IBUPROFENO BRAUN 400 MG SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Ibuprofeno Braun 400 mg Solution for Infusion

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, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ibuprofeno Braun and what is it used for
2. What you need to know before you use Ibuprofeno Braun
3. How to use Ibuprofeno Braun
4. Possible side effects
5. Storage of Ibuprofeno Braun
6. Contents of the pack and other information

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

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

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

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

Do not use Ibuprofeno Braun:

• If you are allergic to ibuprofeno or any of the other ingredients of this medicine (listed in section 6).
• If you have ever had any respiratory problems, asthma, skin rash, runny nose, or facial swelling after taking ibuprofeno, acetylsalicylic acid, or other similar painkillers (NSAIDs).
• If you have a disease that increases your tendency to bleed or have an active bleed.
• If you have active stomach or duodenal ulcers or a history of recurrent ulcers or bleeding in the stomach or duodenum (two or more episodes).
• If you have ever had a bleed or perforation in the stomach or intestine when taking NSAIDs.
• If you have had a brain hemorrhage (cerebrovascular hemorrhage) or other active bleeding.
• If you have severe kidney, liver, or heart disorders.
• If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• If you are in the last trimester of pregnancy.

Warnings and Precautions

Consult your doctor or nurse before starting to use this medicine.

Painkillers and anti-inflammatory drugs like ibuprofeno may be associated with a slightly increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

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 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, facial swelling, and chest pain, have been reported with ibuprofeno. Stop taking Ibuprofeno Braun immediately and contact your doctor or emergency medical services if you notice any of these signs.

Before you are given Ibuprofeno Braun, discuss your treatment with your doctor:

• If you have heart problems, such as heart failure, angina (chest pain), or if you have had a heart attack, had a surgical revascularization, had peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries), or had a stroke (including a transient ischemic attack or TIA).
• If you have high blood pressure, diabetes, or high cholesterol, have a family history of heart disease or stroke, or are a smoker.
• If you have recently undergone major surgery.
• If you have had an ulcer, bleeding, or perforation of the stomach or duodenum. 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 medicine may mask fever, which is an important sign of infection.
• If you have kidney or liver disease, are over 60 years old, or have been taking ibuprofeno 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 insufficient fluid intake, contact your doctor immediately, as ibuprofeno may cause kidney failure as a result of dehydration.
• If you have severe skin reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The use of this medicine should be stopped immediately at the first symptoms of skin rash, mucosal lesions, or any other sign of allergic reaction.
• If you have Crohn's disease or ulcerative colitis, as ibuprofeno may worsen these diseases.
• If you experience any injury, swelling, or redness of the skin or respiratory problems (shortness of breath), stop treatment with the medicine 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 shortly before or after being given this medicine, the adverse effects related to the stomach, intestine, and nervous system may increase.
• If you have fever, nasal polyps, or chronic obstructive respiratory diseases, you have a higher risk of allergic reactions, which can occur in the form of asthma attacks (also called analgesic asthma), rapid swelling (angioedema), or rash.
• It is important that you are given the lowest dose that relieves and controls your pain and that you are not given it for longer than necessary to control your symptoms.
• With the use of this medicine, some cases of aseptic meningitis have been reported. The risk increases if you have systemic lupus erythematosus and related conjunctivopathies.
• The simultaneous use of NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
• If you have an infection; see the "Infections" section below.

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

Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

In general, the use of (different types of) painkillers can cause serious and permanent kidney problems.

With prolonged use of painkillers, headache may occur, which should not be treated with an increase in the dose of the medicine.

Ibuprofeno may alter the results of the following laboratory tests:

• Bleeding time (may be prolonged 1 day after the end of treatment)
• Blood glucose values (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen, serum creatinine, and serum potassium (may increase)
• Liver function tests; increased transaminase levels

If you are going to have clinical tests, are taking ibuprofeno, or have taken it recently, inform your doctor.

Skin Reactions

Severe skin reactions have been reported with Ibuprofeno Braun treatment. Stop taking Ibuprofeno Braun and consult your doctor immediately if you experience any skin rash, mucosal lesions, blisters, and other signs of allergy, as these can be the first signs of a severe skin reaction. See section 4.

Children and Adolescents

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

Use of Ibuprofeno Braun with Other Medicines

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

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

• Other non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors (e.g., celecoxib), may increase the risk of gastrointestinal ulcers and bleeding due to an additive effect.
• Anticoagulant medicines (i.e., medicines to prevent or avoid blood clot formation, such as acetylsalicylic acid, warfarin, or ticlopidine).
• Cardiac glycosides such as digoxin (used to treat heart failure), phenytoin (used to treat epilepsy), or lithium (used to treat depression), which may increase their blood levels when taken simultaneously with ibuprofeno.
• The simultaneous administration of methotrexate (used to treat certain types of cancer or rheumatic diseases) and ibuprofeno (within 24 hours) may increase methotrexate blood levels and the risk of methotrexate toxicity.
• Mifepristone (a medicine used to terminate pregnancy).
• Selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, may also increase the risk of gastrointestinal bleeding.
• Medicines that lower high blood pressure (angiotensin-converting enzyme inhibitors [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 gastrointestinal ulcers and bleeding.
• Diuretics (medicines used to increase urine production, such as bendroflumethiazide), as NSAIDs may reduce the effect of these medicines and increase the risk of kidney disorders (the use of potassium-sparing diuretics with ibuprofeno may cause an increase in potassium blood levels).
• Medicines containing probenecid or sulfinpyrazone may delay the excretion of ibuprofeno.
• Cyclosporin and tacrolimus (used to prevent organ transplant rejection) may increase the risk of kidney damage.
• Sulfonylureas, such as glibenclamide (medicines used to treat diabetes). When these medicines are used together, blood glucose levels should be monitored.
• Antibiotics belonging to the quinolone group, such as ciprofloxacin, due to an increased risk of seizures (epileptic fits).
• Voriconazole and fluconazole (CYP2C9 inhibitors) (used to treat fungal infections) may increase ibuprofeno blood levels.
• Zidovudine (used to treat HIV infection), due to an increased risk of blood accumulation in the joints and the appearance of hematomas.
• Aminoglycosides (a type of antibiotic). NSAIDs may decrease the excretion of aminoglycosides.
• Ginkgo biloba(a medicinal plant often used to treat dementia) may increase the risk of bleeding.

Other medicines may also affect or be affected by ibuprofeno treatment. Therefore, you should always consult your doctor or nurse before being given ibuprofeno with other medicines.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.

Pregnancy

This medicine should not be given 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 tendency and that of your baby to bleed and delay or prolong delivery more than expected.

You should not receive ibuprofeno during the first 6 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 possible time.

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 the 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.

Breast-feeding

This medicine is excreted in breast milk, but it can be used during breast-feeding, provided that the recommended dose is used for the shortest possible time. However, if doses above 1200 mg per day are used or for longer periods, your doctor may recommend that you stop breast-feeding.

Fertility

Ibuprofeno may make it more difficult to become pregnant. If you are planning to become pregnant or are having trouble becoming pregnant, you should tell your doctor.

Driving and Using Machines

Short-term or acute treatment does not require special precautions. However, with prolonged treatment, adverse effects such as fatigue and dizziness may occur, which can affect the ability to drive or use machines, especially if combined with alcohol.

Ibuprofeno Braun Contains Sodium

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

3. How to Use Ibuprofeno Braun

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

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

Dosage

Adults

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

The recommended daily dose is 1200 mg. The maximum daily dose should not exceed 2400 mg in multiple doses.

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

Adequate hydration of the patient should be maintained to minimize the risk of potential kidney-related adverse reactions.

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 switch to oral analgesic treatment as soon as possible.

Method of Administration

Intravenous route. The solution should be administered by intravenous infusion over a period of 30 minutes. Examine the solution before use. If you observe particles in suspension, 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 taken the medicine, consult a doctor immediately or go to the nearest hospital for advice on the risk and the measures to be taken.

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

Problems such as headache, dizziness, feeling of dizziness, and loss of consciousness, as well as abdominal pain, nausea, and vomiting, gastrointestinal bleeding, and liver and kidney problems may occur. You may also experience hypotension, respiratory problems, and bluish discoloration of the skin or mucous membranes (cyanosis).

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

4. Possible Adverse Effects

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

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to treat the symptoms. You may suffer from one or more of the known adverse effects of NSAIDs (see the following information). If you experience any of these adverse effects, you should stop taking this medicine and contact a doctor as soon as possible. Elderly patients who take this medicine have a higher risk of suffering from disorders related to adverse effects.

The most frequently observed adverse effects are gastrointestinal adverse reactions (affecting the stomach and intestine). Peptic ulcers (digestive or intestinal ulcers), perforation (a hole produced in the stomach or intestinal wall), or gastrointestinal bleeding, sometimes fatal, especially in the elderly population, may occur. Nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, tarry 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. Gastritis (inflammation of the stomach) has been observed less frequently. It is noteworthy that the risk of gastrointestinal bleeding depends on the dose interval and treatment duration.

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

Very rare cases of allergic reactions (including infusion-site reactions and anaphylactic shock) and severe cutaneous adverse effects, alopecia (hair loss), photosensitivity reactions, and allergic vasculitis (inflammation of a blood vessel) have been reported.

Stop taking ibuprofen and consult a doctor immediately if you notice any of the following symptoms:

• Round or target-shaped, reddish, 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).
• Widespread skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• Widespread, scaly, 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).

Very rare cases of exacerbation of inflammation-related infections (e.g., development of necrotizing fasciitis) concurrent with NSAID use have also been described.

In exceptional cases, severe skin infections and soft tissue complications during chickenpox.

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

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

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

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

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

• Insomnia (difficulty sleeping), agitation, irritability, or fatigue, anxiety, and restlessness
• Visual disturbances
• Tinnitus (ringing in the ears)
• Reduced urine production and, especially in patients with arterial 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 rash
• Allergic reactions, accompanied by skin rash and pruritus, as well as asthma attacks (possibly accompanied by a drop in blood pressure)

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

• Reversible toxic amblyopia (double vision)
• Hearing disorders
• Esophageal narrowing (of the throat blood vessels), complications of diverticula in the large intestine, and non-specific hemorrhagic colitis. In the case of stomach or intestinal bleeding, these can cause anemia
• Kidney 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
• Stiffness of the neck

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

• Disorders of blood cell formation (anemia, leukopenia, thrombocytopenia, pancytopenia, and agranulocytosis). The first symptoms are fever, sore throat, superficial oral ulcers, pseudo-flu-like symptoms, acute fatigue, nosebleeds, and skin bleeding.
• Palpitations (rapid heartbeat), heart failure, and myocardial infarction
• Arterial hypertension
• Aseptic meningitis (stiff neck, headache, nausea, vomiting, fever, or confusion). Patients with autoimmune disorders (systemic lupus erythematosus and mixed conjunctivitis) seem to have a higher predisposition.
• Inflammation of the esophagus (throat) or pancreas and narrowing of the intestine
• Asthma, difficulty breathing (bronchospasm), difficult breathing, and wheezing
• Systemic lupus erythematosus (an autoimmune disease), severe allergic reaction (facial edema, tongue swelling, throat swelling, accompanied by constriction of the airways, difficult breathing, palpitations, hypotension, and potentially fatal shock)

Adverse 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 failure
• Injection-site reactions, such as swelling, hematoma, or bleeding
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell)
• Generalized red scaly rash with bumps under the skin and blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen Braun if you experience these symptoms and seek medical attention immediately. See also section 2
• Skin becomes sensitive to light

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 leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) 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 Braun

Keep this medicine out of sight and reach of children.

Do not store above 30°C. Do not refrigerate or freeze.

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

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

6. Package Contents and Additional Information

Composition of Ibuprofeno Braun

• The active ingredient is ibuprofen. Each 100 ml vial contains 400 mg of ibuprofen.
• The other ingredients (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

Ibuprofeno Braun is a clear, colorless to pale yellow solution, free of particles in suspension.

The solution is packaged in LDPE vials, 100 ml capacity, with an outer cap, in presentations of 1, 10, and 20 vials.

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 (Barcelona)

Spain

Manufacturer:

B.Braun Medical, S.A.

Ctra. Terrassa, 121, Rubí, Barcelona

08191 - Spain

or

Farmalider, S.A.

c/ Aragoneses, 15

28108 – Alcobendas - Madrid

(Spain).

Last Revision of this Leaflet: January 2025

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