Ibuprofen b. braun

Package leaflet: Information for the patient

Ibuprofen B. Braun, 200 mg, infusion solution
ibuprofen
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or nurse.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents of the leaflet

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

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

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is used in 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 short-term symptomatic treatment of fever, in situations where intravenous administration is clinically justified due to the inability to use other routes of administration.

2. Important information before using Ibuprofen B. Braun

When must Ibuprofen B. Braun not be used:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever previously experienced breathlessness, asthma, skin rash, nasal congestion or facial swelling after taking ibuprofen, acetylsalicylic acid (aspirin), or other similar pain-relieving medicines (non-steroidal anti-inflammatory drugs, NSAIDs);
• if the patient has a condition that predisposes to bleeding or has active bleeding;
• if the patient currently has or has had in the past two or more episodes of stomach ulcer or gastrointestinal bleeding;
• if the patient has ever previously experienced gastrointestinal bleeding or perforation of the stomach or intestines while taking NSAIDs;
• if the patient has bleeding within the brain or any other active bleeding;
• if the patient has severe kidney, liver, or heart disease;
• if the patient is severely dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake);
• if the patient is in the third trimester of pregnancy (last three months).

Warnings and precautions
Before starting treatment with Ibuprofen B. Braun, discuss this with your doctor or nurse.
Taking anti-inflammatory and pain-relieving 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
Severe skin reactions have been reported, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP), associated with the use of ibuprofen. If the patient notices any symptoms related to these severe skin reactions described in section 4, they should stop taking Ibuprofen B. Braun immediately and seek medical help without delay.

Allergic reactions to ibuprofen have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. If any of these symptoms occur, treatment with Ibuprofen B. Braun should be stopped immediately and the patient should contact a doctor or emergency services without delay.

Before using Ibuprofen B. Braun, the patient should discuss treatment with a doctor if:

• the patient has heart conditions such as heart failure, chest pain (angina), a history of heart attack, coronary artery bypass surgery, poor blood circulation in the legs due to narrowed or blocked arteries (peripheral arterial disease), or has had any stroke (including mini-stroke or transient ischaemic attack - TIA);
• the patient has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or is a smoker;
• the patient has recently undergone major surgery;
• the patient has ever had a stomach or duodenal ulcer, gastrointestinal bleeding, or perforation of the stomach or duodenum. In such cases, the doctor may consider prescribing a stomach-protecting medicine;
• the patient has asthma or other respiratory disorders;
• the patient is being treated for an infection – see section "Management in case of infections";
• the patient has kidney or liver disease – in such cases, the doctor may carry out regular monitoring tests. The doctor will inform the patient about the frequency of these tests;
• the patient is dehydrated, e.g. due to diarrhoea; in this case, the patient should drink plenty of fluids and contact a doctor promptly, as ibuprofen may cause kidney failure due to dehydration;
• the patient has Crohn's disease or ulcerative colitis – because ibuprofen may worsen these conditions;
• the patient notices any skin injury, swelling, or redness, or develops breathing difficulties (dyspnoea), the medicine should be stopped immediately and the patient should contact a doctor or nurse;
• the patient has chickenpox – as complications may occur with use of this medicine;
• the patient has a diagnosed inherited metabolic disorder of porphyrin (e.g. acute intermittent porphyria);
• the patient consumes alcohol around the same time as taking this medicine; this may increase the risk of adverse effects in the stomach, intestines, and nervous system;
• the patient has hay fever, nasal polyps, or chronic respiratory diseases with obstructive breathing disorders – as these patients have an increased risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), sudden swelling (angioedema), or skin rash.

Several cases of aseptic meningitis have been reported during treatment with this medicine. The risk of this complication is higher in patients with autoimmune disease such as systemic lupus erythematosus and similar connective tissue disorders.
Blurred or limited vision, visual field defects, and disturbances in colour vision have been reported with oral use of ibuprofen.
Concomitant use of this medicine with other NSAIDs, including selective COX-2 inhibitors, should be avoided.

Management in case of infections
Ibuprofen may mask symptoms of infection such as fever and pain. Therefore, its use may delay appropriate treatment of infections, potentially increasing the risk of complications. This has been observed in patients with bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is using this medicine during an infection and symptoms persist or worsen, medical advice should be sought immediately.

Adverse effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Generally, habitual use of multiple types of painkillers may lead to permanent, severe kidney damage.
Long-term use of painkillers may cause headache that should not be treated with increased doses of these medicines.

Ibuprofen may affect the following laboratory tests:

• bleeding time (may be prolonged for up to 24 hours after stopping the medicine);
• blood glucose levels (may decrease);
• creatinine clearance (may decrease);
• haematocrit or haemoglobin concentration (may decrease);
• blood urea nitrogen, serum creatinine and potassium levels (may increase);
• increased activity of liver aminotransferases. Patients should inform their doctor if they are scheduled for laboratory tests and are currently or recently used ibuprofen.

This medicine is not recommended for use in children weighing less than 20 kg or under 6 years of age.
In dehydrated children and adolescents, there is a risk of impaired kidney function.

Ibuprofen B. Braun and other medicines
Inform your doctor or nurse about all medicines currently or recently taken, as well as any medicines you plan to take.
Some medicines may affect the action of Ibuprofen B. Braun, and this medicine may also affect the action of other medicines. For example:

• other NSAIDs, including COX-2 inhibitors (e.g. celecoxib), may increase the risk of gastrointestinal ulcers and bleeding due to additive effects;
• anticoagulant or antiplatelet medicines (blood thinners such as acetylsalicylic acid, warfarin, ticlopidine);
• medicines used to treat heart failure (cardiac glycosides, e.g. digoxin), epilepsy (phenytoin), or depression (lithium salts) may have increased blood concentrations when taken with ibuprofen;
• methotrexate, a medicine used in the treatment of certain cancers and rheumatic diseases, may have increased blood concentration and toxicity when taken concurrently with ibuprofen (within 24 hours);
• mifepristone, a medicine used to terminate pregnancy;
• antidepressants of the SSRI class, e.g. fluoxetine, which may also increase the risk of gastrointestinal bleeding;
• antihypertensive medicines (ACE inhibitors, e.g. captopril; beta-blockers, e.g. atenolol; angiotensin II receptor antagonists, e.g. losartan);
• corticosteroids (e.g. hydrocortisone), used in inflammatory conditions, as they increase the risk of gastrointestinal ulcers and bleeding;
• diuretics (e.g. bendroflumethiazide), as NSAIDs may reduce their effectiveness and increase the risk of kidney damage (concomitant use of potassium-sparing diuretics with ibuprofen may lead to elevated blood potassium levels);
• medicines containing probenecid or sulfinpyrazone, which may slow down the elimination of ibuprofen from the body;
• immunosuppressants used to prevent transplant rejection (cyclosporine and tacrolimus), which may increase the risk of kidney damage;
• antidiabetic medicines (sulfonylureas, e.g. glibenclamide). Blood glucose levels should be monitored when these medicines are used together;
• quinolone antibiotics, e.g. ciprofloxacin – due to increased risk of seizures;
• antifungal medicines (CYP2C9 inhibitors, e.g. voriconazole, fluconazole), which may increase ibuprofen blood levels;
• medicines used in HIV infection (zidovudine) – due to increased risk of joint haemorrhages and bruising;
• chronic alcohol consumption, which may increase the risk of significant gastrointestinal bleeding;
• aminoglycoside antibiotics – NSAIDs may impair the excretion of aminoglycosides and increase their toxicity;
• Ginkgo biloba (a herbal medicine commonly used in dementia), which may increase the risk of bleeding.

Other medicines may also interact with or be affected by ibuprofen treatment. Therefore, always consult a doctor or nurse before combining ibuprofen with other medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or nurse before using this medicine.

Pregnancy
Ibuprofen should only be used during pregnancy if the doctor considers it absolutely necessary. This medicine must not be given to women during the last three months of pregnancy. It may cause kidney and heart problems in the unborn child. It may also increase the tendency to bleeding in both mother and child and may delay or prolong labour.

Ibuprofen is not recommended during the first six months of pregnancy unless the doctor considers its use absolutely necessary. If ibuprofen is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.

Intravenous ibuprofen treatment should not last longer than 3 days. If ibuprofen is administered beyond the 20th week of pregnancy for more than a few days, it may cause impaired kidney function in the unborn child, leading to reduced amniotic fluid volume (oligohydramnios). It may also cause constriction of a blood vessel (ductus arteriosus) in the baby's heart. If ibuprofen treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
This medicine passes into breast milk but may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration. However, if higher doses or long-term treatment are required, the doctor may advise discontinuing breastfeeding.

Fertility
Ibuprofen may impair fertility. If the patient is planning to conceive or has difficulty conceiving, she should inform her doctor.

Driving and operating machinery
When this medicine is used occasionally or for a short duration, no special precautions are required. However, during prolonged treatment, adverse effects such as fatigue and dizziness may impair the ability to drive or operate machinery. This is particularly important when alcohol is consumed concurrently.

Ibuprofen B. Braun contains sodium. This medicine contains 179 mg of sodium (the main component of table salt) per 50 ml of solution. This corresponds to 9% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Ibuprofen B. Braun

This medicine may only be prescribed by a doctor and must be administered solely by a doctor or nurse in a setting where appropriate equipment is available.
The dose will be individually determined by the doctor based on the patient's body weight and overall condition.

Dosage
In children and adolescents, ibuprofen is dosed according to 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 of age): 200 mg ibuprofen up to 3 times daily; the maximum daily dose of 600 mg must not be exceeded.
• Children weighing 30 kg – 39 kg (10–11 years of age): 200 mg ibuprofen up to 4 times daily; the maximum daily dose of 800 mg must not be exceeded.
• Adolescents weighing ≥ 40 kg (12–17 years of age): 200 mg to 400 mg ibuprofen, up to 3 times daily; the maximum daily dose of 1200 mg must not be exceeded.

This medicine is not recommended for use in children weighing less than 20 kg or under 6 years of age.
The interval between doses should be determined according to symptoms and the maximum daily dose. The interval between doses should not be less than 6 hours. The recommended maximum daily dose must not be exceeded.

The doctor will administer the lowest effective dose for the shortest duration necessary to relieve symptoms. If the patient has a concurrent infection, medical advice should be sought immediately if symptoms (such as fever and pain) persist or worsen. Additionally, the doctor will ensure that the patient receives adequate fluid intake to minimize the risk of renal adverse effects.

Use of this medicine should be limited to situations where oral administration is not possible. Patients should switch to oral therapy as soon as possible.

This medicine will be administered for the shortest possible duration. The medicine should not be administered for longer than 3 days.

Method of administration
Intravenous administration. The solution should be given as a 30-minute intravenous infusion.
The solution should be inspected visually before use. Do not use if particulate matter is observed.

Overdose of Ibuprofen B. Braun
Because dosing is under the supervision of a doctor or nurse, overdose with this solution is unlikely.
However, if a patient receives a higher dose than recommended or if the medicine is accidentally administered to children, contact a doctor or the nearest hospital immediately for advice regarding potential risks and necessary measures.

Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus (ringing in the ears), confusion, ataxia (impaired coordination), and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may occur.

There may also be a drop in blood pressure, bluish discoloration of the skin or mucous membranes (cyanosis), gastrointestinal bleeding, as well as impaired liver and kidney function.

If you have any further doubts about the use of this medicine, please consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions can be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
The patient may experience one or more of the adverse reactions identified so far, typical for NSAIDs (see below).
If any of the adverse reactions listed below occur, stop taking this medicine and contact a doctor as soon as possible.

The most commonly observed adverse events involve the stomach and intestines. Gastrointestinal ulcers (stomach or intestinal ulcers), perforation (tearing) of the stomach or intestinal wall, or gastrointestinal bleeding may occur, sometimes with fatal outcome.
Dyspepsia, black tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis, and Crohn's disease have been reported. Gastritis has been observed less frequently. The risk of gastrointestinal bleeding is particularly dependent on the dose and duration of treatment.

Fluid retention (oedema), hypertension, and heart failure have been reported with the use of NSAIDs. The use of drugs such as ibuprofen may be associated with a slightly increased risk of myocardial infarction or stroke.

Very rarely, severe allergic reactions (including infusion site reactions, anaphylactic shock), serious skin reactions, alopecia (hair loss), photosensitivity skin reactions, and allergic vasculitis have been reported.

Stop taking ibuprofen and seek immediate medical help if you notice any of the following symptoms:

• Reddish, non-elevated, target-shaped or round spots on the trunk, often with blisters in the centre, skin peeling, and ulceration of the mouth, throat, nose, genital organs, or eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome);
• Widespread red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

Exacerbation of inflammatory conditions caused by infections (e.g. development of a connective tissue disease called necrotizing fasciitis) has been reported very rarely with NSAID use.
In exceptional cases, severe skin infections and complications in the subcutaneous tissue may occur during chickenpox.

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

• Fatigue or insomnia, headache, dizziness
• Heartburn, abdominal pain, nausea, vomiting, bloating, diarrhoea, constipation, and slight gastrointestinal bleeding, which may exceptionally lead to anaemia

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

• Dizziness
• Skin rash
• Pain and burning sensation at the site of administration
• Gastrointestinal ulcers, which may lead to bleeding and perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease

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

• Sleep disorders (insomnia), psychomotor agitation, irritability or fatigue, anxiety and restlessness
• Visual disturbances
• Sensation of ringing or buzzing in the ears (tinnitus)
• Reduced urine output and oedema, particularly in patients with hypertension or kidney disease, signs of kidney damage (nephrotic syndrome), interstitial nephritis, which may be accompanied by acute renal failure
• Urticaria, itching, purpura (including allergic purpura), skin rash
• Allergic reactions with skin changes and itching, as well as asthma attacks (which may be accompanied by a drop in blood pressure)

Rare adverse reactions (may affect up to 1 in 1000 people):

• Reversible double vision (toxic amblyopia)
• Hearing disturbances
• Oesophageal stricture, complications of colonic diverticulosis, non-specific haemorrhagic colitis, characterised by severe cramps and diarrhoea. Anaemia may develop if gastrointestinal bleeding occurs.
• Kidney tissue damage (papillary necrosis), particularly with long-term use, increased serum uric acid levels
• Yellowing of the skin or sclera (whites of the eyes), liver dysfunction, liver damage, particularly with long-term use, acute hepatitis
• Psychotic reactions, nervousness, irritability, confusion or disorientation, and depression
• Neck stiffness

Very rare adverse reactions (may affect up to 1 in 10,000 people):

• Blood disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nosebleeds, and subcutaneous haemorrhages
• Rapid heartbeat (palpitations), heart failure, myocardial infarction
• Hypertension
• Aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever, or confusion). Patients with autoimmune diseases (SLE, mixed connective tissue disease) appear to be particularly predisposed.
• Oesophagitis or pancreatitis, intestinal stricture
• Asthma, difficulty breathing (bronchospasm), shortness of breath, and wheezing
• Autoimmune disease called systemic lupus erythematosus, severe allergic reactions (facial swelling, tongue swelling, swelling of the inner part of the larynx with accompanying narrowing of the airways, shortness of breath, rapid heartbeat, drop in blood pressure, and life-threatening shock)

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome
• Liver failure
• Injection site reactions, e.g. swelling, bruising, or bleeding
• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell)
• Red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, discontinue use of Ibuprofen B. Braun and seek immediate medical help. See also section 2.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ibuprofen B. Braun

Keep the medicine out of the sight and reach of children.
There are no special requirements for storage of this medicine.
The medicine should be used immediately after opening. Do not use this medicine if solid particles are visible.
Do not use this medicine after the expiry date stated on the immediate and outer packaging following "EXP".
The batch number is indicated on the immediate and outer packaging following "Lot".
The expiry date refers to the last day of the stated month.

6. Package contents and other information

What Ibuprofen B. Braun contains

• The active substance is ibuprofen. 1 ml of the medicinal product contains 4 mg of ibuprofen. Each 50 ml vial contains 200 mg of ibuprofen.
• The other components are: arginine, sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

What Ibuprofen B. Braun looks like and contents of the pack
A clear, colourless to pale yellow infusion solution free from visible particles.
The solution is contained in LDPE bottles with a capacity of 50 ml, closed with a Twincap-type closure, in packs of 10 and 20 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation 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 further information, please contact the local representative of the Marketing Authorisation Holder.
This medicinal product is authorised for marketing in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: