Ibuprofen B. Braun pediatric 200 mg solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibuprofen B.Braun pediatric 200mg infusion solution

Read this entire leaflet carefully before you start receiving this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or nurse.

• If you experience any adverse reactions, consult your doctor or nurse, even if they are 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 you are given Ibuprofen B. Braun
3. How Ibuprofen B. Braun is administered
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 known as non-steroidal anti-inflammatory drugs or NSAIDs.

This medicine is indicated in adolescents and children with a body weight of at least 20 kg and aged 6 years and 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 due to the unavailability of other routes of administration.

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

Do not receive 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 had breathing problems, asthma, skin rash, runny or itchy nose, or facial swelling after taking ibuprofen, acetylsalicylic acid (aspirin), or other similar painkillers (NSAIDs);
• if you have a condition that increases your tendency to bleed or if you have active bleeding;
• if you have an active stomach ulcer or gastrointestinal bleeding, or a history of two or more episodes of stomach ulcer or bleeding;
• if you have ever had gastrointestinal bleeding or perforation while taking NSAIDs;
• if you have cerebral haemorrhage (cerebral haemorrhage) or any other active bleeding;
• if you have severe kidney, liver, or heart disorders;
• if you have severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake);
• if you are in the last three months of pregnancy.

Warnings and precautions

Talk to your doctor or nurse before you start using this medicine.

Painkillers and anti-inflammatory medicines such as ibuprofen may be associated with a small increased 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 treatment. Stop taking Ibuprofen 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 Ibuprofen B. Braun immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Before you are given Ibuprofen B. Braun, talk to your doctor about treatment if:

• You have heart problems, such as heart failure, chest pain (angina pectoris), or have had a myocardial infarction, undergone surgical revascularization, have poor circulation in the legs or feet due to narrowed or blocked arteries (peripheral arterial disease), or have had any type of stroke (including transient ischaemic attack or TIA).
• You have hypertension, diabetes, or hypercholesterolaemia, have a family history of heart disease or stroke, or are a smoker.
• You have recently undergone major surgery.
• You have had or developed an ulcer, bleeding, or perforation of the stomach or duodenum. In such cases, your doctor may decide to prescribe a stomach-protecting agent.
• You have asthma or another respiratory disorder.
• You have an infection; see the section "Infections" below.
• You have kidney or liver disease, or have been using ibuprofen for a long time, your doctor may need to perform periodic check-ups. Your doctor will advise you on how often these checks should be done.
• You are dehydrated, for example due to diarrhoea; drink plenty of fluids and contact your doctor immediately, as ibuprofen could cause renal failure due to dehydration.
• You have Crohn's disease or ulcerative colitis, as ibuprofen may worsen these conditions.
• You experience any skin injury, swelling, redness, or breathing problems (suffocation), stop treatment immediately and contact your doctor or nurse.
• You have chickenpox, as complications may occur.
• You have a congenital porphyrin metabolism disorder (e.g., acute intermittent porphyria).
• You consume alcohol shortly before or after receiving this medicine, as adverse effects related to the stomach, intestine, and nervous system may increase.
• You have fever, nasal polyps, or chronic obstructive respiratory disorders, as you have a higher risk of allergic reactions, which may present as asthma attacks (also known as analgesic-induced asthma), rapid swelling (Quincke's angioneurotic oedema), or rash.

Cases of aseptic meningitis have been reported with the use of this medicine. The risk increases if you have an autoimmune disease called systemic lupus erythematosus or other connective tissue disorders.

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

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

Infections

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

Adverse reactions can be minimised by using the lowest effective dose for the shortest time needed to control symptoms.

In general, the use of various types of painkillers may cause serious, permanent kidney problems.

Prolonged use of painkillers may cause headaches, which should not be treated by increasing the dose of the medicine.

Ibuprofen may alter the results of the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after treatment ends).
• Blood glucose values (may decrease).
• Creatinine clearance (may decrease).
• Haematocrit or haemoglobin (may decrease).
• Blood urea nitrogen, serum creatinine, and serum potassium (may increase).
• Liver function tests; increased concentrations of transaminases.

If you are undergoing clinical laboratory tests, inform your doctor if you are taking ibuprofen or have taken it recently.

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

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

Use of Ibuprofen B. Braun with other medicines

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

Ibuprofen B. Braun may affect or be affected by certain 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 flow more freely 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 have increased blood concentrations when taken simultaneously with ibuprofen.
• Concomitant administration of a medicine used to treat certain malignant tumours or rheumatic diseases (methotrexate) and ibuprofen (within 24 hours) may increase methotrexate blood concentrations and its toxicity.
• A medicine used to terminate pregnancy (mifepristone).
• A class of drugs used as antidepressants (SSRIs [selective serotonin reuptake inhibitors] such as fluoxetine) may also increase the risk of gastrointestinal and intestinal bleeding.
• Medicines that lower high blood pressure (angiotensin-converting enzyme inhibitors [ACE inhibitors] such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Medicines used to treat inflammation (corticosteroids such as hydrocortisone), as they increase the risk of gastrointestinal and intestinal ulcers or bleeding.
• Medicines used to increase urine production (diuretics such as bendroflumethiazide), as NSAIDs may reduce the effect of these medicines, increasing the risk of kidney disorders (using potassium-sparing diuretics with ibuprofen may cause increased 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 an increased risk of epileptic seizures (convulsions).
• Medicines used to treat fungal infections (CYP2C9 inhibitors such as voriconazole, fluconazole) may increase ibuprofen blood concentrations.
• A medicine used to treat HIV infection (zidovudine), due to an increased risk of blood accumulation in the joints and bruising.
• Chronic alcohol consumption may increase the risk of significant gastrointestinal side effects, including bleeding.
• A type of antibiotic (aminoglycosides). NSAIDs may decrease 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 affect or be affected by ibuprofen treatment. 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 are planning to become pregnant, consult your doctor or nurse before using this medicine.

Pregnancy

If you are pregnant, you will only be given ibuprofen if your doctor considers it absolutely necessary. This medicine must not be given during the last 3 months of pregnancy, as it may harm the foetus or cause problems during delivery. It may cause kidney and heart problems in your foetus. It may affect your tendency and that of your baby to bleed and may delay or prolong labour 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 become pregnant, you should take the lowest 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 foetus 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 treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding

This medicine is excreted in breast milk, but may be used during breastfeeding, provided 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 make it more difficult to conceive. If you are planning to become pregnant or have difficulty conceiving, inform your doctor.

Driving and using machines

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

Ibuprofen B. Braun contains sodium

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

3. How Ibuprofen B. Braun is administered

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

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

In children and adolescents, the dose of ibuprofen depends on body weight or age, from 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 ibuprofen up to 3 times daily, not exceeding a maximum daily dose of 600 mg.

Children weighing 30 kg - 39 kg (10-11 years): 200 mg ibuprofen up to 4 times daily, not exceeding a maximum daily dose of 800 mg.

Adolescents weighing 40 kg or more (12-17 years): 200 mg to 400 mg ibuprofen up to 3 times daily, not exceeding a maximum daily dose of 1,200 mg.

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

The respective dosing interval should be consistent with symptomatology and the maximum daily dose. The interval between doses must not be less than 6 hours. The recommended maximum daily dose must never 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 promptly if symptoms (such as fever and pain) persist or worsen (see section 2). Your doctor will also ensure you have taken in sufficient fluids to minimize the risk of kidney-related adverse effects.

This medicine should only be administered if oral treatment is not possible. You should switch to oral treatment as soon as possible.

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

Method of administration

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

Inspect the solution before use. Discard if any particles are visible.

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

As 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 regarding risk and necessary measures.

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

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus (ringing in the ears), confusion, ataxia (movement coordination disorders), and involuntary eye movements. 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 have been reported.

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.

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 everyone experiences them.

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to treat symptoms. You may experience one or more of the known adverse effects of NSAIDs (see information below). If you experience any of these adverse effects, you must stop taking this medicine and contact a doctor immediately.

The adverse effects observed most frequently affect the stomach and intestine. Peptic ulcers (gastric or intestinal ulcers), 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 mouth lining 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 and duration of treatment.

Cases of fluid accumulation in tissues (edema), hypertension, and heart failure related to NSAID treatment 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 severe allergic reactions (including reactions at the infusion site and anaphylactic shock) and serious skin adverse effects, alopecia (hair loss), photosensitivity (skin becomes sensitive to light), and allergic vasculitis (inflammation of a blood vessel) have been reported.

Stop taking ibuprofen and seek medical attention immediately if you notice any of the following symptoms:

• Circular or target-shaped, reddish, non-elevated skin rashes 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).
• Generalized 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 infections-related inflammation (e.g., development of a flesh-eating disease called necrotizing fasciitis) have also been reported, concurrent with the use of NSAIDs.

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):

• Fatigue or insomnia, headache, and dizziness.
• Stomach burning, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding, which 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 site of administration.
• Gastric or duodenal ulcer, which 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 falling asleep (insomnia), restlessness, irritability or fatigue, anxiety, and agitation.
• Visual disturbances.
• Ringing in the ears (tinnitus).
• Reduced urine output and edema formation, especially in patients with high blood pressure or kidney failure, symptoms due to kidney damage (nephrotic syndrome), and interstitial nephritis, which could be accompanied by acute kidney failure.
• Urticaria, pruritus, purpura (including allergic purpura), and skin rash.
• Allergic reactions, accompanied by skin rash and pruritus, as well as asthma attacks (possibly accompanied by a drop in blood pressure).

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

• 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), especially with prolonged treatment, and increased serum concentration of uric acid in blood.
• Yellowing of the skin or whites of the eyes, liver dysfunction, liver damage (especially with prolonged treatment), and acute inflammation of the liver (hepatitis).
• Psychotic disorders, 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 narrowing of the intestine.
• Photosensitivity and 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.
• Injection site reactions such as swelling, bruising, or bleeding.
• A serious skin reaction known as DRESS syndrome (from its

English acronym). Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, 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 Ibuprofen B. Braun if you experience these symptoms and seek immediate medical attention. See also section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, 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.

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

6. Contents of the container and other information

Composition of Ibuprofen B.Braun

• The active substance is ibuprofen. Each ml of solution contains 4 mg of ibuprofen. Each 50 ml vial 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 injections.

Appearance of Ibuprofen B.Braun and contents of the container

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

The solution is supplied in a primary packaging of 50 ml LDPE bottles with Twincap, available in packs containing 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 responsible

• Braun Medical, S.A.

Ctra. Terrasa, 121

Rubí

08191 Barcelona (Spain)

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder.

Local representative

• Braun Medical, S.A.

Crta. Terrasa, 121

Rubí

08191 Barcelona (Spain)

This medicinal product 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es