus, purpura (including allergic purpura) and skin eruption.
• Allergic reactions, accompanied by skin eruption and pruritus, as well as asthma attacks (possibly accompanied by a drop in blood pressure).

Rare (may affect up to 1 in 1,000 people):

• Reversible double vision (toxic amblyopia).
• Auditory disturbances.
• Narrowing of the esophagus (gastrointestinal vasospasm), complications of diverticulum formation in the large intestine and non-specific hemorrhagic colitis characterized by intense cramps and diarrhea. In the case of gastrointestinal bleeding, these may cause anemia.
• Renal tissue damage (papillary necrosis), and increased serum uric acid concentration.
• Jaundice or yellowing of the whites of the eyes, liver dysfunction, liver damage and acute hepatitis.
• Psychotic reactions, nervousness, irritability, confusion or disorientation and depression.
• Neck stiffness.

Very rare side effects (may affect up to 1 in 10,000 people):

• Blood cell formation disorders (anemia, leukopenia, thrombocytopenia, pancytopenia and agranulocytosis). The first symptoms are fever, sore throat, superficial oral ulcers, pseudogripal symptoms, acute fatigue, nasal bleeding and skin bleeding.
• Accelerated heart rate (palpitations), heart failure and myocardial infarction.
• Hypertension.
• Aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever or confusion). Patients with autoimmune disorders (systemic lupus erythematosus and mixed conjunctivitis) appear to have a higher predisposition.
• Inflammation of the lower part of the throat or pancreas and intestinal narrowing.
• Hair loss.
• Allergic vasculitis.
• Asthma, difficulty breathing (bronchospasm), feeling of lack of air and wheezing.
• A systemic autoimmune disease called systemic lupus erythematosus, severe allergic reaction (facial edema, tongue swelling, throat swelling accompanied by airway constriction, difficult breathing, palpitations, hypotension and potentially fatal shock).

Side effects of unknown frequency (frequency cannot be estimated from available data):

• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• Liver insufficiency.
• Sensitivity to light.
• Reactions at the injection site, such as swelling, hematomas or bleeding.
• A severe skin reaction known as DRESS syndrome (by its English acronym) may occur. DRESS syndrome symptoms include skin eruption, fever, lymph node inflammation and elevated eosinophils (a type of white blood cell).

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. 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 medication.

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

Do not store at a temperature above 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. The medication must be used immediately after opening. Dispose of any unused solution.

From a microbiological standpoint, the product must be administered immediately. The medication should not be stored between 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 coloration.

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

Composition ofIbuprofeno B. Braun

• The active ingredient is ibuprofen. Each 100 ml bottle contains 600 mg of ibuprofen
• The other components (excipients) are arginine, sodium chloride, hydrochloric acid (pH adjustment), sodium hydroxide (pH adjustment) and water for injectable preparations.

Appearance ofIbuprofeno B. Braunand content of the container

Transparent, colorless to pale yellow solution for infusion, without particles.

It is presented in containers of 1, 10 and 20 LPDE 100 ml bottles with Twincap.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing:

B.Braun Medical, S.A.

Carretra de Terrassa, 121

08191 Rubí (Barcelona)

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/”