IBUPROFENO BRAUN 600 mg SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Ibuprofeno Braun 600mg solution for infusion

ibuprofen

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 or nurse.

• If you experience side effects, consult your doctor or nurse, even if they are 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 start using Ibuprofeno Braun
3. How to use Ibuprofeno Braun
4. Possible side effects
5. Storage of Ibuprofeno Braun
6. Contents of the pack and further information

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

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugsor NSAIDs.

This medicine is indicated in adults for the short-term symptomatic treatment of moderate acute pain, when clinically justified, intravenous administration is indicated when other routes of administration are not possible.

2. What you need to know before you start using Ibuprofeno Braun

Do not use Ibuprofeno Braun:

• If you are allergic to ibuprofen 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, and itching of the nose after taking ibuprofen, acetylsalicylic acid, and other similar painkillers (NSAIDs).
• If you have a disease that increases your tendency to bleed or have an active bleed.
• If you have an active stomach or duodenal ulcer or a history of recurrent ulcers (two or more episodes).
• If you have ever had a bleed or perforation in the stomach or intestine when taking NSAIDs.
• If you have cerebral bleeding (cerebrovascular hemorrhage) or other active bleeding.
• If you have severe kidney, liver, or heart disease.
• 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 ibuprofen 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 ibuprofen 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 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 you are given Ibuprofeno Braun, discuss treatment with your doctor:

• If you have heart problems, such as heart failure, angina (chest pain), or if you have had a heart attack, have had surgical revascularization, have had peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries), or have had a stroke (including a transient ischemic attack or TIA).
• If you have high blood pressure, diabetes, 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 other respiratory disorders.
• If you have an infection; see the "Infections" section below.
• If you have kidney or liver disease, are over 60 years old, or use ibuprofen for a prolonged period, 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 due to dehydration.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen may worsen these diseases.
• If you experience any injury, skin swelling, or redness, or respiratory problems (shortness of breath), discontinue treatment with the medicine immediately and contact your doctor or nurse.
• If you have chickenpox, as complications may occur.
• If you have a congenital disorder of porphyrin metabolism (e.g., acute intermittent porphyria).
• If you consume alcohol shortly before or after being given this medicine, it may increase the adverse effects related to the stomach, intestine, and nervous system.
• If you have a fever, nasal polyps, or chronic obstructive respiratory disorders, you are at a higher risk of allergic reactions. Allergic reactions can occur in the form of asthma attacks (also known as analgesic asthma), rapid swelling (Quincke's edema), or rash.
• It is essential 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 conjunctivitis.
• The simultaneous use of NSAIDs, including COX-2 inhibitors (e.g., celecoxib), should be avoided.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medicine 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.

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

Prolonged use of painkillers may cause headache, which should not be treated with an increase in the dose of the medicine.

Regular monitoring of liver values, kidney function, and blood counts is necessary if ibuprofen is administered for a prolonged period.

Ibuprofen 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 concentrations

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

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).

Using Ibuprofeno Braun with other medicines

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

Ibuprofeno Braun may affect or be affected by some 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 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 ibuprofen.
• The simultaneous administration of methotrexate (used to treat certain types of cancer or rheumatism) and ibuprofen (within 24 hours) may increase methotrexate blood levels and the risk of methotrexate toxicity.
• Mifepristone (a medicine used to interrupt 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, increasing the risk of kidney disorders (the use of potassium-sparing diuretics with ibuprofen may cause an increase in blood potassium levels).
• Medicines containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen.
• 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.
• Quinolone antibiotics, such as ciprofloxacin, due to the increased risk of seizures (epileptic fits).
• Voriconazole and fluconazole (CYP2C9 inhibitors used for fungal infections) may increase ibuprofen blood levels.
• Zidovudine (used for HIV infection), due to the increased risk of blood accumulation in the joints and the occurrence of hematomas.
• Aminoglycosides (a type of antibiotic), as 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 treatment with ibuprofen. Therefore, you should always consult your doctor or nurse before being given ibuprofeno with other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 and your baby's tendency to bleed and may prolong or delay delivery more than expected.

You should not receive ibuprofen 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 possible time.

Treatment with ibuprofen by intravenous route should not exceed 3 days. From the 20th week of pregnancy, ibuprofen 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 medicine is excreted in breast milk, but it can be used during breastfeeding, provided the recommended dose is used for the shortest possible time. However, if doses above 1200 mg per day are used, your doctor may recommend that you interrupt breastfeeding.

Fertility

Ibuprofen may make it more difficult to conceive. If you are planning to become pregnant or are having trouble conceiving, tell your doctor.

Driving and using machines

The influence of this medicine, with occasional or short-term use, on the ability to drive and use machines is negligible or minimal. However, the occurrence of significant side effects such as fatigue and dizziness may affect reaction ability, and the ability to drive and operate machinery may be reduced, especially when combined with alcohol.

Ibuprofeno Braun contains sodium.

This medicine contains 360 mg of sodium (main component of cooking/table salt) per vial, which is 18.0% of the maximum recommended daily intake of sodium for an adult.

3. How to use Ibuprofeno Braun

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

The recommended dose in adults is 600 mg by intravenous route (drip into a vein); another dose of 600 mg may be administered 6 to 8 hours later, depending on the intensity of the symptoms and the response to treatment. The maximum daily dose should not be exceeded.

The effective lowest dose should be used for the shortest time 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). Your doctor will also check that you have ingested sufficient fluids to minimize the risk of adverse effects on the kidneys.

Use should be limited to cases where oral administration is not appropriate. Patients should switch to oral treatment as soon as possible.

This medicine is indicated only for short-term acute treatment and should not be used for more than 3 days.

Method of administration

Intravenous route. The solution should be administered by intravenous infusion over a period of 30 minutes. This medicine is indicated for use as a single dose. Examine the solution before use. If you notice particles in suspension, the solution should be discarded.

If you are given more Ibuprofeno Braun than you should

If you think you have received more ibuprofen than you should, tell your doctor or nurse immediately.

Symptoms 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, seizures (mainly in children), inability to coordinate muscle movements, weakness, and dizziness have been reported.

You may also experience low blood pressure, bluish discoloration of the skin or mucous membranes (cyanosis), gastrointestinal bleeding, as well as liver and kidney problems.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

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 ingested.

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 period of time necessary to treat the symptoms. You may experience 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 using this medicine and contact a doctor as soon as possible. Elderly patients who use 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 (stomach or intestinal ulcers), perforation (a hole in the stomach or intestinal wall), or bleeding in the stomach or intestines, sometimes fatal, especially in the elderly population, may occur. Nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, tarry stools, vomiting blood, stomatitis (inflammation of the oral mucosa accompanied by ulcers), colitis (exacerbation of inflammation of the large intestine), and Crohn's disease may also occur. 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 accumulation (fluid 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 reactions at the infusion site and anaphylactic shock) and severe skin adverse effects, alopecia (hair loss), skin sensitivity to light, 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:

• 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 can 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 swollen lymph nodes (DRESS syndrome).
• Widespread, scaly, and reddened skin rash with bumps under the skin and blisters, accompanied by fever, usually appearing 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 been described.

In exceptional cases, severe skin infections and soft tissue complications during chickenpox infection have been reported.

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 falling asleep), agitation, irritability, or fatigue, anxiety, and restlessness.
• Visual disturbances.
• Tinnitus (ringing in the ears).
• Gastric mucosa inflammation.
• Reduced urine production and edema formation, 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):

• Toxic amblyopia (reversible double vision).
• Hearing disorders.
• Esophageal stricture (narrowing of the esophagus), 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 may cause anemia.
• Kidney tissue damage (papillary necrosis), especially with prolonged treatment, and increased serum uric acid concentration in the blood.
• Jaundice or 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 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.
• 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 conjunctivitis) seem to have a higher predisposition.
• Esophageal or pancreatic inflammation and intestinal stricture.
• Asthma, difficulty breathing (bronchospasm), breathing difficulties, and wheezing.
• Systemic lupus erythematosus (an autoimmune disease), severe allergic reaction (facial edema, tongue swelling, throat swelling, accompanied by airway constriction, 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.
• Reactions at the injection site, such as swelling, hematoma, or bleeding.
• A severe skin reaction known as DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) may occur. The symptoms of DRESS syndrome include skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).
• Generalized 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 B. Braun if you experience these symptoms and seek medical attention immediately. See also section 2.

Reporting of Adverse Effects

If you experience any adverse effects, consult your doctor, even if they are possible adverse effects not listed in this leaflet. 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 Ibuprofen Braun

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

This medicine does not require special storage conditions.

The medicine should be used immediately after opening. For single use only. Any remaining solution should be discarded.

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

Do not use this medicine if you notice particles in suspension or discoloration.

6. Package Contents and Additional Information

Composition of Ibuprofen Braun

• The active ingredient is ibuprofen. Each 100 ml of solution contains 600 mg of ibuprofen.
• The other ingredients are L-arginine, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injectable preparations.

Appearance of Ibuprofen Braun and Package Contents

Clear solution, colorless to pale yellow, and free of particles in suspension.

The solution is presented in LDPE vials, 100 ml capacity, with an external stopper, in packs of 10 and 20 vials.

Not all pack sizes may be marketed.

Marketing Authorization Holder

• Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Germany

Manufacturer

• Braun Medical, S.A.

Ctra. Terrasa, 121

Rubí

08191 Barcelona (Spain)

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

This medicine has been authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet:January 2025

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