Label: information for the patient

Ibuprofen Braun 400 mg solution for infusion

Read this label carefully before starting to take this medicine, 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, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

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

3.How to use Ibuprofen Braun

4.Possible adverse effects

5.Storage of Ibuprofen 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 theshort-term symptomatic treatment of moderate acute pain and fever, when oral administration is inappropriate.

No use IbuprofenoBraun:

• 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, skin rash, runny nose and itchy nose or facial swelling after taking ibuprofen, acetylsalicylic acid, and other similar analgesics (NSAIDs).
• -If you have a disease that increases your tendency to bleed or have an active bleeding.
• -If you have active stomach ulcers or a history of recurrent stomach ulcers or bleeding (two or more episodes).
• -If you have ever had stomach or intestinal bleeding or lacerations while taking NSAIDs.
• -If you have active cerebral hemorrhage (cerebrovascular accident) 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 this medication.

Nonsteroidal anti-inflammatory drugs (NSAIDs) 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.

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 generalized acute pustular psoriasis (AGEP) have been reported with ibuprofen treatment. Stop taking Ibuprofeno Braun and seek medical attention 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, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop taking Ibuprofeno Braun immediately and contact your doctor or emergency medical services if you notice any of these signs.

Before administering Ibuprofeno Braun, discuss the treatment with your doctor:

• If you have heart problems, such as heart failure, angina (chest pain), or if you have had a myocardial infarction, have undergone coronary revascularization, have had peripheral artery disease (poor circulation in the legs or feet due to artery narrowing or blockage), or have had a stroke (including transient ischemic attack or TIA).
• If you have hypertension, diabetes, or hypercholesterolemia, have a family history of heart disease or stroke, or if you are a smoker.
• If you have recently undergone major surgery.
• If you have had or developed stomach or duodenal ulcers, bleeding, or perforation. In these cases, your doctor will decide whether to prescribe a stomach protector.
• If you have asthma or another respiratory disorder.
• If you are receiving treatment for an infection, as this medication may mask fever, an important sign of infection.
• If you have kidney or liver disease, are over 60 years old, or have been taking ibuprofen for a long time, your doctor may need to perform regular check-ups. Your doctor will indicate the frequency of these checks.
• If you are dehydrated due to, for example, diarrhea or inadequate fluid intake, contact your doctor immediately, as ibuprofen may cause renal insufficiency due to dehydration.
• If you have severe skin reactions, such as exfoliative dermatitis (skin redness and peeling), Stevens-Johnson syndrome, and toxic epidermal necrolysis (a severe skin disorder that can be fatal). The use of this medication should be discontinued immediately at the first signs of skin rash, mucous membrane lesions, or any other signs of allergic reaction.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen may worsen these conditions.
• If you experience any skin lesions, swelling, or redness, or respiratory problems (asphyxia), stop the treatment immediately and contact your doctor or nurse.
• If you have chickenpox, as complications may occur.
• If you have a hereditary disorder of porphyrin metabolism (e.g., acute intermittent porphyria).
• If you consume alcohol before or after administration, it may increase the adverse effects related to the stomach, intestines, and nervous system.
• If you have fever, nasal polyps, or chronic obstructive respiratory disorders, you have a higher risk of allergic reactions, which may present as asthma attacks (also known as analgesic asthma), rapid swelling (Quincke's angioedema), or rash.
• It is essential to administer the lowest dose that relieves and controls your pain and not to administer it for longer than necessary to control your symptoms.
• Some cases of aseptic meningitis have been reported with the use of this medication. The risk increases if you have systemic lupus erythematosus and conjunctivitis-related disorders.
• The simultaneous use of NSAIDs, including COX-2 inhibitors, should be avoided.
• If you have an infection; see the "Infections" heading later.

Ibuprofeno Braun may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofeno 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 infection symptoms persist or worsen, consult a doctor without delay.

The adverse reactions can be minimized by using the lowest effective dose for the shortest period necessary to control symptoms.

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

Prolonged use of analgesics may cause headache, which should not be treated with an increase in medication dosage.

Ibuprofeno may affect or be affected by the following laboratory tests:

• Bleeding time (may be prolonged 1 day after treatment completion)
• Blood glucose levels (may decrease)
• Creatinine clearance (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 to undergo clinical analysis, are taking ibuprofen, or have taken it recently, inform your doctor.

Skin Reactions

Severe skin reactions associated with Ibuprofeno Braun treatment have been reported. Stop taking Ibuprofeno Braun and seek medical attention immediately if you notice any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Children and Adolescents

The safety and efficacy of this medication have not been established in children and adolescents. This medication is not recommended for use in children and adolescents under 18 years of age.

Use of Ibuprofeno Braun with Other Medications

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

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

• Others anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (e.g., celecoxib), may increase the risk of stomach ulcers and bleeding.
• Anticoagulant medications (i.e., medications to prevent or prevent blood clotting, such as acetylsalicylic acid, warfarin, or ticlopidine).
• Cardiotonic glycosides such as digoxin (used to treat heart failure), phenytoin (used to treat epilepsy), or lithium (used to treat depression) may increase their blood concentrations when taken simultaneously with ibuprofen.
• The simultaneous administration of methotrexate (used to treat certain types of cancer or rheumatic diseases) and ibuprofen (within 24 hours) may increase methotrexate blood concentrations and the risk of toxicity.
• Mifepristone (a medication used to interrupt pregnancy).
• SSRIs (selective serotonin reuptake inhibitors), such as fluoxetine, may increase the risk of gastrointestinal and intestinal bleeding.
• Medications that lower elevated blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, and angiotensin II receptor antagonists, such as losartan).
• Corticosteroids (such as hydrocortisone) (used to treat inflammation), as they increase the risk of stomach ulcers or bleeding.
• Diuretics (medications used to urinate, 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 ibuprofen may increase blood potassium concentrations).
• Medications containing probenecid or sulfinpyrazone may delay ibuprofen excretion.
• Cyclosporine and tacrolimus (used to prevent organ transplant rejection) may increase the risk of kidney damage.
• Sulfonylureas, such as glibenclamide (used to treat diabetes), when used simultaneously, should be monitored for blood glucose levels.
• Quinolone antibiotics, such as ciprofloxacin, may increase the risk of seizures (epileptic crises).
• Voriconazole and fluconazole (CYP2C9 inhibitors) (used to treat fungal infections) may increase ibuprofen blood concentrations.
• Zidovudine (used to treat HIV infection), may increase the risk of joint accumulation and hematomas.
• Aminoglycosides (a type of antibiotic). NSAIDs may decrease aminoglycoside excretion.
• 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 ibuprofen treatment. Therefore, always consult your doctor or nurse before administering ibuprofen with other medications.

Pregnancy, Lactation, and Fertility

Consult your doctor or nurse if you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant.

Pregnancy

This medication should not be administered during the last 3 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 delivery.

This medication should not be taken during the first 6 months of pregnancy unless 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 time possible.

Parenteral ibuprofen treatment should not exceed 3 days. From week 20 of pregnancy, ibuprofen 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 a period longer 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 time possible.However, if higher doses (over 1200 mg per day) or longer treatment periods are used, your doctor may recommend that you stop 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 Machines

Short-term or acute treatment does not require special precautions. However, prolonged treatment may cause adverse effects such as fatigue and dizziness, which may affect your ability to drive or operate machines, especially when combined with alcohol.

Ibuprofeno Braun contains sodium

This medication contains 358 mg of sodium (main component of table salt/for cooking) in each 100 ml bottle of solution. This is equivalent to 17.9% of the recommended daily maximum sodium intake for an adult.

The use of this medication is exclusively hospital-based. A doctor or nurse will administer this medication to you.

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

Dosage

Adults

The recommended dose is 400 mg of ibuprofen, administered intravenously over 30 minutes, every 6 hours as needed.

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

The lowest effective dose and the shortest duration possible should be used according to each patient's needs. After observing the initial response to treatment, the dose and administration frequency should be adjusted according to each patient's needs.

Appropriate 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 as soon as possible.

Administration form

Intravenous route. The solution should be administered via intravenous infusion over a period of 30 minutes. Examine the solution before use. If particles in suspension are observed, the solution should be discarded.

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

If you are given more Ibuprofeno Braun than you should

If you have taken more Ibuprofeno Braun than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or visit the nearest hospital to inform yourself about the risk and seek advice on the measures to be taken.

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

Other problems that may arise include headache, dizziness, feeling of dizziness, and loss of consciousness, as well as abdominal pain, nausea, and vomiting, gastrointestinal or intestinal bleeding, and problems with liver and kidney function. You may also experience hypotension, respiratory problems, and blue discoloration of the skin or mucous membranes (cyanosis).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

The side effects can be minimised by using the lowest effective dose for the shortest period of time necessary to treat the symptoms. You may experience one or more of the known side effects of NSAIDs (see the information below). If you experience any of these side effects, you should stop taking this medicine and contact a doctor as soon as possible. Patients over 65 years old who take this medicine have a higher risk of experiencing some adverse effects-related disorders.

The side effects that have been observed most frequently are gastrointestinal adverse reactions (affecting the stomach and intestines). They can cause peptic ulcers (digestive or intestinal ulcers), perforation (a hole produced in the stomach or intestinal wall) or digestive or intestinal bleeding, sometimes fatal, especially in the elderly population. Nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, black stools, vomiting blood, ulcerative stomatitis (inflammation of the oral mucosa, accompanied by ulceration), exacerbation of colitis (inflammation of the large intestine) and Crohn's disease have been observed. Gastritis (inflammation of the stomach) 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 fluids in tissues), hypertension and heart failure related to NSAID treatment have been reported. Medicines 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 see a doctor 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 reactions can be preceded by fever and pseudogripal symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalised skin eruption, high body temperature and enlarged lymph nodes (DRESS syndrome).
• Generalised scaly, red skin eruption with subcutaneous nodules and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised pustular psoriasis).

Very rare cases of exacerbation of inflammatory conditions related to infections (e.g. development of necrotising fasciitis) concurrent with NSAID use have also been described.

In rare cases, 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):

• Insomnia (sleep problems), agitation, irritability or fatigue, anxiety and restlessness
• Visual disturbances
• Tinnitus (ringing in the ears)
• Reduced urine production and, especially in patients with hypertension or renal insufficiency, 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 toxic amblyopia (double vision)
• Auditory disturbances
• Esophageal stricture (narrowing of the esophagus), complications of diverticulum formation in the large intestine and non-specific colitis. In the case of bleeding in the stomach or intestines, these may cause anemia
• Renal tissue damage (papillary necrosis), especially with prolonged treatment, and increased serum uric acid concentration in blood
• Jaundice or yellowing of the skin or eyes, liver dysfunction, liver damage (especially with prolonged treatment) and acute hepatitis (inflammation of the liver)
• 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, leucopenia, thrombocytopenia, pancitopenia and agranulocytosis). The first symptoms are fever, sore throat, superficial oral ulcers, pseudogripal symptoms, acute fatigue, nasal bleeding and skin bleeding.
• Palpitations (rapid heartbeat), heart failure and myocardial infarction
• Hypertension
• Asymptomatic 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 esophagus or pancreas and intestinal narrowing
• Asthma, difficulty breathing (bronchospasm), difficult breathing and wheezing
• Systemic lupus erythematosus (an autoimmune disease), severe allergic reaction (facial swelling, tongue swelling, throat swelling, accompanied by airway constriction, difficult breathing, palpitations, hypotension and potentially fatal shock)

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

• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• Liver insufficiency
• Reactions at the injection site, such as swelling, hematomas or bleeding
• A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin eruption, lymph node inflammation and elevated eosinophils (a type of white blood cell)
• Generalised red, scaly skin eruption with subcutaneous nodules and blisters located mainly in skin folds, the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised pustular psoriasis). Stop taking Ibuprofen Braun if you experience these symptoms and seek medical attention immediately. See section 2
• The skin becomes sensitive to light

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 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.

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

Composition of Ibuprofen Braun

• The active ingredient is ibuprofen. Each 100 ml bottle contains 400 mg of ibuprofen.
• The other components (excipients) are L-arginine, sodium chloride, hydrochloric acid (pH adjustment), sodium hydroxide (pH adjustment), and water for injection.

Appearance of the product and content of the container

Ibuprofen Braun is a transparent, colorless to pale yellow solution, and free of particles in suspension.

The solution is packaged in LDPE bottles, 100 ml in capacity, with an external head, in presentations of 1, 10, and 20 bottles.

Only some sizes of packaging 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 (Barcelona)

Spain

Responsible for manufacturing:

B. Braun Medical, S.A.

Ctra, Terrassa, 121, Rubí, Barcelona

08191 - Spain

or

Farmalider, S.A.

c/ Aragoneses, 15

28108 –Alcobendas-Madrid

Spain.

Last review of this prospectus: April 2024

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