Ibuprofen B. Braun 600 mg solution for infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ibuprofen B. Braun 600 mg solution for infusion

Ibuprofen

Read all of this leaflet carefully before you start taking this medicine, as 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 or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Ibuprofen B. 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 Ibuprofen B. Braun

Do not use Ibuprofen B. 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 respiratory problems, asthma, rhinitis, angioedema, or urticaria associated with taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you have coagulation disorders.
• If you have peptic ulcer and/or active or recurrent gastrointestinal bleeding (two or more episodes of ulceration or bleeding).
• If you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
• If you have a cerebral hemorrhage or other active bleeding.
• If you have severe kidney, liver, or heart disorders.
• If you suffer from 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 Ibuprofen B. Braun.

Painkillers and anti-inflammatory medicines such as ibuprofen may be associated with a slight increase in the 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 B. Braun treatment. Stop taking Ibuprofen B. Braun and seek medical advice 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, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop taking Ibuprofen B. Braun immediately and contact your doctor or emergency medical services right away if you experience any of these signs.

Inform your doctor:

• If you have edema (fluid retention).
• If you have or have had heart disorders or high blood pressure.
• Your doctor will monitor you more closely if you receive ibuprofen after major surgery.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher with high doses and prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.
• 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 are over 60 years old, your doctor may need to perform regular monitoring. Your doctor will advise you on the frequency of these checks.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this case could lead to renal failure due to dehydration.
• If you have Crohn’s disease or ulcerative colitis, as these types of medicines may worsen these conditions.
• If you are taking medications that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
• If you have an infection; see the section titled "Infections" below.
• Cases of aseptic meningitis have been reported with the use of this medicine; the risk is higher if you have systemic lupus erythematosus or other collagen diseases.
• If you notice skin lesions, swelling, or redness, or have breathing difficulties (suffocation), stop using the medicine immediately and inform your doctor or nurse.
• If you have chickenpox, as complications may occur.
• If you have acute intermittent porphyria.
• It is important to use the lowest effective dose to relieve/control pain and not to take this medicine longer than necessary.

Infections

Ibuprofen B. Braun may mask signs of infection such as fever and pain. Therefore, Ibuprofen B. 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 during an infection and infection symptoms persist or worsen, consult a doctor without delay.

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.

In general, the use of (various types of) analgesics may cause serious, permanent kidney problems.

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

Blurred vision, decreased vision, blind spots in the visual field, and color vision disturbances have been reported with oral ibuprofen.

Concomitant use with NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided.

Allergic reactions may occur during treatment with this medicine, especially at the beginning of treatment. In such cases, treatment must be discontinued.

Use of Ibuprofen B. Braun with other medicines

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

Ibuprofen may interact with or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs), as this may increase the risk of gastrointestinal ulcer and bleeding due to a synergistic effect.
• Anticoagulant medicines (e.g., to treat or prevent clotting problems, such as acetylsalicylic acid, warfarin, ticlopidine). Digoxin, phenytoin, or lithium levels in blood may increase when taken with ibuprofen.
• Medicines used to treat heart failure (cardiac glycosides such as digoxin), epilepsy (phenytoin), or depression (lithium) may have increased blood concentrations when taken simultaneously with ibuprofen.
• Methotrexate taken at the same time as ibuprofen (within a 24-hour interval) may increase its blood levels and the risk of toxicity from this medicine. Your doctor may advise against taking ibuprofen if you are receiving high-dose methotrexate therapy.
• Mifepristone (abortion-inducing agent).
• Antidepressants that are serotonin reuptake inhibitors (SSRIs) and antiplatelet agents may also increase the risk of gastrointestinal bleeding.
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).
• Medicines used to increase urination (diuretics such as bendroflumethiazide), as NSAIDs may reduce the effect of these medicines and increase the risk of kidney disorders (using potassium-sparing diuretics with ibuprofen may lead to increased blood potassium levels).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Medicines used to treat inflammation (corticosteroids such as hydrocortisone), as they increase the risk of gastrointestinal and intestinal ulcers or bleeding.
• Diuretics (medicines used to increase urine output), as they may increase the risk of renal toxicity.
• Medicines containing probenecid and sulfinpyrazone may delay the excretion of ibuprofen.
• Medicines used to prevent organ transplant rejection (cyclosporine and tacrolimus) may increase the risk of kidney damage.
• Sulfonylureas, medicines used for diabetes. Blood glucose levels should be monitored when used together.
• Antibiotics of the quinolone group, due to an increased risk of seizures.
• Voriconazole, fluconazole (CYP2C9 inhibitors) may increase blood levels of ibuprofen.
• HIV medicines (Zidovudine), due to an increased risk of blood accumulation in joints and bruising in hemophilic HIV-positive patients.
• Chronic alcohol consumption may increase the risk of significant stomach and intestinal side effects, including bleeding.
• A type of antibiotic (aminoglycosides). NSAIDs may reduce aminoglycoside excretion and increase toxicity.
• Ginkgo biloba (a herbal remedy often used to treat dementia) may increase the risk of bleeding.

Other medicines may also interact with or be affected by ibuprofen treatment. Therefore, always consult your doctor before using Ibuprofen B. Braun with other medicines.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You will only receive ibuprofen during pregnancy if your doctor considers it absolutely necessary.

Ibuprofen is contraindicated during the last 3 months of pregnancy. It may cause kidney and heart problems in your fetus. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labor beyond expected duration.

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 possible 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 for longer than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding

This medicine is excreted in breast milk, but it may be used during breastfeeding as long as the recommended dose is used for the shortest possible time. However, if higher doses or longer treatment periods are used, your doctor may recommend that you stop breastfeeding.

Fertility

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

Driving and using machines

For short-term or occasional use, no special precautions are needed. However, for prolonged treatment, adverse effects such as fatigue and dizziness may impair your ability to drive or operate machinery. This is especially important when combined with alcohol.

Ibuprofen B. Braun contains sodium

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

3. How to use Ibuprofen B. Braun

This medicine is prescribed to you by a doctor and will be administered only by a doctor or nurse in a setting equipped with appropriate technical equipment.

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor again.

Your doctor will administer the lowest effective dose for the shortest possible duration necessary to avoid adverse effects. Your doctor will also ensure that you have consumed sufficient fluids to minimize the risk of adverse kidney effects.

Dosage

Adults

The recommended dose is 600 mg of ibuprofen every 6–8 hours.

The recommended daily dose is 1200–1600 mg in multiple doses. The maximum daily dose of 2400 mg in multiple doses must not be exceeded.

The lowest effective dose for the shortest duration necessary 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 patient hydration should be maintained to minimize the risk of potential renal 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 of administration is unavailable. Patients should switch to oral analgesic therapy as soon as possible.

Method of administration

Intravenous route

The solution is clear. Before administration, the solution should be inspected visually to ensure it is clear and colorless. Do not use if particulate matter is present or if discoloration is observed.

The solution is administered as an intravenous infusion over 30 minutes.

If you use more Ibuprofen B. Braun than you should

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

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 the urine, low blood potassium levels, chills, and breathing difficulties may occur.

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

In case of overdose or accidental ingestion, go to a Medical Center or contact the Toxicology Information Service at telephone 91 562 04 20, stating 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.

The adverse effects observed most frequently affect the stomach and intestines. Peptic ulcers (digestive or intestinal ulcer), holes in the wall of the stomach or intestine (perforation), or bleeding from the stomach or intestines, sometimes fatal, may occur. Indigestion, tarry stools, vomiting of blood, inflammation of the oral mucosa accompanied by ulceration (ulcerative stomatitis), exacerbation of inflammation of the large intestine (colitis) and Crohn's disease have been reported. Inflammation of the stomach (gastritis) 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 treatment with NSAIDs 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 see a doctor immediately if you notice any of the following symptoms:

• Circular or target-shaped, red, non-elevated 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).
• Widespread skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• Generalized, scaly, red 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 of infections-related inflammation (e.g., development of necrotizing fasciitis) occurring concurrently with the use of NSAIDs have also been described.

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):

• Tiredness or insomnia, headache, and dizziness.
• Heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding which may cause anemia in rare 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):

• Difficulty falling asleep (insomnia), restlessness, irritability or fatigue, anxiety, and agitation.
• Visual disturbances.
• Ringing in the ears (tinnitus).
• Reduced urine output and fluid accumulation in tissue (edema), especially in patients with high blood pressure or renal insufficiency, symptoms due to kidney damage (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 double vision (toxic amblyopia).
• Hearing disorders.
• Narrowing of the esophagus (of the blood vessels in the throat), complications from development of diverticula in the large intestine, and nonspecific hemorrhagic colitis characterized by severe cramps and diarrhea. If bleeding occurs in the stomach or intestine, this may lead to anemia.
• Kidney tissue damage (papillary necrosis), and increased serum concentration of uric acid in blood.
• Yellowing of the skin or whites of the eyes, hepatic dysfunction, liver damage, and acute inflammation of the liver (hepatitis).
• 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 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.
• Rapid heartbeat (palpitations), heart failure, and myocardial infarction.
• High blood pressure.
• 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 lower part of the throat (esophagus) or pancreas, and intestinal narrowing.
• Hair loss.
• Allergic vasculitis.
• Asthma, difficulty breathing (bronchospasm), shortness of breath, and wheezing.
• An autoimmune disease called systemic lupus erythematosus, severe allergic reaction (facial swelling, tongue swelling, throat swelling, 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.
• Liver failure.
• Skin becomes sensitive to light.
• Reactions at the injection site, such as swelling, bruising, or bleeding.
• A serious skin reaction known as DRESS syndrome (from the English acronym) may occur. Symptoms of DRESS syndrome include: skin rash, fever, enlarged 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 B.Braun if you experience these symptoms and seek medical attention immediately. 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaRAM.es

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

5. Storage of Ibuprofen B. 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 container after EXP. The expiry date refers to the last day of the month indicated.

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

From a microbiological standpoint, the product should be administered immediately. The medicine must not be stored between 2-8°C. Otherwise, the duration and conditions of storage and use are the responsibility of the person preparing/administering it.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofen B. Braun

• The active substance is ibuprofen. Each 100 ml vial contains 600 mg of ibuprofen.
• The other components (excipients) are arginine, sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

Appearance of Ibuprofen B. Braun and contents of the pack

Clear, colourless to pale yellow perfusion solution free from particles.

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

B. Braun Medical, S.A.
Carretera de Terrassa, 121
08191 Rubí (Barcelona)
Spain

Last revision of the leaflet: January 2025

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