Prospect: information for the patient

Ibuprofen B.Braun pediatric 200mg solution for infusion

Read this prospect carefully before this medication is started, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.

-If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section4.

1.What is Ibuprofen B.Braun and how it is used

2.What you need to know before Ibuprofen B.Braun is started

3.How to administer Ibuprofen B.Braun

4.Possible adverse effects

5.Storage of Ibuprofen B.Braun

6.Contents of the package and additional information

Ibuprofeno belongs to a group of medicines callednonsteroidal anti-inflammatory drugsor NSAIDs.

This medicine is indicated in adolescents and children with a body weight of 20 kg or more and 6 years or older for the short-term symptomatic treatment of moderate acute pain and the short-term symptomatic treatment of fever, when intravenous administration is clinically justified when other administration routes are not possible.

Do not administer Ibuprofeno B.Braun.

• if you are allergic to ibuprofen or any of the other components of this medication (listed in section6);
• if you have ever had any respiratory problems, asthma, skin rash, runny nose and itchy nose or facial swelling after taking ibuprofen, aspirin or other similar pain relievers (NSAIDs);
• if you have a condition that increases your risk of bleeding or are experiencing an active bleeding;
• if you have active stomach ulcers or bleeding, or a history of two or more episodes of stomach ulcers or bleeding;
• if you have ever experienced stomach or intestinal bleeding or lacerations after taking NSAIDs;
• if you have cerebral hemorrhage (cerebrovascular hemorrhage) or other active bleeding;
• if you have severe kidney, liver or heart problems;
• if you have severe dehydration (caused by vomiting, diarrhea or inadequate fluid intake);
• if you are in the last three months of pregnancy.

Warnings and precautions

Consult your doctor or nurse before starting to use this medication.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

Reactions to the skin:

Severe skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and generalized acute pustular psoriasis (AGEP) have been associated with ibuprofen treatment. Stop taking Ibuprofeno B.Braun and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section4.

Signs of an allergic reaction to this medication, including respiratory problems, facial and neck swelling (angioedema) and chest pain, have been reported with ibuprofen. Stop taking Ibuprofeno B.Braun and contact your doctor or emergency medical services immediately if you notice any of these signs.

Before administering Ibuprofeno B.Braun, discuss the treatment with your doctor:

• if you have heart problems, such as heart failure, chest pain (angina) or have had a myocardial infarction, have undergone coronary revascularization, have had peripheral artery disease (PAD) or have had a stroke (including transient ischemic attack or TIA).
• if you have hypertension, diabetes or hypercholesterolemia, have a family history of heart disease or stroke or are a smoker.
• if you have recently undergone major surgery.
• if you have had or developed stomach ulcers, 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 problems.
• if you have an infection; see the heading "Infections" below.
• if you have kidney or liver disease or have been taking ibuprofen for a long time, your doctor may need to perform regular check-ups. Your doctor will tell you how often these checks should be done.
• if you are dehydrated due to, for example, diarrhea, drink plenty of fluids and contact your doctor immediately, as ibuprofen may cause renal insufficiency due to dehydration in this case.
• if you have Crohn's disease or ulcerative colitis, as ibuprofen may worsen these conditions.
• if you experience any skin lesions, swelling or redness or respiratory problems (asphyxia), stop taking the medication 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 administration of this medication, it may increase the risk of adverse effects related to the stomach, intestines and nervous system.
• if you have fever, nasal polyps or chronic obstructive respiratory diseases, you are at higher risk of allergic reactions, which may present as asthma attacks (also known asanalgesic asthma), rapid swelling (Quincke's angioneuritic edema) or rash.

Some cases of aseptic meningitis have been reported with the use of this medication. The risk is increased if you have a systemic autoimmune disease called systemic lupus erythematosus or other connective tissue diseases.

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

Concurrent use with NSAIDs, among others, including selective cyclooxygenase-2 inhibitors, should be avoided.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibuprofeno may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Adverse reactions can be minimized by using the lowest effective dose for the shortest period necessary to control symptoms.

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

Prolonged use of pain relievers may cause headaches, which should not be treated with increased doses of the medication.

Ibuprofen may affect the results of the following laboratory tests:

• bleeding time (may be prolonged 1day after treatment completion).
• blood glucose levels (may decrease).
• creatinine clearance (may decrease).
• hematocrit or hemoglobin (may decrease).
• blood urea nitrogen, serum creatinine and potassium (may increase).
• liver function tests; increased concentrations of transaminases.

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

This product is not recommended for use in children with a body weight of less than 20kg or under 6 years old.

There is a risk of renal insufficiency in dehydrated children and adolescents.

Use of Ibuprofeno B.Braun with other medications

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

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

• other nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (e.g., celecoxib), may increase the risk of stomach ulcers and bleeding.
• blood thinners (anticoagulants such as aspirin, warfarin or ticlopidine).
• medications used to treat heart failure (cardiac glycosides such as digoxin), epilepsy (phenytoin) or depression (lithium) may increase blood concentrations when taken concurrently with ibuprofen.
• simultaneous administration of a medication used to treat certain types of cancer or rheumatic diseases (methotrexate) and ibuprofen (within 24hours) may increase methotrexate blood concentrations and toxicity.
• a medication used to interrupt pregnancy (mifepristone).
• selective serotonin reuptake inhibitors (SSRIs) used as antidepressants (e.g., fluoxetine) may increase the risk of gastrointestinal and intestinal bleeding.
• blood pressure-lowering medications (ACE inhibitors such as captopril, beta-blockers such as atenolol and angiotensin II receptor antagonists such as losartan).
• corticosteroids used to treat inflammation, as they increase the risk of stomach ulcers or bleeding.
• diuretics used to promote urination (e.g., bendroflumethiazide), as NSAIDs may reduce the effect of these medications, increasing the risk of kidney problems (the use of potassium-sparing diuretics with ibuprofen may increase blood potassium concentrations).
• medications containing probenecid or sulfinpyrazone may delay ibuprofen excretion.
• medications used to prevent organ transplant rejection (ciclosporin and tacrolimus) may increase the risk of renal damage.
• oral hypoglycemic medications (sulfonylureas such as glibenclamide). When these medications are used concurrently, blood glucose levels should be monitored.
• quinolone antibiotics (e.g., ciprofloxacin), as they increase the risk of seizures (convulsions).
• antifungal medications (CYP2C9 inhibitors, such as voriconazole and fluconazole) may increase ibuprofen blood concentrations.
• medications used to treat HIV infection (zidovudine), as they increase the risk of joint accumulation and hematomas.
• chronic alcohol consumption may increase the risk of significant gastrointestinal and intestinal side effects, including bleeding.
• aminoglycoside antibiotics. NSAIDs may decrease the excretion of aminoglycosides and increase toxicity.
• Ginkgo biloba(a medicinal plant commonly used to treat dementia) may increase the risk of bleeding.

Other medications may also affect or be affected by ibuprofen treatment. Therefore, always consult your doctor or nurse before administering ibuprofen with other medications.

Pregnancy, breastfeeding and fertility

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

Pregnancy

if you are pregnant, you will only receive ibuprofen if your doctor considers it absolutely necessary. Do not administer this medication during the last 3months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause renal and cardiac problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong delivery.

Do not receive ibuprofen during the first 6 months of pregnancy unless it is 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 time possible.

intravenous ibuprofen treatment should not exceed 3days. From week20 of pregnancy, ibuprofen may cause renal problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

Breastfeeding

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

Fertility

Ibuprofen may make it difficult to conceive. If you plan to become pregnant or have difficulty becoming pregnant, inform your doctor.

Driving and operating machinery

Short-term or acute treatment does not require special precautions. However, during prolonged treatment, adverse effects such as fatigue and dizziness may occur, which may affect your ability to drive or operate machinery, especially when combined with alcohol.

Ibuprofeno B.Braun contains sodium

This medication contains 179mg of sodium (main component of table salt/for cooking) per 50ml. This is equivalent to 9% of the recommended daily maximum sodium intake for an adult.

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

The dose will be adjusted individually by your doctor depending on your body weight and overall condition.

In children and adolescents, the ibuprofen dose depends on body weight or age, 5 to 10 mg/kg of body weight as a single dose up to a maximum daily dose of 30 mg/kg:

Children weighing 20 kg - 29 kg (6-9 years): 200 mg of ibuprofen up to 3 times a day without exceeding a maximum daily dose of 600 mg.

Children weighing 30 kg - 39 kg (10-11 years): 200 mg of ibuprofen up to 4 times a day without exceeding a maximum daily dose of 800 mg.

Adolescents weighing 40 kg or more (12-17 years): 200 mg to 400 mg of ibuprofen up to 3 times a day without exceeding a maximum daily dose of 1,200 mg.

Not recommended for children with a body weight less than 20 kg or under 6 years of age.

The respective dose interval should be in line with the symptoms and the maximum daily dose. The interval between doses should not be less than 6 hours. Never exceed the recommended maximum daily dose.

You should use the most effective dose for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor as soon as possible if symptoms (such as fever and pain) persist or worsen (see section 2). Your doctor will also check that you have ingested a sufficient amount of fluids to minimize the risk of kidney side effects.

You should only receive this medication if oral treatment is not possible. You should switch to oral treatment as soon as possible.

This medication will only be administered for the shortest period necessary. Treatment should not exceed 3 days.

Administration Form

Intravenous route. The solution should be administered by intravenous infusion over a period of 30 minutes.

Inspect the solution before use. It should be discarded if any particles are observed.

If you are administered more Ibuprofen B. Braun than you should

Since your dose is controlled by a doctor or a nurse, it is unlikely that you will receive too much of this solution.

If you have received more ibuprofen than you should or if the child has received this medication by accident, always contact a doctor or the nearest hospital for an opinion on the risk and advice on what to do.

In case of overdose or accidental ingestion, consult your doctor, nurse, or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The symptoms may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), headache, ringing in the ears, confusion, ataxia (movement coordination disorders) and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, 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 function problems.

If you have any other doubts about the use of this medication, ask your doctor or nurse.

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

The side 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 side effects of NSAIDs (see the information below). If you experience any of these side effects, you should stop taking this medicine and contact a doctor as soon as possible.

The side effects that have been observed most frequently affect the stomach and intestines. They can cause peptic ulcers (digestive or intestinal ulcers), holes in the stomach or intestinal wall (perforation), or bleeding in the stomach or intestines, sometimes fatal. Indigestion, black stools, vomiting blood, inflammation of the mucous membrane of the mouth accompanied by ulceration (stomatitis ulcerosa), exacerbation of inflammation of the large intestine (colitis), and Crohn's disease have been reported. Gastritis has been observed less frequently. It is worth noting that the risk of gastrointestinal bleeding depends on the interval between doses and the duration of treatment.

There have been reports of cases of fluid accumulation in tissues (edema), hypertension, and heart failure related to NSAID treatment. Medicines such as ibuprofen may be associated with a slight increase in the risk of suffering a heart attack (myocardial infarction) or stroke.

There have been reports of very rare severe allergic reactions (including reactions at the injection site and anaphylactic shock) and severe skin side effects, alopecia (hair loss), skin sensitivity to light, and allergic vasculitis (inflammation of a blood vessel).

Stop taking ibuprofen and see a doctor immediately if you notice any of the following symptoms:note any of the following symptoms::

• Circular or target-shaped, red, 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 reactions can be preceded by fever and pseudogripal symptoms (dermatitis exfoliativa, 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 pustular psoriasis).

There have also been reports of very rare exacerbations of inflammatory conditions related to infections (e.g., development of a disease that destroys flesh called necrotizing fasciitis), concurrent with NSAID use.

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

Very common side effects (may affect more than 1 in 10 people):

• Fatigue or insomnia, headache, and dizziness.
• Stomach burning, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding that may cause anemia in exceptional cases.

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

• Dizziness.
• Skin rash.
• Pain and burning sensation at the injection site.
• Gastroduodenal ulcer that may be accompanied by bleeding and perforation. Stomatitis ulcerosa, exacerbation of colitis, and Crohn's disease.

Uncommon (may affect up to 1 in 100 people):

• Difficulty falling asleep (insomnia), agitation, irritability, or fatigue, anxiety, and restlessness.
• Visual disturbances.
• Tinnitus (ringing in the ears).
• Reduced urine production and edema, especially in patients with hypertension or renal insufficiency, symptoms due to renal 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 (may affect up to 1 in 1,000 people):

• Reversible double vision (toxic amblyopia).
• Auditory disturbances.
• Narrowing of the esophagus (gastrointestinal vasospasm), complications of diverticulum formation in the large intestine, and non-specific hemorrhagic colitis characterized by intense cramps and diarrhea. In the case of bleeding in the stomach or intestines, these may cause anemia.
• Renal tissue damage (papillary necrosis), especially with prolonged treatment, and increased serum uric acid concentration in blood.
• Jaundice or yellowing of the white of the eyes, liver dysfunction, liver damage (especially with prolonged treatment) and acute liver inflammation (hepatitis).
• Psychotic reactions, nervousness, irritability, confusion, or disorientation, and depression.
• Neck stiffness.

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

• Blood cell formation disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, and agranulocytosis). The first symptoms are fever, sore throat, superficial oral ulcers, pseudogripal symptoms, acute fatigue, nasal bleeding, and skin bleeding.
• Accelerated heart rate (palpitations), heart failure, and myocardial infarction.
• Hypertension.
• Asymptomatic meningitis (neck stiffness, headache, nausea, vomiting, fever, or confusion). Patients with autoimmune disorders (systemic lupus erythematosus and mixed conjunctivitis) appear to have a higher predisposition.
• Inflammation of the lower part of the throat (esophagus) or pancreas and intestinal narrowing.
• Sensitivity to light and allergic vasculitis.
• Asthma, difficulty breathing (bronchospasm), feeling of lack of air, and wheezing.
• A systemic autoimmune disease called systemic lupus erythematosus, severe allergic reaction (facial edema, tongue swelling, throat swelling accompanied by airway constriction, difficulty breathing, palpitations, hypotension, and potentially fatal shock).

Side effects of unknown frequency (the frequency cannot be estimated from the available data):

• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• Liver insufficiency.
• Reactions at the injection site, such as swelling, hematomas, or bleeding.
• A severe skin reaction known as DRESS syndrome (by its English acronym) may occur. The symptoms of DRESS syndrome include: skin rash, fever, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Generalized red, scaly skin rash with bumps under the skin and blisters located mainly in skin folds, the trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking Ibuprofeno B. Braun if you experience these symptoms and seek medical attention immediately. See section 2.

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus.Also, you can report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use, Website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

The product must be used immediately after opening. Do not use this medication if you observe particles.

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Composition of Ibuprofen B.Braun

• The active ingredient is ibuprofen. Each milliliter of solution contains 4 mg of ibuprofen. Each 50 ml bottle contains 200 mg of ibuprofen.
• The other components are L-arginine, sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injectable preparations.

Appearance of Ibuprofen B.Braun and packaging contents

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

The solutionis presented in a primary packaging of LDPE 50ml with Twincap with 10 and 20bottles of 50ml.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Germany

Manufacturer

B. Braun Medical, S.A.

Ctra. Terrasa, 121

Rubí

08191 Barcelona (Spain)

For more information about this medication, please contact the local representative of the marketing authorization holder.

Local Representative

B. Braun Medical, S.A.

Crta. Terrasa, 121

Rubí

08191 Barcelona (Spain)

This medication is authorized in the member states of theEconomic Area and in the United Kingdom (Northern Ireland)with the following names:

Last review date of this leaflet:August 2024

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) www.aemps.gob.es