IBUPROFEN B. BRAUN 600 mg SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Ibuprofeno B. Braun 600 mg Solution for Infusion

Ibuprofeno

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

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

1. What is Ibuprofeno B. 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 taking Ibuprofeno B. Braun

Do not use Ibuprofeno B. 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, rhinitis, angioedema, or urticaria associated with the consumption of acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you have coagulation disorders.
• If you have peptic ulcers and/or active or recurrent gastrointestinal bleeding (two or more episodes of ulceration or bleeding).
• If you have had a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
• If you have active cerebral 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 take Ibuprofeno B. Braun.

Pain relievers 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 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 acute generalized exanthematous pustulosis (AGEP) have been reported with Ibuprofeno B. Braun. Stop taking Ibuprofeno B. 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 and neck swelling (angioedema), and chest pain, have been reported with ibuprofeno. Stop taking Ibuprofeno B. Braun immediately and contact your doctor or emergency medical services if you notice any of these signs.

Tell your doctor:

• If you have edema (fluid retention).
• If you have or have had heart problems or high blood pressure.
• Your doctor will monitor you more closely if you receive ibuprofeno after major surgery.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by severe abdominal pain or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcers, and in elderly patients. In these cases, your doctor may consider the possibility of associating a stomach protective medication.
• If you have had kidney or liver disease.
• If you have asthma or any other respiratory disorder.
• If you have kidney or liver disease, or if you are over 60, your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofeno may cause kidney failure as a consequence of dehydration.
• If you have Crohn's disease or ulcerative colitis, as medications of this type may worsen these conditions.
• If you are taking medications that affect blood coagulation, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid, or selective serotonin reuptake inhibitors. You should also discuss the use of other medications that may increase the risk of bleeding, such as corticosteroids and antidepressants.
• If you are being treated with diuretics (medications to increase urine production), as your doctor needs to monitor your kidney function.
• If you have an infection, see the "Infections" section below.
• There have been reports of aseptic meningitis with the use of this medicine, and the risk is higher if you have systemic lupus erythematosus and other collagen diseases.
• If you notice lesions, swelling, or redness of the skin, breathing difficulties (asphyxia), stop using the medication immediately and inform your doctor or nurse.
• If you have chickenpox, as complications may arise.
• If you have acute intermittent porphyria.
• It is essential to use the smallest dose that relieves/pain and not to take this medication for longer than necessary to control your symptoms.

• Infections

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

Ibuprofeno may alter the results of the following laboratory tests:

• Bleeding time (may be prolonged 1 day after treatment discontinuation)
• 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 laboratory tests, are taking ibuprofeno, or have taken it recently, inform your doctor.

In general, the use of (different types of) pain relievers can cause severe and permanent kidney problems.

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

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

The simultaneous use of NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.

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

Using Ibuprofeno B. Braun with other medications

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

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

• Other non-steroidal anti-inflammatory drugs (NSAIDs), as they may increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• 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 its blood levels and the risk of toxicity from this medication. Your doctor may advise you not to take ibuprofeno if you are receiving high-dose methotrexate treatment.
• Mifepristone (abortion inducer).
• Selective serotonin reuptake inhibitors and antiplatelet agents may also increase the risk of gastrointestinal bleeding.
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin-II receptor antagonists like losartan)
• Medications used to increase urine production (diuretics like bendroflumethiazide), as NSAIDs may reduce the effect of these medications, increasing the risk of kidney disorders (the use of potassium-sparing diuretics with ibuprofeno may cause an increase in blood potassium levels).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Medications used to treat inflammation (corticosteroids like hydrocortisone), as they increase the risk of gastrointestinal ulcers and bleeding.
• Diuretics, as they may increase the risk of kidney 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 kidney damage.
• Sulfonylureas, medications used for diabetes. It is recommended to monitor blood glucose levels when used together.
• Quinolone antibiotics, due to an increased risk of developing convulsions.
• Voriconazole, fluconazole (CYP2C9 inhibitors) may increase ibuprofeno blood levels.
• Medications for HIV (zidovudine), due to an increased risk of blood accumulation in joints and bruising in HIV-positive hemophiliacs.
• Chronic alcohol consumption may increase the risk of significant stomach and intestinal side effects, including bleeding.
• A type of antibiotic (aminoglycosides). NSAIDs may decrease the excretion of aminoglycosides and increase their toxicity.
• Ginkgo biloba(a medicinal plant frequently used to treat dementia) may increase the risk of bleeding.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking 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 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 lead to low levels of amniotic 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 monitoring.

Breastfeeding

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

Fertility

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

Driving and using machines

In short or occasional treatments, no special precautions are necessary. However, in more prolonged treatments, the occurrence of side effects such as fatigue and dizziness may impair the ability to drive vehicles and/or use machines. This is especially important when combined with alcohol.

Ibuprofeno B. Braun contains sodium

This medication contains 360 mg of sodium (main component of table/cooking salt) per vial. This is equivalent to 18% of the maximum recommended daily sodium intake for an adult.

3. How to use Ibuprofeno B. Braun

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

Follow your doctor's instructions for administration of this medication exactly. In case of doubt, consult your doctor again.

Your doctor will administer the lowest effective dose for the shortest possible time necessary to avoid side effects. Your doctor will also ensure that you have ingested sufficient fluids to minimize the risk of side effects on the kidneys.

Posology

Adults

The recommended dose is 600 mg of ibuprofeno every 6-8 hours.

The recommended daily dose is 1200-1600 mg in multiple doses. Do not exceed the maximum daily dose of 2400 mg in multiple doses.

The lowest effective dose should be used for the shortest 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 patient hydration should be maintained to minimize the risk of possible adverse reactions to the kidneys.

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.

Method of administration

Intravenous route

The solution is transparent. Before administration, the solution should be visually inspected to ensure that it is transparent and colorless. It should not be used if it contains suspended particles or changes in coloration 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 think you have received more ibuprofeno than you should, inform your doctor or nurse immediately.

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

You may also experience hypotension, blue discoloration of the skin or mucous membranes (cyanosis), gastrointestinal or intestinal bleeding, as well as liver and kidney problems.

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.

4. Possible Adverse Effects

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

The adverse effects that have been observed with greater frequency affect the stomach and intestine. Peptic ulcers (digestive or intestinal ulcers), holes in the stomach or intestinal wall (perforation), or bleeding from the stomach or intestines, sometimes fatal, may occur. Indigestion, tarry stools, vomiting blood, inflammation of the oral mucosa accompanied by ulceration (ulcerative stomatitis), exacerbation of colitis, and Crohn's disease have been reported. 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 duration of treatment.

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 your doctor immediately if you notice any of the following symptoms:

• Circular or target-shaped, reddish, and 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 symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread skin rash, high body temperature, and enlargement of lymph nodes (DRESS syndrome).
• Widespread, scaly, and 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):

• Difficulty sleeping (insomnia), agitation, irritability, or fatigue, anxiety, and restlessness.
• Visual disturbances.
• Ringing in the ears (tinnitus).
• Reduced urine production and fluid accumulation in tissue (edema), especially in patients with arterial hypertension or renal insufficiency, symptoms due to kidney damage (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 double vision (toxic amblyopia).
• Hearing disorders.
• Narrowing of the esophagus (of the throat blood vessels), complications of diverticula in the large intestine, and non-specific hemorrhagic colitis characterized by cramps and intense diarrhea. In the case of stomach or intestinal bleeding, these can cause anemia.
• Kidney tissue damage (papillary necrosis) and increased serum uric acid concentration in blood.
• Yellowing of the skin or the whites of the eyes, liver dysfunction, liver damage, and acute liver inflammation (hepatitis).
• 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 symptoms, acute fatigue, nosebleeds, and skin bleeding.
• Rapid heartbeat (palpitations), 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 conjunctivopathy) seem to have a greater predisposition.
• Inflammation of the esophagus or pancreas and narrowing of the intestine.
• Hair loss.
• Allergic vasculitis.
• Asthma, difficulty breathing (bronchospasm), feeling of shortness of breath, and wheezing.
• An autoimmune disease called systemic lupus erythematosus, 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.
• Skin becomes sensitive to light.
• Reactions at the injection site, such as swelling, bruising, or bleeding.
• A severe skin reaction known as DRESS syndrome (from its English acronym) may occur. Symptoms of DRESS syndrome include skin rash, fever, 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 skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno B.Braun if you experience these symptoms and seek immediate medical attention. See also section 2.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, 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 B. 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.

For single use. The medicine must be used immediately after opening. Any unused solution must be discarded.

From a microbiological point of view, the product must be administered immediately. The medicine should not be stored between 2-8°C. Otherwise, the time elapsed and the conditions of use are the responsibility of the person who prepares/administers it.

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

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibuprofeno B. Braun

• The active ingredient is ibuprofen. Each 100 ml vial 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 of Ibuprofeno B. Braun and Package Contents

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

B.Braun Medical, S.A.

Carretra de Terrassa, 121

08191 Rubí (Barcelona)

Spain

Last Revision of this Prospectus:January 2025

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