Ibuprofen B. Braun 600 mg concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibuprofen B.Braun 600 mg concentrate for solution for infusion

ibuprofen

Read the entire leaflet carefully before you start using 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 pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 side effects
5. How to store Ibuprofen B.Braun

Pack contents 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).

Ibuprofen B. Braun is used 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 B. Braun

It is important that you use the lowest dose that relieves/controls your pain and for the shortest duration necessary to control symptoms.

Do not use Ibuprofeno B. Braun:

• If you are allergic to ibuprofen, to other NSAIDs, or to any of the other ingredients of this medicine (listed in section 6).
• If you have a history of bronchospasm, asthma, rhinitis, angioedema, or urticaria associated with the use of acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you have coagulation disorders.
• If you currently have or have a history of stomach/intestinal ulcers 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 cerebral hemorrhage or other active bleeding.
• In case of severe hepatic or renal insufficiency.
• If you have coronary disorders or severe heart failure.
• If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• During the last three months of pregnancy.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Ibuprofeno B. Braun.

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small 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:

Serious skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop taking Ibuprofeno B. 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 B. Braun immediately and contact your doctor or emergency medical services right away if you experience any of these signs.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofeno B. Braun if:

- You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").

• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

• You have edema (fluid retention).

• Your doctor will monitor you more closely if you receive ibuprofen after major surgery.

• You have had or develop an ulcer, bleeding, or perforation in the stomach or duodenum, which may present as severe or persistent abdominal pain and/or black stools, 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 adding a stomach-protective medicine.

• You have had kidney or liver disease.

• You have asthma or any other respiratory disorder.

• You have an infection; see the section "Infections" below.

• 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 show signs of dehydration, e.g., severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this specific case could lead to renal failure due to dehydration.

• You have Crohn's disease or ulcerative colitis, as these types of medicines may worsen these conditions.

• 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).

• You are taking diuretics (medicines to increase urine production), as your doctor needs to monitor your kidney function.

• Cases of aseptic meningitis have been reported with the use of this medicine; the risk is higher if you have an autoimmune disease called systemic lupus erythematosus or other collagen diseases.

• You notice skin lesions, swelling, or redness, or have breathing difficulties (suffocation); stop using the medicine immediately and inform your doctor or nurse.

• You have chickenpox, as complications may occur.

• You have acute intermittent porphyria.

• Cases of blurred or reduced vision, blind spots in the visual field, and changes in color vision have been reported with oral ibuprofen.

• Infections

Ibuprofeno B. Braun may mask signs of infection such as fever and pain. Therefore, Ibuprofeno 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 related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Cardiovascular precautions

Medicines such as Ibuprofeno B. Braun may be associated with a moderate increase in the risk of heart attacks ("myocardial infarctions") or strokes. This risk is more likely when high doses and prolonged treatments are used. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of strokes, or think you may be at risk for these conditions (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist.

Also, this type of medicine may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Using Ibuprofeno B. Braun with other medicines

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

Ibuprofeno B. Braun may affect 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, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Digoxin, phenytoin, or lithium, which may have increased blood levels when taken with ibuprofen.
• A medicine used to treat certain types of cancer or rheumatism (methotrexate), taken at the same time as ibuprofen (within a 24-hour interval), may increase its blood levels and the risk of toxicity. Your doctor may advise against taking ibuprofen if you are receiving high-dose methotrexate treatment.
• Mifepristone (abortion-inducing agent).
• Antidepressants that are selective 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) and diuretics, as they may reduce their effectiveness.
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Medicines used to treat inflammation (corticosteroids), as they increase the risk of gastrointestinal ulcer or bleeding.
• Diuretics (medicines used to increase urine output), as they may increase the risk of renal toxicity.
• Medicines containing probenecid and sulfinpyrazone, which may delay the excretion of ibuprofen.
• Cyclosporine and tacrolimus, which may increase the risk of kidney damage.
• Medicines used to treat diabetes (sulfonylureas). Monitoring of blood glucose levels is recommended when used together.
• Antibiotics of the quinolone group, due to an increased risk of seizures.
• Medicines used to treat fungal infections (CYP2C9 inhibitors such as voriconazole, fluconazole), which may increase ibuprofen blood levels.
• Medicines for HIV (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 serious side effects in the stomach and intestines, including bleeding.

Other medicines may also affect or be affected by treatment with Ibuprofeno B. Braun. Therefore, you should always consult your doctor or pharmacist before using Ibuprofeno 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 or pharmacist before using this medicine.

Pregnancy

If you are pregnant, you will only receive ibuprofen if your doctor considers it absolutely necessary. Ibuprofen is contraindicated during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and may 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 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, 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 longer-term treatment is needed, your doctor may recommend additional monitoring.

Breastfeeding

Breastfeeding interruption is not recommended for short-term treatment at the recommended doses, although ibuprofen and its metabolites pass into breast milk.

Fertility

For women of childbearing age, it should be noted that medicines such as ibuprofen have been associated with a reduced ability to conceive.

Driving and using machines

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

Ibuprofeno B. Braun contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 100 mg/ml, and is therefore considered essentially "sodium-free."

3. How to use Ibuprofen B. Braun

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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 medical equipment.

Posology

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 to relieve symptoms should be used. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

After observing the initial response to treatment, the dose and frequency of administration should be adjusted according to the individual needs of each patient.

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 only, and the duration of treatment should be limited to the acute symptomatic period while the oral route of administration is not available. Patients should switch to oral analgesic therapy as soon as possible.

Method of administration

For intravenous use.

The contents of one vial (6 ml, 600 mg of ibuprofen) must always be diluted in a volume of 100 ml of 9 mg/ml (0.9%) sodium chloride solution, glucosaline solution containing 33 mg/ml glucose (3.3%) and 3 mg/ml NaCl (0.3%), or Ringer's lactate solution. The solution must be diluted aseptically (for storage conditions of the diluted solution, see section 5).

The diluted solution is transparent. Before administration, the solution should be visually inspected to ensure it is clear and colourless. It must not be used if particulate matter is present or if any change in colour is observed.

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

One vial is intended for single-dose use only, and any unused portion must be discarded.

The contents of the vial must not be administered directly without dilution. Direct infusion of this medicine without dilution may cause haemolysis.

If you use more Ibuprofen B. Braun than you should

Since your dose is controlled by a doctor or nurse, it is unlikely that you will be given an excessive amount of this solution.

If you think you have received more ibuprofen than you should have, 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 ataxia (impaired coordination of movement). At higher 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, and problems with liver and kidney function.

In case of overdose or accidental ingestion, go immediately to a Medical Centre or contact the Toxicology Information Service at telephone number 915620420, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

4. Possible adverse effects

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

The frequencies are defined as follows: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), and not known frequency (cannot be estimated from available data).

Cardiac and vascular disorders

Very rare: palpitations, arterial hypertension, cardiac failure, and myocardial infarction.

Frequency not known: chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Blood and lymphatic system disorders

Rare: blood formation disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). Frequent infections with fever, sore throat, superficial mouth ulcers, flu-like state, nosebleeds, and skin bleeding may occur.

Nervous system disorders

Common: headache, dizziness, insomnia, agitation, irritability, and fatigue.

Very rare: during treatment with ibuprofen, some cases of aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever, or confusion) have been observed in patients with systemic lupus erythematosus. Patients with autoimmune diseases (SLE, connective tissue diseases) appear to be predisposed.

Eye disorders

Uncommon: visual disturbances. In such cases, the patient must inform the doctor immediately and discontinue treatment.

Ear and labyrinth disorders

Uncommon: tinnitus (sensation of hearing sounds that do not originate from an external source).

Gastrointestinal disorders

Common: heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation, and blood in stools.

Uncommon: gastrointestinal ulcers, potentially with bleeding and perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis.

Rare: oesophagitis, intestinal stenosis, and diaphragmatic stenosis.

Very rare: pancreatitis.

The patient must seek immediate medical attention if experiencing severe upper abdominal pain or noticing blood in stools or vomit.

Respiratory, thoracic and mediastinal disorders

Very rare: asthma, bronchospasm, difficulty breathing, and wheezing.

Renal and urinary disorders

Rare: renal tissue damage (papillary necrosis), especially with long-term treatment, increasing blood uric acid concentration.

Very rare: reduced urinary excretion and development of oedema, particularly in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal failure. Therefore, renal function should be monitored regularly.

Skin and subcutaneous tissue disorders

Common: skin rash.

Rare: bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome). Alopecia.

Frequency not known: A severe skin reaction known as DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cells).

In exceptional cases, severe skin infections and mild tissue complications may occur during chickenpox infection.

Generalized scaly eruption 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 Ibuprofen B. Braun if you experience these symptoms and seek medical attention immediately. See also section 2.

Stop taking ibuprofen and contact your doctor immediately if you notice any of the following symptoms:

• Circular or target-shaped, reddish, non-elevated spots on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe 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).

Immune system disorders

Common: hypersensitivity reactions with skin rash and urticaria, as well as asthma attacks (possibly with decreased blood pressure).

Rare: severe hypersensitivity reactions. Oedema, tongue swelling, swelling of the inner larynx with airway constriction, breathing difficulties, palpitations, and decreased blood pressure that may be life-threatening may occur. If any of these symptoms occur, even after the first dose, immediate medical attention is required.

Psychiatric disorders

Rare: psychotic reactions and depression.

Hepatobiliary disorders

Rare: hepatic dysfunction, liver damage, and acute hepatitis.

Frequency not known: liver failure.

Infections and infestations

Very rare: exacerbations of inflammation related to infections coinciding with the use of non-steroidal anti-inflammatory drugs.

Symptoms of aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever, or confusion) have been observed during treatment with ibuprofen. Patients with autoimmune diseases (SLE, connective tissue diseases) appear to be predisposed.

Musculoskeletal and connective tissue disorders

Rare: neck stiffness.

General disorders and administration site conditions

Common: pain and burning sensation at the injection site, usually mild. Fatigue.

Other

Very rare: worsening of inflammation during infectious processes.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 indicated on the packaging after EXP. The expiry date refers to the last day of the month shown.

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

After dilution, the solution is chemically stable for 24 hours at 25°C.

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 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 unused medicines and their containers. 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 6 ml vial contains 600 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.

Appearance of the product and contents of the pack

The solution is clear and colourless.

Ibuprofen B.Braun 600 mg concentrate for solution for infusion is available in packs of 1 and 100 vials made of colourless type I glass, each with a rubber stopper.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

• BRAUN MEDICAL, S.A.

Ctra. De Terrassa, 121

08191 Rubí

Spain

Manufacturer:

B.Braun Medical, S.A.

Ronda de los Olivares, parcela 11

Polígono Industrial Los Olivares

23009 Jaén – Spain

Latest revision of this leaflet: January 2025

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