IBUPROFEN BRAUN 400 MG SOLUTION FOR INFUSION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibuprofen Braun 400 mg solution for infusion

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

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

Contents of the leaflet

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

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

Ibuprofen 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 using Ibuprofeno Braun

Do not use Ibuprofeno Braun:

• If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever experienced breathing problems, asthma, skin rash, runny nose, nasal itching, or facial swelling after taking ibuprofen, acetylsalicylic acid, or other similar painkillers (NSAIDs).
• If you have a condition that increases your tendency to bleed or if you have active bleeding.
• If you have active stomach ulcer or gastrointestinal bleeding, or a history of recurrent episodes of stomach ulcer or bleeding (two or more episodes).
• If you have ever had gastrointestinal bleeding or perforation while taking NSAIDs.
• If you have cerebral hemorrhage (cerebral hemorrhage) or any 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 medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when high doses are used. Do not exceed the recommended dose or duration of treatment.

Skin reactions:

Serious 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 ibuprofen treatment. Stop taking Ibuprofeno Braun and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.

Signs of an allergic reaction to this medicine, including breathing difficulties, 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 right away if you experience any of these signs.

Before receiving Ibuprofeno Braun, talk to your doctor if:

• You have heart problems such as heart failure, angina (chest pain), or if you have had a myocardial infarction, undergone surgical revascularization, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including transient ischemic attack or TIA).
• You have hypertension, diabetes, or hypercholesterolemia, a family history of heart disease or stroke, or if you are a smoker.
• You have recently undergone major surgery.
• You have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum. In such cases, your doctor may prescribe a stomach-protecting agent.
• You have asthma or another respiratory disorder.
• You are being treated for an infection, as this medicine may mask fever, an important sign of infection.
• You have kidney or liver disease, are over 60 years old, or have been using ibuprofen long-term, your doctor may need to perform periodic check-ups. Your doctor will advise on the frequency of these checks.
• You are dehydrated due to, for example, diarrhea or insufficient fluid intake, contact your doctor immediately, as ibuprofen may cause renal failure in this situation.
• You have severe skin reactions such as exfoliative dermatitis (redness and peeling of the skin), Stevens-Johnson syndrome, or toxic epidermal necrolysis (a severe skin disorder that can be fatal). This medicine must be discontinued immediately at the first signs of skin rash, mucosal lesions, or any other sign of allergic reaction.
• You have Crohn's disease or ulcerative colitis, as ibuprofen may worsen these conditions.
• You experience skin injury, swelling, redness, or breathing problems (suffocation), stop treatment immediately and contact your doctor or nurse.
• You have chickenpox, as complications may occur.
• You have a hereditary metabolic disorder of porphyrin (e.g., acute intermittent porphyria).
• You consume alcohol shortly before or after receiving this medicine, as adverse effects on the stomach, intestine, and nervous system may increase.
• You have fever, nasal polyps, or chronic obstructive respiratory disorders, as you have a higher risk of allergic reactions, which may present as asthma attacks (also known as analgesic-induced asthma), rapid swelling (Quincke's angioedema), or rash.
• It is important to use the lowest effective dose that relieves and controls your pain and to use it for the shortest duration necessary to control your symptoms.
• Aseptic meningitis has been reported with the use of this medicine. The risk increases if you have systemic lupus erythematosus or related conjunctivopathies.
• Concomitant use with NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided.
• If you have an infection; see the section titled «Infections» below.

Ibuprofeno Braun may mask signs of infection such as fever and pain. Therefore, Ibuprofeno Braun may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms 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 may cause serious, permanent kidney problems.

Prolonged use of painkillers may lead to headaches, which should not be treated by increasing the dose of the medicine.

Ibuprofen may alter the results of the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after treatment ends)
• Blood glucose levels (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 concentrations

If you are undergoing clinical laboratory tests and are currently taking or have recently taken ibuprofen, inform your doctor.

Skin reactions

Serious skin reactions associated with Ibuprofeno Braun treatment have been reported. Stop taking Ibuprofeno Braun and contact your doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.

Children and adolescents

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

Use of Ibuprofeno Braun with other medicines

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

Ibuprofen may affect or be affected by certain medicines. For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (e.g., celecoxib), may increase the risk of gastrointestinal ulcers and bleeding due to additive effects.
• 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 have increased blood concentrations when taken simultaneously with ibuprofen.
• Concomitant administration of methotrexate (used to treat certain malignant neoplasms or rheumatic diseases) and ibuprofen (within 24 hours) may increase methotrexate blood concentrations and risk of toxicity.
• Mifepristone (a medicine used to terminate pregnancy).
• SSRIs (selective serotonin reuptake inhibitors), such as fluoxetine, which may also increase the risk of gastrointestinal and intestinal 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 and intestinal ulcers and bleeding.
• Diuretics (medicines used to increase urine output, such as bendroflumethiazide), as NSAIDs may reduce the effectiveness of these medicines, increasing the risk of kidney disorders (using potassium-sparing diuretics with ibuprofen may lead to increased blood potassium levels).
• Medicines containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen.
• Cyclosporine and tacrolimus (used to prevent organ transplant rejection) may increase the risk of kidney damage.
• Sulfonylureas, such as glibenclamide (medicines used in the treatment of diabetes). Blood glucose levels should be monitored when these medicines are used together.
• 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 ibuprofen blood concentrations.
• Zidovudine (used to treat HIV infection), due to increased risk of joint accumulation and bruising.
• Aminoglycosides (a type of antibiotic). NSAIDs may reduce the excretion of aminoglycosides.
• Ginkgo biloba (a herbal medicine frequently used to treat dementia) may increase the risk of bleeding.

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

This medicine must 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 and your baby's tendency to bleed and delay or prolong labor more than expected.

You should not receive ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest dose for the shortest possible time.

Intravenous ibuprofen treatment should not last longer than 3 days. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

This medicine is excreted in breast milk, but may be used during breastfeeding as long as the recommended dose is used for the shortest possible duration. However, if doses above 1200 mg per day are used or for prolonged periods, your doctor may recommend discontinuing breastfeeding.

Fertility

Ibuprofen may impair fertility. If you plan to become pregnant or have difficulty conceiving, inform your doctor.

Driving and using 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 machinery, especially when combined with alcohol.

Ibuprofeno Braun contains sodium

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

3. How to use Ibuprofen Braun

This medicine is for hospital use only. 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 a doctor without delay 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. The maximum daily dose of 2400 mg in multiple doses must not be exceeded.

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

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

This medicine is indicated for short-term use, and the duration of treatment should be limited to the acute symptomatic period until oral administration becomes available. Patients should switch to oral analgesic therapy as soon as possible.

Method of administration

Intravenous route. The solution must be administered by intravenous infusion over a period of 30 minutes. Examine the solution before use. If particulate matter is observed, the solution must be discarded.

The vial is for single use only, and any unused portion must be discarded.

If you are administered more Ibuprofen Braun than you should

If you have been given more Ibuprofen Braun than you should, or if a child has accidentally ingested the medicine, contact a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken.

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

Problems such as headache, dizziness, lightheadedness, and loss of consciousness, as well as abdominal pain, nausea and vomiting, gastrointestinal or intestinal bleeding, and disturbances in liver and kidney function may occur. Hypotension, respiratory problems, and bluish discoloration of the skin or mucous membranes (cyanosis) may also occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

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

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

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

Cases of edema (fluid accumulation 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 heart attack (myocardial infarction) or stroke.

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

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

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

Very rare cases of worsening inflammation associated with infections (e.g., development of necrotizing fasciitis) have also been reported, concurrent with the use of NSAIDs.

In exceptional cases, severe skin infections and complications in soft tissues during varicella virus infection.

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, which may cause anemia in exceptional cases

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

• Dizziness
• Skin rash
• Pain and burning sensation at the site of administration
• Gastroduodenal ulcer, which 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 (difficulty falling asleep), agitation, irritability or fatigue, anxiety, and restlessness
• Visual disturbances
• Tinnitus (ringing in the ears)
• Reduced urine output and, especially in patients with hypertension or renal insufficiency, nephrotic syndrome and interstitial nephritis, which could 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 (may affect up to 1 in 1,000 people):

• Reversible toxic amblyopia (double vision)
• Hearing disorders
• Narrowing of the esophagus (of the blood vessels in the throat), complications from diverticula formation in the large intestine, and nonspecific hemorrhagic colitis. If bleeding occurs in the stomach or intestine, this may lead to anemia
• Kidney tissue damage (papillary necrosis), especially with prolonged treatment, and increased serum concentration of uric acid in blood
• Yellowing of the skin or whites of the eyes, hepatic dysfunction, liver damage (especially with prolonged treatment), and acute hepatitis (inflammation of the liver)
• Psychotic disorders, nervousness, irritability, confusion or disorientation, and depression
• Neck stiffness

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

• Disorders in blood cell formation (anemia, leukopenia, thrombocytopenia, pancytopenia, and agranulocytosis). Initial symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, acute fatigue, nosebleeds, and skin bleeding.
• Palpitations (rapid heartbeat), 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 connective tissue disease) appear to be more predisposed.
• Inflammation of the esophagus (throat) or pancreas and intestinal narrowing
• Asthma, difficulty breathing (bronchospasm), labored breathing, and wheezing
• Systemic lupus erythematosus (an autoimmune disease), severe allergic reaction (facial swelling, swelling of the tongue, swelling of the throat, accompanied by airway constriction, difficulty breathing, palpitations, hypotension, and potentially fatal shock)

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Hepatic failure
• Reactions at the injection site, such as swelling, bruising, or bleeding
• A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell)
• Generalized red, scaly rash with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno Braun immediately 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen Braun

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

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Ibuprofen Braun

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

Nature of the product and pack contents

Ibuprofen Braun is a clear, particle-free solution, ranging from colourless to pale yellow.

The solution is packaged in 100 ml LDPE vials with an external cap, available in pack sizes of 1, 10 and 20 vials.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

• Braun Medical, S.A.

Ctra. de Terrassa 121

08191 Rubí (Barcelona)

Spain

Manufacturer:

B.Braun Medical, S.A.

Ctra. de Terrassa, 121, Rubí, Barcelona

08191 - Spain

or

Farmalider, S.A.

C/ Aragoneses, 15

28108 – Alcobendas-Madrid

(Spain)

Latest 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/