IBUPROFEN B. BRAUN PEDIATRIC 200 mg SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Ibuprofen B.Braun Pediatric 200mg Solution for Infusion

Read all of this leaflet carefully before you start receiving 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 Ibuprofen B. Braun and what is it used for
2. What you need to know before you are given Ibuprofen B. Braun
3. How Ibuprofen B. Braun is administered
4. Possible side effects
5. Storage of Ibuprofen B. Braun
6. Contents of the pack and further information

1. What is Ibuprofen B. Braun and what is it used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

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

2. What you need to know before you are given Ibuprofen B. Braun

You should not be given Ibuprofeno B.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 (aspirin), or 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 two or more episodes of stomach or duodenal ulcers or bleeding;
• if you have ever had a stomach or intestinal bleed or perforation when taking NSAIDs;
• if you have cerebral bleeding (cerebrovascular hemorrhage) or other active bleeding;
• if you have severe kidney, liver, or heart disorders;
• if you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake);
• if you are in the last three months 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 B. Braun and consult your doctor immediately if you notice any of the 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 B. Braun immediately and contact your doctor or emergency medical services if you notice any of these signs.

Before you are given Ibuprofeno B. Braun, discuss treatment with your doctor:

• If you have heart problems, such as heart failure, chest pain (angina), or if you have had a heart attack, have had surgical revascularization, have had poor circulation in your legs or feet due to narrowing or blockage of the arteries (peripheral arterial disease), or have had a stroke (including a transient ischemic attack or TIA).
• If you have high blood pressure, diabetes, or 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 or developed a stomach or intestinal ulcer or bleeding. In these cases, your doctor will decide whether to prescribe a stomach protector.
• If you have asthma or another respiratory disorder.
• If you have an infection; see the "Infections" heading below.
• If you have kidney or liver disease or have been taking ibuprofen for a long time, your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you are dehydrated due to, for example, diarrhea, drink plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure as a result of dehydration.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen may worsen these diseases.
• If you experience any injury, swelling, or redness of the skin or respiratory problems (shortness of breath), stop 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 receiving 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 have a higher risk of allergic reactions, which can occur in the form of asthma attacks (also called analgesic asthma), rapid swelling (Quincke's edema), or rash.

With the use of this medicine, some cases of aseptic meningitis have been reported. The risk increases if you have an autoimmune disease called systemic lupus erythematosus or other diseases related to connective tissue.

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

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, Ibuprofen 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 are taking this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

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

In general, the 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.

Ibuprofen may affect the results of the following laboratory tests:

• Bleeding time (may be prolonged 1 day after treatment discontinuation).
• Blood glucose values (may decrease).
• Creatinine clearance (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Blood urea nitrogen, serum creatinine, and serum potassium (may increase).
• Liver function tests; increased transaminase levels.

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

The use of this product is not recommended in children with a body weight below 20 kg or under 6 years of age.

There is a risk of kidney failure in dehydrated children and adolescents.

Using Ibuprofeno B.Braun with other medicines

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

Ibuprofeno B. 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.
• Medicines that make the blood more fluid and prevent blood clots (anticoagulants such as acetylsalicylic acid, warfarin, or ticlopidine).
• Medicines used to treat heart failure (cardiac glycosides such as digoxin), epilepsy (phenytoin), or depression (lithium) may increase their blood levels when taken simultaneously with ibuprofen.
• The simultaneous administration of a medicine used to treat certain types of cancer or rheumatic diseases (methotrexate) and ibuprofen (within 24 hours) may increase methotrexate blood levels and toxicity.
• A medicine used to interrupt pregnancy (mifepristone).
• A class of drugs used as antidepressants (SSRIs [selective serotonin reuptake inhibitors] such as fluoxetine) 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 treat inflammation (corticosteroids such as hydrocortisone), as they increase the risk of gastrointestinal ulcers and bleeding.
• Medicines used to urinate (diuretics 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.
• Medicines used to prevent organ transplant rejection (cyclosporine and tacrolimus) may increase the risk of kidney damage.
• Medicines used for diabetes (sulfonylureas such as glibenclamide). When these medicines are used together, blood glucose levels should be monitored.
• Antibiotics belonging to the quinolone group, such as ciprofloxacin, due to the increased risk of epileptic seizures (convulsions).
• Medicines used to treat fungal infections (CYP2C9 inhibitors, such as voriconazole, fluconazole) may increase ibuprofen blood levels.
• A medicine used to treat HIV infection (zidovudine), due to the increased risk of blood accumulation in the joints and the appearance of hematomas.
• Chronic alcohol consumption may increase the risk of significant stomach and intestinal side effects, including bleeding.
• A type of antibiotic (aminoglycosides). NSAIDs may decrease the excretion of aminoglycosides and increase toxicity.
• 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 receiving ibuprofen with other medicines.

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 medicine.

Pregnancy

If you are pregnant, you will receive ibuprofen only if your doctor considers it absolutely necessary. You should not be given this medicine 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 tendency and that of your baby to bleed and delay or prolong delivery more than expected.

You should not receive ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time.

Treatment with 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 cause 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 checks.

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 higher doses are used or for longer periods, your doctor may recommend that you stop breastfeeding.

Fertility

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

Driving and Using Machines

Short-term or acute treatment does not require special precautions. However, during prolonged treatment, side effects such as fatigue and dizziness may occur, which can affect the ability to drive or use machines, especially when combined with alcohol.

Ibuprofeno B.Braun contains sodium

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

3. How Ibuprofeno B. Braun is administered

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

The dose will be adjusted individually by your doctor based on your body weight and general condition.

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

Children weighing 20 kg - 29 kg (6-9 years): 200 mg of ibuprofen up to 3 times a day, not 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, not 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, not exceeding a maximum daily dose of 1,200 mg.

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

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

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a 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.

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

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

Method of Administration

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 given more Ibuprofeno B.Braun than you should

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

If you have received more ibuprofen than you should or if a child has received this medicine by accident, always contact a doctor or the nearest hospital for advice on the risk and measures to be taken.

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

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

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

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

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 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 taking this medicine and contact a doctor as soon as possible.

The adverse effects that have been observed most frequently affect the stomach and intestine. Peptic ulcers (digestive or intestinal ulcers), holes in the stomach or intestinal wall (perforation), or bleeding in the stomach or intestines, sometimes fatal, may occur. Indigestion, tarry stools, vomiting blood, inflammation of the oral mucosa accompanied by ulceration (ulcerative stomatitis), exacerbation of large intestine inflammation (colitis), and Crohn's disease have been reported. Gastritis has been observed less frequently. It is noteworthy that the risk of gastrointestinal bleeding depends on the dose interval and treatment duration.

Cases of fluid accumulation in tissues (edema), 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 severe 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 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 may be preceded by fever and pseudo-flu symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, scaly, and reddened skin rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Very rare cases of exacerbation of inflammation related to infections (e.g., development of a flesh-destroying disease called necrotizing fasciitis) concurrent with NSAID use have been described.

In exceptional cases, severe skin infections and soft tissue complications during chickenpox.

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

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

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

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

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

• Difficulty sleeping (insomnia), agitation, irritability, or fatigue, anxiety, and restlessness.
• Visual disturbances.
• Ringing in the ears (tinnitus).
• Reduced urine production and edema formation, especially in patients with arterial hypertension or renal insufficiency, symptoms due to kidney damage (nephrotic syndrome) and interstitial nephritis, which may be accompanied by acute renal failure.
• Urticaria, itching, purpura (including allergic purpura), and skin rash.
• Allergic reactions, accompanied by skin rash and itching, as well as asthma attacks (possibly accompanied by a drop in blood pressure).

Rare adverse effects (may affect up to 1 in 1,000 people):

• Reversible double vision (toxic amblyopia).
• Hearing disorders.
• Narrowing of the esophagus (of the throat blood vessels), complications of diverticula in the large intestine, and non-specific hemorrhagic colitis characterized by cramps and intense diarrhea. In the case of stomach or intestinal bleeding, these can cause anemia.
• Kidney tissue damage (papillary necrosis), especially with prolonged treatment, and increased serum uric acid concentration in blood.
• Yellowing of the skin or the whites 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 adverse effects (may affect up to 1 in 10,000 people):

• Disorders of blood cell formation (anemia, leukopenia, thrombocytopenia, pancytopenia, and agranulocytosis). The first symptoms are fever, sore throat, superficial oral ulcers, pseudo-flu symptoms, acute fatigue, nosebleeds, and skin bleeding.
• Rapid heartbeat (palpitations), heart failure, and myocardial infarction.
• Arterial hypertension.
• Aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever, or confusion). Patients with autoimmune disorders (systemic lupus erythematosus and mixed conjunctivitis) seem to have a greater predisposition.
• Inflammation of the esophagus or pancreas and narrowing of the intestine.
• Light sensitivity and allergic vasculitis.
• Asthma, difficulty breathing (bronchospasm), shortness of breath, and wheezing.
• An autoimmune disease called systemic lupus erythematosus, severe allergic reaction (facial edema, tongue swelling, throat swelling, accompanied by constriction of the airways, difficult breathing, palpitations, hypotension, and potentially fatal shock).

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

• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• Liver failure.
• Reactions at the injection site, such as swelling, hematoma, or bleeding.
• A severe skin reaction known as DRESS syndrome (from 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).

Widespread, red, scaly rash with bumps under the skin and blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno B. Braun if you experience these symptoms and seek medical attention immediately. See also section 2.

Reporting 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 Ibuprofeno B. Braun

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

This medicine does not require special storage conditions.

The product should be used immediately after opening. Do not use this medicine if you notice particles.

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.

6. Package Contents and Additional Information

Composition of Ibuprofeno B. Braun

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

Appearance of Ibuprofeno B. Braun and Package Contents

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

The solution is presented in a primary packaging of 50 ml LDPE with Twincap, with 10 and 20 vials of 50 ml.

Only certain 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.

Local Representative

• Braun Medical, S.A.

Crta. Terrasa, 121

Rubí

08191 Barcelona (Spain)

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

Date of the 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) www.aemps.gob.es